Abstract: The present invention describes a device for placement in the thoracic cavity of a patient. The device is a cannula, tube or catheter for chest drainage. The device serves as a conduit for drainage of excessive fluid or air buildup in the chest to a receptacle outside the body. The device also serves to prevent influx of fluid or air into the chest cavity, thus preventing pneumothorax or infection. The device incorporates systems for anchoring the chest drainage cannula to the chest and for steering the chest drainage cannula into the thoracic cavity.

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: 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 with a low profile retaining tab. 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.

Abstract: Gastric restriction device implants and their use in controlling body weight are described. In some embodiments, activation of a shape memory material drives an actuator coupled to an implant, resulting in a conformational change in the implant. In some embodiments latch and ratchet mechanisms operate incrementally to increase or decrease a size of a stomal opening produced by the gastric restriction device. Methods are described by which adjusting the size of the stomal opening is used to restrict the rate at which food passes through the stomach.

Abstract: Devices and methods are disclosed for achieving hemostasis in solid visceral wounds. Such devices and methods are especially useful in the emergency, trauma surgery or military setting. In such cases, the patient may have received trauma to the abdominal viscera. The devices utilize flexible, variable depth transfixing bolts that penetrate the viscera. These bolts are pulled tight to 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 bolts come in a variety of lengths and diameters. Since the bolts are flexible, the curvature can be adjusted by the surgeon. The devices are flexible, bendable, and conformable in their wet or dry state. They can be used either straight or configured in a broad range of curvatures to suit the needs of various pathologies.

Abstract: An adjustable implant configured to be implanted within or at least partially around an outer surface of a stomach or esophagus is described. The adjustable implant includes a ratchet. The implant further includes an elongate band comprising a shape-memory material, wherein a first end and a second end of the elongate band are configured to couple to the ratchet, such that the band and the ratchet form an assembly having a loop configuration. Activation of the shape-memory material adjusts the band from a first length to a second length as the ratchet permits movement in a first direction of the first end relative to the second end, changing a circumference of the loop configuration.

Abstract: Devices and methods are disclosed for achieving hemostasis in solid visceral wounds. Such devices and methods are especially useful in the emergency, trauma surgery or military setting. In such cases, the patient may have received trauma to the abdominal viscera. The devices utilize flexible, variable depth transfixing bolts that penetrate the viscera. These bolts are pulled tight to bring the tissue into apposition and hold said tissue in apposition while the wound heals. These bolts overcome the limitations of sutures that are currently used for the same purposes. The bolts come in a variety of lengths and diameters. Since the bolts are flexible, the curvature may be adjusted by the surgeon. The devices are flexible, bendable, and conformable in their wet or dry state. They can be used either straight or through a broad range of curvatures to suit the needs of various pathologies.

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: 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: Disclosed is a device and method for accessing the lower esophageal sphincter through the esophagus. In one embodiment, a catheter is inserted through the mouth or nose of a patient and advanced to the region of the diaphragm. Under fluoroscopy or endoscopy, a hollow needle at the distal end of the catheter punctures the wall of the esophagus from the inside so that the distal end of the needle is positioned outside the esophagus. An implant is next advanced out through the hollow needle to the region outside the sphincter where it is deflected and coerced to bluntly dissect around the circumference of the esophagus, where the implant is left in place to heal. The hollow needle is removed and the esophageal wall is allowed to heal. Subsequent diametric adjustment of the implant allows for tightening or loosening of the sphincter to minimize gastric reflux. The device and method can also be used to treat the pyloric or other body sphincters, hollow organs, or ducts.

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 a hub for a transluminal sheath. The hub provides a handle for grasping the sheath, provides connections for fluid inlet and outlet lines, and provides for attaching mechanisms between the sheath and a dilator. The hub can be used on a non-radially expandable sheath, or it can be used on a sheath having a radially expandable configuration. In an exemplary application, the hub is fitted to a sheath, which provides access for a diagnostic or therapeutic procedure such as ureteroscopy or stone removal.

Abstract: Disclosed is an expandable percutaneous 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 upper gastrointestinal tract and has utility in the performance of procedures in the esophagus and stomach. The access route is through the anterior abdominal wall to the stomach. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement through the abdominal wall and into the stomach. The distal end of the sheath is subsequently 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 diagnosis and repair of gastro esophageal reflux disease.

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: A transluminal sheath is disclosed that permits instrumentation to be passed therethrough. The transluminal sheath comprises a composite structure with an inner layer, an outer layer, and a reinforcing layer. The materials comprising the inner and outer layer are plastically deformable and maintain their shape, once bent into a specific configuration. The reinforcing layer further has radiopacity enhancing coatings to improve visibility under fluoroscopy and a system of flutes running longitudinally, to enhance fluid transport and reduce friction.

Abstract: The present invention describes a device for placement in the thoracic cavity of a patient. The device is a cannula, tube or catheter for chest drainage. The device serves as a conduit for drainage of excessive fluid or air buildup in the chest to a receptacle outside the body. The device also serves to prevent influx of fluid or air into the chest cavity, thus preventing pneumothorax or infection. The device incorporates systems for anchoring the chest drainage cannula to the chest and for steering the chest drainage cannula into the thoracic cavity.

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 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: 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: Devices and methods are disclosed for achieving hemostasis at a wound site following an endovascular procedure. Such wound sealing is necessary generally following a percutaneous procedure where a percutaneous cannula is withdrawn from the vasculature leaving an entry site to the vessel that could bleed if steps are not taken to stop said bleeding. The devices and methods disclosed herein are especially useful in the catheterization laboratory following interventional cardiology or interventional neuroradiology procedures. The devices utilize the introduction sheath that was originally used for the procedure as a guide for the closure. The closure device is inserted through the introduction sheath once any therapeutic or diagnostic devices have been removed. The closure device comprises a two-part sealing material housed in a reservoir system, a mixing chamber, a delivery cannula, exit ports, and a vessel location device.