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.

Reducing crimping damage to polymer scaffold

A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A sheath is placed over the crimped scaffold after crimping to reduce recoil of the crimped polymer scaffold and maintain scaffold-balloon engagement relied on to hold the scaffold to the balloon when the scaffold is being delivered to a target in a body. The sheath is removed by a health professional either by removing the sheath directly or using a tube containing the catheter.

Removable sheath assembly for a polymer scaffold

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

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.

Methods for crimping a polymeric stent onto a delivery balloon

The invention provides a method of manufacturing a polymeric implantable medical device using gel extrusion of high molecular weight polymers or charge-induced orientation to avoid heat degradation of the polymer that might occur during conventional heat extrusion.

Method of fabricating an implantable medical device using gel extrusion and charge induced orientation

Atherosclerotic cardiovascular disease is the leading cause of death and disability in the world, accounting for nearly one-third of all human mortality. In the modern era, the mainstay of therapy for established occlusive lesions in the cardiovascular tree is percutaneous balloon angioplasty and stent implantation. The procedure is widely applied, with over 2 million procedures performed annually, and the acute results are favorable in >95% of patients. Significant problems with angioplasty and stenting remain, however, including the need for early reintervention for restenosis and/or thrombosis, and the requirement for continual antiplatelet therapy as the artery heals. Furthermore, although the remarkable progress in intravascular stent development is incontrovertible, stents still generate an alarming amount of long-term complications including fracture and late thrombosis. In order to circumvent the myriad problems associated with permanent intravascular implants, stents that slowly dissolve after de...

Charles A Simonton

Papers

Coronary and endovascular applications of the Absorb™ bioresorbable vascular scaffold