US20110093069A1 - Implants and methdos for manufacturing same - Google Patents

Implants and methdos for manufacturing same Download PDF

Info

Publication number
US20110093069A1
US20110093069A1 US12/897,498 US89749810A US2011093069A1 US 20110093069 A1 US20110093069 A1 US 20110093069A1 US 89749810 A US89749810 A US 89749810A US 2011093069 A1 US2011093069 A1 US 2011093069A1
Authority
US
United States
Prior art keywords
composition
particles
member
component
applying
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
US12/897,498
Inventor
Alexei Goraltchouk
Dennis E. VanEpps
Thomas E. Powell
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Allergan Inc
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 to US25233009P priority Critical
Application filed by Allergan Inc filed Critical Allergan Inc
Priority to US12/897,498 priority patent/US20110093069A1/en
Assigned to ALLERGAN, INC. reassignment ALLERGAN, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: POWELL, THOMAS E., GORALTCHOUK, ALEXEI, VAN EPPS, DENNIS E.
Publication of US20110093069A1 publication Critical patent/US20110093069A1/en
Application status is Abandoned legal-status Critical

Links

Images

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B05SPRAYING OR ATOMISING IN GENERAL; APPLYING LIQUIDS OR OTHER FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05DPROCESSES FOR APPLYING LIQUIDS OR OTHER FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D3/00Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials
    • B05D3/10Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials by other chemical means
    • B05D3/107Post-treatment of applied coatings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/12Mammary prostheses and implants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/30Inorganic materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2400/00Materials characterised by their function or physical properties
    • A61L2400/18Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment

Abstract

Implantable prosthesis, components of prosthesis, and methods of making same are provided. The methods generally include the steps of providing an implant shell, applying a curable fluid composition to the shell to form a coating thereon and applying a particulate component to the composition. The composition is a mixture, for example, an emulsion, containing a silicone-based elastomer dispersion and droplets of a suspended leachable agent. After the elastomer is stabilized and cured, the particulate component and leachable agent are removed, resulting in an implantable member having a porous, open-cell surface texture designed to be effective in reducing incidence of capsular formation or contraction.

Description

  • This application claims priority to U.S. Provisional Patent Application No. 61/252,330, filed on Oct. 16, 2009, the entire disclosure of which is incorporated herein by this specific reference.
  • BACKGROUND
  • The present invention generally relates to soft tissue implants and more specifically relates to soft tissue implants designed to enhance fixation in the body and/or alter or reduce capsular formation.
  • Soft tissue implants, particularly mammary prostheses, are plagued by problems of capsular formation and contracture. Soon after an implant is placed into the body, an inflammatory response begins to deposit a fibrous capsule around the implant. In most cases, particularly for relatively large and smooth implants, the capsule is comprised of highly organized or aligned collagen fibers. As the capsule matures, certain events may trigger the differentiation of fibroblasts to a contractile phenotype (myofibroblasts). In this or similar scenarios, and if the collagen fibers are aligned, capsular contracture may ensue.
  • Capsular contracture can be debilitating to the patient because of discomfort or even pain caused thereby, can diminish the efficacy of the aesthetic results in both the look and feel of the implant, and can sometimes damage the implant itself. Problems with capsular formation and contracture occur in many implant types such as pacemakers, dura matter substitutes, implantable cardiac defibrillators, pacemaker leads, hernia repair meshes as well as breast and other esthetic implants.
  • It has been established in the literature that surface texturing of implants often helps to reduce the incidence of capsular contracture when compared to smooth surface implants. Furthermore there is increasing evidence regarding the ability of foam covered implants, for example, polyurethane foam coated implants, to reduce contracture rates. However, polyurethane foam coatings are biodegradable and lose their efficacy once the polyurethane degrades. Further, it can be appreciated that degradation of polyurethane foam into the body is undesirable and potentially unhealthy.
  • The present invention addresses at least some of these drawbacks of conventional implants.
  • SUMMARY OF THE INVENTION
  • The present invention provides implantable members and methods for manufacturing implantable members, for example, prostheses, for example, mammary prostheses, as well as components of prostheses, for example, elastomeric shells, which serve as components of mammary prostheses. The invention further provides coverings, for example, laminates for applying to surfaces of implantable devices. The implantable members have surfaces which may enhance fixation and/or alter or reduce capsular formation. In one aspect of the invention, the textured surfaces are defined by a network of interconnected pores and channels which encourages tissue ingrowth and discourages organization of the collagen capsule. Generally, the pores have, on average, more than two interconnections assuming that the average number of interconnections per pore does not vary significantly.
  • The method generally comprises the steps of providing an implantable member, for example an implant shell, for example, a conventional smooth silicone-based implant shell, and applying a curable fluid composition to the shell to form a coating thereon. In one embodiment, the composition comprises a silicone-based mixture including a solvent, and a pore-forming material, for example, a leachable agent, dispersed therein. The composition is allowed to stabilize on the shell, for example, by allowing some of the solvent to evaporate out of the composition or allowing a chemical reaction to occur inducing precipitation of the soluble components. Alternatively, stabilization can be achieved during crosslinking of polymerization of the silicone, precipitation of the silicone or pore-forming material of a combination of the above alone or in conjunction with solvent evaporation.
  • Next, a particulate component, hereinafter sometimes simply referred to as “particles” or a “particle coating”, is applied to the composition coating while the composition coating is less than entirely cured, or at least has a stickiness or tackiness capable of retaining the particulate coating.
  • In some embodiments, the steps of applying a curable fluid composition and applying a particle coating are then repeated, for example, one or more times, for example, three, five or even up to 20 times, until a final coating is applied. The final coating may be a particle coating or a composition coating.
  • After the final coating of particles or fluid composition is applied to the shell, the coated shell is then subjected to suitable curing conditions to solidify the composition with the particles embedded therein.
  • In one embodiment, the particulate coating itself is used to stabilize the coating composition, for example, by absorbing some or all of the solvent, increasing the rate of polymerization of crosslinking of the silicone, promoting precipitation of the silicone or porogen, or a combination of one or more of the above.
  • Once solidified, the leachable agent contained in the composition and the particles embedded therein are then removed from the coating thereby revealing a network of interconnected pores (the structure may include both relatively large pores and relatively smaller pores, for example, micropores) within the cured elastomer. The surface topography created by the processes described herein, when used as a part of an implant at the tissue/implant interface, may be highly effective in altering capsular formation so as to achieve a more preferred morphology, or in reducing or preventing capsular contracture, relative to conventional surface topographies.
  • Removal of the particles and leachable agent may be accomplished by any suitable means effective to remove these materials from the surrounding elastomer “matrix”, and create the desirable surface topography.
  • For example, the particles and/or leachable agent(s) may be extracted by exposing the coating to one or more suitable mediums capable of dissolving, extracting or otherwise removing the particles and/or leachable agent while leaving the cured elastomer matrix generally intact.
  • Generally, the particles, which are typically larger in size than the dispersed leachable agent, serve to create cavities or pores in the cured elastomer while the dispersed leachable agent serves to create microcavities or micropores which serve as interconnections between the pores. This network of interconnected pores and micropores facilitates tissue ingrowth, encourages better fixation of the implant in the patient, and discourages organization of the fibrous capsule, which may help reduce or prevent capsule formation and contraction.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • The present invention may be more clearly understood and the aspects and advantages thereof more clearly appreciated with reference to the following detailed description and accompanying drawings of which:
  • FIGS. 1A-1C represents suitable process steps in a method for manufacturing an elastomeric shell in accordance with an embodiment of the invention;
  • FIGS. 2-6 are cross-sectional views of components of the shell during various steps of the process for making the shell shown in FIGS. 1A-1C.
  • FIG. 7 is a simplified flow chart showing steps in a method for manufacturing an implant shell in accordance with an embodiment of the invention.
  • DETAILED DESCRIPTION
  • Accordingly, implantable composite members and methods for manufacturing such implantable composite members are provided.
  • In one aspect of the invention, the present invention provides an implantable composite member, hereinafter, typically referred to as an “implant”, having a surface that renders the implant effective in reducing the occurrence or severity of capsule formation when the implant is placed in the body. In a specific exemplary embodiment that will now be described, the implant is a fillable mammary prosthesis useful in breast reconstruction or breast augmentation. It should be appreciated, however, that the present invention is not limited to mammary prostheses, but is useful in many situations in which an implant is intended to be permanently or temporarily placed in the body and which capsule formation or contraction is to be avoided or impaired.
  • First, in a method of the invention, an implant member is provided. The implant member may be a fillable, elastomeric implant shell having a configuration of a breast prosthesis. Such shells are intended to be filled, typically, with saline or silicone gel before or after implantation in the breast.
  • Generally, manufacture of such shells is commonly accomplished by applying a liquid dispersion, for example, a silicone elastomer dispersion, to a mandrel having a desired form. The dispersion generally contains a silicone elastomer and a solvent. The silicone elastomer may be polydimethylsiloxane, polydiphenyl-siloxane or some combination of these two materials. Typical solvents include xylene, trichloromethane, heptane, hexane, and toluene.
  • The silicone dispersion forms an elastomeric coating on the mandrel. The coating is cured and the solvent evaporates therefrom. This procedure may be repeated a number of times in order to obtain an implant shell having a desired thickness. This shell may be used as base component for many of the implants of the present invention.
  • In accordance with one aspect of the invention, an implantable member having a desired surface topography is provided. The method comprises the steps of applying a curable fluid composition to a substrate, for example, a surface of an implant shell described above, applying a particulate material to the composition, and in some instances, repeating these steps to achieve layers, for example, alternating layers of composition and particulates. The composition includes a leachable component to be described elsewhere herein. The composition layers are allowed to stabilize between subsequent applications.
  • Once the layering steps are completed, the composition is subject to conditions to allow it to at least partially cure. Curing process steps will depend on the materials used. One or more process steps are performed to remove the particles of the particle layer(s) and the leachable component from the elastomer.
  • The resulting implant has an external surface at least a portion of which is an open-cell porous structure having a topography or porosity that affects capsule formation and/or adhesion of the implant when implanted in a patient.
  • The curable fluid composition may be in the form of an emulsion, dispersion, solution, suspension or mixture containing an elastomer component, a solvent component and a leachable component.
  • The elastomer component may be an uncured silicone polymer, for example, a silicone elastomer. For example, in some embodiments, the elastomer component is a room temperature vulcanizing (RTV) silicone elastomer. The elastomer component may be polydimethyl siloxane, polydiphenyl siloxane or a combination of these two. Possible silicone elastomer systems useful in the present invention include, but are not limited to, oxime, platinum or tin catalyst based systems. Alternatively, the elastomer component may be a non-silicone based material.
  • The solvent component may be any suitable solvent or solvent system, appropriate to the elastomer. Representative examples of solvents include chloroform, acetone, water (buffered saline), dimethyl sulfoxide (DMSO), propylene glycol methyl ether (PM), isopropyl alcohol (IPA), n-propyl alcohol, methanol, ethanol, tetrahydrofuran (THF), dimethylformamide (DMF), dimethyl acetamide (DMAC), N-Methylpyrrolidone (NMP), benzene, toluene, xylene, hexane, cyclohexane, heptane, octane, pentane, nonane, decane, decalin, ethyl acetate, butyl acetate, isobutyl acetate, isopropyl acetate, butanol, diacetone alcohol, benzyl alcohol, 2-butanone, cyclohexanone, dioxane, methylene chloride, carbon tetrachloride, tetrachloroethylene, tetrachloro ethane, chlorobenzene, 1,1,1-trichloroethane, formamide, hexafluoroisopropanol, 1,1,1-trifluoroethanol, and hexamethyl phosphoramide and combinations thereof. In one embodiment, the solvent is selected from the group of solvents consisting of xylene, pentane, hexane, heptane, dichloromethane, trichloromethane, toluene, dimethyl sulfoxide, dioxane, NMP, DMAC, and combinations thereof. The solvent component may comprise one or more different solvents. For example, the solvent component may comprise between one and twenty different solvents. Generally, the solvent may comprise any suitable protic or aprotic solvent, mixture or solution thereof.
  • The leachable component is a leachable material/agent in the form of any suitable solid particulates, semi-solids, composites, gels, for example, hydrogels, liquid droplets, etc. The leachable agent may comprise any suitable polymer, ceramic, metal, composite or combination thereof that can be dissolved or otherwise removed by suitable means from the cured formulation. In some embodiments, the composition comprises one or more different leachable agents. For example, the composition may comprise between one and twenty different types of leachable agents.
  • The elastomer component can be present in the composition in a range of about 1% to about 99% of volume as part of the total dissolved solids and the leachable agent can be in the range of about 1% to about 99% of volume as part of the total dissolved solids. In a specific embodiment of the invention, the composition includes up to 96% leachable phase. In some embodiments, the elastomer component is present in the composition in a range of about 5% to about 80% and the leachable agent is present in the composition in a range of about 20% to about 95% of total dissolved solids. Generally, the total dissolved solids in the composition can range from about 1% to about 50% by weight in solution.
  • The ratio of leachable phase to matrix phase in the composition generally affects the porosity of the final cured composition. For example, a greater percentage of leachable component in the composition will produce a composition layer having greater interconnections between pores.
  • In an exemplary embodiment, the curable fluid composition is in the form of an emulsion, and the leachable agent is present in a concentration of up to about 50% concentration by volume of the emulsion. In some embodiments, the composition comprises a microphase separation containing an elastomer matrix phase and droplets of leachable material in suspended phase, the droplets being about 0.01 μm to about 10,000 μm in diameter, for example, about 1 μm to about 5,000 μm in diameter, for example, about 50 μm to about 400 μm in diameter. After the leachable agent has been leached from the elastomer, voids left behind by the leachable agent will serve as interconnections between voids left by the removed particles.
  • The leachable agent may be, for example, any material that can be dispersed through the elastomer dispersion (elastomer component/solvent system) and can be removed therefrom once the elastomer component is cured. The leachable agent may be an agent that can be removed from the cured elastomer, for example, by leaching, evaporation, sublimation, dissolution, etc. In an exemplary embodiment, the leachable agent is a water soluble material dispersed throughout the elastomer dispersion.
  • Typical leachable agent in accordance with the invention may comprise, for example, polyethylene glycol (PEG) (also known as polyoxyethylene), polyalkylene oxides including polyethylene oxide and polyethylene oxide/polypropylene oxide copolymers (also known as poloxamers), polyhydroxyethylmethacrylate, polyvinylpyrrolidone, polyacrylamide and its copolymers, polylactides, polyglycolides, polyanhydrides, polyorthoesters and their copolymers, proteins including albumin, peptides, liposomes, cationic lipids, ionic or nonionic detergents, salts including potassium chloride, sodium chloride and calcium chloride; sugars including galactose, glucose and sucrose; polysaccharides including soluble celluloses, heparin, cyclodextrins and dextran; and any combination thereof.
  • In some embodiments, the leachable agent is an agent selected from the group of agents consisting of polyvinlyl alcohol, polyethylene glycol, polyacrylic acid, polymethacrylate, poly-lactide, polyglycolide, polycaprolactone, polydioxanone; and derivatives, blends, copolymers, terpolymers, and combinations thereof.
  • In some embodiments, the leachable agent is in the form of droplets of leachable material having diameters in a range of between about 0.01 micron to about 10,000 microns. For example, the leachable agent may be in the form of droplets having diameters in a range of between about 1 micron to about 5,000 microns, for example, in a range of between about 50 microns to about 400 microns.
  • The particulates of the particle layer comprise any suitable particles which may be removed from the cured elastomer, leaving cavities where the particles had been.
  • For example, the particles may comprise particles that can be removed from the elastomer by at least one of mechanical abrasion, leaching, evaporation, sublimation, dissolution etc.
  • In an exemplary embodiment, the particles are a solid, water soluble material. For example, the particles may be material selected from the group of materials consisting of sodium chloride, barium sulfate, potassium nitrate and sodium carbonate.
  • In addition, the particles may have dimensions and shapes as desired to bring about a resulting topography. For example, the particles may be substantially round or spherical, multifaceted, angular, or cubic or a combination thereof. The particles may have an average particle size in a range of between about 0.01 micron to about 10,000 microns, for example, in a range of between about 10 microns to about 6,000 microns, for example, in a range of between about 100 microns to about 900 microns.
  • In some embodiments, the size of the particles is approximately proportional to the thickness of the composition coating on which they are deposited, or the thickness of adjacent interconnecting composition coatings in a multilayered embodiment. For example, particles with an average size of about 500 micron could be used in conjunction with a composition layer having a thickness of about 100 microns to about 500 microns. For particles with an average size of about 300 microns, a composition layer of about 50 microns to about 400 microns could be used.
  • FIGS. 1A-1C illustrate an exemplary process for making an implant in accordance with an embodiment of the invention. Step one is illustrated in 1A. In FIG. 1A, a flexible, elastomeric implantable member 12 is depicted. The partial cross sectional view 11 of the elastomeric implant member 12 is shown in FIG. 1A as well as FIG. 2. The implantable member 12 may be a cured implant shell, such as a conventional, relatively smooth-surfaced, silicone-based elastomeric implant shell, for example, a shell intended to be filled with silicone gel or saline and used as a breast prosthesis.
  • A curable fluid composition 14, as described elsewhere herein, is applied to the outer surface of the shell 12. FIG. 3 shows a partial cross sectional view of a shell 12 having a composition coating 10. This may be accomplished by dipping the shell (as shown by shaded line 13), while the shell is fixed to a mandrel (not shown) into a solution bath containing the curable fluid composition 14 (FIG. 1A). The composition 14 comprises a silicone-based mixture including a solvent, and a leachable agent, as described elsewhere herein. The step of applying the composition 14 to the shell 12 may be accomplished by any suitable means of application, such as dipping and spraying.
  • Next, the composition coating is allowed to stabilize on the shell 12. For example, the shell 12 can be held in a stable position until the composition coating no longer flows freely. This occurs as some of the solvent evaporates from the coating, raising its viscosity. It can be appreciated that the step of allowing the composition to stabilize may be accomplished by various means, for example, by allowing some of the solvent to evaporate out of the composition or allowing a chemical reaction to occur, inducing precipitation of the soluble components. Alternatively, stabilization can be achieved during crosslinking of polymerization of the silicone, or precipitation of the silicone or pore-forming material. Also, a combination of the above-mentioned methods may be used for stabilization of the composition coating.
  • Once the composition 14 has stabilized on the shell 12, the second step is to immerse (see shaded line 15) the shell 12 in a particle bath 16 to apply particles to the composition coating on the shell 12 (FIG. 1B). The particles 18 applied to a composition-coated shell 12 is depicted in FIG. 1B. FIG. 4 shows a partial cross sectional view of a shell 12 with a composition coat 10 and particles 18. Application of the particle coating onto the shell 12, is performed while the composition coating on the shell 12 is still tacky and able to retain the particles. Stabilizing the composition prior to particle application may be accomplished by allowing at least some of the solvent in the composition to evaporate out of the composition until the composition is stable and tacky but not fully cured. Another method, in accordance with one aspect of the invention, for stabilizing the composition is provided in the Example below.
  • Steps one and two can be repeated before the leaching step is carried out, as indicated by shaded line 17. The steps of applying a curable fluid composition and applying a particle coating can be repeated, for example, one or more times, for example, three, five or even up to 20 times, until a final coating is applied. The final coating may be a particle or a composition coating.
  • After the final coating of particles or fluid composition is applied to the shell, the coated shell is then subjected to suitable curing conditions to solidify the composition with the particles embedded therein.
  • In the leaching step 19 (FIG. 1C), which takes place after the solidification step described above, the embedded particles and leachable agent in the composition coating are immersed in a leaching bath 20 and removed. After the removal of the particles, what remains is a network of interconnected pores 21 (the structure may include both relatively large pores and relatively smaller pores, for example, micropores) on the shell.
  • Also see FIG. 7 for a flow chart of the process described herein.
  • Example 1
  • A mixture of about 7.5 wt. % PVA 2000 in water and about 40 wt. % acetoxy RTV silicone in xylene in a 3:1 volumetric ratio is prepared and homogenized for 30 seconds. An acetyl mandrel is placed into the mixture and coated uniformly as in a standard dip-coating process for the manufacturing of breast implant shells. The mandrel is then placed into a fluidized bed reactor with salt granules until no more granules can be deposited on the mandrel (about 5-10 seconds). This addition of salt particles tends to dry and stabilize the mixture by absorbing some of the water, thereby increasing the viscosity of the mixture. The coating is allowed to stabilize further at either 90° C. for about 15 minutes or at room temperature for about ½ hour, or otherwise sufficiently such that the next layer of composition may be applied. The procedure is repeated 3-5 times to obtain a coating of desired thickness.
  • Final curing may be performed at 165° C. for 2 hours, leaching with water or DCM for about 30 minutes for about 3 cycles with each (with agitation), and drying in vacuum overnight.
  • In one embodiment, a material is added to the composition before or after the composition has been applied to the shell, the material being effective to increase the viscosity of the composition, for example, by absorbing some of the solvent. When the leachable agent is in water, for example, a salt can be added in order to dry/stabilize the phase by absorbing the solvent. Other materials that may be helpful in this regard include sugars and other appropriate materials that can accelerate removal of solvent from the composition.
  • Next, a particle coating is applied to the composition to form the pores or cavities in the final elastomer foam structure. Application of the particles may be accomplished by any suitable means, for example, by sprinkling and pressing the particles into the tacky composition coating, or by immersing the tacky, coated shell in a bath of the particles. In the example shown, the particles are applied by immersing the coated shell into a fluidized bath 18 comprising a fluidization medium 19, for example, air, and particulates, for example, salt particles.
  • In some embodiments, the steps of applying the curable fluid composition and applying the particle coating are then repeated one or more times, for example, from about 0.5 up to about 20 times, for example, about 1 to about 10 times, for example, about 2 to about 5 times.
  • In one aspect of the invention, the particle coatings applied to the composition coatings may comprise coatings of particles having relatively different dimensions, one layer from the other. In other words, a first layer of particles may be relatively fine particles and a second layer of particles may be relatively coarse particles, or vice versa.
  • It is contemplated that in some embodiments, interconnectivity between pores may be increased or controlled by causing the particulates in the particle layer to fuse together. For example, in the event that the particles are salt crystals, application of moist heat may be effective increase interconnectivity thereof. Alternatively or additionally, an appropriate amount of a solvent for the particle material may be applied in order to cause the particles to fuse together. Further information which may be useful in appreciating this aspect of the invention may be found in copending, commonly owned U.S. Provisional Patent Application No. 61/177,955, filed on May 13, 2009 and entitled: IMPLANTS AND METHODS FOR MANUFACTURING SAME, the entire disclosure of which is incorporated herein by this reference.
  • For example, in one embodiment, the steps of applying alternating particle and compositions coatings includes applying a first layer of the curable fluid composition to the shell, applying a first layer of particles, for example, relatively small particles, to the composition, applying a second layer of the composition to the first layer of particles, applying a second layer of particles, for example, relatively larger particles, to the second layer of the composition. FIG. 5 is a cross sectional view of a shell showing alternating layers of compositions coatings 10 and particle coatings 18. In a specific embodiment, the first layer of particles comprises particles having an average size in a range of between about 30 microns to about 150 microns, and the second layer of particles comprises particles having an average size in a range of between about 100 microns to about 450 microns. In yet other embodiments, the method further includes applying a third layer of the composition to the second layer of particles, and optionally, providing a third layer of particles, to the third layer of composition. The third layer of particles may have an average size in a range of between about 250 microns to about 750 microns.
  • The layered, coated shell is then subjected to suitable curing conditions to solidify and further stabilize the composition with the particles embedded therein.
  • Next, the particles and leachable agent are then removed from the cured coating, thereby revealing a network of highly interconnected pores within the cured elastomer. FIG. 6 shows the partial cross sectional view of the shell 11 with a network of interconnected pores 21 after the removal of the particles. The step of removing the particles may comprise causing the particles to dissolve or contacting the particles with an abrasive surface. In the same step or in a different step, the leachable agent in the composition layers are removed from the elastomer.
  • In some embodiments, a conventional gas foaming process is used in addition to one or more of the presently described processes of the invention. For example, prior to the steps of applying the composition to the shell, the composition may be aerated by passing a gas, for example, air, through the composition to aerate the composition and create bubbles therein. Advantageously, any surface skin that may begin to form on the aerated composition coating would be opened up during extraction of the leachable phase to reveal highly interconnected pores resulting from the leachable materials, the particulates and the gas bubbles.
  • Removal of the particles and leachable agents may be accomplished by extracting these materials by exposing the layers to one or more suitable mediums capable of dissolving the particles and/or leachable agents. For example, the coated shell is dipped or submerged in a leaching bath 19 (FIG. 1C). The leaching bath may comprise water or an aqueous solution containing an agent capable of dissolving, leaching or otherwise removing the leachable agent and/or particles while leaving the cured elastomer substantially intact.
  • In some embodiments, the particles which are typically larger than the dispersed leachable agent, serve to create pores in the cured elastomer and the dispersed leachable agent serves to create micropores or interconnections between the relatively larger pores.
  • The resulting open-cell structure is believed to facilitate tissue ingrowth, improve fixation or adhesion of the implant and discourages organization of the collagen capsule which forms about the implant, which may help reduce capsular contraction.
  • In another aspect of the invention, an implantable composite member is provided in which the composite member has an external surface at least a portion of which is an open-cell porous structure, the composite member being made by one of the processes described herein.
  • In yet other embodiments of the invention, each of the first and second layers of particles are made up of substantially uniformly sized/shaped particles. In another aspect of the invention, each of the first and second layers of particles are made up of differently sized or shaped components.
  • After finishing the shell according to the steps described above, the steps required to make a finished mammary prosthesis may be conventional. First, any opening left by the mandrel support is patched with uncured silicone elastomer sheeting. If the prosthesis is to be filled with silicone gel, this gel is added and cured, the filled prosthesis packaged, and the packaged prosthesis sterilized. If the prosthesis is to be inflated with a saline solution, a valve is assembled and installed, the prosthesis is post cured if required, and the prosthesis is then cleaned, packaged and sterilized. A combination silicone/saline mammary prosthesis can also be made.
  • A method has been described for creating an outer layer having an open-cell structure in a silicone elastomer member. More specifically, the method can be applied to create a medical implant with an external surface layer of silicone elastomer having an open-cell structure, to create strips having a textured surface for control of scar formation, or to improve a process for making mammary prostheses. The product made by this method has also been described and is expected to have great utility in reducing capsular contraction, in preventing or controlling scar formation, and in anchoring medical implants.
  • Scar tissue formation in the healing of a wound or surgical incision is also a process involving the growth of fibrous tissue. A visible scar results from this healing process because the fibrous tissue is aligned in one direction. However, it is often aesthetically desirable to prevent scar formation, especially in certain types of plastic surgery. A member having an open-cell structure surface made in accordance with the present invention can be placed subcutaneously within a healing wound or incision to prevent the fibrous tissue from aligning and thereby prevent or reduce scar formation.
  • It is often important to anchor medical implants against movement. Mammary prostheses are one example of implants that must be anchored. Facial implants are another example of implants that must be anchored. With facial implants it is particularly important that they be anchored securely against movement because of their prominent location. Providing such implants with an open-cell structure surface made in accordance with the present invention is a particularly advantageous way to ensure that they will be anchored securely.
  • Example 2
  • A composition is prepared by mixing polyethylene glycol monomethyl ether (2000 Da), which will serve as a leachable agent, with a low viscosity silicone elastomer dispersion, for example, (e.g. polydimethylsiloxane, polydiphenylsiloxane, poly(dimethylsiloxane-co-diphenylsiloxane), poly(dimethylsiloxane-ran-diphenylsiloxane), etc.), in an organic solvent (e.g. xylene), and at about 5 to about 40 wt %, or in some specific embodiments, 17, 25 and 35 wt % of acetoxy RTV silicone. This composition is applied to the surface of an elastomeric shell held on a mandrel or other mechanical support. The layer is allowed to evaporate most of the solvent off.
  • A coating of sodium chloride crystals (about 250 μm to about 850 μm size) are applied to the tacky composition layer by submerging the coated shell into a fluidized bath of salt and air. This forms a relatively uniformly distributed single layer particle coating.
  • The elastomer is allowed to evaporate the solvent off and subsequently cured at approximately 145° C.
  • The coated shell is then submerged in an aqueous washing medium at approximately 40° C. and gently agitated to remove the particles and leachable agent.
  • Example 3
  • The same process is performed as in Example, 1, except that the composition is a mixture of 10 mL xylene, 10 mL DCM, 5 mL by dry volume PEG 2000 and 5 mL by dry volume acetoxy RTV silicone elastomer.
  • Example 4
  • The same process is performed as in Example 2, except that the composition is a mixture of
  • 5 mL water
    1 mL xylene
    0.5 mL by dry volume PVA 1500
    0.2 mL by dry volume RTV.
  • In another aspect of the invention, an article, for example a thin, flexible sheet, useful as a laminate, is provided. More specifically, the present invention provides a biocompatible sheet suitable for use as a laminate on an implantable device or object, in order to enhance tissue adhesion or ingrowth when the implantable device or object is implanted in a patient. Thus, the manufacture of the materials in accordance with the invention is not limited to conventional dipping processes but may be made by other suitable means, for example, through the lamination of a sheet that is prepared by molding or casting. For example, it is contemplated by the inventors that a sheet or laminate can be prepared by casting the fluid material with all the components present in various ratios (DCM, PEG)+(Xylene, RTV), and in some instances, mixed and shaken with the particulate component, for example, salt crystals added to the liquid. The particulate and fluid mixture can be shaken or mixed and cast onto a substrate or into a mold cavity. In some embodiments, the particulate component comprises salt in a range of about 10% to about 99% of total dissolved solids. In a more specific embodiment, the salt is present at about 25% to about 60%. It can be appreciated that different amounts and different particle sizes/shapes of salt will produce laminates having different porosities. Once cured, the laminate can be laminated, by any conventional means known in the art, onto a medical device or implant or other object to be implanted in a body, for example, any object or device which would be improved by the addition of such a laminate on one or more surfaces of the object or device. For example, the sheet may be laminated to catheter cuffs for long term implantable catheters, dura-matter substitutes or the like.
  • Example 5
  • A laminate for an implant is prepared as follows. A fluid composition made up of 10 mL xylene, 10 mL DCM, 5 mL by dry volume PEG 2000 and 5 mL by dry volume acetoxy RTV silicone elastomer is mixed with 3.5 mL by volume salt particles. This mixture is shaken together to ensure substantially uniform distribution of particles. The mixture is cast molded by applying the mixture to a mold surface to form a layer having a uniform thickness of between about 1 mm to about 5 mm. The layer is allowed stabilize and is cured at about 120° C. for a sufficient period of time. The cured sheet is removed from the mold surface and is then contacted with a gentle spray of pure water to remove all of the leachable components and salt particles. The resulting, thin, flexible, porous silicone foam sheet is then further processed and sterilized and packaged for sale or storage for later use as a laminate on a surface of an implantable device.
  • Example 6
  • The process of Example 5 is performed with the additional steps of repeating, three times, the step of applying a fluid composition/particulate mixture to the stabilized layer prior to the step of curing. The final thin, flexible sheet is a multilayered sheet and, in this example, has a thickness of greater than about 5 mm.
  • Example 7
  • The process of Example 5 is performed, however the cured stabilized sheet is not contacted with a spray of water to remove the leachable agents and particulates before being packaged for sale or storage. Instructions are provided with regard to: removing the leachable agents and particulates, sterilization, and bonding the sheet to a surface of a medical device.
  • Example 8
  • The process of Example 5 is performed to make two square sheets of uncured foam, approximately 240 mm×240 mm. A layer of silicone adhesive in DCM is applied, by spraying or brushing, to one side of each of the sheets. The sheets are stretched uniformly and positioned one on top of the other, adhesive side facing each other, over a newly molded breast implant shell filled with silicone or air. The foam sheets are joined together at the edge of the implant and affixed by suitable clamps at the perimeter of the implant. Twenty four hours later, the clamps are removed. Excess foam is die-cut away from the implant by a press. The implant/foam is exposed to 140° C. for 2.5 hours for final post-curing.
  • While this invention has been described with respect to various specific examples and embodiments, it is to be understood that the invention is not limited thereto and that it can be variously practiced within the scope of the invention.

Claims (20)

1. An implantable member having an external surface at least a portion of which is an open-cell porous structure, the member made by the method comprising the steps of:
(a) providing an implantable shell;
(b) applying a curable fluid composition to the shell, the composition comprising a mixture containing an elastomer component, a leachable agent and a solvent component;
(c) applying a layer of particles to the composition;
(d) allowing the composition to stabilize; and
(e) removing the particles and the leachable agent from the stabilized composition to form a composite material having an external surface at least a portion of which is an open-cell porous structure.
2. The member of claim 1 wherein the implantable shell is a shell for a breast implant.
3. The member of claim 1 wherein the leachable agent is a water soluble polymer.
4. The member of claim 1 wherein the leachable agent is an agent selected from the group of agents consisting of polyvinyl alcohol, polyethylene glycol, polyacrylic acid; polymethacrylate, poly-lactide, polyglycolide, polycaprolactone, polydioxanone, derivatives thereof, blends thereof, copolymers thereof, terpolymers thereof, and combinations thereof.
5. The member of claim 1 wherein the solvent component includes a solvent selected from the group consisting of xylene, pentane, hexane, dichloromethane (DCM), dimethyl sulfoxide, dioxane, NMP, DMAc, and combinations thereof.
6. The member of claim 1 wherein the mixture is an emulsion.
7. The member of claim 1 wherein the particles comprise a material selected from the group of materials consisting of sodium chloride, barium sulfate, potassium nitrate, sodium carbonate.
8. The member of claim 1 wherein the particles are substantially round.
9. The member of claim 1 wherein the leachable agent is in the form of droplets having diameters in a range of between about 50 microns to about 400 microns.
10. The member of claim 9 wherein the particles have an average particle size in a range of between about 100 microns to about 900 microns.
11. The member of claim 1 wherein the particles have an average particle size in a range of between about 100 microns to about 900 microns.
12. The member of claim 1 further comprising the step of repeating steps (b) and (c) prior to the step of removing, to form a layered structure.
13. The member of claim 1 wherein the step of removing comprises contacting the stabilized composition with a solvent for the particles and the leachable agent.
14. An implantable composite member having an external surface at least a portion of which is an open-cell porous structure, the member made by the method comprising the steps of:
(a) providing an implantable shell;
(b) applying a first layer of a curable fluid composition to the shell, the composition comprising a mixture containing an elastomer component, a leachable agent and a solvent component;
(c) applying a first layer of particles to the composition;
(d) applying a second layer of the composition to the first layer of particles;
(e) applying a second layer of particles to the second layer of the composition;
(f) allowing the composition to stabilize; and
(g) removing the particles and the leachable agent from the stabilized composition to form a composite material having an external surface at least a portion of which is an open-cell porous structure.
15. The member of claim 14 wherein the first layer of particles comprises relatively small particles and the second layer of particles comprises relatively large particles.
16. An article suitable for use in as a laminate for an implant, the article comprising:
a flexible sheet made by the process of:
(a) applying a particulate component and a curable fluid composition to a mold surface, the fluid composition comprising a mixture containing an elastomer component, a leachable agent and a solvent component;
(b) allowing the fluid composition component to stabilize; and
(c) removing at least one of the particulate component and the leachable agent from the stabilized composition to form a sheet having an external surface at least a portion of which is an open-cell porous structure; and
(d) removing the sheet from the mold surface.
17. An article comprising:
a sheet suitable for use as a laminate on an implantable object to enhance tissue adhesion or ingrowth when the implantable object is implanted in a patient;
the sheet made by a process comprising the steps of:
applying a fluid/particulate mixture to a substrate or mold surface, the fluid/particulate mixture comprising a particulate component and a curable fluid component, the curable fluid component containing an elastomer component, a leachable agent and a solvent component;
allowing the fluid/particulate mixture to stabilize; and
removing the sheet from the substrate or mold surface.
18. The article of claim 17 further comprising the step of removing at least one of the particulate component and the leachable agent from the stabilized fluid/particulate mixture to form a porous sheet after the step of allowing the fluid/particulate mixture to stabilize.
19. The article of claim 18 wherein the step of removing at least one of the particulate component and leachable agent is performed prior to the step of removing the sheet from the substrate of mold surface.
20. The article of claim 17 wherein the sheet is a layered sheet and the process further comprises the step of repeating the applying step prior to the step of removing the sheet from the substrate or mold surface.
US12/897,498 2009-10-16 2010-10-04 Implants and methdos for manufacturing same Abandoned US20110093069A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US25233009P true 2009-10-16 2009-10-16
US12/897,498 US20110093069A1 (en) 2009-10-16 2010-10-04 Implants and methdos for manufacturing same

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US12/897,498 US20110093069A1 (en) 2009-10-16 2010-10-04 Implants and methdos for manufacturing same
US13/942,104 US8951596B2 (en) 2009-10-16 2013-07-15 Implants and methods for manufacturing same
US14/602,907 US20150132469A1 (en) 2009-10-16 2015-01-22 Implants and methods for manufacturing same

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US13/942,104 Continuation US8951596B2 (en) 2009-10-16 2013-07-15 Implants and methods for manufacturing same

Publications (1)

Publication Number Publication Date
US20110093069A1 true US20110093069A1 (en) 2011-04-21

Family

ID=43567536

Family Applications (3)

Application Number Title Priority Date Filing Date
US12/897,498 Abandoned US20110093069A1 (en) 2009-10-16 2010-10-04 Implants and methdos for manufacturing same
US13/942,104 Active US8951596B2 (en) 2009-10-16 2013-07-15 Implants and methods for manufacturing same
US14/602,907 Abandoned US20150132469A1 (en) 2009-10-16 2015-01-22 Implants and methods for manufacturing same

Family Applications After (2)

Application Number Title Priority Date Filing Date
US13/942,104 Active US8951596B2 (en) 2009-10-16 2013-07-15 Implants and methods for manufacturing same
US14/602,907 Abandoned US20150132469A1 (en) 2009-10-16 2015-01-22 Implants and methods for manufacturing same

Country Status (9)

Country Link
US (3) US20110093069A1 (en)
EP (1) EP2488224A1 (en)
JP (1) JP2013508024A (en)
KR (1) KR20120087152A (en)
CN (1) CN102665776A (en)
AU (1) AU2010307139A1 (en)
CA (1) CA2777771A1 (en)
RU (1) RU2012119244A (en)
WO (1) WO2011046806A1 (en)

Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090326654A1 (en) * 2008-06-30 2009-12-31 Allergan, Inc. Fillable prosthetic implant with gel-like properties
US20110196489A1 (en) * 2010-02-05 2011-08-11 Allergan, Inc. Biocompatible structures and compositions
US20120245685A1 (en) * 2009-11-19 2012-09-27 Won Seok Yu Artificial breast implant provided on the surface threof with silicon open cell foam layer, and method for producing the same
WO2013048978A1 (en) * 2011-09-26 2013-04-04 Allergan, Inc. Silicone implant with imprinted texture
WO2013055884A1 (en) * 2011-10-14 2013-04-18 Applied Silicone Corporation System and method for curing, sterilization and aseptic packaging of medical devices
US20130165957A1 (en) * 2010-08-31 2013-06-27 Politecnico Di Torino Implantable Prosthetic Devices and Solvent-Casting Methods for Manufacturing Same
US8506627B2 (en) 2008-08-13 2013-08-13 Allergan, Inc. Soft filled prosthesis shell with discrete fixation surfaces
US8546458B2 (en) 2010-12-07 2013-10-01 Allergan, Inc. Process for texturing materials
WO2014040649A1 (en) 2012-09-17 2014-03-20 Phonak Ag Cic hearing aid seal and method of manufacturing the same
US8679570B2 (en) 2010-04-27 2014-03-25 Allergan, Inc. Foam-like materials and methods for producing same
US8679279B2 (en) 2010-11-16 2014-03-25 Allergan, Inc. Methods for creating foam-like texture
US8685296B2 (en) 2010-05-11 2014-04-01 Allergan, Inc. Porogen compositions, method of making and uses
US8801782B2 (en) 2011-12-15 2014-08-12 Allergan, Inc. Surgical methods for breast reconstruction or augmentation
US8877822B2 (en) 2010-09-28 2014-11-04 Allergan, Inc. Porogen compositions, methods of making and uses
US8889751B2 (en) 2010-09-28 2014-11-18 Allergan, Inc. Porous materials, methods of making and uses
US8951596B2 (en) 2009-10-16 2015-02-10 Allergan, Inc. Implants and methods for manufacturing same
US9044897B2 (en) 2010-09-28 2015-06-02 Allergan, Inc. Porous materials, methods of making and uses
US9138308B2 (en) 2010-02-03 2015-09-22 Apollo Endosurgery, Inc. Mucosal tissue adhesion via textured surface
US9138310B2 (en) 2007-11-05 2015-09-22 Allergan, Inc. Soft prosthesis shell texturing method
US9138309B2 (en) 2010-02-05 2015-09-22 Allergan, Inc. Porous materials, methods of making and uses
US9539086B2 (en) 2014-05-16 2017-01-10 Allergan, Inc. Soft filled prosthesis shell with variable texture
US9688006B2 (en) 2012-12-13 2017-06-27 Allergan, Inc. Device and method for making a variable surface breast implant
US9848972B2 (en) 2008-08-13 2017-12-26 Allergan, Inc. Dual plane breast implant
US10092392B2 (en) 2014-05-16 2018-10-09 Allergan, Inc. Textured breast implant and methods of making same

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3012849A1 (en) * 2016-02-08 2017-08-17 Lifecell Corporation Biologic breast implant
CN105997302A (en) * 2016-07-18 2016-10-12 青岛三帝生物科技有限公司 3D printing-based capsule contracture-preventive breast prosthesis manufacturing method and breast prosthesis

Citations (95)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3186921A (en) * 1962-10-24 1965-06-01 Miles Lab Process for preparing galactose oxidase by fermentation
US3366975A (en) * 1965-06-04 1968-02-06 William J. Pangman Compound prosthesis
US3559214A (en) * 1968-10-17 1971-02-02 William J Pangman Compound prosthesis
US3665520A (en) * 1970-10-07 1972-05-30 Medical Eng Corp Surgically implantable breast prosthesis
US3934274A (en) * 1974-10-29 1976-01-27 Hartley Jr John H Deflatable mammary augmentation prosthesis
US4157085A (en) * 1978-03-24 1979-06-05 Dow Corning Corporation Surgically implantable tissue expanding device and the method of its use
US4264990A (en) * 1979-01-24 1981-05-05 Hamas Robert S Mammary prosthesis
US4329385A (en) * 1980-12-19 1982-05-11 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Texturing polymer surfaces by transfer casting
US4428082A (en) * 1980-12-08 1984-01-31 Naficy Sadeque S Breast prosthesis with filling valve
US4433440A (en) * 1979-02-26 1984-02-28 Cohen I Kelman Prosthesis formed by inner and outer inflatable containers
US4499211A (en) * 1981-07-28 1985-02-12 Hoechst Aktiengesellschaft Open-cell/microporous molded article
US4573999A (en) * 1983-10-14 1986-03-04 Netto Daniel J Human breast prosthesis
US4592755A (en) * 1985-06-11 1986-06-03 Ethyl Corporation Mammary implant
US4636213A (en) * 1985-01-24 1987-01-13 Pakiam Anthony I Implantable prosthesis
US4643733A (en) * 1983-04-04 1987-02-17 Hilton Becker Permanent reconstruction implant and method of performing human tissue expansion
US4648880A (en) * 1984-08-30 1987-03-10 Daniel Brauman Implantable prosthetic devices
US4650487A (en) * 1980-10-27 1987-03-17 Memorial Hospital For Cancer And Allied Diseases Multi-lumen high profile mammary implant
US4651717A (en) * 1985-04-04 1987-03-24 Dow Corning Corporation Multiple envelope tissue expander device
US4740208A (en) * 1980-11-21 1988-04-26 Cavon Joseph F Cast gel implantable prosthesis
US4795464A (en) * 1987-02-09 1989-01-03 Tertulin Eberl Artificial breast
US4803025A (en) * 1984-04-23 1989-02-07 Swiss Aluminium Ltd. Ceramic foam
US4828560A (en) * 1988-02-17 1989-05-09 Mcgman Medical Corporation Spring ring tissue expander
US4841992A (en) * 1987-12-17 1989-06-27 Dow Corning Wright Corporation Tissue expander and method of making and using
US4899764A (en) * 1987-12-17 1990-02-13 Dow Corning Wright Tissue expander and method of making and using
US4902294A (en) * 1986-12-03 1990-02-20 Olivier Gosserez Implantable mammary prosthesis adapted to combat the formation of a retractile shell
US4906423A (en) * 1987-10-23 1990-03-06 Dow Corning Wright Methods for forming porous-surfaced polymeric bodies
US4936858A (en) * 1986-07-22 1990-06-26 Keeffe Paul O Implantable fabric pouch for mammary prosthesis
US5002572A (en) * 1986-09-11 1991-03-26 Picha George J Biological implant with textured surface
US5007929A (en) * 1986-11-04 1991-04-16 Medical Products Development, Inc. Open-cell, silicone-elastomer medical implant
US5007940A (en) * 1989-06-09 1991-04-16 American Medical Systems, Inc. Injectable polymeric bodies
US5022942A (en) * 1987-05-27 1991-06-11 Mentor Corporation Method of making textured surface prosthesis implants
US5026394A (en) * 1989-01-10 1991-06-25 Baker James L Mammary implant
US5092348A (en) * 1989-01-17 1992-03-03 Mcghan Medical Corporation Textured tissue expander
US5092882A (en) * 1990-05-04 1992-03-03 Lynn Lawrence A Multiple compartment breast prosthesis
US5104409A (en) * 1989-01-10 1992-04-14 Baker James L Mammary implant
US5116387A (en) * 1989-06-09 1992-05-26 American Medical Systems, Inc. Preparation of injectable polymeric bodies
US5185297A (en) * 1986-09-16 1993-02-09 Lanxide Technology Company, Lp Ceramic foams
US5207709A (en) * 1991-11-13 1993-05-04 Picha George J Implant with textured surface
US5282856A (en) * 1987-12-22 1994-02-01 Ledergerber Walter J Implantable prosthetic device
US5296069A (en) * 1991-12-27 1994-03-22 Silimed-Silicone E. Instrumental Medico Cirurgico E. Hosiptalar Ltda. Process for manufacturing implants having coated surfaces
US5480430A (en) * 1993-06-04 1996-01-02 Mcghan Medical Corporation Shape-retaining shell for a fluid filled prosthesis
US5496370A (en) * 1992-03-13 1996-03-05 Robert S. Hamas Gel-like prosthetic device
US5496367A (en) * 1993-01-13 1996-03-05 Fisher; Jack Breast implant with baffles
US5507808A (en) * 1994-10-26 1996-04-16 Becker; Hilton Filling tube and seal construction
US5522896A (en) * 1989-02-15 1996-06-04 Xomed, Inc. Biocompatible composite material
US5525275A (en) * 1993-07-27 1996-06-11 Pmt Corporation Method of manufacture of enhanced surface implant
US5605693A (en) * 1991-10-18 1997-02-25 Seare, Jr.; William J. Methods of making a porous device
US5607473A (en) * 1994-06-20 1997-03-04 Dr. Helbig GmbH & Co. Orthopadische Produkte KG Breast prosthesis
US5630843A (en) * 1994-06-30 1997-05-20 Rosenberg; Paul H. Double chamber tissue expander
US5630844A (en) * 1995-06-07 1997-05-20 Novamed Medical Products Manufacturing, Inc. Biocompatible hydrophobic laminate with thermoplastic elastomer layer
US5855588A (en) * 1996-10-03 1999-01-05 General Surgical Innovations, Inc. Combination dissector and expander
US5871497A (en) * 1996-10-03 1999-02-16 General Surgical Innovations, Inc. Combination dissector and expander
US5895423A (en) * 1996-02-23 1999-04-20 Coloplast Corporation Attachable two-chamber breast prosthesis
US6071309A (en) * 1995-03-22 2000-06-06 Knowlton; Edward W. Segmental breast expander for use in breast reconstruction
US6074421A (en) * 1997-04-05 2000-06-13 Medisyn Technology, Ltd. Seamless breast prosthesis
US6183514B1 (en) * 1999-08-16 2001-02-06 Hilton Becker Self positioning breast prosthesis
US6203570B1 (en) * 1999-11-24 2001-03-20 John L. Baeke Breast implant with position lock
US6206930B1 (en) * 1998-08-10 2001-03-27 Charlotte-Mecklenburg Hospital Authority Absorbable tissue expander
US6214926B1 (en) * 1999-04-01 2001-04-10 Rhodia Inc. Silicone membranes formed without the use of 1-1-1 trichloroethane
US6214045B1 (en) * 1997-10-10 2001-04-10 John D. Corbitt, Jr. Bioabsorbable breast implant
US20020038147A1 (en) * 1999-10-22 2002-03-28 Miller Archibald S. Breast implant
US6387133B1 (en) * 1998-07-16 2002-05-14 Laboratoire Perouse Implant Reconstruction implant
US6520989B1 (en) * 2000-01-18 2003-02-18 Board Of Trustees Of The University Of Arkansas Extreme volume flexible integrity prosthesis
US20030036803A1 (en) * 2001-08-14 2003-02-20 Mcghan Jim J. Medical implant having bioabsorbable textured surface
US6531523B1 (en) * 2000-10-10 2003-03-11 Renal Tech International, Llc Method of making biocompatible polymeric adsorbing material for purification of physiological fluids of organism
US6544287B1 (en) * 1998-12-11 2003-04-08 Gerald W. Johnson Solid filled implants
US20030093151A1 (en) * 2000-12-22 2003-05-15 Guangzhou Wanhe Material Co. Ltd. Implantable mammary prosthesis with flexible sheet
US6673285B2 (en) * 2000-05-12 2004-01-06 The Regents Of The University Of Michigan Reverse fabrication of porous materials
US20040010225A1 (en) * 2001-07-18 2004-01-15 Schuessler David J. Rotationally molded medical articles
US6692527B1 (en) * 1999-12-01 2004-02-17 Howard T. Bellin Non-rotating breast implant
US20050055093A1 (en) * 2003-09-03 2005-03-10 Brennan William A. System and method for breast augmentation
US20050070124A1 (en) * 2003-09-30 2005-03-31 International Business Machines Corporation Direct photo-patterning of nanoporous organosilicates, and method of use
US6875233B1 (en) * 2003-06-10 2005-04-05 Hinging breast implant
US6881226B2 (en) * 1997-10-10 2005-04-19 John D. Corbitt, Jr. Bioabsorbable breast implant
US20050112169A1 (en) * 2003-05-21 2005-05-26 Dexcom, Inc. Porous membranes for use with implantable devices
US6900055B1 (en) * 1998-10-28 2005-05-31 Cellon S.A. Preparation of porous silicone rubber for growing cells or living tissue
US20060036320A1 (en) * 2004-08-13 2006-02-16 Keith Job Spray method for forming shells for prostheses
US20070093911A1 (en) * 2003-04-28 2007-04-26 Helmut Fricke Soft tissue implant such as breast implant, calf muscle implant or the like
US20070104693A1 (en) * 2005-11-07 2007-05-10 Quijano Rodolfo C Breast augmentation system
US20070104695A1 (en) * 2005-11-07 2007-05-10 Quijano Rodolfo C Breast augmentation and reconstruction system
US20070116735A1 (en) * 2002-07-31 2007-05-24 Macropore Biosurgery, Inc. Apparatus and method for preventing adhesions between an implant and surrounding tissues
US20070190108A1 (en) * 2004-05-17 2007-08-16 Arindam Datta High performance reticulated elastomeric matrix preparation, properties, reinforcement, and use in surgical devices, tissue augmentation and/or tissue repair
US20080009830A1 (en) * 2006-06-27 2008-01-10 Fujimoto Kazuro L Biodegradable elastomeric patch for treating cardiac or cardiovascular conditions
US7323208B2 (en) * 2004-11-30 2008-01-29 The Regents Of The University Of Michigan Modified porous materials and method of forming the same
US20080071371A1 (en) * 2006-09-20 2008-03-20 Robert Elshout Texturizing surfaces
US20080075752A1 (en) * 2003-10-01 2008-03-27 University Of Washington Novel Porous Biomaterials
US20090045166A1 (en) * 2005-11-11 2009-02-19 Yangyang Li Method of enhancing biocompatibility of elastomeric materials by microtexturing using microdroplet patterning
US20090082864A1 (en) * 2007-09-19 2009-03-26 Gaoyuan Gavin Chen Naturally contoured, preformed, three dimensional mesh device for breast implant support
US20090087641A1 (en) * 2005-11-14 2009-04-02 Favis Basil D Porous nanosheath networks, method of making and uses thereof
US20090093878A1 (en) * 2005-06-28 2009-04-09 Ami Glicksman Human implantable tissue expander
US7520896B2 (en) * 2004-10-28 2009-04-21 Fahd Benslimane Breast implant, use of an associated pouch, and method for determination of a breast implant
US20090118829A1 (en) * 2007-11-05 2009-05-07 Allergan, Inc. Soft prosthesis shell texturing method
US7641688B2 (en) * 2004-09-16 2010-01-05 Evera Medical, Inc. Tissue augmentation device
US7645475B2 (en) * 2004-03-03 2010-01-12 Mentor Corporation Devices having a textured surface
US20100042211A1 (en) * 2008-08-13 2010-02-18 Allergan, Inc. Soft filled prosthesis shell with discrete fixation surfaces

Family Cites Families (164)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2324735A (en) 1941-01-16 1943-07-20 Abraham N Spanel Composite rubber article and method of producing same
US2805208A (en) 1952-11-05 1957-09-03 Du Pont Process for preparing resinous expanded solid
US3189921A (en) 1962-04-11 1965-06-22 William J Pangman Compound prosthesis
US3293663A (en) 1963-08-12 1966-12-27 Dow Corning Surgically implantable human breast prosthesis
US3600718A (en) 1969-12-29 1971-08-24 Dow Corning Inflatable prosthesis
US3852832A (en) 1972-10-24 1974-12-10 Heyer Schulte Corp Prosthesis with fixation means
US4034751A (en) 1975-11-24 1977-07-12 International Paper Company Polymeric sheets as synthetic medical dressings or coverings for wounds
DE2738268A1 (en) 1977-08-25 1979-03-08 Basf Ag Hydrophobic polyurethane foams for oelabsorption
US4231979A (en) 1979-10-12 1980-11-04 Research Corporation High surface area permeable material
US4298997A (en) 1979-10-23 1981-11-10 Rybka F James Device for inhibiting the formation of fibrous capsular contractures in silicone breast implants and method
US4773909A (en) 1981-10-06 1988-09-27 Memorial Hospital For Cancer And Allied Diseases Multi-lumen high profile mammary implant
US4840628A (en) 1980-11-21 1989-06-20 Cavon Joseph F Non-enveloped gel prosthesis
US4470160A (en) 1980-11-21 1984-09-11 Cavon Joseph F Cast gel implantable prosthesis
US4298998A (en) 1980-12-08 1981-11-10 Naficy Sadeque S Breast prosthesis with biologically absorbable outer container
US4482577A (en) 1980-12-16 1984-11-13 Albert Goldstein Coating process of elastomeric material
US4610690A (en) 1983-02-22 1986-09-09 Mentor Corporation Rupture resistant prosthesis with bonded surface layer and method of forming same
EP0125400B1 (en) 1983-04-18 1987-07-01 EBERL, Tertulin Breast prosthesis
US4531244A (en) 1983-07-14 1985-07-30 Hamas Robert S Mammary prosthesis with multiple flow spaces
US4772285A (en) 1984-05-09 1988-09-20 The Board Of Trustees Of The Leland Stanford Junior University Collagen coated soft tissue prostheses
US4584324A (en) 1984-10-26 1986-04-22 Dow Corning Corporation Silicone foam, water-based, aerosol composition
US4944749A (en) 1985-01-23 1990-07-31 Hilton Becker Implant and inflating construction
US4647618A (en) 1985-05-24 1987-03-03 Dow Corning Corporation Method of producing a silicone water-based elastomer
US4608396A (en) 1985-10-16 1986-08-26 Dow Corning Corporation Method of producing elastomeric silicone foam
JPS62231658A (en) 1985-12-30 1987-10-12 American Hospital Supply Corp Implantation for breast prosthesis
AU617667B2 (en) * 1986-11-04 1991-12-05 Allergan, Inc. Open-cell, silicone-elastomer medical implant and method for making
CA1322441C (en) 1986-11-04 1993-09-28 Joel Quaid Open-cell, silicone-elastomer medical implant and method for making
US4773908A (en) 1986-12-18 1988-09-27 Hilton Becker Filling tube and seal construction for inflatable implant
US4960425A (en) 1987-05-27 1990-10-02 Mentor Corporation Textured surface frosthesis implants
US4859383A (en) 1987-06-01 1989-08-22 Bio Med Sciences, Inc. Process of producing a composite macrostructure of organic and inorganic materials
US4808558A (en) 1987-08-26 1989-02-28 Lanxide Technology Company, Lp Ceramic foams
US4790848A (en) 1987-11-27 1988-12-13 Dow Corning Wright Breast prosthesis with multiple lumens
US5035249A (en) 1987-12-17 1991-07-30 Dow Corning Wright Corporation Method of making envelope for tissue expander
US6228116B1 (en) 1987-12-22 2001-05-08 Walter J. Ledergerber Tissue expander
US4955907A (en) 1987-12-22 1990-09-11 Ledergerber Walter J Implantable prosthetic device
US4950292A (en) 1988-04-20 1990-08-21 Dow Corning Corporation Tissue expanders
FR2630637B1 (en) 1988-04-27 1997-09-12 Muller Guy Henri New prosthesis alveolar
US5219361A (en) 1988-09-16 1993-06-15 Clemson University Soft tissue implant with micron-scale surface texture to optimize anchorage
US5011494A (en) 1988-09-16 1991-04-30 Clemson University Soft tissue implant with micron-scale surface texture to optimize anchorage
US4944750A (en) 1988-10-12 1990-07-31 Cox-Uphoff International Reel Composite shell material for prosthesis
US4859712A (en) 1988-10-12 1989-08-22 Cox-Uphoff International Silicone foam and method for making it
US4955909A (en) 1989-01-31 1990-09-11 Bioplasty, Inc. Textured silicone implant prosthesis
US4969899A (en) 1989-03-08 1990-11-13 Cox-Uphoff International Inflatable implant
US5158573A (en) 1989-06-09 1992-10-27 American Medical Systems, Inc. Injectable polymeric bodies
US4965430A (en) 1989-09-18 1990-10-23 Dow Corning Wright Corp. Method of laser machining molds with microtextured surfaces
US5158571A (en) 1990-03-09 1992-10-27 Picha George J Tissue expander and method for expanding tissue
US5236453A (en) 1990-03-09 1993-08-17 Picha George J Mammary implant and method for reducing capsule contracture
US5147398A (en) 1990-05-04 1992-09-15 Lynn Lawrence A Multiple compartment breast prosthesis
US5128088A (en) 1990-08-14 1992-07-07 Hollister Incorporated Continuous method for making adhesive-lined male external catheters
US5993716A (en) 1990-10-19 1999-11-30 Draenert; Klaus Material and process for its preparation
US5034422A (en) 1990-12-19 1991-07-23 Foamex Lp Low density, high temperature resistant polymeric bodies
US5348788A (en) 1991-01-30 1994-09-20 Interpore Orthopaedics, Inc. Mesh sheet with microscopic projections and holes
US5354338A (en) 1991-02-22 1994-10-11 Ledergerber Walter J Texturized covering for implants
US5271736A (en) 1991-05-13 1993-12-21 Applied Medical Research Collagen disruptive morphology for implants
US5135959A (en) 1991-05-20 1992-08-04 Sorrento Engineering Corporation Method of impregnating reticulated foam with polymide foam and products thereof
JP2571881B2 (en) 1991-07-11 1997-01-16 リグナイト株式会社 Method for producing a silicone porous body
US5246454A (en) 1991-07-22 1993-09-21 Peterson Robert L Encapsulated implant
US5171269A (en) 1991-08-29 1992-12-15 Medical Engineering Corporation Mammary prosthesis
US5146933A (en) 1991-09-20 1992-09-15 Dow Corning Wright Corporation Implantable prosthetic device and tethered inflation valve for volume
US5376117A (en) 1991-10-25 1994-12-27 Corvita Corporation Breast prostheses
US5236454A (en) 1991-11-04 1993-08-17 Miller Archibald S Stacked breast implant
US5236457A (en) 1992-02-27 1993-08-17 Zimmer, Inc. Method of making an implant having a metallic porous surface
US5358521A (en) 1992-04-01 1994-10-25 Fred Shane Multiple-layer prosthesis implant with tissue tactility
US5534023A (en) 1992-12-29 1996-07-09 Henley; Julian L. Fluid filled prosthesis excluding gas-filled beads
US5964803A (en) 1993-07-27 1999-10-12 Pmt Corporation Enhanced surface implant and method of manufacture
US5545220A (en) * 1993-11-04 1996-08-13 Lipomatrix Incorporated Implantable prosthesis with open cell textured surface and method for forming same
US5437824A (en) 1993-12-23 1995-08-01 Moghan Medical Corp. Method of forming a molded silicone foam implant having open-celled interstices
ES2159316T3 (en) 1994-03-31 2001-10-01 Ernest C Manders Extensor dimensionally adjustable soft tissue.
FR2721198B1 (en) 1994-06-16 1996-10-31 Caravel Jean Baudoin flexible implantable prosthesis used in surgery for the volume increase or reconstruction of soft tissues, including mammary prosthesis.
US5549671A (en) 1994-12-28 1996-08-27 Mcghan Medical Corporation Adjunctive filler material for fluid-filled prosthesis
US5605696A (en) * 1995-03-30 1997-02-25 Advanced Cardiovascular Systems, Inc. Drug loaded polymeric material and method of manufacture
US5545217A (en) 1995-04-20 1996-08-13 C.M. Offray & Son, Inc. Breast implant
US6099565A (en) 1995-06-07 2000-08-08 Sakura, Jr.; Chester Y. Prosthetic tissue implant and filler therefor
FR2735354B1 (en) 1995-06-13 1997-08-14 Perouse Implant Lab Breast prosthesis
US6113634A (en) 1996-04-23 2000-09-05 F + E Gesellschaft fur Bekleidungsinnovation mbH & Co. KG Breast prosthesis and method for making the same
US5824081A (en) 1996-09-13 1998-10-20 Lipomatrix Incorporated Hydraulic foam tissue implant
US5935164A (en) 1997-02-25 1999-08-10 Pmt Corporaton Laminated prosthesis and method of manufacture
US6146418A (en) 1997-02-28 2000-11-14 Berman; Mark Body implant and method of implanting
US5965076A (en) 1997-09-22 1999-10-12 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Method for fabricating soft tissue implants with microscopic surface roughness
EP1047459B1 (en) 1997-10-21 2002-09-18 augmentec Aktiengesellschaft Implantologie-Epithetik Implant made of resorbable phosphateglass
JP3400740B2 (en) 1999-04-13 2003-04-28 東芝セラミックス株式会社 Calcium phosphate porous sintered body and manufacturing method thereof
US6315796B1 (en) 1999-05-13 2001-11-13 Board Of Trustees Of The University Of Arkansas Flexible seamless memory tissue expanding implant
FR2794361B1 (en) 1999-06-02 2001-10-19 Arnaud Rochebiliere Breast prosthesis
US6432138B1 (en) 2000-03-07 2002-08-13 Promatrx, Inc. Controlled porosity 3-D fabric breast prosthesis
US20030105469A1 (en) 2001-05-09 2003-06-05 Regene Ex Ltd. Bioresorbable inflatable devices, incision tool and methods for tissue expansion and tissue regeneration
US6464726B1 (en) 2000-07-13 2002-10-15 Jenna Heljenek Breast implant system and method of augmentation
GB0030635D0 (en) 2000-12-15 2001-01-31 Aortech Internat Plc Soft tissue implant
FR2822383B1 (en) 2001-03-23 2004-12-17 Perouse Lab Prosthesis for plastic reconstruction hydrophilicity properties improved and process for their preparation
US6605116B2 (en) 2001-04-03 2003-08-12 Mentor Corporation Reinforced radius mammary prostheses and soft tissue expanders
ES2190339B1 (en) 2001-05-07 2004-11-01 Ricardo Gonzalez De Vicente For breast prostheses.
DE10135275A1 (en) 2001-07-13 2003-01-30 Jotec Gmbh Implant and method for its preparation
US6702857B2 (en) 2001-07-27 2004-03-09 Dexcom, Inc. Membrane for use with implantable devices
AU2002329845A1 (en) 2001-08-24 2003-03-10 Radiant Holdings, Llc Silicone foam
WO2003024698A1 (en) 2001-08-24 2003-03-27 Radiant Holdings, Llc Method of producing silicone foam utilizing a mechanical foaming agent
US6755861B2 (en) 2001-10-16 2004-06-29 Granit Medical Innovation, Inc. Device for providing a portion of an organism with a desired shape
US7058439B2 (en) 2002-05-03 2006-06-06 Contourmed, Inc. Methods of forming prostheses
FR2840617B1 (en) 2002-06-10 2004-09-10 Rhodia Chimie Sa materials production process porous silicone
WO2004006806A1 (en) 2002-07-10 2004-01-22 Marlen Andreevich Sulamanidze Endoprosthesis for reparative anaplastic surgery.
US8048444B2 (en) 2002-07-31 2011-11-01 Mast Biosurgery Ag Apparatus and method for preventing adhesions between an implant and surrounding tissues
CA2503193A1 (en) 2002-10-22 2004-05-06 The Biomerix Corporation Method and system for intravesicular delivery of therapeutic agents
US20050043585A1 (en) 2003-01-03 2005-02-24 Arindam Datta Reticulated elastomeric matrices, their manufacture and use in implantable devices
US20040143327A1 (en) 2003-01-17 2004-07-22 Ku David N. Solid implant
US7282241B2 (en) 2003-04-22 2007-10-16 International Business Machines Corporation Patterned, high surface area substrate with hydrophilic/hydrophobic contrast, and method of use
US7081135B2 (en) 2003-06-09 2006-07-25 Lane Fielding Smith Mastopexy stabilization apparatus and method
US7632291B2 (en) 2003-06-13 2009-12-15 Trivascular2, Inc. Inflatable implant
US6802861B1 (en) 2003-08-26 2004-10-12 Rsh-Gs Trust Structured breast implant
JP4452487B2 (en) 2003-12-01 2010-04-21 セイコーNpc株式会社 Class D amplifier
JP5019342B2 (en) * 2003-12-25 2012-09-05 シンジーテック株式会社 Silicone elastomer porous material
AU2005213499B2 (en) 2004-02-06 2010-09-02 Georgia Tech Research Corporation Surface directed cellular attachment
US7364592B2 (en) 2004-02-12 2008-04-29 Dexcom, Inc. Biointerface membrane with macro-and micro-architecture
US7674426B2 (en) 2004-07-02 2010-03-09 Praxis Powder Technology, Inc. Porous metal articles having a predetermined pore character
US7476249B2 (en) 2004-08-06 2009-01-13 Frank Robert E Implantable prosthesis for positioning and supporting a breast implant
US6932840B1 (en) 2004-09-08 2005-08-23 Absolute Breast Solutions Implant device
US7244270B2 (en) 2004-09-16 2007-07-17 Evera Medical Systems and devices for soft tissue augmentation
GB2421440A (en) 2004-12-21 2006-06-28 Ishay Wahl Breast implant with securing means
US20060224239A1 (en) 2005-04-04 2006-10-05 Tiahrt Leif K Breast implant
US7081136B1 (en) 2005-04-18 2006-07-25 Techno Investments Llc Adjustable gel filled mammary prosthesis and method
TWI382918B (en) * 2005-04-19 2013-01-21 Sulzer Chemtech Ag Uses of a method for the manufacture of foamed shaped polymer parts of liquid silicone rubber
WO2006116392A2 (en) 2005-04-27 2006-11-02 The Regents Of The University Of Michigan Particle-containing complex porous materials
US20060282164A1 (en) 2005-06-08 2006-12-14 Joann Seastrom Implant shell and filler apparatus
US7368065B2 (en) 2005-06-23 2008-05-06 Depuy Products, Inc. Implants with textured surface and methods for producing the same
ES2389378T3 (en) 2005-10-26 2012-10-25 Allergan, Inc. Breast implant with stable cohesive gel variable
US7547393B2 (en) 2005-12-07 2009-06-16 General Electric Company Membrane structure and method of making
US7625405B2 (en) 2006-02-08 2009-12-01 Neosthetic, Llc Breast implant and method of manufacture
US8535719B2 (en) 2006-07-07 2013-09-17 University Of Pittsburgh - Of The Commonwealth System Of Higher Education Biohybrid elastomeric scaffolds and methods of use thereof
US7998152B2 (en) 2006-12-21 2011-08-16 Frank Robert E Implantable prosthesis for periareolar mastopexy
MX2009010396A (en) 2007-03-29 2009-12-02 Tyrx Pharma Inc Biodegradable, polymer coverings for breast implants.
WO2009110917A1 (en) 2007-06-07 2009-09-11 Osteotherapeutics, L.L.C. Bone cement compositions for use as growth factor carriers and methods of making same
US7942930B2 (en) 2007-06-15 2011-05-17 Q-Med Ab Biocompatible implant system and method
US8425600B2 (en) 2007-11-14 2013-04-23 G. Patrick Maxwell Interfaced medical implant assembly
US20110035004A1 (en) 2007-11-14 2011-02-10 Maxwell G Interfaced medical implant
US20090171049A1 (en) 2007-12-27 2009-07-02 Linhardt Jeffrey G Segmented reactive block copolymers
US20090198331A1 (en) 2008-02-01 2009-08-06 Kesten Randy J Implantable prosthesis with open cell flow regulation
US20090198333A1 (en) 2008-02-05 2009-08-06 Hilton Becker Method for texturing the surface of a synthetic implant
US20090198332A1 (en) 2008-02-05 2009-08-06 Hilton Becker Method for texturing the surface of a synthetic implant
US8506627B2 (en) 2008-08-13 2013-08-13 Allergan, Inc. Soft filled prosthesis shell with discrete fixation surfaces
CA2734252A1 (en) * 2008-08-20 2010-02-25 Allergan, Inc. Self-sealing shell for inflatable prostheses
US8357628B2 (en) * 2008-08-29 2013-01-22 Agilent Technologies, Inc. Inorganic/organic hybrid totally porous metal oxide particles, methods for making them and separation devices using them
US8182872B2 (en) * 2008-09-25 2012-05-22 Imec Method of fabricating a porous elastomer
US20100292790A1 (en) * 2009-05-13 2010-11-18 Allergan, Inc. Implants and methods for manufacturing same
US20110106249A1 (en) 2009-09-02 2011-05-05 Hilton Becker Self supporting and forming breast implant and method for forming and supporting an implant in a human body
US8202317B2 (en) 2009-09-02 2012-06-19 Hilton Becker Self supporting and forming breast implant and method for forming and supporting an implant in a human body
US8197542B2 (en) 2009-09-02 2012-06-12 Hilton Becker Self supporting implant in a human body and method for making the same without capsular contracture
US20110093069A1 (en) 2009-10-16 2011-04-21 Allergan, Inc. Implants and methdos for manufacturing same
KR101067475B1 (en) 2009-11-19 2011-09-27 유원석 Breast implant that has surface with silicone open cell foam layer, and its manufacturing method
EP2528538A2 (en) 2010-01-28 2012-12-05 Allergan, Inc. Open celled silicone foams, implants including them and processes for making same
US20110196488A1 (en) 2010-02-03 2011-08-11 Allergan, Inc. Degradation resistant implantable materials and methods
US20120004722A1 (en) 2010-02-03 2012-01-05 Allergan, Inc. Degradation resistant implantable materials and methods
KR101861390B1 (en) 2010-05-11 2018-05-28 알러간, 인코포레이티드 Porous materials, methods of making and uses
WO2011097499A1 (en) 2010-02-05 2011-08-11 Allergan, Inc. Biocompatible structures and compositions
DK2569021T3 (en) 2010-05-11 2017-04-10 Allergan Inc Porogensammensætninger, to processes for preparation and uses
US9205577B2 (en) 2010-02-05 2015-12-08 Allergan, Inc. Porogen compositions, methods of making and uses
US9138309B2 (en) 2010-02-05 2015-09-22 Allergan, Inc. Porous materials, methods of making and uses
US8679570B2 (en) 2010-04-27 2014-03-25 Allergan, Inc. Foam-like materials and methods for producing same
US20110276134A1 (en) 2010-05-10 2011-11-10 Allergan, Inc. Silicone implant with imprinted texture
US20110276133A1 (en) 2010-05-10 2011-11-10 Allergan, Inc. Porous materials, methods of making and uses
US20120041555A1 (en) 2010-05-10 2012-02-16 Allergan, Inc. Silicone implant with imprinted texture
AU2011267923A1 (en) 2010-06-16 2013-01-31 Allergan, Inc. Open-cell surface foam materials
WO2012024600A1 (en) 2010-08-20 2012-02-23 Allergan, Inc. Implantable materials
US8889751B2 (en) 2010-09-28 2014-11-18 Allergan, Inc. Porous materials, methods of making and uses
US8877822B2 (en) 2010-09-28 2014-11-04 Allergan, Inc. Porogen compositions, methods of making and uses
US9044897B2 (en) 2010-09-28 2015-06-02 Allergan, Inc. Porous materials, methods of making and uses
US8679279B2 (en) 2010-11-16 2014-03-25 Allergan, Inc. Methods for creating foam-like texture
US8546458B2 (en) 2010-12-07 2013-10-01 Allergan, Inc. Process for texturing materials
US8801782B2 (en) 2011-12-15 2014-08-12 Allergan, Inc. Surgical methods for breast reconstruction or augmentation

Patent Citations (101)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3186921A (en) * 1962-10-24 1965-06-01 Miles Lab Process for preparing galactose oxidase by fermentation
US3366975A (en) * 1965-06-04 1968-02-06 William J. Pangman Compound prosthesis
US3559214A (en) * 1968-10-17 1971-02-02 William J Pangman Compound prosthesis
US3665520A (en) * 1970-10-07 1972-05-30 Medical Eng Corp Surgically implantable breast prosthesis
US3934274A (en) * 1974-10-29 1976-01-27 Hartley Jr John H Deflatable mammary augmentation prosthesis
US4157085A (en) * 1978-03-24 1979-06-05 Dow Corning Corporation Surgically implantable tissue expanding device and the method of its use
US4264990A (en) * 1979-01-24 1981-05-05 Hamas Robert S Mammary prosthesis
US4433440A (en) * 1979-02-26 1984-02-28 Cohen I Kelman Prosthesis formed by inner and outer inflatable containers
US4650487A (en) * 1980-10-27 1987-03-17 Memorial Hospital For Cancer And Allied Diseases Multi-lumen high profile mammary implant
US4740208A (en) * 1980-11-21 1988-04-26 Cavon Joseph F Cast gel implantable prosthesis
US4428082A (en) * 1980-12-08 1984-01-31 Naficy Sadeque S Breast prosthesis with filling valve
US4329385A (en) * 1980-12-19 1982-05-11 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Texturing polymer surfaces by transfer casting
US4499211A (en) * 1981-07-28 1985-02-12 Hoechst Aktiengesellschaft Open-cell/microporous molded article
US4643733A (en) * 1983-04-04 1987-02-17 Hilton Becker Permanent reconstruction implant and method of performing human tissue expansion
US4573999A (en) * 1983-10-14 1986-03-04 Netto Daniel J Human breast prosthesis
US4803025A (en) * 1984-04-23 1989-02-07 Swiss Aluminium Ltd. Ceramic foam
US4648880A (en) * 1984-08-30 1987-03-10 Daniel Brauman Implantable prosthetic devices
US4636213A (en) * 1985-01-24 1987-01-13 Pakiam Anthony I Implantable prosthesis
US4651717A (en) * 1985-04-04 1987-03-24 Dow Corning Corporation Multiple envelope tissue expander device
US4592755A (en) * 1985-06-11 1986-06-03 Ethyl Corporation Mammary implant
US4936858A (en) * 1986-07-22 1990-06-26 Keeffe Paul O Implantable fabric pouch for mammary prosthesis
US5002572A (en) * 1986-09-11 1991-03-26 Picha George J Biological implant with textured surface
US5185297A (en) * 1986-09-16 1993-02-09 Lanxide Technology Company, Lp Ceramic foams
US5007929A (en) * 1986-11-04 1991-04-16 Medical Products Development, Inc. Open-cell, silicone-elastomer medical implant
US5007929B1 (en) * 1986-11-04 1994-08-30 Medical Products Dev Open-cell silicone-elastomer medical implant
US4902294A (en) * 1986-12-03 1990-02-20 Olivier Gosserez Implantable mammary prosthesis adapted to combat the formation of a retractile shell
US4795464A (en) * 1987-02-09 1989-01-03 Tertulin Eberl Artificial breast
US5022942A (en) * 1987-05-27 1991-06-11 Mentor Corporation Method of making textured surface prosthesis implants
US4906423A (en) * 1987-10-23 1990-03-06 Dow Corning Wright Methods for forming porous-surfaced polymeric bodies
US4841992A (en) * 1987-12-17 1989-06-27 Dow Corning Wright Corporation Tissue expander and method of making and using
US4899764A (en) * 1987-12-17 1990-02-13 Dow Corning Wright Tissue expander and method of making and using
US5383929A (en) * 1987-12-22 1995-01-24 Ledergerber; Walter J. Implantable prosthetic device
US5282856A (en) * 1987-12-22 1994-02-01 Ledergerber Walter J Implantable prosthetic device
US6187043B1 (en) * 1987-12-22 2001-02-13 Walter J. Ledergerber Implantable prosthetic device
US4828560A (en) * 1988-02-17 1989-05-09 Mcgman Medical Corporation Spring ring tissue expander
US5026394A (en) * 1989-01-10 1991-06-25 Baker James L Mammary implant
US5104409A (en) * 1989-01-10 1992-04-14 Baker James L Mammary implant
US5092348A (en) * 1989-01-17 1992-03-03 Mcghan Medical Corporation Textured tissue expander
US5522896A (en) * 1989-02-15 1996-06-04 Xomed, Inc. Biocompatible composite material
US5116387A (en) * 1989-06-09 1992-05-26 American Medical Systems, Inc. Preparation of injectable polymeric bodies
US5007940A (en) * 1989-06-09 1991-04-16 American Medical Systems, Inc. Injectable polymeric bodies
US5092882A (en) * 1990-05-04 1992-03-03 Lynn Lawrence A Multiple compartment breast prosthesis
US5605693A (en) * 1991-10-18 1997-02-25 Seare, Jr.; William J. Methods of making a porous device
US5624674A (en) * 1991-10-18 1997-04-29 Seare, Jr.; William J. Porous product mold form
US5207709A (en) * 1991-11-13 1993-05-04 Picha George J Implant with textured surface
US5296069A (en) * 1991-12-27 1994-03-22 Silimed-Silicone E. Instrumental Medico Cirurgico E. Hosiptalar Ltda. Process for manufacturing implants having coated surfaces
US5496370A (en) * 1992-03-13 1996-03-05 Robert S. Hamas Gel-like prosthetic device
US5496367A (en) * 1993-01-13 1996-03-05 Fisher; Jack Breast implant with baffles
US5480430A (en) * 1993-06-04 1996-01-02 Mcghan Medical Corporation Shape-retaining shell for a fluid filled prosthesis
US5525275A (en) * 1993-07-27 1996-06-11 Pmt Corporation Method of manufacture of enhanced surface implant
US5607473A (en) * 1994-06-20 1997-03-04 Dr. Helbig GmbH & Co. Orthopadische Produkte KG Breast prosthesis
US5630843A (en) * 1994-06-30 1997-05-20 Rosenberg; Paul H. Double chamber tissue expander
US5507808A (en) * 1994-10-26 1996-04-16 Becker; Hilton Filling tube and seal construction
US6071309A (en) * 1995-03-22 2000-06-06 Knowlton; Edward W. Segmental breast expander for use in breast reconstruction
US5630844A (en) * 1995-06-07 1997-05-20 Novamed Medical Products Manufacturing, Inc. Biocompatible hydrophobic laminate with thermoplastic elastomer layer
US5895423A (en) * 1996-02-23 1999-04-20 Coloplast Corporation Attachable two-chamber breast prosthesis
US5855588A (en) * 1996-10-03 1999-01-05 General Surgical Innovations, Inc. Combination dissector and expander
US5871497A (en) * 1996-10-03 1999-02-16 General Surgical Innovations, Inc. Combination dissector and expander
US6074421A (en) * 1997-04-05 2000-06-13 Medisyn Technology, Ltd. Seamless breast prosthesis
US6214045B1 (en) * 1997-10-10 2001-04-10 John D. Corbitt, Jr. Bioabsorbable breast implant
US6881226B2 (en) * 1997-10-10 2005-04-19 John D. Corbitt, Jr. Bioabsorbable breast implant
US6387133B1 (en) * 1998-07-16 2002-05-14 Laboratoire Perouse Implant Reconstruction implant
US6206930B1 (en) * 1998-08-10 2001-03-27 Charlotte-Mecklenburg Hospital Authority Absorbable tissue expander
US6900055B1 (en) * 1998-10-28 2005-05-31 Cellon S.A. Preparation of porous silicone rubber for growing cells or living tissue
US6544287B1 (en) * 1998-12-11 2003-04-08 Gerald W. Johnson Solid filled implants
US6214926B1 (en) * 1999-04-01 2001-04-10 Rhodia Inc. Silicone membranes formed without the use of 1-1-1 trichloroethane
US6183514B1 (en) * 1999-08-16 2001-02-06 Hilton Becker Self positioning breast prosthesis
US20020038147A1 (en) * 1999-10-22 2002-03-28 Miller Archibald S. Breast implant
US6203570B1 (en) * 1999-11-24 2001-03-20 John L. Baeke Breast implant with position lock
US6692527B1 (en) * 1999-12-01 2004-02-17 Howard T. Bellin Non-rotating breast implant
US6520989B1 (en) * 2000-01-18 2003-02-18 Board Of Trustees Of The University Of Arkansas Extreme volume flexible integrity prosthesis
US6673285B2 (en) * 2000-05-12 2004-01-06 The Regents Of The University Of Michigan Reverse fabrication of porous materials
US6531523B1 (en) * 2000-10-10 2003-03-11 Renal Tech International, Llc Method of making biocompatible polymeric adsorbing material for purification of physiological fluids of organism
US20030093151A1 (en) * 2000-12-22 2003-05-15 Guangzhou Wanhe Material Co. Ltd. Implantable mammary prosthesis with flexible sheet
US20040010225A1 (en) * 2001-07-18 2004-01-15 Schuessler David J. Rotationally molded medical articles
US20030036803A1 (en) * 2001-08-14 2003-02-20 Mcghan Jim J. Medical implant having bioabsorbable textured surface
US20070116735A1 (en) * 2002-07-31 2007-05-24 Macropore Biosurgery, Inc. Apparatus and method for preventing adhesions between an implant and surrounding tissues
US20070093911A1 (en) * 2003-04-28 2007-04-26 Helmut Fricke Soft tissue implant such as breast implant, calf muscle implant or the like
US20050112169A1 (en) * 2003-05-21 2005-05-26 Dexcom, Inc. Porous membranes for use with implantable devices
US7192450B2 (en) * 2003-05-21 2007-03-20 Dexcom, Inc. Porous membranes for use with implantable devices
US6875233B1 (en) * 2003-06-10 2005-04-05 Hinging breast implant
US7169180B2 (en) * 2003-09-03 2007-01-30 Brennan William A System and method for breast augmentation
US20050055093A1 (en) * 2003-09-03 2005-03-10 Brennan William A. System and method for breast augmentation
US20050070124A1 (en) * 2003-09-30 2005-03-31 International Business Machines Corporation Direct photo-patterning of nanoporous organosilicates, and method of use
US20080075752A1 (en) * 2003-10-01 2008-03-27 University Of Washington Novel Porous Biomaterials
US7645475B2 (en) * 2004-03-03 2010-01-12 Mentor Corporation Devices having a textured surface
US20070190108A1 (en) * 2004-05-17 2007-08-16 Arindam Datta High performance reticulated elastomeric matrix preparation, properties, reinforcement, and use in surgical devices, tissue augmentation and/or tissue repair
US20060036320A1 (en) * 2004-08-13 2006-02-16 Keith Job Spray method for forming shells for prostheses
US7641688B2 (en) * 2004-09-16 2010-01-05 Evera Medical, Inc. Tissue augmentation device
US7520896B2 (en) * 2004-10-28 2009-04-21 Fahd Benslimane Breast implant, use of an associated pouch, and method for determination of a breast implant
US7323208B2 (en) * 2004-11-30 2008-01-29 The Regents Of The University Of Michigan Modified porous materials and method of forming the same
US20090093878A1 (en) * 2005-06-28 2009-04-09 Ami Glicksman Human implantable tissue expander
US20070104695A1 (en) * 2005-11-07 2007-05-10 Quijano Rodolfo C Breast augmentation and reconstruction system
US20070104693A1 (en) * 2005-11-07 2007-05-10 Quijano Rodolfo C Breast augmentation system
US20090045166A1 (en) * 2005-11-11 2009-02-19 Yangyang Li Method of enhancing biocompatibility of elastomeric materials by microtexturing using microdroplet patterning
US20090087641A1 (en) * 2005-11-14 2009-04-02 Favis Basil D Porous nanosheath networks, method of making and uses thereof
US20080009830A1 (en) * 2006-06-27 2008-01-10 Fujimoto Kazuro L Biodegradable elastomeric patch for treating cardiac or cardiovascular conditions
US20080071371A1 (en) * 2006-09-20 2008-03-20 Robert Elshout Texturizing surfaces
US20090082864A1 (en) * 2007-09-19 2009-03-26 Gaoyuan Gavin Chen Naturally contoured, preformed, three dimensional mesh device for breast implant support
US20090118829A1 (en) * 2007-11-05 2009-05-07 Allergan, Inc. Soft prosthesis shell texturing method
US20100042211A1 (en) * 2008-08-13 2010-02-18 Allergan, Inc. Soft filled prosthesis shell with discrete fixation surfaces

Cited By (34)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9138310B2 (en) 2007-11-05 2015-09-22 Allergan, Inc. Soft prosthesis shell texturing method
US20090326654A1 (en) * 2008-06-30 2009-12-31 Allergan, Inc. Fillable prosthetic implant with gel-like properties
US8506627B2 (en) 2008-08-13 2013-08-13 Allergan, Inc. Soft filled prosthesis shell with discrete fixation surfaces
US9918829B2 (en) 2008-08-13 2018-03-20 Allergan, Inc. Soft filled prosthesis shell with discrete fixation surfaces
US9848972B2 (en) 2008-08-13 2017-12-26 Allergan, Inc. Dual plane breast implant
US9138311B2 (en) 2008-08-13 2015-09-22 Allergan, Inc. Soft filled prosthesis shell with discrete fixation surfaces
US9393106B2 (en) 2008-08-13 2016-07-19 Allergan, Inc. Soft filled prosthesis shell with discrete fixation surfaces
US8951596B2 (en) 2009-10-16 2015-02-10 Allergan, Inc. Implants and methods for manufacturing same
US20120245685A1 (en) * 2009-11-19 2012-09-27 Won Seok Yu Artificial breast implant provided on the surface threof with silicon open cell foam layer, and method for producing the same
US9138308B2 (en) 2010-02-03 2015-09-22 Apollo Endosurgery, Inc. Mucosal tissue adhesion via textured surface
US20110196489A1 (en) * 2010-02-05 2011-08-11 Allergan, Inc. Biocompatible structures and compositions
US9138309B2 (en) 2010-02-05 2015-09-22 Allergan, Inc. Porous materials, methods of making and uses
US9072821B2 (en) 2010-02-05 2015-07-07 Allergan, Inc. Biocompatible structures and compositions
US8679570B2 (en) 2010-04-27 2014-03-25 Allergan, Inc. Foam-like materials and methods for producing same
US8685296B2 (en) 2010-05-11 2014-04-01 Allergan, Inc. Porogen compositions, method of making and uses
US20130165957A1 (en) * 2010-08-31 2013-06-27 Politecnico Di Torino Implantable Prosthetic Devices and Solvent-Casting Methods for Manufacturing Same
US8889751B2 (en) 2010-09-28 2014-11-18 Allergan, Inc. Porous materials, methods of making and uses
US9593224B2 (en) 2010-09-28 2017-03-14 Allergan, Inc. Porogen compositions, methods of making and uses
US9044897B2 (en) 2010-09-28 2015-06-02 Allergan, Inc. Porous materials, methods of making and uses
US9522502B2 (en) 2010-09-28 2016-12-20 Allergan, Inc. Porous materials, methods of making and uses
US8877822B2 (en) 2010-09-28 2014-11-04 Allergan, Inc. Porogen compositions, methods of making and uses
US9155613B2 (en) 2010-11-16 2015-10-13 Allergan, Inc. Methods for creating foam-like texture
US8679279B2 (en) 2010-11-16 2014-03-25 Allergan, Inc. Methods for creating foam-like texture
US8546458B2 (en) 2010-12-07 2013-10-01 Allergan, Inc. Process for texturing materials
WO2013048978A1 (en) * 2011-09-26 2013-04-04 Allergan, Inc. Silicone implant with imprinted texture
WO2013055884A1 (en) * 2011-10-14 2013-04-18 Applied Silicone Corporation System and method for curing, sterilization and aseptic packaging of medical devices
US8801782B2 (en) 2011-12-15 2014-08-12 Allergan, Inc. Surgical methods for breast reconstruction or augmentation
US9521495B2 (en) 2012-09-17 2016-12-13 Sonova Ag CIC hearing aid seal and method of manufacturing the same
WO2014040649A1 (en) 2012-09-17 2014-03-20 Phonak Ag Cic hearing aid seal and method of manufacturing the same
US9688006B2 (en) 2012-12-13 2017-06-27 Allergan, Inc. Device and method for making a variable surface breast implant
US9539086B2 (en) 2014-05-16 2017-01-10 Allergan, Inc. Soft filled prosthesis shell with variable texture
US9808338B2 (en) 2014-05-16 2017-11-07 Allergan, Inc. Soft filled prosthesis shell with variable texture
US10092392B2 (en) 2014-05-16 2018-10-09 Allergan, Inc. Textured breast implant and methods of making same
US10350055B2 (en) 2014-05-16 2019-07-16 Allergan, Inc. Textured breast implant and methods of making same

Also Published As

Publication number Publication date
US8951596B2 (en) 2015-02-10
RU2012119244A (en) 2013-11-27
WO2011046806A1 (en) 2011-04-21
CA2777771A1 (en) 2011-04-21
CN102665776A (en) 2012-09-12
KR20120087152A (en) 2012-08-06
EP2488224A1 (en) 2012-08-22
AU2010307139A1 (en) 2012-05-17
JP2013508024A (en) 2013-03-07
US20130302511A1 (en) 2013-11-14
US20150132469A1 (en) 2015-05-14

Similar Documents

Publication Publication Date Title
Sachlos et al. Making tissue engineering scaffolds work. Review: the application of solid freeform fabrication technology to the production of tissue engineering scaffolds
US4034751A (en) Polymeric sheets as synthetic medical dressings or coverings for wounds
US5502092A (en) Biocompatible porous matrix of bioabsorbable material
JP3563498B2 (en) Polytetrafluoroethylene implantable tubular prosthesis
Chen et al. Scaffold design for tissue engineering
CN1136922C (en) Implantable bioresorbable membrane and method for preparation thereof
US4878907A (en) Synthetic vascular prosthesis
US9050176B2 (en) At least partially resorbable reticulated elastomeric matrix elements and methods of making same
EP0822788B1 (en) Drug release coated stent
CN101448534B (en) Anisotropic nanoporous coatings for medical implants
US20060199876A1 (en) Bioceramic composite coatings and process for making same
EP0888140B1 (en) Coated bioabsorbable beads for wound treatment
CA2525792C (en) Reticulated elastomeric matrices, their manufacture and use in implantable devices
CA1322834C (en) Biocompatible microporous polymeric materials and methods of making same
US5736160A (en) Process and device for treating and healing a bone void
US20030083741A1 (en) Valved prosthesis with porous substrate
US4906423A (en) Methods for forming porous-surfaced polymeric bodies
JP5049119B2 (en) The method for biocompatible bone implant composition and bone defect repair
US20060134160A1 (en) Calcium phosphate coated implantable medical devices and processes for making same
US4101984A (en) Cardiovascular prosthetic devices and implants with porous systems
EP2346440B1 (en) Soft filled prosthesis shell with discrete fixation surfaces
US20060089705A1 (en) Drug release coated stent
US20100318108A1 (en) Composite mesh devices and methods for soft tissue repair
Maquet et al. Design of macroporous biodegradable polymer scaffolds for cell transplantation
Oh et al. Fabrication and characterization of hydrophilic poly (lactic-co-glycolic acid)/poly (vinyl alcohol) blend cell scaffolds by melt-molding particulate-leaching method

Legal Events

Date Code Title Description
AS Assignment

Owner name: ALLERGAN, INC., CALIFORNIA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:GORALTCHOUK, ALEXEI;VAN EPPS, DENNIS E.;POWELL, THOMAS E.;SIGNING DATES FROM 20101011 TO 20101023;REEL/FRAME:025322/0422

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION