Techniques for guide-wire based advancement of a tool
Inventors
Assignees
Vatelch Cardio Ltd • Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-12251307-B2
Publication Date
2025-03-18
Expiration Date
2033-12-03
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Abstract
An anchor is shaped to define a helix. A deployment tool is reversibly coupled to the anchor, and includes a lance. The deployment tool is configured to transluminally advance the anchor to the heart, and to stabilize the anchor at the tissue by driving the lance into the tissue. The deployment tool is also configured to anchor the anchor to the tissue, for example, by driving the tissue-penetrating helix into the tissue while the anchor remains stabilized at the tissue by the lance in the tissue, and to subsequently retract the lance from the tissue while leaving the anchor anchored to the tissue. Other embodiments are also described.
Core Innovation
The invention provides apparatus and methods for repair of an atrioventricular valve and associated chordae tendineae in a patient, particularly addressing ischemic heart disease that causes mitral regurgitation due to papillary muscle dysfunction and dilation of the left ventricle. The apparatus includes a tissue-engaging element such as a tissue anchor, which can be transluminally advanced and secured to cardiac tissue, and an adjustment mechanism slidable along a guidewire to adjust tension in repair chords functioning as artificial chordae tendineae or to adjust distances in the ventricular wall.
The invention also addresses the problem of securely anchoring the tissue anchor to specific cardiac tissue such as papillary muscles by providing a deployment tool comprising a lance to stabilize the anchor while the tissue-penetrating helix is driven into the tissue. The lance is subsequently retracted while leaving the anchor implanted. A guide member with a chord-engaging element allows the deployment tool to be guided transluminally along the chordae tendineae to the papillary muscle, facilitating precise anchoring.
The invention solves the problem of implanting, adjusting, and securing repair chords or annuloplasty ring structures in a minimally invasive manner using guidewire-based advancement along docking stations coupled to the tissue anchors. It supports bidirectional tensioning and relaxing of repair chords via a spool assembly housed within the adjustment mechanism. The invention permits implantation in beating hearts during minimally invasive or open heart procedures, enabling repair by restoring heart valve function and ventricular dimensions.
Claims Coverage
The patent includes multiple independent claims that describe apparatus and methods for advancing and anchoring tissue anchors to cardiac tissue, using guidewire-based transluminal delivery and deployment tools with specific features.
Anchor shaped to define a tissue-penetrating helix and deployment tool with a lance
An apparatus comprising an anchor shaped as a tissue-penetrating helix and a deployment tool which includes a lance. The deployment tool is configured to transluminally advance the anchor to the heart, stabilize the anchor at tissue by driving the lance into the tissue, anchor the anchor into the tissue while stabilized by the lance, and subsequently retract the lance while leaving the anchor secured.
Guide member with chord-engaging element for guided transluminal advancement
A guide member percutaneously deliverable to the heart includes a distal chord-engaging element configured for reversible sliding coupling to a chorda tendinea and a longitudinal element leading to it. The deployment tool is configured to slide along this longitudinal element toward the chord-engaging element to advance the anchor to the tissue.
Housing and chord-engaging element configuration
A housing percutaneously deliverable to the heart is shaped to define an opening through which the chord-engaging element is intracardially extendable. The chord-engaging element can helix-wrap around the chorda tendinea and transition from a constrained straight state inside the housing to a helical shape upon extension.
Method for transluminal advancement, stabilization, anchoring, and retraction
A method comprising transluminally advancing an anchor coupled to a guidewire and deployment tool including a lance to the heart, advancing an implant along the guidewire toward the anchor, stabilizing the anchor by driving the lance into tissue, anchoring the anchor by driving its tissue-penetrating helix while stabilized, and retracting the lance while leaving the implant secured by the anchor.
The independent claims cover apparatus and methods involving use of a helical tissue anchor, deployment tools with lances to stabilize and anchor tissue anchors at cardiac tissue via transluminal delivery along guidewires and guide members with chord-engaging elements. They also describe housings facilitating deployment and methods enabling secure implantation and adjustment of repair chords and anchors at cardiac sites.
Stated Advantages
Facilitates minimally invasive transcatheter or open-heart implantation of repair chords and anchors to cardiac tissue, reducing strain during implantation.
Allows precise anchoring of tissue anchors at papillary muscles or ventricular tissue with stabilization using a lance, improving placement accuracy.
Permits bidirectional adjustment of repair chord tension in situ to optimize valve leaflet positioning and heart wall dimensions.
Improves procedural control and implant stability by using guidewires, docking stations, and adjustable spool assemblies.
Documented Applications
Repair of atrioventricular valves, including the mitral and tricuspid valves, by implanting artificial chordae tendineae and annuloplasty ring structures to restore valve function.
Replacement or support of prosthetic heart valves using implants slidable along guidewires and coupled to tissue anchors.
Guided delivery and anchoring of tissue anchors to papillary muscles or ventricular muscle tissue via chordae tendineae engagement for valve repair or wall dimension adjustment.
Adjusting length and tension of implanted repair chords during minimally invasive or open-heart surgical procedures.
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