Abstract: An introduction arrangement for a fenestrated or branched stent graft (13) intended for deployment into the lumen of a vessel having a blind vessel extending from it. The introducer (1) has a distal end intended to remain outside a patient in use and a proximal end with a nose cone dilator (11) and an arrangement to retain the branched stent graft distally of the nose cone dilator. A sheath (15) on the introducer extends over the branched stent graft to the nose cone dilator. An indwelling catheter (21) extends from the distal end of the introducer and enters the fenestration or side arm and through to the nose cone dilator, the indwelling catheter has a guide wire (29) extending through it. The guide wire can be extended beyond the nose cone dilator in use before the sheath is withdrawn from the branched stent graft so that it can be snared from the contra-lateral artery.

Abstract: A system is provided for delivering respective anchors into spaced apart locations along an annulus of a mitral valve. The system includes a first catheter member having a first lumen formed therein for receiving a first guide wire and also includes a second catheter member that is configured to move between an expanded position and a collapsed position relative to the first catheter member. The second catheter member has a lumen formed therein for receiving a second guide wire when the second catheter member is in the expanded position. The second catheter member is fixedly connected to the first catheter member by a first connector (that defines first and second living hinges) which is configured to deploy under a select condition to automatically cause the second catheter member to move to the expanded position.

Abstract: Methods and devices are provided for attaching soft tissue to bone. In general, a deployment device, insertion assembly, and suture anchor are provided. The insertion assembly is coupled between the deployment device and the suture anchor to allow the deployment device to deploy the suture anchor into bone. Each of the various components disclosed herein can be used alone, in combination with one another, or in combination with various other devices.

Abstract: A deployment device for deploying a self-expanding fenestrated stent graft. The device includes a fenestrated stent graft retained on an introducer. The introducer includes a main catheter and an auxiliary catheter preloaded within the introducer and extending from distal the distal end of the stent graft, into the lumen of the stent graft and through the fenestration.

Abstract: A method and apparatus for securing a suture to bone can include grasping a first suture portion with a grasping member on a positioning tool. The first suture portion can be located into a first cannulation defined in the positioning tool. A cutting member can be advanced through a second cannulation defined on the positioning tool and out through a distal opening defined on the positioning tool. A first bone hole can be cut into the bone with the cutting member. A flexible member advancing tool can be advanced through the first cannulation. The first suture portion can be urged out of the distal opening and into the first bone hole.

Abstract: Devices, systems and methods for passing a suture. In general, described herein are suturing devices, such as suture passers, as well as methods of suturing tissue. These suture passing devices are dual deployment suture passers in which a first distal jaw member is moveable at an angle with respect to the longitudinal axis of the elongate body of the device and the second distal jaw member is retractable proximally to the distal end region of the elongate body and/or the first jaw member. Methods of suturing tissue using a dual deployment suture passer are also described.

Abstract: A suture locking device includes a carrier member, a locking assembly, a suture path, and an actuator assembly. The locking assembly includes a first locking member having an outer surface portion, and a second locking member having an inner surface portion. The suture path is receptive of a suture and defined at least partially through the first locking member, between the outer and inner surface portions, and at least partially through the carrier member. The actuator assembly is operable to move the first and second locking members together to lock the suture relative to the lock assembly.

Abstract: A device for transcatheter gathering of tissue of a heart valve leaflet may include an elongated tube extending in a longitudinal direction and having an open distal end, a tissue securing component disposed at the distal end of the elongated tube, and a capture tool movable in the elongated tube between a retracted position and an extended position. The elongated tube may have an inner surface and a lumen extending therethrough. The tissue securing component may include a clip having a roller and a support element. The roller may be rotatable relative to the support element. The capture tool may be operable to capture tissue of the heart valve leaflet and to draw the captured tissue into the tissue securing component. The tissue securing component may be adapted to be applied to the captured tissue to hold the captured tissue in a gathered configuration.

Abstract: An apparatus for applying surgical clips to tissue includes a handle assembly having a trigger and a shaft extending therefrom. The shaft includes at least one surgical clip therein. Each clip includes a pair of legs connected by a crossbar. Each of the pair of legs has an inwardly and an outwardly facing surface, the outwardly facing surface having a raised profile protruding therefrom and extending longitudinally therealong. A jaw assembly is disposed at a distal end of the shaft and includes first and second opposed jaws moveable between a spaced apart and an approximated position. Each jaw defines a recess extending longitudinally along opposing inner surfaces thereof. Each recess defines a longitudinally extending groove having a profile substantially complementary to the raised profile of the legs of the clips. The legs of each clip are positionable at least partially within respective grooves of the recesses of the jaws.

Abstract: The invention relates to a sealing device for repair of cardiac and vascular defects or tissue opening such as a patent foramen ovale (PFO) or shunt in the heart, the vascular system, etc. and particularly provides an occluder device and trans-catheter occluder delivery system. The sealing device would have improved conformity to heart anatomy and be easily deployed, repositioned, and retrieved at the opening site.

Abstract: A tissue-removing catheter includes a cutter. The catheter also includes a longitudinal force-transmitting member extending along a catheter body and being longitudinally movable relative to the catheter body. A distal end portion of the longitudinal force-transmitting member is operatively connected to a distal longitudinal portion of a cutter housing such that distal movement of the longitudinal force-transmitting member relative to the catheter body and the cutter imparts pivoting of the distal longitudinal portion to its open position to expose the cutter.

Abstract: An introduction arrangement for a fenestrated or branched stent graft (13) intended for deployment into the lumen of a vessel having a blind vessel extending from it. The introducer (1) has a distal end intended to remain outside a patient in use and a proximal end with a nose cone dilator (11) and an arrangement to retain the branched stent graft distally of the nose cone dilator. A sheath (15) on the introducer extends over the branched stent graft to the nose cone dilator. An indwelling catheter (22) extends from the distal end of the introducer and enters the fenestration or side arm and through to the nose cone dilator, the indwelling catheter has a guide wire (29) extending through it. The guide wire can be extended beyond the nose cone dilator in use before the sheath is withdrawn from the branched stent graft so that it can be snared from the contra-lateral artery.

Abstract: Methods and devices for separating an implanted object, such as a pacemaker lead, from tissue surrounding such object in a patient's vasculature system. Specifically, the surgical device includes a handle, an elongate sheath and a circular cutting blade that extends from the distal end of the sheath upon actuating the handle. The circular cutting blade is configured to engage the tissue surrounding an implanted lead and cut such tissue in a coring fashion as the surgical device translates along the length of the lead, thereby allowing the lead, as well as any tissue remaining attached to the lead, to enter the device's elongate shaft. The surgical device has a barrel cam cylinder in the handle assembly that imparts rotation of the blade and a separate cam mechanism in the tip of outer sheath assembly that imparts and controls the extension and retraction of the blade.

Abstract: Drug eluting vascular closure devices and methods for closing a blood vessel puncture site disposed at a distal end of a tissue tract are described. The devices and methods rely on a combination of the body's own natural mechanism to achieve hemostasis with chemical and/or biological agents to accelerate the hemostatic process. One method includes the steps of introducing a closure device through the tissue tract and deploying an expansible member at a distal end of the device within the blood vessel to occlude the puncture site. A chemical and/or biological sealing member disposed proximal the expansible member is then displaced so as to expose a chemical and/or biological region or release region of the device. At least one chemical and/or biological agent is thereafter released from the device and into the tissue tract to accelerate the occlusion process in the tract.

Abstract: A method for reducing an axial profile of a valve implant includes providing a valve implant having a longitudinal axis and a delivery catheter having a central axis and a distal receiving section. The method further includes helically rolling the valve implant around a rolling axis that is offset at an angle of about 15 degrees to about 60 degrees with respect to the longitudinal axis to form a rolled valve implant having a rolled axis, where the rolled axis is the same as the rolling axis. The method further includes aligning the rolled axis of the rolled valve implant with the central axis of the delivery catheter. The method further includes inserting the rolled valve implant into the distal receiving section of the delivery catheter.

Abstract: A method of delivering a prosthetic mitral valve includes delivering a distal anchor from a delivery sheath such that the distal anchor self-expands inside a first heart chamber on a first side of the mitral valve annulus, pulling proximally on the distal anchor such that the distal anchor self-aligns within the mitral valve annulus and the distal anchor rests against tissue of the ventricular heart chamber, and delivering a proximal anchor from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that the proximal anchor self-expands and moves towards the distal anchor to rest against tissue of the second heart chamber. The self-expansion of the proximal anchor captures tissue of the mitral valve annulus therebetween.

Abstract: A rotatable cutter for a tissue-removing catheter includes a central hub, flutes spaced apart from one another around the circumference of the central hub, and arcuate cutting members. Each cutting member includes an arcuate cutting edge extending along an arc length of the cutting member for cutting tissue as the cutter is rotated. A raised element of each cutting member has a leading cutting edge at a leading end of the distal cutting member for cutting tissue as the cutter is rotated. A clearance portion of each cutting member is recessed, relative to the longitudinal axis of the cutter, from the raised element and extends from the raised element to a trailing end of the cutting member to provide clearance for the leading cutting edge of an adjacent and opposing distal cutting member.

Abstract: The invention relates to a low profile lumen free balloon catheter and a system for advancing the lumen free balloon from a build wire to a wire guide. The low profile balloon lacks an internal wire guide cannula between the catheter shaft and the soft tip. A releasable engagement is provided to connect/disconnect the build wire to/from the wire guide. A soft tip seals around the wire guide following advancement of the balloon catheter over the wire guide.

Abstract: Described are medical graft products, systems, and methods for treating fistulae. Certain products of the invention are configured to have portions residing in and around a primary fistula opening, e.g., one occurring in a wall of the alimentary canal. One such product includes a biocompatible graft body which is configured to block at least the primary opening. The graft body includes a capping member, which is configured to contact portions of the alimentary canal wall adjacent to the primary opening, and an elongate plug member extending from the capping member, which is configured to extend into at least a portion of the fistula. In certain embodiments, a graft body component has the capacity to expand or otherwise change form to provide a suitable capping arrangement. Such a component can include a resilient wire frame, e.g., one that is self-expandable or one that requires at least some manipulation in order to expand.

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 engageable with an inside surface of the capsule wall. The capsule is slideably 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.