Abstract: Devices and methods for accessing the pericardial space of a heart are described here. Access devices may generally comprise a tissue-engaging member, a tissue-piercing member, and a guide element. The access device may be introduced to the surface of a pericardium, where the tissue-engaging member may be deployed to engage a portion of the pericardium without engaging the epicardial surface of the heart. Once the access device has engaged the pericardium, the device may manipulate the pericardium to increase the distance between a portion of the pericardium and the epicardial surface of the heart. Once a sufficient space has been created, the tissue-piercing member may be advanced to pierce the pericardium and enter the pericardial space. The guide element may then be introduced into the pericardial space to provide an access pathway to the heart for other devices.

Abstract: An endovascular graft of the present invention embodies a graft system utilizing the textile fabric of the prosthesis for drug storage and delivery. These drug-eluting devices involve treating the textile fabric with therapeutic agents to provide a method of delivery to both the outer surface of the graft and the inner surface of the graft. An endovascular graft system having a fuzz texturing on the outer periphery of the graft where the texturing includes a therapeutic agent coating applied to the texturing material is also contemplated. An expandable attachment frame further includes drug storage and delivery capabilities in the cavities formed in the V-hooks and apices. Therapeutic agents can also included in the radiopaque coating or loading to serve as a reservoir for controlled drug delivery.

Abstract: Described here are systems and methods for affecting tissue within a body to form a lesion. Some systems comprise tissue-affecting devices, devices that guide the advancement of the tissue-affecting elements to a target tissue region, devices that locate and secure tissue, and devices that help position the tissue-affecting devices along the target tissue. The methods described here comprise advancing a first tissue-affecting device to a first surface of a target tissue, advancing a second tissue-affecting device to a second surface of the target tissue, and positioning the first and second devices so that a lesion may be formed in the tissue between them. In some variations, the devices, systems, and methods described here are used to treat atrial fibrillation by ablating fibrillating tissue from an endocardial surface and an epicardial surface of a heart. Methods of closing, occluding, and/or removing the left atrial appendage are also described.

Abstract: A surgical apparatus and methods for severing and welding tissue, in particular blood vessels. The apparatus includes an elongated shaft having a pair of relatively movable jaws at a distal end thereof. A first heating element on one of the jaws is adapted to heat up to a first temperature and form a welded region within the tissue, while a second heating element on one of the jaws is adapted to heat up to a second temperature and sever the tissue within the welded region. The first and second heating elements may be provided on the same or opposite jaws. A control handle provided on the proximal end of the elongated shaft includes controls for opening and closing the jaws, and may include an actuator for sending current through the first and second heating elements. The first and second heating elements may be electrically connected in series, and the first heating element may be bifurcated such that it conducts about one half of the current as the second heating element.

Abstract: A system for gaining access to an interventional site within vasculature through a vessel wall or other structure such as that of a medical device. An apparatus is provided to accomplish a sealed worksite as are sensor delivery systems including sealable sensor devices that are adapted to be placed at the interventional site.

Abstract: Described here are devices for closing one or more tissues, and handles for controlling these devices. Generally, the devices described here comprise a snare loop assembly, wherein the snare loop assembly comprises a snare and a suture loop, and a handle for controlling the snare loop assembly. In some variations the snare loop assembly may comprise a retention member that may releasably connect the suture loop to the snare. In other variations the devices comprise one or more force-reducing suture locks to help prevent the suture loop from inadvertently disengaging from the snare loop assembly. In still other variations, the excess-suture management features. The handles described here may be configured to remove excess suture from a suture loop, and may also be configured to release the suture loop from the snare loop assembly.

Abstract: A system for gaining access to an interventional site within vasculature through a vessel wall or other structure such as that of a medical device. An apparatus is provided to accomplish a sealed worksite as are sensor delivery systems including sealable sensor devices that are adapted to be placed at the interventional site.

Abstract: A surgical apparatus and methods for severing and welding tissue, in particular blood vessels, include a pair of relatively movable jaws at a distal end of an elongated shaft. A first heating element on one of the jaws is adapted to heat up to a first temperature and form a welded region within the tissue, while a second heating element on one of the jaws is adapted to heat up to a second temperature and sever the tissue within the welded region. A force-limiting mechanism is provided to limit the pressure applied to the tissue by the jaws to ensure that the tissue is severed and the ends effectively welded within a short amount of time.

Abstract: The present invention embodies an endovascular graft having an attachment frame connection mechanism that allows placement of the main body component in vasculature in combination with limb components. Various limb component-to-main body component attachment mechanisms are provided which ensure a reliable bond while facilitating a smaller delivery profile.

Abstract: An endovascular graft having an improved positioning mechanism capable of positioning and securing a bifurcated graft into a bifurcated vessel described. The graft can include a sleeve affixed to graft that is used in combination with a contralateral wire loop for placement of the graft within vasculature. The graft may include a structure for post deployment positioning into the bifurcated aneurysm area. Furthermore, the endovascular graft may be configured to form a sealing pocket that expands with induced fluid pressure and prevents fluid leaks at an attachment site.

Abstract: The present invention embodies delivery systems and methods of repairing vasculature. Various embodiments of bifurcated grafts and limb components can be delivered by delivery systems that provide enhanced control of self-expanding structure of a modular grafting system.

Abstract: Delivery systems and methods for delivering modular endovascular graft devices that allow one portion of the repair device to be deployed while maintaining control of the other portions. One system includes an elongate inner member including an anchor stop ring, the anchor stop ring including a plurality of recesses, each sized to receive a portion of the trunk portion and embedding portion of a respective hook in the delivery configuration, each embedding portion extending radially outwardly at an acute angle relative to the trunk portion in the delivery configuration. The delivery systems are simpler to use, easier to manufacture and facilitate better packing of the repair device.

Abstract: A graft provided with a flexible sealing member to substantially prevent blood from leaking between the graft a lumen into which the graft is placed. In one embodiment, the flexible sealing member may be pressed against the vascular wall by an outwardly biased spring means attached to the sealing member. In other embodiments, the sealing member may be self-positioning upon deployment of the graft. The sealing member also may be formed into the shape of a toroid, which may be filled with thrombogenic material causing blood permeating into the toroid-shaped space to coagulate therein and hold the sealing member in place. It is also contemplated that the sealing member be formed from tufts of frayed yarn protruding circumferentially from the outer surface of the graft. A method of manufacturing such tufted yarn sealing members is also disclosed.

Abstract: A graft provided with a flexible sealing member to substantially prevent blood from leaking between the graft a lumen into which the graft is placed. In one embodiment, the flexible sealing member may be pressed against the vascular wall by an outwardly biased spring means attached to the sealing member. In other embodiments, the sealing member may be self-positioning upon deployment of the graft. The sealing member also may be formed into the shape of a toroid, which may be filled with thrombogenic material causing blood permeating into the toroid-shaped space to coagulate therein and hold the sealing member in place. It is also contemplated that the sealing member be formed from tufts of frayed yarn protruding circumferentially from the outer surface of the graft. A method of manufacturing such tufted yarn sealing members is also disclosed.

Abstract: The present invention embodies an endovascular graft having an attachment frame connection mechanism that allows placement of the main body component in vasculature in combination with limb components. Various limb component-to-main body component attachment mechanisms are provided which ensure a reliable bond while facilitating a smaller delivery profile.

Abstract: The present invention embodies delivery systems and methods for delivering modular endovascular graft devices that allow one portion of the repair device to be deployed while maintaining control of the other portions. The delivery systems are simpler to use, easier to manufacture and facilitate better packing of the repair device.

Abstract: An endovascular graft having an improved positioning mechanism capable of positioning and securing a bifurcated graft into a bifurcated vessel described. The graft can include a sleeve affixed to graft that is used in combination with a contralateral wire loop for placement of the graft within vasculature. The graft may include a structure for post deployment positioning into the bifurcated aneurysm area. Furthermore, the endovascular graft may be configured to form a sealing pocket that expands with induced fluid pressure and prevents fluid leaks at an attachment site.

Abstract: An improved reduced diameter intraluminal grafting system capable of deploying a bifurcated graft into a bifurcated vessel is described. The system having a pliable jacket guard configured to ensure atraumatic delivery and deployment of the bifurcated graft. The bifurcated graft is comprised of a main tubular member and two tubular legs with attachment systems configured into each of the three ends of the graft. The bifurcated graft along with the mechanisms required to position and attach the bifurcated graft fit within a single delivery catheter for intraluminal delivery. The bifurcated graft, positioning mechanisms and attaching mechanisms are configured such that a small diameter delivery catheter can be utilized. The methods of positioning and attaching the bifurcated graft are also described.

Abstract: The present invention embodies delivery systems and methods for delivering modular endovascular graft devices that allow one portion of the repair device to be deployed while maintaining control of the other portions. The delivery systems are simpler to use, easier to manufacture and facilitate better packing of the repair device.

Abstract: Protector elements for use in combination with medical devices configured to repair vasculature or other body lumens. In one aspect, the protector elements embody a cuff which provides a medical device with atraumatic surface and a desirable profile. In another aspect, the protector elements provide a medical device with enhanced structural integrity.