Abstract:
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.
Abstract:
A method of manufacturing a tissue expander for implanting into a body of a living subject can include mixing granules of a solute with an elastomer. The method can further include forming a matrix with the elastomer. The granules can be embedded within the elastomer. The elastomer can define boundaries of a plurality of chambers within the matrix. The method can further include curing the elastomer, such that the boundaries of the matrix are permeable to water at a temperature between a desired temperature range.
Abstract:
A breast implant includes a flexible shell having an anterior face including an outer surface and an inner surface, and a marker attached to the inner surface of the anterior face of the shell. The marker includes a first layer of material having a radiopaque surface with readable characters for identifying a characteristic of the breast implant while in vivo, and a second layer of non-radiopaque material laminated onto the radiopaque surface. The readable characters defined by an outline formed from an absence of at least a portion of material of the radiopaque surface. The first layer of material with the readable characters is interposed between the inner surface of the anterior face of the shell and the second layer, and the readable characters are viewable in vivo using conventional imaging techniques.
Abstract:
A tissue expansion device can be implanted temporarily beneath skin of a patient and removed upon expansion of overlying tissue. The device can include an expandable shell having a smooth or glossy outer surface and an injection port. The expandable shell can form an expandable chamber and have an anterior portion and a posterior portion. The injection port can be coupled to the anterior portion of the shell and be in fluid communication with the chamber and configured to permit injection of fluid into the chamber from a hypodermic needle. The device can have a plurality of tabs coupled to the posterior portion of the shell having one or more colors or attributes. The device can also include an orientation indicator visible along the anterior portion of the shell for assisting a clinician and orienting the device during the implantation procedure.
Abstract:
A device can be used for both tissue expansion within a body of a patient as well as a permanently implanted prosthesis. Such a device can include an expandable elastomeric matrix and granules of a solute embedded within the matrix. The matrix can define boundaries of a plurality of chambers within the matrix. The device, when implanted within the body of the patient, can be exposed to fluid within the patient to create an osmotic gradient across a boundary of the device. Based on the gradient, fluid permeates the elastomer and gradually expands the chambers. The rate of expansion can be programmed to allow the body to naturally adapt to the volume, which increases until achieving a target volume in an expanded state.
Abstract:
A tissue expansion device can be implanted temporarily beneath skin of a patient and removed upon predetermined expansion of overlying tissue. The device can include an expandable shell having a smooth or glossy outer surface and an injection port. The expandable shell can form an expandable chamber and have an anterior portion and a posterior portion. The injection port can be coupled to the anterior portion of the shell and be in fluid communication with the chamber and configured to permit injection of fluid into the chamber from a hypodermic needle. The device can have a plurality of tabs coupled to the posterior portion of the shell having one or more colors or attributes. The device can also include an orientation indicator visible along the anterior portion of the shell for assisting a clinician and orienting the device during the implantation procedure.
Abstract:
A soft breast prosthesis is provided, the prosthesis having a surface configuration advantageous for dual plane placement of the prosthesis in a breast.
Abstract:
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.
Abstract:
A breast implant includes a flexible shell having an anterior face including an outer surface and an inner surface, and a marker attached to the inner surface of the anterior face of the shell. The marker includes a first layer of material having a radiopaque surface with readable characters for identifying a characteristic of the breast implant while in vivo, and a second layer of non-radiopaque material laminated onto the radiopaque surface. The readable characters defined by an outline formed from an absence of at least a portion of material of the radiopaque surface. The first layer of material with the readable characters is interposed between the inner surface of the anterior face of the shell and the second layer, and the readable characters are viewable in vivo using conventional imaging techniques.
Abstract:
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 to 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.