# US 8,465,485 B2 · Energy based devices and methods for treatment of patent foramen ovale

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- Number: US 8,465,485 B2
- Document ID: US8465485B2
- Status: Granted
- Kind: B2
- Application number: 13/234,908
- Filed: 2011-09-16
- Published: 2012-01-12
- Granted: 2013-06-18
- Earliest claimed: 2003-03-27
- Assignees: Terumo Kabushiki Kaisha
- Applicants: William Malecki; Dan Francis; Kenneth Horne; Mark E. Deem; Hanson Gifford; Jose Alejandro
- Inventors: William Malecki; Dan Francis; Kenneth Horne; Mark E. Deem; Hanson Gifford; Jose Alejandro
- Web page: https://patentgrep.com/patent/US8465485B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/1445: {at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod}
- A61B 2017/00575: {for closure at remote site, e.g. closing atrial septum defects}
- A61B 2017/00867: {shape memory effect}
- A61B 2018/00261: {arranged in a line}
- A61B 2018/00285: {Balloons}
- A61B 2018/00291: {using suction}
- A61B 2018/00351: {Heart}
- A61B 2018/00619: {Welding}
- A61B 2018/0063: {Sealing}
- A61B 2018/00702: {Power or energy}
- A61B 2018/00791: {Temperature}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/1472: {for use with liquid electrolyte, e.g. virtual electrodes}
- A61B 2090/3614: {using optical fibre}
- C08L 2201/12: Shape memory
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)

## Abstract

Methods, devices and systems for treating patent foramen ovale (PFO) involve advancing a catheter device to a position in a heart for treating a PFO, bringing tissues adjacent the PFO at least partially together, and applying energy to the tissues to substantially close the PFO acutely. Catheter devices generally include an elongate catheter body, at least one tissue apposition member at or near the distal end for bringing the tissues together, and at least one energy transmission member at or near the distal end for applying energy to the tissues. In some embodiments, the tissue apposition member(s) also act as the energy transmission member(s). Applied energy may be monopolar or bipolar radiofrequency energy or any other suitable energy, such as laser, microwave, ultrasound, resistive heating or the like.

## Claims

### Claim 1

A catheter device for treating a patent foramen ovale in a heart, the heart including a septum secundum tissue and a septum primum tissue adjacent the patent foramen ovale, the catheter device comprising:
an elongate catheter body having a proximal end and a distal end;
a first tissue apposition member and a second tissue apposition member located at or near the catheter body distal end and configured to move so as to bring the septum primum and septum secundum tissues adjacent the patent foramen ovale at least partially together, the first tissue apposition member being configured contact the septum secundum tissue adjacent the patent foramen ovale from a right atrium of the heart without penetrating the septum secundum tissue, the second tissue apposition member being configured to pierce into the septum primum tissue of the heart; and
at least one energy transmission member at or near the distal end for applying energy to the tissues to substantially close the patent foramen ovale acutely,
wherein the first and second tissue apposition members comprise a clamp for clamping the tissues together.

### Claim 2

A method for treating a patent foramen ovale in a heart with a catheter device, the heart including a septum secundum tissue and a septum primum tissue adjacent the patent foramen ovale, the method comprising:
positioning an elongate catheter body having a proximal end and a distal end, such that the distal end is adjacent the patent foramen ovale;
moving a first tissue apposition member and a second tissue apposition member, which are disposed at or near the distal end of the catheter body, so as to bring the septum primum and septum secundum tissues adjacent the patent foramen ovale at least partially together, the first tissue apposition member being moved to contact the septum secundum tissue adjacent the patent foramen ovale from a right atrium of the heart without penetrating the septum secundum tissue, and the second tissue apposition member being moved to pierce into the septum primum tissue of the heart; and
applying energy to the primum and septum secundum tissues, via at least one energy transmission member disposed at or near the distal end of the catheter body, to substantially close the patent foramen ovale acutely.