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: 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: 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 gastrointestinal system and has utility in the performance of endoscopic retrograde cholangiopancreatography (ERCP). 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 gallstone or pancreatic stone removal.

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 that may be expanded and locked into position. The frame 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 of the current invention 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: This invention relates to active protective garments which are inconspicuously worn by an individual and which activate upon certain conditions being met. Activation causes inflation of regions of the active protective garment to provide padding and impact cushioning for the wearer. The invention is an active protective garment such as pair of shorts or pants, a jacket, a vest, underwear, and the like. The garments comprise multiple layers of material that constrain pockets or regions that are inflatable by a source of compressed gas or foam. The garments also comprise sensors to detect ballistic parameters such as acceleration, distance, relative acceleration, and rotation. The sensor information is used to determine whether activation is required. Detection and activation are accomplished in a very short time period in order to offer maximal protection for the individual wearing the garment.

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: An expandable sheath is insertable into a patient through an incision. Once inserted and advanced to the target surgical site, the sheath can be expanded to an enlarged diameter. The wall of the sheath is fabricated from a tubular structure comprising filamentous elements that extend axially and at least partially circumferentially along the length of the sheath. The tubular filamentous material is drawn or expanded axially to create the small diameter configuration that is inserted into the patient. A standoff attaches the distal end of the tubular filamentous material to the sheath hub by way of radially movable anchors. Additional filamentous tubular material extends out the proximal end of the hub. A compression mechanism forces the additional filamentous tubular material in the distal direction which causes axial compression and radial or diametric dilation of the working length of the sheath, that part of the sheath that extends beyond the proximal end of the hub.

Abstract: Devices and methods are disclosed for achieving hemostasis in traumatized patients. The devices utilize fluid impermeable outer surfaces and distributed pressure to achieve tamponade and hemostasis, primarily by exertion of pressure. The devices are capable of serving as carriers for throabogenic or antipathogenic agents. Peripheral haemostatic packing devices include optional adhesive hemostatic barriers to cover the entire wound area over the hemostatic pack. 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: 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 herein are especially useful in the emergency, trauma surgery or military setting, and most especially during damage control procedures. 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 either standard instruments or custom devices that are subsequently removed leaving the clips implanted, on a temporary or permanent basis, to provide for hemostasis or leakage prevention, or both. These clips overcome the limitations of clips and sutures that are currently used for the same purposes.

Abstract: Devices and methods are disclosed for achieving chest drainage in humans or other animals. Chest drainage is often required following traumatic injury or surgery. The devices and methods disclosed herein are especially useful in the emergency, trauma surgery or military setting. The devices utilize a chest tube with a cutting distal end and a central blunt trocar. The blunt trocar or obturator shields the sharp cutting distal end of the chest tube until controllably retracted. Once the blunt trocar or obturator is retracted, the chest tube is advanced out through its sterile, protective package and into the patient. The blunt trocar is advanced back into its position to shield the sharp tip of the chest tube during patient insertion. The chest tube also includes a hold-down mechanism that is created by an adhesive seal to the patient's chest and ribbons or straps that are wrapped around the chest tube once it is correctly positioned.

Abstract: An access device comprises a thin-walled sheath that is insertable into a patient through a small surgically created incision. The incision may be created using a cutdown or a percutaneous method such as that known as the Seldinger technique. Once inserted and advanced to the target surgical site, the sheath is selectively, and controllably, expanded to a desired diameter. The thin wall of the sheath is fabricated from a rectangular piece of material such as metal or plastic with two cut edges. The rectangular piece of metal or plastic is rolled tightly to create the small diameter configuration that is inserted into the patient. A cam or control member is affixed to the innermost edge of the rectangular piece of metal or plastic. The control member extends to the proximal most portion of the sheath. By rotating the control member, the operator causes the thin wall piece of rolled material to unfurl into a larger or smaller diameter, depending on the direction of rotation.

Abstract: In one embodiment, an access sheath includes a movable coil sheath that is insertable into a patient through an endoluminal or surgical approach. The sheath is inserted into a patient in a flattened configuration. A plurality of separate coils, elements, or hoops are connected by a fixed member and a control member, which are moved relative to each other to flatten the coils or hoops. Once inserted and advanced to the target surgical site, the sheath is selectively, and controllably, unflattened or expanded to a desired diameter or cross-section. A control member is affixed to one edge of the sheath and runs in the axial direction. By translating the control member in a direction parallel to the axis of the sheath, the operator causes the hoops or coils to rotate into a plane perpendicular or lateral to the axis of the sheath. A mechanical lock at the proximal end of the sheath permits the control member to be selectively constrained from translation and thus lock the sheath diameter in place.

Abstract: A system 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: 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: A system is disclosed for creating a hole in a body vessel or hollow organ. Such holes are useful in surgically preparing the hollow organ or body vessel for connection with another hollow organ, body vessel or prosthetic conduit. For example, an assist device is generally connected to the left ventricle through a ventriculotomy created at the apex of the left ventricle. This ventriculotomy is most easily created with a punch or trephine. Control over such a procedure must be precise so as not to damage the ventricular wall or intracardiac structures such as papillary muscles, chordae tendinae, etc. The punch of the current invention allows for precise location and alignment of the cutting segment. The punch of the current invention also allows for precise advance of the cutting blade and a very clean cut of the tissue. Such clean cuts improve the healing when the hole in the body vessel or hollow organ is closed or attached to a connection, either prosthetic or natural.

Abstract: Devices and methods are disclosed for achieving chest drainage in humans or other animals. Chest drainage is often required following traumatic injury or surgery. The devices and methods disclosed herein are especially useful in the emergency, trauma surgery or military setting. The devices utilize a chest tube with a cutting distal end and a central blunt trocar. The blunt trocar or obturator shields the sharp cutting distal end of the chest tube until controllably retracted. Once the blunt trocar or obturator is retracted, the chest tube is advanced out through its sterile, protective package and into the patient. The blunt trocar is advanced back into its position to shield the sharp tip of the chest tube during patient insertion. The chest tube also includes a hold-down mechanism that is created by an adhesive seal to the patient's chest and ribbons or straps that are wrapped around the chest tube once it is correctly positioned.

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: A stent and stent catheter for intra-cranial use. The stent is a rolled sheet stent and is releasably mounted on the distal tip of the catheter by means of a non-sliding retention and release mechanism. The non-sliding release mechanism is operated remotely at the proximal end of the catheter by means of a linear translator. The stent is rolled tightly on the distal tip of the catheter and flexibility of the tightly rolled stent is promoted by ribbed or slatted construction (or, alternatively, slotted construction) in which the various layers of the stent are provided with numerous slats which counter align when the stent is expanded to form an imperforate wall from a plurality of perforate layers.

Abstract: A system is disclosed for cannulating the vena cava of a patient during cardiopulmonary bypass procedures. Such cannulation is necessary for drainage of venous blood from the patient so that it may be oxygenated and pumped back to the patient to perfuse tissues during cardiac surgery and, more specifically, during periods of ischemic cardiac arrest or dysfunction. The device of the present invention not only provides venous drainage for cardiopulmonary bypass, but also performs the function of routing cardioplegic solution through the heart in the retrograde direction. Such cardioplegia provides protection to the heart during periods of ischemic cardiac arrest. This invention replaces a plurality of cannulae currently used for open-heart surgery, thus simplifying the surgical field and improving visibility of the heart. The device allows for the delivery of retrograde cardioplegia to the coronary circulation of both the right and the left side of the heart.

Abstract: An endoluminal prosthesis includes a tubular graft, an expandable annular support structure and a restraining mechanism restraining the prosthesis in a collapsed configuration in which the annular support structure is compressed to a low profile. The restraining mechanism holds the annular support structures in the collapsed configuration until the prosthesis is positioned for deployment. The restraining mechanism is then released to allow the annular support structures to expand into conforming engagement with the inner wall of a lumen in which the prosthesis is to be deployed. A feature according to the invention provides a balloon catheter onto which the prosthesis is loaded for deployment where the balloon is expanded to provide a radial force to release the restraining mechanism. Another feature provides for a restraining member that breaks upon application of the radial force to release the annular support structure from its constrained configuration.