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: 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: Novel surgical sutures and novel medical devices made from novel semi-crystalline, glycolide-rich A-B-A triblock copolymers of glycolide and lactide, wherein said B-segment is a fully amorphous random copolymer of glycolide and lactide, for long term medical applications are disclosed. The novel polymer compositions are useful for long term absorbable surgical sutures, meshes and other medical devices, especially for patients with compromised healing. The novel sutures have improved properties and improved breaking strength retention, while still substantially absorbing within about a 120-day period post-implantation.

Abstract: The present invention is directed to a length adaptive surgical suture comprising a monofilament or a braid of a plurality of filaments, the suture having an original length when implanted and a second length that is different from the original length within a first twenty-four (24) hour period of time after implantation to accommodate tissue swelling. The present invention is also directed to configurations and combinations that enable length adaptive results.

Abstract: The present invention is directed to continuous reaction processes for preparing a glycolide/L-lactide copolymer formulation by continuously introducing glycolide monomer, L-lactide monomer, initiator and optionally a catalyst into at least one continuous reactor vessel under dry nitrogen environment, wherein the monomers, initiator, and optional catalyst are mixed at a first lower temperature and then transferred to a second continuous reactor operating at a second higher temperature, and then exothermally reacting and maintaining at a steady state, the blend of glycolide monomer, lactide monomer, initiator and optional catalyst to produce a PLGA copolymer reaction product.

Abstract: Novel surgical sutures and novel medical devices made from novel semi-crystalline, glycolide-rich A-B-A triblock copolymers of glycolide and lactide, wherein said B-segment is a fully amorphous random copolymer of glycolide and lactide, for long term medical applications are disclosed. The novel polymer compositions are useful for long term absorbable surgical sutures, meshes and other medical devices, especially for patients with compromised healing. The novel sutures have improved properties and improved breaking strength retention, while still substantially absorbing within about a 120-day period post-implantation.

Abstract: The invention relates to novel processes for the lamination of semi-crystalline, high-melting point, low glass transition polymeric films, which are extruded and subsequently laminated on various thermally sensitive substrates to form laminated medical device constructs in a specific time interval to allow low processing temperatures to avoid polymer film and/or substrate degradation or heat-related distortions. Also disclosed are laminated medical device constructs made from such processes.

Abstract: Novel surgical sutures and novel medical devices made from novel semi-crystalline, glycolide-rich A-B-A triblock copolymers of glycolide and lactide, wherein said B-segment is a fully amorphous random copolymer of glycolide and lactide, for long term medical applications are disclosed. The novel polymer compositions are useful for long term absorbable surgical sutures, meshes and other medical devices, especially for patients with compromised healing. The novel sutures have improved properties and improved breaking strength retention, while still substantially absorbing within about a 120-day period post-implantation.

Abstract: The present invention is directed methods of making absorbable poly(p-dioxanone) pellets by melt polymerization of p-dioxanone conducted in a single reactor with a temperature regulator by charging a melt reactor with a mixture of p-dioxanone (PDO) monomer, initiator, catalyst, and optionally a dye; melt polymerizing the mixture in the melt reactor with sufficient agitation of the mixture to allow complete mixing of the monomer and for sufficient time to form a PDO polymer product having an unreacted PDO monomer content of at least 65 mole percent; placing the PDO polymer product under a vacuum to remove at least portion of unreacted PDO; discharging the PDO polymer product from the melt reactor directly into an in-line, underwater pelletizer to produce undried PDO pellets, collecting the undried PDO pellets, and storing the collected PDO pellets in the freezer or a vacuum chamber prior to drying.

Abstract: The present invention is directed methods of making absorbable poly(p-dioxanone) pellets by melt polymerization of p-dioxanone conducted in a single reactor with a temperature regulator by charging a melt reactor with a mixture of p-dioxanone (PDO) monomer, initiator, catalyst, and optionally a dye; melt polymerizing the mixture in the melt reactor with sufficient agitation of the mixture to allow complete mixing of the monomer and for sufficient time to form a PDO polymer product having an unreacted PDO monomer content of at least 65 mole percent; placing the PDO polymer product under a vacuum to remove at least portion of unreacted PDO; discharging the PDO polymer product from the melt reactor directly into an in-line, underwater pelletizer to produce undried PDO pellets, collecting the undried PDO pellets, and storing the collected PDO pellets in the freezer or a vacuum chamber prior to drying.

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: The present invention is directed methods of making absorbable poly(p-dioxanone) pellets by melt polymerization of p-dioxanone conducted in a single reactor with a temperature regulator by charging a melt reactor with a mixture of p-dioxanone (PDO) monomer, initiator, catalyst, and optionally a dye; melt polymerizing the mixture in the melt reactor with sufficient agitation of the mixture to allow complete mixing of the monomer and for sufficient time to form a PDO polymer product having an unreacted PDO monomer content of at least 65 mole percent; placing the PDO polymer product under a vacuum to remove at least portion of unreacted PDO; discharging the PDO polymer product from the melt reactor directly into an in-line, underwater pelletizer to produce undried PDO pellets, collecting the undried PDO pellets, and storing the collected PDO pellets in the freezer or a vacuum chamber prior to drying.

Abstract: Novel surgical sutures and novel medical devices made from novel semi-crystalline, glycolide-rich A-B-A triblock copolymers of glycolide and lactide, wherein said B-segment is a fully amorphous random copolymer of glycolide and lactide, for long term medical applications are disclosed. The novel polymer compositions are useful for long term absorbable surgical sutures, meshes and other medical devices, especially for patients with compromised healing. The novel sutures have improved properties and improved breaking strength retention, while still substantially absorbing within about a 120-day period post-implantation.

Abstract: The invention relates to novel processes for the lamination of semi-crystalline, high-melting point, low glass transition polymeric films, which are extruded and subsequently laminated on various thermally sensitive substrates to form laminated medical device constructs in a specific time interval to allow low processing temperatures to avoid polymer film and/or substrate degradation or heat-related distortions. Also disclosed are laminated medical device constructs made from such processes.

Abstract: Novel semi-crystalline, p-dioxanone-rich ABA triblock copolymers of p-dioxanone and epsilon-caprolactone, where “B” block is a random copolymer of p-dioxanone and epsilon-caprolactone, and absorbable devices for long term medical applications are disclosed. The novel polymer compositions are useful for long term absorbable surgical sutures, and other medical devices.

Abstract: The invention relates to novel processes for the lamination of semi-crystalline, high-melting point, low glass transition polymeric films, which are extruded and subsequently laminated on various thermally sensitive substrates to form laminated medical device constructs in a specific time interval to allow low processing temperatures to avoid polymer film and/or substrate degradation or heat-related distortions. Also disclosed are laminated medical device constructs made from such processes.

Abstract: Absorbable medical devices based on novel foams and films made from semi-crystalline, segmented copolymers of lactide and epsilon-caprolactone exhibiting long term absorption characteristics are disclosed. Also disclosed are methods of producing said foams and films, and useful polymer solutions.

Abstract: Absorbable medical devices based on novel foams and films made from semi-crystalline, segmented copolymers of lactide and epsilon-caprolactone exhibiting long term absorption characteristics are disclosed. Also disclosed are methods of producing said foams and films, and useful polymer solutions.

Abstract: Novel absorbable polymeric blends are disclosed. The blends have a first absorbable polymer type that is a polylactide polymer or a copolymer of lactide and glycolide and a second absorbable polymer type that is poly(p-dioxanone), wherein the first absorbable polymer type or the second absorbable polymer type or the first absorbable polymer type and the second absorbable polymer type additionally comprise a first polymeric component and a second polymeric component. The first polymeric component has a higher weight average molecular weight than the second polymeric component and at least one of said components is at least partially end-capped by a carboxylic acid. The novel polymeric blends are useful for manufacturing medical devices having dimensional stability, having engineered degradation and breaking strength retention in vivo. Also disclosed are novel absorbable medical devices made from these novel polymer blends, as well as novel methods of manufacture.

Abstract: The invention relates to novel processes for the lamination of semi-crystalline, high-melting point, low glass transition polymeric films, which are extruded and subsequently laminated on various thermally sensitive substrates to form laminated medical device constructs in a specific time interval to allow low processing temperatures to avoid polymer film and/or substrate degradation or heat-related distortions. Also disclosed are laminated medical device constructs made from such processes.