Abstract: A prosthesis for treating a body passage includes a micro-porous tubular element and a support element. The tubular element is formed from a thin-walled sheet having a wall thickness of 25 micrometers or less, preferably a coiled-sheet exhibiting temperature-activated shape memory properties. The mesh pattern includes a plurality of openings in the sheet having a maximum dimension of not more than about 200 micrometers, thereby acting as a filter trapping embolic material while facilitating endothelial growth therethrough. The support element includes a plurality of struts, preferably having a thickness of 100-150 micrometers. The support element is preferably an independent component from the tubular element. Alternatively, the support element may be attached to or integrally formed as part of the tubular element. The tubular and support elements are placed on a catheter in contracted conditions and advanced endoluminally to a treatment location within a body passage.

Abstract: A stent-graft having an exo-skeleton attached to a tubular graft, the tubular graft having a peripheral wall defining a lumen therein extending between first and second ends. One or more support elements, defining the exo-skeleton, are attached to the tubular graft, each support element extending generally peripherally around the tubular graft, each support element including generally axial segments and generally peripheral segments. A plurality of first fasteners attach the plurality of support elements to the wall of the tubular graft, at least one generally axial segment being slidably engaged by each first fastener. A plurality of second fasteners also attach the plurality of support elements to the wall of the tubular graft, each second fastener substantially anchoring a generally peripheral segment of the respective support element to the wall of the tubular graft.

Abstract: A stent-graft having an exo-skeleton attached to a tubular graft, the tubular graft having a peripheral wall defining a lumen therein extending between first and second ends. The exo-skeleton may assume contracted and enlarged conditions, and includes one or more serpentine elements, each extending both peripherally and axially along at least a portion of the peripheral wall. Coiled-sheet stents are provided on the ends of the tubular graft for anchoring the ends within a body passage. Each serpentine element is a zigzag structure extending peripherally about the peripheral wall, with a plurality of serpentine elements distributed axially along the peripheral wall. The serpentine elements are individually attached to the peripheral wall and/or connector elements may extend between adjacent serpentine elements. Alternatively, each serpentine element may define a generally sinusoidal shape extending axially along the peripheral wall.

Abstract: A coiled-sheet stent includes a tubular body having a longitudinal axis, a circumference, and a thickness, and having a size configured for introduction into a body lumen. The tubular body includes a plurality of cylindrical bands, each band including a generally zig-zag pattern defined by a series of sequential arcuate-shaped diagonal elements connected to one another and extending about the circumference. Longitudinal connectors extend between adjacent cylindrical bands. Slots are formed in the tubular body oriented about the circumference of the tubular body, thereby providing reduced thickness regions in the longitudinal connectors that have a thickness that is substantially smaller than the thickness of the cylindrical bands of the tubular body.

Abstract: A prosthesis for treating a body passage includes a micro-porous tubular element and a support element. The tubular element is formed from a thin-walled sheet having a wall thickness of 25 micrometers or less, preferably a coiled-sheet exhibiting temperature-activated shape memory properties. The mesh pattern includes a plurality of openings in the sheet having a maximum dimension of not more than about 200 micrometers, thereby acting as a filter trapping embolic material while facilitating endothelial growth therethrough. The support element includes a plurality of struts, preferably having a thickness of 100–150 micrometers. The support element is preferably an independent component from the tubular element. Alternatively, the support element may be attached to or integrally formed as part of the tubular element. The tubular and support elements are placed on a catheter in contracted conditions and advanced endoluminally to a treatment location within a body passage.

Abstract: A unidirectional handle device for an endoluminal device includes an outer tubular member and an elongate inner member slidably received in the outer tubular member. The unidirectional handle includes a handle member, a needle bearing clutch disposed in the handle member, a control member guide, and shaft rotatable in a single direction disposed within the handle member. The shaft is rotatable in a single direction by its engagement with the needle bearing clutch. The shaft is in rotational engagement with the outer tubular member of the endoluminal device. The outer tubular member is slidable from a distal position to a proximal position when the shaft is rotated in the single direction. The unidirectional handle device provides substantially no backlash of the outer tubular member. In addition, the unidirectional handle device advantageously produces a tension-retaining effect during use.

Abstract: An apparatus for delivering a stent into a blood vessel includes a sheath having a rounded bullet-shaped distal portion including a plurality of flexible leaflets integrally molded thereto. The stent is disposed in its contracted condition within a lumen of the sheath proximate the distal portion. A bumper is slidably disposed within the lumen that includes a helical compression coil, a bumper element attached to the helical coil including a blunt distal edge for abutting the stent, and an extension element extending distally from the bumper element through the stent and between the leaflets to facilitate introducing the apparatus over a guidewire. The sheath is formed by inserting a bullet into a blunt-ended tube, and inserting the tube into a bullet-shaped bore in a heated die until the tube material is softened and deforms into a rounded bullet shape. Slits are then cut into the distal portion to create the leaflets.

Abstract: A coiled-sheet stent includes a tubular body having a longitudinal axis and a circumference, and a plurality of cylindrical bands formed in the tubular body, each band having a zig-zag pattern including a series of sequential diagonal elements connected to one another and extending about the circumference. A plurality of longitudinal connectors extend between and connect adjacent bands. The diagonal elements have an arcuate shape, all diagonal elements in each band being oriented in either a clockwise or counter-clockwise direction about the circumference. The tubular body is expandable between contracted and enlarged conditions, and the zig-zag pattern is expandable between unstretched and unstretched conditions, the zig-zag pattern being biased towards the stretched condition above a transition temperature, thereby at least partially defining the enlarged condition.

Abstract: A stent for endovascular placement in the body having radiopaque markers in the shape of sleeves attached to struts of the stent. In a preferred embodiment, radiopaque sleeve markers are attached surrounding the terminal end of struts at the ends of a stent so that the location within the body of the stent can be identified by fluoroscopy or other methods. Upon placement of the sleeve marker on the stent strut, the marker is attached to the strut by a snap-fit mechanism, or by deforming or changing the shape of the marker and/or the strut to inhibit removal of the marker.

Abstract: A prosthesis is provided for treating aneurysms, occlusive disease of vessels and body organs, and arterio-venous fistulas, occurring in single and bifurcated lumens. The prosthesis comprises an expandable coiled sheet portion having a biocompatible graft, either a sheet or tube, affixed thereto along part or all of the circumference of the coiled sheet portion. The prosthesis has a small delivery profile, making it suitable for use in a variety of body vessels. Methods of making and deploying the prosthesis in single and bifurcated lumens are also provided.

Abstract: A vascular filter is provided that includes a tubular member having proximal and distal ends, and a guidewire lumen. An expandable frame is attached to the tubular member capable of assuming collapsed and enlarged conditions, and filter material is attached to the frame, the filter material having an open proximal end when the frame assumes its enlarged condition. An apparatus for recovering a vascular filter from a blood vessel is also provided that includes a sheath and a retrieval member deployable from the sheath. The retrieval member includes a connector on its distal end for securing the tubular member, such as an expandable member within a recess for receiving the tubular member. The vascular filter may be constrained in its collapsed condition in a sheath, and the tubular member advanced over a guidewire to a location downstream of a treatment site. The vascular filter is deployed and expanded to its enlarged condition across the blood vessel, the guidewire remaining in place.

Abstract: A prosthesis for treating a body passage includes a micro-porous tubular element and a support element. The tubular element is formed from a thin-walled sheet having a wall thickness of 25 micrometers or less, preferably a coiled-sheet exhibiting temperature-activated shape memory properties. The mesh pattern includes a plurality of openings in the sheet having a maximum dimension of not more than about 200 micrometers, thereby acting as a filter trapping embolic material while facilitating endothelial growth therethrough. The support element includes a plurality of struts, preferably having a thickness of 100-150 micrometers. The support element is preferably an independent component from the tubular element. Alternatively, the support element may be attached to or integrally formed as part of the tubular element. The tubular and support elements are placed on a catheter in contracted conditions and advanced endoluminally to a treatment location within a body passage.

Abstract: A stent-graft having an exo-skeleton attached to a tubular graft, the tubular graft having a peripheral wall defining a lumen therein extending between first and second ends. One or more support elements, defining the exo-skeleton, are attached to the tubular graft, each support element extending generally peripherally around the tubular graft, each support element including generally axial segments and generally peripheral segments. A plurality of first fasteners attach the plurality of support elements to the wall of the tubular graft, at least one generally axial segment being slidably engaged by each first fastener. A plurality of second fasteners also attach the plurality of support elements to the wall of the tubular graft, each second fastener substantially anchoring a generally peripheral segment of the respective support element to the wall of the tubular graft.

Abstract: A coiled-sheet stent includes a tubular body having a longitudinal axis, a circumference, and a thickness, and having a size configured for introduction into a body lumen. The tubular body includes a plurality of cylindrical bands, each band including a generally zig-zag pattern defined by a series of sequential arcuate-shaped diagonal elements connected to one another and extending about the circumference. Longitudinal connectors extend between adjacent cylindrical bands. Slots are formed in the tubular body oriented about the circumference of the tubular body, thereby providing reduced thickness regions in the longitudinal connectors that have a thickness that is substantially smaller than the thickness of the cylindrical bands of the tubular body.

Abstract: A unidirectional handle device for an endoluminal device includes an outer tubular member and an elongate inner member slidably received in the outer tubular member. The unidirectional handle includes a handle member, a needle bearing clutch disposed in the handle member, a control member guide, and shaft rotatable in a single direction disposed within the handle member. The shaft is rotatable in a single direction by its engagement with the needle bearing clutch. The shaft is in rotational engagement with the outer tubular member of the endoluminal device. The outer tubular member is slidable from a distal position to a proximal position when the shaft is rotated in the single direction. The unidirectional handle device provides substantially no backlash of the outer tubular member. In addition, the unidirectional handle device advantageously produces a tension-retaining effect during use.

Abstract: Methods and apparatus are provided for temporarily excluding an aneurysm or an arterio-venous fistula from a flow path by transluminally disposing a hollow balloon catheter structure within the aneurysm so that its proximal and distal ends extend past the aneurysm while maintaining continuity of the flow path, and then injecting a synthetic molding material or a biological hardening agent into the aneurysm cavity to cause solidification of the volume within the cavity. Once the material within the excluded aneurysm has solidified, the balloon catheter structure is deflated and removed, so that the hardened mass forms a new lining for the organ or vessel, and relieves the weakened tissue of the aneurysm or fistula from further flow-induced stress.

Abstract: A prosthesis is provided for treating aneurysms, occlusive disease of vessels and body organs, and arterio-venous fistulas, occurring in single and bifurcated lumens. The prosthesis comprises an expandable coiled sheet portion having a biocompatible graft, either a sheet or tube, affixed thereto along part or all of the circumference of the coiled sheet portion. The prosthesis has a small delivery profile, making it suitable for use in a variety of body vessels. Methods of making and deploying the prosthesis in single and bifurcated lumens are also provided.

Abstract: A delivery apparatus includes a tubular sheath including proximal, intermediate, and distal portions defining a lumen. A wall of the distal portion is transparent, allowing observation of the lumen within the distal portion. The distal portion terminates in a rounded distal tip including a plurality of leaflets. A self-expanding stent is disposed within the intermediate portion, and a bumper member is slidably disposed within the lumen proximate the stent. Before use, the sheath is retracted to bump the stent forward into the distal portion until the stent is observed within the distal portion. After the apparatus has been pre-loaded, the distal portion is advanced into a blood vessel, e.g., across a stenosis, and the sheath is retracted, causing the leaflets to open and allow the stent to be deployed, whereupon the stent automatically expands to dilate the stenosis.

Abstract: A prosthesis is provided for treating aneurysms, occlusive disease of vessels and body organs, and arterio-venous fistulas, occurring in single and bifurcated lumens. The prosthesis comprises an expandable coiled sheet portion having a biocompatible graft, either a sheet or tube, affixed thereto along part or all of the circumference of the coiled sheet portion. The prosthesis has a small delivery profile, making it suitable for use in a variety of body vessels. Methods of making and deploying the prosthesis in single and bifurcated lumens are also provided.

Abstract: A stent including a helical mesh coil is provided having a substantially rectangular cross-section and a band width equal to at least one-quarter to one-third of the maximum expanded circumference of the stent. The helical mesh has a multiplicity of openings forming a lattice that preferably provides about 60% open space or more. Alternative embodiments of the stent include free ends that preferentially overlap neighboring turns of the coil, and integrally formed barbs that enhance resistance to localized compressive forces. Methods of deploying the helical mesh coil stent also provided.