Systems and methods for percutaneously supporting and manipulating a septal wall

Abstract

A catheter-based system for percutaneously supporting and articulating a septal wall of a heart includes a catheter and a flanged device. The flanged device includes a distal anchor and a proximal anchor, and has a radially collapsed configuration and a radially expanded configuration. When the flanged device is in the radially expanded configuration and disposed through a transseptal puncture in the septal wall, the flanged device is configured to anchor to the septal wall to permit manipulation thereof whereby an angle between an axis through the transseptal puncture and an axis through a native valve is reduced. The proximal anchor and the distal anchor may each be self-expanding or balloon expandable. The flanged device may further include a flanged device shaft. The flanged device shaft may be releasably coupled to the catheter.

1 . A catheter-based system for percutaneously supporting and articulating a septal wall of a heart, the catheter-based system comprising:
 a catheter; and   a flanged device disposed at a distal end of the catheter, the flanged device having a central lumen and including:
 a distal anchor configured for engagement with a first side of the septal wall; and 
 a proximal anchor configured for engagement with a second side, opposite the first side, of the septal wall, 
   wherein the flanged device has a radially collapsed configuration for delivery within a vasculature and a radially expanded configuration, and   wherein when the flanged device is in the radially expanded configuration and disposed through a transseptal puncture in the septal wall, the flanged device is configured to support and manipulate or articulate the interatrial septum.   
     
     
         2 . The catheter-based system of  claim 1 , wherein the septal wall is an interatrial septum and wherein the flanged device is configured to manipulate or articulate the interatrial septum such that when the interatrial septum is manipulated or articulated, an angle between a first central axis that extends through the transseptal puncture and a second central axis that extends through a native mitral valve is less than the angle between the first central axis that extends through the transseptal puncture and the second central axis that extends through the native mitral valve when the interatrial septum is not manipulated or articulated by the flanged device. 
     
     
         3 . The catheter-based system of  claim 1 , wherein the proximal anchor and the distal anchor each include a collapsed state corresponding to the radially collapsed configuration of the flanged device and an expanded state corresponding to the radially expanded configuration of the flanged device. 
     
     
         4 . The catheter-based system of  claim 3 , wherein the septal wall is an interatrial septum and wherein when the flanged device is in the radially expanded configuration and is disposed through the transseptal puncture in the interatrial septum, the distal anchor is in the expanded state and is configured to be disposed adjacent to and engaged with the interatrial septum in a left atrium and the proximal anchor is in the expanded state and is configured to be disposed adjacent to and engaged with the interatrial septum in a right atrium such that the flanged device is anchored to the interatrial septum to permit manipulation or articulation of the interatrial septum. 
     
     
         5 . The catheter-based system of  claim 3 , wherein the distal anchor includes a self-expanding frame such that the distal anchor is self-expanding from the collapsed state to the expanded state. 
     
     
         6 . The catheter-based system of  claim 5 , wherein the proximal anchor includes a self-expanding frame such that the proximal anchor is self-expanding from the collapsed state to the expanded state. 
     
     
         7 . The catheter-based system of  claim 3 , wherein the distal anchor is a distal anchor balloon, and the distal anchor balloon is inflatable from the collapsed state to the expanded state. 
     
     
         8 . The catheter-based system of  claim 7 , wherein the proximal anchor is a proximal anchor balloon, wherein the proximal anchor balloon is inflatable from the collapsed state to the expanded state. 
     
     
         9 . The catheter-based system of  claim 1 , wherein the proximal anchor is spaced from the distal anchor by a length of the flanged device shaft. 
     
     
         10 . The catheter-based system of  claim 1 , wherein the flanged device further includes a flanged device shaft, wherein the distal anchor is coupled to or extends from a distal portion of the flanged device shaft and the proximal anchor is coupled to or extends from a proximal portion of the flanged device shaft. 
     
     
         11 . The catheter-based system of  claim 10 , wherein the flanged device shaft is removably coupled to the distal end of the catheter. 
     
     
         12 . The catheter-based system of  claim 1 , wherein the flanged device further includes a sealing mechanism configured to seal a passageway of the flanged device shaft. 
     
     
         13 . The catheter-based system of  claim 12 , wherein the sealing mechanism is disposed within the passageway of the flanged device shaft. 
     
     
         14 . The catheter-based system of  claim 12 , wherein the sealing mechanism is a hemostatic seal. 
     
     
         15 .- 20 . (canceled) 
     
     
         21 . A catheter-based system for percutaneously supporting and articulating a septal wall of a heart, the catheter-based system comprising:
 a catheter including an catheter shaft having a passageway extending therethrough; and   a flanged device removably coupled to a distal end of the catheter shaft, the flanged device having a central lumen and including:
 a distal anchor configured for engagement with a first side of the septal wall; and 
 a proximal anchor configured for engagement with a second side, opposite the first side, of the septal wall, 
   wherein the flanged device has a radially collapsed configuration for delivery within a vasculature and a radially expanded configuration configured to be disposed through a transseptal puncture in the septal wall, and   wherein the catheter is configured to manipulate the catheter shaft with the flanged device coupled thereto and in the radially expanded configuration such that the catheter and the flanged device support and manipulate or articulate the septal wall.   
     
     
         22 . The catheter-based system of  claim 21 , wherein the catheter shaft passageway and flanged device central lumen are configured to receive a medical device therethrough. 
     
     
         23 . The catheter-based system of  claim 21 , wherein the catheter further includes pull wires for manipulating the catheter shaft with the flanged device coupled thereto and in the radially expanded configuration such that the catheter and the flanged device support and manipulate or articulate the septal wall. 
     
     
         24 . The catheter-based system of  claim 21 , wherein the catheter shaft comprises a shape memory material configured to return to a curved shape with the flanged device coupled thereto and in the radially expanded configuration to manipulate or articulate the septal wall. 
     
     
         25 . The catheter based system of  claim 21 , wherein:
 the catheter shaft comprises an inner shaft;   the catheter further includes an outer shaft;   the flanged device is disposed within the outer shaft when in the radially compressed configuration; and   the catheter further comprises a handle including an actuator configured to slide the outer shaft relative to the inner shaft and the flanged device to exposed the flanged device such that the flanged device expands from the radially compressed configuration to the radially expanded configuration.   
     
     
         26 . A catheter-based system for percutaneously supporting and articulating a septal wall of a heart, the catheter-based system comprising:
 a catheter including:
 an outer shaft including an outer shaft lumen; 
 an inner shaft disposed within the outer shaft lumen; and 
 a handle including an actuator for translating the outer shaft relative to the inner shaft; and 
   a flanged device removably coupled to a distal end of the inner shaft, the flanged device having a central lumen and including:
 a distal anchor; and 
 a proximal anchor; 
   wherein the flanged device has a radially collapsed configuration for delivery within a vasculature when disposed within the outer shaft and a radially expanded configuration when the outer shaft is retracted from the flanged device and configured to be disposed through a transseptal puncture in the septal wall such that the distal anchor engages a first side of the septal wall and the proximal anchor engages as second side of the septal wall opposite the first side, and   wherein the catheter is configured to manipulate the inner shaft with the flanged device coupled thereto and in the radially expanded configuration such that the catheter and the flanged device support and manipulate or articulate the septal.