Patent application number | Description | Published |
20090030515 | ALL-BARRIER ELASTOMERIC GEL-FILLED BREAST PROSTHESIS - An elastomeric gel-filled prosthetic implant having a shell made of a single gel barrier layer. The barrier layer is formed of a homogeneous silicone elastomer capable of sterically retarding permeation of the silicone gel through the shell and having a bleed rate that is less than about 40% of the bleed rate of current shells which use a sandwiched construction with an internal barrier layer. Further, the barrier layer shell is made of a material that exhibits a wet strength that is comparable to or greater than current shells. The silicone elastomer may be a polydimethyl siloxane, and the substituted chemical group is a diphenyl group with a minimum mole percent of at least 13%. The implant may be designed for breast reconstruction or augmentation such that the shell is accordingly shaped. The shell wall thickness is at least 0.254 mm (0.010 inches), and desirably about 0.456 mm (0.018 inches). The implant shell may be made by dip-forming, spray-forming, or rotational molding. The exterior may be smooth or textured. | 01-29-2009 |
20090149953 | FORM STABLE BREAST IMPLANT SIZER AND METHOD OF USE - An insertable preformed sizer for a breast implant that regains its form after deformation and insertion into a cavity formed within breast tissue. The sizer is used to evaluate the size of the cavity and help determine proper sizes and shapes of breast implants to use. The implant sizer is intended to be disposable and is made of a cost-efficient material such as a medical grade foam or elastomer. The foam or elastomer material has the ability to be squeezed or collapsed into an extremely small delivery shape and then resiliently expand back to its original shape against the constraining forces of surrounding breast tissue. | 06-11-2009 |
20090270985 | Flush Patch For Elastomeric Implant Shell - An elastomeric prosthetic implant having a shell and a patch providing a reinforced access region on the shell for introduction of manufacturing implements, such as a gel-filling tool. The shell may cover the entire inner face of the patch, or a substantial part thereof, and a peripheral edge of the patch and the shell cooperate to form a flush interface with no sudden surface steps on both interior and exterior surfaces of the implant. The removal of any surface steps eliminates undesirable tactile discontinuities and stress points that may cause the shell wall to wear or may irritate the surrounding tissues. The prosthetic implant may be a breast implant formed of a silicone elastomer. The patch may be the same material or a liquid silicone rubber, but at least has similar material properties such as elastic modulus, durometer and elongation. The patch may include a channel used for introducing silicone to the mold to form the shell, for venting the mold cavity during the mold process, and/or for introducing the silicone gel into the hollow prosthesis. | 10-29-2009 |
20100049316 | SELF-SEALING SHELL FOR INFLATABLE PROSTHESES - A self-sealing shell useful as a component of a soft fluid-filled prosthetic implant is provided. The shell is at least partly constructed of a wall made of a colloid of an elastomeric polymer matrix and particles of a water-swellable material distributed therein. | 02-25-2010 |
20100049317 | SELF-SEALING SHELL FOR INFLATABLE PROSTHESES - A self-sealing shell useful as a component of a soft fluid-filled prosthetic implant is provided. The shell is at least partly constructed of a wall made of a colloid of an elastomeric polymer matrix and particles of a water-soluble material distributed therein. | 02-25-2010 |
20100228347 | FLUSH PATCH FOR ELASTOMERIC IMPLANT SHELL - An elastomeric fluid-filled prosthetic implant having a shell and a patch providing a reinforced access region on the shell for introduction of manufacturing implements, such as a gel-filling tool. The shell may cover the entire inner face of the patch, or a substantial part thereof, and a peripheral edge of the patch and the shell cooperate to form a flush interface with no sudden surface steps on both interior and exterior surfaces of the implant. The removal of any surface steps eliminates undesirable tactile discontinuities and stress points that may cause the shell wall to wear or may irritate the surrounding tissues. The prosthetic implant may be a breast implant formed of a silicone elastomer. The patch may be the same material or a liquid silicone rubber, but at least has similar material properties such as elastic modulus, durometer and elongation. The patch may include a channel, such as a self-sealing channel, used for introducing silicone to the mold to form the shell, for venting the mold cavity during the mold process, and/or for introducing the silicone gel into the hollow prosthesis. The patch may be combined with a fluid fill valve for manually adjusting the amount of a fluid such as saline within the shell after the mold process. | 09-09-2010 |
20110046729 | Reinforced Prosthetic Implant With Flexible Shell - A fluid-filled soft prosthetic implant having a shell with a reinforced shell wall. The soft prosthetic implant may be for breast reconstruction or augmentation, or to restore the normal appearance of soft tissue in the buttocks, chin, calf, etc. The implants may be reinforced using several methods: reinforcement of the shell wall, non-homogeneous gel-filling, or both. At least a portion of the perimeter region desirably has a shell wall thickness greater than the average shell wall thickness of either the anterior face or the posterior face. The added material at the perimeter region strengthens that area in which a large percentage of implant ruptures occur. The reinforced perimeter also helps prevent the implant from collapsing or folding, which can cause undesirable rippling or wrinkling visible through the patient's skin. The remainder of the shell will desirably have a nominal wall thickness to retain the overall softness and supple feel of the implant. The implant shell may be filled with gels of different gel cohesiveness to counterbalance any reinforced area or to provide added reinforcement. | 02-24-2011 |
20110257743 | SOFT PROSTHETIC IMPLANT MANUFACTURING PROCESS - A soft prosthetic implant, for example, a breast implant, having a shell filled with a fluid. One or more components of the soft prosthetic implant receive a unique identifier for traceability during the manufacturing process. The unique identifier is placed on one component, such as a patch molded-in-place with a shell to form a soft prosthetic implant. Information about the respective components, as well as process parameters, can be stored on the unique identifier for later reference. The unique identifier may be a two-dimensional printed label or laser-etched characters, or may be a three-dimensional embossed or indented region. The unique identifier may be a separate label attached to the respective component, or may be formed in the component, such as with embossing. | 10-20-2011 |
20110270391 | INFLATABLE PROSTHESES AND METHODS OF MAKING SAME - An inflatable tissue expander or more permanent prosthesis, suitable for implantation in a breast, is provided. The tissue expander includes a puncturable, self-sealing anterior portion forming a fillable cavity, and posterior portion that is puncture resistant. The anterior portion includes a silicone-based elastomer material having a mesh embedded therein. The posterior portion includes a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed in a spaced apart fashion. | 11-03-2011 |
20110270392 | ALL-BARRIER ELASTOMERIC GEL-FILLED BREAST PROSTHESIS - An elastomeric gel-filled prosthetic implant having a shell made of a single gel barrier layer. The barrier layer is formed of a homogeneous silicone elastomer capable of sterically retarding permeation of the silicone gel through the shell and having a bleed rate that is less than about 40% of the bleed rate of current shells which use a sandwiched construction with an internal barrier layer. Further, the barrier layer shell is made of a material that exhibits a wet strength that is comparable to or greater than current shells. The silicone elastomer may be a polydimethyl siloxane, and the substituted chemical group is a diphenyl group with a minimum mole percent of at least 13%. The implant may be designed for breast reconstruction or augmentation such that the shell is accordingly shaped. The shell wall thickness is at least 0.254 mm (0.010 inches), and desirably about 0.456 mm (0.018 inches). The implant shell may be made by dip-forming, spray-forming, or rotational molding. The exterior may be smooth or textured. | 11-03-2011 |
20110288639 | Inflatable prostheses and methods of making same - An inflatable tissue expander, suitable for implantation in a breast, is provided. The tissue expander includes a puncturable, self-sealing anterior portion forming a fillable cavity, and posterior portion that is puncture resistant. The anterior portion includes a silicone-based elastomer material having a mesh embedded therein. The posterior portion includes a first composite guard and a second composite guard, each composite guard including an arrangement of puncture resistant members and a flexible substrate having a first side on which the puncture resistant members are disposed in a spaced apart fashion. | 11-24-2011 |
20120010706 | NON-ROTATING IMPLANT ASSEMBLY AND BACKING PLATE THEREFOR - The present specification discloses a backing plate comprising a front surface and a back surface comprising a plurality of parallel ridges and grooves, and soft tissue implants comprising such backing plates. | 01-12-2012 |
20120139157 | FLUSH PATCH FOR ELASTOMERIC IMPLANT SHELL - An elastomeric prosthetic breast implant is provided having a shell and a patch forming a flush interface with the shell and no sudden surface steps on both interior and exterior surfaces of the shell. | 06-07-2012 |
20120165934 | COLLAPSIBLE, FORM-STABLE, FILLABLE BREAST PROSTHESIS - Provided is a flexible, collapsible, implantable breast prosthesis which is form stable such that it can be inserted through a relatively small incision and then will regain its configuration and maintain its shape within the breast. The prosthesis may include an anterior portion including a closed-cell silicone foam. | 06-28-2012 |
20120303120 | FLUSH PATCH FOR ELASTOMERIC IMPLANT SHELL - An elastomeric prosthetic breast implant is provided having a shell and a patch forming a flush interface with the shell and no sudden surface steps on both interior and exterior surfaces of the shell. | 11-29-2012 |
20130131800 | BREAST IMPLANTS HAVING A FLUSH PATCH AND METHODS OF USING SAME TO AUGMENT OR RECONSTRUCT A BREAST - Elastomeric fluid-filled prosthetic implants having an elastomeric shell and a flush patch are provided as well as methods for making and using such implants. | 05-23-2013 |
20130131801 | SELF-SEALING SHELL FOR INFLATABLE PROSTHESES - A self-sealing shell useful as a component of a soft fluid-filled prosthetic implant is provided. The shell is at least partly constructed of a wall made of a colloid of an elastomeric polymer matrix and particles of a water-soluble material distributed therein. | 05-23-2013 |
20130245758 | INFLATABLE PROSTHESES AND METHODS OF MAKING SAME - An inflatable tissue expander or more permanent prosthesis, suitable for implantation in a breast, is provided. | 09-19-2013 |
20140077411 | REINFORCED PROSTHETIC IMPLANT WITH FLEXIBLE SHELL - A fluid-filled soft prosthetic implant having a shell with a reinforced shell wall. The soft prosthetic implant may be for breast reconstruction or augmentation, or to restore the normal appearance of soft tissue in the buttocks, chin, calf, etc. The implants may be reinforced using several methods: reinforcement of the shell wall, non-homogeneous gel-filling, or both. At least a portion of the perimeter region desirably has a shell wall thickness greater than the average shell wall thickness of either the anterior face or the posterior face. The added material at the perimeter region strengthens that area in which a large percentage of implant ruptures occur. The reinforced perimeter also helps prevent the implant from collapsing or folding, which can cause undesirable rippling or wrinkling visible through the patient's skin. The remainder of the shell will desirably have a nominal wall thickness to retain the overall softness and supple feel of the implant. The implant shell may be filled with gels of different gel cohesiveness to counterbalance any reinforced area or to provide added reinforcement. | 03-20-2014 |