Abstract:
A method of making a balloon expandable braided stent with a restraint to initially prevent self-expansion and the resulting product. Multiple strands of a resilient metal or plastic are braided to form a tubular configuration of a predetermined outside diameter which assumes a lesser diameter when the tubular stent is longitudinally stretched. When in its stretched condition, it is coated with a polymeric material which is then cross-linked to effectively "freeze" the intersections of the braided structure holding it in its reduced diameter configuration. The tubular stent is designed to be placed within a body vessel using a balloon stent delivery catheter. When the balloon surrounded by the braided wire stent is inflated, the stent expands initially to an extent to break the bonds of plastic material between the intersections of the strands, thereby permitting self-expansion to take place. The coating may also comprise a hydrogel or an elastomeric impregnated with the water soluble particles which softens and/or deteriorates upon exposure to an aqueous media, such as blood.
Abstract:
A process for preparing coating compositions of a commingled hydrogel of a polyurethane-polyurea polymer hydrogel and at least one other polymer hydrogel of a polymer different from polyurethane-polyurea; a process for making materials composed of a polymeric plastic or rubber substrate or a metallic substrate, with a coating of the commingled hydrogel thereon; and a process for making medical devices with a coating of the commingled hydrogel thereon, are disclosed. The coating compositions tenaciously adhere to the substrate materials and medical devices to which they are applied due to bonding of a tie coat to a reactive substrate surface and due to the commingling of the two hydrogel components. The coating compositions and coated materials and medical devices are non-toxic and biocompatible, making them ideally suited for use in applications such as for catheters, catheter balloons and stents. In such applications, the coating compositions, coated materials, and coated medical devices made therefrom demonstrate low coefficients of friction in contact with body fluids, especially blood, as well as a high degree of wear permanence over prolonged use. The commingled hydrogel coatings are capable of being dried to facilitate storage of the devices to which they have been applied, and can be instantly reactivated for later use by exposure to water.