Abstract: An implantable medical device (30) for treating aortic dissections includes a stent graft part (34) having a bulbous section (48) of greater radial diameter than the radial diameter of first and second sections (60,62) of the stent graft part (34). The bulbous section (48) is able to close off the false lumen (10) of an aortic dissection, thereby to prevent any fluid backflow into the false lumen (10). Radiopaque markers (70) may be provided for orientation and deployment purposes. The device (30) is able to treat chronic dissections and reduce false lumen backflow, which remains otherwise an unresolved issue in the endovascular treatment of false lumen aneurysms.

Abstract: The present disclosure relates to an endoluminal prosthesis, such as a stent graft that includes one or more fenestrations to accommodate endovascular disease, such as an aneurysm in cases where one or more side branches is involved. In one aspect, the prosthesis includes fenestrations that are pivotable to accommodate the dynamic geometry of the aortic branches. In another aspect, the pivotable fenestrations include a first perimeter, a band of flexible material attached and surrounding the first perimeter, a second perimeter attached to and surrounding the band of flexible material and a support frame disposed about a surface of the band of flexible material. The first perimeter, band of flexible material, and second perimeter have a geometric shape. The support frame includes a plurality of support units having curved segments. The curved segments of the support units may be concave with respect to an exterior surface of the prosthesis.

Abstract: A nickel-titanium-rare earth (Ni—Ti-RE) alloy comprises nickel at a concentration of from about 35 at. % to about 65 at. %, a rare earth element at a concentration of from about 1.5 at. % to about 15 at. %, boron at a concentration of up to about 0.1 at. %, with the balance of the alloy being titanium. In addition to enhanced radiopacity compared to binary Ni—Ti alloys and improved workability, the Ni—Ti-RE alloy preferably exhibits superelastic behavior. A method of processing a Ni—Ti-RE alloy includes providing a nickel-titanium-rare earth alloy comprising nickel at a concentration of from about 35 at. % to about 65 at. %, a rare earth element at a concentration of from about 1.5 at. % to about 15 at. %, the balance being titanium; heating the alloy in a homogenization temperature range below a critical temperature; and forming spheroids of a rare earth-rich second phase in the alloy while in the homogenization temperature range.

Abstract: The present disclosure relates to an introducer assembly. The introducer assembly includes an introducer sheath having a proximal end. A lumen is disposed longitudinally through the interior of the introducer sheath. A hub is attached about the proximal end of the sheath. The hub includes an opening disposed through its center. The opening is in fluid communication with the lumen of the sheath. A dilator clip is releasably attached to the hub of the introducer sheath. The dilator clip comprises a base having a proximal portion and a distal portion. Disposed on the distal portion of the dilator clip is a dilator. The dilator is coaxially positioned within the lumen of the introducer sheath while the dilator clip is attached to the hub.

Abstract: A system and a method for joining an upper and lower esophageal sacs in an infant are provided. The system includes a first elongate member having a first magnet, the first magnet including an end portion configured to abut an interior surface of the upper esophageal sac. The system also includes a second elongate member having a second magnet, the second magnet including an end portion configured to abut an interior surface of the lower esophageal sac. The system further includes a third elongate member having a third magnet and a spacer positioned distal to the third magnet. The third elongate member is positionable in the upper esophageal sac after the first elongate member has been removed. A magnetic force between the first magnet and the second magnet is configured to pull the first magnet and the second magnet towards each other to lengthen the upper and lower esophageal sacs.

Abstract: Described are devices, methods and systems for securing sutures external to the body. In certain aspects, a suture securement device includes a base paddle defining a slot and a suture aperture in communication with the slot, and a rotating paddle having an extension arm with a suture aperture. In such embodiments, the extension arm can rotate within the slot to frictionally crimp a suture, such that the suture is substantially prevented from moving with the apertures.

Abstract: An endovascular stent graft delivery device has portion to remain outside a patient in use and a proximal portion to be introduced into a patient. The proximal portion has a dilator at the proximal end and a length extending module is fastened to the dilator and extends proximally. The length extending module has a proximal end which in use extends out of the patient. The dilator has a dilator marker and the length extending module has a first and second marker at the distal and proximal ends of the length extending module. The first marker and the second marker are at the same relative circumferential position on the length extending module so that the rotational position of the elongate body within the patient can be determined.

Abstract: The present invention provides apparatus and methods for performing endoscopic mucosal resection and endoscopic submucosal dissection of tissue. In a first embodiment, a catheter having proximal and distal ends and a balloon disposed near the distal end of the catheter is provided. A portion of the distal end of the catheter is configured to be inserted beneath a section of mucosal tissue having a lesion, and the balloon is configured to be inflated to lift the mucosal tissue in an upward direction, thereby facilitating removal of the tissue comprising the lesion. Optionally, a surgeon may advance a needle knife through the catheter to further incise submucosal tissue while the balloon is in the inflated state. If to desired, a flushing fluid may be provided to a target site during the procedure.

Abstract: A fenestrated implantable medical device, such as a stent graft (10) is provided with a plurality of zigzag stents (12) of which two or more form fenestrations (34, 36) using part of the stents (12) as a support frame (30, 32) for the fenestrations (34, 36). The frames (30, 32) are preferably covered by radiopaque wire (44) coiled around the stent structures. The radiopaque coil (44) provides easy reference to the fenestrations (30, 32) for imaging purposes.

Abstract: A system and a method of positioning a wire guide are provided. The method includes inserting a wire guide in a first configuration into a lumen of a catheter, distally advancing the wire guide to a distal portion of the lumen so that a distal end of the wire guide is distal to an opening in a wall of the catheter and advancing a distal portion of the wire guide through the opening by distally advancing the distal portion relative to the catheter so that the distal end remains in the lumen as the distal portion of the wire guide extends out of the opening. The method includes advancing the distal portion of the wire guide further out of the opening so that the distal end exits through the opening so that the distal portion is distal to the distal end of the wire guide in a second configuration.

Abstract: An echogenic medical device includes a shaft having a proximal portion, a distal portion, first and second opposing longitudinal sides, and a passageway extending therethrough. The distal end includes a beveled opening communicating with the passageway, and extending between a distal tip portion disposed along the first longitudinal side and a heel portion disposed along the second longitudinal side. A first echogenic region extends circumferentially around the shaft at the distal portion. The first echogenic region is structured for providing a signal visible along the circumference of the shaft under ultrasound visualization. A second echogenic region extends along a length of the second longitudinal side and is substantially aligned with the heel portion. The second echogenic region is structured and arranged for providing a generally linear signal visible under ultrasound examination along the second longitudinal side, and substantially not visible along the first longitudinal side.

Abstract: Described are methods and systems for engaging sutures and anchors and the resulting suture and anchor sets. In certain aspects, an end of the suture may be heated to create a melted mass of suture material. The melted mass may act as a shoulder to resist backing out of a hole in the anchor through which the suture is threaded, thereby engaging the suture and the anchor. Adhesive material may optionally be used to enhance the engagement between the suture and anchor.

Abstract: An endoluminal prosthesis that includes a support structure comprising a curvilinear portion having a first strut and a second strut that meet at an apex. Disposed on the support structure is an anchor with an anchor body and one or more barbs extending outwardly from the anchor body and where the anchor body comprises a multi-filar tube fits at least partially about, and conforms to the first strut, second strut, and the apex.

Abstract: Methods and apparatuses of stents with likely reduced rates of tissue perforation are provided. Some embodiments include reducing the profile of a portion of the stent using a wire profile reduction electropolishing bath and/or other wire profile reduction means.

Abstract: An attachment system for tissue apposition or manipulation and a method of attaching a suture to a tissue for apposition or manipulation of the tissue are provided. The system includes an attachment device including a body having a proximal portion and a distal portion. The attachment device further includes a tissue attachment portion operably connected to the distal portion wherein the tissue attachment portion has a shape that is maintained throughout a tissue apposition procedure. The attachment device also includes a suture operably connected to the body and having an unconnected proximal end and a retaining structure at the proximal portion of the body. The retaining structure configured to releasably mate with a complementary retaining structure on a stylet.

Abstract: Methods and apparatuses for space-optimized visualization catheters are provided. Some embodiments utilize complimentary metal-oxide-semi-conductor (“CMOS”) technology integrated into a CMOS camera train holder system that may be a stand-alone component for use with a visualization catheter, such as a baby endoscope, or may be fabricated/extruded as a part of the catheter itself. Some embodiments of apparatuses, methods, and equivalents thereto provide better direct visual feedback to the medical personnel performing the procedure while providing a similarly-sized outer diameter visualization catheter device having an increased space therein for additional lumens and equipment or by reducing the overall outer diameter of the visualization catheter.

Abstract: Methods and apparatuses for space-optimized visualization catheters are provided. Some embodiments utilize complimentary metal-oxide-semi-conductor (“CMOS”) technology integrated into a CMOS camera train holder system that may be a stand-alone component for use with a visualization catheter, such as a baby endoscope, or may be fabricated/extruded as a part of the catheter itself. Some embodiments of apparatuses, methods, and equivalents thereto provide better direct visual feedback to the medical personnel performing the procedure while providing a similarly-sized outer diameter visualization catheter device having an increased space therein for additional lumens and equipment or by reducing the overall outer diameter of the visualization catheter.

Abstract: Methods and apparatuses for space-optimized visualization catheters are provided. Some embodiments utilize complimentary metal-oxide-semi-conductor (“CMOS”) technology integrated into a CMOS camera train holder system that may be a stand-alone component for use with a visualization catheter, such as a baby endoscope, or may be fabricated/extruded as a part of the catheter itself. Some embodiments of apparatuses, methods, and equivalents thereto provide better direct visual feedback to the medical personnel performing the procedure while providing a similarly-sized outer diameter visualization catheter device having an increased space therein for additional lumens and equipment or by reducing the overall outer diameter of the visualization catheter.

Abstract: Methods and apparatuses for space-optimized visualization catheters are provided. Some embodiments utilize complimentary metal-oxide-semi-conductor (“CMOS”) technology integrated into a CMOS camera train holder system that may be a stand-alone component for use with a visualization catheter, such as a baby endoscope, or may be fabricated/extruded as a part of the catheter itself. Some embodiments of apparatuses, methods, and equivalents thereto provide better direct visual feedback to the medical personnel performing the procedure while providing a similarly-sized outer diameter visualization catheter device having an increased space therein for additional lumens and equipment or by reducing the overall outer diameter of the visualization catheter.

Abstract: A prosthesis introducer system may include an introducer. A trigger wire release mechanism and a restraining member may be positioned near the distal end of the introducer. The system may include first and second trigger wires, each including a proximal portion releasably coupleable to a portion of a prosthesis and a distal portion coupled to the trigger wire release mechanism. The second trigger wire may be engaged by the restraining member. Each of the first and second trigger wires may include a taut portion. The second trigger wire may include a slack portion extending distally from the taut portion and positioned distal of the restraining member. Upon actuation of the trigger wire release mechanism, the first trigger wire may be releasable from the prosthesis and the second trigger wire may be releasable subsequent to the release of the first trigger wire.