Abstract: A device for application onto incisions or wounds with a liquid rapidly polymerizable adhesive for forming skin closure systems, comprising a flat porous mesh elongated along a longitudinal axis and having an upper side and an opposing lower or wound facing side and a central portion in immediate vicinity of the axis; further having a plurality of pores and windows in said mesh, said windows substantially larger than said pores and arranged along said longitudinal axis in said central portion; a crosslinking or polymerization accelerator or initiator disposed in or on said mesh; and a pressure sensitive adhesive disposed on at least a portion of the lower surface of said mesh.

Abstract: A system or device for skin closure comprises an elastic flat flexible tape elongated along a longitudinal axis and having a lower side and an opposing upper side, said tape having a pressure sensitive adhesive on at least a portion of the lower side, said tape having a plurality of openings arranged side-by-side with spaces between said openings oriented across the longitudinal axis.

Abstract: The present is directed to systems for ex vivo testing performance of a hemostatic or sealing product attached to an animal organ and fully covering a cored channel in said organ, comprising: a pressure sensor positioned proximate to said hemostatic or sealing product in said cored channel; a monitoring or recording device configured to receive pressure readings from said pressure sensor; and a pressurized fluid source connected to said cored channel and configured to supply said pressurized fluid into said cored channel under constant or variable pressure. The present invention is also directed to methods of use for such systems.

Abstract: The present invention is directed to a hemostatic semi-solid paste material comprising a bioabsorbable carrier hemostatic material; and a supplemental hemostatic agent; wherein the paste material has an elongated form extending along a lengthwise axis with an aspect ratio of at least 3; wherein the paste is self-supporting and syringe extrudable; and wherein the supplemental hemostatic agent has a non-homogenous distribution profile across a cross-section taken across the lengthwise axis. In another aspect, the present invention relates to devices for forming and expressing the hemostatic material.

Abstract: A breast implant or tissue expander includes an implant shell having an inner chamber and a tube detachably connected with the implant shell. The tube has a first lumen that is in fluid communication with the inner chamber for adding fluid into the inner chamber to increase the size of said implant shell or for removing fluid from the inner chamber to reduce the size of the implant shell. The tube has a second lumen and one or more lateral openings in fluid communication with the second lumen for draining fluid that collects in tissue surrounding the implant shell. The breast implant has a fluid inlet opening formed in the implant shell, and a valve disposed within the fluid inlet opening. The valve is normally biased into a closed position, and is opened by inserting the distal end of the tube into the fluid inlet opening.

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: An implantable device for control over the size of emphysematous bullae in a lung, including: an elongated central region having a fixed axial length; a first end including a first anchor; and a second end including a second anchor.

Abstract: The present invention is directed to a spray applicator for spraying a tissue treatment medicant onto a tissue that has a container containing the medicant and is positioned at a proximal end of the spray applicator; a spray tip positioned at a distal end of the spray applicator; a cannula connecting the container with the spray tip; an actuatable dispensing mechanism at a proximal end of the applicator to express the medicant from the container through the cannula and through the spray tip toward the tissue; an optional pressurized gas source discharging a gas through the cannula in the vicinity of the spray tip or inside the spray tip; and a distance indicator that provides indicia of the distance between the spray tip and the tissue but does not prevent positioning the spray tip closer to the tissue than a defined distance for the distance indicator.

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 surgical incision drape, comprises a flexible substantially flat areal substrate having an upper side and an opposing tissue-facing side, having a longitudinal axis and a pressure sensitive adhesive disposed on the tissue-facing side; at least one hollow microtubular compartment containing a flowable medical agent, said hollow microtubular compartment positioned to intersect the longitudinal axis and embedded into the substrate or positioned on the substrate.

Abstract: A disposable coating applicator container for applying a coating of a therapeutic agent upon an object to be coated. The disposable coating applicator container includes a sealable container, the sealable container having a container bottom, the container bottom having upwardly extending walls, each upwardly extending wall terminating in an upper edge, and a closure for sealing a device compartment formed in part by the upwardly extending walls, the closure adjacent to the upper edges of the upwardly extending walls; and a therapeutic agent positioned in fluid communication with the device compartment, wherein the disposable coating applicator container comprises a flexible material and is in the form of a bag-like structure.

Abstract: Provided are rapidly cross-linkable silicone compositions, systems, kits, and methods for filling implanted medical devices in situ, the implanted medical devices, including for example, body implants and tissue expanders, the compositions including a platinum divinyl disiloxane complex; a low viscosity vinyl terminated polydimethylsiloxane; a low viscosity hydride terminated polydimethylsiloxane; and a silicone cross-linker, where the rapidly cross-linkable silicone composition has a viscosity of ?150 cPs for ?1 min. post-preparation and ?300 cPs?5 min. post-preparation, at ambient temperature.

Abstract: A method of reducing surgical site infection (SSI), using a coated medical device having a tissue penetrating surface and an abradable coating on the medical device comprising at least one antimicrobial agent in the coating.

Abstract: The present invention is directed to an implantable medical device, comprising: a device body, with at least a portion of said body coated by a sensing coating that comprises an echogenic material or a radiopaque material, or combinations thereof, said sensing coating configured to dissolve or swell in presence of at least one infection biomarker; wherein a portion of said sensing coating is covered by a protective film, forming a protected portion, said protected portion configured not to dissolve or swell in presence of said biomarker and methods of detecting presence of biomarkers in the vicinity of an implanted medical device.

Abstract: Provided are rapidly cross-linkable silicone foam compositions, kits, and methods for filling implanted medical devices in situ or in vivo, the implanted medical devices, including for example, body implants and tissue expanders, the compositions including a platinum divinyl disiloxane complex; a low viscosity vinyl terminated polydimethylsiloxane; a low viscosity hydride terminated polydimethylsiloxane; a silicone cross-linker; and a gas and/or gas-filled microcapsules, where the rapidly cross-linkable silicone foam composition has a viscosity of ?150 cPs for ?1 min. post-preparation and ?300 cPs?5 min. post-preparation, at ambient temperature.

Abstract: An implant delivery sleeve comprises a tubular wall having a proximal end with a proximal opening, a distal end with a distal opening, and an implant delivery channel extending between the proximal and distal ends of said tubular wall. A plurality of bands interconnect portions of the tubular wall for constricting the implant delivery channel adjacent the distal end of the tubular wall. As an implant is advanced toward the distal end of the tubular wall, the constriction squeezes and/or deforms the implant for facilitating insertion into an incision that is smaller than the normal size of the implant.

Abstract: Novel compositions and systems for closure of wounds are disclosed. The compositions provide devices of improved flexibility and elasticity and are readily applied to wound sites or over wound closure devices. The present invention is also directed to a novel platinum catalyst for use in such compositions. The catalyst provides for rapid curing on topical surfaces such as skin and bonds to such surfaces in about 2-5 minutes.

Abstract: A gas sterilizable syringe includes an enclosure having walls that define a fluid chamber. A flowable material is disposed within the fluid chamber of the enclosure. A plunger is assembled with the enclosure and is moveable toward a distal end of the enclosure for dispensing the flowable material. One or more apertures are formed in at least one of the walls of the enclosure. A gas permeable barrier covers at least one of the apertures formed in at least one of the walls of the enclosure for enabling sterilization gases to pass through the at least one aperture covered by the gas permeable barrier while preventing the flowable material from passing through the at least one of aperture. The gas permeable barrier is permeable to the sterilization gases and impermeable to the flowable material disposed within the fluid chamber of the enclosure.

Abstract: A disposable dressing forms a compartment around and above a wound site and a volatile antimicrobial compound is allowed to sublimate/evaporate into the compartment. A heating element is included in the dressing, with heat stimulating wound healing and simultaneously accelerating sublimation/evaporation of the antimicrobial compound.

Abstract: A device for application onto wounds with a liquid rapidly polymerizable adhesive for forming skin closure systems, comprising a thin flexible flat porous tape, preferably a mesh, elongated along a longitudinal axis and having a lower side or wound-facing side and an opposing upper side, a periphery, and central portion in immediate vicinity of the axis; said tape coated or impregnated with an initiator or accelerator of polymerization; said tape having a plurality of elongated traces of soluble pressure sensitive adhesive (PSA) disposed on the wound-facing side; said traces covering from about 3% to about 50% of area of said tape and extending from the periphery to the central portion of said tape.