Abstract: The present invention relates to method and apparatus for dispensing a beneficial agent into an expandable medical device. The method includes the step of placing an expandable medical device on a mandrel, the medical device forming a cylindrical device having a plurality of openings and dispensing a beneficial agent into the plurality of openings.

Abstract: A method is provided for the semi-synthesis of taxane intermediates useful in the preparation of paclitaxel and docetaxel from 9-dihydro-13-acetylbaccatin III. The preparation of a suitably protected baccatin III backbone from 9-dihydro-13-acetylbaccatin III, and the insertion of the phenylisoserine side chain onto the protected baccatin III from 9-dihydro-13-acetylbaccatin III to form the taxane derivatives, paclitaxel and docetaxel is disclosed.

Abstract: A rapid exchange balloon catheter has a short rapid exchange length for faster catheter exchanges the balloon catheter includes a balloon structure having a balloon leg connected to a catheter shaft. Marker bands may be provided in the balloon leg for facilitating measurement of a dimension of physiological features. A stiffening wire extending longitudinally at least partially into the balloon leg may be provided to supplement and control the flexibility characteristics of the balloon leg.

Abstract: An implantable drug delivery device loaded with a beneficial agent is provided, wherein the beneficial agent is in two different forms, a first form having a higher solubility and a second form having a lower solubility, and wherein the two different forms are present in a proportion which is selected to achieve a desired release rate.

Abstract: An expandable tissue supporting device of the present invention employs ductile hinges at selected points in the expandable device. When expansion forces are applied to the device as a whole, the ductile hinges concentrate expansion stresses and strains in small well defined areas. The expandable medical device including ductile hinges provides the advantages of low expansion force requirements, relatively thick walls which are radio-opaque, improved crimping properties, high crush strength, reduced elastic recoil after implantation, and control of strain to a desired level. The expandable tissue supporting device includes a plurality of elongated beams arranged in a cylindrical device and connected together by a plurality of ductile hinges.

Abstract: An expandable medical device has a plurality of elongated struts, the plurality of elongated struts being joined together to form a substantially cylindrical device. The device is expandable from a cylinder having a first diameter to a cylinder having a second diameter, and the plurality of struts each having a strut width in a circumferential direction. At least one of the struts includes at least one opening extending at least partially through a thickness of the strut. A beneficial agent can be loaded into the opening within the strut. The expandable medical device may further include a plurality of ductile hinges formed between the elongated struts, the ductile hinges allowing the cylindrical device to be expanded or compressed from the first diameter to the second diameter by deformation of the ductile hinges.

Abstract: An expandable medical device having a plurality of elongated struts, the plurality of elongated struts being joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter, and the plurality of struts each having a strut width in a circumferential direction. At least one of the plurality of struts includes at least one opening extending at least partially through a thickness of said strut. A beneficial agent may be loaded into the opening within the strut. The expandable medical device may further include a plurality of ductile hinges formed between the elongated struts, the ductile hinges allowing the cylindrical device to be expanded or compressed from the first diameter to the second diameter by deformation of the ductile hinges.

Abstract: An electropolishing device for polishing a cylindrical medical device such as a stent includes anodes in the form of rollers arranged to contact an exterior surface of the device. A drive mechanism rotates the anodes periodically during the electropolishing process to change a contact point between the anodes and the medical device. A tilting mechanism can also be used for periodically tilting the anodes during the electropolishing process to allow bubbles to escape from one end of the stent.

Abstract: An electropolishing device for polishing a cylindrical medical device such as a stent includes anodes in the form of rollers arranged to contact an exterior surface of the device. A drive mechanism rotates the anodes periodically during the electropolishing process to change a contact point between the anodes and the medical device. A tilting mechanism can also be used for periodically tilting the anodes during the electropolishing process to allow bubbles to escape from one end of the stent.

Abstract: A drug delivery device is provided with openings for directional delivery of a plurality of therapeutic agents to blood vessels or other lumens or organs. In particular, the invention relates to the delivery of different therapeutic agents, different quantities of therapeutic agents, or different release profiles of the same or different therapeutic agents in different directions from the drug delivery device. The invention is useful, for example, for delivering antirestenotic, antithrombotic, antiplatelet, antiproliferative, antineoplastic, immunosuppressive, angiogenic, anti-inflammatory, or antiangiogenic agents and/or vasodilators to a blood vessel. In one embodiment, antiproliferative, antineoplastic, angiogenic, antiangiogenic, anti-inflammatory, and/or antirestenotic agents are delivered to the wall of a blood vessel and antithrombotic agents, antiplatelet agents, and/or vasodilators are delivered to the lumen of a blood vessel.

Abstract: An expandable medical device includes elongated struts which are joined together to form a substantially cylindrical device. The device is expandable from a cylinder having a first diameter to a cylinder having a second diameter. Each of the struts has a width in a circumferential direction and a thickness. At least one of the struts includes at least one opening that extends at least partially through the strut's thickness. A beneficial agent may be loaded into the opening within the strut. The expandable medical device may also include ductile hinges, formed between the elongated struts, which deform to allow the cylindrical device to be expanded or compressed from the first diameter to the second diameter.

Abstract: An advanceable, non-removable guide wire balloon catheter delivery system for a stent includes a balloon dilation catheter comprising a balloon defined by at least parts of an inner tubular element and an outer tubular element, a guidewire disposed in and having a limited range of longitudinal movement relative to the inner tubular element, and an expandable stent mounted on the balloon. A method of implanting a stent in a patient is also disclosed.

Abstract: A balloon catheter includes a catheter shaft, a balloon, and a guidewire lumen extending through the lumen. A core wire with a distal coil are positioned in the catheter shaft proximal of the balloon, and a hypotube is positioned in a longitudinally extending inflation lumen, to provide both flexibility and pushability to the catheter shaft.

Abstract: A method and system for delivering drug includes a first set of holes filled with a first formulation of the drug and a second set of holes filled with a second formulation of the same drug. This dual formulation or dual release kinetic system allows the creation of specifically tailored release kinetics by summation of multiple release kinetics.

Abstract: A system for loading a beneficial agent into holes in a medical device includes a punch system for punching plugs of beneficial agent from a thin sheet into the holes in the medical device. The loading of a beneficial agent in the form of a thin film allows the formation of multilayered structures within the holes to control release kinetics and prevent any meniscus which occurs when a beneficial agent is deposited as a liquid in the holes and dried. The punch type loading system also can provide the ability to deliver large and potentially sensitive molecules including proteins, enzymes, antibodies, antisense, ribozymes, gene/vector constructs, and cells including endothelial cells.

Abstract: A system for delivery of a beneficial agent in the form of a viscous liquid or paste allows holes in a medical device to be loaded in a single step process. The loading of a beneficial agent in a paste form also provides the ability to deliver large and potentially sensitive molecules including proteins, enzymes, antibodies, antisense, ribozymes, gene/vector constructs, and cells including endothelial cells.

Abstract: A method for decreasing the level of restenosis following a stent placement medical intervention involves the continuous administration of a dose of an immunosuppressant or anti-inflammatory agent from reservoirs in a stent to vascular tissue in need of treatment in a controlled, two phase drug release profile. It is envisioned that the vascular tissue in need of treatment is arterial tissue, specifically coronary arterial tissue. The agent or drug can be the calcineurin inhibitor Pimecrolimus. The drug can be held within reservoirs in the stent in a drug delivery matrix comprised of the drug and a bioresorbable polymeric material and optionally additives to regulate the drug release.

Abstract: A method for decreasing the level of restenosis following a stent placement medical intervention involves the continuous administration of a dose of an anti-restenotic agent, such as Pimecrolimus, from the stent to vascular tissue in need of treatment in a controlled and extended drug release profile for a period of at least 45 days in vivo. The in vivo release profile is determined by in vivo animal experiments involving implanting a series of stents in animals, explanting the stents from the animals at selected time points, and extracting remaining drug from the explanted stents.

Abstract: The beneficial agent is applied into the holes in a medical device in a dry particulate form and is adhered in the hole in a manner that allows release of the drug in a controlled manner. The drug material would be formed into particles and placed in the holes. The solvent would be added to partially liquefy and adhere the drug into the holes. After application of the solvent, the particles are adhered together in a substantially uniform drug containing matrix. The particles may include drug alone or drug in combination with other materials including a matrix.

Abstract: A method for decreasing the level of restenosis following a stent placement medical intervention involves the continuous administration of a dose of an anti-restenotic agent, such as paclitaxel, from the stent to vascular tissue in need of treatment in a controlled, extended, and substantially linear drug release profile. The method of substantially linear extended release increases the therapeutic effectiveness of administration of a given dosage. In one example, a method of reducing restenosis includes delivering paclitaxel from a stent to an artery at a minimum release rate of 1 percent of the total dosage of paclitaxel on the stent per day throughout an entire administration period from the time of implantation of the stent until the time that substantially all the paclitaxel is released from the stent.