Fluoroscopic visualization of heart valve anatomy
Inventors
HOFFER, Eran • Avivi, Sarit • Herman, Yaron • Sheps, Tal • Aviv, Ehud • Manash, Boaz • Kutzik, Meir • Cohen, Or
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-12364606-B2
Publication Date
2025-07-22
Expiration Date
2040-07-22
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Abstract
A radiopaque frame is transluminally advanced to an atrium of a heart of a subject. The frame is expanded within a valve adjacent the atrium such that part of the frame remains disposed in the atrium. While the frame remains expanded within the valve, progressive portions of an annuloplasty structure are progressively positioned and anchored around the annulus using multiple anchors by, for each of the anchors sequentially (i) while fluoroscopically imaging the frame and a distal end of a delivery tool, and facilitated by mechanical guidance from the frame, positioning the distal end of the delivery tool between the frame and a wall of the atrium; and (ii) driving the anchor into the annulus laterally from the frame. Subsequently, the frame is contracted and withdrawn from the subject while leaving the annuloplasty structure anchored around the annulus. Other embodiments are also described.
Core Innovation
The invention provides systems and methods for aiding implantation of cardiac devices under the guidance of fluoroscopy using radiopaque devices which act as guides. These devices facilitate enhanced imaging of cardiac anatomy during implantation of cardiac implants, particularly along native heart valve annuli. The radiopaque devices, also called annulus-marking devices or anatomy-marking devices, are configured to track the circumference of native heart valve annuli and include features such as base frames that match the annulus shape and struts projecting from the frame to indicate valve commissures.
These annulus-marking devices are compressible during delivery and expandable upon positioning to mark the annulus. They may be fabricated from a single piece of superelastic radiopaque material and include adjustment mechanisms to expand or contract their perimeter. Radiopaque filaments may be coupled to the devices to mark the annulus and tissue coupled thereto by pressing against or swaying with tissue movement. The devices are used as guides for implantation of implants such as annuloplasty structures, which can be contracted along the valve annulus and anchored by tissue anchors deployed under imaging.
The problem being addressed is the need to minimize patient exposure to fluoroscopy during implantation of medical devices in catheter-based cardiac valve repair and replacement procedures. The use of radiopaque annulus-marking devices facilitates precise placement and anchoring of implants along the valve annulus under fluoroscopy, thus enhancing imaging accuracy and reducing fluoroscopy time and patient radiation exposure.
Claims Coverage
The independent claims cover implant-guided methods and devices for cardiac valve repair involving radiopaque frames and annulus-marking devices with specific structural and functional features.
Method of implanting annuloplasty structure guided by an expandable radiopaque frame
Advancing a radiopaque frame transluminally to the atrium, expanding the frame so part remains in the atrium, positioning and anchoring portions of an annuloplasty structure progressively around the annulus using multiple anchors under fluoroscopic imaging and mechanical guidance from the frame, and subsequently contracting and withdrawing the frame while leaving the annuloplasty structure anchored.
Expanding frame with rail and mesh features
Expanding the frame such that it includes a rail extending along the annulus, a mesh defining a bulging ledge portion that abuts the valve, a sloped upstream portion tapering into the atrium, and optionally a trumpet portion within the ventricle.
Frame structural configurations
Expanding the frame into various shapes including bulbous, umbrella, spherical, partially spherical, ovoid, teardrop, conical, pear-shaped, braided mesh, or conical stent.
Mechanical and tactile guidance during positioning
Positioning the distal end of the delivery tool between the frame and atrial wall facilitated by mechanical guidance and tactile feedback, including fluoroscopic identification of bending caused by pressing against heart tissue.
Incorporation of valve leaflets and valve-specific orientation
The frame includes leaflets regulating blood flow during positioning and anchoring, and asymmetrical orientation of the frame toward the aortic valve when treating the mitral valve.
The claims cover a comprehensive method and system for intravascular implantation of annuloplasty devices using an expandable radiopaque frame that provides mechanical and imaging guidance within heart chambers. The frame's various shapes, adjustment mechanisms, and tactile feedback features enable precise, fluoroscopy-guided implantation and anchoring of cardiac implants specifically at native heart valve annuli, with post-implant retrieval of the radiopaque frame.
Stated Advantages
Facilitation of enhanced imaging of cardiac anatomy during implantation, improving visualization of native heart valve annuli.
Minimization of patient exposure to fluoroscopy by providing precise guidance for implant positioning and anchoring.
Provision of mechanical guidance and tactile feedback during implant delivery to ensure accurate placement.
Retrievability of the visualization devices following implantation, reducing implanted foreign material.
Capability to measure annulus height and rotationally orient devices with respect to valve tissue for improved implantation precision.
Documented Applications
Aiding implantation of cardiac devices under the guidance of fluoroscopy to repair or replace native heart valves, especially the mitral and tricuspid valves.
Use of radiopaque annulus-marking devices for guiding and positioning annuloplasty structures and tissue anchors around the native valve annulus in beating hearts.
Measuring annulus height using annulus-marking devices during implantation procedures.
Mapping native heart valve annulus and surrounding tissue using mapping catheters and magnetic or electrophysiological mapping subunits.
Guidance and positioning of annuloplasty devices with minimally-invasive, percutaneous, transvascular, thoracoscopic, or open-heart surgical delivery.
Use in simulation environments, animal models, or cadavers for training or procedural planning.
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