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: Embodiments of the present disclosure are directed to medical devices, methods, and systems for delivering a medical device to a target site. In one embodiment, a medical device includes a proximal lobe and a distal lobe, at least one of the proximal lobe or the distal lobe configured to receive a delivery device therethrough. The medical device also includes a central engagement member disposed between the proximal lobe and the distal lobe, the central engagement member configured to be engaged by a delivery device for facilitating deployment of the proximal and distal lobes at the target site.

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: A heart valve assembly (100) includes a heart valve (116), a self-expandable and collapsible stent (112), and a sealing member (114). The stent (112) includes an inflow end (120) and an outflow end (122), and surrounds and supports the heart valve (116). The sealing member (114) is connected to the inflow end (120) of the stent (112) and extends around a periphery of the stent (112). The sealing member (114) is connected to the inflow end (120) of the stent (112), overlaps a portion of the heart valve (116), and extends around an outer periphery of the stent (112).

Abstract: Embodiments of the present invention provide medical devices and methods for treating a target site within the body, such as for treating vascular abnormalities. For example, one embodiment provides a stent graft including an occlusive material having a preset, overlapping configuration comprising at least three inverted overlapping layers that are folded over one another. The at least three inverted overlapping layers are configured to be separated and disposed within a catheter in a non-overlapping configuration and return to the preset, overlapping configuration when deployed from the catheter.

Abstract: An occlusion device for occluding a cavity defined by a body is provided, and includes first and second laterally-expandable portions each formed of a woven tubular fabric and having opposed proximal and distal ends. The first portion is insertable into the cavity so as to be substantially disposed therein upon lateral expansion thereof. A connective element tethers the distal end of the first portion and the second portion, and is cooperable therewith to form a collapsible assembly extending along an insertion axis. Retention members, operably engaged with each of the first and second portions and spaced apart about a laterally outward surface thereof, are adapted to engage the body, after insertion of the collapsed assembly, second portion-first, into the cavity, and subsequent lateral expansion of the first and second portions, so as to retain the assembly substantially within the cavity. An associated deployment method is also provided.

Abstract: Medical devices are provided that include at least one layer that defines a proximal end, a distal end, and an expanded volume portion between the proximal and distal ends. The expanded volume portion defines a longitudinal axis extending between the proximal and distal ends. A first end feature including a reversible connection for attachment to a pusher member may be attached to the proximal end. The first end feature may define a first axis between its opposing ends. Similarly, a second end feature defining a second axis between its opposing ends may be located at the distal end. In the contracted state (e.g., when constrained within a delivery catheter), the first axis and the second axis may be aligned with the longitudinal axis, and in the expanded state (e.g., when deployed), the first axis and/or the second axis may be angled with respect to the longitudinal axis.

Abstract: A device and method for delivering a vascular device to a target site is provided that maintains a proximal portion of the vascular device within a tubular sleeve by positioning a stop of an inner member at a distal opening of the tubular sleeve to block the opening. Once the stop has been moved distally via movement of the inner member to clear the opening, a band of increased thickness on the inner member can urge the proximal portion of the vascular device out of the tubular sleeve to deploy the vascular device. The vascular device may be recaptured within a delivery sheath prior to the full deployment of the proximal portion of the vascular device from the tubular sleeve by re-positioning the stop at the distal opening to hold the vascular device within the tubular sleeve as the delivery device is retracted with respect to the delivery sheath.

Abstract: A multi-layer occluder for treating a target site within the body is provided. The occluder may include first and second layers. For example, the first layer may include braided strands of metallic material, and the second layer may include braided strands of polymeric material. At least one of the first or second layers may be configured to facilitate thrombosis.

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: Embodiments of the present invention provide medical devices and methods for treating a target site within the body, such as for treating vascular abnormalities. For example, one embodiment provides medical device including a first tubular member that includes a first portion, a second portion, and a central portion disposed between the first portion and the second portion. Each of the first and second portions have a radius that is larger than that of the central portion, and the second portion has a preset, relaxed configuration in which a portion of the second portion has a partial discoid shape defined by an inversion of a portion of a discoid into itself.

Abstract: A tubular structure and method for making a tubular structure are provided, where the tubular structure includes at least one layer of braided strands. In general, at least one portion of the braided strands exhibits a braid pattern of crests and troughs (e.g., a wave pattern, which may include sinusoidal, square, and/or sawtooth waves) along a length of the tubular structure. The wave pattern can be created by rotating the mandrel onto which the tubular structure is braided during the braiding process, such as by angularly oscillating the mandrel about its longitudinal axis or about its transverse axis. As a result, the tubular structures may have increased radial strength, collapse resistance, torque transmission, column strength, and kink resistance. The tubular structures may be used in medical devices, such as stent-grafts, as well as in other medical and non-medical devices, such as in hoses, tubing, filters, and other devices.

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: 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 occluder device for occluding a gap between a medical device and adjacent body tissue includes a conformable body having a hollow interior, a leading end and a trailing end; and a port disposed at the trailing end of the body and in fluid communication with the interior of the body.

Abstract: A self-expandable ring seals a gap between a medical device and adjacent body tissue. The ring is disposed about the medical device and configured to self-expand from a first radius in a compressed condition to a second radius in an expanded condition, the second radius being greater than the first radius. The ring may be formed from a compliant biocompatible foam configured and arranged to conform to the body tissue.

Abstract: An occluder for sealing gaps between a medical device and adjacent body tissue includes an expandable body configured to fill the gaps between the medical device and the body tissue. The occluder includes a fastener at one end of the body and adapted to couple to a first end of the medical device, and an expandable disk at the other end of the body and adapted to couple to the medical device at a position spaced from the first end.

Abstract: Embodiments of the present disclosure are directed to medical devices, methods, and systems for delivering a medical device to a target site. In one embodiment, a medical device includes a tubular member having a proximal end and a distal end, the tubular member having an expanded configuration and a relaxed configuration. The medical device further includes a tether comprising a first end and a second end, the first end coupled to the proximal end or the distal end of the tubular member. In addition, the medical device includes an engagement member coupled to the second end of the tether and disposed at least partially within the tubular member and between the proximal and distal ends of the tubular member in the relaxed configuration.

Abstract: Embodiments of the present disclosure are directed to medical devices, methods, and systems for delivering a medical device to a target site. In one embodiment, a medical device includes a proximal lobe and a distal lobe, at least one of the proximal lobe or the distal lobe configured to receive a delivery device therethrough. The medical device also includes a central engagement member disposed between the proximal lobe and the distal lobe, the central engagement member configured to be engaged by a delivery device for facilitating deployment of the proximal and distal lobes at the target site.

Abstract: An occlusion device for occluding a cavity defined by a body is provided, and includes first and second laterally-expandable portions each formed of a woven tubular fabric and having opposed proximal and distal ends. The first portion is insertable into the cavity so as to be substantially disposed therein upon lateral expansion thereof. A connective element tethers the distal end of the first portion and the second portion, and is cooperable therewith to form a collapsible assembly extending along an insertion axis. Retention members, operably engaged with each of the first and second portions and spaced apart about a laterally outward surface thereof, are adapted to engage the body, after insertion of the collapsed assembly, second portion-first, into the cavity, and subsequent lateral expansion of the first and second portions, so as to retain the assembly substantially within the cavity. An associated deployment method is also provided.