Apparatus and methods for minimally invasive transcatheter transapical puncture, imaging, and catheter alignment techniques
Inventors
Assignees
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Publication Number
US-11744566-B2
Publication Date
2023-09-05
Expiration Date
Abstract
A delivery catheter system includes a guide catheter, an anchor catheter, a collapsible and expandable anchor, a balloon formed from a portion of the positioning catheter, and a needle. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The anchor may be configured to be received within the anchor catheter. The balloon may be inflated or deflated and provide mechanical support to enable the needle to pierce a ventricle wall. A metallic guide wire can simultaneously be inserted through the aorta to outline the heart when viewed through fluoroscopic imaging.
Core Innovation
The invention relates to a minimally invasive transcatheter mitral valve implantation system using a guide catheter, a balloon, a radially translatable needle, and a collapsible and expandable anchor catheter. The system creates a transapical puncture with reduced need for chest incision or intercostal puncture by using catheter-based access and deployment components arranged for transapical delivery of an expandable anchor for a prosthetic heart valve.
A delivery approach is described in which a guide wire is advanced through an aorta into a left ventricle and advanced substantially along an interior surface of the left ventricle such that the guide wire outlines at least a portion of the left ventricle. The guide catheter is advanced into a left atrium, and a transapical puncture is created by advancing a needle from the guide catheter along a trajectory through a ventricular wall, where the trajectory is determined at least partially based on an image of the guide wire under fluoroscopy.
Fluoroscopy-visible indicia and markers are used to determine and confirm catheter alignment for the transapical puncture trajectory. A metallic guide wire outlines the left ventricle under fluoroscopy, and catheter indicia and markers are used to determine trajectory, including marker geometry and radially positioned internal catheter markers, with an annulus center longitudinal axis determined from boundary measurements and aligned prior to puncture.
Claims Coverage
The independent claim covers a method for delivering an expandable anchor for a prosthetic heart valve by guiding a wire and catheter to enable a transapical puncture, where the puncture trajectory is determined based on an image of the guide wire under fluoroscopy. Six inventive features are reflected across the independent and dependent claims.
Fluoroscopy-based transapical puncture trajectory using an imaged guide wire
Advancing a guide wire through an aorta into a left ventricle such that the guide wire outlines at least a portion of the left ventricle; advancing a guide catheter into a left atrium; creating a transapical puncture by advancing a needle from the guide catheter along a trajectory through a ventricular wall, wherein the trajectory is determined at least partially based on an image of the guide wire under fluoroscopy.
Fluoroscopy-visible guide catheter indicia with perpendicular marker alignment
The guide catheter has fluoroscopy-visible indicia, including a first marker aligned with a longitudinal axis of the guide catheter and a second marker aligned with a distal end of the guide catheter, where the first marker is substantially perpendicular to the second marker.
Alignment of a guide catheter marker with the native mitral valve annulus axis
Aligning the first marker with a longitudinal axis of a native mitral valve annulus prior to creating the transapical puncture in the heart.
Internal radially positioned catheter with fluoroscopy-visible indicia
The guide catheter includes an internal catheter positioned radially within the guide catheter, the internal catheter including second indicia visible under fluoroscopy.
Internal catheter marker geometry with perpendicular alignment
The second indicia include a third marker substantially aligned with a longitudinal axis of the internal catheter and a fourth marker substantially aligned with a distal end of the internal catheter, wherein the third marker is substantially perpendicular to the fourth marker.
Determining mitral annulus boundaries from anterior-posterior leaflet contact
Moving the guide catheter in a first anterior-to-posterior direction substantially along a plane extending through an annulus of a native mitral valve to contact anterior and posterior leaflets of the native mitral valve to determine a first set of boundaries of the annulus.
The core claim focuses on determining a transapical puncture trajectory based on an image of a guide wire under fluoroscopy. The dependent claim refinements define fluoroscopy-visible marker geometries on the guide catheter and an internal radially positioned catheter, add pre-puncture alignment of a marker with a native mitral valve annulus longitudinal axis, and include determining mitral annulus boundaries from anterior-to-posterior leaflet contact along a plane.
Stated Advantages
Reduced need for chest incision/intercostal puncture.
Documented Applications
Minimally invasive transcatheter mitral valve implantation using catheter-based delivery components to create a transapical puncture for prosthetic heart valve anchor delivery.
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