Abstract: A portable reverse isolation box (PRIB) for protecting an object from the environment and/or protecting a user from the object. The PRIB includes a housing comprising a container and a lid, wherein the container has structural integrity and at least a portion of the lid is transparent, and further wherein the housing forms an airtight and watertight isolation bay when the lid is mounted on the container; a port formed in the container; and a disposable flexible element mounted in the port in an airtight and watertight relationship, the flexible element being capable of assuming a concave configuration so as to permit a user to manipulate the object within the isolation bay without opening the lid.

Abstract: A novel baby nipple assembly for use with a flexible drink pouch, wherein the baby nipple assembly generally comprises a mount subassembly (sometimes hereinafter referred to as simply “the mount” or “the disk”) for attachment to the flexible drink, pouch, and a nipple subassembly (sometimes hereinafter referred to as simply “the nipple”) for connection to the mount subassembly, wherein the mount subassembly comprises a relatively large fiat element for adhesion to an outside surface of the flexible drink pouch, and the nipple subassembly comprises (1) means for connection to the mount subassembly, (ii) a sharp tube for extending through the mount subassembly and puncturing the side all of the flexible drink pouch, and (iii) a soft nipple in fluid communication with the sharp tube, whereby a baby or young child can suckle on the nipple and receive the beverage from the flexible drink pouch.

Abstract: A device for clearing obstructions from a medical tube, such as a chest tube, is disclosed in various embodiments. The device features a clearance member in the form of a loop. The loop desirably has a diameter that substantially corresponds to the inner diameter of the medical tube. Also desirably, the loop presents a substantially unobstructed pathway therethrough for the flow of material from a location in the medical tube distal to the loop to a location in the medical tube proximal to the loop regardless whether the clearance member is being translated or is at rest in the medical tube. Methods of utilizing such a device are also disclosed.

Abstract: A heart size measuring tool includes a tubular body, a flexible measuring cord having length indicia, a measuring cord support mechanism movable between retracted and extended states with respect to the body, and an actuating mechanism to move the measuring cord support mechanism. When in the retracted state the measuring cord support mechanism is positioned within the tubular body with the measuring cord in a collapsed position. When the measuring cord support mechanism is in the extended state the measuring cord extends around a portion of a heart to be measured. A scale on the body can be used in connection with the indicia on the measurement cord to provide a reading of the heart size.

Abstract: Described here are devices, systems and methods for forming a fistula between two blood vessels. Generally, the systems may comprise a first catheter which may comprise a fistula-forming element. The fistula-forming element may comprise one or more electrodes, mechanical cutting elements, laser sources, or combinations thereof, and may be used to assist in fistula formation. In some instances, a system may comprise a second catheter, which may comprise a fistula-forming element. One or more of the catheters may comprise one or more markers, magnetic alignment elements, and/or one shape-changing elements.

Abstract: Described here are devices, systems and methods for forming a fistula between two blood vessels. Generally, the systems may comprise a first catheter which may comprise a fistula-forming element. The fistula-forming element may comprise one or more electrodes, mechanical cutting elements, laser sources, or combinations thereof, and may be used to assist in fistula formation. In some instances, a system may comprise a second catheter, which may comprise a fistula-forming element. One or more of the catheters may comprise one or more markers, magnetic alignment elements, and/or one shape-changing elements.

Abstract: Described here are devices, systems and methods for forming a fistula between two blood vessels. Generally, the systems may comprise a first catheter which may comprise a fistula-forming element. The fistula-forming element may comprise one or more electrodes, mechanical cutting elements, laser sources, or combinations thereof, and may be used to assist in fistula formation. In some instances, a system may comprise a second catheter, which may comprise a fistula-forming element. One or more of the catheters may comprise one or more markers, magnetic alignment elements, and/or one shape-changing elements.

Abstract: A delivery assembly for delivering a prosthetic heart valve can include a first elongate component and a second elongate component. The delivery assembly can include a temporary valve location to which the prosthetic heart valve can be releasably mounted and an implantation location to which the prosthetic heart valve can also be releasable mounted. The delivery assembly can move from a delivery state with the prosthetic heart valve mounted to the temporary location to an implantation state with the prosthetic heart valve repositioned from the temporary location to the implantation location. The prosthetic heart valve can subsequently be deployed from the implantation location. The position of the prosthetic heart valve relative to the first elongate component at the temporary location is different than a position of the prosthetic heart valve relative to the first elongate component at the implantation location.

Abstract: A device for clearing obstructions from a medical tube, such as a chest tube, is disclosed in various embodiments. The device features a clearance member in the form of a loop. The loop desirably has a diameter that substantially corresponds to the inner diameter of the medical tube. Also desirably, the loop presents a substantially unobstructed pathway therethrough for the flow of material from a location in the medical tube distal to the loop to a location in the medical tube proximal to the loop regardless whether the clearance member is being translated or is at rest in the medical tube. Methods of utilizing such a device are also disclosed.

Abstract: Devices and methods for performing intravascular procedures without cardiac bypass include embodiments of temporary filter devices, temporary valves, and prosthetic valves. The temporary filter devices have a cannula which provides access for surgical tools for effecting repair of cardiac valves. The cannula may have filters which prevent embolitic material from entering the coronary arteries and aorta. The valve devices may also have a cannula for insertion of the valve into the aorta. The valve devices expand in the aorta to occupy the entire flow path of the vessel and operate to prevent blood flow and to permit flow through the valve. The prosthetic valves include valve fixation devices which secure the prosthetic valve to the wall of the vessel. The prosthetic valves are introduced into the vascular system in a compressed state, advanced to the site of implantation, and expanded and secured to the vessel wall.

Abstract: A device for delivery of a cardiac support device for treating cardiac disease of a heart includes a multistage deployment mechanism and an actuating mechanism for controlling the positions of the deployment mechanism. The deployment mechanism is operable to change between a retracted state and an extended state, and includes a plurality of independent stages, including, in one embodiment, a first stage including a guide structure for location adjacent a portion of the patient's heart when in the extended state. A second stage is movably coupled to the first stage, and is guided by the guide structure between the retracted and extended states. The second stage further releasably engages and supports the cardiac support device and positions the cardiac support device at the desired implantation location, guided by the guide structure of the stage. In some embodiments, the deployment mechanism may include additional stages.

Abstract: The present invention is TAH system for auto-regulating blood flow and maintaining the asymmetric pressure balance in the mammalian cardiovascular system by decreasing the resistance in blood flow and minimizing the pressure gradients to exploit the in-flow pressure sensitivities of continuous flow pumps. The system further includes laminar flow generating manifolds connected to the atrium at one end and attached to pumps linked to the great vessels at the other, such that the in-let flow sensitivities of the pumps are maximized to auto-regulate blood flow, providing adequate pulmonary and systemic arterial flow to support normal metabolism and end-organ function and maintain the appropriate asymmetric physiologic pressure balance between the systemic and pulmonary systems of the mammalian cardiovascular system.

Abstract: Apparatus for resecting a diseased heart valve, the apparatus comprising: a body portion; a first handle and a second handle; a cutting blade; a set of retaining arms; a pass-off tool having a first attachment device configured to selectively engage the first handle attached to the body portion so as to allow placement of the second handle of the body portion adjacent to the diseased heart valve, and a controller tool having a second attachment device at the distal end thereof, the second attachment device configured to selectively engage the second handle attached to the body portion so as to allow positioning of the body portion adjacent to the diseased heart valve, a cutting blade actuator configured to cause the cutting blade to selectively rotate, and a retaining arm actuator configured to selectively position the set of retaining arms from the contracted state to the expanded state.

Abstract: A novel catheter-based system which ligates the left atrial appendage (LAA) on the outside of the heart, preferably using a combination of catheters and/or instruments, e.g., a guide catheter positioned inside the left atrial appendage which may assist in locating the left atrial appendage and/or assist in the optimal placement of a ligature on the outside of the appendage, and a ligating catheter and/or instrument outside the heart in the pericardial space to set a ligating element at the neck of the left atrial appendage.

Abstract: A method for implanting a cardiac support device (CSD) on a patient's heart. An amount of contrast agent sufficient to cause structures on the heart to be visible upon fluoroscopic or other imaging is introduced into the pericardial space surrounding the heart. The heart and contrast agent are imaged to provide a visual indication of the location of the structures of the heart. The CSD is placed on the heart using the visual indications provided by the imaging.

Abstract: Apparatus for resecting a diseased heart valve, the apparatus including: a body portion; a first handle and a second handle; a cutting blade; a set of retaining arms; a pass-off tool having a first attachment device configured to selectively engage the first handle attached to the body portion so as to allow placement of the second handle of the body portion adjacent to the diseased heart valve, and a controller tool, having a second attachment device at the distal end thereof, the second attachment device configured to selectively engage the second handle attached to the body portion so as to allow positioning of the body portion adjacent to the diseased heart valve, a cutting blade actuator configured to cause the cutting blade to selectively rotate, and a retaining arm actuator configured to selectively position the set of retaining arms from the contracted state to the expanded state.

Abstract: A novel baby nipple assembly for use with a flexible drink pouch, wherein the baby nipple assembly generally comprises a mount subassembly (sometimes hereinafter referred to as simply “the mount” or “the disk”) for attachment to the flexible drink pouch, and a nipple subassembly (sometimes hereinafter referred to as simply “the nipple”) for connection to the mount subassembly, wherein the mount subassembly comprises a relatively large flat element for adhesion to an outside surface of the flexible drink pouch, and the nipple subassembly comprises (i) means for connection to the mount subassembly, (ii) a sharp tube for extending through the mount subassembly and puncturing the side wall of the flexible drink pouch, and (iii) a soft nipple in fluid communication with the sharp tube, whereby a baby or young child can suckle on the nipple and receive the beverage from the flexible drink pouch.

Abstract: An apparatus is provided in one example embodiment and includes a body section having an upper surface, a lower surface, and an inner edge circumferentially arranged around at least a portion of an open area. The apparatus also includes a tool extending from the body section into the open area for holding a graft vessel. The lower surface of the body section opposes a receiving vessel when the tool is positioned to transfer the graft vessel to the receiving vessel, such that the graft vessel is axially accessible through the open area to be attached to the receiving vessel. In more specific embodiments, the body section has first and second opposing ends defining a gap sized to permit the vessel to pass through.

Abstract: A method for implanting a cardiac support device (CSD) on a patient's heart. An amount of contrast agent sufficient to cause structures on the heart to be visible upon fluoroscopic or other imaging is introduced into the pericardial space surrounding the heart. The heart and contrast agent are imaged to provide a visual indication of the location of the structures of the heart. The CSD is placed on the heart using the visual indications provided by the imaging.