Abstract:
Methods are disclosed for conditioning a polymeric stent after sterilization, and/or after crimping and before packaging, such that the properties of the polymeric stent fall within a narrower range of values. The stent is exposed to a controlled temperature at or above ambient for a period of time after radiation sterilization and/or after crimping and before sterilization. As a result, the polymeric stent properties, particularly radial strength and number-average molecular weight of the polymer of the polymeric stent, fall within a narrower range.
Abstract:
Methods of making a biodegradable polymeric stent made from poly(L-lactide) and a low concentration of L-lactide monomer is disclosed. The concentration of L-lactide is adjusted to provide a degradation behavior that is suitable for different treatment applications including coronary, peripheral, and nasal. Methods include making a poly(L-lactide) material for a stent with uniformly distributed L-lactide monomer through control of polymerization conditions during PLLA synthesis, control of post-processing conditions, or both.
Abstract:
A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A single piece sheath is placed over the scaffold immediately following crimping of the scaffold to the balloon. The single piece sheath is replaced by a two-piece sheath, which is removed prior to performing a medical procedure using the medical device.
Abstract:
Methods and systems for controlling the moisture content of biodegradable and bioresorbable polymer resin during extrusion above a lower limit that allows for plasticization of the polymer resin melt and below an upper limit to reduce or prevent molecular weight loss are disclosed. Methods are further disclosed involving plasticization of a polymer resin for feeding into an extruder with carbon dioxide and freon.
Abstract:
A medical device-includes a polymer scaffold crimped to a catheter having an expansion balloon. The scaffold is crimped to the balloon by a process that includes inflating the delivery balloon during a diameter reduction to improve scaffold retention. A crimping temperature is maintained at about the onset of glass transition of the polymer material to facilitate more rapid stabilization of mechanical properties in the scaffold following crimping.
Abstract:
A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. The scaffold is crimped to the catheter by a multi-step process for increasing scaffold-catheter yield following a crimping sequence. Damage reduction during a crimping sequence includes modifying blades of a crimper, adopting a multi-step crimping sequence, and inflating a supporting balloon to support the scaffold during crimping.
Abstract:
A medical device includes a polymer stent crimped to a catheter having an expansion balloon. The stent is crimped to the balloon by a process that includes heating the stent to a temperature below the polymer's glass transition temperature to improve stent retention without adversely affecting the mechanical characteristics of the stent when later deployed to support a body lumen. A variable diameter sheath with a central portion that prevents expansion of the stent when the balloon is pressurized and larger diameter ends is disposed over the crimped stent-balloon assembly. The balloon is pressurized and the larger diameter ends of the sheath allow the balloon beyond the ends of the stent to expand. The balloon is then depressurized.
Abstract:
Methods for fabricating a polymeric stent with improved fracture toughness including radial expansion of a polymer tube and fabricating a stent from the expanded tube are disclosed. The polymer tube is disposed within a mold and may be heated with radiation. The heated tube radially expands within the mold.
Abstract:
This invention relates to blends of high, optionally medium, and low molecular weight polyesters where at least the low molecular weight polyester is substituted with an acidic moiety, the biodegradation of the blends being controllable by selection of the mean molecular weigh of each fraction, the quantity of each fraction in the blend and the amount and pKa of the acidic moiety(ies).
Abstract:
Methods for fabricating a polymeric stent with improved fracture toughness including radial expansion of a polymer tube and fabricating a stent from the expanded tube are disclosed. The polymer tube is disposed within a mold and may be heated with radiation. The heated tube radially expands within the mold.