Abstract: A system for forming a suture connector in situ includes a suture connector placement device having a handle, an outer shaft, an intermediate shaft, and a push rod, and a suture connector having a sleeve and a plug. The intermediate shaft is slidingly disposed through a lumen of the outer shaft, and the push rod is slidingly disposed through a lumen of the intermediate shaft. When the suture connector is in a loaded configuration within the suture connector placement device, the sleeve is radially disposed over the intermediate shaft and the plug is positioned proximal to the sleeve within the lumen of the intermediate shaft. Distal advancement of the push rod moves the plug into the sleeve and proximal retraction of the intermediate shaft releases the resilient sleeve onto the plug, thereby securing two suture portions between the sleeve and the plug. The system is then utilized to trim the suture portions.

Abstract: A scaffolded stent-graft includes a graft material comprising an inner surface and an outer surface. The inner surface defines a lumen within the graft material. The scaffolded stent-graft further includes a scaffold comprising a mesh coupled to the graft material at the outer surface. The scaffold is configured to promote tissue ingrowth therein. In this manner, the scaffold enhances tissue integration into the scaffolded stent-graft. The tissue integration enhances biological fixation of the scaffolded stent-graft in vessels minimizing the possibility of endoleaks and migration.

Abstract: A prosthetic assembly for repairing a target tissue defect within a target vessel region configured includes an exclusion structure sized to substantially bypass target tissue defect, and includes a branch assembly. The branch assembly can include a self-expanding outer branch prosthesis having an inflow region configured to deform to a non-circular cross-sectional-shape when deployed, and a support structure at least partially disposed within the inflow region. The support structure preserves blood flow to the branch vessel while the deformed inflow region inhibits blood leakage between and/or around the prosthetic assembly.

Abstract: A delivery system for percutaneously delivering and deploying a stented prosthetic heart valve. The delivery device includes a delivery sheath slidably disposed over an inner shaft, and a capture assembly. The capture assembly includes a spindle and a biasing member. The spindle is attached to the inner shaft and defines slot. The biasing member is disposed within the slot and self-transitions from a deflected condition to a normal condition. In a delivery state, the delivery sheath retains the prosthesis over the inner shaft and coupled to the spindle via the capture slot, including a portion of the prosthetic valve being engaged within the slot and the biasing member forced to the deflected condition. In a deployment state, the delivery sheath is proximally withdrawn and the biasing member self-transitions toward the normal condition to eject the prosthetic valve from the capture slot.

Abstract: A venous valve prosthesis includes a frame and a prosthetic valve coupled to the frame. With the venous valve prosthesis implanted in a vein, the prosthetic valve includes a closed configuration wherein an outer surface of the prosthetic valve is in contact with a wall of the vein around a circumference of the prosthetic valve to prevent blood from flowing past the prosthetic valve between the wall of the vein and the outer surface of the prosthetic valve. The prosthetic valve is configured to move to an open configuration such that at least a portion of an outer wall of the prosthetic valve partially collapses away from the wall of the vein in response to antegrade blood flow through the vein to enable blood flow between the outer surface of the prosthetic valve and the wall of the vein.

Abstract: A handle component of a medical device is disclosed for delivering a material to an enclosed cavity or space. The handle component includes a self-contained mechanism for holding the material and for providing or releasing the material to the enclosed cavity. The handle component also includes a pressure relief valve in fluid communication with the mechanism and the enclosed cavity. The pressure relief valve is configured to indicate when delivery of the material to the enclosed cavity reaches a preselected or set pressure and to thereby assure precise filling of the enclosed cavity with the material.

Abstract: A dilatation or fatigue tester for a stent-graft prosthesis includes a sample holder having a compressible member that defines a chamber for receiving a stent-graft prosthesis in an expanded state, a bearing assembly disposed to contact and act on an exterior surface of the compressible member of the sample holder, and an actuation assembly operably coupled to the bearing assembly for rotating the bearing assembly relative to the sample holder. Rotation of the bearing assembly cyclically compresses the compressible member of the sample holder to thereby provide cyclical radial loading and unloading of a stent-graft prosthesis received therein for simulating physiologic loading conditions of a stent-graft prosthesis within a vasculature due to a beating heart.

Abstract: A system for forming a suture connector in situ includes a suture connector placement device having a handle, an outer shaft, an intermediate shaft, and a push rod, and a suture connector having a sleeve and a plug. The intermediate shaft is slidingly disposed through a lumen of the outer shaft, and the push rod is slidingly disposed through a lumen of the intermediate shaft. When the suture connector is in a loaded configuration within the suture connector placement device, the sleeve is radially disposed between the intermediate shaft and the outer shaft and the plug is positioned proximal to the sleeve within the lumen of the intermediate shaft. Distal advancement of the push rod moves the plug into the sleeve and proximal retraction of the intermediate shaft releases the resilient sleeve onto the plug, thereby securing two suture portions between the sleeve and the plug.

Abstract: An occlusion bypassing apparatus for re-entering the true lumen of a vessel after subintimally bypassing an occlusion in a vessel. The apparatus includes an outer shaft component, a needle component, and an inflatable balloon. The outer shaft component has a side port proximal to a distal end thereof and a needle lumen there-through that includes a curved distal portion that terminates at the side port of the outer shaft component. The needle component is configured to be slidably disposed within the needle lumen of the outer shaft component. The inflatable balloon includes a body portion that is disposed distal to the side port of the outer shaft component, and the body portion of the balloon has a flattened profile in an inflated state with first and second chambers that laterally extend from opposing sides of the outer shaft component for stabilizing the apparatus within a subintimal space.

Abstract: A delivery system for delivering a prosthesis, the delivery system including a housing, a sheath extending from within the housing, a clutching mechanism housed within the housing, and a cable. The clutching mechanism includes a one-way clutch that transmits a torque from an actuator to an inner shaft assembly when the actuator is rotated in a first direction and does not transmit a torque from the actuator to the inner shaft assembly when the actuator is rotated in a second opposing direction. The actuator is accessible from an exterior of the housing. The cable has a first end coupled to a proximal portion of the sheath and a second end coupled to the inner shaft assembly, and actuation of the actuator causes the actuator to rotate in the first direction, thereby causing the inner shaft assembly to wind up a portion of cable and retract the sheath.

Abstract: A stent-graft delivery system includes a balloon, a sleeve disposed over the balloon, and a stent graft mounted over the sleeve. The sleeve includes a weakened area between a first end and a second end of the sleeve such that when the balloon is expanded, the balloon expands from a center portion of the balloon towards the ends of the balloon. The weakened area of the sleeve may be a slit, a thinner wall section, grooves, notches, or other weakening features. The sleeve may be adhesively attached to an outer shaft of the catheter or to an outer surface of the balloon.

Abstract: A delivery system for a stent-graft is disclosed having a tip capture device and a tip release handle mechanism configured to actuate the tip capture device. The tip release handle mechanism includes a rotatable grip component and a tip release actuation component. The grip component may be rotatable in a first direction to transition a proximal stent of the stent-graft from the delivery state to a partially deployed state and rotatable in an opposite, second direction to transition the proximal stent from the partially deployed state to a fully deployed state. The grip component is operably coupled to the tip release actuation component. The delivery system further includes a shaft component operably coupled to the tip release actuation component and the tip capture device.

Abstract: A dilatation or fatigue tester for a stent-graft prosthesis includes a sample holder having a compressible member that defines a chamber for receiving a stent-graft prosthesis in an expanded state, a bearing assembly disposed to contact and act on an exterior surface of the compressible member of the sample holder, and an actuation assembly operably coupled to the bearing assembly for rotating the bearing assembly relative to the sample holder. Rotation of the bearing assembly cyclically compresses the compressible member of the sample holder to thereby provide cyclical radial loading and unloading of a stent-graft prosthesis received therein for simulating physiologic loading conditions of a stent-graft prosthesis within a vasculature due to a beating heart.

Abstract: A reconfigurable delivery system is disclosed having a multi-lumen delivery catheter configuration that permits the delivery and staged release of a self-expanding main vessel stent-graft and a delivery sheath configuration that permits the introduction of various medical devices for the delivery and implantation of various branch vessel stent-grafts that are to be mated with the main vessel stent-graft. A method is disclosed wherein the delivery system is first used in the multi-lumen delivery catheter configuration to deliver and release a main vessel stent-graft that is configured for placement in the abdominal aorta for treatment of short-neck infrarenal, juxtarenal, and/or suprarenal aneurysms and then used in the delivery sheath configuration to facilitate the delivery of branch vessel stent-grafts that are configured to extend from the main vessel stent-graft into a respective renal artery.

Abstract: A delivery system for delivering a prosthesis, the delivery system including a housing, a sheath extending from within the housing, a clutching mechanism housed within the housing, and a cable. The clutching mechanism includes a one-way clutch that transmits a torque from an actuator to an inner shaft assembly when the actuator is rotated in a first direction and does not transmit a torque from the actuator to the inner shaft assembly when the actuator is rotated in a second opposing direction. The actuator is accessible from an exterior of the housing. The cable has a first end coupled to a proximal portion of the sheath and a second end coupled to the inner shaft assembly, and actuation of the actuator causes the actuator to rotate in the first direction, thereby causing the inner shaft assembly to wind up a portion of cable and retract the sheath.

Abstract: A variable zone high metal to vessel ratio stent includes a proximal high metal to vessel ratio zone, a central low metal to vessel ratio zone, and a distal high metal to vessel ratio zone. The proximal high metal to vessel ratio zone is deployed with fixation and sealing to healthy tissue of a main vessel superior to branch vessels and an aneurysm. The central low metal to vessel ratio zone is deployed directly on ostai of the branch vessels. However, as the central low metal to vessel ratio zone is highly permeable, blood flows from the main vessel through the central low metal to vessel ratio zone and into branch vessels.

Abstract: A reconfigurable delivery system is disclosed having a multi-lumen delivery catheter configuration that permits the delivery and staged release of a self-expanding main vessel stent-graft and a delivery sheath configuration that permits the introduction of various medical devices for the delivery and implantation of various branch vessel stent-grafts that are to be mated with the main vessel stent-graft. A method is disclosed wherein the delivery system is first used in the multi-lumen delivery catheter configuration to deliver and release a main vessel stent-graft that is configured for placement in the abdominal aorta for treatment of short-neck infrarenal, juxtarenal, and/or suprarenal aneurysms and then used in the delivery sheath configuration to facilitate the delivery of branch vessel stent-grafts that are configured to extend from the main vessel stent-graft into a respective renal artery.

Abstract: A suturing device includes a handle, an elongated body, at least one suture snag, at least one pair of needles, and at least one suture pair. The suture snag is moveable between a deployed position in which two distal arm portions thereof radially extend away from the elongated body and a retracted position in which the two distal arm portions are disposed within the elongated body. The suture pair is slidingly disposed through the needle pair. The suturing device deploys the suture snag within a vessel adjacent to an arteriotomy, extends the needle pair through a vessel wall around the arteriotomy and through the deployed suture snag, extends the suture pair beyond the distal ends of the needle pair, and then utilizes the suture snag to capture the extended suture pair by retracting the suture snag to pull first or distal ends of the sutures back into the suturing device.

Abstract: A suturing device includes a handle, an elongated body, at least one suture snag, at least one pair of needles, and at least one suture pair. The suture snag is moveable between a deployed position in which two distal arm portions thereof radially extend away from the elongated body and a retracted position in which the two distal arm portions are disposed within the elongated body. The suture pair is slidingly disposed through the needle pair. The suturing device deploys the suture snag within a vessel adjacent to an arteriotomy, extends the needle pair through a vessel wall around the arteriotomy and through the deployed suture snag, extends the suture pair beyond the distal ends of the needle pair, and then utilizes the suture snag to capture the extended suture pair by retracting the suture snag to pull first or distal ends of the sutures back into the suturing device. An inflatable balloon or an expandable suture capture component may be alternatives to the suture snag for capturing the suture ends.

Abstract: A suturing device includes a handle, an elongated body, at least one suture snag, at least one pair of needles, and at least one suture pair. The suture snag is moveable between a deployed position in which two distal arm portions thereof radially extend away from the elongated body and a retracted position in which the two distal arm portions are disposed within the elongated body. The suture pair is slidingly disposed through the needle pair. The suturing device deploys the suture snag within a vessel adjacent to an arteriotomy, extends the needle pair through a vessel wall around the arteriotomy and through the deployed suture snag, extends the suture pair beyond the distal ends of the needle pair, and then utilizes the suture snag to capture the extended suture pair by retracting the suture snag to pull first or distal ends of the sutures back into the suturing device. An inflatable balloon or an expandable suture capture component may be alternatives to the suture snag for capturing the suture ends.