Apparatus and methods for minimally invasive transapical access
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Publication Number
US-11751995-B2
Publication Date
2023-09-12
Expiration Date
Abstract
A delivery catheter system includes an anchor catheter, a collapsible and expandable anchor, a balloon 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 catheter may be positioned radially inward of the anchor catheter, and may include an inflatable balloon at a distal end thereof. The balloon may be in fluid communication with the balloon catheter. The needle may be positioned radially inward of the balloon catheter and may be translatable relative to the balloon, the needle having a sharp distal tip.
Core Innovation
The invention relates to a method of delivering an expandable prosthetic heart valve anchor to a heart of a patient using a delivery catheter system. The system includes an anchor catheter that maintains an anchor in a collapsed condition, an inflatable balloon catheter positioned radially inward of the anchor catheter, and a needle positioned radially within the anchor catheter with a sharp distal tip. The method advances the anchor catheter through a puncture in an atrial septum into a left atrium and then into a left ventricle.
A transapical puncture is created by advancing the radially positioned needle distally relative to the anchor catheter and through a ventricular wall. The method advances the anchor catheter at least partially through the transapical puncture, while the balloon catheter is positioned radially inward and the balloon is in fluid communication with the balloon catheter. The balloon is in the inflated condition while the needle is advanced through the ventricular wall of the heart of the patient.
The anchor is released from the anchor catheter so that the anchor transitions from the collapsed condition to an expanded condition while the anchor catheter is positioned at least partially through the transapical puncture. The disclosed catheter system is configured to support deployment of an expandable tether anchor for a prosthetic heart valve, including an anchor with wire mesh discs and one-way gripping features, and delivery and deployment arrangements involving patient access and positioning through cardiac structures.
Claims Coverage
The independent claim recites a delivery method with four inventive features: catheter-based navigation through the atrial septum into the left ventricle, needle creation of a transapical puncture from a radially inward needle position, a radially inward balloon catheter with the balloon inflated during needle advancement, and releasing an expandable anchor while the anchor catheter is positioned at least partially through the transapical puncture.
Atrial septum to left ventricle anchor delivery with collapsed-to-expanded transition
Positioning the anchor within an anchor catheter maintaining the anchor in a collapsed condition, advancing the anchor catheter through a puncture in an atrial septum to a left atrium, advancing from the left atrium to a left ventricle, and releasing the anchor so the anchor transitions from the collapsed condition to an expanded condition while the anchor catheter is positioned at least partially through the transapical puncture.
Radially inward needle creates a transapical puncture
Advancing a needle positioned radially within the anchor catheter distally relative to the anchor catheter through a ventricular wall to create a transapical puncture.
Inflatable balloon catheter radially inward of anchor catheter with inflated needle puncture timing
Positioning a balloon catheter radially inward of the anchor catheter, the balloon catheter including an inflatable balloon at a distal end in fluid communication with the balloon catheter, wherein the balloon has an inflated condition and a deflated condition, and wherein the balloon is in the inflated condition while the needle is advanced through the ventricular wall.
Release of expandable anchor while anchor catheter is positioned through transapical puncture
Advancing the anchor catheter at least partially through the transapical puncture and releasing the anchor from the anchor catheter while allowing the anchor to transition from the collapsed condition to an expanded condition while the anchor catheter is positioned at least partially through the transapical puncture.
Balloon and needle sequencing relative to transapical puncture
Deflating the balloon after advancing the needle through the ventricular wall and before advancing the anchor catheter through the transapical puncture; and/or advancing a deflated balloon through a transapical puncture before advancing an anchor catheter through the same transapical puncture; and/or inflating a balloon to dilate a transapical puncture after a deflated balloon is positioned at least partially within that puncture.
Tapered inflated balloon geometry
The balloon tapers toward a distal end while inflated.
Port catheter alignment with native mitral valve annulus axis
Steering a port catheter within a patient's left atrium so its distal end is substantially aligned with a central longitudinal axis through the patient's native mitral valve annulus.
Overall, the claim set centers on delivering an expandable prosthetic heart valve anchor via an anchor catheter while using a radially inward balloon catheter and a radially positioned needle to create and manage a transapical puncture. Coverage also includes dependent timing and sequencing of balloon inflation and deflation relative to needle advancement and puncture traversal, tapered inflated balloon geometry, and port catheter steering and alignment with the native mitral valve annulus axis.
Stated Advantages
Documented Applications
No documented applications found
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