Abstract: A medical device for removing a thrombus includes an outer sheath and an inner catheter. The inner catheter is disposed within the inner lumen of the outer sheath. The device also includes a rollsock which is everted upon itself and connected to the distal ends of the outer sheath and inner catheter. A scraping device is attached to the outer surface of the rollsock, such that when the outer sheath is moved relative to the inner catheter the scraping device is exposed to an inner surface of a body vessel.

Abstract: A method for manufacturing a stent delivery system having a holder and at least one stent configured to expand from a first diameter to a second diameter is provided. The manufacturing method includes compressing the stent to the first diameter, inserting the stent into a first tube, placing a second tube inside the first tube and inside an inner diameter of the stent. The second tube is airtight. The manufacturing method also includes applying pressure and heat suitable to the second tube, thereby blowmolding the second tube against the stent.

Abstract: A marker and pushing member are provided with lateral extensions connected to a connecting portion. The connecting portion connects the marker/pushing member to a proximal or distal end of the stent. The lateral extensions distribute forces applied to the marker/pushing member so that part of the force is applied to the connecting member and part of the force is applied to a portion of the stent structure that is not directly connected to the connecting member.

Abstract: A medical device for embolic protection within a patient's body vessel is provided. The device comprises inner and outer tubular members each having proximal and distal ends and a lumen formed through the proximal and distal ends. A flexible everting filter portion includes a body having a first end attached to the distal end of the inner tubular member and a second end attached to the distal end of the outer tubular member. The inner and outer tubular members are movable relative to one another to position the filter portion within the body vessel. The filter portion is movable from a collapsed, everted delivery and removal configuration to an expanded, generally non-everted deployed configuration. The filter portion expands radially outward to engage the filter body with an enclosing vessel wall. The filter portion allows the passage of blood cells and prevents the passage of emboli or thrombi through the body vessel.

Abstract: A method for manufacturing a stent delivery system having a holder and at least one stent configured to expand from a first diameter to a second diameter is provided. The manufacturing method includes compressing the stent to the first diameter, inserting the stent into a first tube, placing a second tube inside the first tube and inside an inner diameter of the stent. The second tube is airtight. The manufacturing method also includes applying pressure and heat suitable to the second tube, thereby blowmolding the second tube against the stent.

Abstract: The present invention relates to a medical device delivery system. The delivery system includes an introducer sheath having an elongated tubular member having a passageway extending generally longitudinally therethrough. The passageway is defined by an inner surface of the tubular member and is configured to receive a medical device moveably disposed therein, where at least a portion of the inner surface of the inner tube comprises a non-uniform surface configured to reduce surface contact between the inner surface and the medical device. The delivery system includes an inner catheter configured to slidably extend throughout the passageway of the introducer sheath. A prosthesis is disposed within a distal portion of the introducer sheath, where the prosthesis is supported within the introducer sheath by the inner catheter.

Abstract: A tubular prosthesis delivery system has an inner tubular member having a distal end including a prosthesis-carrying portion and a proximal end intended to remain outside the patient. An outer tubular member has a distal end spaced from the prosthesis-carrying portion of the inner member. A coupling member couples the inner and outer tubular members to each other in fixed relationship generally at a location intended to remain outside the patient. An intermediate tubular member located between the inner and outer tubular members has a distal end adapted to cover the tubular prosthesis and a proximal end that projects proximally beyond the proximal ends of both the inner and outer tubular members. The proximally projecting end of the intermediate tubular member is longitudinally movable with respect to the coupled inner and outer tubular members by a distance sufficient to retract the intermediate tubular member distal end from any position covering the prosthesis carried by the inner member.

Abstract: Prosthetic valves for implantation in a body vessel are provided. Prosthetic valves according to the invention comprise first and second frame members and a graft member at least partially disposed between the first and second frame members. The graft member forms a valve that permits fluid flow through the body vessel in a first direction and substantially prevents fluid flow through the body vessel in a second, opposite direction.

Abstract: Methods of implanting a prosthetic valve in a body vessel are provided. A first expandable frame member is delivered to and deployed at a point of treatment in a body vessel. A second expandable frame member is delivered to the point of treatment. The second expandable frame member has an attached graft member that forms a valve adapted to permit fluid flow through the body vessel in a first direction and to substantially prevent fluid flow through the body vessel in a second, opposite direction. After deployment of the first expandable frame member, the second expandable frame member is deployed at the point of treatment such that the second frame member is positioned radially inward of the first frame member within said body vessel to form a prosthetic valve.

Abstract: An introducer apparatus and a method for forming an introducer apparatus. The apparatus comprises an inner liner having a passageway extending longitudinally therethrough. A coil in a stressed, radially expanded condition is positioned longitudinally around said inner tube. A polymeric outer tube is positioned longitudinally around the coil and the inner liner, and is bonded to the inner liner through the spaces between the turns of the coil. The polymeric outer tube is formed in a manner such that it maintains the coil in its stressed radially expanded condition. In a preferred embodiment, the inner liner and outer tube comprise a polyimide.

Abstract: An introducer sheath for deploying a stent to a target site within a body passageway of a patient. The introducer sheath includes a tubular inner liner having a proximal portion, a distal portion, and an outer surface. A first reinforcing element, and a second reinforcing element are positioned along the outer surface of the inner liner. The first reinforcing element comprises a braid the second reinforcing element comprises a coil. The braid is positioned at the proximal portion of the inner liner and extends distally therefrom. The coil is positioned at the distal portion longitudinally adjacent the braid. The braid has a length that may extend about 90% of the length of the sheath. An outer jacket is positioned longitudinally around the reinforcing elements, and is connected to the inner liner between the respective wires of the braid and the coil.

Abstract: An improved delivery system for an implantable medical device includes a retention sheath for an implantable medical device. The retention sheath includes a central lumen extending from a proximal end to a distal end of the retention sheath, and a tapered portion disposed at a distal end of the retention sheath. The tapered portion of the retention sheath includes a first layer made of a low-friction material. The first layer may be movable from a compressed, folded configuration in an initial position, to a substantially uncompressed and unfolded configuration in a deployment position. The retention sheath also includes a second layer made of an expandable material. The second layer is disposed radially outward of and in contact with the first layer, and the second layer is configured to expand in a substantially radially outward direction when the first layer moves from the initial position to the deployment position.

Abstract: A method of making a self-expanding stent includes disposing a stent comprising a shape memory alloy about an inflatable body, and applying a coolant to a surface of the stent. The inflatable body is inflated to radially expand the stent to an expanded diameter from an initial diameter, and the coolant is reapplied to the surface of the stent. The inflatable body is deflated, and the stent is positioned about a mandrel sized to accommodate the expanded diameter of the stent, where the stent reaches a mandrel-defined diameter. The stent is heat set at the mandrel-defined diameter so as to impart a memory of an expanded configuration of the stent to the shape memory alloy.

Abstract: An improved delivery system for an implantable medical device includes a retention sheath having a proximal end, a distal end, and an inner lumen extending from the proximal end to the distal end. The implantable medical device is disposed within the inner lumen of the retention sheath, which restrains the implantable medical device. A plurality of substantially incompressible rings are disposed within the inner lumen of the retention sheath in a stacked co-axial configuration that extends from the proximal end of the retention sheath in a pre-deployment position to a proximal end of the implantable medical device. Each ring in the plurality of separate rings abuts at least a portion of an adjacent ring. The plurality of separate rings is configured to prevent the implantable medical device from moving toward a proximal end of the retention sheath when the retention sheath is moved from the pre-deployment position to a deployment position.

Abstract: A system for delivery of a medical device to a target site within the body of a patient includes an introducer sheath, and a delivery assembly receivable within a passageway of the sheath. The delivery assembly comprises an inner tubular and an outer tubular member. At least a distal portion of the inner tubular member has a diameter such that the medical device is receivable thereover. The outer tubular member is generally coaxial with the inner tubular member, and has a length such that the outer tubular member distal end terminates proximal to the inner tubular member distal portion. The outer tubular member has a first outer diameter at the proximal end and extends for a length of the outer tubular member to a first diameter boundary point. The outer tubular member has a gradual inward taper in the distal direction from the boundary point to a second outer diameter, and has an abrupt outward taper in the distal direction from the second diameter to the first diameter.

Abstract: A system for delivery of a medical device to a target site within the body of a patient includes an introducer sheath, and a delivery assembly receivable within a passageway of the sheath. The delivery assembly comprises an inner tubular and an outer tubular member. At least a distal portion of the inner tubular member has a diameter such that the medical device is receivable thereover. The outer tubular member is generally coaxial with the inner tubular member, and has a length such that the outer tubular member distal end terminates proximal to the inner tubular member distal portion. The outer tubular member has a first outer diameter at the proximal end and extends for a length of the outer tubular member to a first diameter boundary point. The outer tubular member has a gradual inward taper in the distal direction from the boundary point to a second outer diameter, and has an abrupt outward taper in the distal direction from the second diameter to the first diameter.

Abstract: The present embodiments provide a coated stent for use in a medical procedure that comprises a coating and a stent disposed over the coating. The stent has a first expanded state in which an inner diameter of the stent is less than or equal to an outer diameter of the coating, thereby causing an inner surface of the stent to engage the outer surface of the coating. The stent may comprise a shape-memory material that is preconfigured to expand to the first expanded state. In one example, the stent may be temporarily held in a second expanded state having an inner diameter larger than the outer diameter of the coating, placed over the coating in the second expanded state, and then allowed to return to the first expanded state to engage the coating.

Abstract: A system for delivery of a medical device to a target site within the body of a patient includes an introducer sheath, and a delivery assembly receivable within a passageway of the sheath. The delivery assembly comprises an inner tubular and an outer tubular member. At least a distal portion of the inner tubular member has a diameter such that the medical device is receivable thereover. The outer tubular member is generally coaxial with the inner tubular member, and has a length such that the outer tubular member distal end terminates proximal to the inner tubular member distal portion. The outer tubular member has a first outer diameter at the proximal end and extends for a length of the outer tubular member to a first diameter boundary point. The outer tubular member has a gradual inward taper in the distal direction from the boundary point to a second outer diameter, and has an abrupt outward taper in the distal direction from the second diameter to the first diameter.

Abstract: A method (112) of loading an expandable medical device in a low vapor environment. The method includes placing the device in a loading chamber (114) at, for example, room temperature and removing (116) from the chamber any undesirable contaminants such as water vapor that can form condensation on the device when the device is cooled for compression into a transfer tube or delivery catheter. The temperature in the chamber is lowered (118) to a temperature below the transition temperature (martensitic finish) of the device. The device is compressed (120) below its' transition temperature and loaded (122) into a delivery or transfer device.

Abstract: Apparatus and methods are provided for improved deployment of self-expanding stents. One advantage of the improved delivery system is that energy storage within a portion of an outer sheath and/or an inner tube may be reduced during the deployment of the stent. In a first embodiment, the outer sheath and the inner tube may be coupled together using a plurality of engaging threaded members, such that circumferential rotation of the inner tube with respect to the outer sheath retracts the outer sheath to deploy the stent. In an alternative embodiment, a fluid reservoir may be provided between the inner tube and the outer sheath. A proximal sealing ring may be disposed annularly between the inner tube and the outer sheath, such that when the fluid reservoir is filled, the proximal sealing ring is urged proximally to engage and retract the outer sheath.