Cinching of dilated heart muscle
Inventors
Keidar, Yaron • Nia, Nima V. • Rowe, Stanton J. • Cao, Hengchu • Reich, Tal
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-12364605-B2
Publication Date
2025-07-22
Expiration Date
2038-11-08
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Abstract
Methods, systems, and apparatuses for treating a heart are provided. Methods can include obtaining and using an implant. One or more catheters can be used to properly position and attach the implant in a desired location in a chamber of the heart, for example, such that (i) a first portion of the implant is anchored to a first site on a wall of the chamber, (ii) a second portion of the implant is anchored to a second site on the wall of the chamber, (iii) a mid-portion of the implant extends in a curved path along the wall of the chamber between the first site and the second site, and (iv) an elongate contraction member of the implant cuts across the chamber between the first site and the second site. Other embodiments are described.
Core Innovation
The invention provides methods, systems, and apparatuses for treating and reshaping a heart or a portion thereof by implanting an elongate flexible sleeve with an elongate contraction member. This implant is affixed or anchored to distinct tissue sites on a chamber wall of the heart, such as the left ventricle, with a mid-portion of the implant extending in a curved path along the wall between the first and second anchored sites. The elongate contraction member spans directly across the chamber between these sites and can be tensioned to reduce the direct distance between them, thereby reshaping the heart chamber.
The background problem addressed is valvular regurgitation caused by ischemic heart disease and the associated dilatation of the left ventricle and valve annulus. Such dilatation can prevent valve leaflets, including the mitral valve, from properly coapting, leading to increased stroke volume, reduced cardiac output, and weakening of the heart. The invention targets this problem by implanting and tensioning a device that reshapes the ventricular wall to reduce the anatomical conditions causing valve dysfunction.
The methods utilize one or more catheters to deliver the implant to precise tissue sites within the heart without capturing chordae tendineae, particularly positioning the implant between structures such as papillary muscles and valve annuli. Anchors or attachment means are passed through or attached to the implant sleeve at multiple longitudinal locations on the heart tissue. After anchoring, the contraction member is tensioned, either by pulling directly or through an adjustment component like a spool, to cinch the sleeve and reshape or reduce the distance between anchored tissue sites, thereby improving heart function.
Claims Coverage
The patent includes independent claims directed to methods for implanting and tensioning an implant within a heart chamber, with key inventive features regarding implant structure, implantation technique, and reshaping action.
Method for implanting and reshaping a heart chamber using a tensionable implant
Advancing a delivery tube into a heart chamber; advancing an implant through the delivery tube; anchoring first and second portions of the implant to distinct sites on the chamber wall with a mid-portion extending in a curved path; positioning an elongate contraction member cutting across the chamber; and reshaping the chamber by tensioning the contraction member to reduce the direct distance between the first and second sites.
Implantation without capturing chordae tendineae
Implanting the device to anchor the sleeve without capturing a chorda tendinea between the implant and chamber wall.
Reduction of radius of curvature by tensioning the contraction member
Reducing the radius of curvature of the mid-portion curved path along the chamber wall by tensioning the elongate contraction member.
Transluminal, transapical, and transseptal delivery pathways
Advancing the delivery tube transluminally through the atria, valves, septum, or via transapical access to the targeted chamber.
Implant configuration of sleeve and contraction member
Positioning the contraction member within or alongside the sleeve to extend from first to second portion, configured so that pulling shortens the effective length and contracts the sleeve.
Specific anchoring sites including ventricular wall, papillary muscles, and septum
Anchoring first and second portions to posterior wall, interventricular septum, posterior and anterior papillary muscles, with optional anchoring of the mid-portion at the apex or circumferentially.
Sliding contraction member through housing with locking mechanism
Sliding the contraction member through an eyelet in a housing coupled to an implant portion, with a locking mechanism allowing unlocked and locked states controlling movement.
Using an adjustment mechanism with spool for tensioning the contraction member
Applying tension by actuating an adjustment mechanism involving a spool that collects the contraction member by rotation, optionally with external adjustment tools.
Progressive anchoring of the mid-portion in multiple longitudinal sites
Anchoring the mid-portion progressively to distributed sites along the chamber wall.
The independent claims collectively cover methods of delivering and implanting a flexible sleeve with a contraction member into a heart chamber, anchoring it to multiple tissue locations along a curved path, and reshaping the heart by tensioning the contraction member to reduce the distance between anchor points while avoiding chordae tendineae capture, using defined implant structures and adjustable locking mechanisms.
Stated Advantages
The implant reshapes the heart chamber wall to reduce mitral regurgitation and improve cardiac output by restoring valve leaflet coaptation.
Implantation avoids capturing chordae tendineae to prevent interference with native heart structures.
The method enables minimally invasive delivery via transfemoral, transseptal, or transapical approaches.
The implant allows for adjustable post-implantation tensioning and locking to optimize heart reshaping.
Documented Applications
Treatment and reshaping of the left ventricle of a heart to reduce mitral valve regurgitation.
Implantation in other heart chambers, including right ventricle, left atrium, and right atrium, for reshaping purposes.
Use in subjects identified with heart failure with reduced ejection fraction (HFrEF) or type Mb mitral regurgitation.
Interested in licensing this patent?