Implant having multiple adjusting mechanisms
Inventors
Miller, Eran • Reich, Tal • GROSS, AMIR • Sheps, Tal • Cabiri, Oz
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-12274620-B2
Publication Date
2025-04-15
Expiration Date
2032-11-01
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Abstract
An implant structure, comprises a body portion, a first adjusting mechanism, and a second adjusting mechanism. The body portion is configured to be secured within a heart of a patient. The first adjusting mechanism is coupled to a first portion of the body portion, and comprises a first ring that surrounds the first portion and is moveable with respect to the body portion. The second adjusting mechanism is coupled to a second portion of the body portion, and comprises a second ring that surrounds the second portion and is moveable with respect to the body portion. A first elongate tool is configured to remodel tissue of the heart by actuating the first adjusting mechanism. A second elongate tool is configured to remodel tissue of the heart by actuating the second adjusting mechanism.
Core Innovation
The invention provides an implant structure for repairing heart valves, particularly for functional mitral regurgitation (FMR), a common form of valvular heart disease where the mitral valve does not close properly, causing blood regurgitation into the left atrium. The implant comprises a body portion shaped to be secured within the heart, coupled with multiple adjusting mechanisms including at least a first adjusting mechanism and a second adjusting mechanism. Each adjusting mechanism includes a rotatable structure, such as a rotatable ring or spool, which is moveable with respect to the body portion.
The implant includes an adjustable annuloplasty ring structure comprising a flexible, longitudinally-compressible segment housed in a tubular body with a lumen containing flexible longitudinal contracting members. The first adjusting mechanism is coupled to this contracting member to adjust the perimeter of the annuloplasty ring by varying the tension in the contracting member. The second adjusting mechanism is mounted on the outer surface of the tubular body and is coupled to flexible longitudinal tension members that extend toward the ventricle and couple to cardiac tissue such as papillary muscles or ventricular walls, enabling adjustment of their positions or distension and possibly acting as artificial chordae tendineae.
The implant allows independent, reversible adjustment of the valve annulus perimeter and the position or tension of the ventricular tissue via the first and second adjusting mechanisms, respectively. The adjusting mechanisms use rotatable spools that can be actuated by elongate tools inserted transluminally or through minimally invasive or open-heart procedures. Locking mechanisms are included to maintain adjustments securely, and these can be manipulated intracorporeally. The implant and adjusting mechanisms facilitate real-time postoperative adjustment of the valve and ventricular tissue remodeling while the heart is beating, potentially improving therapy effectiveness and patient prognosis.
Claims Coverage
The claims define several inventive features related to an implant structure with multiple adjusting mechanisms and associated tools for heart tissue remodeling, focusing on the structure's components, adjustment capabilities, and methods of use.
Adjustable implant structure with dual rotatable rings
An implant structure comprising a body portion configured for securing within a heart atrium, a first adjusting mechanism with a first ring moveable around a first body portion, and a second adjusting mechanism with a second ring moveable around a second body portion of the implant; the rings surround respective body portions and are independently adjustable.
Elongate tools for remodeling heart tissue
A first elongate tool configured to actuate the first adjusting mechanism and a second elongate tool configured to actuate the second adjusting mechanism, allowing remodeling of heart tissue via intracorporeal actuation.
Guide members facilitating tool advancement
A first and second longitudinal guide member with distal ends coupled to the respective adjusting mechanisms, enabling transluminal advancement of the elongate tools along these guides to the adjusting mechanisms.
Rotational actuation and bidirectional rotation
The adjusting mechanisms are configured to be actuated by applying rotational forces via the elongate tools, with both first and second adjusting mechanisms rotatable bidirectionally for reversible adjustment.
Locking mechanisms with intracorporeal state transitions
Each adjusting mechanism includes a locking mechanism having locked and unlocked states, where adjustments are inhibited in the locked state, and transition between these states can be performed intracorporeally using the elongate tools.
Annulus ring configured for securing to valve annulus
The implant structure includes an annulus ring designed to be secured to the annulus of a heart valve, such as a mitral valve, providing structural placement and support.
Methods of securing and remodeling heart tissue using the implant
Methods include securing the implant body portion within the heart atrium or to a valve annulus, and remodeling tissue by intracorporeally actuating the first and second adjusting mechanisms using the respective elongate tools, potentially via transluminal approaches, and while the heart is beating.
The claims broadly cover an implant structure with multiple independently adjustable rotatable ring mechanisms, associated elongate tools for actuation, guide systems for tool advancement, locking mechanisms for secure adjustment, and methods of implanting and adjusting the device for remodeling heart valve and ventricular tissue in beating hearts, via minimally invasive or open procedures.
Stated Advantages
Enable remodeling of mitral valve annulus and ventricular tissue to treat functional mitral regurgitation by adjusting both valve perimeter and papillary muscle position.
Allow reversible and independent adjustment of multiple mechanisms to optimize heart valve function in real time while the heart is beating.
Facilitate minimally-invasive or percutaneous implantation and intracorporeal adjustment using elongate tools and guide members.
Provide locking mechanisms that secure adjusted positions yet can be unlocked intracorporeally for further manipulation.
Permit shaping of the annuloplasty ring into desirable configurations, including saddle shapes, for improved mimicry of native valve geometry.
Documented Applications
Repair and remodeling of the mitral valve in patients suffering from functional mitral regurgitation by adjusting the valve annulus perimeter and papillary muscle position.
Treatment of ventricular wall distension by repositioning ventricular tissue using flexible longitudinal tension members coupled to adjusting mechanisms.
Use of the implant as artificial chordae tendineae to support mitral valve function.
Implantation of the device through open-heart, minimally-invasive, or percutaneous transcatheter transluminal procedures.
Real-time, off-pump adjustment of heart valve morphology and ventricular tissue tension guided by imaging feedback to optimize hemodynamics.
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