Abstract: This disclosure relates to endolumenal medical devices coated with a taxane therapeutic agent in one or more solid form(s) having varying dissolution rates. Particularly preferred coatings comprise amorphous paclitaxel, dihydrate paclitaxel, or combinations thereof that provide durable coatings that release paclitaxel over a desired period of time, which can be on the order of hours, days or weeks. Preferred embodiments relate to medical device coatings of paclitaxel, or paclitaxel analogs or derivatives, having one or more polymorph solid forms that provide a prolonged release of paclitaxel within a body vessel without requiring a polymer carrier or barrier layer to achieve the desired rate of paclitaxel elution.

Abstract: A delivery system (10) for implanting a medical device (30) such as a venous valve into the vasculature of a patient. The delivery system includes a delivery catheter (11) having a device-containing portion (15) adjacent to the distal end (14) thereof, and an inner member (16) extending through the catheter and beyond the distal end thereof, to an atraumatic distal tip portion (17) forward of the catheter distal end. The inner member extends through the medical device in the device-containing region, includes a proximal portion (18) with a sufficiently large diameter to prevent longitudinal movement of the device as the catheter is retracted during deployment, and centers the device upon release from the distal catheter end during deployment.

Abstract: Described are percutaneous vascular valves (11) free of attached support structures and deployment systems (31) and methods for providing attachment of the valves within a vascular vessel.

Abstract: A method for deploying a stent delivery system having a blowmolded holder is provided. The stent is configured to expand from a first diameter to a second diameter. The holder is blowmolded to an inner surface of the compressed state. The holder contacts the inner surface and at least portions of side surfaces of the stent, and the holder and the stent have an interference fit therebetween. The deployment method includes delivering the compressed stent placed on the blowmolded holder and the holder into a predetermined deployment side. The deployment method further includes releasing the stent from interference with the holder and expanding the stent from the compressed stent to the expanded stent.

Abstract: A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material.

Abstract: A method for embolic protection during treatment of a stenotic lesion in a body vessel is provided. The method comprises disposing an embolic protection device in an undeployed state in the body vessel. The device comprises a basket with a set of struts extending from a distal end to a proximal end of the basket, the struts being arranged to define an opening at the distal end, the basket having an expanded state and a collapsed state. A core wire with a distal end and a proximal end is able to reciprocate through the opening at the distal end of the basket. A filter bag is attached only at the distal end of the core wire, the filter bag being located distally to the distal end of the basket when in the collapsed state. The method further comprises moving the core wire relative to the basket to expand the basket and the filter bag in a deployed state downstream from the stenotic lesion to capture emboli during treatment of the stenotic lesion.

Abstract: A multi-port stent graft delivery device (2) has an annular access lumen (26) between a delivery catheter (24) and a main sheath (6), at least one indwelling access sheath (28, 30) within the access lumen, and an indwelling guide wire (36, 38) within the or each access sheath and a stent graft (16) retained in the delivery device. Upon deployment of the stent graft into the vasculature of a patient the indwelling guide wire can be used to facilitate stabilization of the access sheath during cathertization of a side branch and deployment of a side arm covered or uncovered stent therein through the advanced access sheath. A manifold associated (4) with a handle provides a plurality of access ports (41, 43). A docking balloon may also be used.

Abstract: System and methods for applying vascular therapy to a body vessel using a chamber capable of negative and/or positive pressure relative to ambient are provided. The chamber includes one or more pressure-isolated chambers. A pressure and/or vacuum source is connected to the pressure chamber, and is configured to provide distinct pressures within each pressure-isolated chamber. A controller is coupled to the pressure source, and is configured to control the pressure source such that pressure within each of the pressure-isolated chambers is controlled cyclically to simulate a pulsating pump or peristaltic-like pump action within the body vessel. The use of negative pressure is sequenced such that the resistance to pressure toward the heart is reduced. This effectively “pulls” blood flow toward the heart and creates more space for incoming blood flow. During simulation, medical devices may be introduced to and/or diagnostics may be performed on the targeted vessel.

Abstract: A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract, and at least one layer 18 of a bioactive agent posited over at least one surface of the structure 12. Optionally, the device 10 can include at least one porous, preferably polymeric layer 20 posited over the layer 18 of bioactive agent, and can alternatively or additionally include at least one coating layer 16 posited on one surface of the structure 12, the at least one layer 18 of bioactive agent being posited in turn on at least a portion of the coating layer 16. The porous layer 20 and the coating layer 16 each provide for the controlled release of the bioactive material from the device 10. The structure 12 is preferably configured as a stent graft. The polymer of the porous layer 20 is preferably applied by vapor or plasma deposition.

Abstract: The present disclosure generally provides a multiple balloon assembly used as part of the distal region of a medical device that is capable of delivering a therapeutic agent into a body vessel having bodily fluid. The multiple balloon assembly comprises an inner balloon and an outer balloon. The outer balloon further comprises a proximal taper region, a middle region, and a distal taper region. The inflation of the inner balloon causes the middle region of the outer balloon to contact the inner wall of the body vessel, thereby, occluding the flow of fluid through the body vessel. The proximal taper region and the distal taper region are configured such that they do not touch the inner wall of the body vessel. One of the distal taper and proximal taper regions has a plurality of apertures configured to allow for the therapeutic agent to be delivered into the body vessel at a predetermined rate.

Abstract: The present invention provides apparatus and methods for facilitating folding of a balloon before, during or after a medical procedure. In a first embodiment, the apparatus generally comprises at least one catheter shaft member, a balloon disposed on a distal region of the catheter shaft member, and at least one folding member disposed along at least a proximal region of the balloon. The folding member may comprise at least one radially-outward projecting member integrally formed with or attached to the balloon, or an internally-formed groove in the balloon, which is adapted to promote twisting of the balloon to reduce the profile of the balloon in the deflated state. Optionally, biasing members may be disposed between the folding member and an adjacent portion of the balloon to promote folding of the balloon in a clockwise or counter-clockwise direction.

Abstract: The present invention concerns an improved stent in which the limbs have been fabricated from a medium having a cross sectional profile in which at least one segment is flat and straight, whereby the stent is provided with improved expansion characteristics.

Abstract: The disclosure relates to a method and apparatus for coating a medical device. The method includes providing an electrospinning apparatus and simultaneously electrospinning at least one solution onto a first surface and an opposing second surface. The apparatus comprises a first spinneret and a second spinneret. An energy source is electrically coupled to the first spinneret and the second spinneret. The first spinneret and second spinneret comprise a reservoir and an orifice fluidly coupled to the reservoir. The first spinneret orifice is located substantially opposite the second spinneret orifice.

Abstract: An implantable flow modifying device and a method of modifying flow through a lumen are provided. The flow modifying device includes a flexible member configured for permitting fluid flow through the body lumen in a first direction at a first rate and for restricting fluid flow through the body lumen in a second direction at a second rate. The flexible member includes a passageway defined by a sheath of biocompatible material, the passageway having a first end portion and a second end portion. The first end portion is sized and shaped to at least partially restrict fluid flow in the first direction and capable of at least partially collapsing in response to fluid flow in the second direction. The second end portion is adapted to seal with a wall of the body lumen. A diameter of a first opening defined in the first end portion is smaller than a diameter of a second opening defined in the second end portion.

Abstract: A reinforcing ring (10) for a fenestration (32) of a stent graft which can be surface treated such as by passivation and/or electropolishing. The reinforcing ring has several turns of a substantially inextensible resilient wire (12) in a circular two dimensional planar shape and terminal ends (14) at each end of the wire. The terminal ends each comprising a loop (14) and a tail (16). The tail is folded back and extends around the circular shape. Each of the tails of the terminal loops can have an enlarged end. The reinforcing ring can be straightened out for surface treatment such as passivation and/or electropolishing with substantially no part of the circular shape, the loops or tails touching each other.

Abstract: A coupling wire guide structured to be slidably coupled to a previously introduced wire guide. The coupling wire guide generally includes a main body having a distal end and a coupling tip connection to the distal end. The coupling tip includes a coupling portion defining a coupling passageway having a proximal port and a distal port. A slot is formed in the coupling tip and is in communication with the coupling passageway. The slot extends from the proximal port to the distal port, thereby permitting the coupling wire guide to be “clipped-on” to the mid-section of the previously introduced wire guide or any location having the most efficacy.

Abstract: An introducer or delivery system for introducing implants or medical devices such as embolic protection devices within a patient allows deployment within vessels having a tortuous anatomy. The delivery system includes an actuator wire within the delivery catheter which enables the delivery catheter to be bent near a distal end thereof upon actuation of the actuator wire.

Abstract: An embolic protection device for capturing emboli during treatment of a stenotic lesion in a body vessel is disclosed. The device comprises a basket and a filter attached to the basket. The basket has a deployed state and an undeployed state. The basket includes a reticulated body having an outer diameter. The reticulated body includes a plurality of struts connected together in a singly staggered configuration distally along a longitudinal axis to a distal end. The plurality of struts of the reticulated body is configured to fold along the longitudinal axis. The basket has a proximal stem proximally extending from the body. The filter portion has a lip attached to the distal end defining an opening of the filter portion when the basket is in the deployed state for capturing emboli. The filter portion extends from the lip to a filter end.

Abstract: A detachable embolization coil is screw threaded at the proximal end for releasable attachment to a delivery member within a delivery catheter. The coil has a proximal fibred portion and a distal non-fibred portion, the axial length of the non-fibred portion being as great or greater than the axial length of the non-fibred portion. The fibred portion carries a plurality of fibres of thrombogenic fibrous material. In this way, a partially delivered coil may be retracted into a delivery catheter for repositioning, substantially without hindrance from clotting.

Abstract: The present invention provides apparatus and methods for deployment of a modular stent-graft system. In one embodiment, a prosthesis comprises a first tubular graft comprising a layer of graft material, at least one lumen extending longitudinally therein, and a first fenestration extending through the layer of graft material. A layer of fenestration covering material attaches to the layer of graft material. The layer of fenestration covering material is disposed in the lumen of the first tubular graft and partitions the first fenestration from the lumen of the first tubular graft. A first non-stented opening is disposed proximal to the first fenestration and communicates with the first fenestration between the layer of graft material and the fenestration covering material. In use, a proximal end of a second tubular graft sealably engages the first non-stented opening, and the second tubular graft further extends through the first fenestration and into a branch vessel.