Abstract: A delivery system for implanting a medical device into the body of a patient or subject and a method of use thereof. The delivery system includes a delivery catheter having a catheter lumen and an inner member extending therethrough. The inner member includes a distal tip portion, a proximal portion, and an intermediate portion, the intermediate portion being disposed adjacent to the distal end of the delivery catheter. A first sealing member, positioned near a distal end of the proximal portion, forms a fluid seal between the inner member and an inside surface of the delivery catheter. A second sealing member, positioned near a proximal end of the distal tip portion, forms a fluid seal between the inner member and an inside surface of the delivery catheter. The intermediate portion extends between the first seal and the second seal. In one embodiment, a medical device and a hydrating fluid are present in a device-containing region between the intermediate portion and the delivery catheter.

Abstract: Stent-graft delivery systems having a tip capture mechanism with a plurality of elongated cables that allow for gradual deployment and repositioning of a stent-graft prosthesis. The tip capture mechanism includes a guiding assembly, a distal tip assembly, and a plurality of cables. In a first relative position, the distal tip assembly extends the guiding assembly to temporarily constrain the distal ends of the cables and an intermediate portion of each cable constrains an endmost crown of the prosthesis. In this first relative position, tension on the cables may be selectively adjusted to allow for both gradual continuous radial expansion and contraction of the endmost crowns of the stent-graft prosthesis. In a second relative position, the distal tip assembly does not extend over the guiding assembly and thus does not constrain the distal ends of the cables, and thereby the cables do not constrain the endmost crowns.

Abstract: A delivery system for a self-expanding medical device is provided. The delivery system includes an outer sheath that radially restrains the medical device. First and second inner catheters are disposed within the outer sheath. The first inner catheter is a composite structure with a closed coil wire covered by a polymer outer layer. The second inner catheter is disposed within the closed coil wire but is not attached to the closed coil wire.

Abstract: A stent graft introducer (1) which includes a handle arrangement which by telescopic movement of a slide or slide portions (104, 106) into a handle portion (100) causes controlled sequential deployment of a stent graft (14). Stops (218,217, 218, 219) ensure actions are carried out in a selected order. A sheath (116) of the introducer is fixed to a slide portion such that with retraction of the slide portion the sheath is withdrawn from a stent graft retained on the introducer and at a selected position trigger wires retaining the stent graft onto the introducer are also released. Interconnections between the slides and the handle are provided to prevent relative rotation and re-extension after full retraction.

Abstract: A valve loading apparatus is provided for loading a crimped prosthetic valve into a lumen of a delivery system. The valve recoil adapter can counteract recoil of a compressed prosthetic valve, and maintain the valve at its desired crimp diameter. An integrated bioprosthesis/delivery system is provided for delivering a bioprosthesis to a target area within a body lumen is provided. The delivery system includes a valve covering member and a compressing member, which compresses the valve covering member to surround, hold, and/or compress the valve during delivery to the target area.

Abstract: A modular catheter system including a sheath projecting distally from a delivery catheter having a main body module An inner core module carrying a stent thereon, the inner core being axially movable through the main body of the delivery catheter and the delivery catheter sheath, a handle member supported by the main body of the delivery catheter, the handle member being selectively axially engageable with the inner core such that the handle member and the inner core move together in an axial direction when the handle member is engaged with the inner core; and an adjustment member supported by the main body, the adjustment member being configured such that rotation of the adjustment member causes the adjustment member to move axially along the main body by either axially sliding the handle member relative to the main body or by rotating the adjustment member.

Abstract: Method for treating a Roux-en-Y patient having fistulas and leaks as a result of bariatric surgery. A gastrointestinal implant device is anchored in the esophagus and extends through a stomach pouch into an intestine anastomosed to the stomach pouch to prevent fistulas and other damaged tissue from making contact with food and fluids entering the esophagus. The gastrointestinal implant device includes an unsupported flexible sleeve and an anchor coupled to a proximal portion of the sleeve. The flexible sleeve is open at both ends, and adapted to extend below a jejunum. The anchor is adapted to be retained within the esophagus, preferably just above the gastroesophageal (GE) Junction. The anchor can include a stent such as a wave anchor and is collapsible for catheter-based delivery and removal.

Abstract: An introducer sheath. The introducer sheath includes a tubular body. The tubular body extends from a distal end toward a proximal end. The tubular body includes a lumen. The lumen is defined at least partially by a wall. The tubular body includes a secondary channel. The secondary channel is disposed within the wall. The secondary channel is configured to receive a guidewire.

Abstract: A medical system including an elongate member and an elongate element associated with the elongate member so that a shape of the elongate member can be altered upon applying energy to the element.

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: An endoprosthesis includes a stent structure having an elongate member longitudinal portions of which overlap to define the crossover structures. The stent structure may also include loop structures, which are contiguous with the crossover structures, through which a filament extends. A guard structure is secured to the stent structure and located adjacent to the crossover structures to obstruct displacement of the filament between the longitudinal portions of the elongate member of the crossover structures. A method for operating the endoprosthesis includes displacing the loop structures toward one another along the filament to displaced positions relative to the suture structure for reducing the respective profiles of the stent structure and patch structure.

Abstract: A catheter assembly has an engaged state and an unengaged state comprising a proximal member having a longitudinal axis and a distal member having a longitudinal axis. A distal end of the proximal member is removably engageable to the distal member. The distal member has a first distal portion and a second distal portion, and the first distal portion is retractable from the second distal portion. In the engaged state the distal member is substantially freely rotatable about its longitudinal axis and in relation to the proximal member. In the engaged state the proximal member is constructed and arranged to be moved in a direction along the longitudinal axis such that proximal movement of the proximal member retracts at least the first distal portion of the distal member from at least the second distal portion.

Abstract: A deployment device for repair of a transected body vessel is described herein. Device can have a handle and one or more shafts coupled thereto. A prosthesis being retained by a sheath can be coupled to the delivery device. The sheath can have end portions coupled to one or more shafts. Rotation of a shaft can retract a sheath portion away from either end of the prosthesis for expansion thereof prior to the middle of the prosthesis. Continued rotation of a shaft can completely remove the sheath from the prosthesis, so that the prosthesis is fully expanded and couples the first and second vessel portions of the transected vessel together. Prosthesis may be retained by overlapping a tubular sheath and lacing a threading member therethrough. Prosthesis may be retained by a splittable sheath.

Abstract: Embodiments of the present disclosure are directed to stents, valved-stents, and associated methods and systems for their delivery via minimally-invasive surgery.

Abstract: An endovascular delivery system includes a pre-loaded, small guide wire for snaring via the contralateral side of a bifurcated prosthesis for deployment of a graft extension to the contralateral side of the bifurcated prosthesis. The pre-loaded guidewire avoids a cannulation step in the deployment of typical bifurcated stent grafts. Deployment methods using the pre-loaded guidewire and endovascular grafts having a pre-routed lumen for a secondary contralateral access guidewire are also described.

Abstract: Catheters, as well as related systems and methods are disclosed.

Abstract: A medical device deployment system includes an inner shaft telescopically received within a retractable sheath and a medical device positioned over the inner shaft. A handle assembly houses a hollow washer and includes a hollow handle body having an open distal end receiving the inner shaft and the retractable sheath. An open proximal end of the retractable sheath is attached to the washer and the inner shaft is received through an opening of the washer. In a pre-deployment configuration, the washer has an initial position within the handle body, an expandable fluid chamber within the handle body has an initial volume, and the retractable sheath restricts radial expansion of the medical device. In a post-deployment configuration, the washer has a retracted position proximally spaced from the initial position, the fluid chamber has an expanded volume, and the retractable sheath is retracted and permits radial expansion of the medical device.

Abstract: A method and devices for relieving pressure in the left atrium of a patient's heart is disclosed. The method includes using an ablative catheter in a minimally invasive procedure to prepare an opening from the coronary sinus into a left atrium of the patient's heart. Once the opening is prepared, the opening may be enlarged by a technique such as expanding a balloon within the opening. A stent is then placed within the coronary sinus of the patient, with a transverse portion expanding within the opening, allowing blood to flow from the left atrium to the coronary sinus and then to the right atrium. Pressure within the left atrium is thus relieved.

Abstract: An endoluminal prosthesis introducer may include an elongate tubular sheath including a reinforced longitudinal segment and a peelable longitudinal segment extending distally from the reinforced segment. An elongate tubular cannula may be disposed within the sheath. Upon application of a force applied to a distal end of the sheath, the peelable segment may progressively split in a proximal direction, and the reinforced segment may longitudinally move relative to the cannula in a distal direction.

Abstract: The present disclosure describes treatment of the vasculature of a patient with an expandable implant. The implant is constrained to a reduced delivery diameter for delivery within the vasculature by at least one sleeve. The implant can be constrained to other diameters, such as an intermediate diameter. The sleeves can be expanded, allowing for expansion of the diameter of the expandable implant, by disengaging a coupling member from the sleeve or sleeves from outside of the body of the patient. The expandable implant can comprise a steering line or lines which facilitate bending and steering of the expandable implant through the vasculature of a patient.

Abstract: A stent delivery and deployment system for use primarily with self-expanding stents, incorporating a traction tube extending over the length of the diametrically compacted and constrained stent and everting back over itself, with the outer everted portion of the traction tube preferably extending to the proximal end of the delivery system. A constraining sleeve is provided between the inner, non-everted portion and outer, everted portion of the traction tube, the constraining sheath extending over the length of the constrained stent prior to deployment and diametrically constraining the diametrically compacted self-expanding stent. The application of tension to the proximal end of the traction tube causes the constraining sheath to move in a proximal direction, freeing the constrained stent as it moves and allowing the stent to deploy against the wall of the body conduit within which it is located during the deployment process.

Abstract: An apparatus and method of deploying a stent graft having a proximal anchor stent ring includes restraining proximal apexes of the proximal anchor stent ring between a spindle body of a spindle and a control release sleeve of a tapered tip. The control release sleeve is advanced relative to the spindle to release a first proximal apex through an opening in the control release sleeve while the remaining proximal apexes remain restrained by the control release sleeve. The control release sleeve is further advanced relative to the spindle to release the remaining proximal apexes from the control release sleeve. In another example, a stent capture fitting has variable length stent capture fitting arms. As the stent capture fitting is retracted, the proximal apexes of the proximal anchor stent ring are sequentially exposed from and released by the variable length stent capture fitting arms.

Abstract: A monorail guides a guide wire introduced into an outer tube in a catheter for stent surgery. The catheter includes the outer tube having an outer hole, an inner tube installed in the outer tube, and a guide wire inserted into the outer hole and the inner tube and protruding outwards from a front end of the inner tube so that the outer tube and the inner tube move along the guide wire so as to be guide a stent. The monorail includes a separation guide which is inserted into and fixed in the outer tube and configured such that the guide wire that is inserted into the outer hole is spaced apart from the inner tube without making contact with the inner tube.

Abstract: A stent delivery system includes an elongate delivery member; a self-expanding proximal bumper disposed on a distal region of the delivery member in a radially contracted configuration, where the proximal bumper is biased to expand to a radially expanded configuration; a self-expanding stent disposed over the delivery member in a radially contracted configuration distal of the proximal bumper; and a sheath disposed over the stent, proximal bumper, and delivery member, and configured to constrain the proximal bumper and stent in their radially contracted configurations, where the proximal bumper, when in its radially expanded configuration, has a cross-sectional dimension greater than an inner diameter of the sheath, such that the proximal bumper contacts the sheath and prevents movement of the stent proximal of the proximal bumper, and such that, as the delivery member is moved distally relative to the sheath, the proximal bumper pushes the stent in a distal direction.

Abstract: Apparatus and methods for facilitating deployment of an implantable medical device including a stent graft. A restraining device, such as cord or suture, holds at least the proximal end of the stent in a radially inwardly compressed configuration during delivery to a desired location within the lumen of a patient's vessel. Withdrawal of one or more trigger wires facilitates the release and removal of the restraining cord from the proximal end of the stent so as to allow the stent to become fully deployed within vessel.

Abstract: The present embodiments provide systems and methods for deploying at least a portion of a stent, comprising a retaining member having a main body. At least one slot is formed into the main body. The at least one slot comprises a circumferentially enclosed segment and an axial opening. A portion of a stent is restrained from moving radially outward when disposed within the circumferentially enclosed segment, and the portion of the stent is self-expandable radially outward when aligned with the axial opening.

Abstract: The present invention is directed to an intraluminal guiding device having an expandable guiding member so as to facilitate and overcome the difficulties associated with obtaining contra-lateral leg access of a bifurcated stent or a bifurcated stent graft with a second guidewire and a method for treating abdominal aortic aneurysms with such a device. The guiding device comprises an expandable member releasably or permanently affixed to a delivery system which facilitates placement and advancement of a second delivery system.

Abstract: A stent graft introducer for intraluminal deployment of a stent graft (26), the introducer comprising a stent graft release mechanism (6) to allow partial release of the stent graft (26) when carried on the introducer, whereby control of the stent graft can be maintained while allowing access into the lumen of the stent graft from at least one end of the stent graft. The partial release can comprise partial release of one end of the stent graft.

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: A medical device delivery system is provided including a restraining sheath and a medical device disposed therein. The sheath may include an elongated tubular inner liner having a passageway extending generally longitudinally therethrough. The sheath includes a medical device nesting region located near its distal end. The sheath also may include a strengthening layer and an outer layer. While the outer diameter of the medical device nesting region can be generally constant or partially tapered, an inner diameter of the medical device nesting region generally increases towards the distal end. Methods for manufacturing various components of the medical device delivery system are also disclosed.

Abstract: An endoluminal prosthesis includes an expandable stent graft that includes a cannula extending through a lumen of the stent graft. A suture is threaded along the perimeter of the graft through openings therein, with an inner end of the suture mounted to the cannula. The cannula is rotatable relative to the graft to wind or unwind the suture around the cannula and cause the graft to become compressed when wound or allow the graft to expand when unwound. The cannula includes an attachment member for retaining an inner end of the suture, and the attachment member can release the inner end of the suture when adjustment of the graft diameter is no longer desired.

Abstract: An expandable stent and delivery system are provided for treating body vessel defects, such as partially occluded blood vessels and aneurysms. The delivery system includes a core member having a threaded core member portion configured to interlock with a threaded strut member portion of the expandable stent. The expandable stent is mounted thusly onto the core member for movement within a delivery catheter and deployment to a body vessel defect. The deployment catheter is used to compress the interlocked threaded strut member portion into engagement with the threaded core member portion.

Abstract: Stents and methods of using stents are provided. Stents of the invention provide external support structure for a blood vessel segment disposed within, wherein the stents are capable of resilient radial expansion in a manner mimicking the compliance properties of an artery. The stent may be formed of a knitted or braided mesh formed so as to provide the needed compliance properties. A venous graft with the stent and a vein segment disposed within is provided, wherein graft is capable of mimicking the compliance properties of an artery. Methods of selecting stents for downsizing and methods of using the stents of the invention in downsizing and smoothening are provided. Methods of replacing a section of an artery with a venous graft including a stent of the invention are provided. Methods of reducing intimal hyperplasia in implanted vein segment in a venous graft using stents of the invention are provided.

Abstract: A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable prosthesis frame. The valve may be delivered transluminally or transmyocardially using a thorascopic or other limited access approach using a delivery catheter. Preferably, the initial partial expansion of the valve is performed against the native valve annulus to provide adequate anchoring and positioning of the valve as the remaining portions of the valve expand. The valve may be delivered using a retrograde or antegrade approach. When delivered using a retrograde approach, a delivery catheter with a pull-back sheath may be used, while antegrade delivery is preferably performed with a delivery catheter with a push-forward sheath that releases the proximal end of the valve first.

Abstract: A method for assembling a stent graft onto a balloon delivery catheter is disclosed. The method includes the steps of: assembling a graft over a stent with attached security rings and inserting the ends of the graft between the stent and the rings; placing the assembled stent graft on the delivery balloon of the delivery catheter; and crimping the stent graft onto the balloon. The stent may include a plurality of axially aligned belts that include a plurality of mid belts, and first and second end belts, where each of the mid belts includes a plurality of circumferentially spaced struts having first and second ends adjoining first sinusoidal-shaped elements, and each of the first and second end belts includes at least about twice the number of circumferentially spaced struts adjoining second sinusoidal-shaped elements. Also disclosed is a stent graft for use in practicing the method.

Abstract: Medical systems and related methods are described. In some embodiments, the medical systems include an outer member defining a slot. In certain embodiments, the outer member at least partially surrounds an inner member, and the outer and inner members are configured so that an implantable medical endoprosthesis can be disposed between the outer and inner members.

Abstract: Systems, methods, and devices for the treatment of acute ischemic stroke that provide immediate blood flow restoration to a vessel occluded by a clot and, after reestablishing blood flow, address the clot itself. Immediate blood flow restoration advantageously can facilitate natural lysis of the clot and also can reduce or obviate the concern for distal embolization due to fragmentation of the clot. Several embodiments of the invention provide for progressive, or modular, treatment based upon the nature of the clot. For example, the progressive treatment can include immediate restoration of blood flow, in-situ clot management, and/or clot removal depending on the particular circumstances of the treatment. The in-situ clot management can include, for example, lysis, maceration, and/or removal.

Abstract: New devices, systems, and methods are disclosed for preventing, treating, and/or at least minimizing ischemia and/or reperfusion injury by restoring and/or modulating blood flow, particularly in the cerebral vasculature where blood vessels are narrow and tortuous. These devices, systems, and methods make it possible for a clinician to adequately and systematically restore blood flow to ischemic tissue while simultaneously modulating the blood flow to minimize reperfusion injury. New thrombectomy devices and systems, which, for example, expand with greater radial force, further enable improved binding with clots and restoration of blood flow.

Abstract: A method of implanting a prosthesis in a patient at a treatment site includes providing a prosthesis delivery system with an inner sheath and an outer sheath. The prosthesis is loaded inside the inner sheath. The inner sheath containing the prosthesis is loaded within the outer sheath. The outer sheath is advanced in a patient towards the treatment site up to a given position at a distance from the treatment site. While retaining the outer sheath in the given position, the inner sheath is advanced out from the outer sheath to the treatment site to align the prosthesis with the treatment site and the inner sheath is retracted to at least partially implant the prosthesis at the treatment site. Upon completion of prosthesis implantation, both of the inner and outer sheaths are retracted from the patient.

Abstract: A highly flexible delivery device (2) for a stent graft (6) particularly for deployment into the thoracic arch of a patient. The delivery device has a distal handle (7), a pusher catheter (4) extending proximally from the handle to a proximal nose cone dilator (11), a guide wire catheter (3) extending from the proximal nose cone dilator to the pusher catheter. To give flexibility the guide wire catheter comprises a nitinol tube, the nose cone dilator has a high flexibility and the pusher catheter has a graded flexibility being more flexible at its proximal end than at its distal end. The graded flexibility can be provided by joined segments (4a, 4b and 4c) of different flexibility or by a inner metal tube (72) to give rigidity over some of the length. Alternatively the graded flexibility can be provided by tapering the wall thickness (80, 80a) of the pusher catheter.

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 stent delivery system includes a self-expanding stent, an inner tube body which has a guide wire lumen, and a sheath which has the stent contained within the tip section thereof. The stent can be discharged by moving the sheath to the base end side relative to the inner tube body. The inner tube body is provided at a position within the base end section of the stent and is provided with an elastic member for pressing the stent in the direction to the sheath. The stent is gripped by the elastic member and the sheath and is adapted to be slidable relative to the sheath.

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 stent delivery assembly can include a stent, a tube, a shaft slidably disposed within the tube, and an engagement member on the shaft. The engagement member is operable via the shaft so as to facilitate manipulation of the stent via the shaft. The engagement member can engage the stent inner wall and cooperating with the tube to grip the stent. The shaft is arranged within the tube with a close tolerance between the shaft and the tube so as to provide stability during retraction or advancement of the shaft.

Abstract: A system for delivering an expandable implant into the vasculature of a patient, including an elongated core element having a proximal end accessible exterior to the patient and a distal end including at least one feature for engaging a proximal portion of the implant in a collapsed state. The system further includes an expansion limiter having an inner diameter and a length sufficient to cover the proximal portion of the implant and to retain the proximal portion in the collapsed state, and at least one elongated member having a distal end connected to the expansion limiter and a proximal end accessible exterior to the patient to enable proximal movement of the expansion limiter to release the implant.

Abstract: A removable sleeve extends around an expandable stent graft to constrain the expandable stent graft toward a collapsed configuration. The sleeve is held together by a coupling member to constrain the expandable device toward the collapsed configuration for endoluminal delivery to a vascular treatment site. The sleeve is openable by displacing the coupling member away from the sleeve to allow outward expansion of the expandable device toward an expanded configuration. The sleeve is separate from the expandable device so as to be removable from the treatment site after deployment of the expandable device.

Abstract: A medical device-includes a scaffold crimped to a catheter having an expansion balloon. The scaffold is crimped to the balloon by a process that includes one or more balloon pressurization steps. The balloon pressurization steps are selected to enhance scaffold retention to the balloon while retaining, at least partially, the original balloon folds as the balloon is pressurized and de-pressurized within a crimper head. By at least partially retaining the original balloon folds, a uniformity of scaffold expansion by the balloon is improved.

Abstract: A device and method for treating pathological narrowing of fluid-carrying conduits of the human body (such as blood vessels) in an area of a bifurcation is disclosed. In particular, a stent delivery system configured to carry one or more of a pair of dissimilar stents. At least one of the stents is particularly suited for treating a widened portion of a blood vessel immediately proximal to a bifurcation. The stent delivery system can also include a handpiece adapted to selectively deliver the stents.

Abstract: A delivery device for implanting a medical device that includes an expandable fixation member adapted to fix the position of the medical device within a lumen of a human body. The delivery device has an inner shaft rotatably disposed in a tubular outer shaft. A retention member is secured to and rotatable with the inner shaft and has a free end and a retainer portion adapted to protrude outwardly through an exit aperture in the outer shaft to extend circumferentially about the exterior of the outer shaft. The fixation member of the medical device may be retained on the tubular shaft in a low profile configuration by the outwardly protruding retainer portion and may be released to expand upon retraction of the retainer portion in response to rotation of the inner shaft.

Abstract: An implantable system for endoluminal delivery of expandable devices having one or more sleeves and one or more sleeve pull back lines. The sleeve pull back lines enable retraction of the one or more sleeves, with various benefits resulting therefrom.