Abstract: An implantable prosthesis for percutaneous placement within a vein that forces opposing portions of the vessel wall of a vein together to create a new valve of autologous vein tissue to be operable to alternate between a valve closed configuration and a valve open configuration. When in a preset closed configuration, the implantable prosthesis pushes or pulls portions of the vessel wall of the vein together to substantially close the vein lumen and prevent retrograde blood flow from backflowing through the new valve in the valve closed configuration. The implantable prosthesis has leg portions that may be pushed apart in response to antegrade blood flow through the vein to allow the new valve to achieve the valve open configuration.

Abstract: Percutaneous methods and apparatuses for forming a venous valve from autologous tissue. A catheter having a retractable dissecting system received therein is delivered to a target location where a new venous valve is to be created. A distal balloon or other radially-expandable component mounted on the catheter is expanded against the vein wall, and the dissecting system is proximally retracted to deploy one or more dissecting components that dissect a subintimal layer of the vein wall. Radial expansion of the dissecting component(s) within the vein wall creates one or more leaflets and corresponding pocket/sinuses in the vein that collectively act as a venous valve, and/or the radially-expandable component of the catheter is subsequently collapsed such that the dissecting component(s) each pull a flap of the dissected tissue towards the vein lumen to create one or more leaflet(s) and corresponding pocket/sinuses in the vein.

Abstract: Percutaneous methods and apparatuses for forming a venous valve from autologous tissue. A catheter having a retractable dissecting system received therein is delivered to a target location where a new venous valve is to be created. A distal balloon or other radially-expandable component mounted on the catheter is expanded against the vein wall, and the dissecting system is proximally retracted to deploy one or more dissecting components that dissect a subintimal layer of the vein wall. Radial expansion of the dissecting component(s) within the vein wall creates one or more leaflets and corresponding pocket/sinuses in the vein that collectively act as a venous valve, and/or the radially-expandable component of the catheter is subsequently collapsed such that the dissecting component(s) each pull a flap of the dissected tissue towards the vein lumen to create one or more leaflet(s) and corresponding pocket/sinuses in the vein.

Abstract: Percutaneous methods and apparatuses for forming a venous valve from autologous tissue. A catheter having a retractable dissecting system received therein is delivered to a target location where a new venous valve is to be created. A distal balloon or other radially-expandable component mounted on the catheter is expanded against the vein wall, and the dissecting system is proximally retracted to deploy one or more dissecting components that dissect a subintimal layer of the vein wall. Radial expansion of the dissecting component(s) within the vein wall creates one or more leaflets and corresponding pocket/sinuses in the vein that collectively act as a venous valve, and/or the radially-expandable component of the catheter is subsequently collapsed such that the dissecting component(s) each pull a flap of the dissected tissue towards the vein lumen to create one or more leaflet(s) and corresponding pocket/sinuses in the vein.

Abstract: A stent includes a wave form that includes a cable including a plurality of strands. The wave form has a plurality of struts and a plurality of crowns, with each crown connecting two adjacent struts. The wave form is wrapped around a longitudinal axis at a pitch to define a plurality of helical turns. The stent includes a filler located within the cable. The filler includes a therapeutic substance.

Abstract: An implantable prosthesis for percutaneous placement within a vein that forces opposing portions of the vessel wall of a vein together to create a new valve of autologous vein tissue to be operable to alternate between a valve closed configuration and a valve open configuration. When in a preset closed configuration, the implantable prosthesis pushes or pulls portions of the vessel wall of the vein together to substantially close the vein lumen and prevent retrograde blood flow from backflowing through the new valve in the valve closed configuration. The implantable prosthesis has leg portions that may be pushed apart in response to antegrade blood flow through the vein to allow the new valve to achieve the valve open configuration.

Abstract: Percutaneous apparatus for forming a bicuspid venous valve from autologous tissue are disclosed. A multilumen catheter is disclosed that includes a delivery shaft positioned on either side of the balloon. When the balloon is inflated within the vein at a treatment location where a bicuspid valve is to be created, the delivery shafts are pressed into the wall of the vein by the inflated balloon so that exit ports in the delivery shafts are at diametrically opposed locations. The delivery shafts may than be used to deliver puncture elements through the exit ports and into the vessel wall to gain access to a subintimal layer of the vein wall. In this manner, the inventive multilumen catheter aids in making properly positioned flaps of venous tissue for creating a bicuspid venous valve from autologous tissue.

Abstract: A catheter apparatus for removing an obstruction within a body lumen includes an elongate tubular shaft defining a lumen and a flexible membrane that fluidly seals the distal end of the tubular shaft. At least one cutting element or tool is attached to and distally extends from the flexible membrane. An actuating mechanism is operatively connected to a proximal end of the tubular shaft. The actuating mechanism displaces a fluid disposed within the lumen of the tubular shaft in such a manner that the fluid oscillates the flexible membrane and the cutting element attached thereto. Accordingly, the catheter apparatus uses pulsatile fluid flow through the tubular shaft to transmit energy from the driving mechanical at the proximal end of the catheter apparatus to the flexible membrane at the distal end of the catheter apparatus. The transmitted energy causes the cutting element to oscillate and break up a target blood clot.

Abstract: Percutaneous methods and apparatuses for forming a venous valve from autologous tissue. A catheter having a retractable dissecting system received therein is delivered to a target location where a new venous valve is to be created. A distal balloon or other radially-expandable component mounted on the catheter is expanded against the vein wall, and the dissecting system is proximally retracted to deploy one or more dissecting components that dissect a subintimal layer of the vein wall. Radial expansion of the dissecting component(s) within the vein wall creates one or more leaflets and corresponding pocket/sinuses in the vein that collectively act as a venous valve, and/or the radially-expandable component of the catheter is subsequently collapsed such that the dissecting component(s) each pull a flap of the dissected tissue towards the vein lumen to create one or more leaflet(s) and corresponding pocket/sinuses in the vein.

Abstract: A stent includes a wave form that includes a cable including a plurality of strands. The wave form has a plurality of struts and a plurality of crowns, with each crown connecting two adjacent struts. The wave form is wrapped around a longitudinal axis at a pitch to define a plurality of helical turns. The stent includes a filler located within the cable. The filler includes a therapeutic substance.

Abstract: An implantable prosthesis for percutaneous placement within a vein that forces opposing portions of the vessel wall of a vein together to create a new valve of autologous vein tissue to be operable to alternate between a valve closed configuration and a valve open configuration. When in a preset closed configuration, the implantable prosthesis pushes or pulls portions of the vessel wall of the vein together to substantially close the vein lumen and prevent retrograde blood flow from backflowing through the new valve in the valve closed configuration. The implantable prosthesis has leg portions that may be pushed apart in response to antegrade blood flow through the vein to allow the new valve to achieve the valve open configuration.

Abstract: An implantable prosthesis for percutaneous placement within a vein that forces opposing portions of the vessel wall of a vein together to create a new valve of autologous vein tissue to be operable to alternate between a valve closed configuration and a valve open configuration. When in a preset closed configuration, the implantable prosthesis pushes or pulls portions of the vessel wall of the vein together to substantially close the vein lumen and prevent retrograde blood flow from backflowing through the new valve in the valve closed configuration. The implantable prosthesis has leg portions that may be pushed apart in response to antegrade blood flow through the vein to allow the new valve to achieve the valve open configuration.

Abstract: Percutaneous methods of forming a venous valve from autologous tissue are disclosed. The methods include percutaneously creating one or two subintimal dissections for forming one or two flaps of intimal tissue. In one method, a puncture element is delivered by a catheter based delivery system to a treatment site where a new venous valve is to be created. The puncture element is deployed to gain access to a subintimal layer of the vein wall. A dilation balloon is than positioned and inflated within the subintimal layer to create a flap and corresponding pocket/sinus in the vein, which than acts as a one-way monocuspid valve in the manner of a native venous valve. In a similar manner, methods of forming new bicuspid venous valves by subintimal dissections are also disclosed.

Abstract: Percutaneous apparatus for forming a bicuspid venous valve from autologous tissue are disclosed. A multilumen catheter is disclosed that includes a delivery shaft positioned on either side of the balloon. When the balloon is inflated within the vein at a treatment location where a bicuspid valve is to be created, the delivery shafts are pressed into the wall of the vein by the inflated balloon so that exit ports in the delivery shafts are at diametrically opposed locations. The delivery shafts may than be used to deliver puncture elements through the exit ports and into the vessel wall to gain access to a subintimal layer of the vein wall. In this manner, the inventive multilumen catheter aids in making properly positioned flaps of venous tissue for creating a bicuspid venous valve from autologous tissue.

Abstract: Percutaneous methods of forming a venous valve from autologous tissue are disclosed. The methods include percutaneously creating one or two subintimal dissections for forming one or two flaps of intimal tissue. In one method, a puncture element is delivered by a catheter based delivery system to a treatment site where a new venous valve is to be created. The puncture element is deployed to gain access to a subintimal layer of the vein wall. A dilation balloon is than positioned and inflated within the subintimal layer to create a flap and corresponding pocket/sinus in the vein, which than acts as a one-way monocuspid valve in the manner of a native venous valve. In a similar manner, methods of forming new bicuspid venous valves by subintimal dissections are also disclosed.

Abstract: A catheter apparatus for removing an obstruction within a body lumen includes an elongate tubular shaft defining a lumen and a flexible membrane that fluidly seals the distal end of the tubular shaft. At least one cutter member is attached to and distally extends from the flexible membrane. An actuating mechanism is operatively connected to a proximal end of the tubular shaft. The actuating mechanism displaces a fluid disposed within the lumen of the tubular shaft in such a manner that the fluid oscillates the flexible membrane and the cutter member attached thereto. Accordingly, the catheter apparatus uses pulsatile fluid flow through the tubular shaft to transmit energy from the driving mechanical at the proximal end of the catheter apparatus to the flexible membrane at the distal end of the catheter apparatus. The transmitted energy causes the cutting member to oscillate and break up a target blood clot.

Abstract: A catheter apparatus for removing an obstruction within a body lumen includes an elongate tubular shaft defining a lumen and a flexible membrane that fluidly seals the distal end of the tubular shaft. At least one cutting element or tool is attached to and distally extends from the flexible membrane. An actuating mechanism is operatively connected to a proximal end of the tubular shaft. The actuating mechanism displaces a fluid disposed within the lumen of the tubular shaft in such a manner that the fluid oscillates the flexible membrane and the cutting element attached thereto. Accordingly, the catheter apparatus uses pulsatile fluid flow through the tubular shaft to transmit energy from the driving mechanical at the proximal end of the catheter apparatus to the flexible membrane at the distal end of the catheter apparatus. The transmitted energy causes the cutting element to oscillate and break up a target blood clot.