Abstract: The present embodiments provide systems and methods suitable for delivering a therapeutic agent to a target site. In one example, the system comprises a container for holding the therapeutic agent, and a pressure source having pressurized fluid, wherein the pressure source is in selective fluid communication with at least a portion of the container. A catheter is placed in fluid communication with the container, and has a lumen sized for delivery of the therapeutic agent to a target site. A housing is configured to securely retain the container. The system further comprises a camera having a camera head coupled to the catheter, wherein the camera provides a visual image of the target site during delivery of the therapeutic agent.

Abstract: An aortic stent graft includes a stent with a framework attached to a fabric tube by a plurality of suture ties. The fabric tube includes a plurality of discrete attachment areas that are at least partially surrounded by at least one permeable graft area. The fabric tube is one of a weave and a knit of thermoplastic yarn. Each of the suture ties associated with the discrete attachment areas at least one of penetrates through and encircles a respective one of the discrete attachment areas. The weave or knit of the discrete attachment areas is identical to that of the permeable graft area with an exception that a wall thickness of each of the discrete attachment areas is flattened relative to, and thinner than, a wall thickness of the permeable graft area.

Abstract: A vascular intervention device delivery system, such as for implanting a self expanding stent, includes a thumbwheel rotatably mounted in a handle. A catheter has a proximal end attached to the handle and a distal carrier segment for mounting a stent thereon. A retractable sheath is movable to a position retracted proximally to uncover the distal carrier segment. A pull with a curved cross section extends between the thumbwheel and the retractable sheath. An idler wheel with a perimeter notch is rotatably mounted in the handle proximal to the thumbwheel. A pin is movably in the handle between a first position received in the perimeter notch to block rotation of the idler wheel, and a second position outside of the perimeter notch to permit rotation of the idler wheel. The pull wraps around the idler wheel to return in a direction for being wound onto a spool of the thumbwheel.

Abstract: A joining arrangement between a main tube (3) and a side arm (5) in a side arm stent graft (1). The side arm (5) is stitched into an aperture (11) in the main tube and is in fluid communication with it. The aperture is triangular, elliptical or rectangular and the side arm is cut off at an angle to leave an end portion having a circumferential length equal to the circumference of the aperture. The side arm can also include a connection socket (76) comprising a first resilient ring (79) around the arm at its end, a second resilient ring (80) spaced apart along the arm from the first ring and a zig zag resilient stent (82) between the first and second rings. The zig-zag resilient stent can be a compression stent. Both the main tube and the side arm are formed from seamless tubular biocompatible graft material.

Abstract: A temporary diameter reduction constraint arrangement for a stent graft in combination with a stent graft is disclosed. The stent graft has a proximal end and a distal end and comprises a biocompatible graft material tube and a plurality of longitudinally spaced apart self-expanding stents fastened thereto, including at least an end stent and a plurality of intermediate stents. The constraint arrangement comprises: an elongate receiver extending longitudinally within the graft material tube; a first wire extending longitudinally along the graft material tube in a first serpentine pattern; and a second wire extending longitudinally along the graft material tube in a second serpentine pattern, wherein at least one of the first and second wires repeatedly loops over the receiver along a longitudinal length of the stent graft thereby securing the stent graft to the receiver. In one embodiment there is also a plurality of loops of thread to reduce the stent graft.

Abstract: A method of modifying a surface of a medical device for implantation or disposition inside a patient is described. The medical device comprises a structure having at least one surface. The method includes the steps of: placing the medical device into a plasma chamber substantially free from contaminants and substantially sealing the plasma chamber from the atmosphere; removing at least an outermost layer of any oxide layer from the at least one surface of the structure by a plasma oxide-removal process, whilst maintaining the plasma chamber under seal from the atmosphere; and subsequently forming a new oxide layer at the least one surface of the structure by introducing at least one gas into the plasma chamber, whilst maintaining the plasma chamber under seal from the atmosphere. A medical device including a bulk material and an oxide layer disposed over at least one surface of the medical device. The oxide layer is substantially pure and free from contaminants.

Abstract: Disclosed herein is an assembly including a balloon catheter as an inner catheter for the delivery of a self-expanding stent. The delivery assembly may lack a separate pusher structure. A method of using a single assembly to delivery a self-expanding stent and provide a post-dilatation step is also described herein.

Abstract: A balloon catheter includes a balloon which is both of high strength and radiopaque. The balloon includes an outer strengthened layer which includes a strengthening element at least partially embedded within the layer. Concentrically within the strengthened layer there is a radiopaque layer which includes a high concentration of radiopaque material distributed in the radiopaque layer. The strengthened layer acts as a support to the radiopaque layer which is otherwise be unable to withstand the pressure to which the balloon is normally inflated for deployment and in the course of a medical procedure. The structure provides a high strength radiopaque balloon with a relatively thin balloon wall optimizing balloon flexibility and wrappability. There is also disclosed a method of making a balloon which uses an internal support layer in a raw tubing which is then removed following formation of a balloon.

Abstract: A method of improving the fatigue life of a superelastic medical device includes applying a compressive stress to a fatigue critical location of a medical device comprising a superelastic nickel-titanium alloy, where the compressive stress induces a compressive strain of greater than 9% in the fatigue critical location. After inducing the compressive strain, the compressive stress is released. A tensile stress is applied to the fatigue critical location of the medical device, where the tensile stress induces a tensile strain of greater than 9% in the fatigue critical location. After inducing the tensile strain, the tensile stress is released. After application and release of each of the compressive stress and the tensile stress, the fatigue critical location includes a non-zero amount of residual strain, and the medical device may exhibit improved fatigue properties.

Abstract: The endoluminal prosthesis assembly comprises a first stent graft having a first end and a second end and an interior lumen. The first stent graft has an expanded position and a compressed position and defines an access port disposed through a wall of the first stent graft between the first and second ends of the first stent graft. The endoluminal prosthesis assembly further comprises a second stent graft being disposed entirely within the interior lumen of the first stent graft. The second stent graft is disposed within the first stent graft and has an expanded position and a compressed position. In the compressed position, the second stent graft contacts only a portion of an interior wall of the first stent graft and the access port is in fluid communication with the interior lumen of the first stent graft.

Abstract: Disclosed herein is an endoscope system and a handle for a medical device that allows for rotation of the device when a locking member is disengaged by an operator, but does not allow for rotation when the locking member is engaged. Such a handle allows for an operator to maintain the position of an endoscope even when the operator removes his or her hand from the controls of the scope.

Abstract: A device for use with a uterine tamponade apparatus, such as the Bakri® postpartum hemorrhage balloon, is disclosed. The device comprises an anchor for deployment within the vagina to securely retain the balloon in its proper position within the uterine cavity, allowing the balloon to function as intended for the control and management of postpartum hemorrhage and uterine bleeding. Methods of use of the vaginal anchor are also disclosed.

Abstract: An endoluminal prosthesis system for being deployed in a patient's aorta near the heart includes a graft having a tubular body with a lumen extending from proximal end configured to be deployed near a patient's heart to a distal end configured to be deployed away from the patient's heart. A collar around the graft is sized and configured to be sutured to a patient's aorta. Passageways in the middle portion of the graft permit fluid communication from the lumen of the graft to an exterior of the graft. A respective bridging branch is disposed at each of the passageways, each of the bridging branches having an inner opening and an outer opening so that the bridging branches provide fluid communication from the lumen of the graft to the exterior of the graft. A respective bridging graft is sized and arranged to mate with each of the bridging branches.

Abstract: The present embodiments provide systems and medical formulations suitable for delivering therapeutic powders to a target site. In one embodiment, the system comprises a delivery device, a first powder being formed of particles of a first material, and a second powder being formed of particles of a second material, wherein the second material is different than the first material. At least some of the particles of the first powder and the second powder are bound together to form bonded particles. The bonded particles are simultaneously delivered to the target site by the delivery device. In one embodiment, a medical formulation may comprise carbomer present in a range between about 60-80% by weight of the formulation, bentonite present in a range of between about 5-15% by weight of the formulation, and calcium carbonate present in a range of between about 10-30% by weight of the formulation.

Abstract: A line pull assembly for a prosthetic delivery device includes a rail assembly defining a rail cavity, a longitudinal axis and a hand-gripable slider assembly. The slider is mounted to the rail assembly for sliding movement along it. The slider has a body slidably mounted to the rail assembly, the body having an inner body portion within the rail cavity. A line receiver for receiving a pullable line sits within the inner body portion. A release ring is mounted around the rail assembly and is operably connected to the inner body portion. The slider is locked against sliding movement until the release ring is moved the unlocked position. In the unlocked position, the inner body portion is slideably moveable by sliding movement of the release ring to transfer a pulling force through the line receiver.

Abstract: An implantable endoluminal prosthesis for replacing a damaged aortic valve is provided. In one embodiment, the prosthesis includes a balloon-expandable stent, a tubular conduit that extends into the ascending aorta, and a self-expanding stent. The tubular conduit extends across the balloon-expandable stent. The tubular conduit includes an artificial valve. The self-expanding stent extends across the tubular conduit into the ascending aorta. The balloon-expandable stent, the tubular conduit, and the self-expanding stent are coupled to provide unidirectional flow of fluid into the aorta and further into the coronary arteries. Also provided is a method for implanting the endoluminal prosthesis.

Abstract: A tubular graft may include a first woven layer, where the first woven layer forms a first side of the tubular graft; a second woven layer, where the second woven layer forms a second side of the tubular graft; and a tapered portion having an edge, where the edge connects the first woven layer and the second woven layer, where the tapered portion includes a first weft thread, a second weft thread, and a third weft thread, and where a floating portion of a first warp end extends from the first weft thread to the third weft thread such that the floating portion bypasses the second weft thread.

Abstract: In various embodiments, the present invention provides a functionalized thermoplastic polyurethane (TPU) containing bulk incorporated or surface-grafted quaternary ammonium compounds (QAC)s for contact-killing of a variety of microbes, where the QACs are on the surface of TPU to provide a sterile surface material that prevents bacteria commonly involved in device-associated infections (DAIs) from proliferating. The functionalized TPUs of the present invention can be formed into a wide variety of 3-dimensional shapes, such as catheters, medical tubing, laryngeal or tracheal stents, sutures, prosthetics, wound dressings, and/or a coating for medical devices and contains the residue of either a QAC containing diol monomer or an alkene functional diol monomer, which then allows the TPU to be functionalized with a QAC containing disulfide or free thiol compound, to form a quaternary ammonium functionalized thermoplastic polyurethane compound having antimicrobial properties for use in medical devices.

Abstract: A stent delivery system includes an elongate shaft including a proximal portion, a distal portion, at least one lumen extending at least partially therethrough, and a stent receiving portion on the distal portion of the elongate shaft. A stent is positioned on the stent receiving portion of the elongate shaft, the stent having a first configuration and a second configuration. A proximal constraining arrangement is engaged with a proximal end of the stent. A distal constraining arrangement is engaged with a distal end of the stent. A release wire is disposed through the elongate shaft and releasably engaged with portion of the proximal constraining arrangement and the distal constraining arrangement member. A handle assembly is operably connected to the proximal constraining arrangement and the distal constraining arrangement, the handle assembly comprising a brake assembly. The proximal arrangement and the distal arrangement are coupled to the brake of the handle.

Abstract: A stent delivery system includes an elongate shaft including a proximal portion, a distal portion, at least one lumen extending at least partially therethrough, and a stent receiving portion on the distal portion of the elongate shaft. A stent is positioned on the stent receiving portion of the elongate shaft, the stent having a first configuration and a second configuration. A sheath is positioned longitudinally around the inner elongate shaft, the elongate shaft extending coaxially at least partially within the lumen of the sheath is also included. A proximal constraining arrangement is engaged with a proximal end of the stent. A distal constraining arrangement is engaged with a distal end of the stent. A handle assembly comprising an axially moveable outer shuttle, a first inner shuttle operably connected to the proximal constraining arrangement and a second inner shuttle operably connected to the distal constraining arrangement and outer sheath.