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:
An apparatus and method for controlling inflation pressure, pressurization rate, and volumetric flow rate of a balloon during deployment of a stent or scaffold is disclosed.
Abstract:
A medical device implantable within a peripheral vessel of the body composed of a bioresorbable polymer is disclosed. The device has a high resistance to fracture, is very flexible, and has a high crush recovery when subjected to crushing, axial, or torsional forces.
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:
A medical device-includes a scaffold crimped to a catheter having an expansion balloon. The scaffold is crimped to the balloon by a process that includes one or more balloon pressurization steps. The balloon pressurization steps are selected to enhance scaffold retention to the balloon and maintain a relatively uniform arrangement of balloon folds about the inner surface of the crimped scaffold so that the scaffold expands in a uniform manner when the balloon is inflated.
Abstract:
Bioabsorbable scaffolds are disclosed with a rigid polymer component and a rubbery polymer component. The rubbery polymer component is miscible, partially miscible, or immiscible with the rigid polymer component.
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:
Methods of treating a diseased blood vessel exhibiting stenosis with a bioabsorbable stent are disclosed. The implanted stent supports the section of the vessel at an increased diameter for a period of time to allow the vessel to heal. The stent loses radial strength sufficient to support the section of the vessel in less than 6 months after implantation, loses mechanical integrity, and then erodes away from the section. The biodegradable stent results in changes in properties of plaque with time as the stent degrades. The time-dependent properties include the luminal area of the plaque and plaque geometric morphology parameters.
Abstract:
A method to reduce or minimize the reduction in molecular weight of a stent during processing is disclosed. The stent has a scaffolding including a polymer formulation comprising PLLA and polymandelide. The polymandelide reduces the molecular weight drop during processing, particularly during sterilization. The stent scaffolding can further include one or more additional stabilizing agents that additionally reduce the molecular weight drop during processing.
Abstract:
Stent scaffolds that include a polymeric structure or structures bonded to the scaffold and extending along their length are disclosed. The polymeric structure extends across some or all of the gaps in struts along the length of the scaffold. Segmented scaffolds are also disclosed that include two or more axial segments arranged end to end not connected by link sruts.