Abstract: A fastener delivery system including a handle, a sheath, a delivery shaft extending distally from the handle and within the sheath, and an internal assembly within the sheath. The internal assembly includes a support member extending along a support member axis, a helical track coupled to the support member and configured to receive a helical fastener having a helical fastener pitch, and a driver configured to advance the helical fastener axially along the helical track. The helical track has a helical track pitch corresponding to the helical fastener pitch to permit passage of the helical fastener along the helical track. The helical track includes a neutral axis portion.

Abstract: A prosthesis fastener applier includes a handle, a plurality of input controls, and a fastener delivery shaft. The handle contains a motor and a control circuit. The input controls are connected to the handle and communicatively connected to the control circuit. The fastener delivery shaft includes a fastener cartridge and a driver shaft. The fastener cartridge includes a plurality of internal threads configured to receive a plurality of helical fasteners in stacked relationship. The driver shaft is operatively connected to the motor, disposed within the fastener cartridge, and configured to pass through respective inner diameters of the helical fasteners. The control circuit is configured to control the motor in response to signals from one or more of the input controls to rotate the driver shaft to cause one or more of the helical fasteners to be advanced axially relative to the fastener cartridge.

Abstract: An implantable prosthetic valve includes an outer tubular wall or other body having an axial passage extending from an inlet end to an outlet end. The wall may be constructed of a flexible biocompatible material, and a pair of apposed valve leaflets is usually disposed in the axial passageway of the outer tubular wall or body. Each valve leaflet has an inlet edge, an outlet edge, and a pair of lateral edges extending between the inlet edge and the outlet edge. The outlet edges are configured to be normally open to allow unrestricted fluid flow and close together when fluid pressure is applied to the outlet end. In some instances, the inlet edge, the outlet edge, and the pair of lateral edges of each leaflet are integrated along their entire lengths into the outer tubular wall. In other instances, the leaflets may be formed as a separate structure or assembly that is attached within the tubular wall or body.

Abstract: An endovascular guide catheter includes a guide tube and a handle. The flexible guide tube has a distal end portion configured to deflect via actuation of a pull wire. The handle is coupled to the guide tube and comprises a steering assembly configured to actuate the pull wire to deflect the distal end portion of the guide tube. The steering assembly can comprise a stationary rack, a gear, a reel, and a slider. The gear engages the rack and the reel is coupled to and configured to rotate with the gear. The pull wire is coupled to the reel such that rotation of the reel causes the pull wire to wind or unwind around the reel. The slider is adapted for translation relative to the rack. Translation of the slider translates the reel relative to the rack and rotation of the gear along the rack rotates the reel.

Abstract: A fenestrated aortic cuff is configured to be delivered endovascularly to a target region, deployed, fastened, and sealed to a vessel wall, e.g., in a neck region of an aortic aneurysm. Example fenestrated cuffs provide a suitable landing zone for a commercially available endograft, which may be, in some cases, positioned below or above the renal arteries in order to complete exclusion of an abdominal aortic aneurysm (AAA) or a thoracic aortic aneurysm (TAA), respectively, from systematic circulation. In some cases, fenestrated cuff function is facilitated and improved by employing active fixation and sealing mechanisms, including, e.g., helical fasteners, which may allow deployment of the fenestrated cuff in short neck regions with limited sealing area.

Abstract: A prosthesis fastener applier includes a handle, a plurality of input controls, and a fastener delivery shaft. The handle contains a motor and a control circuit. The input controls are connected to the handle and communicatively connected to the control circuit. The fastener delivery shaft includes a fastener cartridge and a driver shaft. The fastener cartridge includes a plurality of internal threads configured to receive a plurality of helical fasteners in stacked relationship. The driver shaft is operatively connected to the motor, disposed within the fastener cartridge, and configured to pass through respective inner diameters of the helical fasteners. The control circuit is configured to control the motor in response to signals from one or more of the input controls to rotate the driver shaft to cause one or more of the helical fasteners to be advanced axially relative to the fastener cartridge.

Abstract: Systems and methods introduce and deploy prosthesis into a blood vessel or hollow body organ by intra-vascular access. The prosthesis is secured in place by fasteners which are implanted by an applier that is also deployed by intra-vascular access. The applier is configured to permit controlled, selective release of the fastener in a step that is independent of the step of implantation.

Abstract: A prosthesis fastener applier includes a handle, a plurality of input controls, and a fastener delivery shaft. The handle contains a motor and a control circuit. The input controls are connected to the handle and communicatively connected to the control circuit. The fastener delivery shaft includes a fastener cartridge and a driver shaft. The fastener cartridge includes a plurality of internal threads configured to receive a plurality of helical fasteners in stacked relationship. The driver shaft is operatively connected to the motor, disposed within the fastener cartridge, and configured to pass through respective inner diameters of the helical fasteners. The control circuit is configured to control the motor in response to signals from one or more of the input controls to rotate the driver shaft to cause one or more of the helical fasteners to be advanced axially relative to the fastener cartridge.

Abstract: A guide device establishes a guide passage through a guide tube, through which an operative tool can be deployed into an interior body region for use. A steering assembly, in use, deflects or bends the distal end region of the guide tube, so that the operative tool can be placed in a desired orientation with respect to tissue. The steering assembly is desirable configured for single handed operation by the clinician. The steering assembly is also desirably configured to provide a mechanical advantage sufficient to translate relatively small increments of clinician control into relatively larger increments of guide tube deflection. In one arrangement, the steering assembly includes a rack and pinion linkage system. In another arrangement, the steering assembly includes a pivoting lever system.

Abstract: Method and apparatus for implanting radially expandable prostheses in the body lumens rely on tacking or anchoring of the prostheses with separately introduced fasteners. The prostheses may be self-expanding or balloon expandable. After initial placement, a fastener applier system is introduced within the expanded prostheses to deploy a plurality of fasteners at least one prosthesis end, usually as each end of the prosthesis. The fasteners are usually helical fasteners which are delivered from a helical track in the fastener applier by rotation with a rotator wire. The fasteners will be applied singly, typically in circumferentially spaced-apart patterns about the interior of each end of the prosthesis.

Abstract: An endovascular guide catheter includes a guide tube and a handle. The flexible guide tube has a distal end portion configured to deflect via actuation of a pull wire. The handle is coupled to the guide tube and comprises a steering assembly configured to actuate the pull wire to deflect the distal end portion of the guide tube. The steering assembly can comprise a stationary rack, a gear, a reel, and a slider. The gear engages the rack and the reel is coupled to and configured to rotate with the gear. The pull wire is coupled to the reel such that rotation of the reel causes the pull wire to wind or unwind around the reel. The slider is adapted for translation relative to the rack. Translation of the slider translates the reel relative to the rack and rotation of the gear along the rack rotates the reel.

Abstract: Devices, systems, and methods for implanting expandable prostheses in the body lumens rely on stapling or anchoring the prostheses with separately introduced fasteners. The prostheses may be self-expanding or balloon expandable, and may include a single lumen or more than one lumen. After initial placement, a stapling system is introduced within the expanded prosthesis to deploy a plurality of fasteners to at least one prosthesis end. The stapling system may apply a force to the prosthesis to modify the shape of the prosthesis to conform to the shape of the vessel wall. The stapling system can be deflected in one or more distinct steerable segments. A lumen extension or lumens may be coupled to the prosthesis to extend the reach of the prosthesis within the implantation site. Fasteners may also be applied to the lumen extensions.

Abstract: An endovascular guide catheter includes a guide tube and a handle. The flexible guide tube has a distal end portion configured to deflect via actuation of a pull wire. The handle is coupled to the guide tube and comprises a steering assembly configured to actuate the pull wire to deflect the distal end portion of the guide tube. The steering assembly can comprise a stationary rack, a gear, a reel, and a slider. The gear engages the rack and the reel is coupled to and configured to rotate with the gear. The pull wire is coupled to the reel such that rotation of the reel causes the pull wire to wind or unwind around the reel. The slider is adapted for translation relative to the rack. Translation of the slider translates the reel relative to the rack and rotation of the gear along the rack rotates the reel.

Abstract: Devices, systems, and methods for implanting prostheses in the body lumens rely on tacking or anchoring the prostheses with separately introduced fasteners. After initial placement, a fastener applier system is introduced within the expanded prostheses to deploy a plurality of fasteners to at least one prosthesis end. The fasteners are usually helical fasteners which are releasably restrained on the fastener driver, and are delivered by rotation of the fastener driver. The fasteners may be applied singly, typically in circumferentially spaced-apart patterns about the interior of at least one end of the prosthesis. A lumen extension or lumens may be coupled to the prosthesis to extend the reach of the prosthesis within the implantation site. Fasteners may also be applied to the lumen extensions.

Abstract: A fenestrated aortic cuff is configured to be delivered endovascularly to a target region, deployed, fastened, and sealed to a vessel wall, e.g., in a neck region of an aortic aneurysm. Example fenestrated cuffs provide a suitable landing zone for a commercially available endograft, which may be, in some cases, positioned below or above the renal arteries in order to complete exclusion of an abdominal aortic aneurysm (AAA) or a thoracic aortic aneurysm (TAA), respectively, from systematic circulation. In some cases, fenestrated cuff function is facilitated and improved by employing active fixation and sealing mechanisms, including, e.g., helical fasteners, which may allow deployment of the fenestrated cuff in short neck regions with limited sealing area.

Abstract: A fenestrated aortic cuff is configured to be delivered endovascularly to a target region, deployed, fastened, and sealed to a vessel wall, e.g., in a neck region of an aortic aneurysm. Example fenestrated cuffs provide a suitable landing zone for a commercially available endograft, which may be, in some cases, positioned below or above the renal arteries in order to complete exclusion of an abdominal aortic aneurysm (AAA) or a thoracic aortic aneurysm (TAA), respectively, from systematic circulation. In some cases, fenestrated cuff function is facilitated and improved by employing active fixation and sealing mechanisms, including, e.g., helical fasteners, which may allow deployment of the fenestrated cuff in short neck regions with limited sealing area.

Abstract: Apparatus and methods utilize an intraluminal fastener applier having a guide body with a longitudinal axis. The guide body is sized and configured for intraluminal deployment in a hollow body organ. An actuated assembly is carried by the guide body that is selectively operable to generate an implantation force to implant at least one fastener into tissue within the hollow body organ. The actuated assembly includes a driven member extending generally along the longitudinal axis, which is sized and configured to engage a selected fastener. The actuated assembly also includes a drive member coupled to the driven member to impart the implantation force to the driven element in a direction that is at an angle to the longitudinal axis of the guide body.

Abstract: Systems and methods for deploying a prosthesis in a tissue region in a hollow body organ or blood vessel provide a first prosthesis and a second prosthesis, each having a prosthetic material and a scaffold that supports the prosthetic material. The first prosthesis has a proximal neck region, and the second prosthesis has an end region. The end region is sized and configured to telescopically fit with the proximal neck region to form a composite prosthesis. The systems and methods manipulate a fastener attachment assembly to implant at least one fastener to secure the composite prosthesis in the tissue region.

Abstract: Systems and methods introduce and deploy prosthesis into a blood vessel or hollow body organ by intra-vascular access. The prosthesis is secured in place by fasteners which are implanted by an applier that is also deployed by intra-vascular access. The applier is configured to permit controlled, selective release of the fastener in a step that is independent of the step of implantation.

Abstract: Systems and methods introduce and prosthesis into a blood vessel or hollow body organ by intra-vascular access. The prosthesis is secured in place by fasteners which are implanted by an applier that is also deployed by intra-vascular access. The applier is configured to permit controlled, selective release of the fastener in a step that is independent of the step of implantation.