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 removable tubular restraint or by structural elements built into the wall of the expandable portion of the sheath. In one application, the sheath is utilized to introduce a formed in place orthopedic fixation rod such as for use in spinal fixation procedures, preparation of a spinal segment, or placement of a vertebral body spacer. The sheath can further comprise structural elements to permit re-collapse of the sheath under fluid pressure following completion of the procedure and prior to removal from the patient.

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 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: 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: 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: 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 diagnostic or therapeutic procedures such as ureteroscopy, cardiac electrophysiology, gastroenterology, and spinal access.

Abstract: A rotationally vibrating imaging catheter and method of utilization has an array of ultrasound or optical transducers and an actuator along with signal processing, display, and power subsystems. The actuator of the preferred embodiment is a solid-state nitinol actuator. The actuator causes the array to oscillate such that the tip of the catheter is rotated through an angle equal to or less than 360 degrees. The tip is then capable of rotating back the same amount. This action is repeated until the desired imaging information is acquired. The rotationally vibrating catheter produces more imaging points than a non-rotating imaging catheter and eliminates areas of missing information in the reconstructed image. Rotationally vibrating catheters offer higher image resolution than stationary array catheters and greater flexibility and lower costs than mechanically rotating imaging catheters.

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 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 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 antipathogenic agents. 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 hemostatic barriers to cover the entire wound area over the hemostatic pack.

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.

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: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, small 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 implant delivery catheters. The access route is through the ventricular myocardium, more specifically at the left ventricular apex, into the aortic root. 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, which is removed prior to the introduction of implant delivery catheters. In an exemplary application, the sheath includes a supported proximal end, a supported distal end, and a collapsible center section.

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 removable tubular restraint or by structural elements built into the wall of the expandable portion of the sheath. In one application, the sheath is utilized to introduce a formed in place orthopedic fixation rod such as for use in spinal fixation procedures, preparation of a spinal segment, or placement of a vertebral body spacer. The sheath can further comprise structural elements to permit re-collapse of the sheath under fluid pressure following completion of the procedure and prior to removal from the patient.

Abstract: Devices and methods are disclosed for achieving hemostasis in patients who have received skin-penetrating wounds to the periphery, including the head, arms, and legs. Such haemostatic packing devices and methods are especially useful in the emergency, trauma surgery, or military setting. The devices utilize fluid impermeable barriers surrounded by exterior dams and pressure to achieve tamponade and hemostasis, primarily by exertion of force to hold the dams against the skin surrounding a wound. The devices are capable of serving as carriers for thrombogenic, antimicrobial or antipathogenic agents. The devices do not require the use of adhesives to work as they are attached to the patient using mechanical locking devices. Peripheral haemostatic packing devices include optional adhesive hemostatic barriers to attach at least a portion of the device to the skin or to assist with initial coupling of a hold-down strap to another strap using a more secure mechanical lock.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, small 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 upper vascular system and has utility in the introduction and removal of therapeutic or diagnostic microcatheters. The access route is through the femoral arteries or the iliac arteries to the cerebrovasculature. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the cerebrovasculature. The distal end of the sheath is subsequently expanded using a radial dilatation device, which is removed prior to the introduction of microcatheters.

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.

Abstract: A stent and stent catheter for intra-cranial use.

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. Filters are used in the line to remove particulates and bubbles from the blood before they are pumped back to the patient but current filters are inefficient at removing small bubbles and debris 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.

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.