Sealing device and delivery system
View Patent ↗The invention relates to a sealing device for repair of cardiac and vascular defects or tissue opening such as a patent foramen ovale (PFO) or shunt in the heart, the vascular system, etc. and particularly provides an occluder device and trans-catheter occluder delivery system. The sealing device would have improved conformity to heart anatomy and be easily deployed, repositioned, and retrieved at the opening site.
1. A sealing device comprising:
an expandable frame comprising a plurality of wires, each of the wires extending helically and continuously from a proximal end to a distal end of the frame and through a center region therebetween;
first and second portions of each of the plurality of wires forming a wound proximal eyelet and a wound distal eyelet, respectively, and the plurality of wires forming a proximal disk and a distal disk when the sealing device assumes a deployed configuration, the proximal disk and the distal disk each disposed between the proximal eyelet and the distal eyelet, each wire of the plurality of wires forming a respective petal of the proximal disk and forming a respective petal of the distal disk, wherein adjacent petals of the proximal disk overlap one another and are not interwoven with one another, adjacent petals of the distal disk overlap one another and are not interwoven with one another, and each of the petals is configured to conform to tissue;
central portions of the plurality of wires converging at the central region to form a wound intermediate eyelet, the wound intermediate eyelet being arranged between the proximal disk and the distal disk, and each of the plurality of wires converging at the central region in a different location around a circumference of the wound intermediate eyelet and further wound around in the central region to form the wound intermediate eyelet; and
a sealing member attached to the expandable wire frame and covering the proximal disk, the distal disk, the proximal eyelet, the distal eyelet, and the wound intermediate eyelet.
2. The sealing device of claim 1 , wherein the expandable frame further comprises a locking loop configured to release during deployment and lock the sealing device in the deployed configuration, and the locking loop arranged from the proximal eyelet and configured to lock the sealing device in the deployed configuration.
3. The sealing device of claim 2 , wherein the locking loop is further configured to attach to a delivery system.
4. The sealing device of claim 2 , wherein the intermediate eyelet comprises a portion of each wire of the plurality of wires wound in a looped configuration.
5. The sealing device of claim 1 , wherein the expandable wire frame comprises at least 5 wires.
6. The sealing device of claim 1 , wherein the sealing member comprises a material selected from the group consisting of polyester, polyethylene, polypropylene, fluoropolymer, polyurethane, silicone, nylon, and silk.
7. The sealing device of claim 6 , wherein the fluoropolymer comprises polytetrafluoroethylene.
8. The sealing device of claim 7 , wherein the polytetrafluoroethylene comprises expanded polytetrafluoroethylene.
9. The sealing device of claim 1 , wherein the plurality of wires comprise nitinol.
10. The sealing device of claim 9 , wherein the nitinol comprises 10% by weight platinum.
11. The sealing device of claim 10 , wherein the nitinol is drawn filled nitinol.
12. The sealing device of claim 1 , wherein the sealing member is attached to the plurality of wires.
13. The sealing device of claim 12 , wherein the sealing member is attached to the plurality of wires by an adhesive.
14. The sealing device of claim 13 , wherein the adhesive comprises FEP.
15. The sealing device of claim 1 , further comprising a distal bumper located distal to the distal eyelet.
16. The sealing device of claim 1 , wherein at least one of the eyelets are formed into a non-circular shape.
17. The sealing device of claim 1 , wherein portions of the petals of the proximal disk define an outer perimeter of the proximal disk.
18. The sealing device of claim 17 , wherein portions of the petals of the distal disk define an outer perimeter of the distal disk.
19. The sealing device of claim 1 , wherein the expandable frame comprises only 5 wires.
20. The sealing device of claim 1 , wherein the expandable frame is self-expandable.
21. The sealing device of claim 1 , wherein at least one of the wires further comprises a portion that extends proximally from the distal end of the frame and forms a locking loop.
22. The sealing device of claim 1 , wherein each of the petals is configured to conform to heart tissue adjacent an opening in the heart tissue.