Abstract: A tissue expander is disclosed herein. The tissue expander may comprise a shell defining a chamber, and having a flexible wall and a port disposed through the flexible wall. The shell may also include a channel disposed through the flexible wall. A first syringe containing a first volume of a liquid may be connected to the chamber of the tissue expander via the channel. A second syringe containing a second volume of the liquid may be connected to the chamber via the port at least approximately one week after the first volume of liquid is injected. The first volume of liquid may be injected more quickly than the second volume of liquid.

Abstract: A delivery sleeve for assisting delivery of a tissue implant may include an enclosure an orifice, and a throat. A cinching mechanism, which may include a fastener, may be disposed about the throat. The fastener may be used to fasten the cinching mechanism in a cinched configuration to maintain the throat in a closed configuration. The cinching mechanism may include implant-size indicators thereon. A lubricant or lubricious material may be included upon an inner surface of the enclosure. The cinching mechanism may be used to change the configuration of the throat from an open configuration to a closed configuration. The fastener helps maintain the throat in a closed configuration.

Abstract: A method of making an implantable prosthesis includes applying a gelling enhancer layer over an inner surface of a wall of a silicone shell having anterior and posterior walls surrounding an interior volume. The method includes filling the interior volume of the shell with a silicone gel and curing the silicone gel. The cured silicone gel that is located within a zone that is in the vicinity of the gelling enhancer layer has a higher level of cohesiveness than the cured silicone gel that is located outside the zone. The zone of the silicone gel having the higher level of cohesiveness has a thickness of 2-10 mm. The silicone gel located outside the zone has a first concentration level of a gelling enhancer and the silicone gel located within the zone has a second concentration level of the gelling enhancer that is 5%-300% greater than the first concentration level.

Abstract: A method of removing fluid from breast tissue surrounding a tissue expander includes identifying a location of an injection port of a tissue expander, and obtaining a needle including a needle shaft defining a lumen, the needle including a closed tip at the distal end of the needle shaft and at least one lateral opening formed in an outer wall of the needle shaft that is in fluid communication with the lumen. The method includes inserting the closed tip of the needle through skin of the patient, the breast tissue, and the injection port until the closed tip of the needle contacts a needle guard, visually confirming that the at least one lateral opening of the needle is not located outside of the patient's skin, and aspirating fluid from the breast tissue via the at least one lateral opening of the needle.

Abstract: The subject matter disclosed herein relates to an encoded cinching mechanism for use with an implant delivery sleeve. The delivery sleeve includes: an enclosure having a first portion, an orifice, and a throat disposed between the first portion and the orifice; and a cinching mechanism disposed about the throat, in which the cinching mechanism comprises a plurality of demarcations each of which are indicative of a sized opening of the throat.

Abstract: A suture implant for approximating tissue without tying knots includes a suture having a first end with a fixed knot, a second end, and a slip knot located between the first and second ends, which defines a large suture loop having a length. The slip knot defines a dynamic end of the large suture loop that is located opposite a closed end of the large suture loop. A tissue anchor is coupled with the first end of the suture. Pulling the second end of the large suture loop away from the slip knot slides the slip knot and the tissue anchor toward the closed end of the large suture loop and reduces the length of the large suture loop. The suture implant includes a needle having a leading end and a trailing end and a small suture loop secured to the trailing end of the needle that is coupled with the closed end of the large suture loop.

Abstract: 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.

Abstract: An adjustable implant is disclosed herein. The adjustable implant may comprise a shell including membrane and a base and having a first diameter in a plane parallel to the base. A band may be disposed within the shell. The band may have a first end and a second end connected to a spool. The band may be in a round (e.g., elliptical) configuration having a second diameter in the plane that is less than the first diameter. By wrapping the band onto the spool, the diameter of the band may be decreased and the height of the implant may be increased. By unwrapping the band from the spool, the diameter of the band may be increased and the height of the implant may be decreased.

Abstract: The present disclosure describes various embodiments of adjustable implants, particularly permanent breast implants, intended for implantation into a subject, particularly a human subject. In some embodiments, the adjustable implant comprises a shell including a resilient shell membrane, a first reservoir containing a fluid, e.g., a saline, a second reservoir including a resilient second-reservoir membrane, and a pump. The pump may include a first pump actuator, a first pump inlet, and a first pump outlet. The first reservoir and second reservoir may be disposed within the shell and be in fluid communication via the pump. Fluid may be transferred between the two reservoirs to change the profile of the implant.

Abstract: A tissue expander having an integrated drain includes a shell having an opening and one or more drainage holes, and an injection port disposed in the opening of the shell and forming a fluid-tight seal with the shell. The injection port includes a needle guard having a needle guard base with a top surface. The injection port includes a moveable barrier membrane overlying the top surface of the needle guard base. The moveable barrier membrane is moveable between a first position for inflating and deflating the shell with a first fluid and a second position for draining a second fluid from outside the shell. A magnet is coupled with the moveable barrier membrane, and a compressible spring is connected with the magnet. The compressible spring is compressed for storing energy as the moveable barrier membrane moves from the first position to the second position.

Abstract: An implantable prosthesis includes a silicone shell having an apex, a base, a radius located between the apex and the base, and a dome extending between the apex and the radius. The silicone shell has an outer surface and an inner surface that surrounds an interior volume of the silicone shell. A silicone gel material is disposed within the interior volume of the silicone shell. A gelling enhancer layer containing a gelling enhancer covers the inner surface of the silicone shell. After the silicone gel material has been thermally cured, the silicone gel material that is located within a zone that is in the vicinity of the gelling enhancer layer has a higher level of cohesiveness than the silicone gel material that is located outside the zone. The gelling enhancer contains crosslinker and/or platinum catalyst, such as a Karstedt catalyst.

Abstract: A wound closure assembly includes an insertion tool having a proximal end and a distal section, such as a curved distal section, having a penetrating tip and first and second notches that are formed on opposite sides of the distal section. The assembly includes a tissue anchor having a hollow body and an insertion tool channel extending through the hollow body. First and second spaced tips project distally from the distal end of the hollow body and oppose one another on opposite sides of the insertion tool channel. The distal section of the insertion tool is inserted into the insertion tool channel of the tissue anchor so that the penetrating tip is distal to the first and second spaced tips, with the first and second spaced tips nested within the first and second notches for generating a releasable interference fit between the tissue anchor and the insertion tool.

Abstract: A tissue expander is disclosed herein. The tissue expander may comprise a shell defining a chamber, and having a flexible wall and a port disposed through the flexible wall. The shell may also include a channel disposed through the flexible wall. A first syringe containing a first volume of a liquid may be connected to the chamber of the tissue expander via the channel. A second syringe containing a second volume of the liquid may be connected to the chamber via the port at least approximately one week after the first volume of liquid is injected. The first volume of liquid may be injected more quickly than the second volume of liquid.

Abstract: An implant-delivery sleeve may comprise an enclosure having at least one opening and at least one vent conduit. The vent conduit may extend along a surface of the enclosure to assist in removing fluids (e.g., blood and air) from the tissue pocket to facilitate implantation of the implant.

Abstract: A method of making a self-sealing patch for a tissue expander implant includes providing a first sheet having a first sheet outer perimeter and a first sheet inner edge defining a first central opening, providing a second sheet having a second sheet outer perimeter and a second sheet inner edge defining a second central opening, aligning the first and second sheet outer perimeters and the first and second sheet inner edges, capturing an outer washer between the first and second sheet outer perimeters for attaching the first and second sheets together, and capturing an inner washer between the first and second sheet inner edges for attaching the first and second sheets together. The method includes spacing an inner perimeter of the outer washer from an outer perimeter of the inner washer to form a sealed annular space between the attached first and second sheets, and disposing a hydrophobic material within the sealed annular space.

Abstract: A tissue expander having an integrated drain includes an outer shell having an opening and one or more drainage holes. An injection port is disposed in the opening of the shell and forms a fluid-tight seal with the shell. The injection port includes a needle guard having a needle guard base with a top surface, and a barrier membrane that overlies the top surface of the needle guard base. The barrier membrane defines an inflation chamber located between the top surface of the needle guard base and a bottom surface of the barrier membrane, and a drainage chamber overlying a top surface of the barrier membrane. The tissue expander includes one or more inflation ports that are in fluid communication with the inflation chamber for inflating and deflating the outer shell with a first fluid. A drainage conduit is in fluid communication with and extends between the drainage chamber and the one or more drainage holes for draining a second fluid from outside the shell.

Abstract: An implantable prosthesis includes a shell having an apex, a base, a radius located between the apex and the base, and a dome extending between the apex and the radius. The shell has an outer surface and an inner surface that surrounds an interior volume of the shell. At least one rib is integrally formed with the inner surface of the shell and projects inwardly from the inner surface of the shell into the interior volume of the shell. The shell has an interior volume that is adapted to receive a biocompatible filler material.

Abstract: A mammary tissue expander device including an inflatable shell having an anterior side and a posterior side, the anterior side having an upper pole portion and a lower pole portion meeting at an apex, and an injection port for receiving fluid therethrough to inflate the expander, and a substantially flat attachment flap coupled to the posterior side of the shell, and extending in an inferior direction beyond an inferior edge of the shell by a distance D such that the attachment flap may be extended around the inferior edge and upwards to overlay at least a portion of the anterior side of the shell.