Treating dysfunctional cardiac tissue
Inventors
Annest, Lon S. • Argento, Claudio • Butler, William • Heflin, Ernest
Assignees
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Publication Number
US-10624744-B2
Publication Date
2020-04-21
Expiration Date
Abstract
Medical devices, systems, and methods reduce the distance between two points in tissue, often for treatment of congestive heart failure and often in a minimally invasive manner. An anchor is inserted along an insertion path through a first wall of the heart. An arm of the anchor is deployed and rotationally positioned according to a desired alignment. Application of tension to the anchor may draw the first and second walls of the heart into contact along a desired contour so as to effect a desired change in the geometry of the heart. Additional anchors may be inserted and aligned with the first anchor to close off a portion of a ventricle such that the ventricle is geometrically remodeled and disease progression is reversed, halted, and/or slowed.
Core Innovation
A minimally- and percutaneously delivered cardiac anchor-based system is provided for treating a failing heart in congestive heart failure. The system reduces ventricular volume by drawing opposed heart walls into an aligned apposition along a desired contour or line of apposition, and excludes a dysfunctional or scarred ventricular portion.
A first anchor is delivered through a first heart wall and positioned on an exterior surface of the first wall, and a second anchor is delivered adjacent a perforation in another heart wall. A tension member couples the anchors so that tension draws the walls toward one another.
The system supports placement of anchor pairs to extend an excluded contour and produce geometric remodeling of the heart, including remodeling that may be performed prophylactically. The disclosed anchoring concept is implemented with catheter-based approaches that include a first catheter, an introducer, a guidewire, and anchor delivery through perforations in the heart walls.
Additional disclosed system configurations include catheter-based delivery architectures that transition components from low-profile advancement within a lumen to post-lumen deployment of the anchors, together with locking mechanisms, anchor assemblies, hemostatic plugs or hemostasis valves, suction lumens for stabilization, and tether cutting mechanisms, enabling delivery through percutaneous heart access paths and supporting Epicardial Catheter-based Ventricular Reconstruction and percutaneous ventricular reduction.
Claims Coverage
Two independent claims are provided. Both claims focus on a percutaneous catheter-based system that delivers first and second anchors on opposed heart walls and uses a tension member to draw the walls toward one another.
Percutaneous right-heart access with septal perforation and coupled anchors
A first catheter advanced through a femoral vein or internal jugular vein into a right ventricle, an introducer disposed within the first catheter and advanced to perforate the septum, and a guidewire advanced through the septum to a left ventricle positionable adjacent an anterior or lateral wall. The introducer perforates the anterior or lateral wall when the first catheter is positioned adjacent thereto, the guidewire is advanceable through that perforation to position a distal end external to the heart, a first anchor delivered through the anterior or lateral wall into an exterior surface position, and a second anchor delivered adjacent the septum within the right ventricle. A tension member operably couples the first and second anchors and is configured to draw the septum and the anterior or lateral wall toward one another via tension.
Catheter-delivered first and second anchors on opposed walls with coupled tension
A catheter advanced percutaneously through an atrium into a first chamber with a distal end positionable adjacent a first wall, an elongate body disposed in a lumen and advanced to perforate dysfunctional tissue of the first wall, and a guidewire advanced through the first wall to position a distal end within a second chamber. The catheter is advanceable over the guidewire through the first wall into the second chamber, with the elongate body advanced within the second chamber to perforate dysfunctional tissue of a second wall, and the guidewire advanced through the second wall to position a distal end external to the heart. A first anchor deliverable to a position adjacent the second wall and a second anchor deliverable to a position adjacent the first wall, with a tension member operably coupling the first and second anchors and configured to draw the first and second walls toward one another via tension.
Across both independent claims, the core claim coverage includes catheter-based percutaneous access to opposed heart walls, perforation of dysfunctional tissue and/or perforations in the septum and/or wall(s), delivery of first and second anchors to respective wall exterior positions, and a tension member coupling the anchors to draw the walls toward one another to exclude dysfunctional tissue and produce ventricular reduction/geometric remodeling.
Stated Advantages
Reduces ventricular volume by drawing opposed heart walls into aligned apposition along a desired contour.
Excludes a dysfunctional or scarred ventricular portion.
Produces geometric remodeling by extending an excluded contour using multiple anchors or anchor pairs.
May be performed prophylactically.
Documented Applications
Minimally- and percutaneously delivered cardiac anchor-based system for treating congestive heart failure via percutaneous ventricular reduction and/or Epicardial Catheter-based Ventricular Reconstruction.
Geometric remodeling of the heart, including extending an excluded contour using multiple anchor pairs.
Prophylactic performance for remodeling, as described in the document.
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