Abstract: The present invention provides an improved vascular occlusion device having improved flexibility and retention of the type fabricated from braided tubular metal fabric having an expanded preset configuration and an elongated collapsed reduced diameter configuration for delivery through a catheter to a treatment site and shaped to create an occlusion of an abnormal opening in a body organ or vessel, the woven metal fabric having a memory property whereby the medical device tends to return to said expanded preset configuration when unconstrained. The device further including at least one disk portion adjacent a body cylindrical portion formed from the fabric and having a transition diameter between the disk and cylindrical portion, significantly smaller than the diameter of the disk and the diameter of the cylindrical portion.

Abstract: Branched braided stent or graft devices and processes for fabrication of the devices are disclosed in which a trunk portion and two hinge leg portions are fabricated in one piece braided from a single plurality of filaments, whereby the legs contain the full plurality of filaments and the trunk portion contains a subset of the same plurality of filaments. The fabrication process involves braiding the hinged legs on a mandrel while retaining loops of filament between the hinged leg portions for subsequent braiding of the trunk portion of the stent or graft.

Abstract: A method and apparatus for providing safe and efficient transcatheter correction of the shape of heart chambers, valves, or other body members. The apparatus generally performs this correction by securing a tether to body surfaces. The attachment device includes an anchor comprising a wire braid and at least one clamp affixed to and constraining a portion of the wire braid, the clamp having threading for temporarily coupling the anchor to a delivery member and an internal lumen through which the tether can pass. The device also includes a locking member cooperating with the lumen to lock the tether to the clamp at a preselected position along the length of the tether.

Abstract: A collapsible medical device and associated methods of occluding an abnormal opening in, for example, a body organ, wherein the medical device is shaped from plural layers of a heat-treatable metal fabric. Each of the fabric layers is formed from a plurality of metal strands and the assembly is heat-treated within a mold in order to substantially set a desired shape of the device. By incorporating plural layers in the thus-formed medical device, the ability of the device to rapidly occlude an abnormal opening in a body organ is significantly improved.

Abstract: A catheter deliverable stent/graft especially designed to be used in a minimally invasive surgical procedure for treating a variety of vascular conditions such as aneurysms, stenotic lesions and saphenous vein grafts, comprises an innermost tubular structure and at least one further tubular member in coaxial arrangement. In one embodiment, the innermost tubular structure is of a length (L1) and is formed by braiding a relatively few strands of highly elastic metallic alloy. The pick and pitch of the braid are such as to provide relative large fenestrations in the tubular wall that permit blood flow through the wall and provide the primary radial support structure. A portion of the innermost tubular structure of a length L1 is surrounded by a further braided tubular structure having relatively many strands that substantially inhibit blood flow through the fenestrations of the innermost tubular structure.

Abstract: A stent/graft especially designed to be used in a minimally invasive surgical procedure for treating an abdominal aortic aneurysm (AAA) comprises an innermost tubular structure of a length (L1) formed by braiding a relatively few strands of shape memory alloy wire. The pick and pitch of the braid are such as to provide relative large fenestrations in the tubular wall. A portion of the innermost tubular structure of a length L2<L1 is surrounded by a further braided tubular structure having relatively many strands that occlude the fenestrations of the innermost tubular structure. The composite structure can be stretched to reduce the outer diameter of the stent/graft, allowing it to be drawn into a lumen of a delivery catheter. The catheter can then be advanced through the vascular system to the site of the AAA and then ejected, allowing it to self-expand with the portion L2 bridging the aneurysm.

Abstract: The present invention provides a delivery mechanism for percutaneously routing a stent or graft through the vascular system and procedures for addressing an aneurysm or an otherwise damaged vessel. The delivery system includes an outer tubular guide catheter 20, an inner tubular delivery (pusher) catheter 14 coaxially disposed and slidable relative to the outer guide catheter and an elongated flexible wire or cable 26 that is coaxially insertable through the lumen of the inner tubular catheter and that has a frusto-conical bead affixed at the distal end thereof which is sized to at least partially fit within the lumen of the inner pusher catheter when a proximally directed tension force is applied between the elongated flexible wire or cable 26 with respect to the pusher catheter 14.

Abstract: Implantable occlusion devices that include one or more flanges extending from a tubular body are disclosed. The flange or flanges may assist in retention of the device within a vessel, cavity, appendage, etc. At least one flange on the occlusion device may include a concave surface proximate one end of a body. Because of the shape of the flange, e.g., its concavity, the occlusion device may resist dislocation due to e.g., the forces generated within the left atrial appendage during atrial filbrillation.

Abstract: A collapsible medical device and associated methods of occluding an abnormal opening in, for example, a body organ, wherein the medical device is shaped from plural layers of a heat-treatable metal fabric. Each of the fabric layers is formed from a plurality of metal strands and the assembly is heat-treated within a mold in order to substantially set a desired shape of the device. By incorporating plural layers in the thus-formed medical device, the ability of the device to rapidly occlude an abnormal opening in a body organ is significantly improved.

Abstract: An intravascular flow restrictor comprises a braided tubular structure designed to be placed in the main pulmonary artery for limiting blood pressure in the lungs. The braided structure is designed to be collapsed for placement in a delivery catheter but when ejected from the delivery catheter, assumes a substantially larger diameter disk shaped device having one or more longitudinal channels or passways therethrough.

Abstract: A collapsible medical device and associated methods of occluding an abnormal opening in, for example, a body organ, wherein the medical device is shaped from plural layers of a heat-treatable metal fabric. Each of the fabric layers is formed from a plurality of metal strands and the assembly is heat-treated within a mold in order to substantially set a desired shape of the device. By incorporating plural layers in the thus-formed medical device, the ability of the device to rapidly occlude an abnormal opening in a body organ is significantly improved.

Abstract: A collapsible medical device and associated method for grafting a lumen of selected organs and vessels, wherein the medical device is shaped from a shape memory fabric. The device is preferably made from a continuous tubular fabric and each end terminates with an open end for passage there through. Each end further includes a securing member attached to an outer perimeter of the end, wherein a substantial plane formed by the perimeter intersects the longitudinal axis of the tubular fabric at either an acute or obtuse angle. The fabric may be heat treated within a mold in order to substantially set a desired shape of the device. The securing member may also attach to the end of a guide wire or delivery catheter, thereby allowing deployment and later retrieval after deployment of the device.

Abstract: The present invention provides a method of forming a medical device and medical devices which can be formed in accordance with the method. In one embodiment, the method includes the steps of a) providing a metal fabric formed of a plurality of strands formed of a metal which can be heat treated to substantially set a desired shape; b) deforming the metal fabric to generally conform to a surface of a molding element; c) heat treating the metal fabric in contact with the surface of the molding element to substantially set the shape of the fabric in its deformed state; and d) removing the metal fabric from contact with the molding element. The resulting metal fabric will define a medical device which can be collapsed for passage through a catheter or the like for deployment in a channel of a patient's body.

Abstract: An intravascular flow restrictor comprises a braided tubular structure designed to be placed in the main pulmonary artery for limiting blood pressure in the lungs. The braided structure is designed to be collapsed for placement in a delivery catheter but when ejected from the delivery catheter, assumes a substantially larger diameter disk shaped device having one or more longitudinal channels or passways therethrough.

Abstract: An intravascular flow restrictor comprises a braided tubular structure designed to be placed in the main pulmonary artery for limiting blood pressure in the lungs. The braided structure is designed to be collapsed for placement in a delivery catheter but when ejected from the delivery catheter, assumes a substantially larger diameter disk shaped device having one or more longitudinal channels or passways therethrough.

Abstract: An intravascular flow restrictor comprises a braided tubular structure designed to be placed in the main pulmonary artery for limiting blood pressure in the lungs. The braided structure is designed to be collapsed for placement in a delivery catheter but when ejected from the delivery catheter, assumes a substantially larger diameter disk shaped device having one or more longitudinal channels or passways therethrough.

Abstract: The present invention provides a method of forming a medical device and medical devices which can be formed in accordance with the method. In one embodiment, the method includes the steps of a) providing a metal fabric formed of a plurality of strands formed of a metal which can be heat treated to substantially set a desired shape; b) deforming the metal fabric to generally conform to a surface of a molding element; c) heat treating the metal fabric in contact with the surface of the molding element to substantially set the shape of the fabric in its deformed state; and d) removing the metal fabric from contact with the molding element. The resulting metal fabric will define a medical device which can be collapsed for passage through a catheter or the like for deployment in a channel of a patient's body. Medical devices made in accordance with this method can have varying structures.

Abstract: A method of treating a physiologic condition by providing a metal fabric formed of a plurality strands, wherein the strands have been heat-treated to set a desired shaped, the medical device then being further heat-treated in a mold having a shape of a desired medical device to set the shape the fabric in a deformed state to the shape of the desired medical device that can be collapsed for passage through a catheter for deployment in a patient's body.

Abstract: A collapsible medical device and associated method for grafting a lumen of selected organs and vessels, wherein the medical device is shaped from a shape memory fabric. The device is preferably made from a continuous tubular fabric and each end terminates with an open end for passage there through. Each end further includes a securing member attached to an outer perimeter of the end, wherein a substantial plane formed by the perimeter intersects the longitudinal axis of the tubular fabric at either an acute or obtuse angle. The fabric may be heat treated within a mold in order to substantially set a desired shape of the device. The securing member may also attach to the end of a guide wire or delivery catheter, thereby allowing deployment and later retrieval after deployment of the device.

Abstract: The present invention provides aneurysm occlusion devices 60, 160 formed from a resilient metal fabric and a method for reliably and effectively occluding aneurysms. In accordance with one aspect of the invention, the aneurysm devices include a body portion 80 which is sized to be received within an aneurysm and an anchor 70 which is sized, and may also be preformed into a specific shape, to engage the lumen of a vessel having the aneurysm thereon. The aneurysm occluder 60 may also include a generally tubular central portion 62 extending between the body portion and the anchor, the central portion being sized and shaped to be received within the neck of the aneurysm. The present invention has particular advantages over prior minimally invasive techniques for occluding aneurysms in that it can both fill the aneurysm and occlude or “stent” the neck of the aneurysm in one step. It also minimizes damage to healthy vessel tissue by localizing contact with the interior of the vessel.