Sealing device and delivery system
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 method of delivering a medical device to a delivery site within a patient, comprising:
providing a delivery system comprising a delivery catheter, a first tube slidably disposed within the delivery catheter, a second tube slidably disposed within the first tube, a housing having a slot, a linear actuator within the slot, and a retrieval cord;
loading the medical device into the delivery catheter, wherein the medical device comprises:
an expandable frame formed from a plurality of wires, each of the wires extending from a proximal end of the frame to a distal end of the frame, wherein first and second end portions of each of the plurality of wires are wound around a longitudinal axis of the medical device to define a proximal eyelet at the proximal end of the frame and a distal eyelet at the distal end of the frame, respectively, the plurality of wires also forming a proximal disk and a distal disk when the medical device assumes an expanded 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, adjacent petals of the distal disk overlap one another, and each of the petals is configured to conform to tissue; and
a sealing member at least partially encapsulating the frame,
wherein the first tube and the retrieval cord are releasably attached to the proximal end of the frame, and the second tube is releasably attached to the distal end of the frame;
advancing the delivery catheter to the delivery site;
moving the first tube and the second tube distally in relation to the delivery catheter by actuating the linear actuator to cause the medical device to protrude from the delivery catheter;
decoupling the first tube from the proximal end of the frame and the second tube from the distal end of the frame; and
decoupling the retrieval cord from the proximal end of the frame.
2. The method of claim 1 , wherein the frame further comprises an intermediate eyelet defined by winding intermediate portions of the plurality of wires around the longitudinal axis, wherein the intermediate eyelet is disposed between the proximal disk and the distal disk.
3. The method of claim 2 , wherein the sealing member is wrapped around the intermediate portions of the plurality of wires defining the intermediate eyelet.
4. The method of claim 1 , wherein the sealing member substantially encapsulates the frame.
5. The method of claim 1 , wherein the sealing member is wrapped around the second end portions of each of the plurality of wires defining the distal eyelet.
6. The method of claim 1 , wherein the sealing member is wrapped around the first end portions of each of the plurality of wires defining the proximal eyelet.
7. The method of claim 1 , wherein the plurality of wires comprises five wires.
8. The method 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.
9. The method of claim 8 , wherein the fluoropolymer comprises polytetrafluoroethylene.
10. The method of claim 9 , wherein the polytetrafluoroethylene comprises expanded polytetrafluoroethylene.
11. The method of claim 1 , wherein the plurality of wires comprise nitinol.
12. The method of claim 11 , wherein the nitinol comprises 10% platinum by weight.
13. The method of claim 11 , wherein the nitinol is drawn filled nitinol.
14. The method of claim 1 , wherein the sealing member is attached to at least some wires of the plurality of wires.
15. The method of claim 14 , wherein the sealing member is attached to at least some wires of the plurality of wires by an adhesive.
16. The method of claim 15 , wherein the adhesive comprises FEP.
17. The method of claim 1 , wherein the medical device further comprises a distal bumper located distal to the distal eyelet.
18. The method of claim 17 , wherein the medical device further comprises a device lock loop.
19. The method of claim 18 , wherein release of the device lock loop locks the medical device in a deployed state.
20. The method of claim 1 , wherein the plurality of wires extend helically from the proximal end of the frame to the distal end of the frame.
21. The method of claim 1 , wherein at least one of the proximal eyelet or the distal eyelet has a non-circular cross-sectional shape.
22. The method of claim 1 , wherein the delivery site is a septal defect.
23. The method of claim 22 , wherein the septal defect is a patent foramen ovale.
24. The method of claim 1 , wherein the delivery catheter comprises a radiopaque marker band.
25. The method of claim 1 , further comprising, prior to the decoupling, moving the first tube distally in relation to the second tube to allow the medical device to assume the expanded configuration.
26. The method of claim 1 , wherein the size of the delivery catheter is about 10 french.
27. The method of claim 1 , wherein the delivery catheter comprise a guidewire port.
28. The method of claim 1 , wherein the retrieval cord is releasably coupleable to the medical device.
29. The method of claim 28 , wherein the retrieval cord releasably couples the delivery system with the proximal eyelet of the medical device.
30. The method of claim 1 , wherein the first tube comprises a distal opening through which a device lock loop releasably couples the proximal end of the frame with the first tube.
31. A method of sealing a defect or tissue opening in a heart, comprising:
providing a medical device that includes:
an expandable frame formed from a plurality of wires, each of the wires extending from a proximal end of the frame to a distal end of the frame, wherein first and second end portions of each of the plurality of wires are wound around a longitudinal axis of the medical device to define a proximal eyelet at the proximal end of the frame and a distal eyelet at the distal end of the frame, respectively, the plurality of wires also forming a proximal disk and a distal disk when the medical device assumes an expanded 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, adjacent petals of the distal disk overlap one another, and each of the petals is configured to conform to tissue; and
a sealing member at least partially encapsulating the frame;
advancing a delivery system, to which the medical device is releasably attached, to a location of the defect or tissue opening in the heart, wherein the delivery system comprises:
a housing having a slot;
a first tube that is releasably attached to the proximal end of the frame;
a second tube that is releasably attached to the distal end of the frame, the second tube being slidably disposed within the first tube; and
a linear actuator located within the slot of the housing, wherein advancing the linear actuator along the slot of the housing advances the first tube, the second tube, and the medical device; and
deploying, using the delivery system, the medical device at the location of the defect or tissue opening.
32. The method of claim 31 , wherein the defect site is a septal defect.
33. The method of claim 32 , wherein the septal defect is a patent foramen ovale.