Annuloplasty ring delivery catheters
Inventors
Sheps, Tal • Hammer, Tal • Reich, Tal • GROSS, AMIR • Zipory, Yuval • Cabiri, Oz • Gross, Yosef
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-12350158-B2
Publication Date
2025-07-08
Expiration Date
2029-05-04
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Abstract
Apparatus is provided for repairing a cardiac valve, the apparatus including a catheter sized for delivery through vasculature of a subject and an elongated and flexible annuloplasty structure having an annuloplasty structure axis. The annuloplasty structure is sized and configured for delivery to a heart of the subject through the catheter substantially along a catheter axis of the catheter while the annuloplasty structure axis is substantially parallel to the catheter axis. The apparatus also includes a plurality of anchors configured for delivery to a region of cardiac tissue from a proximal end of the catheter toward a distal end of the catheter and substantially along the annuloplasty structure axis and the catheter axis while at least a portion of the annuloplasty structure is within a delivery passage of the catheter. Other embodiments are also described.
Core Innovation
The invention provides a system and method for repairing a cardiac valve using an adjustable partial annuloplasty ring delivered via a catheter system. The annuloplasty ring comprises a flexible sleeve with a plurality of anchors that are deployed through the sleeve and anchored into cardiac tissue to secure the sleeve around the valve annulus. The system includes an anchor deployment manipulator that advances within the sleeve lumen to deploy the anchors into tissue, typically at controlled angles to achieve secure anchoring, such as from the left atrium into the upper region of the ventricular wall.
The system further comprises a multi-component tubular system with steerable catheters configured to deliver the annuloplasty ring to the heart with precise orientation, enabling controlled positioning and anchoring of the implant to the valve annulus. The catheters utilize rotational locking mechanisms that allow independent steering and orientation control of distal catheter segments to facilitate navigation through vasculature and precise deployment at the target site. An adjustment mechanism including a rotatable spool adjusts and tightens the annuloplasty ring after anchoring to achieve therapeutic effect.
The problem solved by the invention is related to ischemic heart disease causing dilation of the mitral valve annulus, which prevents proper leaflet coaptation, causing mitral regurgitation and subsequent cardiac dysfunction. Existing repair techniques face challenges in secure, minimally invasive delivery, precise positioning, reliable anchoring, and controllable adjustment of the annuloplasty ring. This invention addresses these by providing a flexible, steerable catheter system and anchoring mechanism that enables accurate, secure delivery and deployment of an adjustable annuloplasty ring to restore valve function.
Claims Coverage
The claims disclose thirteen main inventive features related to a cardiac valve repair system comprising a catheter, an annuloplasty structure, anchors, and various control and delivery mechanisms.
Catheter and annuloplasty structure delivery system
A catheter sized for intravascular delivery having a delivery passage and a catheter axis, and an elongated, flexible annuloplasty structure with an axis aligned substantially parallel to the catheter axis for delivery to the heart via the catheter.
Anchor delivery and deployment manipulator
An elongated, flexible deployment manipulator including an anchor driver that independently introduces, advances, and anchors multiple anchors along the annuloplasty structure within the delivery passage of the catheter to cardiac tissue.
Steerable deployment manipulator
The deployment manipulator is steerable, enabling navigation and precise positioning.
Independent control mechanisms
The system includes first and second control mechanisms configured for independent movement of the catheter and the deployment manipulator, enabling incremental release of the annuloplasty structure concurrent with anchor deployment.
Outer and inner catheter system with coaxial arrangement
The system comprises an inner catheter (steerable in a plane) nested within an outer catheter with a lumen sized to hold the inner catheter coaxially, enabling a multi-bend formation for delivery.
Multi-bend formation for delivery and deployment
The system supports a multi-bend configuration separating the outer catheter, inner catheter, and annuloplasty structure into distinct domains with defined spatial disposition and planes for effective navigation and placement.
Locking mechanisms to inhibit rotation
The system includes first and second locking mechanisms located at distal and proximal regions, respectively, configured to inhibit rotation of the inner catheter relative to the outer catheter during deployment.
Anchors deliverable through and penetrating the annuloplasty structure
Each anchor is deliverable along the elongate lumen of the annuloplasty structure and configured to penetrate and pass through material of the structure into cardiac tissue from within the lumen.
Method of delivery and sequential anchoring
A method claims sequential transluminal advancement of the catheter, delivery of the annuloplasty structure, and sequential independent introduction, advancement, and deployment of multiple anchors through the catheter and into the annulus from within the atrium.
Multi-bend formation during anchor deployment
During anchor deployment, the catheter, inner catheter, and annuloplasty structure assume a multi-bend formation, with specific domains and bends corresponding to anatomical and procedural alignment.
Exposed annuloplasty structure during anchor deployment
Anchors are deployed while a first portion of the annuloplasty structure remains exposed out of the catheter's distal opening at the valve, and a second portion remains within the delivery passage.
Anchor deployment while annular structure partially anchored
A first anchor is anchored at the valve while subsequent anchors are delivered and deployed independently with the first portion anchored and the second portion within the catheter.
Kit comprising catheter components and anchors for valve repair
A kit comprising an outer catheter, an inner catheter, an annuloplasty structure, a deployment manipulator with anchors, and control mechanisms for independent steering and incremental release during transvascular delivery and anchoring of the annuloplasty structure.
In summary, the claims cover a catheter-based system and associated methods for delivery, steering, anchoring, and tension adjustment of an annuloplasty structure using independent coaxial catheter components and steerable manipulators with locking mechanisms, enabling minimally invasive cardiac valve repair.
Stated Advantages
Reduced risk of accidental release of system components and reduced damage to surrounding tissue by containing tools and anchors within a sleeve during left atrial introduction.
Facilitates returning to and adjusting previously deployed anchors due to contained lumen and use of screw-type helical anchors for removal or tightening.
Provides precise and secure anchoring in thicker ventricular tissue to improve implant stability and reduce risk of atrial perforation.
Enables controlled navigation and positioning using steerable catheters with independent steering in orthogonal planes and rotational locking to avoid mutual distortion.
Incremental adjustment of annuloplasty ring tension via a spool mechanism accessible through the catheter lumen.
Multi-bend catheter formation enhances maneuverability in vasculature and precise delivery to the valve annulus.
Documented Applications
Repair of a dilated atrioventricular valve, such as the mitral valve, particularly ischemic mitral regurgitation.
Anchoring adjustable partial annuloplasty rings through transcatheter or minimally invasive procedures.
Delivery and implantation of annuloplasty rings in left and right atria, specifically for mitral and tricuspid valve repair.
Use of steerable coaxial catheters to access the heart chambers to deliver valve repair implants.
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