Abstract: An improved process for coating implantable medical devices utilizes a number of techniques for improving the stability of therapeutic agents contained within the coating. The stability of the therapeutic agents may be improved by creating substantially solvent-free, amorphous forms of the therapeutic agents.

Abstract: Methods for delivering at least one medical device to a desired location for treatment, and then selectively deploy it in position, include an improved handle. One of the possible features of the handle may be to selectively hold the delivery system components at any desired configuration during deployment and positioning of the medical device. Another possible feature of the handle may be more than one mode of operation, in which the deployment of the medical device can selectively proceed at more than one speed. Yet another possible feature of the handle may be a locking mechanism that resists inadvertent or accidental movement or retraction of the stent delivery system components during packaging, sterilization, shipping, storage, handling and preparation of the stent delivery system.

Abstract: Systems and methods for fatigue testing one or more stents based on measured electrical resistance levels of each stent. Pairs of lead lines from an ohmmeter are connected to a respective stent. The respective stent is mounted onto an expander having an interior tapered portion into which a correspondingly tapered expansion pin is received. Cyclic loading strains are applied to the respective stent as an expansion pin is inserted into a corresponding one of the expanders. Stent fracture or failure occurs when cyclic loading exceeds the stents architectural and material capacity. Such fracture fatigue or failure is identified by increased electrical resistance levels. Resistance may be continuously monitored to more readily identify the onset of fatigue or failure. The expansion pins extend from a movable plate, and the expanders comprise a part of corresponding stations that extend from a fixed plate.

Abstract: A preferred embodiment of a stent provides a folded strut section that provides both structural rigidity and reduction in foreshortening of the stent mechanism. A flexible section provides flexibility for delivery of the stent mechanism. In a second embodiment, flexible section columns are angled with respect to each other, and to the longitudinal axis of the stent. These relatively flexible sections are oppositely phased in order to negate any torsion along their length. In yet another embodiment, the flexible connector can take on an undulating shape (like an “N”), but such that the longitudinal axis of the connector is not parallel with the longitudinal axis of the stent. Finally, a new method is disclosed for making stents. The method consists of performing a standard photochemical machining process of cutting, cleaning and coating the tube with a photoresist.

Abstract: The present invention relates to a medical device, and in particular, to a stent-based valve. The valve includes a radially expandable structural frame comprising a proximal anchor and a distal anchor. The proximal and distal anchors are formed from a lattice of interconnected elements, and have a substantially cylindrical configuration with first and second open ends and a longitudinal axis extending there between. The stent based valve also comprises one or more connecting members, each having a first and a second end. The first end of each connecting member is attached to the proximal anchor and the second end of each connecting member is attached to the distal anchor. A biocompatible valve assembly is attached to the proximal anchor and extends distally along the one or more connecting members.

Abstract: A steerable balloon catheter including a balloon catheter supported by a steerable guidewire having a deflectable distal tip. The guidewire comprises a longitudinal hypotube and a spring coil attached to the distal end of the hypotube and includes a longitudinally movable deflection member which is attached to the distal end of the spring coil and a tip retaining member which extends from the distal end of the hypotube to the distal end of the spring coil for providing very precise deflection of the distal tip of the balloon catheter.

Abstract: The present invention relates to a medical device, and in particular, to a stent-based valve. The valve includes a radially expandable structural frame including an anchor structure having a first and a second open end, a connecting member having a first and a second end, and a cantilever valve strut having a first and a second end. The first end of the connecting member is attached to the second end of the anchor structure. The first end of the cantilever valve strut is cooperatively associated with the second end of the connecting member. The prosthetic valve further includes a biocompatible membrane assembly having a substantially tubular configuration about the longitudinal axis, with a first open and a second closed end. The first end of the membrane assembly is attached to the structural frame along the second end of the cantilever valve strut.

Abstract: An endoprosthesis for repairing and treating abdominal aortic aneurysms. The endoprosthesis features an anchoring and sealing component and low profile bifurcated legs. A biocompatible graft material is secured to at least the bifurcated legs in order to provide two endoleg fluid flow lumens or conduits. The bifurcated legs have staggered stent elements that nest to contribute to the low profile nature of the device and additional longitudinal struts between pair of the staggered stent elements to increase the longitudinal stiffness of the bifurcated legs while maintaining the patency of the lumen created thereby.

Abstract: A stent in the form of a thin-walled, multi-cellular tubular structure is provided. The tubular structure has a longitudinal axis and the stent includes a plurality of circumferential sets of strut members. Each set of the strut members is longitudinally displaced from each other and connected to each other by longitudinally extending links. Each set of the strut members forms a closed and cylindrical portion of the stent. Further, each set of the strut members includes a plurality of connected curve sections and diagonal sections. The sets of the strut members further include end sets of strut members located at each end of the stent and central sets of strut members located between the end sets of the strut members.

Abstract: A system, apparatus, and method for treating, repairing, an aneurysm, preferably an aortic aneurysm, and most preferably, an abdominal aortic aneurysm as described herein. The systems, devices, and methods described herein include a first prosthesis or stent gasket, and at least one second prosthesis for bypassing the aneurysm. The first prosthesis is configured and adapted to accommodate a section of artery upstream of the aneurysm, wherein the section is unsuitable for anchoring a typical first prosthesis.

Abstract: An emboli extraction catheter and vascular filter system comprising a guidewire, a vascular filter attached near the distal end of the guidewire, and an emboli extraction catheter. The vascular filter has a smaller first diameter for insertion into the lumen of a vessel, and a second larger diameter for expanding to substantially equal the diameter of the lumen and to be placed in generally sealing relationship with the lumen. The emboli extraction catheter is a flexible catheter comprising a hub attached to the proximal end of the catheter. The hub further comprises a sideport and means for maintaining a seal on the guidewire. The emboli extraction catheter can be used to aspirate embolic particulates, so as to avoid their accidental release after they are captured in a vascular filter, and can also be used to empty full vascular filters of embolic particulates which may block distal flow.

Abstract: A system for loading self-expanding stents into a stent delivery system that comprises a lubricious coating on one or more components to substantially reduce the frictional forces associated with loading stents. The stents may be bare or coated stents. The lubricious coating comprises glycerol.

Abstract: A catheter with proximal and distal ends having a spiral centering device attached near the catheter distal end. The spiral centering device has at least one spiral strut having a proximal end and a distal end. The spiral centering device resiliently tends to center the distal end portion of the catheter, steering the catheter away from the vessel wall during insertion through the vasculature and toward the treatment site. The spiral centering catheter may facilitate access to tortuous anatomy by preventing the distal catheter tip from catching on irregularities in the lumenal surface. If a stent is provided on the catheter, the spiral centering catheter may also facilitate uniform stent expansion by stabilizing the catheter during stent deployment.

Abstract: Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism's reaction to the introduction of the medical device to the organism. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the formation of blood clots. Also, the devices may be modified to promote endothelialization. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Abstract: A drug and drug delivery system may be utilized in the treatment of vascular disease. A local delivery system is coated with rapamycin or other suitable drug, agent or compound and delivered intraluminally for the treatment and prevention of neointimal hyperplasia following percutaneous transluminal coronary angiography. The local delivery of the drugs or agents provides for increased effectiveness and lower systemic toxicity.

Abstract: The present invention is a “rescue” catheter that is designed to be placed over a fixed wire stent delivery catheter after angiography reveals that an intimal dissection has occurred typically as an edge dissection either just proximal or just distal to the stent.

Abstract: The present invention relates to a medical device and method of forming the medical device. In particular, the present invention relates to a medical device having a tubular membrane structure over a radially expandable structural frame, and to a method of forming the tubular membrane on the radially expandable structural frame. In one aspect, a structural frame is placed over a spinning mandrel and a fiber is electro-statically spun over at least a portion of the structural frame forming a membrane. A transfer sheath may be used between the mandrel and structural frame to prevent the electro-statically spun fiber from adhering to the mandrel. In another aspect, a first membrane is spun over the mandrel before the structural frame is placed over the mandrel. In this aspect, at least a portion of the structural frame is sandwiched between the membranes. The membrane or membranes and structural frame form a fiber spun frame assembly. The fiber spun frame assembly may be coated with an elastic polymer.

Abstract: The invention is a system, apparatus, and method for treating, and/or repairing an aneurysm, preferably an aortic aneurysm, and most preferably, an abdominal aortic aneurysm. The systems, devices, and methods of the present invention include a prosthesis assembly for establishing a fluid flow path between an upstream portion of an artery and at least one bifurcated downstream portion of the artery.

Abstract: A balloon catheter for medical treatment of a patient has an improved tip design and methods of making the tip. The balloon catheter has a flexible shaft with proximal and distal ends, a hub affixed to the proximal end, and a balloon affixed to the shaft near the distal end. At least a distal portion of the shaft includes a tubular inner body, and the balloon has a distal leg affixed to the inner body. A short, tubular tip member is placed in contact with the distal end of the inner body, and a shrink tube is placed around the point of contact. A wire mandrel is passed through a lumen defined by the inner body and tip member. While the shrink tube is heated, compressing the tip member and inner body, the mandrel is moved. This combination of heat, radial pressure, and mandrel movement causes a blending of the materials of the inner body and the tip member. The resulting joint of the tip member and inner body is both strong and flexible.

Abstract: Local drug delivery medical devices are utilized to deliver therapeutic dosages of drugs, agents or compounds directly to the site where needed. The local drug delivery medical devices utilize various materials and coating methodologies to maintain the drugs, agents or compounds on the medical device until delivered and positioned.