Abstract: A vascular closure device comprising a retrievable sheath-delivered contractible, clip device with structural radial or terminal members with terminal and non-terminal hooks that engage the vessel wall. Unlike other vascular closure clips, this device is delivered on the outside rather than the inside of sheath. Closure of the tissue opening can be effected by the feet of the clip engaging the puncture, aperture, or wound edges and memory characteristics of the device cause a contraction of the members, bringing the members into apposition and the wound edges together, permitting immediate vascular closure and healing of the blood vessel. The device can be delivered and recovered by an intravascular sheath.

Abstract: A generally U-shaped surgical staple comprises a base 10 and a pair of generally “L”-shaped legs 12 extending substantially perpendicularly from opposite ends of the base respectively. The legs 12 in use of the staple are bent through approximately 90° relative to the base. To effect a greater compression of the stapled tissue the legs include a penetrative portion 16 adjacent the tip and a compressive structure 30 which, due to its increased height relative to that of the penetrative portion, spreads the compressive forces of the staple further along the length of the incision being closed. The compressive portion also provides a depth stop to avoid the tip penetrating too deeply into the tissue in which it is deployed.

Abstract: A method of preparing a stable chitosan hemostatic implant including preparing a lyophilizable solution of chitosan polymers and freezing the solution to obtain a frozen chitosan composition. The method further includes placing the frozen chitosan composition under vacuum so as to substantially dry the chitosan composition and curing the dried chitosan composition by first exposing it to a relative humidity and then curing the dried chitosan composition under heat so as to crosslink the chitosan polymers.

Abstract: A scaffold is provided for managing access through tissue. The scaffold can support the tissue during medical procedures. The scaffold is placed around or proximate an opening in tissue. The scaffold can expand when medical devices are introduced through the scaffold and through the opening and retract when the medical devices are removed. When the medical devices are removed, the scaffold closes automatically to substantially close the opening.

Abstract: Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

Abstract: A device for closing an opening in a wall of a body lumen includes a closure element with a first flange and a second flange. Both the first flange and the second flange may have a delivery cross-sectional dimension and a deployed cross-sectional dimension. The device for closing an opening further includes a first coupler element disposed on the first flange and a second coupler element disposed on the second flange, the first and second coupler elements cooperating to couple the first flange to the second flange.

Abstract: An introducer sheath and methods of making the introducer sheath are described. The introducer sheath may include a hub portion and a tubular portion. The hub portion may include a substantially non-planar valve portion in a relaxed state. The valve portion may include an aperture configured to receive a medical device. A hub portion may be formed using a forming device. An aperture may be formed through a distal surface of the valve portion.

Abstract: Methods and devices for closing a puncture wound in a liquid carrying vessel are provided. In one exemplary embodiment, a surgical stapler is provided having a locator tube with an inflatable member formed thereon and adapted to be positioned within a liquid carrying vessel adjacent a puncture wound, and a staple applying apparatus that is slidably disposed on a portion of the locator tube and that is adapted to apply a surgical staple to seal a puncture wound in a liquid carrying vessel.

Abstract: The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

Abstract: A device for closing an opening in a wall of a body lumen includes a closure element with a first flange and a second flange. Both the first flange and the second flange may have a delivery cross-sectional dimension and a deployed cross-sectional dimension. The device for closing an opening further includes a first coupler element disposed on the first flange and a second coupler element disposed on the second flange, the first and second coupler elements cooperating to couple the first flange to the second flange.

Abstract: A clip for closing a puncture in a body lumen comprises a clip having a resiliently expandable circumference and a plurality of barbed prongs extending at least approximately in the same direction from one edge of the clip. A device for deploying such a clip is described. A method for deploying such a clip is also described.

Abstract: An introducer sheath and methods of making the introducer sheath are described. The introducer sheath may include a hub portion and a tubular portion. The hub portion may include a substantially non-planar valve portion in a relaxed state. The valve portion may include an aperture configured to receive a medical device. A hub portion may be formed using a forming device. An aperture may be formed through a distal surface of the valve portion. A valve portion may be formed in a cap defining a cavity sized to elastically receive a proximal end of the hub portion.

Abstract: An introducer sheath and methods of making the introducer sheath are described. The introducer sheath may include a hub portion and a tubular portion. The hub portion may include a substantially non-planar valve portion in a relaxed state. The valve portion may include an aperture configured to receive a medical device. A hub portion may be formed using a forming device. An aperture may be formed through a distal surface of the valve portion.

Abstract: Devices, systems, methods and kits are provided for endoscopically accessing a body cavity and providing a directed pathway toward a target tissue within the cavity. The directed pathway is provided by a multi-catheter guiding system which is positioned in a desired configuration, generally directed toward the target tissue. Interventional devices may then be passed through the guiding system to the target tissue. Depending on the location of the target tissue and the desired angle of approach, the guiding system may be required to maintain one or more curves in one or more planes to properly direct the interventional devices. The multi-catheter guiding system of the present invention comprises an outer guiding catheter and a coaxially positioned inner guiding catheter, each of which independently form curvatures so that together the curves properly direct the interventional device.

Abstract: A device for closing an opening in a wall of a body lumen includes a closure element with a first flange and a second flange. Both the first flange and the second flange may have a delivery cross-sectional dimension and a deployed cross-sectional dimension. The device for closing an opening further includes a first coupler element disposed on the first flange and a second coupler element disposed on the second flange, the first and second coupler elements cooperating to couple the first flange to the second flange.

Abstract: An introducer sheath and methods of making the introducer sheath are described. The introducer sheath may include a hub portion and a tubular portion. The hub portion may include a substantially non-planar valve portion in a relaxed state. The valve portion may include an aperture configured to receive a medical device. A hub portion may be formed using a forming device. An aperture may be formed through a distal surface of the valve portion. A valve portion may be formed in a cap defining a cavity sized to elastically receive a proximal end of the hub portion.

Abstract: A clip for closing a puncture in a body lumen comprises a clip having a resiliently expandable circumference and a plurality of barbed prongs extending at least approximately in the same direction from one edge of the clip. A device for deploying such a clip is described. A method for deploying such a clip is also described.

Abstract: A clip for closing a puncture hole in a blood vessel comprises a ring having a resiliently expandable circumference and a plurality of barbed prongs extending at least approximately in the same direction from one edge of the ring. A device for deploying such a clip is also described.

Abstract: Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

Abstract: Implantable hemostatic products with improved stability are prepared from crosslinked chitosan hemostatic compositions. The crosslinked chitosan hemostatic compositions have improved stability and can be prepared into a variety of implantable medical devices in various shapes and sizes so as to be usable for inhibiting blood flow and ooze from substantially any type of internal bleeding site. For example, the chitosan compositions can be prepared into hemostatic gauze pads, bandages, dressings, wound plugs, incision plugs, arteriotomy plugs, tissue fillers, sealers, sheets, rolls, combinations thereof, and the like.