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 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 and has utility in the introduction and removal of balloon counterpulsation catheters. The access route is through the femoral arteries and the iliac arteries into the aorta, where an intra-aortic balloon pump catheter is positioned to provide cardiac support. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device.

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: 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: 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 and has utility in the performance of procedures in the left atrium. 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 to the right atrium and through the atrial septum into the left atrium. The distal end of the sheath is subsequently expanded using a radial dilatation device.

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 and has utility in the introduction and removal of balloon counterpulsation catheters. The access route is through the femoral arteries and the iliac arteries into the aorta, where an intra-aortic balloon pump catheter is positioned to provide cardiac support. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement to the arteries into the aorta. The distal end of the sheath is subsequently expanded using a radial dilatation device.

Abstract: A venous valve prosthesis includes a hollow conduit (40) defining a central passageway through which blood may flow. Opposing, pliable leaflet members (30) are located within the conduit and move back and forth between a first, open position, whereby blood may flow through the central passageway in a first direction, and a second, closed position, whereby blood is prevented from backflowing through the central passageway in a second direction which is opposite the first direction. A hollow and generally cylindrical support member (10, 20) retains the leaflet members and is coaxially disposed within the conduit. The support member includes opposing cutaway regions (18) defining two axially extending struts (16) supporting the leaflet members. The cutaway regions, in cooperation with the struts, allow the leaflet members to collapse inwardly to the closed position.

Abstract: Disclosed is a balloon catheter having an inflatable balloon having a radiation carrier such as a radiation delivery layer thereon. In one embodiment, the radiation delivery layer comprises one or more layers of metal foil, such as gold. The foil is irradiated, and the balloon is thereafter positioned at a treatment site in a vessel and expanded to bring the metal foil layer into close proximity with the vessel wall. In another embodiment, the radiation carrier is in the form of a dopant in the balloon material. Methods of using the balloon include radiation dosing a site following a balloon dilatation or other procedure, and simultaneously performing balloon angioplasty and radiation dosing.

Abstract: A venous valve prosthesis includes a hollow conduit (40) defining a central passageway through which blood may flow. Opposing, pliable leaflet members (30) are located within the conduit and move back and forth between a first, open position, whereby blood may flow through the central passageway in a first direction, and a second, closed position, whereby blood is prevented from backflowing through the central passageway in a second direction which is opposite the first direction. A hollow and generally cylindrical support member (10, 20) retains the leaflet members and is coaxially disposed within the conduit. The support member includes opposing cutaway regions (18) defining two axially extending struts (16) supporting the leaflet members. The cutaway regions, in cooperation with the struts, allow the leaflet members to collapse inwardly to the closed position.

Abstract: Disclosed is a balloon catheter having an inflatable balloon having a radiation carrier such as a radiation delivery layer thereon. In one embodiment, the radiation delivery layer comprises one or more layers of metal foil, such as gold. The foil is irradiated, and the balloon is thereafter positioned at a treatment site in a vessel and expanded to bring the metal foil layer into close proximity with the vessel wall. In another embodiment, the radiation carrier is in the form of a dopant in the balloon material. Methods of using the balloon include radiation dosing a site following a balloon dilatation or other procedure, and simultaneously performing balloon angioplasty and radiation dosing.

Abstract: Disclosed is a site specific microcapsule delivery system and microcapsules for delivering one or more active agents to a preselected site. The system includes a catheter and microcapsules. A preferred embodiment of the catheter includes an inner inflatable balloon having an outer perforated delivery balloon concentrically disposed thereon. The microcapsule preferably comprises a water dissolvable core, and at least one outer protective shell. In a preferred embodiment, the core comprises phosphorous 31 and the outer shell comprises PGLA or other water soluble material. Neutron beam activation of the core produces phosphorous 32, for emitting therapeutic radiation to the treatment site. The outer protective shell dissipates over time, and, following a predetermined delivery period, the outer shell is removed and the central core dissipates to leave only biologically compatible break down products.

Abstract: Disclosed is a balloon catheter having an inflatable balloon having a radiation carrier such as a radiation delivery layer thereon. In one embodiment, the radiation delivery layer comprises one or more layers of metal foil, such as gold. The foil is irradiated, and the balloon is thereafter positioned at a treatment site in a vessel and expanded to bring the metal foil layer into close proximity with the vessel wall. In another embodiment, the radiation carrier is in the form of a dopant in the balloon material. Methods of using the balloon include radiation dosing a site following a balloon dilatation or other procedure, and simultaneously performing balloon angioplasty and radiation dosing.

Abstract: A minimally-invasive surgery apparatus for causing the lumen of a vein to collapse to prevent blood flow through the vein, e.g., a varicose vein or a side branch of the saphenous vein, includes an electrode which is electrically connected to a power source, and the electrode is percutaneously advanced into the vein. Then, the power source is activated to energize the electrode and thus the blood vein until the blood vein sufficiently collapses to block the lumen of the vein. A feedback loop is also provided for sensing electrical impedance of the tissue within the vein being energized and for deenergizing the electrode when the impedance reaches a predetermined value.

Abstract: A minimally-invasive surgery apparatus for causing the lumen of a vein to collapse to prevent blood flow through the vein, e.g., a varicose vein or a side branch of the saphenous vein, includes an electrode which is electrically connected to a power source, and the electrode is percutaneously advanced into the vein. Then, the power source is activated to energize the electrode and thus the blood vein until the blood vein sufficiently collapses to block the lumen of the vein. A feedback loop is also provided for sensing electrical impedance of the tissue within the vein being energized and for deenergizing the electrode when the impedance reaches a predetermined value. The apparatus can also be used to block a fallopian tube.

Abstract: A minimally-invasive surgery apparatus for causing the lumen of a vein to collapse to prevent blood flow through the vein, e.g., a varicose vein or a side branch of the saphenous vein, includes an electrode which is electrically connected to a power source, and the electrode is percutaneously advanced into the vein. Then, the power source is activated to energize the electrode and thus the blood vein until the blood vein sufficiently collapses to block the lumen of the vein. A feedback loop is also provided for sensing electrical impedance of the tissue within the vein being energized and for deenergizing the electrode when the impedance reaches a predetermined value.