Devices and methods for closure of a patent foramen ovale

Abstract

The present invention provides devices and methods for closing a physical anomaly comprising two overlapping layers of tissue, such as a patent foramen ovale (“PFO”). A PFO is comprised of two overlapping layers of malformed interatrial septa, the septum primum and the septum secundum, that form a tunnel between the right atrium and the left atrium. The closure device includes two wings connected to a central arm. The device is delivered through the PFO tunnel in a substantially linear configuration such that the central arm is seated within the PFO tunnel, the first wing extends into the right atrium, and the second wing extends into the left atrium. Once implanted, the closure device is reconfigured such that the arm is seated within the PFO tunnel, the first wing folds against the septum secundum, and the second wing folds against the septum primum, thereby sealing the defect.

1 .- 25 . (canceled) 
     
     
         26 . A method for closing a patent foramen ovale (PFO) in a heart, the PFO comprising a lumen between a septum primum and a septum secundum, the method comprising the steps of:
 providing a closure device comprising a first wing, a first arm, a second arm, and a second wing;   providing an assembly sheath having a lumen extending longitudinally through its length, the lumen sized and configured to contain the closure device in a collapsed configuration;   providing a delivery catheter having a lumen extending longitudinally through its length, the lumen sized and configured to contain the assembly sheath;   inserting the closure device into the lumen of the assembly sheath such that the closure device is in a collapsed configuration;   advancing the delivery catheter into a desired location within the heart;   connecting the assembly sheath to the delivery catheter;   advancing the closure device through the assembly sheath into the delivery sheath;   delivering the closure device at least partially within the PFO;   withdrawing the delivery catheter such that the first arm and the second arm are positioned within the lumen of the PFO, the second wing is positioned in a left atrium of the heart, and the first wing is positioned in a right atrium of the heart;   rotating the closure device such that the first wing and the second wing are about parallel to the septum secundum and the septum primum, respectively; and   interlocking the first arm and second arm such that the second wing is positioned against the septum primum and the first wing is positioned against the septum secundum, wherein the first wing and the second wing exert force on the septum secundum and septum primum, respectively, to push overlapping layers of the septum secundum and the septum primum together to close the PFO.   
     
     
         27 . The method of  claim 26  wherein positioning the second wing in a left atrium of the heart includes withdrawing the delivery catheter such that the second wing self-expands into a predetermined shape, and positioning the first wing in a right atrium of the heart includes withdrawing the delivery catheter such that the first wing self-expands into a predetermined shape. 
     
     
         28 . The method of  claim 27  wherein the predetermined shape is an ellipse. 
     
     
         29 . The method of  claim 26  wherein inserting the closure device into the lumen of the assembly sheath comprises: positioning the first wing in a first container of a compression device; positioning the second wing in a second container of the compression device; positioning the first and second arms in a connecting member of the compression device; inserting the assembly sheath into the compression device such that the assembly sheath extends at least partially into the first container of the compression device; and compressing the first and second wings into the assembly sheath. 
     
     
         30 . The method of  claim 29  further including the step of flushing the first container, the second container, and the connecting tube with liquid prior to compressing the first wing. 
     
     
         31 . The method of  claim 26  wherein inserting the closure device into the lumen of the assembly sheath comprises: positioning the first wing between a first tube and a second tube of a compression device; positioning the second wing distal to the second tube of the compression device; positioning the first and second arms in the second tube of the compression device; inserting the assembly sheath into the compression device such that the assembly sheath extends at least partially into the first tube of the compression device; and compressing the first and second wings into the assembly sheath. 
     
     
         32 . A method for closing a patent foramen ovale (PFO) between a septum primum and a septum secundum, the method comprising:
 providing a first closure component including a first body portion connected between a first tab and a first wing, the first body portion including a first passage extending longitudinally therethrough;   providing a second closure component including a second body portion connected between a second tab and a second wing, the second body portion including a second passage extending longitudinally therethrough;   positioning the first and second body and tab portions into the patent foramen ovale;   sliding the second tab portion within the first passage;   sliding the first tab portion within the second passage;   engaging the septum primum between the first and second body portions and the first wing; and   engaging the septum secundum between the first and second body portions and the second wing.   
     
     
         33 . A method for closing a patent foramen ovale (PFO) between a septum primum and a septum secundum, the method comprising:
 providing a first arm with proximal and distal ends, the proximal end pivotally connected to a first wing via a first hinge, the first hinge including a first projection;   providing a second arm with proximal and distal ends, the proximal end pivotally connected to a second wing via a second hinge, the second hinge including a second projection;   engaging the distal end of the first arm with the second projection to rotate the second wing with respect to the second arm; and   engaging the distal end of the second arm with the first projection to rotate the first wing with respect to the first arm.   
     
     
         34 . The method of  claim 32 , further including rotating the first and second body and tab portions within the patent foramen ovale until the first wing and the second wing are substantially parallel to the septum primum and the septum secundum, respectively. 
     
     
         35 . The method of  claim 32 , further including engaging a first hinge portion disposed on the first body portion with the second tab. 
     
     
         36 . The method of  claim 35 , wherein engaging the septum primum between the first and second body portions and the first wing comprises rotating the first wing about the first hinge element. 
     
     
         37 . The method of  claim 32 , further including engaging a second hinge portion disposed on the second body portion with the first tab. 
     
     
         38 . The method of  claim 37 , wherein engaging the septum secundum between the first and second body portions and the second wing comprises rotating the second wing about the second hinge element. 
     
     
         39 . The method of  claim 32 , wherein sliding the second tab portion within the first passage and sliding the first tab portion within the second passage includes expanding the first wing and second wing, respectively, into a pre-determined shape. 
     
     
         40 . The method of  claim 32 , further including interlocking the first tab portion and the second tab portion such that the first wing and the second wing are secured in place about the PFO. 
     
     
         41 . The method of  claim 33 , wherein engaging the distal end of the first arm with the second projection comprises rotating the second projection toward the proximal end of the second arm. 
     
     
         42 . The method of  claim 33 , wherein engaging the distal end of the second arm with the first projection comprises rotating the first projection toward the proximal end of the first arm. 
     
     
         43 . The method of  claim 33 , further including sliding the distal end of the first arm into a first passage extending longitudinally within a proximal portion of the second arm, and sliding the distal end of the second arm into a second passage extending longitudinally within a proximal portion of the first arm. 
     
     
         44 . The method of  claim 43 , further including securing the distal end of the first arm within the passage of the second arm, and securing the distal end of the second arm within the passage of the first arm. 
     
     
         45 . The method of  claim 33 , further including interlocking the distal end of the first arm with the distal end of the second arm.