Abstract: The present invention relates to surgical instruments and methods for enhancing properties of tissue repaired or joined by surgical staples and, more particularly to surgical instruments and methods designed to enhance the properties of repaired or adjoined tissue at a target surgical site, especially when sealing an anastomosis between adjacent intestinal sections to improve tissue viability under hypoxia conditions, prevent tissue inflammation, and to prevent leakage. The present invention further relates to hypothermic circular stapling instruments configured to pre-cool the tissues being joined by staples.

Abstract: The present invention is directed to devices and methods for monitoring the purity of monomers, adjusting the polymerization conditions, and consequently improving a polymerization reaction process. In one method, monomer purity is estimated using an on-line evaluation by raising the temperature of the monomer formulation having a defined melting point to a first elevated temperature at least 20° C. above a preset melting point for a selected monomer formulation; cooling the monomer formulation at a controlled cooling rate in the range from about 0.5 to 50° C. per minute; measuring at least one critical property selected from the group consisting of a) crystallization peak temperature at the onset of crystallization, b) an area under the crystallization peak, which represents the heat or enthalpy of crystallization, ?Hc and combinations thereof, comparing the at least one of the selected critical properties measures relative to such properties for standard setting monomer formulations.

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 novel two-step process for batch coating surgical needles with cross-linked silicone coatings is disclosed. The surgical needles are cured using a two-step process. The coatings on the needles are partially cured in the first step and mechanically separated. The coatings on the needles are then fully cured in the second step.

Abstract: A non-hazardous cleaning solution/process has been developed to remove oxide residues from the surface of blackened needles. Low concentrations of citric acid solution are mixed with blackened needles and treated in an ultrasonic tank for short period of time (<5 minutes). The oxide residues are substantially removed. Quite surprisingly and unexpectedly, the penetration performance of the cleaned needles are greatly improved by up to 50% over other tested cleaning solutions.

Abstract: The present invention relates devices capable of continuous and simultaneous expression of components of a multi-part biomedical composition with variable mixing ratios. The device has at least two syringes that contain the inter-reactive components of the multi-part biomedical composition. At least the barrel of the first syringe has a first retention compartment having a cross-sectional area dimension that is larger than the cross-sectional area of a second retention compartment. The first piston has a cross-sectional dimension that matches the inside cross-sectional dimension of the small dimensioned retention compartment, while a ring-shaped gasket is located within the large dimensioned retention compartment and has an outside cross-sectional dimension that matches an interior dimension of the large dimension retention compartment.

Abstract: The present invention is directed to circular surgical staplers for anastomotic joining of tissue comprising a stapling head connected to an opposing anvil, said stapling head containing a plurality of deployable staples in concentric arrays; a plurality of resorbable medicant-releasing microneedles, the microneedles comprising elongated rods having a sharp tissue-penetrating distal end and a proximal end; with the microneedles releasably disposed on or within the stapling head or the anvil. The present invention is also directed to methods of use of such stapler devices.

Abstract: A scaffold for joining two layers of tissue, comprises a substantially flat and flexible body having a top surface, a bottom surface and sidewalls; at least one channel within the body starting at an injection port; a plurality of first passages on the top surface and a plurality of second passages on the bottom surface, said passages in fluid communication with the channel; a plurality of third passages penetrating the body from the top surface to the bottom surface, said plurality of third passages not in fluid communication with the channel.

Abstract: A device is disclosed for the securement of dermal tissues. The device provides approximation and eversion of the tissue as well as the placement of a fixation element that bridges a wound. The fixation element may be produced in several fixed or dynamic configurations that may or may not alter the ability to engage tissue in response to stresses placed upon the fixation member post-deployment. The delivery device inserts the fastener percutaneously through the epidermis into the sub-dermal position without entering the wound margins with any part of the approximation portion of the delivery device.

Abstract: A swaging system for attaching surgical needles to sutures and testing the attachment strength includes a bottom swaging die and a top swaging die that is configured to move up and down along a swaging axis that is in alignment with the bottom swaging die. The bottom swaging die includes a swaging tool mounted thereon that extends toward the top swaging die along the swaging axis. The swaging tool includes an upper end having a top surface with a swaging notch for swaging a needle to a suture to form an armed surgical needle, and a testing notch, adjacent the swaging notch, for conducting a pull test on the armed surgical needle.

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: Disclosed is an infinitely adjustable depth stop for a laparascopic instrument having a shaft, the depth stop including a first component having a first annular space adapted to allow the shaft to be fitted therethrough. The first annular space has a reducible diameter and an interference surface against which the shaft may be fitted. Upon reduction of the reducible diameter, the interference surface frictionally engages the shaft to arrest relative movement of the depth stop along the shaft. The frictional engagement may be along a curve, a spiral curve, or an area. Means are also provided to reopen the reducible diameter to release the depth stop.

Abstract: The present invention relates generally to agents and devices for promoting hemostasis and tissue sealing and, more particularly, to hemostatic pads comprising bioabsorbable scaffolds that can deliver lyophilized hemostasis promoting proteins, such as fibrinogen and thrombin, to a wound site or injured organ or tissue.

Abstract: A device that is inserted through the abdominal wall and into the digestive tract of a human is disclosed. The device may be placed through a method such as percutaneous endoscopic gastrostomy (PEG). The device includes a gastrostomy style structure that provides fluid communication with the external environment of the patient with the internal contents of the stomach. The device is produced with a series of slotted collection channels that preferentially, when connected to a source of negative relative pressure, directs a significant volume of the high calorie fluidic components of the chyme out of the digestive tract, preventing exposure to the absorptive tissues of the digestive tract when simple sugars and carbohydrates are consumed.

Abstract: An applicator instrument for dispensing surgical fasteners includes a housing having a cartridge opening, an elongated shaft extending from the housing, and a cartridge insertable into the cartridge opening, the cartridge having a plurality of surgical fasteners pre-loaded into the cartridge. The applicator instrument has a firing system disposed within the housing, and an actuator for activating the firing system to commence a firing cycle for removing one of the surgical fasteners from the cartridge and driving the removed surgical fastener from the housing to a distal end of the elongated shaft. In one embodiment, the cartridge includes a cartridge body having an upper end and a lower end insertable into the cartridge opening. The surgical fasteners are arrayed in a stack that extends between the upper and lower ends of the cartridge body.

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.