Abstract: The present invention is directed to a multi-compartment medical device for segregated storage and on demand mixing of at least two components and expression of the resulting mixture from the device. The mixing device comprises a syringe having an open end and outlet and containing a first component; and a cap with a fixed outer body and an expandable chamber contained therein, wherein said cap is removably attached to the outlet of the syringe and a cross-section of the cap is larger than a syringe cross-section and the cap is shorter than the syringe.

Abstract: Novel apparatus and methods for coating surgical needles in batch processes are disclosed. The apparatus and methods are particularly useful for applying uniform silicone lubricious coatings to surgical needles in bulk quantities using a novel separation and spray coating system and method.

Abstract: A novel caloric bypass device that is inserted through the oral cavity and into the digestive tract of a human is disclosed. The device is deliverable as either a unitary or modular structure that preferentially directs a significant volume of the high calorie fluidic components of the chyme through the digestive tract, preventing exposure to the absorptive tissues of the digestive tract and, in some forms, stimulates negative feedback to the patient when simple sugars and carbohydrates are consumed. Also disclosed is a novel method of reducing or restricting caloric intake using this device to prevent or minimize contact with the absorptive tissues of the digestive tract.

Abstract: An applicator instrument for dispensing surgical fasteners includes a housing, an elongated shaft having a proximal shaft section and an articulating distal shaft section extending from the housing, a firing system disposed within the housing, an actuator that is engageable for commencing a firing cycle of the firing system, and an articulation lever provided on the housing for selectively articulating the articulating distal shaft section of the elongated shaft. The applicator instrument includes a cam plate disposed within the housing that is linked with the articulating distal shaft section and that coupled with the articulation lever for being rotated by the articulation lever between a first or horizontal position for straightening the articulating distal shaft section and a second or vertical position for articulating the articulating distal shaft section.

Abstract: A surgical fastener includes a first leg having a first distal barb and a first proximal barb that extend inwardly, and a second leg having a second distal barb and a second proximal barb that extend inwardly. A bridge interconnects proximal ends of the first and second legs. A first distance between opposing inner tips of the first and second distal barbs is greater than a second distance between opposing inner tips of the first and second proximal barbs. The first leg tapers inwardly between the proximal and distal ends thereof and has a cross-sectional area that is greater at the proximal end than at the distal end. The second leg tapers inwardly between the proximal and distal ends thereof and has a cross-sectional area that is greater at the proximal end than at the distal end. An insertion tool engages a crown on the proximal side of the bridge.

Abstract: Provided herein is a single component sealant formulation (e.g. in a liquid form), methods for its preparation, and use. The formulation includes fibrinogen; vitamin K-dependent clotting zymogens comprising at least Factor II (FII) and Factor X (FX).

Abstract: A barbed suture including a body with barbs on the periphery, a pointed end, and an anchor at one end to resist movement of the suture in the direction of the pointed end is provided. One or more limbs on the anchor may be provided, which may be arcuate, of varying lengths, and of varying distribution about the periphery of the suture body. Other anchor designs are provided. Methods of placing single-directional and bi-directional barbed sutures to approximate the tissue on each side of a wound and to position and support tissue in the absence of a wound, as in cosmetic surgery, are provided, and may include terminal J-stitches or S-stitches. Methods of placement may be made with sharp, pointed ends, which may be needles, or insertion devices. Sinusoidal patterns of sutures that have amplitudes generally perpendicular to the resultant holding force of the suture are provided.

Abstract: A novel medical device for treating obesity is disclosed. The device is inserted through the oral cavity and into the digestive tract of a human. The device is a passive catheter-style structure that preferentially directs a significant volume of the high calorie fluidic components of the chyme through the digestive tract, preventing exposure to the absorptive tissues of the digestive tract and, in some forms, stimulates negative feedback to the patient when simple sugars and carbohydrates are consumed. The device may be installed or removed though the use of standard endoscopy, or may be offered in the form of an ingestible device. The device may be inflatable or preformed for use within the digestive tract. Also disclosed is a novel method of using the medical device to control obesity.

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: 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: The present invention is directed to a device for the expression of a hemostatic powder having an elongated reservoir with a manual air pump, such as a bellows, at a proximal end and an expression port at a distal end. A porous filter is slidably disposed within the reservoir between the bellows and plunger and the expression port, and a spring is disposed within the reservoir between the air pump and the plunger. The powder is disposed within the reservoir between the porous filter and the expression port, and the pump is in a fluid communication with the expression port through the porous filter and through the powder.

Abstract: A suture having a first end for penetrating tissue, an elongated suture body having a periphery; a plurality of retainers on the periphery, and a second end having a variable loop of variable circumference, wherein the variable loop includes a fixed loop slidably engaging the elongated body for slidingly varying the circumference of the variable loop, and wherein the first end may pass through the variable loop to secure tissue as an anchor, the anchor preventing movement of the suture in the direction of deployment of the first end.

Abstract: A package for a medical device includes a tray with a top surface, a bottom surface, a proximal end, a distal end, and first and second lateral sides that extend between the proximal and distal ends. The package has a retainer sleeve wrapped around the tray, the retainer sleeve including a top panel covering the top surface of the tray, a bottom panel covering the bottom surface of the tray, and a connecting panel extending between the top and bottom panels and covering one of the first and second lateral sides of the tray. The top panel of the retaining sleeve includes a proximal edge, a distal edge, an outer edge, a cut that extends inwardly from the outer edge, and an extended tab that extends along the outer edge of the top panel and distally beyond the cut formed in the outer edge of the top panel. The extended tab is tucked under the connecting panel and disposed between the connecting panel and one of the first and second lateral sides of the tray covered by the connecting panel.

Abstract: The present invention discloses methods for producing a surgical suture having a reduced cross-sectional area portion from monofilaments fibers of various polymeric and metallic materials. Also disclosed are novel sutures having novel tips. Novel suture tipping apparatuses are also disclosed. The monofilament is subjected to the application of thermal treatment coupled with application of mechanical shaping of the fiber element to produce a deformed cross sectional portion of the suture body. The deformed suture body region is subsequently subjected to a trimming operation within a punching/stamping die. The reduced section of the suture body region and is severed to form a suture having a reduced-cross sectional area end portion. Preferably, each reduced region is severed approximately in the center of the trimmed reduced cross sectional area portion to form a suture having both ends of a reduced cross-sectional area.

Abstract: A wound closure device and a method of its use are disclosed. The wound closure device comprises a wound closure strip, the wound closure strip comprising a wound-facing side and a top side, the wound-facing side comprises an adhesive applied over at least a portion of the wound facing side of the wound closure strip and a non-symmetric, two-part release liner assembly detachably adhered to the adhesive, the release liner assembly comprising a first section and a second section with the second section comprising a wound closure strip-free portion forming a tab.

Abstract: A curved surgical fastener for anchoring medical devices to tissue includes a curved member having a proximal end, a distal end, and a tissue penetrating end at the distal end of the curved member. The curved member has a total curvature of less than 360 degrees between the proximal and distal ends. The proximal end of the curved member lies in a first plane, the distal end of the curved member lies in a second plane that is offset from the first plane, and the curved member has an intermediate section that extends between the first and second planes. The curved member includes a compound curve having a proximal section with a first radius of curvature and a distal section with a second radius of curvature that is different than the first radius of curvature.