Intra-atrial implants having variable thicknesses to accommodate variable thickness in septum
The invention is a septal implant that can accommodate variable thicknesses of the patient's atrial septum as well the variable thicknesses of septums across a population. The invention is able to accomplish this result by having flexible annular flanges that define a gap into which the septum fits. Due to the flexible nature of the annular flanges, the gap is adjustable.
1. A device for directing blood flow across in the atrial septum in a heart of a patient, the device comprising: a. a core segment having a length greater than the atrial septum and defining a passage, the core segment having a first diameter when deployed; b. a first flexible annular flange joining a first end of the core segment, wherein the first flexible annual flange is configured to form a substantially flat surface that contacts one side of the atrial septum, forming a first contacting surface; and c. a second flexible annular flange joining a second end of the core segment; wherein a distal portion of the second flexible annular flange is formed to lie at a parallel angle to and to contact the other side of the atrial septum, forming a second contacting surface, and wherein the first contacting surface is greater than the second contacting surface; a flow control element attached to 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, wherein at least a portion of the first and second annular flanges define an annular gap, and wherein said annular gap is smaller than the length of the core segment.
2. The device of claim 1 wherein the annular gap is has a width less than a thickness of the septum.
3. The device of claim 1 wherein the annular gap has a width greater than a thickness of the septum.
4. 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.
5. 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.
6. The device of claim 5 wherein at least one of the plurality of flange segments is longer than another one of the flange segments.
7. The device of claim 5 , wherein at least one of said plurality of flange segments comprises a radiopaque marker.
8. The device of claim 1 wherein the device is self-expandable upon deployment.
9. The device of claim 1 wherein the device is balloon-expandable.
10. The device of claim 1 wherein the core segment comprises a substantially open mesh.
11. The device of claim 10 wherein the core segment is comprised of a nonbraided material.
12. The device of claim 1 , wherein said flow control element opens upon an occurrence of a pressure differential between said two sides of said flow control element.
13. The device of claim 12 wherein said flow control element allows fluid to flow through said passage from an area of higher pressure to an area of lower pressure.
14. The device of claim 13 , wherein said pressure differential is at least 2 mm Hg.
15. The device of claim 1 , wherein said flow control element is a valve.
16. The device of claim 15 , wherein said valve comprises at least two leaflets.
17. The device of claim 1 , wherein the flow control element is configured to allow sufficient flow from the left atrium to the right atrium to relieve elevated left atrial pressure.