摘要:
An insertable preformed sizer (20) 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.
摘要:
A self-sealing shell (22) useful as a component of a soft fluid-filled prosthetic implant is provided. The shell is at least partly constructed of a wall (28) made of a colloid of an elastomeric polymer matrix (32) and particles (34) of a water-swellable material distributed therein.
摘要:
A system and method for molding the shell of a medical device or other molded article is disclosed. The system includes a multi-axis rotational molding machine (50) in which a mold (100) is mounted. The mold (100) has a cavity (60) in the shape of the article to be molded. The mold (100) seals to hold a vacuum. In operation, silicone or other molding material is inserted into the mold (100), vacuum is applied to the mold (100), the mold (100) is rotated about at least two axes (A, B) and a molding material coats the inside walls of the mold (100) to form the shell or other desired article. A rotationally molded medical article is also disclosed.
摘要:
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.
摘要:
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 (122) of a colloid of an elastomeric polymer matrix (132) and particles (134) of a water-soluble material distributed therein.
摘要:
An elastomeric prosthetic implant having a shell (244) and a patch (242) 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.
摘要:
An elastomeric gel-filled prosthetic implant (10) having a shell made of a single gel barrier layer. The barrier layer (14) 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.