Transcatheter closure of patent foramen ovale with bipolar RF application

1 . A system for transseptal closure of the patent foramen ovale (PFO) comprising:

a tubular loader defining a lumen;

a first RF applicator comprising

a first cable defining a distal end and a proximal end;

a first disc coupled to the distal end of the first cable and insertable into the left atrium, the first disc fabricated from an electrically conductive, resilient material that achieves an expanded disc-shaped configuration when deployed from the tubular loader and a collapsed configuration when positioned within the lumen of the tubular loader; and

a first contact at the proximal end of the first cable for electrical attachment to a bipolar RF generator;

a second RF applicator comprising

a second cable defining a distal end and a proximal end;

a second disc coupled to the distal end of the second cable and insertable into the right atrium, the second disc fabricated from an electrically conductive, resilient material that achieves an expanded disc-shaped configuration when deployed from the tubular loader and a collapsed configuration when positioned within the lumen of the tubular loader; and

a second contact at the proximal end of the second cable for electrical attachment to the bipolar RF generator,

the first disc being located distal to the second disc,

the first disc and the second disc being deployable directly from the lumen of the tubular loader,

when in the collapsed configuration, the first disc contacting the lumen of the tubular loader and when in the collapsed configuration, the second disc contacting the lumen of the tubular loader, and

the system configured for withdrawal of the first disc and the second disc into the lumen following deployment of the first disc and the second disc.

2 . The system of claim 1 , wherein the first and second discs are configured to expand to the expanded disc-shaped configuration upon deployment from the lumen of the tubular loader.

3 . The system of claim 1 , further comprising a tubular withdrawal member defining a lumen and insertable over the first cable and the first disc to collapse the first disc into the lumen of the tubular withdrawal member for withdrawal from the left atrium across the septum.

4 . The system of claim 1 , wherein the diameter of the first and second discs is about 1.5 cm to about 3.5 cm.

5 . The system of claim 1 , wherein the second disc defines an aperture for the first cable to extend therethrough.

6 . The system of claim 1 , wherein the first and second discs are fabricated from a shape memory alloy.

7 . The system of claim 6 , wherein the first and second discs are fabricated from nitinol.

8 . The system of claim 1 , wherein the length of the first and second cables is about 80 cm.

9 . The system of claim 1 , further comprising a transseptal sheath.

10 . A method of transseptal closure of the patent foramen ovale (PFO) comprising:

inserting a distal end of a tubular loader into the left atrium of a subject's heart via the right atrium and the septum;

deploying a first RF applicator directly from the tubular loader across the septum and into the left atrium, the first RF applicator comprising a first cable and a first disc fabricated from an electrically conductive, resilient material in a collapsed configuration within and contacting the tubular loader;

deploying the first disc beyond the distal end of the tubular loading such that the first disc is allowed to resiliently expand from the collapsed configuration to an expandable disc-shaped configuration;

withdrawing the first RF applicator such that the first disc is in apposition against the septum;

withdrawing the tubular loader such that the distal end of the tubular loader is within the right atrium;

deploying a second RF applicator directly from the tubular loader beyond the distal end of the tubular loader and into the right atrium, the second RF applicator comprising a second cable and a second disc fabricated from an electrically conductive, resilient material such that the second disc is allowed to resiliently expand from a collapsed position contacting the tubular loader into an expanded disc-shaped configuration;

advancing the second RF applicator such that the second disc is in apposition against the septum, thereby approximating the septum primum and septum secundum; and

applying bipolar RF energy across the first and second disc to the septum via the first and second cables.

11 . The method of claim 10 , wherein inserting the distal end of the tubular loader into the left atrium of a subject's heart via the right atrium and the septum comprises inserting the tubular loader through the PFO.

12 . The method of claim 10 , wherein inserting the distal end of the tubular loader into the left atrium of a subject's heart via the right atrium and the septum comprises inserting the tubular loader through a transseptal puncture.

13 . The method of claim 10 , wherein deploying the first RF applicator and deploying the second RF applicator comprise providing the first and second discs having a diameter of about 1.5 cm to about 3.5 cm.

14 . The method of claim 10 , wherein deploying the second RF applicator comprises providing an aperture in the second disc for the first cable to extend therethrough.

15 . The method of claim 10 , wherein deploying the first RF applicator and deploying the second RF applicator comprises providing the first and second discs fabricated from a shape memory alloy.

16 . The method of claim 10 , further comprising, after applying bipolar RF energy across the first and second disc to the septum, withdrawing the second disc into the lumen of the tubular loader.

17 . The method of claim 16 , further comprising, providing a tubular withdrawal member.

18 . The method of claim 17 , further comprising advancing the tubular withdrawal member over the second cable into the right atrium.

19 . The method of claim 18 , further comprising withdrawing the first disc into the lumen of tubular withdrawal member.

20 . The method of claim 19 , further comprising withdrawing the tubular withdrawal member and the second RF applicator from the subject's heart.