Abstract: A method for manufacturing a monofilament barbed suture. The method includes positioning a mandrel device adjacent to a rotary mount on which a razor is mounted, the mandrel device comprising a mandrel mounted to a fixture, a filament in contact with a curved surface of the mandrel; and rotating the razor with the rotary mount so that an edge of the razor impinges upon an exterior surface of the filament to impart a linear cut to the filament to a cut depth within the filament to form a barb. The mandrel has a diameter of 4 millimeters or less.

Abstract: The invention relates to a rapid setting liquid lung sealant that forms a highly adherent and elastic hydrogel. Provided are lung sealants comprising two high molecular weight (20 kDa) multi-arm PEG compositions wherein the first PEG composition includes an alkaline buffer and the second PEG composition includes a mildly acidic buffer for optimized set up time and extended working time. In some embodiments, the PEGs further comprise a radioprotectant such as tocopherol. In some embodiments, a colorant is added to one or both PEGs of the lung sealant to improve visualization of the lung sealant against human lung tissue.

Abstract: The present invention is directed to methods for processing absorbable, slow-to-crystallize poly(p-dioxanone) ground resin and its fines utilizing a twin-screw extruder apparatus to produce uniform pellets. Advantageously, the ground resin materials resulting from solid-state polymerization do not undergo processing, such as sieving, to remove fines from the feedstock for an extrusion and pelletizing system that has been configured with an inverted temperature profile along the extrusion barrel. The resulting PDS pellets have improved resin uniformity and greater polymer yield for improved operational efficiencies and production of extruded filaments.

Abstract: The present invention is directed to a sealant patch for use on or over sensitive tissue, comprising: a flat, flexible, bioresorbable substrate coated by a moisture-activated adhesive on one side thereof, wherein said adhesive is at least partially inactivated in a first portion of said patch, but remains active in peripheral areas surrounding the first portion. The adherence of the first portion to the tissue is weaker versus adherence in the peripheral areas. The adhesive in the first portion is fully or partially inactivated or pre-reacted prior to application of the sealant patch to the tissue.

Abstract: A method of making a biocompatible composition for sealing tissue includes mixing a first fluid having a first reactive component (e.g., an electrophile) and a second fluid having a second reactive component (e.g., a nucleophile) to form a mixture and expressing the mixture. During expression, a pH modifying fluid (e.g., NaOH) is added to the mixture at a rate that changes. In one embodiment, a higher ratio of the pH modifying fluid is added to the mixture during a first expressing stage and a lower ratio of said pH modifying fluid is added to the mixture during a second expressing stage. During the first expressing stage, a mixing ratio of the pH modifying fluid, the first fluid and the second fluid is 0.7-1.4:1:1. During the second expressing stage, the mixing ratio of the pH modifying fluid, the first fluid and the second fluid is 0.12-0.24:1:1.

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 system for dispensing a biocompatible reactive formulation includes a first chamber containing a first fluid having a first reactive component, a second chamber containing a second fluid having a second reactive component, and a third chamber containing a third fluid.

Abstract: Novel compositions and systems for closure of wounds with antimicrobial effectiveness 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: The present invention is directed to an absorbable hemostatic nonwoven patch that utilizes a biocompatible substrate comprised of melt-blown microfibers as webbed sheets that are layered and bonded/entangled in descending density and ascending porosity; with the substrate having a high flexibility, strength and porosity that is suitable for coating cross-linkable active molecules and ability for laparoscopic use or trocar deployment, ultimately for functional use as a highly effective hemostat in addressing problematic bleeding during both open and minimally invasive surgical procedures.

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: Novel compositions and systems for closure of wounds with antimicrobial effectiveness provide devices of improved flexibility and elasticity and are readily applied to wound sites or over wound closure devices. A novel platinum catalyst comprising platinum tetramethyldivinyl disiloxane diethyl maleate complex for use in such compositions provides for rapid curing on topical surfaces such as skin and bonds to such surfaces in about 2-5 minutes.

Abstract: A healthcare system accommodates spasmodic clinical workflows for populating a records database associated with a surgical platform or other digital healthcare platform. An interoperability engine receives data streams including events from various electronic health records systems that provide data events according to varying format, order, and timing dependent on their corresponding clinical workflows. The interoperability engine maps indeterminate events to expected events associated with a clinical workflow based on a clinical workflow management file, an industry standard model, a general parsing model, or a combination thereof. The interoperability engine may furthermore detect non-compliance of received events and may generate feedback indicative of a compliance assessment.

Abstract: The present invention provides a kit for preparing a composition for sealing a lung tract, comprising: (a) a first component comprising: (i) a fibrinogen solution, and (ii) prewet gelatin particles in an aqueous solution; and (b) a second component comprising: (i) a thrombin solution, and (ii) a dry gelatin powder; wherein the first and second components are stored separately and configured for mixing together to form a composition that is flowable and cross-linkable. The composition may be used to seal tissue tracts such as lung tissue tracts.

Abstract: A method of dispensing surgical fasteners includes providing an applicator instrument having a housing with a cartridge opening, an elongated shaft extending from the housing, a firing system disposed within the housing for dispensing surgical fasteners, and an actuator for activating the firing system. The method includes forming a surgical opening in tissue, inserting a distal end of the elongated shaft into the surgical opening, inserting a cartridge containing a plurality of first surgical fasteners into the cartridge opening, and engaging the actuator for dispensing one of the first surgical fasteners from the distal end of the elongated shaft.

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. In an alternate embodiment, the device is multi-segmented and the wound closure strip may be coextensive with the release liner assembly.

Abstract: The present invention is directed to multi-layered wound dressings having a carrier layer, at least two sublayers, wherein each sublayer contains at least one reactive, cross-linkable component and the at least two reactive, cross-linkable components are co-reactive with the other and at least one reactive, cross-linkable has a protective leaving group and a buffering salt agent.

Abstract: An expandable biodegradable hemostatic matrix comprised of oxidized cellulose, and having a density ranging from about 0.8 to about 1.2 gr/cm3 is disclosed herein. The matrix may be expandable to at least 3 times its original volume within 4 sec upon contact with an aqueous solution room temperature. Further disclosed are methods for making the hemostatic matrix as well as method of treating a wound.

Abstract: The present invention is directed to medical devices having a first porous substrate layer with at least a surface coating thereon of a first co-reactive component and a second substrate layer with at least a surface coating layer of a second co-reactive component that reacts with the first co-reactive component, and a removable barrier layer positioned between the first substrate layer and second substrate layer and in contact with said first substrate layer and said second substrate layer.

Abstract: A sealant delivery system includes a syringe assembly having side-by-side syringes and a vial assembly having side-by-side vials. A first vial is aligned with a distal end of a first syringe and has a vial opening at the proximal end thereof that is closed by a first sealing membrane. A second vial is aligned with a distal end of a second syringe and has a second vial opening at the proximal end thereof that is closed by a second sealing membrane. The vial assembly includes a first piercing element moveable between a retracted position and an extended position for piercing the first sealing membrane to provide fluid communication between the first fluid chamber and the first vial, and a second piercing element moveable between a retracted position and an extended position for piercing the second sealing membrane to provide fluid communication between the second fluid chamber and the second vial.

Abstract: The present invention relates to a hemostatic absorbable composition, comprising: a flowable plurality of separate aggregates each comprising: a plurality of absorbable carrier particles coated on a surface thereof by a plurality of smaller particles comprising an absorbable supplemental hemostasis-promoting agent. In some embodiments, the absorbable carrier particles comprise gelatin or collagen, and the supplemental hemostasis-promoting agent comprises oxidized cellulose, oxidized regenerated cellulose, carboxylic oxidized cellulose, carboxylic oxidized regenerated cellulose, thrombin, or tranexamic acid.