Abbott Cardiovascular Systems, Inc.

James Oberhauser

Yunbing Wang

Lothar W Kleiner

Thierry Glauser

Manish Gada

Xiao Ma

Stephen D Pacetti

Bethany Steichen

Ni Ding

David K Wrolstad

Rommel Lumauig

Byron Lambert

Mary Beth Kossuth

Vincent J Gueriguian

Joel Harrington

Richard Rapoza

Syed F A Hossainy

Syed F Hossainy

Chad Joseph Abunassar

Diem Uyen Ta

Senthil Kumar Eswaran

Jill A McCoy

Jonathan D Halderman

Bruce M Wilson

Fuh-Wei Tang

Matthew J Gillick

Justin K Mann

Boyd V Knott

Kathleen Yan

Mark C Johnson

Annie Liu

Jeremy B Beer

Lily Ayo Roberts

Bobby Bruce Speed

Susan Veldhof

Jana Buccola

Sean A Mcniven

Bobby B Speed

A method of accelerated aging of bioresorbable polymer scaffolds including exposing the scaffold to water is disclosed. The scaffold is exposed to water at a controlled temperature for a selected aging time. The functional outputs, such as radial strength, expandability, and % recoil obtained from aged scaffolds predict those of real-time aging of the scaffold. The accelerated aging factor, which is the required shelf life divided by the aging time, is significantly higher for poly(L-lactide) scaffolds tested than thermal aging.

Accelerated aging for polymeric scaffolds

Methods are disclosed including thermally processing a scaffold to increase the radial strength of the scaffold when the scaffold is deployed from a crimped state to a deployed state such as a nominal deployment diameter. The thermal processing may further maintain or increase the expansion capability of the scaffold when expanded beyond the nominal diameter.

Thermal processing of polymer scaffolds

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.

Controlling moisture in and plasticization of bioresorbable polymer for melt processing

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.

Bioabsorbable stent and treatment that elicits time-varying host-material response

A method of treating vascular disease in a patient is disclosed that comprises deploying a bioabsorbable polymer scaffold composed of a plurality of struts at a stenotic segment of an artery of a patient, wherein after the scaffold supports the segment at an increased diameter for a period of time the polymer degrades and is progressively replaced by de novo formation of malleable provisional matrix comprising proteoglycan, wherein as the scaffold becomes more malleable and becomes disconnected as it degrades, wherein following coverage of the struts by a neointima layer and loss of mechanical support provided by the scaffold, the scaffold is pulled outward by positive remodeling of the vessel wall of the scaffolded segment.

Assessment of a drug eluting bioresorbable vascular scaffold

A polymer tube is processed using a solid phase process for improving mechanical characteristics of the tube, including radial strength and stiffness. The tube is made into a scaffold possessing improved mechanical and use characteristics, such as a reduced crimped profile and improved deliverability.

Methods for solid phase processing of tubes and medical devices made from the processed tubes

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.

Biodegradable stent with adjustable degradation rate

Methods of treating with 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.

Method of making a poly(L-lactide) stent with tunable degradation rate

Bioresorbable polymer vascular scaffolds made of combinations of polylactide and polycaprolactone having a high molecular weight polymer, thin struts in a selected range and sufficient radial strength to support a vessel upon deployment. The scaffolds have degradation behavior of molecular weight, radial strength, and mass that are conducive to healing of a vessel including providing patency to a vessel, reduction of radial strength, breaking up, and resorbing to allow return of the vessel to a natural state.

High molecular weight polylactide and polycaprolactone copolymer and blends for bioresorbable vascular scaffolds

Method of treating with poly(L-lactide) stent with tunable degradation rate

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.

Uniform crimping and deployment methods for polymer scaffold

Methods of treating a diseased blood vessel exhibiting stenosis with a bioabsorable 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.

Bioabsorbable stent that modulates plaque geometric morphology and chemical composition

An apparatus and method for controlling inflation pressure and pressurization rate of a balloon during deployment of a stent or scaffold are disclosed. The apparatus and method involve a pressure attenuator for controlling an inflation rate of the delivery balloon.

Control of balloon inflation rate during deployment of scaffold

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.

Drug delivery device for peripheral artery disease

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Saratoga, CA, United States of America

James Oberhauser