Abstract: The invention provides for methods and catheter apparatus for passing one or more guidewires (via the use of one or more telescoping guidewire lumens) through a chronic total occlusion of a vasculature. The catheter apparatus may include: a catheter shaft having a distal end; one or more telescoping guidewire lumen catheters passing longitudinally through the shaft, wherein the one or more guidewire lumen catheters are capable of telescoping beyond the distal end of the catheter shaft; an expansible distal portion of the shaft; and a retractable sheath covering at least a portion of the expansible distal portion of the shaft, wherein retracting the retractable sheath from the expansible distal portion of the shaft directly activates the expansible distal portion of the shaft causing expansion of the expansible distal portion of the shaft.

Abstract: A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A sheath pair is placed over the crimped scaffold after crimping to reduce recoil of the crimped polymer scaffold and maintain scaffold-balloon engagement relied on to hold the scaffold to the balloon when the scaffold is being delivered to a target in a body. The sheath pair is removed by a health professional before placing the scaffold within the body.

Abstract: A thromboembolic removal system for treating ischemic stroke, including a guide and occlusion catheter, a delivery and aspiration catheter, an aspiration pump, a thromboembolic receiver, and a thromboembolic separator.

Abstract: A delivery device and method for use, the delivery device including a stent device, a restraining sheath, and a pull member. The restraining sheath is mounted coaxially over the stent device for maintaining the stent device in a delivery configuration, and may include a line of weakness extending axially. The pull member is to be pulled so as to split the restraining sheath at the line of weakness and withdraw the restraining sheath from over the stent device. The pull member and the line of weakness may be located on opposing sides of the restraining sheath. The pull member may have an inner part extending inside of the restraining sheath, an outer part extending outside of the restraining sheath, and a wrap around portion therebetween for wrapping around an axial end of the restraining sheath to radially capture the restraining sheath between the inner and outer parts.

Abstract: A catheter assembly includes an expandable device that is disposed at a distal end of a catheter and expandable toward a fully deployed outer dimension. A fiber extends from the catheter and is releasably coupled to a side wall of the expandable device near or at an end of the expandable device to maintain an inner curvature of the expandable device as the expandable device is deployed.

Abstract: Stent delivery systems, clip members for use with stent delivery systems, and methods for making and using the same are disclosed. An example stent delivery system may include an inner shaft having a distal region. A stent may be disposed about the distal region. A deployment sheath may be slidably disposed about the inner shaft. A handle may be coupled to the inner shaft. The handle may include a clip member having a first holding portion and a second holding portion. The inner shaft may extend through the first holding portion and the second holding portion. A holding cuff may be thermally bonded to the inner shaft. The holding cuff may be positioned between the first holding portion and the second holding portion.

Abstract: A stent delivery system can include a core member, first and second restraints, and a stent engagement component. The core member can have a distal segment. The first and second restraints can be coupled to the core member distal segment and axially spaced apart from each other to provide an axial gap. The first and second restraints can each have an outer profile that tapers radially inwardly in directions away from the gap. The stent engagement component can be at least partially disposed in the axial gap between the first and second restraints such that the component is slidably and rotatably coupled to the core member distal segment.

Abstract: An implantable flow restrictor device is disclosed for initially restricting, then gradually restoring blood flow through a body vessel after an interventional procedure. A self-expanding annular member having a constricted diameter gives the device a frustoconical configuration that reduces blood flow therethrough upon initial deployment at a treatment site. The annular member is constricted by a plurality of linkages that operate to allow the annular member to gradually expand, thereby transforming the flow restrictor device to a cylindrical configuration that allows unimpeded blood flow therethrough. In one embodiment, expansion of the annular member is achieved via biodegradation of the linkages. In another embodiment, expansion of the annular member is achieved via creep deformation of the linkages. The flow restrictor device may be attached to an endoluminal prosthesis, or may be a separate complementary component that is delivered during an interventional procedure.

Abstract: The invention is direction to an alignment apparatus comprising a central sheath, an alignment sheath, and at least one stent. The central sheath and the alignment sheath each have a wall and a distal end where the wall of the alignment sheath is engaged to the wall of the central sheath. The wall of the central sheath defines a central lumen that has a central guide wire extending therethrough and the wall of the alignment sheath defines an alignment lumen that has an alignment guide wire extending therethrough. The distal end of the alignment sheath is positioned proximally to the distal end of the central sheath. The alignment apparatus has at least one stent disposed about one of the alignment guide wire or the central guide wire. The at least one stent has a pre-delivered state so that when the at least one stent is in the pre-delivered state, it is contained within at least one of the central sheath and the alignment sheath.

Abstract: A system for treating disease involving branching vessels of a mammal system can include a main graft assembly (i) having a lumen permitting fluid flow therethrough, and (ii) configured to expand within a first vessel of a mammal; and a branch graft assembly including a branch cover (i) having a cover lumen permitting fluid flow therethrough; and (ii) configured to expand within a branch vessel that branches from the first vessel. The branch graft assembly may also include an expandable branch stent extending within the cover lumen. The branch graft assembly may further include a branch sheath (i) extending between the branch stent and the cover lumen, and (ii) constraining radial expansion of the branch stent within the cover lumen.

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: Endoprothesis delivery systems and methods for making an using the same. An example medical endoprosthesis delivery system may include an inner member. An outer member may at least partially surround the inner member. The inner member and the outer member may be configured so that an implantable medical endoprosthesis can be disposed therebetween. A coupling device may be coupled to a portion of the outer member so that, when there is substantially no slack in the coupling device, as the coupling device moves in a proximal direction the portion of the outer member moves in the proximal direction. An adjustable stop may be coupled to the coupling device so that, when there is slack in the coupling device, as the adjustable stop is moved in the proximal direction, the amount of slack in the coupling device can be reduced.

Abstract: A capsule assembly for an endograft introducer is disclosed. The assembly comprises: a capsule and a capsule plug. The capsule has a cavity for receiving an end of a stent graft and a capsule wall terminating in a distal end. The capsule plug comprises: a tip portion having a lead-in surface and an abutment surface; and a tail portion having an external surface engagable with an inside surface of the capsule wall. The capsule is slidably movable with respect to the capsule plug from a first position in which the distal end of the capsule wall surrounds an opening into the cavity to a second position in which the distal end of the capsule wall is positioned proximally with respect to the abutment surface, whereby movement of the tip portion into the capsule is resisted by abutment between the distal end of the capsule wall and the abutment surface.

Abstract: An endovascular stent-graft is provided that is configured to assume a radially-compressed delivery state and a radially-expanded deployment state. The endovascular stent-graft comprises a flexible stent member; and a tubular fluid flow guide, which comprises a graft material, and which is attached to the stent member. The stent member includes a generally circumferential section that is shaped so as to define at least one fixation member having a sharp tip. When the stent-graft is in the radially-expanded deployment state, the fixation member protrudes radially outward. When the stent-graft is in the radially-compressed delivery state, at least a portion of the fixation member is convex as viewed from outside the stent-graft, such that the sharp tip points radially inward.

Abstract: An arrangement for temporarily retaining a side arm (36) of a stent graft (30) in a selected position during loading thereof onto a deployment device, the side arm extending from an ostium (38) in the tubular body (32) and substantially helically around and along the tubular body to an open end (40). A first tie down wire (48) is stitched through the tubular body and through the side arm and then through the biocompatible graft material of the tubular body at the open end of the side arm. The stent graft can then be loaded into a sheath of a deployment device for the stent graft. There can be a second tie down wire (50) stitched through the biocompatible graft material of the tubular body and through the side arm and then through the biocompatible graft material of the tubular body at the ostium end of the side arm. The first and/or second tie down wires can be withdrawn after the stent graft is loaded into the sheath or left in place until delivery.

Abstract: A distal embolic protection device for dedicated use in cerebral arterial blood vessels is described. The distal embolic protection device comprises a variable-thickness micro-guidewire and a collapsible filtering device mounted on the microguidewire over two mobile attachment points so that in its collapsed configuration, the thickness of the microguidewire and the filtering device at this region is less than or equal to 0.017 inch (0.432 mm) in thickness to be able to pass through existing conventional microcatheters. The mobile attachment points allow for rotatory and longitudinal mobility of the microguidewire while the filtering device is stable thereby decreasing the risk of trauma to the fragile cerebral arterial blood vessels. Preferably, the filtering device comprises an expansion assembly, e.g., a plurality of struts attached to a filter membrane that are in a folded position which self expand to the desired dimensions within the cerebral blood vessels.

Abstract: An implant for blood vessels, in particular to influence the flow of blood in the area of arteriovenous malformations. The implant has a wall comprising individual filaments combined so as to form a circular braiding, the circular braiding being positioned in elongated form and with a reduced diameter in an insertion catheter and expanding at the placement site thus adapting to the vessel diameter and increasing its braiding density.

Abstract: A medical device is provided. The medical device includes a vessel-engaging member attached to a distal end of a delivery wire via a connection mechanism. The vessel-engaging member includes a plurality of rows and a plurality of bridges positioned between each adjacent row, each of the bridges connecting a vertex of a first row with a corresponding vertex of a second row. The vessel-engaging member further includes first and second tapered sections coupled to the connection mechanism, each of the tapered sections projecting from a proximal row and tapering in a direction from the proximal row toward the connection mechanism, each of the tapered sections having a length measured along a longitudinal axis, wherein the length of the first tapered section is less than the length of the second tapered section.

Abstract: Some embodiments of the present disclosure are directed to a stent loading and delivery device, and methods for making and using the device. The device includes a handle assembly and an outer tubular member extending distally from the handle assembly. A proximal end of the outer tubular member is attached to a first handle of the handle assembly. The device includes an intermediate tubular member slidably disposed within the outer tubular member and an inner elongate member extending distally from the handle assembly within the intermediate tubular member. A stent constrainment mechanism is attached to a distal end of the intermediate tubular member and can receive a stent into a distal opening of the stent constrainment mechanism in an expanded state. Upon longitudinal actuation of the outer tubular member the stent constrainment mechanism collapses radially inward around the stent to constrain it within the outer tubular member.

Abstract: A delivery device includes a guidewire catheter and a delivery assembly extending about the guidewire catheter. The delivery assembly includes a locking mechanism that selectively engages a proximal handle of the delivery assembly with a push rod to which a vascular prosthesis is directly or indirectly attached. When an actuator selectively disengages the proximal handle from the handle body, rotation of the proximal handle is independent of longitudinal movement of the vascular prosthesis relative to the handle body, whereby the proximal handle can be moved along the handle body with rotation.

Abstract: One embodiment is directed to a system for deploying a device to a distal location across a vessel, comprising an elongate introducer sheath tubing member comprising open-cell fibrous wall material defining a lumen therethrough, wherein in a collapsed configuration the sheath has a first cross-sectional outer diameter and a first lumen inner diameter, and in an expanded configuration, the sheath has a second cross-sectional outer diameter and a second lumen inner diameter; and a substantially non-porous expandable layer coupled to a proximal portion of sheath and configured to prevent fluids present in the lumen from crossing the fibrous wall material.

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 transluminal delivery system and a method of assembling. The system includes a cylindrical, inner-catheter component and a retractable sheath surrounding the component and defining a space between the component and the sheath to receive a self-expanding luminal prosthesis between the component and the sheath. The inner-catheter component may include at least one sleeve having fibers, at least one connected sleeve portion connected to the inner catheter, and at least one unconnected sleeve portion slidably engaging the inner catheter such that when the sheath retracts, the unconnected portion expands and sleeve fibers engage the prosthesis's luminal surface, wherein the engagement opposes proximal stent movement.

Abstract: Prosthesis delivery devices and methods are provided that enable precise control of prosthesis position during deployment. The prosthesis delivery devices may carry multiple prostheses and include deployment mechanisms for delivery of a selectable number of prostheses. Control mechanisms are provided in the prosthesis delivery devices that control either or both of the axial and rotational positions of the prostheses during deployment. This enables the deployment of multiple prostheses at a target site with precision and predictability, eliminating excessive spacing or overlap between prostheses. In particular embodiments, the prostheses of the invention are deployed in stenotic lesions in coronary or peripheral arteries, or in other vascular locations.

Abstract: A stent comprised of a valve and a scaffolding structure having components configured to allow at least a portion of the stent to decrease in diameter in response to an axial force applied to the stent. Further, the components and elements of the stent may be configured to balance transverse forces applied to the stent, thus reducing the incidence of infolding.

Abstract: A medical treatment system and method of treatment is described having an implant that can be positioned and deployed, then undeployed to allow repositioning of the implant. The system includes a self-expanding medical implant that longitudinally foreshortens upon radially expanding from a radially compacted state, a distal interface configured to attach the implant to a distal mount of a delivery device, and a proximal interface configured to attach the implant to a proximal mount of the delivery device. Moving the distal mount longitudinally away from the proximal mount applies a longitudinal tension to the implant causing the implant to expand longitudinally and contract radially, and moving the distal mount toward the proximal mount reduces a longitudinal tension in the implant allowing the implant to expand radially toward a fully expanded state.

Abstract: Devices and methods for stent advancement, including methods for instructing another or others how to advance a stent into an anatomical structure or into a testing/demonstration synthetic structure, such as a polymer tube. The advancement may be achieved by at least two periods of stent engagement that drive a stent distally from a sheath separated by a period of non-engagement.

Abstract: A stent delivery system including an elongate shaft of a medical device, a stent selectively coupled to a distal portion of the elongate shaft, and a coupling mechanism for selectively coupling the stent to the elongate shaft by inserting a tab on one of the stent or the elongate shaft into an opening in the other of the stent or the elongate shaft. The tab may be deflected from a first position to a second position to disengage the tab from the opening.

Abstract: A stent loading and delivery system, the delivery system comprising an inner elongate tubular member having a proximal end and a distal end, an intermediate elongate tubular member having a proximal end and a distal end in sliding relationship to said inner elongate tubular member and an external elongate tubular member having a proximal end and a distal end in sliding relationship to said intermediate elongate tubular member, said intermediate elongate tubular member comprising a stop mechanism at its proximal end, wherein the stop mechanism prevents the external elongate tubular member from being slid past the stop mechanism when the external elongate tubular member is slid in a proximal direction.

Abstract: A self-expanding stent is delivered to an affected site within the human body with a guide wire and hand-manipulable control apparatus. The stent is capable of full expansion along a pre-determined length of its body with the remainder of the overall length conically tapering to a fixed connection point with the guide wire with a flexible joint between the sections. A covering sheath delivers the stent to the affected area with a tip capable of penetrating a blockage or obstruction in a vessel such that the stent can be exposed to begin its expansion. Once the obstruction is opened, the stent can be recaptured or retrieved by pulling it back into the sheath, collapsing the expanded stent with the assistance of the conical portion and flexible joint, and withdrawing the stent and wire completely from the vessel. A rotating motion will cause the conical and cylindrical sections of the stent to separate at the flexible joint.

Abstract: Methods for crimping a stent on an expandable member of a delivery catheter, and devices and methods for treating a bifurcation are disclosed. A method for crimping includes positioning a stent having a first portion and a second portion over the expandable member, and non-uniformly crimping the stent to the expandable member. The method can include routing an elongate shaft under the second portion of the stent and through the side hole so as to be routed external to the first portion. The stent second portion can be crimped so that the elongate shaft can be slidably disposed relative to the stent second portion prior to deployment of the stent.

Abstract: The device includes at least a tubular endoprosthesis (6), deployable between a retracted state and a dilated state, and a hollow support (10) which extends longitudinally between a proximal end (18) and a distal end (16). The support (10) is provided, in the vicinity of the distal end (16), with at least a transverse retention opening. The device includes at least a releasable threadlike tie (12, 14) for holding the endoprosthesis (6) on the support (10). The tie is engaged in the retention opening (28) and actuated from the proximal end (18) of the support (10) to release the endoprosthesis (6). The support (10) includes, over at least a portion of its length, a spring (24) forming the support. The spring (24) has contiguous turns over at least a portion of its length.

Abstract: A woven, self-expanding stent device has one or more strands and is configured for insertion into an anatomical structure. The device includes a coupling structure secured to two different strand end portions that are substantially aligned with each other. The two different strand end portions include nickel and titanium. The coupling structure is not a strand of the device.

Abstract: A delivery assembly and methods for accurately positioning a stent within a body lumen are disclosed. The delivery assembly comprises a stent releasably attached to the distal end of an inner catheter. A handle at the proximal end of the assembly is operatively connected to the proximal end of an outer catheter and is configured for imparting axial movement to the outer catheter. A sheath is fixed to the handle or inner catheter and disposed about at least a portion of the outer catheter. The sheath comprises indicia visible to the user of the assembly to identify a particular measured distance from a selected point on the sheath to a selected point on one or more components of the delivery device. The inner catheter and sheath are fixed components that do not move relative to each other during axial movement of the outer catheter.

Abstract: A composite stent and a method for making the same are provided.

Abstract: A catheter assembly for endoluminal delivery of a device to a treatment site utilizing a single motion deployment for opening and removal of a flexible protective sleeve or constraining sleeve.

Abstract: Controlled deployable medical devices that are retained inside a body passage and in one particular application to vascular devices used in repairing arterial dilations, e.g., aneurysms. Such devices can be adjusted during deployment, thereby allowing at least one of a longitudinal or radial re-positioning, resulting in precise alignment of the device to an implant target site.

Abstract: Apparatus and methods for delivering prosthetic segments to a body lumen, utilize a device having an elongated flexible member including proximal and distal ends, a plurality of prosthetic segments releasably arranged axially along the elongated flexible member near the distal end and an outer sheath slidably disposed over at least a portion of the prosthetic segments. The apparatus further includes a separator disposed on the outer sheath and adapted to engage the prosthetic segments. The separator is also adapted to be retracted proximally over the prosthetic segments and advanced distally to separate a proximal group of the prosthetic segments from a distal group of the prosthetic segments which are to be deployed in the body lumen.

Abstract: Described herein are flexible implantable devices or stents that can conform to the shape of vessels of the neurovasculature. In some embodiments, the devices can direct blood flow within a vessel away from an aneurysm or limit blood flow to the aneurysm. In some embodiments, a vascular remodeling device includes a first section and a protruding section. During deployment, the device expands from a compressed configuration to an expanded configuration. The first section anchors the device in an afferent vessel and/or in an efferent vessel of a bifurcation and the protruding section is positioned in the junction of the bifurcation having an aneurysm and across the neck of the aneurysm or at least partially within the aneurysm.

Abstract: A drug delivery balloon is provided, the a balloon having an outer surface, and a tunable coating disposed on at least a length of the balloon surface. The tunable coating includes a first therapeutic agent and a first excipient, and can include a second therapeutic agent and a second excipient. The first and second therapeutic agents have different dissolution rates during balloon inflation and therefore provide a coating that is tunable.

Abstract: Devices and methods for the endovascular repair of aneurysms approximate to side branch vessels and more particularly to devices and methods for placing an acutely angled bifurcated stent graft.

Abstract: Disclosed herein are implantable, radially expandable medical prostheses, including but not limited to stents, and delivery and loading systems applicable to the same, including disposable, detachable distal chambers, and methods for using the same.

Abstract: Disclosed herein is a medical wire with an intracorporeally indwelling member connected to the leading end part of a conductive wire through a thermally-fusible connecting member, wherein the contact of the leading end part of the conductive wire with the intracorporeally indwelling member can be surely prevented even when the connecting member is deformed. The medical wire comprises a conductive wire and an intracorporeally indwelling member connected to the leading end part of the conductive wire through a thermally-fusible connecting member, in which the connecting member is heated and fused by a high-frequency current supplied through the conductive wire, thereby releasing the intracorporeally indwelling member, wherein a non-conductive spacer for preventing the contact of the intracorporeally indwelling member with the conductive wire is provided between them.

Abstract: A stent delivery assembly and methods of use are provided. The assembly can comprise a catheter, a cover member, a core member, a stent, and a stent retention mechanism. The stent can extend within the cover member lumen and have a section extending at least partially between an inner layer of the cover member and the core member. The stent retention mechanism can be coupled to the core member and comprise an outer surface that is configured to exert a radially outward force against the stent for axially restraining the stent relative to the core member when the stent is in contact with the inner layer of the cover member.

Abstract: A device and method for endovascular repair of a patient's aorta is disclosed. The device includes a frame component that has a balloon-expandable frame and a self-expanding frame secured to the balloon-expandable frame. The device also includes a valve element positioned at the proximal end of the frame component. The device may include another prosthetic component that may be secured to the frame component. The prosthetic component may include at least one conduit configured to receive a covered stent.

Abstract: An attachment mechanism for coupling a stent to a delivery system is disclosed. The attachment mechanism is configured to pivot relative to an inner shaft assembly of the delivery system in order to release the stent from the delivery system.

Abstract: An embodiment of the invention provides a prosthesis delivery system comprising a delivery catheter having an expandable member and a prosthesis carried over the expandable member. The prosthesis includes a radially expandable scaffold section and at least two anchors extending axially from an end thereof; and means for capturing at least the anchors to prevent the anchors from divaricating from the expandable member as the catheter is advanced through a patient's vasculature.

Abstract: A bi-directional stent delivery system includes an inner elongate shaft, a radially expandable prosthesis disposed over the inner elongate shaft, an outer elongate shaft, and a shuttle sheath disposed over the radially expandable prosthesis. The distal portion of the inner shaft is releasably coupled to the distal portion of the shuttle sheath, and the distal portion of the outer shaft is releasably coupled the proximal portion of the shuttle sheath. Distal advancement of the inner shaft advances the shuttle sheath distally when the outer shaft is uncoupled from the shuttle sheath, thereby allowing the prosthesis to radially expand from a proximal end to a distal end. Proximal retraction of the outer shaft retracts the shuttle sheath proximally when the inner shaft is uncoupled from the shuttle sheath, thereby allowing the prosthesis to radially expand from a distal end to a proximal end thereof.

Abstract: A balloon catheter and a stent delivery system are disclosed, which includes a shaft portion of which an axially orthogonal cross section of an outer peripheral surface has a polygonal shape, and a balloon which is foldable on the outer peripheral surface of the shaft portion and in which turned-back portions are formed when folded. Portions formed to linearly extend along an axial direction in the turned-back portions are respectively positioned on sides of the polygonal shape. A stent can be arranged on an outer periphery of a balloon in the balloon catheter and expands in response to dilation of the balloon.

Abstract: There is disclosed herein a transluminal delivery system for a self-expanding luminal prosthesis, the system comprising an inner catheter component (30) and a retractable sheath (12) to surround the component thereby to define an annular space to receive the prosthesis (10), the component exhibiting an anti-sliding component, for abutting a luminal surface portion of the prosthesis (10) to restrain the prosthesis from sliding with the sheath (12), and relative to the inner catheter (30), while the sheath retracts relative to the prosthesis to release the prosthesis progressively into the target bodily lumen characterized in that the anti-sliding component is or includes at least one sleeve (36, 50, 66, 76) having a length direction parallel to the longitudinal axis of the annular space and having at least one bound portion (33, 52, 64, 65, 74) of its length that is not free to slide on the inner catheter, and at least one unbound portion of its length with a capability to slide axially on the inner catheter (