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:
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 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, ΔHc 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 absorbable polymeric blends made from components wherein at least one of the components is synthesized using mixtures of mono- and di-functional initiators are disclosed. The blends have a first component that is a polylactide polymer or a copolymer of lactide and glycolide and a second component that is either poly(p-dioxanone) homopolymer, or a poly(p-dioxanone-co-glycolide) copolymer. The novel polymeric blends provide medical devices having dimensional stability. Also disclosed are novel absorbable medical devices made from these novel polymer blends, as well as novel methods of manufacture.
Abstract:
A bimodal bioabsorbable polymer composition. The composition includes a first amount of a bioabsorbable polymer polymerized so as to have a first molecular weight distribution; a second amount of said bioabsorbable polymer polymerized so as to have a second molecular weight distribution having a weight average molecular weight between about 10,000 to about 50,000 Daltons, the weight average molecular weight ratio of said first molecular weight distribution to said second molecular weight distribution is at least about two to one; wherein a substantially homogeneous blend of said first and second amounts of said bioabsorbable polymer is formed in a ratio of between about 50/50 to about 95/5 weight/weight percent. Also disclosed are a medical device, a method of making a medical device and a method of melt blowing a semi-crystalline polymer blend.
Abstract:
Novel semi-crystalline, segmented copolymers of lactide and epsilon-caprolactone exhibiting long term absorption characteristics are disclosed. The novel polymer compositions are useful for long term absorbable meshes, surgical sutures, especially monofilament sutures, and other medical devices.
Abstract:
Copolymers exhibiting the following combinations of properties, including without limitation, ε-caprolactone in an amount ranging from about 12 to about 70 mole percent, glycolide in an amount ranging from about 30 to about 88 mole percent, crystallinity ranging from about 10 to about 50% as measured by WAXD or about 10 to about 50 J/g as measured by DSC, and an inherent viscosity ranging from about 0.5 to about 1.45 dL/g as measured in a 0.1 g/dl solution of HFIP at 25° C.; a method for melt blowing such copolymers and nonwoven constructs produced therefrom are described herein.
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 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.