Abstract: An implantable prosthetic valve assembly having a support stent, or frame, having circumferential struts with multiple bends forming obtuse angles when the valve assembly is expanded to its functional size. The frame can be manufactured with one or more of the circumferential struts in a partially collapsed state and a flexible valve member can be mounted to the partially collapsed frame. The partially collapsed struts can be formed with multiple bends having angles selected to facilitate crimping of the frame to a profile suitable for percutaneous delivery. When the frame is expanded, the bends can expand to form obtuse angles, thereby enhancing the rigidity of the frame to better resist closing forces exerted on the valve assembly.

Abstract: An advancing mechanism for an endoscope constituted of: a generally tubular shaped sheath exhibiting an inner diameter and a length sufficient to at least partially encase an articulating section of the endoscope, the sheath comprising a plurality of deployable members arrayed thereabout, each exhibiting a first end attached to the sheath and a second end longitudinally extending away from the first end, each of the deployable members movable from a closed position to an open position, wherein in the closed position the deployable members do not substantially extend past an outer surface of the sheath and in the open position the second end of each of the deployable members extend past the outer surface of the sheath, and wherein in the open position each of the deployable members exhibit an angle in relation to the outer surface of the sheath of up to 60 degrees.

Abstract: A prosthetic valve for catheter delivery is disclosed. The prosthetic valve comprises a valve assembly having an inlet, a plurality of leaflets and commissural points. The prosthetic valve also includes a support stent comprising a web-like construction and plurality of longitudinal support beams. The support stent is configured to be collapsible for percutaneous delivery through a blood vessel and expandable to contact the the native valve. The support stent supports the inlet of the valve assembly and the commissural points of the valve assembly are secured at the longitudinal support beams. The longitudinal support beams comprise a plurality of bores and the leaflets are secured to the longitudinal support beams via threads passing through the plurality of bores.

Abstract: A method for implanting a prosthetic valve apparatus in a novel location which replaces the function of a native diseased valve. The prosthetic valve apparatus includes a one way valve and an expandable valve seating. anchoring and securing apparatus in a newly created orifice near or at the center of the anterior valve leaflet. The prosthetic valve apparatus also causes the sealing of the native valve and thus results in a solution for paravalvular leakage and regurgitation.

Abstract: A valve prosthesis device is disclosed suitable for implantation in body ducts. The device comprises a support stent, comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet. The support stent is provided with a plurality of longitudinally rigid support beams of fixed length.

Abstract: An apparatus and method for anchoring an elongated object, for example a wire, in tubular body vessel, such as arteries, veins, the colon, bile ducts, etc. are disclosed. The wire may be a catheter, a guide wire, a tube or an electrical lead. In one embodiment, a fixation device is advanced over the wire and, upon external actuation, either deforms the wire or deploys an anchoring mechanism so as to secure the wire against the vessel wall. The anchoring mechanism can be easily removed from the vessel even in the presence of vessel occlusion. In another embodiment, a wire tensioned between two locations on a distal section of the wire deforms the wire and urges the wire into wall apposition.

Abstract: An improved crimping mechanism and method well-suited for use with stented prosthetic heart valves. The crimping mechanism includes a plurality of jaws configured for linear non-rotational movement toward a central axis. A rotational plate is formed with a plurality of spiral grooves or tracks for engaging the jaws. Rotational movement of the spiral tracks produces linear movement of the jaws. Nesting of the inner ends of the jaws permits each to be acted on along different radial lines while their inner faces move together evenly to reduce the crimping aperture in a smooth fashion. The crimping mechanism is particularly well-suited for use with stented prosthetic heart valves, such as a prosthetic aortic valve, though it can also be applied to other stented heart valves, venous valves, and even stent grafts which tend to be fairly large.

Abstract: A guidewire stop is disclosed which can be positioned and frictionally locked to a bare guidewire at a user-defined location. The guidewire stop can be used to stop and/or lock a medical device, such as an embolic filter, at a treatment site inside a body lumen. The medical device may be attached to the guidewire stop.

Abstract: Methods and apparatus are provided for treating congestive heart by actively or passively enhancing perfusion to the renal arteries. A first embodiment comprises a specially configured balloon catheter and extracorporeal pump, wherein the pump operates in a “once-through” fashion or alternating volume displacement mode. In another embodiment the catheter includes a pair of balloons to isolate a region of the aorta, and a third balloon that directs flow into the renal arteries. In still further embodiments, a stent or cuff having a constricted region is deployed in or around the aorta, respectively, to create a backpressure upstream of the stent or cuff. Methods of enhancing renal perfusion also are provided.

Abstract: A user-actuatable guidewire stop is disclosed which can be used to stop and/or lock a medical device on a guidewire advanced through a body lumen. The guidewire stop is configured as a coil spring having an inner lumen configured to slideably and rotationally receive the guidewire in an unlocked configuration, and to frictionally engage the guidewire in a locked configuration. The coil spring is composed of turns having at least one protrusion disposed on a turn of the coil spring and adapted for engagement with a corresponding recess disposed on an adjacent turn of the coil spring, wherein the at least one protrusion interlocks with the corresponding recess to maintain the coil spring in the unlocked configuration. The coil spring transitions into the unlocked configuration by disengaging the at least one protrusion from the corresponding recess.

Abstract: Methods and apparatus are provided for treating congestive heart by actively or passively enhancing perfusion to the renal arteries. A first embodiment comprises a specially configured balloon catheter and extracorporeal pump, wherein the pump operates in a “once-through” fashion or alternating volume displacement mode. In another embodiment the catheter includes a pair of balloons to isolate a region of the aorta, and a third balloon that directs flow into the renal arteries. In still further embodiments, a stent or cuff having a constricted region is deployed in or around the aorta, respectively, to create a backpressure upstream of the stent or cuff. Methods of enhancing renal perfusion also are provided.

Abstract: A disposable sterile handle cover uses a flexible bag, a portion of the open side of which is held snugly by a retaining ring to the inside of a conical skirt. A first set of spikes include variable length spikes protruding from the inner wall, to secure the bag against the handle. A second set of spikes protrude inwardly from the retaining ring and promote stretching and orderly application of the to the handle.

Abstract: A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state.

Abstract: The present invention provides a series of new percutaneous concepts of paravalvular repairs including identifying the leak location, several repair techniques and finally built-in means for leak prevention, built on percutaneous valves. A catheter-delivered device locates cavities occurring between a prosthetic valve and the wall of the body vessel where the valve is implanted, the cavities producing paravalvular leaks during diastole, the device comprising at least one of a plurality of flexible wires, the wire having attached to it a balloon, wherein the balloon is pulled by the leak through the cavity and wherein the wire then serves to mark the cavity location.

Abstract: A two-part implantable heart valve and procedure are disclosed that allow expansion and positioning of a first part of the implantable heart valve having a temporary or transient valvular structure. A second part of the implantable heart valve is deployed within the first part and attaches thereto. The valvular structure of the second part then acts to function as the heart valve replacement. A tool or system is provided for determining an adequate percutaneous heart valve size for a given stenotic valve. A balloon can be inflated inside the stenotic valve to a desired pressure. When this pressure is reached an angiographic image is taken and the balloon diameter is measured at a waist area created by contact between the balloon and the stenotic valve. The diameter represents the minimum percutaneous heart valve diameter to be implanted.

Abstract: A retrieval catheter for retrieving deployed medical devices includes a first guidewire lumen and a second guidewire lumen spaced radially from the first guidewire lumen. The first guidewire lumen has a distal end portion configured to recapture a medical device, such as a collapsed embolic protection device, deployed in a body lumen and secured to a guidewire extending through the first guidewire lumen. The second guidewire lumen receives a second guidewire which may be advanced past a first interventional site to perform a second procedure. The retrieval catheter may be provided with a soft tip to reduce trauma to the body tissue.

Abstract: A delivery catheter includes a constraining sheath coupled to a distal end of the catheter, and a medical device, such as an embolic protection device (EPD) or a stent, constrained by the sheath. A wire may extend proximally from the constraining sheath and be coupled thereto. A proximal pulling force on the wire causes the wire to tear the constraining sheath, thereby releasing the medical device from a constrained configuration to an expanded configuration.

Abstract: An improved crimping mechanism well-suited for use with stented prosthetic heart valves. The crimping mechanism includes a plurality of jaws configured for linear non-rotational movement toward a central axis. A rotational plate is formed with a plurality of spiral grooves or tracks for engaging the jaws. Rotational movement of the spiral tracks produces linear movement of the jaws. Nesting of the inner ends of the jaws permits each to be acted on along different radial lines while their inner faces move together evenly to reduce the crimping aperture in a smooth fashion. The crimping mechanism is particularly well-suited for use with stented prosthetic heart valves, such as a prosthetic aortic valve, though it can also be applied to other stented heart valves, venous valves, and even stent grafts which tend to be fairly large.

Abstract: A guidewire stop is disclosed which can be positioned and frictionally locked to a bare guidewire at a user-defined location. The guidewire stop can be used to stop and/or lock a medical device, such as an embolic filter, at a treatment site inside a body lumen. The medical device may be attached to the guidewire stop.

Abstract: A user-actuatable guidewire stop is disclosed which can be used to stop and/or lock a medical device on a guidewire advanced through a body lumen. In one embodiment, the guidewire stop is configured as a coil spring having an inner lumen configured to slideably and rotationally receive the guidewire in an unlocked configuration, and to frictionally engage the guidewire in a locked configuration, wherein in the inside diameter of the coil spring in the locked configuration is smaller than the diameter in the unlocked configuration. A restraining member maintains the coil spring in the unlocked configuration during deployment and is removed at the interventional site causing the coil spring to collapse onto the guidewire. The guidewire stop can be employed with an embolic filter or another intravascular device.