Abstract: A prosthetic graft assembly (40, 120) is disclosed for placement of a patient's aortic arch and repair of the descending aorta in a procedure which requires only a sternotomy. The assembly includes a descending graft element (40) which includes an eversible cuff (52) which can be wrapped over a cut end (26) of the descending aorta (18). Distal perfusion can be re-established prior to aortic arch replacement. A second prosthetic element (120), optimised to the patient, is fitted with a replacement for the aortic arch and attached to the descending aorta graft (40). An introducer assembly (30) having a transparent or translucent sheath (70) enables the descending aortic graft element (40) to be deployed without the use of x-rays.

Abstract: The disclosure relates to cannulae, delivery systems, methods of making cannulae, and methods of making delivery systems. A delivery system comprises an elongate outer tubular member defining an outer tubular member lumen, a cannula having a circumferential wall extending between a proximal end and a distal end and defining an interior lumen, and an intraluminal medical device disposed within the outer tubular member lumen distal to the cannula and not about the cannula. A pattern of openings arranged in an interrupted spiral extends circumferentially along the cannula.

Abstract: The present embodiments provide systems and methods for improved retention of stents on a delivery system. In one embodiment, a delivery system comprises a catheter and a balloon. A proximal end of the balloon is secured to an exterior surface of the catheter at a first location, and a distal end of the balloon is secured to the exterior surface of the catheter at a second location. A plurality of bands are disposed in a circumferential space situated between the exterior surface of the catheter and an interior surface of the balloon. The plurality of bands may comprise at least four bands that are discretely spaced-apart in an axial direction from one another along a length of the catheter. At least one stent is secured to the exterior surface of the balloon in a compressed delivery state.

Abstract: A modular handle assembly comprises a stationary main handle having proximal and distal ends. A first handle extends proximally from the main handle and is rotationally moveable relative to the main handle, the first handle having proximal and distal ends, wherein a rotational interface is located at the distal end. A second handle extends distally from the main handle and is rotationally moveable relative to the main handle, the second handle having proximal and distal ends, wherein a rotational interface is located at the proximal end. The proximal end of the main handle comprises a first rotational interface that is configured to engage with a rotational interface at the distal end of the first handle and wherein the distal end of the main handle comprises a second rotational interface that is configured to engage with the rotational interface at the proximal end of the second handle.

Abstract: A branched and fenestrated prosthesis may include a main tubular graft body including a proximal end opening, a distal end opening, a lumen, and a sidewall. A branch may extend from the sidewall and may include a first end opening, a second end opening, and a lumen. A fenestration may be disposed in the sidewall and positioned distal of the second end opening of the branch. The branched and fenestrated prosthesis may include a plurality of branches and a plurality of fenestrations.

Abstract: There is disclosed, among other things, embodiments of a biopsy needle for taking a full core sample through soft tissue. In the illustrated embodiments, the needle includes a single monolithic tubular member having a notch cut part-way through a distal portion of the tubular member to form an arch-shaped finger. At least a portion of the finger is bent toward the notch and into the lumen of the tubular member. Methods for using these embodiments are also described.

Abstract: A method of treating a lesion in a gastrointestinal tract and an injectate system are provided. The method includes injecting a crosslinkable gel into a first tissue layer, the crosslinkable gel increasing a volume of the first tissue layer. The method also includes providing a crosslinker and resecting a portion of a first tissue layer having the increased volume away from a second tissue layer creating an exposed region in a remaining portion of the first layer and leaving a portion of the gel covering at least a portion of the exposed region. The injectate system includes a crosslinkable gel and a crosslinker where the crosslinkable gel and the crosslinker form a crosslinked gel having a compressive modulus of about 10-500 kPa.

Abstract: The present embodiments provide a medical device for implantation in a patient comprising a stent and a valve. The stent comprises a proximal region comprising a cylindrical shape having a first outer diameter in an expanded state, and a distal region comprising a cylindrical shape having a second outer diameter in the expanded state. The second outer diameter is greater than the first outer diameter. A proximal region of the valve is at least partially positioned within the proximal region of the stent, and the distal region of the valve is at least partially positioned within one of tapered and distal regions of the stent. When implanted, the proximal region of the stent and the proximal region of the valve are aligned with a native valve, and the distal region of the valve is distally spaced-apart from the native valve.

Abstract: An introducer assembly includes a catheter having a proximal end, a distal end extending to a distal tip of the introducer assembly, and an outer catheter wall. The catheter includes a medical device holding portion proximate the distal end, a guide wire lumen extending between the proximal and distal ends, and a side opening extending through the outer wall to the guide wire lumen. The side opening and the guide wire lumen are simultaneously open and the guide wire lumen and side opening are able to receive a guide wire therethrough. The catheter is flexible at least in the location of the side opening. The catheter also includes a plurality of one stiffening mandrel lumens extending from the proximal end and a plurality of stiffening mandrels.

Abstract: A device for use with a uterine tamponade balloon catheter apparatus, such as the Bakri postpartum hemorrhage balloon, is disclosed. The device comprises a stylet comprising a hub at its proximal end and an atraumatic tip at its distal end. The device is configured to be removably coupled to the tamponade balloon catheter apparatus to aid in the insertion and positioning of the tamponade balloon catheter within the uterine cavity, allowing the balloon to function as intended for the control and management of postpartum hemorrhage and uterine bleeding. The tamponade balloon catheter includes an echogenic element to aid in visualization by ultrasound during insertion and use. Methods of use of the device are also disclosed.

Abstract: An inflation device includes a balloon and a shaft coupled to one another via an overmold that includes a shut-off ridge. The shaft is in pressure communication with the balloon. Therefore, when fluid pressure is increased in the shaft the balloon may inflate. The use of shut-offs to form the overmold including shaping the shut-off ridge should result in an overmold with no flash and few or no bubbles within its structure.

Abstract: Medical systems, devices and methods are provided for engaging tissue, e.g. for clipping tissue, closing a perforation or performing hemostasis. Generally, the medical system including a housing, first and second jaws rotatable relative to the housing, a driver, and an elongate drive wire. The elongate drive wire may be disconnected from the driver, first and second jaws, and the housing, which are left in vivo engaged with the tissue.

Abstract: Medical devices that include a trigger assembly for a rotatable catheter and methods of use are described. An example medical device includes a housing, a catheter, a drive assembly, and a trigger assembly. The trigger assembly is partially disposed within the housing and includes a trigger, a drive initiator, a drive member, a flip drive, and a biasing member. The trigger is moveable between a first position and a second position relative to the housing. The flip drive is moveable between a neutral position, a first drive position, and a second drive position. The drive assembly moves relative to the housing when the flip drive is in the first drive position and the trigger is moved from its first position to its second position.

Abstract: A loading dilator may include a first portion and a second portion. The first portion may include a first proximal end, a first distal end, and a first outer surface extending between the first proximal end and the first distal end. The second portion may include a second proximal end, a second distal end, and a second outer surface extending between the second proximal end and the second distal end. The first outer surface may include a plurality of slits extending along at least a portion of the length of the first portion. The plurality of slits may be spaced apart circumferentially around a longitudinal axis of the first portion. The length of the second portion may be smaller than the length of the first portion.

Abstract: Described are a multipurpose handles that can be incorporated into medical device delivery systems. Also described are medical devices, including medical snare devices, that can incorporate the handles or features thereof. An actuation button of the multipurpose handle can be moved longitudinally to move a device portion (e.g. snare loop) longitudinally, e.g. for deployment or retraction. The actuation button can also be rotated to rotate a device portion (e.g. snare loop). Sealing arrangements can be provided and can provide sealing functions in respect of a controlled medical device structure while the actuation button is moved longitudinally or rotated. Methods of using the handles and medical snare or other devices incorporating them are also described.

Abstract: A stent for use in a medical procedure having opposing sets of curved apices, where the curved section of one set of apices has a radius of curvature that is greater than the curved section of the other set of apices. One or more such stents may be attached to a graft material for use in endovascular treatment of, for example, aneurysm, thoracic dissection, or other body vessel condition.

Abstract: A system suitable for delivering a therapeutic agent to a target site may include a container for holding a therapeutic agent, a pressure source having pressurized fluid, where the pressure source is in selective fluid communication with at least a portion of the container, a catheter in selective fluid communication with the container and configured for delivery of the therapeutic agent to a target site, a first valve connected between the container and the catheter, a second valve connected between the pressure source and the container, a button configured to selectively actuate the second valve, and a brake assembly coupled to the first valve and configured to selectively permit actuation of the second valve, such that when the first valve is in a first state, the brake assembly blocks the button such that the button does not actuate the second valve.

Abstract: The present embodiments provide a medical device for implantation in a patient comprising a stent and a valve. The stent comprises a proximal region comprising a cylindrical shape having a first outer diameter in an expanded state, and a distal region comprising a cylindrical shape having a second outer diameter in the expanded state. The second outer diameter is greater than the first outer diameter. A proximal region of the valve is at least partially positioned within the proximal region of the stent, and the distal region of the valve is at least partially positioned within one of tapered and distal regions of the stent. When implanted, the proximal region of the stent and the proximal region of the valve are aligned with a native valve, and the distal region of the valve is distally spaced-apart from the native valve.

Abstract: A stent comprises a framework that includes a sequence of cells that each occupy a discrete segment of the stent length, and each of the cells includes a plurality of struts with ends connected at respective vertices. In some forms the hollow cylindrical shape of the framework is moveable among a loading diameter that is smaller than a tube diameter, which is smaller than an expanded diameter, and every strut of the framework is oriented parallel to the stent axis when the hollow cylindrical shape is at the tube diameter. In other forms the framework includes T-bars that connect adjacent cells, where the T-bars have a column that has a minimum width perpendicular to the long axis that is wider than a maximum width of each of the struts, and the column defines at least one slot. In still other forms, the framework exhibits geometries that facilitate a high packing density for the framework when the stent is in a compressed tube or loading configuration.

Abstract: A stent graft having an internal bidirectional branch formed from a tubular segment of graft material. The internal bidirectional branch extends within the lumen of the stent graft and proximally and distally from a lateral opening in the sidewall of the stent graft. The tubular segment from which the stent graft is made is partitioned into first and second sections along a length of the tubular segment to form the internal bidirectional branch. The lateral opening has a length and a width that may be greater than the diameter of the internal bidirectional branch and may be in the shape of a quadrilateral. The internal bidirectional branch and the stent graft are formed from a single piece of graft material.