Abstract: 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.

Abstract: Diffusion and infusion resistant implantable devices and methods for reducing pulsatile pressure are provided. The implantable device includes a balloon implantable within a blood vessel of a patient, e.g., the pulmonary artery. The balloon is injected with a fluid mixture comprising a constituent fluid(s) and a diffusion-resistant gas to provide optimal balloon volume and limit fluid diffusion throughout multiple cardiac cycles. The fluid mixture may be pressurized such that the balloon is transitionable between an expanded state and a collapsed state responsive to pressure fluctuations in the blood vessel.

Abstract: Full contour absorbable implants for breast surgery redistribute breast volume between the breast's upper and lower poles in exact and desirable ratios. The implants preferably redistribute breast volume so that the upper pole breast volume is 20-40% of the total volume, and the lower pole breast volume is 60-80% of the total volume. The implants are also designed to provide specific curvatures to the poles of the breast, and to angulate the nipple areolar complex slightly skyward so that the patient's nipple is positioned at an angle above the nipple meridian reference line. The implants are designed to be transitory, with sufficient strength retention to allow transition from support of the breast by the implant to support by regenerated host tissue growing in and around the implants, without any significant loss of support during or subsequent to remodeling. The implants may optionally be used with permanent breast implants.

Abstract: Breast fixation devices for use in breast reconstruction and breast augmentation limit the rotation or movement of breast implants after implantation that results in an unnatural appearance of the breast. The breast fixation devices can include a thin-walled enclosure in the shape of a pouch. A breast implant is secured inside the pouch to limit movement by applying compression to the breast implants, or using a mating or interlocking mechanism between the pouch and breast implant. The pouches containing the breast implants are implanted in the breast. Tissue in-growth into the pouch limits movement of the pouch-breast implant assembly and thereby limits rotation, migration, and displacement of the breast implant. The pouches preferably comprise poly-4-hydroxybutyrate or copolymer thereof.

Abstract: Methods, devices and systems for delivering a device assembly into a gastric or other space within the body, allowing the device to expand to occupy volume within the gastric space and, after an effective period of time, delivering a substance or stimulus to begin breakdown of the expanded device so that it may release from the body.

Abstract: The silicone-based ink for additive manufacturing includes a siloxane macromer, and a porogen mixture comprising a water-soluble porogen and a surfactant. The product of additive manufacturing with a silicone-based ink includes a three-dimensional printed structure including a plurality of continuous filaments arranged in a predefined pattern and a plurality of inter-filament pores defined by the predefined pattern of the continuous filaments. In addition, each continuous filament of the three-dimensional printed structure includes a silicone matrix having an open cell structure with a plurality of intra-filament pores, and the intra-filament pores form continuous channels through the silicone matrix.

Abstract: The present invention provides, in various embodiments, a breast implant which can have a shell with an opening. A patch can cover the opening. A silicone gel can be disposed within the shell and an RFID transponder can be embedded within the silicone gel, so that the implant can be conveniently identified while inside the human body.

Abstract: A medical device comprising an implantable subcutaneous access port having a septum penetrable by a needle; the septum having a cavity located between an outer wall and an inner wall, the cavity containing a flowable media comprising a plurality of displaceable particles arranged to move in response to the needle being inserted through the outer wall and into the cavity and reposition around the needle.

Abstract: Implants having symmetry are described. The implant may comprise a biocompatible material and have at least two planes of symmetry, including symmetry about an equator of the implant. The implant may be a body contouring implant, wherein a posterior side of the implant is symmetric about the equator to an anterior side of the implant.

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: Embodiments of the disclosure relate to an optical fiber cable having at least one optical fiber, a cable jacket and a foam layer. The cable jacket includes an inner surface and an outer surface in which the outer surface is an outermost surface of the optical fiber cable. The inner surface is disposed around the at least one optical fiber. The foam layer is disposed between the at least one optical fiber and the cable jacket. The foam layer is made of an extruded product of at least one thermoplastic elastomer (TPE), a chemical foaming agent, and a crosslinking agent. The foam layer has a closed-cell morphology having pores with an average effective circle diameter of less than 100 ?m. Further, the foam layer has a compression modulus of less than 1 MPa when measured at 50% strain.

Abstract: The present disclosure provides tissue products produced from adipose tissues, as well as methods for producing such tissue products. The tissue products can include acellular tissue matrices for treatment of a breast.

Abstract: 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.

Abstract: Provided is a cured product using a composition that is capable of quick curing at low temperatures while having sufficient pot life at room temperature, a method of producing the same, a laminate, and an optical device. A method of producing an organopolysiloxane cured product is provided. The method includes: (i) performing, without irradiating with high-energy radiation, a hydrosilylation reaction upon a composition containing a first hydrosilylation reaction catalyst that exhibits activity in the composition and a second hydrosilylation reaction catalyst that does not exhibit activity when not irradiated with high-energy radiation, but exhibits activity in the composition when irradiated with high-energy radiation, to obtain a thickened material that is fluid at room temperature or a thermoplastic material that is non-fluid at room temperature but exhibits fluidity at 100° C.

Abstract: Packaging for a breast implant, the packaging comprising a lid and a cavity, wherein one of the lid or the cavity is configured to provide direct delivery of the breast implant from the packaging to a surgical pocket. A method for the direct delivery of a breast implant from breast implant packaging to a surgical pocket, the method comprising the steps of: a. ensuring that a delivery device present in a lid or a cavity of the packaging is in a delivery position; b. forming an aperture in the delivery device, thereby opening the packaging; c. transferring the breast implant to the delivery device; d. positioning the delivery device in contact with the surgical pocket; and e. delivering the breast implant to the surgical pocket.

Abstract: Tissue expanders and methods of their manufacture and use are disclosed herein. A tissue expander shell according to the present disclosure may include a shape and topography that facilitates uniform or substantially uniform expansion and contraction of the tissue expander. In at least one example, the shell may include a series of topographical features, such as ridges, grooves, channels, valleys, canals, protrusions, pleats, creases, or folds. In some embodiments, these features may have a curved or wavy cross sectional profile. For example, the shell may include a series of concentric curved ridges.

Abstract: 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.

Abstract: The present disclosure relates to a method for manufacturing nose implant, including obtaining a 3-dimensional image of a nasal bone and a 3-dimensional image of a nasal cavity; modeling a nasal cartilage by applying information of anatomy between the nasal bone, nasal cavity, and nasal cartilage, to the 3-dimensional image of the nasal bone and the 3-dimensional image of the nasal cavity; and modeling an inner shape of where the implant may be seated, from the 3-dimensional image of the nasal bone and the modelled nasal cartilage.

Abstract: Implantable transponders comprising no ferromagnetic parts for use in medical implants are disclosed herein. Such transponders may assist in preventing interference of transponders with medical imaging technologies. Such transponders may optionally be of a small size, and may assist in collecting and transmitting data and information regarding implanted medical devices. Methods of using such transponders, readers for detecting such transponders, and methods for using such readers are also described.

Abstract: Devices, systems, and methods for delivering prosthesis implants into surgically-created implant pockets in a subject and for preventing capsular contracture resulting from surgical insertion of prosthesis implants. The device may include a delivery member operable to wrap around the implant thereby forming a conforming cavity around the implant that conforms to the shape of the implant. The delivery member is also operable to propel the implant from the conforming cavity into the implant pocket in the subject upon the application of mechanical force to the delivery member. The device also includes a shielding member coupled with the delivery member. The shielding member is operable to shield the implant from at least a portion of the dissection tunnel connecting the incision to the implant pocket during delivery of the implant to the implant pocket.

Abstract: The present invention concerns a method to prepare a filler with a hyaluronic acid, which has improved properties of chemical-physical stability over time and optimal viscosity for cutaneous injection. In particular the method comprises a first step in which the hyaluronic acid is crosslinked, and a subsequent step for the neutralization and hydration of the crosslinked hyaluronic acid.

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: Disclosed is a process for the preparation of hydrogels consisting of crosslinked glycosaminoglycans, which comprises: a) reacting at least one hybrid cooperative complex obtained by heating aqueous solutions of low- and high-molecular-weight glycosaminoglycans at 80-160° C. with a diepoxide as crosslinker in a ratio with the complex ranging between 0.1 and 1 equivalents, preferably between 0.2 and 0.4 equivalents, the concentration by weight of the complex in the solution ranging between 1% and 15%, preferably between 2% and 10%; b) purifying by dialysis, ultrafiltration and diafiltration.

Abstract: Techniques and devices for improved breast surgeries are provided. The devices can include tissue matrix and synthetic meshes for surrounding breast implants or tissue expanders to provide improved implant outcomes for pre-pectoral implantation or other implantation techniques.

Abstract: A novel and advantageous implant device and methods for implanting the device are provided. Particularly, novel and advantageous devices and methods for breast reconstruction are provided. More particularly, novel and advantageous devices and methods for breast reconstruction to provide a more realistic form are provided.

Abstract: A tapered sleeve is provided that includes a lubricating coating on an inner surface. An implant (e.g., a pre-filled silicon breast implant) is introduced into a large end of the sleeve and extruded into a surgical pocket of minimal access incision size through a small-sized end of the apparatus.

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 elastomeric polymer, comprising (1) a hard segment in the amount of 10% to 60% by weight of the elastomeric polymer, wherein the hard segment includes a urethane, urea or urethaneurea; and (2) a soft segment in the amount of 40% to 90% by weight of the elastomeric polymer. The soft segment comprises (a) at least 2% by weight of the soft segment of at least one polyether macrodiol, and/or at least one polycarbonate macrodiol; and (b) at least 2% by weight of the soft segment of at least one polyisobutylene macrodiol and/or diamine.

Abstract: Full contour absorbable implants for breast surgery redistribute breast volume between the breast's upper and lower poles in exact and desirable ratios. The implants preferably redistribute breast volume so that the upper pole breast volume is 20-40% of the total volume, and the lower pole breast volume is 60-80% of the total volume. The implants are also designed to provide specific curvatures to the poles of the breast, and to angulate the nipple areolar complex slightly skyward so that the patient's nipple is positioned at an angle above the nipple meridian reference line. The implants are designed to be transitory, with sufficient strength retention to allow transition from support of the breast by the implant to support by regenerated host tissue growing in and around the implants, without any significant loss of support during or subsequent to remodeling. The implants may optionally be used with permanent breast implants.

Abstract: Devices, systems, and methods for delivering prosthesis implants into surgically-created implant pockets in a subject and for preventing capsular contracture resulting from surgical insertion of prosthesis implants. The device may include a delivery member operable to wrap around the implant thereby forming a conforming cavity around the implant that conforms to the shape of the implant. The delivery member is also operable to propel the implant from the conforming cavity into the implant pocket in the subject upon the application of mechanical force to the delivery member. The device also includes a shielding member coupled with the delivery member. The shielding member is operable to shield the implant from at least a portion of the dissection tunnel connecting the incision to the implant pocket during delivery of the implant to the implant pocket.

Abstract: A device having a structured coating for adhering to rough, in particular biological, surfaces, includes a carrier layer, wherein a plurality of protrusions is arranged on the carrier layer, which protrusions each comprise at least a shaft having an end face pointing away from the surface, and wherein a further layer is arranged at least on the end face, wherein the layer has a different modulus of elasticity than the protrusion in question. The further layer can also fill the intermediate spaces between the protrusions such that an internal structured coating is produced.

Abstract: 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.

Abstract: A prosthetic insertion apparatus and related methods of use in delivering filled prosthetic bladders through a skin incision and into a surgical cavity or pocket. The prosthetic insertion apparatus imparts control and retention properties to a surgical professional such the prosthetic bladder can be oriented and manipulated into the surgical cavity without risk of inadvertent dropping of the prosthetic bladder and without imparting damaging stress or torque to the bladder. Suitable materials can be utilized that are selected as having advantageous properties including lubricity, rigidity, easily sterilizable, and high strength.

Abstract: Systems and methods for an extended tissue expander according to various aspects of the present technology may function in conjunction with a graft material for temporary implantation into a patient to form a pocket for a permanent implant. Systems and methods may comprise an extended tissue expander comprising an extension portion that may be integral to a posterior section of a shell of the extended tissue expander, wherein the extension portion extends from the posterior section forming an at least partially continuous annular rim around the circumference of the shell. The graft material may overlay an anterior portion of the shell and may be coupled to the at least partially continuous annular rim with bioabsorbable sutures. Upon implantation, the shell may be partially filled with a filler material until the graft material is gently pressed against a posterior portion of the patient skin flap, promoting its integration.

Abstract: A prosthetic implant transfer device is provided that may be used to insert a prosthetic implant through a surgical opening. In some embodiments, the device may comprise a flexible sheet of material that may be formed into an elongated hollow structure. The flexible sheet of material includes a plurality of fasteners that may be selected and engaged to define a desired size distal opening.

Abstract: A dermal tissue allograft includes a dermal matrix having a profile including first and second vertices, a first imaginary axis extending between the first and second vertices, a first peripheral edge extending along a continuous path from the first vertex to the second vertex on a first side of the first imaginary axis, and a second peripheral edge extending along a continuous path from the first vertex to the second vertex on a second side of the first imaginary axis. The first peripheral edge includes an apogee, a convex portion, and a concave portion. The convex and concave portions meet at a transition point located on the first peripheral edge between its apogee and the second vertex. The second peripheral edge includes an apogee and is convex. The second perpendicular distance is greater than the first perpendicular distance. The dermal matrix has a substantially uniform thickness across its profile.

Abstract: A method for coating a sterile breast prosthesis packaged within a sterile blister package with a lubricious material while maintaining the sterility of the breast prosthesis is described.

Abstract: An implantable portal includes a septum that has embedded therein an indicia adapted to identify at least one characteristic of the portal. The indicia may be formed as an impression at a base layer of the septum, and is filled with a radiopaque material. The septum base layer is covered by liquid silicone, which bonds with the septum base layer when solidified, so that an integral one-piece septum, with the identifier indicia embedded therein, is effected. The indicia embedded septum is fitted to the reservoir housing of the portal for providing identification information for that portal. The septum embedded indicia is viewable visually and also by x-ray or computer tomography imaging.

Abstract: The invention provides new devices for implantation in a patient having irregular textured surfaces, which devices show significantly improved cellular response compared to conventional smooth and textured implants, indicating that significantly improved biocompatihility would be achieved in vivo. Methods for making such new devices and surface textures are also disclosed.

Abstract: The breast implant of the present invention comprises a first pouch, a plurality of second pouches, and a plurality of third pouches. The first pouch has a first enclosing membrane and a first lumen formed by the first enclosing membrane. The interior of the first lumen includes a dome and a bottom portion corresponding to the dome. Each second pouch has a second enclosing membrane and a second lumen formed by the second enclosing membrane. The second pouches are provided in the first lumen and radiate from the center of the dome. Each third pouch has a third enclosing membrane and a third lumen formed by the third enclosing membrane. The third pouches are provided between the second pouches in the first lumen and are arranged in strings that extend from the center of the dome.

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: By rotationally casting soft robots, no bonding of different material layers is required. Soft robots including one or more integrated enclosed compartments are constructed from fibers that are embedded directly into the mold prior to adding elastomeric precursors.

Abstract: A nipple implant assembly and method for implanting the nipple implant are provided. The nipple implant assembly includes a nipple skeleton with or without areola made of metallic or non-metallic memory-shape bio-compatible material. The nipple implant assembly may consist of holes to allow growth of natural breast tissue into the implant for improved holding better attachment of the implant into the human's tissue. The nipple implant assembly may be coated by or cast in a polymeric coating.

Abstract: Apparatus, systems, and methods for inserting prosthesis implants into surgically-created implant pockets in a subject and for preventing capsular contracture resulting from surgical insertion of prosthesis implants. The apparatus includes a base having an upper surface and a lower surface and having an aperture formed therein which extends through the upper surface and the lower surface of the base. The apparatus also includes a tubular member that is coupled to the base. The inner bore of the tubular member is operable to receive the implant and has a substantially uniform cross-sectional width over the predetermined length. The apparatus is capable of shielding the implant from microbial contamination, including contamination by the endogenous flora of the subject, during insertion of the implant into the surgically-created implant pocket.

Abstract: Devices and methods of treatment useful in implantation and post-implantation procedures are described. The devices and methods may be used to correct deformities and/or asymmetries in tissues near an implant, support tissues near an implant, and/or refine the shape of an area of the body after placement of an implant, for example. The method may include inserting a cannula into tissue adjacent to or near an implant of a patient, and delivering fat or other filler material(s) to the tissue, wherein the cannula is configured to prevent or otherwise minimize the risk of damaging the implant, e.g., a breast implant. The cannula may include an elongate member having a lumen therein, an atraumatic distal tip, and an opening disposed proximal to the distal tip, the opening being in fluid communication with the lumen for delivering the fat or other filler material(s).

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.

Abstract: A sensor device includes a first detector circuit, a near field communication (NFC) circuit, and a sensor package. The first detector circuit configured to detect a stimulus using a resistive change polymer type detector, a capacitive shift polymer type detector, a dielectric change polymer type detector, a graphene based sensor, or a metal-oxide (MOX) type detector. The NFC circuit having an NFC powered receiver and an NFC data transceiver. The NFC power receiver configured to receive power from a mobile device using an NFC standard protocol and to provide operating power for the sensor device. The NFC data transceiver configured to transmit data to the mobile device using the NFC standard protocol, the data corresponding to the first stimulus. The sensor package configured to house the first detector circuit and the NFC circuit.

Abstract: The disclosure describes a breast implant device product that mimics the natural pectoral fat of the breast and is characterized by an incomplete pyramid with isosceles triangular base and wedge-shaped edges and sloping faces that meet at acute angles with variable degree located medially, laterally, and on the top and a footprint characterized by a semicircular lower portion and an oval paraboloid upper portion and a center of gravity located closer to the footprint than to the profile, the said footprint is advantageously converging and moving towards the underlying surface as the chest wall with a method of manufacturing and a method of use of the said implant including a breast pyramid sizing system.

Abstract: The invention relates to a three-dimensional medical implant, comprising a first thin porous component, and a first load-bearing and volume-creating component, which is connected to the first thin porous component; wherein the load-bearing and volume-creating component comprises an organized structure.

Abstract: Improved breast prostheses, methods of making breast prostheses, and methods of treatment using such breast prostheses are described.