Abstract: Modular systems comprising a cannula and at least one access port adjacent to a distal end of the cannula provide insertion of one or more therapeutic or diagnostic devices into a vessel or cardiac tissue through a single incision site. Other embodiments include a vessel introducer or multi-port introducer. The devices can be operated in combination or independently. The systems can be employed to provide multiple therapies, including blood perfusion, filtration, aspiration, vessel occlusion, atherectomy, and endoscopic devices. Methods of using the system for vessel cannulation are also disclosed herein.

Abstract: A filter device for temporary placement of a filter in an artery or vein is disclosed. The device includes an expandable filter mounted on a distal end of a catheter. The filter comprises a plurality of circumferentially adjacent porous segments that are arranged generally about the surface of a cone having an open base, and the segments are engaged to one another by means, such as a hook. The filter conforms to the interior of a vessel wall when expanded and contracts to a consistent diameter without bunching when stowed. Methods of using the filter device to entrap and remove embolic material from a vessel during endovascular procedures are also disclosed.

Abstract: The invention provides a device having first and second balloons. Each of the first and second balloons communicates with an inflation lumen. A differential pressure gauge communicates with both inflation lumens. Each of the inflation lumens also communicates independently with a pump for inflating the balloon. The pressure gauge may include a shut-off valve for terminating inflation in the second balloon when the pressure within the first balloon exceeds the pressure in the second balloon. The pressure gauge may also include a pressure limiter. Methods of using the devices for measuring diameter and pressure of a balloon occluder deployed in a vessel or body cavity are disclosed.

Abstract: A probe having the ability to deliver cardioplegia solution to the coronary sinus under direct visualization and to provide venous drainage from the right atrium for cardiopulmonary bypass. The probe has an elongate tubular member, including a distal end, a proximal end, and a lumen. A membrane, optionally perforated, mounted within the lumen of the tubular member partitions the lumen and is removable or penetrable by a cardioplegia catheter. The distal end comprises a toroidal balloon or a circumferential recessed vacuum manifold. A vacuum port communicates with the distal end of the tubular member or the vacuum manifold. Methods of using the cardioplegia access view probe for catheterization of the coronary sinus and for venous return as herein described are also disclosed.

Abstract: Systems and methods convey a closure material into a catheter, e.g., to seal a puncture site in a blood vessel. The closure material comprises a mixture of first and second components, which, upon mixing, undergo a reaction to form solid closure material composition. The first component may be a lyophilized polyethylene glycol (PEG) material contained within a vial. The second component may be a buffered albumin solution plus water contained within a syringe. An applicator provides easy and effective mixing of the components and delivery of the mixture to the puncture site.

Abstract: An expansion mechanism that includes an elongate instrument and a plurality of struts arranged around the elongate instrument provides radial expansion of a medical device. Each strut has a first end pivotally connected to the elongate instrument and a second strut that expands radially outward. Each strut further carries a flexible line which has a proximal end and a distal end. The distal end of each line passes beyond the second end of the strut which carries it and is attached to the strut immediately adjacent the strut which carries it. Methods of using such an expansion mechanism are also disclosed, particularly to provide deployment of medical devices within a patient's blood vascular system.

Abstract: Systems and methods employ functional instruments to close incisions and wounds using a suture knot in combination with a biocompatible material composition. The systems and methods are well suited for use, for example, at a vascular puncture site following a vascular access procedure.

Abstract: An expansion mechanism that includes an elongate instrument and a plurality of struts arranged around the elongate instrument provides radial expansion of a medical device. Each strut has a first end pivotally connected to the elongate instrument and a second strut that expands radially outward. Each strut further carries a flexible line which has a proximal end and a distal end. The distal end of each line passes beyond the second end of the strut which carries it and is attached to the strut immediately adjacent the strut which carries it. Methods of using such an expansion mechanism are also disclosed, particularly to provide deployment of medical devices within a patient's blood vascular system.

Abstract: An expansion frame system for deploying medical devices in a patient's body cavity. The system typically includes an inner wire disposed within a lumen of an outer wire. Distal ends of the inner and outer wires are attached to a substantially circular frame at first and second points. During use, the outer wire is displaced relative to the inner wire, causing the circular frame to rotate about an axis perpendicular to the line defined by the first and second points. Medical devices, such as a filter, a stent, an occluder or a manometer, can be mounted on the circular frame. The diameter of the expansion frame can be varied to achieve optimal contact with the luminal wall of the body cavity. Methods of using the expansion frame system for temporary or permanent placement of a medical device is disclosed.

Abstract: An atrial isolator comprising two tubular members, two lumens, drainage ports, and expandable occluders. The expandable occluders are adapted to engage an opening of the superior vena cava into the right atrium or the inferior vena cava and right tricuspid valve into the right atrium. The second tubular member is inserted into the lumen of the first tubular member to provide a displacement between the first expandable occluder and the second expandable occluder which is adjustable. A cardioplegia port is located between the two expandable occluders and in communication with a cardioplegic lumen. Methods of using such an atrial isolator are also disclosed, particularly to provide circulatory isolation of the heart and coronary blood vessels, and cardioplegia delivery.

Abstract: A suture-free clamp for sealing body tissue during introduction of medical devices, such as a cannula, aspirator, stent, endoscope, and pressure monitor. The clamp may be used in a patient's vascular tissues, such as the right atrium and the aorta. The clamp comprises a generally cone-shaped housing which includes a lumen for receiving a medical device, and a collar having a central opening for passage of a medical device, the collar connected to a proximal end of the housing by a plurality of struts. The proximal end of the housing and the collar each has an annular surface. The two surfaces are opposed, and are operable to clamp tissue therebetween, and to thereafter release the tissue by releasing the clamp. Methods are also disclosed for using the suture-free clamp for sealing body tissues during introduction of a medical device.

Abstract: An expansion mechanism that includes an elongate instrument and a plurality of struts arranged around the elongate instrument provides radial expansion of a medical device. Each strut has a first end pivotally connected to the elongate instrument and a second strut that expands radially outward. Each strut further carries a flexible line which has a proximal end and a distal end. The distal end of each line passes beyond the second end of the strut which carries it and is attached to the strut immediately adjacent the strut which carries it. Methods of using such an expansion mechanism are also disclosed, particularly to provide deployment of medical devices within a patient's blood vascular system.

Abstract: An expansion mechanism which includes an elongate instrument and a plurality of struts arranged around the elongate instrument provides radial expansion of a medical device. Each strut has a first end pivotally connected to the elongate instrument and a second strut which expands radially outward. Each strut further carries a flexible line which has a proximal end and a distal end. The distal end of each line passes beyond the second end of the strut which carries it and is attached to the strut immediately adjacent the strut which carries it. Methods of using such an expansion mechanism are also disclosed, particularly to provide deployment of medical devices within a patient's blood vascular system.

Abstract: An expansion frame system for deploying medical devices in a patient's body cavity. The system typically includes an inner wire disposed within a lumen of an outer wire. Distal ends of the inner and outer wires are attached to a substantially circular frame at first and second points. During use, the outer wire is displaced relative to the inner wire, causing the circular frame to rotate about an axis perpendicular to the line defined by the first and second points. Medical devices, such as a filter, a stent, an occluder or a manometer, can be mounted on the circular frame. The diameter of the expansion frame can be varied to achieve optimal contact with the luminal wall of the body cavity. Methods of using the expansion frame system for temporary or permanent placement of a medical device is disclosed.

Abstract: A direct stick tear-away introducer having an elongate intraluminal medical device, comprising a proximal and a distal end. A sheath is disposed about the medical device and extends from the distal end of the medical device. A blade is bonded to a distal end of the sheath, and a weakened region on the sheath extends longitudinally from the distal end to a proximal end of the sheath. The introducer has the ability to incise a body tissue and allow insertion of a medical device housed within the introducer into the body tissue. Methods for using the devices herein are also disclosed.

Abstract: An expansion frame system for deploying medical devices in a patient's body cavity. The system typically includes an inner wire disposed within a lumen of an outer wire. Distal ends of the inner and outer wires are attached to a substantially circular frame at first and second points. During use, the outer wire is displaced relative to the inner wire, causing the circular frame to rotate about an axis perpendicular to the line defined by the first and second points. Medical devices, such as a filter, a stent, an occluder or a manometer, can be mounted on the circular frame. The diameter of the expansion frame can be varied to achieve optimal contact with the luminal wall of the body cavity. Methods of using the expansion frame system for temporary or permanent placement of a medical device is disclosed.

Abstract: A filter device for temporary placement of a filter in an artery or vein is disclosed. The device includes an expandable filter mounted on a distal end of a catheter. The filter comprises a plurality of circumferentially adjacent porous segments which are arranged generally about the surface of a cone having an open base, and the segments are engaged to one another by means, such as a hook. The filter conforms to the interior of a vessel wall when expanded and contracts to a consistent diameter without bunching when stowed. Methods of using the filter device to entrap and remove embolic material from a vessel during endovascular procedures are also disclosed.

Abstract: A suture-free clamp for sealing body tissue during introduction of medical devices, such as a cannula, aspirator, stent, endoscope, and pressure monitor. The clamp may be used in a patient's vascular tissues, such as the right atrium and the aorta. The clamp comprises a generally cone-shaped housing which includes a lumen for receiving a medical device, and a collar having a central opening for passage of a medical device, the collar connected to a proximal end of the housing by a plurality of struts. The proximal end of the housing and the collar each has an annular surface. The two surfaces are opposed, and are operable to clamp tissue therebetween, and to thereafter release the tissue by releasing the clamp. Methods are also disclosed for using the suture-free clamp for sealing body tissues during introduction of a medical device.

Abstract: The invention provides a device having first and second balloons. Each of the first and second balloons communicates with an inflation lumen. A differential pressure gauge communicates with both inflation lumens. Each of the inflation lumens also communicates independently with a pump for inflating the balloon. The pressure gauge may include a shut-off valve for terminating inflation in the second balloon when the pressure within the first balloon exceeds the pressure in the second balloon. The pressure gauge may also include a pressure limiter. Methods of using the devices for measuring diameter and pressure of a balloon occluder deployed in a vessel or body cavity are disclosed.

Abstract: A probe having the ability to deliver cardioplegia solution to the coronary sinus under direct visualization and to provide venous drainage from the right atrium for cardiopulmonary bypass. The probe has an elongate tubular member, including a distal end, a proximal end, and a lumen. A membrane, optionally perforated, mounted within the lumen of the tubular member partitions the lumen and is removable or penetrable by a cardioplegia catheter. The distal end comprises a toroidal balloon or a circumferential recessed vacuum manifold. A vacuum port communicates with the distal end of the tubular member or the vacuum manifold. Methods of using the cardioplegia access view probe for catheterization of the coronary sinus and for venous return as herein described are also disclosed.