Abstract: A system is disclosed for removing gas bubbles from blood during circulatory assist procedures. Such bubbles are generated, along with particulate matter, in an extracorporeal circulatory bypass system by the pump, oxygenator and other components. Current filters are inefficient at removing small bubbles that can cause neurological defects and renal and other organ failures in the patient. An active filter apparatus and method is disclosed that forces the bubbles to the center of the system where they are removed from the blood before the blood exits the filter. The filter comprises an axially elongate cylindrical shell with a blood inlet, a blood outlet and a gas outlet. A motor driven impeller spins the blood within the shell and forces the gas toward the center by centripetal force, utilizing the buoyancy effects of the bubbles in blood, whereby the bubbles can be bled off at the center of 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: Devices and methods for achieving hemostasis and leakage control in hollow body vessels such as the small and large intestines, arteries, and veins as well as ducts leading to the gall bladder and other organs. The devices and methods disclosed are especially useful in the emergency, trauma surgery, or military setting. In such cases, the patient may have received trauma to the abdomen, extremities, neck or thoracic region. The devices utilize removable or permanently implanted, broad, soft, parallel jaw clips with minimal projections to maintain vessel contents without damage to the tissue comprising the vessel. These clips are applied using devices that are subsequently removed leaving the clips implanted, on a temporary or permanent basis, to provide for hemostasis or leakage prevention, or both. The clips come in a variety of shapes and sizes. The clips may be placed and removed by open surgery or laparoscopic access.

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 from a proximal end to a distal end of 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 includes a shape memory material and is transformable, in response to application of an activation energy, from a first configuration to a second configuration, wherein the first configuration and second configuration differ in a size of at least one dimension of the at least one adjustable element.

Abstract: Systems and methods for removing obstructions from, delivering implantable devices or substances in or near and/or restoring flow through body lumens, such as blood vessel lumens. A catheter having a proximal portion of a first diameter and a distal portion of a second diameter (smaller than the first diameter) is advanced into a body lumen. The distal portion of the catheter is caused to expand to a diameter that is larger than the second diameter but no larger than the first diameter. A working device is then advanced out of the distal end of the catheter and used to remove obstructive matter, deliver an implantable device or substance and/or restore flow. The distal portion can be reduced in diameter prior to removal from the body.

Abstract: A system for preventing air from entering a first catheter of a multi-catheter system. Air is prevented from entering the proximal end of the first catheter by an axially elongate chamber having an impeller, the chamber being affixed to the proximal end of the first catheter. The air is removed through a port near the centerline of the chamber. Liquid removed with the air is returned to the chamber to minimize liquid loss during the procedure. A second catheter inserted through the chamber and into the first catheter is unable to entrain gas into the first catheter because any gas that enters the chamber is routed to the centerline of the chamber where it is removed. Inflow of fluid from an external pump scrubs the second catheter shaft of air bubbles attached by surface tension.

Abstract: Devices and methods are disclosed for achieving hemostasis in patients who have received skin-penetrating wounds to the body in regions such as the shoulder, pelvis, neck, or groin, where standard bandages are difficult to apply and where large blood vessels exist which can hemorrhage severely. Such haemostatic packing devices and methods are especially useful in the emergency, trauma surgery, or military setting. The devices utilize packing pillows that are held in place by rigid structures that can cause the packing pillows to be brought into the wounds and be held in place while the packing pillows are inflated to fill the wounds, prevent bleeding, and tamponade hemorrhaging large blood vessels exposed therein.

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: 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, 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 performance of procedures in the left atrium. 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 to the right atrium and through the atrial septum into the left atrium. The distal end of the sheath is subsequently expanded using a radial dilatation device.

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 vascular graft comprises a perforate tubular compressible frame having a fabric liner disposed over at least a portion of the frames lumen. The graft may be used in combination with a base structure to form a bifurcated graft in situ. The base structure compresses a compressible frame having a fabric liner which defines a pair of divergent legs. The base structure is positioned within the aorta so that one leg enters each iliac. The tubular grafts can then be introduced into each leg to form the bifurcated structure. A graft delivery catheter includes a controllably flared sheath which facilitates recapture of a partially deployed graft.

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 may be 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 sufficiently compact that it will fit in a compartment of most emergency rescue vehicles, thus making it more available for use than standard traction splints in use today. The traction splint is either a separate device or integrated into a backboard.

Abstract: Disclosed is an expandable percutaneous sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion to a second, enlarged cross-sectional configuration. The sheath is maintained in the first, low cross-sectional configuration by a tubular restraint. In one application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as percutaneous nephrostomy or urinary bladder access.

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: An adjustable annuloplasty device is described. The device includes a body member comprising a shape memory material, the body member configured to be placed at or near a base of a valve of a heart. The device further includes a hysteretic material configured to undergo magnetic hysteresis in response to a first activation energy, the hysteretic material being in thermal communication with the shape memory material. The body member may have a first size of a body member dimension in a first configuration and a second size of the body member dimension in a second configuration. When the body member is in position in the heart, a change from the first configuration to the second configuration changes a size of a dimension of the annulus of the valve.

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. In such cases, 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 are flexible, bendable, and conformable in their wet or dry state so that they exert distributed pressure on the wound. Peripheral haemostatic packing devices include optional adhesive structures to attach one packing device to another. The hemostatic packing devices may be placed and removed by open surgery or laparoscopic access without generating excessive re-bleeding. The devices can be inserted into a wound and filled with fluid, gel, or particulates through an axially elongate tube to generate pressure to tamponade the wound.

Abstract: Devices and methods are disclosed for protecting individuals from the sharp ends of medical objects following use on a patient. Such sharp objects include hypodermic needles, scalpel blades, cannulae, trocars, and the like. The invention utilizes a disposable protective cover for the used sharp. The protective cover is designed to surround and embed the sharp in a permanent cover that is blunt and will not permit further puncture or cutting with the sharp. In an embodiment, the protective cover also absorbs any fluids on or in the used sharp and prevents any fluids from escaping the protective cover. The sharp cover is configured to irreversibly lock, once closed. A refillable or replaceable dispenser dispenses the protective covers at points of use. A disposable receptacle receives the used sharp embedded in the protective cover. When the receptacle is full, the entire receptacle may be discarded in a medical waste container.

Abstract: A system for preventing air from entering a first catheter of a multi-catheter system. Air is prevented from entering the proximal end of the first catheter by an axially elongate chamber having an impeller, the chamber being affixed to the proximal end of the first catheter. The air is removed through a port near the centerline of the chamber. Liquid removed with the air is returned to the chamber to minimize liquid loss during the procedure. A second catheter inserted through the chamber and into the first catheter is unable to entrain gas into the first catheter because any gas that enters the chamber is routed to the centerline of the chamber where it is removed. Inflow of fluid from an external pump scrubs the second catheter shaft of air bubbles attached by surface tension.

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 frame or inflatable member that may be 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 sufficiently compact that it will fit in a compartment of most ambulances and emergency rescue vehicles, thus making it more available for use than standard traction splints in use today. The traction splint is either a separate device or integrated into a backboard.