Abstract: A system and process for placing a percutaneous valve device in a body lumen at the location of implantation is provided which enhances the accuracy of the placement. Anchors and placement wires are used to fix the implantation target and guide the device to the implantation site. The system and method are applicable to pre-assembled percutaneous valve devices as well as a modular prosthetic valve device. The modular valve device comprises two or more device modules and is designed to be delivered unassembled and then assembled in the body lumen at or near the site where implantation occurs. The device modules may be assembled before or after the implantation target is fixed with the anchor, and then placed using the placement system in a manner similar to how a pre-assembled percutaneous valve device may be placed in accordance with the invention.

Abstract: A catheter tip having a spring element that imparts longitudinal flexibility, pushability and radial rigidity to the catheter tip, thereby improving deliverability, is provided. The spring element also provides radial support to the distal edge of the catheter tip. The spring element may taper distally, but may have a substantially constant inner luminal diameter. The spring element may be partially covered or embedded, leaving its distal end exposed. The spring element may also include spaced coils in a proximal region. The apparatus may be used with any interventional catheter system, but is particularly suitable for use with balloon-expandable stent systems and balloon-angioplasty systems, where flexibility of the catheter tip and minimal flaring of the distal edge of the catheter tip is desirable.

Abstract: An expandable helical stent is provided, wherein the stent may be formed of an amorphous metal alloy or other non-amorphous metal with a securement. The stent is formed from flat or tubular metal in a helical coiled structure which has an undulating pattern. The main stent component may be formed of a single helically coiled component. Alternatively, a plurality of helically coiled ribbons may be used to form a stent heterogeneous in design, material, or other characteristic particular to that stent. The helical tubular structure may be secured with a securement, such as a weld, interlock or a polymer, to maintain the helical coils in a tubular configuration. The helical coils of the main stent component may be spaced apart or nestled to each other. The nestling of the undulation of adjacent helical coils contributes to maintaining the tubular shape of the helically coiled stent.

Abstract: An attachment mechanism and method for attaching or coupling a guide wire to a catheter for re-canalization or opening a passage through an occlusion in a blood vessel is provided. The attachment mechanism generates friction forces against the guide wire to couple the guide wire to a catheter, which design permits a greater force to be used on the guide wire during a re-canalization procedure. The invention also encompasses use of the attachment mechanism in conjunction with active catheters, which have vibration-generating means to oscillate the distal end of the catheter or a component in the distal end of the catheter, to add vibration motion, preferably axial vibration motion, to the increased force that may be applied to the guide wire for purposes of penetrating an occlusion. The methods of the invention relate to methods of attaching the guide wire to the catheter and methods of treating a vessel having a partial or total occlusion.

Abstract: A system and process for placing a percutaneous valve device in a body lumen at the location of implantation is provided, which enhances the accuracy of the placement. Anchors and placement wires are used to fix the implantation target and guide the device to the implantation site. The system and method are applicable to preassembled percutaneous valve devices as well as a modular prosthetic valve device. The modular valve device comprises two or more device modules and is designed to be delivered unassembled and then assembled in the body lumen at or near the site where implantation occurs. The device modules may be assembled before or after the implantation target is fixed with the anchor, and then placed using the placement system in a manner similar to how a preassembled percutaneous valve device may be placed in accordance with the invention.

Abstract: An attachment mechanism and method for attaching or coupling a guide wire to a catheter for re-canalization or opening a passage through an occlusion in a blood vessel is provided. The attachment mechanism generates friction forces against the guide wire to couple the guide wire to a catheter, which design permits a greater force to be used on the guide wire during a re-canalization procedure. The invention also encompasses use of the attachment mechanism in conjunction with active catheters, which have vibration-generating means to oscillate the distal end of the catheter or a component in the distal end of the catheter, to add vibration motion, preferably axial vibration motion, to the increased force that may be applied to the guide wire for purposes of penetrating an occlusion. The methods of the invention relate to methods of attaching the guide wire to the catheter and methods of treating a vessel having a partial or total occlusion.

Abstract: The invention provides a device for fine adjustment of a prosthetic valve device and a method of adjusting the position of a prosthetic valve after implantation. The adjustment mechanism includes complementary structures on a valve member and device frame that cooperate to provide relative axial and/or angular motion between the valve member and device frame (and thus the native vessel). The adjustment mechanism of the invention may also include a means for selectively maintaining the relative position of the valve member and device frame. The device and method are particularly applicable for use with a modular prosthetic valve device that is assembled in the body lumen.

Abstract: An expandable helical stent is provided, wherein the stent may be formed of an amorphous metal alloy or other non-amorphous metal with a securement. The stent is formed from flat or tubular metal in a helical coiled structure which has an undulating pattern. The main stent component may be formed of a single helically coiled component. Alternatively, a plurality of helically coiled ribbons may be used to form a stent heterogeneous in design, material, or other characteristic particular to that stent. The helical tubular structure may be secured with a securement, such as a weld, interlock or a polymer, to maintain the helical coils in a tubular configuration. The helical coils of the main stent component may be spaced apart or nestled to each other. The nestling of the undulation of adjacent helical coils contributes to maintaining the tubular shape of the helically coiled stent.

Abstract: An attachment mechanism and method for attaching or coupling a guide wire to a catheter for re-canalization or opening a passage through an occlusion in a blood vessel is provided. The attachment mechanism generates friction forces against the guide wire to couple the guide wire to a catheter, which design permits a greater force to be used on the guide wire during a re-canalization procedure. The invention also encompasses use of the attachment mechanism in conjunction with active catheters, which have vibration-generating means to oscillate the distal end of the catheter or a component in the distal end of the catheter, to add vibration motion, preferably axial vibration motion, to the increased force that may be applied to the guide wire for purposes of penetrating an occlusion. The methods of the invention relate to methods of attaching the guide wire to the catheter and methods of treating a vessel having a partial or total occlusion.

Abstract: An expandable helical stent is provided, wherein the stent may be formed of an amorphous metal alloy or other non-amorphous metal with a securement. The stent is formed from flat or tubular metal in a helical coiled structure which has an undulating pattern. The main stent component may be formed of a single helically coiled component. Alternatively, a plurality of helically coiled ribbons may be used to form a stent heterogeneous in design, material, or other characteristic particular to that stent. The helical tubular structure may be secured with a securement, such as a weld, interlock or a polymer, to maintain the helical coils in a tubular configuration. The helical coils of the main stent component may be spaced apart or nestled to each other-maintain the tubular shape of the helically coiled stent and prevent the polymer layer from sagging at any point between cycles of the coils.

Abstract: The present invention provides a modular prosthetic valve device having two or more device modules for percutaneous delivery unassembled at or near the valve implantation site and assembly at least in part using a self-assembly member, and a system and method of folding, delivering and assembling the device. The device modules may include a support structure and a valve module. The valve module has an unassembled, folded delivery configuration, and an unfolded, assembled (via the self-assembly member) working configuration. The valve module may be a single-piece leaflets substructure or a plurality of valve sections. The self-assembly member has a delivery configuration and may be reverted to a preset configuration for valve module assembly. The unassembled valve module may be rolled along its circumferential axis towards its height to a folded diameter equivalent to one rolled leaflet, providing a percutaneous valve device having a smaller delivery diameter than pre-assembled valve devices.

Abstract: The invention provides a device for fine adjustment of a prosthetic valve device and a method of adjusting the position of a prosthetic valve after implantation. The adjustment mechanism includes complementary structures on a valve member and device frame that cooperate to provide relative axial and/or angular motion between the valve member and device frame (and thus the native vessel). The adjustment mechanism of the invention may also include a means for selectively maintaining the relative position of the valve member and device frame. The device and method are particularly applicable for use with a modular prosthetic valve device that is assembled in the body lumen.

Abstract: A modular prosthetic valve device for implantation in a patient and a system for and method of delivering such a modular valve device and assembling it in vivo are disclosed. The valve device is designed as two or more modules to be delivered unassembled, spatially separate, and combined into an assembled valve device in the body at or near the site of implantation. The valve device of the invention is deliverable as modules, providing a smaller delivery diameter than pre-assembled percutaneous valves, permitting use of a delivery device of reduced diameter, and increasing the flexibility of the valve device during delivery, compared to percutaneous valve devices in the art. The modules of the valve device may be connected by pull wires for delivery sequentially, and then assembled by remote manipulation using the pull wires. Various locking mechanisms are provided for attaching the device modules together.

Abstract: The present invention provides a modular prosthetic valve device having two or more device modules for percutaneous delivery unassembled at or near the valve implantation site and assembly at least in part using a self-assembly member, and a system and method of folding, delivering and assembling the device. The device modules may include a support structure and a valve module. The valve module has an unassembled, folded delivery configuration, and an unfolded, assembled (via the self-assembly member) working configuration. The valve module may be a single-piece leaflets substructure or a plurality of valve sections. The self-assembly member has a delivery configuration and may be reverted to a preset configuration for valve module assembly. The unassembled valve module may be rolled along its circumferential axis towards its height to a folded diameter equivalent to one rolled leaflet, providing a percutaneous valve device having a smaller delivery diameter than pre-assembled valve devices.

Abstract: An expandable helical stent is provided, wherein the stent may be formed of an amorphous metal alloy or other non-amorphous metal with a securement. The stent is formed from flat or tubular metal in a helical coiled structure which has an undulating pattern. The main stent component may be formed of a single helically coiled component. Alternatively, a plurality of helically coiled ribbons may be used to form a stent heterogeneous in design, material, or other characteristic particular to that stent. The helical tubular structure may be secured with a securement, such as a weld, interlock or a polymer, to maintain the helical coils in a tubular configuration. The helical coils of the main stent component may be spaced apart or nestled to each other to maintain the tubular shape of the helically coiled stent and prevent the polymer layer from sagging at any point between cycles of the coils.

Abstract: A modular prosthetic valve device for implantation in a patient and a system for and method of delivering such a modular valve device and assembling it in vivo are disclosed. The valve device is designed as two or more modules to be delivered unassembled, spatially separate, and combined into an assembled valve device in the body at or near the site of implantation. The valve device of the invention is deliverable as modules, providing a smaller delivery diameter than pre-assembled percutaneous valves, permitting use of a delivery device of reduced diameter, and increasing the flexibility of the valve device during delivery, compared to percutaneous valve devices in the art. The modules of the valve device may be connected by pull wires for delivery sequentially, and then assembled by remote manipulation using the pull wires. Various locking mechanisms are provided for attaching the device modules together.

Abstract: An apparatus, system, and method for re-canalization or opening a passage through an occlusion in a blood vessel is provided. The apparatus and method, which are appropriate for cardiovascular and peripheral vessels, use a pulling member and a spring element, for example a compression spring, to oscillate a distal component disposed at a distal end of the spring element. The apparatus further includes a sleeve covering the spring element and at least a portion of the distal component. The sleeve may reduce friction between the spring element and the vessel lumen as the spring element vibrates during operation of the apparatus. The sleeve may also serve to protect or seal the spring element from blood and/or plaque debris that is loosened from an occlusion during a re-canalization procedure.

Abstract: A therapeutic device and therapeutic method for delivering electrical energy or medicament to a body tissue or organ utilizing ultrasonic vibration to cause a device implanted in the body tissue or organ to be treated to discharge an electrical current or medicament to the target area.

Abstract: An intravascular stent especially suited for implanting in curved arterial portion. The stent retains longitudinal flexibility after expansion. The stent is formed of intertwined meander patterns forming triangular cells. The cells are adapted to provide radial support, and also provide longitudinal flexibility after expansion. The cells also provide increase coverage of a vessel wall. Loops in the stent are disposed and adapted to cooperate, so that after expansion of said stent within a curved lumen, the stent is curved and cells on the outside of the curve open in length, but narrow in width, whereas cells on the inside of the curve shorten in length, but thicken in width to maintain a density of the stent element area which is much more constant than otherwise between the inside and outside of the curve. The stent also minimizes flaring out by eliminating free loops of the radially supporting circumferential bands of loops.

Abstract: An expandable helical stent is provided, wherein the stent may be formed of a main stent component and a securement. The main stent component is formed from a flat strip having one or more undulating side bands that may be connected to form geometrically shaped cells and are helically wound to form a stent. The helical coils of the main stent component may be spaced apart or nestled to each other. The nestling of the undulation of adjacent helical windings contributes to maintaining the tubular shape and uniformity of the helically coiled stent. Alternatively, the flat strip may comprise a single undulating pattern. At the ends of the main stent component are end bands, which when wound, form a cylindrical ring. In one embodiment, one or more struts of the main stent component may have a width sufficient to include one or more fenestrations. The fenestrated struts may be connected by loops or turns wherein the material is narrower than that of the fenestrated struts to provide enhanced flexibility.