Abstract: A system and method for deploying an occluding device that can be used to remodel an aneurysm within the vessel by, for example, neck reconstruction or balloon remodeling. The system comprises an introducer sheath and an assembly for carrying the occluding device. The assembly includes an elongated flexible member having an occluding device retaining member for receiving a first end of the occluding device, a proximally positioned retaining member for engaging a second end of the occluding device and a support surrounding a portion of the elongated flexible member over which the occluding device can be positioned.

Abstract: A stent deployment device and methods for use, where the device comprises: (a) an outer sheath having a proximal end and a distal end, (b) a pull apparatus at least partially disposed within the outer sheath, where a portion of the pull apparatus is sized and shaped to receive a stent or a stent graft, (c) a push apparatus, where a portion of the push apparatus is sized to fit within a portion of the pull apparatus, and (d) a push-pull drive mechanism in mechanical communication with the pull and push apparatuses, where the push-pull drive mechanism includes at least a push and a pull gear or a push and a pull reel sized and shaped based on a stent ratio.

Abstract: An intravascular stent is provided for treatment of an aneurysm in a vessel wall of a cranial blood vessel. The stent includes at least one a flow-shaping member including a flow-facing surface that protrudes from an inner surface of the stent and is configured to control at least one of the direction, velocity and secondary flow characteristics of the blood flow within the aneurysm.

Abstract: An introducer assembly (40) for use in the deployment of implantable medical devices such as stents and stent grafts includes a carrier element (20), a dilator tip (18) located at the distal end of the carrier element (40) and sheath (32) movable between a device covering position and a device deployment position. In the device deployment position, a restricted annular gap (34) is created between the distal end (36) of the sheath (32) and the proximal end (38) of the dilator tip (18). The gap (34) is restricted by a restriction mechanism (50) located at the proximal, external end, of the introducer assembly (40). The gap (34) allows for the progressive deployment of the medical device from the introducer (40) and for simultaneous retraction of the dilator tip (18) thereby avoiding snagging of the dilator tip (18) against the wall of a patient's vessels and of the medical device.

Abstract: A method of moving a stent device into an outer sheath of a stent: device delivery system is disclosed. The stent device (4) is Crimped into a collapsed configuration onto the loading mandrel (6). The loading mandrel is pushed towards the outer sheath as the engaging surfaces (10) resist relative longitudinal movement between the stent device and the loading mandrel to move the stent device into the outer sheath (16). Upon entering the outer sheath, the stent device expands radially until radially constrained by the outer sheath.

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: A suture passer assembly is used for manipulating a suture with a selectively moveable wire member. The suture passer assembly includes at least one grasping member and a single-body hollow tube. The tube defines a first end, a second end, a tube wall, and a tube passage extending from the first end to the second end. The wire member is moveably received within the tube passage. The tube wall includes at least one aperture that is disposed between the first end and the second end. A first portion of the grasping member extends through the tube wall and into the tube passage via the aperture. A second portion of the grasping member remains outside the hollow tube. The first portion is operable to grasp the wire member and selectively move the wire member relative to the hollow tube due to manipulation of the second portion of the grasping member.

Abstract: The present invention provides methods for fabricating a stent using a chemical treatment to smooth, polish or strengthen the stent. One such treatment involves exposing the stent to acetone or a similar solvent. In certain embodiments, the additional step comprises placing the stent in a bath containing acetone, or a similar solvent, where the bath also contains the polymer the stent is composed of. The acetone bath step may be conducted at a temperature that is below the glass transition temperature. The present invention also provides for methods of fabricating a stent using an acetone bath that comprises poly (lactic) acid. Other embodiments provide for methods of fabricating a stent using an acetone bath that comprises poly (lactic) acid and polyethylene glycol.

Abstract: A stent graft system for intraluminal deployment in an aorta and a branch vessel that includes an aorta stent graft for deployment within the aorta and defining a lumen for the passage of blood therethrough, and having a fenestration positioned and sized so as to allow blood to flow to a contiguous branch vessel. The system also includes a branch vessel prosthesis, preferably a stent graft, having a tubular portion and a flaring portion, such that, when deployed, the flaring portion is located within the lumen of the aorta stent graft and the tubular portion passes through the fenestration and into the branch vessel. A balloon expansion catheter expands the tubular portion and flare the flaring portion. The expansion of the tubular portion and the flaring of the flaring portion may occur sequentially or simultaneously.

Abstract: A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A single piece sheath is placed over the scaffold immediately following crimping of the scaffold to the balloon. The single piece sheath is replaced by a two-piece sheath, which is removed prior to performing a medical procedure using the medical device.

Abstract: A method of implanting a bridging device for supporting occlusive masses within an aneurysm located at a vascular bifurcation.

Abstract: Medical device delivery systems, and related methods and components, are disclosed.

Abstract: In at least one embodiment of the present invention a balloon catheter is provided. The balloon catheter comprises a shaft having a lumen formed therethrough. Connected to the shaft is an inflatable balloon. The inflatable balloon has a balloon wall defining a balloon interior surface and a balloon exterior surface that is opposite the interior surface. In fluid communication with the balloon wall is the lumen for inflating the balloon to define an inflated state and for collapsing the balloon to define a deflated state. The balloon wall is textured in the deflated state such that the balloon interior surface is spatially registered with the balloon exterior surface. The balloon in the inflated state is tensioned to have a surface roughness substantially less than a surface roughness of the balloon in the deflated state.

Abstract: A heart valve delivery apparatus includes a valve carrying member. A prosthetic valve is crimped onto the valve carrying member at a location that is distal or proximal to the balloon member, thereby providing a smaller profile delivery apparatus.

Abstract: A delivery device for a collapsible prosthetic heart valve includes an operating handle and a catheter assembly. The operating handle may include a housing defining a movement space therein, a carriage assembly moveable in a longitudinal direction within the movement space, a deployment actuator coupled to the housing and rotatable relative to the housing, and a coupling assembly rotationally fixed to the deployment actuator. The catheter assembly may include a first shaft around which a compartment is defined and a distal sheath operatively connected to the carriage assembly. Movement of the carriage assembly in the longitudinal direction in the movement space may move the distal sheath between the closed condition and the open condition. The coupling assembly may have an engaged position in which rotation of the deployment actuator moves the carriage assembly, and a disengaged position in which rotation of the deployment actuator does not move the carriage assembly.

Abstract: A stent graft deployment device assembly (10) has a cylindrical fixed handle (6) to be gripped and held by a user and an tubular release handle (30) extending through the fixed handle. The release handle can be moved through the fixed handle. The deployment device assembly has a pusher assembly and a sheath (18) to cover a stent graft on the pusher assembly. The pusher assembly is connected to the fixed handle and the sheath is connected to the release handle so that retraction of the release handle through the fixed handle causes the sheath to be retracted from the stent graft on the pusher assembly. The fixed handle has a rotator component (36) with internal first and second screw threads. The tubular release handle has an external screw thread (31) which engages with the first screw thread. The external screw thread (31) can extend along part, all or in segments along the release handle. A release clamp (48) on the pusher has pins which engage with the second screw thread.

Abstract: In a method of accessing and closing a vessel, a vessel is percutaneously accessed through a first opening in the vessel wall at a first location. A stent-graft is delivered through the first opening to a second location. The stent-graft is deployed at the second location. The vessel is then accessed through a second opening through the vessel wall at the second location, wherein the second opening is generally aligned with a fenestration through the graft material of the stent-graft. A delivery device is advanced through the second opening, the fenestration, and the stent-graft lumen to a third location spaced from the first location and the second location. After the delivery device is retracted through the lumen of the stent-graft and out of the fenestration and the second opening, the stent graft is rotated or translated such that the fenestration is not aligned with the second opening.

Abstract: Described herein are flexible implantable occluding devices that can, for example, navigate the tortuous vessels of the neurovasculature. The occluding devices can also conform to the shape of the tortuous vessels of the vasculature. In some embodiments, the occluding devices can direct blood flow within a vessel away from an aneurysm or limit blood flow to the aneurysm. Some embodiments describe methods and apparatus for adjusting, along a length of the device, the porosity of the occluding device. In some embodiments, the occluding devices allows adequate blood flow to be provided to adjacent structures such that those structures, whether they are branch vessels or oxygen-demanding tissues, are not deprived of the necessary blood flow.

Abstract: A combined multi-lumen central access catheter and an embolic filter, further comprising an imaging modality to facilitate intravascular imaging of the filter.

Abstract: A control system for controlling movement of a medical device delivery system, a stent delivery system and a method for controlling movement of a medical device delivery system are provided. The control system includes a rotatable gear operably connected to a first movable member and a second movable member movable by the rotatable gear. The first movable member is operably connected to the first shaft and the second movable member operably connected to the second shaft. The first movable member moves the first shaft and the second movable member moves the second shaft to change a position of the first shaft relative to the second shaft and to change a configuration of a medical device operably connected to the first shaft and the second shaft.

Abstract: A medical device for blood flow restoration and/or for use as an implantable member in a human vessel includes a self-expanding member, a guidewire, and a connection mechanism. The self-expanding member includes a plurality of cells and filaments having specific ranges of thicknesses, widths, and heights. The self-expanding member can take on a volume-reduced coiled form with overlapped edges, and can generate optimal radial forces against a vessel wall and/or thrombus when deployed and expanded.

Abstract: A method for securing an implantable medical device onto a balloon which includes applying a coating, which includes a film-forming polymer and at least one solvent, to the outer surface of the balloon. The solvents can include alcohol, water, ether and combinations thereof. The film-forming polymer can include a zwitterionic polymer, such as, for example a phosphorylcholine polymer. The coating can be applied to the entire balloon surface or a portion of the surface. The implantable medical device is then positioned on the outer surface of the balloon and secured. The film-forming polymer is then allowed to cure in order to define an adhesive layer between an inner surface of the implantable medical device and the outer surface of the balloon. This method prevents or reduces the leaching or redistribution of any therapeutic agents dispersed within or on the surface of the implantable medical device.

Abstract: A combined multi-lumen central access catheter and an embolic filter, further comprising an imaging modality to facilitate intravascular imaging of the filter.

Abstract: Embodiments provide methods and systems for treating aneurysms using filling structures filled with a curable medium. An embodiment of a method comprises positioning at least one double-walled filling structure across the aneurysm and filling the structure(s) with a filling medium so that an outer wall conforms to the inside of the aneurysm and an inner wall forms a generally tubular lumen to provide for blood flow. The lumen is supported with a balloon or other expandable device while and/or after filling. The pressure within the structure and/or in the space between an external wall of the structure and the aneurysm wall is monitored and a flow of the medium into the structure is controlled responsive to the pressure. The pressure can also be used to determine a filling endpoint. The medium is hardened while the lumen remains supported by the balloon. The balloon is then removed after the medium hardens.

Abstract: Deflection devices, systems, and methods for the prevention of stroke. Devices hereof comprise an extension portion and an anchor portion, both of which are configured to prevent the device from advancing into the artery extending from the aortic arch in which the device may be positioned. Additionally, a retrieval system is provided, the system comprising a sleeve catheter and a retrieval device slidably disposed therein. The distal end of the retrieval device comprises one or more attachment portions configured to engage at least a portion of the anchor portion of a device positioned within an artery extending from the aortic arch.

Abstract: A handle for an implant deployment device converts rotational movement into longitudinal movement in order to provide controlled release of one or more trigger wires. The handle also allows the trigger wire to be withdrawn into the device so that it does not need to be separately removed. A preferred handle includes a rotatable portion (120) and a slideable portion (122). Releasable locks (88, 188) ensure that the handle is used to carry out implant deployment steps in a specific order.

Abstract: Apparatus and methods are provided for flaring a stent deployed within a branch vessel including an ostium communicating with a main vessel, a first end of the stent extending at least partially from the branch. A catheter is provided that includes a first balloon carried on its distal end, and a second balloon that includes a distal section overlying at least a portion of the first balloon and a proximal section. The catheter distal end is introduced into the main vessel and positioned through the ostium and stent into the branch until the first balloon is disposed within the stent. The first balloon is expanded to anchor the stent, and the second balloon is expanded to flare the first end of the stent. Optionally, the first balloon is expanded further, e.g., to expand the stent within the branch body lumen and/or dilate the lesion.

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: Methods of treating congenital heart defects in infants and children with bioabsorbable polymer stents are described. The treatments reduce or eliminate the adverse affects of congenital heart defects or may be palliative.

Abstract: A stent system is provided for stenting a bifurcated vessel structure having a parent vessel and a daughter vessel. The stent system has a parent vessel stent and a daughter vessel stent. The parent vessel stent has a substantially tubular body that is configured to be deployed into the parent vessel. This body has an angular flap that is openable to extend into the daughter vessel. The daughter vessel stent has a substantially tubular body that is configured to be deployed through the flap in the parent vessel stent into the daughter vessel. The daughter vessel stent has an angled tail portion that is configured to overlap with the flap of the parent vessel stent when both stents are deployed in the vessel structure. A method of stenting using this system is also provided.

Abstract: A prosthesis delivery system including a prosthesis mounted on an elongate member. The prosthesis has a locking member positioned on the prosthesis. The locking member includes a reduced diameter portion with two opposing surfaces that are configured to engage opposing proximal and distal sides of a radially extending member on the elongate member to lock or limit the longitudinal position of the prosthesis on the elongate member during delivery of the prosthesis to a treatment site.

Abstract: A pusher assembly for a stent delivery device includes a distal end of an elongate member and a stent-engaging member having proximal and distal ends. The proximal end of the stent-engaging member is mechanically coupled to the distal end of the inner member by a connector, or the proximal end of the stent-engaging member is at least partially inside the distal end of the elongate inner member. The stent-engaging member includes a portion that radially outwardly extends towards the distal end of the stent-engaging member, or the stent-engaging member includes a portion that radially outwardly extends towards the distal end of the stent-engaging member. The stent-engaging member is configured to move a stent when distally advanced and configured to not move a stent when proximally retracted. A stent delivery device includes an elongate outer member, an elongate inner member coaxially positioned within the outer member, and the pusher assembly.

Abstract: Devices, systems and methods support tissue in a body organ for the purpose of restoring or maintaining native function of the organ. The devices, systems, and methods do not require invasive, open surgical approaches to be implemented, but, instead, lend themselves to catheter-based, intra-vascular and/or percutaneous techniques.

Abstract: A delivery system having an improved handle allowing operation of the delivery system with one hand while maintaining accuracy in delivery and deployment of a prosthesis in a body lumen. The delivery system includes a sheath and a handle. The handle includes a slide shaft having a threaded outer surface, and a hub assembly coupled to the sheath. The hub assembly includes an inner slider having a thread tooth pivot support, a thread tooth pivotably mounted to the thread tooth pivot support, a distal sleeve having a thread tooth press member pressing on the thread tooth, and a proximal sleeve. Motion of the distal sleeve relative to the inner slider pivots the thread tooth on the thread tooth pivot support to engage and disengage the hub assembly with the threaded outer surface. The distal sleeve is rotatably coupled to the proximal sleeve, and the proximal sleeve is prevented from rotating to provide a stable grip to allow operation of the catheter with one hand.

Abstract: Methods and devices are disclosed for manipulating the airway, such as to treat obstructive sleep apnea. An implant is positioned within the body with respect to the airway. The spatial orientation of the airway is manipulated, directly or indirectly, to affect the configuration of the airway. In general, the implant is manipulated to displace the trachea in an inferior direction, resist superior displacement of the trachea and/or to alter the tracheal wall tension. The implant restrains the trachea in the manipulated configuration.

Abstract: A dual valve prosthesis having a self-expanding anchoring frame with first and second prosthetic valve assemblies attached to the anchoring frame is disclosed. Each of the first and second prosthetic valve assemblies includes a balloon-expandable stent structure with a prosthetic valve secured therein. In a disclosed method, the first and second prosthetic valve assemblies include prosthetic mitral and aortic valves, respectively, and the dual heart valve prosthesis is configured to replace both the native mitral and aortic valves of the heart in a single transcatheter heart valve implantation procedure.

Abstract: Medical devices for delivering stents, prosthetic valve devices, and other implantable articles inside a patient's body are provided. The devices have an elongate inner compression member having a proximal end and a distal mating end with a tapered portion and outer engaging surface, a first portion proximal to the distal mating end, and the tapered portion having a smaller cross sectional area than the first portion and being more flexible than the first portion. The devices further have an inner guide channel member with a first end and a second end defining a channel of substantially uniform inner diameter, the second end having an outer diameter, and the first end having a taper extending from the second end outer diameter to a smaller second outer diameter. A joint is configured for melt bonding or implanting the inner compression member distal mating end and the inner guide channel member second end.

Abstract: In one preferred embodiment, a prosthesis is provided that can be selectively expanded by increasing the temperature of the prosthesis within the patient. The prosthesis is composed of a shape memory material that expands when heated to a temperature greater than an average body temperature, allowing the user to selectively heat and therefore expand the prosthesis at a desired location.

Abstract: A prosthesis delivery handle with a bushing (66) with two adjacent internal threads (64, 74) with different diameters and pitch surrounding a tubular threaded first shaft member (36) cooperating with the first thread (64) and a second inner member with a protrusion (82) extending through an axial slot in the tubular first member such that the protrusion runs in the second thread (74). First and second members are connected to an external shaft (112) and an internal element (102) so that when the bushing is rotated first and second members travel axially with different speeds the internal shaft and an external shaft move accordingly.

Abstract: Removable cardiac implants, applicators for inserting, repositioning and/or removing them, and methods of using them are described. In particular, removable or repositionable ventricular partitioning devices are described. Systems including removable implants and applicators for inserting and/or removing them are also described.

Abstract: A releasable top cap system for a delivery device having an emergency release includes a top cap having a top portion and a bottom portion releasably attached to the top portion, the bottom portion having two adjacent side portions. A cannula is positioned distal to the top cap having a proximal end and a distal end. A connector is attached to the proximal end of the cannula. A pair of wire components extend throughout the length of the cannula. Each wire component has a distal end and a proximal end. The proximal end of each wire component is attached to the male luer lock component and the distal end of each wire component is attached to the side portions of the top cap assembly.

Abstract: A segmented balloon expandable stent graft includes a graft material and a plurality of cylindrical stent elements coupled to the graft material. The plurality of cylindrical stent elements are plastically deformable when expanded from a radially compressed configuration to a radially expanded configuration. The plurality of cylindrical stent elements includes a first end stent element, a second end stent element, and a plurality of middle stent elements. The first and second end stent elements are independent of the plurality of middle stent elements. The first and second end stent elements are more resistant to radial expansion than the plurality of middle stent elements such that the plurality of middle stent elements plastically deform from the radially compressed configuration to the radially expanded configuration when inflated by a balloon prior the first and second end stent elements.

Abstract: Interventional procedures on the carotid arteries are performed through a transcervical access while retrograde blood flow is established from the internal carotid artery to a venous or external location. A system for use in accessing and treating a carotid artery includes an arterial access device, a shunt fluidly connected to the arterial access device, and a flow control assembly coupled to the shunt and adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state. The flow control assembly includes one or more components that interact with the blood flow through the shunt.

Abstract: Catheter for delivery of a medical device such as a stent or filter includes an inner tubular member and an outer tubular member movable relative to the inner tubular member. The outer tubular member is disposed at the distal end of the inner tubular member. The inner tubular member includes a fluid lumen defined therein, the fluid lumen having a fluid flow port directed to the exterior surface of the inner tubular member. A pressure chamber is defined by the inner tubular member, the outer tubular member, a proximal seal and a distal seal, and is in fluid communication with the fluid flow port, wherein fluid introduced through the fluid flow port and into the pressure chamber applies a force on the proximal seal to move the outer tubular member in a proximal direction allowing the medical device constrained by the outer tubular member to be released.

Abstract: A low profile stent device consisting of a stent plus an optional covering is placed percutaneously into a blood vessel to provide vascular closure to a nearby large diameter arteriotomy site. A self-expanding stent device is mounted onto a balloon for postdilitation and is held in a small diameter configuration by an outer case. A balloon expandable stent device has hinge and strut features that provide it with crush resistance. The cone and sheath of the deliver catheter serves as a dilator and introducer sheath to assist in delivery. An attachable guidewire reduces profile by eliminating a guidewire lumen. A locator balloon placed through the large diameter arteriotomy introducer sheath assists positioning.

Abstract: Balloon catheters and stent delivery systems including bifurcated stent delivery systems are disclosed. An example bifurcated stent delivery system may include an elongate shaft including a proximal section, a midshaft section, and a distal section. The proximal section may include a tubular member having a plurality of slots formed therein. The slots may be arranged in one or more sections having differing slot densities. The midshaft section may include a guidewire port in fluid communication with a guidewire lumen formed in the shaft. A main branch balloon may be coupled to the shaft. A side branch balloon may be disposed adjacent to the main branch balloon. A stent may be disposed on the main branch balloon and on the side branch balloon.

Abstract: A deployment device to deploy a prosthesis for interconnecting vessel portions of a body vessel is described herein. The device includes a support frame and an actuation member coupled to the support frame. The actuation member is movable between a first and a second position. A retaining member is movable between a closed and a open position. In the closed position, the retaining member forms a chamber to retain a length of a prosthesis in a compressed configuration. In the open position, the retaining member is positioned to allow the prosthesis to move to an expanded configuration. Movement of the actuation member to the second position causes movement of the retaining member to the open position. One or more retractable cuffs can be positioned over the ends of the prosthesis for selectively retaining the corresponding prosthesis ends in the compressed configuration.

Abstract: Aneurysms are treated by filling at least one double-walled filling structure with a curable medium within the aneurysm. The filling structures may be delivered over balloon deployment mechanisms in order to shape and open tubular lumens therethrough. Scaffolds are placed into the tubular lumens in order to help maintain the shape, anchor the filling structures in place, and provide improved blood flow transition into and out of the tubular lumens.

Abstract: An endovascular delivery system includes an endovascular prosthetic device and a signal active guide wire engaging the endovascular prosthetic device. A rotary encoder is coupled with the guide wire and the endovascular prosthetic device to provide an encoder signal on the guide wire. The encoder signal is indicative of axial angular position of the endovascular prosthetic device during implantation of the endovascular prosthetic device in a body of a patient.

Abstract: A thoracic arch stent graft (1) has a tubular body of a biocompatible graft material (3) and at least one fenestration (13, 15) in the wall on one side thereof. A combination guide and tubular side arm assembly (20, 22) is mounted into the or each fenestration. The combination guide and tubular side arm assembly comprises a tubular portion (24) and a funnel portion (26) extending from a distal end of the tubular portion. The funnel portion has an angled open end. The tubular portion and the funnel portion are formed from a biocompatible graft material wall and have a lightweight space frame (38 40) formed from a resilient wire and supporting the graft material and defining the combination guide and tubular side arm assembly.