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 protective cover is designed to surround and sequester the sharp in a shell that is 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 devices are configured to be integral to procedure trays or kits such that space and discarded materials are minimized along with the potential for injuring someone with a used, contaminated medical sharp.

Abstract: Methods for performing certain medical procedures wherein a steerable endoluminal punch is used to not only gain access but to create a channel or punch through tissue, thus facilitating follow-up therapeutic procedures. The distal end of the steerable endoluminal punch is controllably articulated by the operator using a control device at the proximal end.

Abstract: This invention is a transvascularly placed steerable guidewire, further including internal steerability and the ability to articulate in a direction at right angles to its longitudinal axis at or near its distal end. The steerable guidewire is generally fabricated from stainless steel and includes an outer tube, an inner tube, hub structures, and a distal articulating region. The steerable guidewire can be advanced through a body lumen in its straight configuration and then be selectively articulated or curved to permit negotiation of tortuous curvature. 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. Removal of the hub can result in a limp guidewire or maintenance of a forced curvature of the distal end of the guidewire.

Abstract: An endoluminal needle or punch is describes wherein the distal end of the endoluminal needle is able to articulate laterally out of the longitudinal axis of the steerable endoluminal needle. The endoluminal needle further comprise a blunted distal end configuration that is minimally traumatic. Under control by the user, at the proximal end of the endoluminal needle, a sharp stylet can be advanced to punch tissue and then be retracted to maximize safety. The endoluminal needle is configured for use within an introducer.

Abstract: An endoluminal punch system including a sheath and dilator. The endoluminal punch may include energy delivery system capable of being transmitted from the proximal end to the distal end of the endoluminal punch to assist with tissue crossing and incisions. The dilator may include selectively deployable cutting mechanism to create incisions in tissue that are larger than their basic external diameter. The system may also be configured to reduce the risk of generating plastic emboli during insertion of the endoluminal punch.

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 protective cover is designed to surround and sequester the sharp in a shell that is 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 devices are configured to be integral to procedure trays or kits such that space and discarded materials are minimized along with the potential for injuring someone with a used, contaminated medical sharp.

Abstract: This invention is a transvascularly placed steerable guidewire, further including internal steerability and the ability to articulate in a direction at right angles to its longitudinal axis at or near its distal end. The steerable guidewire is generally fabricated from stainless steel and includes an outer tube, an inner tube, hub structures, and a distal articulating region. The steerable guidewire can be advanced through a body lumen in its straight configuration and then be selectively articulated or curved to permit negotiation of tortuous curvature. 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. Removal of the hub can result in a limp guidewire or maintenance of a forced curvature of the distal end of the guidewire.

Abstract: An endoluminal needle or punch is describes wherein the distal end of the endoluminal needle is able to articulate laterally out of the longitudinal axis of the steerable endoluminal needle. The endoluminal needle further comprise a blunted distal end configuration that is minimally traumatic. Under control by the user, at the proximal end of the endoluminal needle, a sharp stylet can be advanced to punch tissue and then be retracted to maximize safety. The endoluminal needle is configured for use within an introducer.

Abstract: A transseptal needle or punch is described wherein the distal end of the transseptal needle is able to articulate laterally out of the longitudinal axis of the steerable transseptal needle. The transseptal needle includes a blunted distal end configuration that is minimally traumatic. Under control by the user or a computer, the transseptal needle can be articulated to generate various curves with high bending force. The transseptal needle is configured for use with an introducer which can also include side windows.

Abstract: A catheter system can be used to remove obstructions, deliver implantable devices or substances, and/or restore flow through body lumens. The system can include an outer shaft having a lumen, sidewall, and a longitudinal window in the sidewall, an inner shaft disposed within the lumen, and an expandable member having a first end coupled to the outer shaft and a second end coupled to the inner shaft through the window. The expandable member can be positioned adjacent to a target region while in the collapsed configuration. The expandable member can be expanded to an expanded configuration by relative movement of the outer shaft and the inner shaft.

Abstract: A transseptal needle or punch is described wherein the distal end of the transseptal needle is able to articulate laterally out of the longitudinal axis of the steerable transseptal needle. The transseptal needle includes a blunted distal end configuration that is minimally traumatic. Under control by the user or a computer, the transseptal needle can be articulated to generate various curves with high bending force. The transseptal needle is configured for use with an introducer which can also include side windows.

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

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

Abstract: A transseptal needle or punch wherein the distal end of the transseptal needle is able to articulate laterally out of the longitudinal axis of the steerable transseptal needle. The transseptal needle further comprise a blunted distal end configuration that is minimally traumatic. Under control by the user or a computer, at the proximal end of the transseptal needle can be articulated to generate various curves with high bending force. The transseptal needle is configured for use within a transseptal introducer.

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 system and method for removing gas bubbles from fluid. An active filter apparatus forces the bubbles to the center of the filter, while a pump supplies fluid to the filter.

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: An endoluminal punch with a penetrating stylet and a vibration generator. The vibration generator is operable to cause vibrations and rapid reciprocation of the distal tip of the stylet to facilitate penetration of the stylet through resistant body tissue such as the fossa ovalis. The vibration generator may also be operable to cause vibration of the distal tip of the punch itself, to facilitate passage of the punch through an initial perforation created by the stylet.

Abstract: An endoluminal needle or punch is describes wherein the distal end of the endoluminal needle is able to articulate laterally out of the longitudinal axis of the steerable endoluminal needle. The endoluminal needle further comprise a blunted distal end configuration that is minimally traumatic. Under control by the user, at the proximal end of the endoluminal needle, a sharp stylet can be advanced to punch tissue and then be retracted to maximize safety. The endoluminal needle is configured for use within an introducer.