A size adjustable cover used for soft tissue reinforcement which is adapted to envelop an implantable device, such as a breast implant, in a surgical application. The cover is formed using a circular two-dimensional implantable matrix material having an inner circle and a plurality of fringes which radiate circumferentially from the inner circle. The implantable device is positioned upon the inner circle, and the plurality of fringes are folded inwardly to form an overlapping implant pocket which envelops the implantable device. Each fringe further has a punched opening, allowing a loop of suture thread to link each fringe together. Certain fringes are excluded from the loop to create stabilization tabs which radiate from the inner circle and are attached to a site of host implantation to stabilize the cover and the implantable device within.

A device to be implanted in a subject's body to form an implant for replacing and/or increasing a volume of soft tissue, the device being of the type including a three-dimensional frame which defines an inner space in the frame. The frame is typically bio-absorbable and includes two side apertures forming a transverse passage for inserting a vascular pedicle. The device further has at least two bio-absorbable textile sheets that can be stacked on each other in the inner space of the frame.

A device to be implanted in a subject's body to form an implant for replacing and/or increasing a volume of soft tissue, the device being of the type including a three-dimensional frame which defines an inner space in the frame. The frame is typically bio-absorbable and includes two side apertures forming a transverse passage for inserting a vascular pedicle. The device further has at least two bio-absorbable textile sheets that can be stacked on each other in the inner space of the frame.

An implantable prosthetic device, such as a breast implant, includes a shell made of a biocompatible elastomeric material. The shell has a front portion and a base that surround an interior volume of the shell. A scaffold is disposed within the interior volume of the shell. The scaffold has an inner surface facing the base and an outer surface facing the front portion of the shell. A silicone gel is disposed within the interior volume of the shell. The scaffold has a shape that mirrors the shape of the front portion of the shell. The scaffold reinforces the shell to provide form stability for maintaining the shape of the shell and minimizing folding, dimpling and/or wrinkling of the shell. A second scaffold may be nested within the first scaffold. The second scaffold has a smaller outer dimension than an inner dimension of the first scaffold.

An implantable prosthetic device, such as a breast implant, includes a shell made of a biocompatible elastomeric material. The shell has a front portion and a base that surround an interior volume of the shell. A scaffold is disposed within the interior volume of the shell. The scaffold has an inner surface facing the base and an outer surface facing the front portion of the shell. A silicone gel is disposed within the interior volume of the shell. The scaffold has a shape that mirrors the shape of the front portion of the shell. The scaffold reinforces the shell to provide form stability for maintaining the shape of the shell and minimizing folding, dimpling and/or wrinkling of the shell. A second scaffold may be nested within the first scaffold. The second scaffold has a smaller outer dimension than an inner dimension of the first scaffold.

A tissue expansion system includes an expandable bladder for placement beneath the skin corresponding to a tissue to be expanded, a fluid source, a pump coupled to both the fluid source and the expandable bladder to deliver inflation medium thereto, a controller for the pump, a pressure sensor for monitoring pressure within the expandable bladder and informing the action of the controller, and a carrier for holding at least the fluid source, pump, and controller. The carrier is wearable as a bra or form-fitting vest and is shaped to mimic the appearance of natural breasts for the patient. The fluid source can have an outward facing surface that is relatively rigid to maintain a curved shape mimicking that of natural breast(s). The inward facing surface of the fluid source may be flexible to conform to the shape of the underlying skin and tissue as it is expanded.

A tissue expansion system includes an expandable bladder for placement beneath the skin corresponding to a tissue to be expanded, a fluid source, a pump coupled to both the fluid source and the expandable bladder to deliver inflation medium thereto, a controller for the pump, a pressure sensor for monitoring pressure within the expandable bladder and informing the action of the controller, and a carrier for holding at least the fluid source, pump, and controller. The carrier is wearable as a bra or form-fitting vest and is shaped to mimic the appearance of natural breasts for the patient. The fluid source can have an outward facing surface that is relatively rigid to maintain a curved shape mimicking that of natural breast(s). The inward facing surface of the fluid source may be flexible to conform to the shape of the underlying skin and tissue as it is expanded.

Methods of processing images, such as ultrasound images, to determine integrity of an implant are described. The method may include receiving an ultrasound image of an implant in a body of a subject; determining one or more characteristics of a surface of the implant based on an intensity of pixels of the ultrasound image; generating a predicted status of the implant based on the one or more characteristics by comparison of the one or more characteristics with a database of image data; and displaying the predicted status of the implant. The implant may be a breast implant, for example, wherein the method is useful for analyzing the presence or probability of extracapsular ruptures, contractures, and combinations thereof.

Methods of processing images, such as ultrasound images, to determine integrity of an implant are described. The method may include receiving an ultrasound image of an implant in a body of a subject; determining one or more characteristics of a surface of the implant based on an intensity of pixels of the ultrasound image; generating a predicted status of the implant based on the one or more characteristics by comparison of the one or more characteristics with a database of image data; and displaying the predicted status of the implant. The implant may be a breast implant, for example, wherein the method is useful for analyzing the presence or probability of extracapsular ruptures, contractures, and combinations thereof.

A medical device may include a shaft extending between a proximal end and a distal end. The shaft may include a lumen therein. The medical device may include a handle coupled to the proximal end of the shaft and may include a mode selector. The mode selector may be adapted to transition between a first mode and a second mode of the medical device. The medical device may further include a compressed fluid source. In the first mode, the compressed fluid source may be fluidly coupled with the shaft so as to impart a negative pressure in at least a portion of the lumen. In the second mode, the compressed fluid source may be fluidly coupled with the shaft so as to impart a positive pressure in the at least a portion of the lumen.