Abstract: A steerable transseptal punch system and method of using the steerable transseptal punch system to access the left atrium.

Abstract: A steerable transseptal punch.

Abstract: A system and method for removing gas bubbles from blood during circulatory assist procedures. An active filter apparatus forces the bubbles to the center of the system where they are removed from the blood before the blood exits the filter.

Abstract: A device and method for achieving hemostasis and leakage control in vascular structures and other body ducts or vessels in an emergency room or trauma situation. The device has at least one shunt that contains an obturator on an end of the shunt. The shunt is inserted into a damaged vessel or lumen for sealing the leak or hemorrhage. Two shunts that both contain obturators on one of their ends can be inserted into two different vessels or lumens when the vessel or lumen has been severed. The obturators allow for the improved ease of insertion into the vessel or lumen. The two shunts are then releasably attached to restore fluid communication through the vessel or lumen. The shunt is placed temporarily within the patient and then removed when definitive repair can be achieved by a qualified physician.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of balloon counterpulsation catheters. The access route is through the femoral arteries and the iliac arteries into the aorta, where an intra-aortic balloon pump catheter is positioned to provide cardiac support. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device.

Abstract: A steerable guidewire. The steerable guidewire is fabricated includes an outer tube, an inner tube, a hub, and a distal articulating region. The steerable guidewire hub can be removed to permit advancement of catheters over its proximal end followed by re-attachment of the hub to permit deflection of the distal end of the steerable guidewire.

Abstract: Devices and methods are disclosed for achieving control and stabilization of bone fractures in mammals, most specifically humans. Stabilization and traction is often required to support fractured bones of the arms or legs. The devices and methods disclosed herein are especially useful in the emergency or military setting. The devices utilize a collapsible, inflatable member that is expanded and locked into position. The frame or inflatable member is fabricated primarily from polymeric materials with low radiodensity. The limb contact regions are adjustable to fit a wide variety of limb sizes and fracture locations. The traction applied by the splint is adjustable, controllable and measurable. The traction splint is compact and will fit in a compartment of most emergency rescue vehicles, thus making it more available for use than standard traction splints used today. The traction splint is either a separate device or integrated into a backboard.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The distal end of the sheath is maintained in the first, low cross-sectional configuration and expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as ureteroscopy or stone removal.

Abstract: Devices and methods are disclosed for achieving hemostasis in traumatized patients. Such haemostatic packing devices and methods are especially useful in the emergency, trauma surgery or military setting. The patient may have received trauma to abdominal viscera, the thoracic cavity or the periphery. The devices utilize fluid impermeable outer surfaces and distributed pressure to achieve tamponade and hemostasis, primarily by exertion of pressure. The devices come in a variety of configurations including sheet, rolled sheet, folded sheet and polygonal solids including extruded shapes. The devices are capable of serving as carriers for thrombogenic or anti-pathogenic agents. The devices are flexible, bendable, and conformable in their wet or dry state so that they exert distributed pressure on the wound. The hemostatic packing devices may be placed and removed by open surgery or laparoscopic access without generating excessive re-bleeding, and may further comprise antimicrobial or thrombogenic regions.

Abstract: A parent artery occlusion (PAO) device which provides for immediate occlusion of a cerebral artery to isolate a defect. The PAO device includes a self-expanding wire-frame prolate structure which is partially covered with an ePTFE membrane.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, collapsed cross-sectional configuration, subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration, and subsequent removal in a third, collapsed cross-sectional configuration. The sheath is configured for use in the vascular system and has utility in the introduction and removal of implant delivery catheters. The access route is through the femoral arteries and the iliac arteries into the aorta. The distal end of the sheath is maintained in the first, collapsed cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is then expanded using a radial dilatation device, which is removed prior to the introduction of implant delivery catheters. The distal end of the sheath is subsequently reduced to a diametrically small size for removal.

Abstract: A coring tool for creating a hole in a body vessel or hollow organ. The coring tool includes an expandable anvil against which the cutter can be advanced following passage of the collapsed anvil through the tissue to be excised and subsequent expansion of the anvil.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system. The access route is through the inferior vena cava to the right atrium, where a trans-septal puncture, followed by advancement of the catheter is completed. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement through the atrial septum into the left atrium. The distal end of the sheath is expanded using a radial dilator. In one application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as electrophysiological mapping of the heart, radio-frequency ablation of left atrial tissue, placement of atrial implants, valve repair, or the like.

Abstract: A parent artery occlusion (PAO) device which provides for immediate occlusion of a cerebral artery to isolate a defect. The PAO device includes a self-expanding wire-frame prolate structure which is partially covered with an ePTFE membrane.

Abstract: A prosthetic implant for treating a diseased aortic valve is described. The prosthetic implant includes a substantially tubular body configured to be positioned in an aorta of a patient, at or near the patient's aortic valve. The body includes a lumen extending through the body; and an adjustable frame surrounding the lumen. The prosthetic implant further includes at least one adjustable element located in or on the body and extending at least partially around a circumference of the lumen. The at least one adjustable element is transformable, in response to application of an activation energy, from a first configuration to a second configuration. The at least one adjustable element may engage at least one of a root of the aorta, an annulus of the aortic valve, and the patient's left ventricle, when the at least one adjustable element is in the second configuration.

Abstract: A system and method for removing gas bubbles from blood during circulatory assist procedures. An active filter apparatus forces the bubbles to the center of the system where they are removed from the blood before the blood exits the filter.

Abstract: A device for protecting cerebral vessels or brain tissue during treatment of a carotid vessel includes a catheter having a distal portion, a proximal portion and a lumen extending therebetween, the catheter including first and second expandable areas provided over the length of the catheter. The device includes a first elongate member insertable longitudinally through the lumen of the catheter, the first elongate member being configured for stretching at least a portion of the catheter and causing one of the first and second expandable areas to transition from an expanded state to a collapsed state. The device further includes a second elongate member insertable longitudinally through the lumen of the catheter, the second elongate member being configured for stretching at least a portion of the catheter and causing the other of the first and second expandable areas to transition from an expanded state to a collapsed state.

Abstract: A steerable transseptal punch.

Abstract: Surgical bolts are useful for solid visceral wound hemostasis. The devices utilize flexible, variable depth transfixing bolts that penetrate the viscera. These bolts bring the tissue into apposition and hold said tissue in apposition while the wound heals. These bolts, or soft tissue rivets, overcome the limitations of sutures that are currently used for the same purposes. The devices are flexible, bendable, and conformable in their wet or dry state. The bolts include pressure plates that are capable of exerting compressive pressure over broad areas of visceral wounds without causing tearing of the friable parenchyma. The bolts are placed and removed by open surgery or laparoscopic access. The bolts can be placed into tissue where both sides of the bolt are exposed, or they can be placed blindly into tissue where the bolt does not protrude out of the tissue at its distal end.

Abstract: A device and method for achieving hemostasis and leakage control in vascular structures and other body ducts or vessels in an emergency room or trauma situation. The device has at least one shunt that contains an obturator on an end of the shunt. The shunt is inserted into a damaged vessel or lumen for sealing the leak or hemorrhage. Two shunts that both contain obturators on one of their ends can be inserted into two different vessels or lumens when the vessel or lumen has been severed. The obturators allow for the improved ease of insertion into the vessel or lumen. The two shunts are then releasably attached to restore fluid communication through the vessel or lumen. The shunt is placed temporarily within the patient and then removed when definitive repair can be achieved by a qualified physician.