Energy based devices and methods for treatment of patent foramen ovale

Abstract

Methods and apparatus for treatment of patent foramen ovale (PFO) provide for applying energy to tissues adjacent the PFO with a catheter device to substantially close the PFO acutely. Apparatus generally includes a catheter device having at least one energy transmission member at or near its distal end configured to apply energy to PFO tissues to acutely, substantially close the PFO. Applied energy may be monoploar or bipolar radiofrequency energy or any other suitable energy, such as laser, microwave, ultrasound, resistive heating or the like. Some embodiments of a catheter device further include one or more tissue apposition members near the distal end for helping bring PFO tissues together, such as a PFO covering member, a vacuum applying member and/or the like. PFO closure via energy-based approaches of the invention may help prevent stroke, treat migraine headache, and possibly treat or prevent other medical conditions.

1 . Apparatus for treating a patent foramen ovale in a heart, the apparatus comprising: 
 a catheter device having a proximal end and a distal end; and    at least one energy transmission member adjacent the distal end for applying energy to or removing energy from tissues adjacent the patent foramen ovale to substantially close the patent foramen ovale acutely.    
     
     
         2 . Apparatus as in  claim 1 , further comprising at least one tissue apposition member adjacent the distal end for at least partially bringing together the tissues.  
     
     
         3 . Apparatus as in  claim 2 , wherein the at least one energy transmission member is coupled with the at least one tissue apposition member.  
     
     
         4 . Apparatus as in  claim 3 , wherein the at least one energy transmission member is movable relative to the at least one tissue apposition member.  
     
     
         5 . Apparatus as in  claim 2 , wherein the at least one tissue apposition member comprises a tissue covering member.  
     
     
         6 . Apparatus as in  claim 5 , wherein the tissue covering member covers the patent foramen ovale to allow blood pressure in a left atrium of the heart to bring the tissues together.  
     
     
         7 . Apparatus as in  claim 5 , wherein the tissue covering member comprises at least one suction member for applying vacuum force to the tissues to bring the tissues together.  
     
     
         8 . Apparatus as in  claim 5 , wherein the tissue covering member is expandable from a first delivery dimension to a second treatment dimension.  
     
     
         9 . Apparatus as in  claim 5 , further comprising a flexible isolation portion disposed between the tissue covering member and the catheter device to prevent unwanted movement of the tissue covering member during use.  
     
     
         10 . Apparatus as in  claim 5 , wherein the at least one energy transmission member is coupled with the tissue covering member.  
     
     
         11 . Apparatus as in  claim 1 , further comprising a guide member for advancing through the patent foramen ovale, wherein the catheter device is slidably disposed over the guide member.  
     
     
         12 . Apparatus as in  claim 11 , wherein the guide member comprises: 
 a guide catheter; and    at least one expandable member disposed within the guide catheter, wherein the guide catheter is retractable to expose the expandable member to allow it to expand within the patent foramen ovale.    
     
     
         13 . Apparatus as in  claim 12 , wherein the expandable member comprises at least two members that expand apart to provide lateral force to the tissues adjacent the patent foramen ovale.  
     
     
         14 . A method as in  claim 13 , wherein the exposed expanding member provides the lateral force without extending into the left atrium of the heart.  
     
     
         15 . Apparatus as in  claim 12 , wherein the expandable member comprises a spring loaded member.  
     
     
         16 . Apparatus as in  claim 12 , wherein the expandable member comprises a shape memory material.  
     
     
         17 . Apparatus as in  claim 11 , wherein the guide member comprises a guidewire divided along a portion of its length, the divided portion comprising expandable shape memory material.  
     
     
         18 . Apparatus as in  claim 11 , wherein the guide member comprises at least one tip for contacting a left atrial surface of the tissues adjacent the patent foramen ovale.  
     
     
         19 . Apparatus as in  claim 18 , wherein the at least one tip is conformable to the left atrial surface.  
     
     
         20 . Apparatus as in  claim 18 , wherein the guide member is retractable to engage the at least one tip with the left atrial surface.  
     
     
         21 . Apparatus as in  claim 11 , wherein the guide member comprises at least one of the at least one energy transmission member.  
     
     
         22 . Apparatus as in  claim 21 , wherein the guide member comprises an expandable member for expanding within the PFO, and wherein the expandable member comprises at least one radiofrequency energy transmission member.  
     
     
         23 . Apparatus as in  claim 1 , wherein the at least one energy transmission member transmits at least one of radiofrequency energy, cryogenic energy, resistive heat energy, ultrasound energy, microwave energy and laser energy.  
     
     
         24 . Apparatus as in  claim 23 , wherein the at least one energy transmission member comprises at least one monopolar radiofrequency transmission member.  
     
     
         25 . Apparatus as in  claim 23 , wherein the at least one energy transmission member comprises at least two bipolar radiofrequency transmission members.  
     
     
         26 . Apparatus as in  claim 23 , wherein the at least one energy transmission member comprises at least one curved radiofrequency transmission member.  
     
     
         27 . Apparatus as in  claim 23 , wherein the at least one energy transmission member comprises at least one of a mesh material and a braid material.  
     
     
         28 . Apparatus as in  claim 1 , wherein the at least one energy transmission member comprises a guide member for advancing through the patent foramen ovale.  
     
     
         29 . Apparatus as in  claim 28 , wherein the guide member includes at least one expandable portion for expanding within the patent foramen ovale to at least partially bring together the tissues adjacent the patent foramen ovale.  
     
     
         30 . Apparatus as in  claim 1 , further comprising at least one sensor coupled with the catheter device for sensing an amount of energy delivered to the tissues by the at least one energy transmission member.  
     
     
         31 . Apparatus as in  claim 30 , wherein the at least one sensor is selected from the group consisting of an infrared sensing device, thermistors and thermocouples.  
     
     
         32 . Apparatus as in  claim 30 , further comprising a microprocessor coupled with the at least one sensor for processing sensed data to determine when the amount of delivered energy has reached a desired amount of energy.  
     
     
         33 . Apparatus as in  claim 1 , further comprising a microprocessor coupled with the catheter device for sensing and controlling energy transmission by the energy transmission member.