Intra-atrial implants made of non-braided material
Several unique intra-cardiac pressure devices, placement catheters, methods of placement and methods of treating heart failure are presented. The intra-cardiac pressure devices presented allow sufficient flow from the left atrium to the right atrium to enable the relief of elevated left atrial pressure and resulting patient symptoms. The intra-cardiac pressure devices are made of a non-braided material.
1. A device for implanting in an opening is a septal wall in a heart of a patient, the device comprising:
a core segment defining a passage through which fluid can flow after implantation of the device, the passage comprising a diameter larger than about 5 mm, the flow being from one side of the septal wall to another side of the septal wall, the core segment having a first diameter when deployed;
a first annular flange contiguous with the core segment; and
a second annular flange contiguous with the core segment,
wherein the device is collapsible, enabling the core segment to have a second diameter less than the first diameter thereby enabling percutaneous delivery of the device to the heart of the patient, and
wherein the core segment comprises a non-braided substantially open mesh.
2. The device of claim 1 wherein at least one of the first annular flange and the second annular flange is more flexible than the core segment.
3. The device of claim 1 wherein at least one of the first annular flange and the second annular flange comprises a plurality of flange segments.
4. The device of claim 3 wherein at least one of the plurality of flange segments is longer than another one of the flange segments.
5. The device of claim 3 , wherein at least one of said plurality of flange segments comprises a radiopaque marker.
6. The device of claim 1 wherein the device is self-expandable upon deployment.
7. The device of claim 1 wherein the device is balloon-expandable.
8. The device of claim 1 wherein the flanges define a gap to accommodate the septal wall.
9. The device of claim 8 wherein the gap is variable, thereby enabling the accommodation of variable septal thicknesses.
10. The device of claim 1 further comprising a flow control element having two sides and attached to said core segment.
11. The device of claim 10 , wherein said flow control element opens upon an occurrence of a pressure differential between said two sides of said flow control element.
12. The device of claim 11 wherein said flow control element allows fluid to flow through said passage from an area of higher pressure to an area of lower pressure.
13. The device of claim 12 , wherein said pressure differential is at least 2 mm Hg.
14. The device of claim 10 , wherein said flow control element is a valve.
15. The device of claim 14 , wherein said valve comprises at least two leaflets.