Direct cardiac pressure monitoring
A septal closure device includes a frame comprising one or more tissue anchor features, an occluding membrane, and a pressure sensor device attached to the occluding membrane.
1. A septal closure device comprising:
a wireform frame comprising:
a central portion defining a circular shape; and
a plurality of anchor loops that project radially outward from the central portion, each of the plurality of anchor loops forming a respective internal void;
a planar occluding membrane formed as a sheet coupled to the central portion of the wireform frame and spanning a central void within the central portion of the wireform frame, the central void and occluding membrane lying in a plane that is perpendicular to an ax is of the circular shape of the central portion; and
a pressure sensor device attached to the occluding membrane;
wherein:
the occluding membrane sheet covers an entirety of the central void within the central portion outside of a portion occupied by the pressure sensor device;
the occluding membrane sheet does not cover the internal voids of the plurality of anchor loops;
the pressure sensor device comprises a first portion disposed on a first side of the occluding membrane sheet and a second portion disposed on a second side of the occluding membrane sheet; and
the pressure sensor device is supported solely by the occluding membrane sheet and not directly by the wireform frame.
2. The septal closure device of claim 1 , wherein the first portion of the pressure sensor device comprises a first pressure sensor element, and the second portion of the pressure sensor device comprises a second pressure sensor element.
3. The septal closure device of claim 1 , wherein the occluding membrane comprises a cloth, the cloth holding the pressure sensor device in suspension.
4. The septal closure device of claim 1 , wherein the occluding membrane comprises woven polymer fibers.
5. The septal closure device of claim 1 , wherein the pressure sensor device comprises a rigid cylindrical body.
6. The septal closure device of claim 1 , wherein, in a non-deflected configuration, the plurality of anchor loops are coplanar with the central portion.
7. The septal closure device of claim 1 , wherein each of the plurality of anchor loops has a radially inner neck that is open to the central void of the wireform frame.
8. The septal closure device of claim 1 , wherein:
the plurality of anchor loops comprises four angularly distributed diamond-shaped loop anchors emanating from the central portion of the wireform frame;
the central portion of the wireform frame has a form of a segmented ring lying in the plane perpendicular to the axis of the central portion; and
the pressure sensor device passes through the occluding membrane, the pressure sensor device being co-axial with the axis of the central portion of the wireform frame.
9. The septal closure device of claim 8 , wherein each of the four angularly distributed loop anchors originates at a neck portion defined by and emanating from end portions of adjacent segments of the segmented ring and expands moving radially outward to form the diamond shape.
10. The septal closure device of claim 8 , wherein:
a first loop anchor and a second loop anchor of the four angularly distributed loop anchors each include an eyelet at a distal end of the respective loop anchor; and
the first loop anchor and the second loop anchor are positioned opposite one another about the segmented ring.
11. The septal closure device of claim 1 , wherein
the wireform frame comprises a plurality of arc segments that define the circular shape of the central portion, the central portion having a form of a circular boundary with a plurality of angular breaks;
the occluding membrane sheet comprises a cloth having a perimeter attached to the central portion.
12. The septal closure device of claim 11 , wherein the plurality of anchor loops have neck regions defining the plurality of angular breaks of the circular boundary.
13. The septal closure device of claim 1 , wherein the wireform frame is formed from a single, continuous wire.
14. The septal closure device of claim 1 , wherein each of the plurality of anchor loops has a diamond shape with a width that is greater than a length of the anchor loop.