Abstract: A predilation device may comprise a shaft portion and a distal tip having helical threadings. The predilation device may further include a rapid exchange element rotatably coupled to the shaft portion. A guidewire may slidably engage the rapid exchange element and may guide the predilation device to a lesion site. The predilation device may be positioned with the distal tip abutting the lesion. The shaft portion may be rotated, thereby rotating the tip and causing the tip to pass through the lesion and predilate the lesion. In some embodiments, the tip may remove lesion material.

Abstract: A medical device crimping system comprises a crimper and a plurality of protective strips. The crimper defines a crimping iris, which has an open state and a closed state. In the open state the cross-sectional area of the crimping iris is greater than in the closed state. The plurality of protective strips extend longitudinally through the crimping iris. Each of the strips is radially offset from one another. The strips protect the stent from direct contact with the crimping blades of the crimper.

Abstract: Methods and apparatuses for manufacturing medical devices.

Abstract: A medical device crimping system comprises a crimper and a plurality of protective strips. The crimper defines a crimping iris, which has an open state and a closed state. In the open state the cross-sectional area of the crimping iris is greater than in the closed state. The plurality of protective strips extend longitudinally through the crimping iris. Each of the strips is radially offset from one another. The strips protect the stent from direct contact with the crimping blades of the crimper.

Abstract: A catheter comprises a catheter shaft, at least a portion of which defines a medical device receiving region, and at least one sleeve. The at least one sleeve comprises a tubular member constructed and arranged to transition between an extended state and a retracted state. The tubular member has a first portion being engaged to a portion of the catheter shaft adjacent to the medical device receiving region. In the extended state a second portion is constructed and arranged to at least partially overlay the medical device receiving region. In the retraced state the second portion is removed from about the medical device receiving region. At least one of the first portion and the second portion of the tubular member are at least partially constructed from a shape memory material.

Abstract: A medical device crimping system comprises a crimper and a plurality of protective strips. The crimper defines a crimping iris, which has an open state and a closed state. In the open state the cross-sectional area of the crimping iris is greater than in the closed state. The plurality of protective strips extend longitudinally through the crimping iris. Each of the strips is radially offset from one another. The strips protect the stent from direct contact with the crimping blades of the crimper.

Abstract: The present invention concerns bio-compatible medical devices and process for preparation thereof. The process includes electrostatically forming a first layer on a structure. The first layer can include a combination of at least one active substance and at least one polymer and/or binder. A second layer is formed on the structure to cover the first layer. The second layer can be a solvent or a combination of solvents. The evaporation of the second layer causes the first layer to reflow and bind to the structure.

Abstract: A method of manufacturing a medical device, such as an endoprosthesis, includes reducing the size of the medical device, and vibrating the device. In embodiments, the device is vibrated ultrasonically.

Abstract: The invention relates to a method and device for coating a device with time-release drugs by providing a plurality of micro coated pellets having different release rates on the surface of the medical device structure, e.g., a stent. Organizing the micro pellets with different release rates on the structure can result in the structure having a plurality of release regions with varying release profiles.

Abstract: Methods of manufacturing porous coatings and medical devices having porous coatings are provided. In embodiments of the invention, an inert additive, a therapeutic agent, and a polymer are applied to the body of a medical device to form a coating. The therapeutic agent and the polymer are insoluble in the inert additive. After drying the coating, the inert additive may be removed to form pores.

Abstract: The present invention is directed to a method for coating a surface of a medical device with a coating composition. The method involves chilling the surface to be coated to below the freezing point of at least one solvent contained in the composition. This coating composition is applied to the chilled surface, and a portion of the coating composition is allowed to freeze onto the surface. The surface can then be heated (either by the application of heat from an external source, by allowing to heat by ambient air) to above the freezing point of the solvent in the coating composition to allow the solvent to thaw and be removed, thereby forming a smooth, uniform coating on the surface of the medical device.

Abstract: A stent or sheath having one or more cutting blades may be constructed for implantation in the body. A balloon having one or more cutting blades may be used with a stent or a sheath.

Abstract: An apparatus and method for improved control of low viscosity fluid flow during electrohydrodynamic spray deposition of the fluid to coat small targets, such as medical devices like stents. The apparatus includes a target holder which applies a first electrical potential to a target, a coating fluid transporter such as a wick, a siphon tube or a siphon tube with a wick therein along which the coating fluid flows from a reservoir to a dispensing end of the transporter, and an electrode which applied a second electrical potential to the coating fluid sufficient to cause the coating fluid to be attracted from the dispensing end of the transporter toward the target. This provides a target coating apparatus with highly self-regulating coating fluid flow characteristics despite the low viscosity of the coating fluid, while producing highly consistent and uniform target coatings.

Abstract: In one embodiment of the present invention a system for maneuvering an implant to a target site and deploying the implant at the target site is provided. This system includes an inner housing and an outer housing where the inner housing is slidable within the outer housing. The outer housing may have a working channel with a first end and a second end and a piercing jaw moveably coupled to the first end. The inner housing may have a working passage with a distal end and a proximal end, the distal end having a piercing jaw moveably coupled to it.

Abstract: A catheter comprises a catheter shaft, at least a portion of which defines a medical device receiving region, and at least one sleeve. The at least one sleeve comprises a tubular member constructed and arranged to transition between an extended state and a retracted state. The tubular member has a first portion being engaged to a portion of the catheter shaft adjacent to the medical device receiving region. In the extended state a second portion is constructed and arranged to at least partially overlay the medical device receiving region. In the retraced state the second portion is removed from about the medical device receiving region. At least one of the first portion and the second portion of the tubular member are at least partially constructed from a shape memory material.

Abstract: The present invention concerns bio-compatible medical devices and process for preparation thereof. The process includes electrostatically forming a first layer on a structure. The first layer can include a combination of at least one active substance and at least one polymer and/or binder. A second layer is formed on the structure to cover the first layer. The second layer can be a solvent or a combination of solvents. The evaporation of the second layer causes the first layer to reflow and bind to the structure.

Abstract: A medical balloon composed of a micro-composite material which provides for radial expansion of a balloon to a predetermined extent, but which has minimal longitudinal growth during balloon inflation. The micro-composite material includes a fibril component, a matrix component, and optionally, a compatibilizer. The fibril component may preferably be liquid crystal polymer fibers randomly scattered through out the balloon material. The liquid crystal polymers are created by extrusion at high speed. An alternative fibril component may be a PET fibers which are uniformly spaced about the balloon material and extend through out the length of the balloon material tube.

Abstract: An apparatus and method for improved control of low viscosity fluid flow during electrohydrodynamic spray deposition of the fluid to coat small targets, such as medical devices like stents. The apparatus includes a target holder which applies a first electrical potential to a target, a coating fluid transporter such as a wick, a siphon tube or a siphon tube with a wick therein along which the coating fluid flows from a reservoir to a dispensing end of the transporter, and an electrode which applied a second electrical potential to the coating fluid sufficient to cause the coating fluid to be attracted from the dispensing end of the transporter toward the target. This provides a target coating apparatus with highly self-regulating coating fluid flow characteristics despite the low viscosity of the coating fluid, while producing highly consistent and uniform target coatings.

Abstract: A method of manufacturing a medical device, such as an endoprosthesis, includes reducing the size of the medical device, and vibrating the device. In embodiments, the device is vibrated ultrasonically.

Abstract: A medical device, such as a stent, for delivering a biologically active material to body tissue of a patient and a method of making such a medical device are disclosed. The medical device has a tubular sidewall, wherein the sidewall is comprised of a plurality of struts each having an outer surface, an inner surface opposite the outer surface, and at least one side surface adjacent to and connecting the outer and inner surfaces. The outer surface or the inner surface is covered at least in part with a first coating comprising a first polymeric material and a first coating material, such as a biologically active material, e.g., paclitaxel, paclitaxel analogues, paclitaxel derivatives, or a combination thereof. The outer surface or inner surface not covered with the first coating is covered with a second coating comprising a second polymeric material and that is substantially free of the first coating material. Preferably, the first coating is applied to the outer surface of the strut.