Removable intracardiac RF device
The present invention provides systems and methods for occluding or closing a patent foramen ovale of a patient (PFO). The invention includes a catheter carrying an energy delivery element. The catheter introduces the energy delivery element into the patent foramen ovale of a patient's heart. Once appropriately positioned, the energy delivery element applies energy, such as radiofrequency energy, to the tissues surrounding the patent foramen ovale. The application of energy causes the tissues to join together, occluding the patent foramen ovale. The energy delivery element may be removable or permanently implanted in the patent foramen ovale.
1. A removable device for occluding a patent foramen ovale (PFO) comprising:
a sheath comprising a proximal end, a distal end, and a lumen;
an elongated member, one of said sheath and said elongated member axially moveable relative to the other;
an energy delivery element comprising at least one coil comprising an electrode for delivering RF energy, said energy delivery element comprising a proximal end and a distal end, wherein said energy delivery element is coupled at its distal end and proximal end to said elongated member, wherein said energy delivery element is operatively joined to an energy source; and
a push rod moveable along said elongated member, wherein said push rod engages the proximal end of said energy delivery element when moving distally along said elongated member to facilitate deployment of said energy delivery element.
2. The removable device of claim 1 , wherein said energy delivery element is maintained in a non-coiled state within said sheath and wherein said energy delivery element forms said at least one coil when said energy delivery element is deployed beyond the distal end of said sheath.
3. The removable device of claim 1 wherein said energy delivery element comprises a shape memory alloy.
4. The removable device of claim 3 , wherein said shape memory alloy is nitinol.
5. The removable device of claim 1 , wherein said at least one coil is a spiral shaped coil.
6. The removable device of claim 1 , wherein said energy source supplies RF energy to said energy delivery element.
7. The removable device of claim 1 , wherein said at least one coil is coupled to a locating member for locating the PFO.
8. The removable device of claim 7 , wherein the locating member is disc-shaped.
9. The removable device of claim 7 , wherein the locating member comprises at least one coil.
10. The removable device of claim 7 , wherein the locating member comprises a circle, a sphere, an oval, an ellipse, a triangle or a rectangle.
11. The removable device of claim 1 , wherein said energy delivery element further comprises a coating of releasable material that is deposited into a PFO tunnel.
12. The removable device of claim 11 , wherein said coating of releasable material comprises a sleeve.
13. The removable device of claim 11 , wherein said releasable material that is deposited into a PFO tunnel is selected from the group consisting of a polymer, a bioabsorbable material, a growth stimulating material, and a metal with a low melting point.
14. The removable device of claim 1 , further comprising a device for applying negative pressure to the septum primum and septum secundum of the PFO.
15. The removable device of claim 1 , further comprising a second coil comprising a second electrode.
16. The removable device of claim 15 , wherein the second coil comprises a proximal end coupled to said elongated member and a distal end moveable relative to the proximal end of the second coil.
17. The removable device of claim 1 , wherein the distal end of the energy delivery element is joined to the distal end of said elongated member.
18. The removable device of claim 1 , wherein either one or both of the distal end and proximal end of said energy delivery element is releasably coupled to said elongated member.