Two valve caval stent for functional replacement of incompetent tricuspid valve
View Patent ↗A two valve caval stent for functional replacement of an incompetent tricuspid valve. The device is designed for minimally invasive percutaneous transcatheter placement and includes two stents connected by a bridge sized to span the right atrium, and two valves anchored by the stents in the superior and inferior vena cavas. Each of the valves optionally has a conical shape divided by supporting struts into three cusps that simulate the action of a native tricuspid valve.
1. A two valve caval stent for functional replacement of an incompetent tricuspid valve, comprising:
caval valves including a superior vena cava valve and inferior vena cava valve, each of said caval valves including a flexible valve membrane having at least three cusps and a plurality of cone support struts supporting each of said cusps at angularly spaced apart locations, each of said flexible valve membranes having a generally conical shape allowing said cusps to flex inwardly and segment the blood flow through said valves;
a first stent adapted to anchor said superior vena cava valve within the superior vena cava of a vertebrate body;
a second stent adapted to anchor said inferior vena cava valve within the inferior vena cava of said body;
a bridge, sized to span the right atrium, connecting said first and second vascular stents and said caval valves; and
wherein the ends of said cone support struts opposite the apex of said conically shaped caval valves are non-cantilevered and are movably mounted to said bridge to adjust the distance between said caval valves prior to fixation inside the body.
2. The two valve caval stent of claim 1 wherein said bridge includes a plurality of elongate connecting struts having ends attached to said first and second stents.
3. The two valve caval stent of claim 2 wherein said bridge includes three or more of said connecting struts are angularly spaced apart.
4. The two valve caval stent of claim 1 wherein the length of said connecting struts is at least 10 centimeters.
5. The two valve caval stent of claim 1 wherein each of said caval valves is comprised of a flexible valve membrane having three cusps.
6. The two valve caval stent of claim 5 and further comprising:
a plurality of support struts supporting each of said cusps of said caval valves at angularly spaced apart locations.
7. The two valve caval stent of claim 6 and further comprising:
a plurality of mounting ferrules attached to each of said support struts and slidably mounted to said connecting struts, said mounting ferrules adapted to be crimped into a fixed position along said support struts so as to fix the position of said caval valves a pre-established spaced apart distance corresponding to the desired implant locations within the superior and inferior vena cavas.
8. The two valve caval stent of claim 7 wherein each of said flexible valve membranes has a generally conical shape and defines a tip aperture sized to allow slidable passage of a correspondingly sized guidewire.
9. The two valve caval stent of claim 1 wherein said first and second stents are formed of a cross-braided wire netting construction.
10. The two valve caval stent of claim 9 wherein said first and second stents are formed of a shape memory alloy and have a self-expanding construction.
11. The two valve caval stent of claim 10 wherein said first and second stents are generally tubular shaped and expand inside the body to a diameter varying from about 20 to 25 mm.
12. The two valve caval stent of claim 11 wherein said first and second stents have central facing and peripheral ends and a generally tubular shape that flares to an increased diameter at said peripheral end.
13. The two valve caval stent of claim 1 and further comprising:
a plurality of barbs positioned along the periphery of said first and second stents.
14. The two valve caval stent of claim 1 wherein said bridge includes at least one orientation marker along its length.