Annuloplasty implants
Inventors
GROSS, AMIR • Sheps, Tal • Hammer, Tal • Reich, Tal • Aviv, Ehud
Assignees
Valtech Cardio Ltd • Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-12138165-B2
Publication Date
2024-11-12
Expiration Date
2031-06-23
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Abstract
A method for treating a native heart valve of a patient includes anchoring a plurality of anchors of an implant into tissue around an annulus of the valve. At the annulus, a force-distribution element is incorporated into the implant such that the force-distribution element extends along a longitudinal portion of the elongate contracting member. The method can also include circumferentially tightening the annulus by pulling the plurality of anchors closer together, such as by actuating a contracting mechanism of a contracting system, such that (i) the contracting mechanism, coupled to an elongate contracting member of the implant, applies a longitudinal tensioning force to the elongate contracting member, and (ii) the force-distributing element distributes the longitudinal tensioning force over at least two of the anchors. Other embodiments are also described.
Core Innovation
The invention provides an adjustable implantable structure comprising a flexible sleeve and a contracting assembly for repairing a dilated valve annulus of a native atrioventricular valve, such as a mitral or tricuspid valve. The implant is configured to be anchored to tissue around the annulus via a plurality of anchors, and includes a longitudinal contracting member that is coupled to a contracting mechanism. The contracting assembly is configured to apply a longitudinal contracting force to the sleeve, contracting at least a portion of the sleeve between two defined sites while preserving other portions, such as the anterior annulus that should not be contracted.
A key feature of the invention is the incorporation of a force-distribution element along a longitudinal portion of the elongate contracting member, extending toward an end of the sleeve. This element distributes the longitudinal tensioning force applied by the contracting mechanism over at least two of the anchors, preventing concentration of force on single anchors and improving anchoring stability. The force-distribution element may be a cylindrical tube, a coiled element with tightly wound coils, or otherwise longitudinally non-compressible and flexible.
Additionally, the implant structure can be configured as a closed loop placed completely around the valve annulus, including the anterior portion between fibrous trigones. The sleeve forms overlapping portions at the anterior annulus, to which anchors can penetrate both portions to maintain a closed loop and prevent annulus dilation. Contracting members and contraction are restricted to non-anterior portions of the sleeve, thus maintaining anterior annulus length and avoiding contraction where tissue is part of the heart skeleton.
Claims Coverage
The claims cover methods and apparatus for an implantable valve repair system comprising a longitudinal contracting member with an incorporated force-distribution element, arranged around the valve annulus, and actuated by a contracting mechanism, with features related to anchor placement, force distribution, loop configuration, and contraction control.
Force-distribution element incorporated into the implant
An implant structure comprising a force-distribution element that extends along a longitudinal portion of an elongate contracting member, configured to distribute the longitudinal tensioning force over multiple anchors during contraction of the valve annulus.
Contracting mechanism coupled to a longitudinal contracting member
A contracting mechanism, including a rotatable structure, coupled to a longitudinal contracting member arranged between two sites on the implant structure, configured to apply longitudinal contracting force only between those sites, preserving other portions.
Closed loop configuration with overlapping sleeve portions
Arranging the sleeve in a closed loop with overlapping first and second portions defining a longitudinally overlapping portion positioned along the anterior annulus, with anchors penetrating both sleeve portions to maintain loop integrity and non-contraction at the anterior annulus.
Distributed anchor placement beyond contraction ends
Coupling tissue anchors to the sleeve at longitudinal sites beyond the ends of the contracting member to distribute contraction forces over multiple anchors, preventing force concentration on single anchors near contracting member ends.
Use of contraction-restricting elements
Incorporation of contraction-restricting elements such as coiled or stiff segments configured to restrict contraction beyond a predetermined amount in specified portions of the implant during longitudinal contraction of other portions.
Closure element at sleeve openings
A closure element disposed near at least one end of the sleeve, such as end flaps or self-closing strips, configured to close openings in the implant structure after deployment to prevent thrombosis or for other reasons.
Multi-segment contracting members and mechanisms
Use of first and second longitudinal contracting members coupled to the same contracting mechanism at an intermediary site along the sleeve, wherein rotation of the mechanism contracts both members and the sleeve portion between anchor points.
The claims describe a valve repair implant and method integrating a longitudinal contracting member with a force-distribution element and multiple anchored segments in a closed-loop configuration, with contraction limited to selected sleeve portions, incorporation of contraction-restricting elements, and closure mechanisms. These elements provide controlled annulus tightening while preserving critical annulus anatomy and improving implant anchoring and stability.
Stated Advantages
Distributes longitudinal tensioning force over multiple anchors, preventing force concentration at single anchors and improving implant stability.
Allows contraction of the implant only along desired portions of the annulus while preserving the anterior annulus length to maintain heart skeleton integrity.
Provides improved anchoring by employing anchors that penetrate overlapping sleeve portions to maintain closed-loop implant configuration.
Enables partial contraction of the annulus with restriction of contraction at certain portions via contraction-restricting elements for better annulus reshaping.
Facilitates less invasive transcatheter or minimally invasive procedures with steerable deployment and anchor release tools contained within the implant lumen.
Closure mechanisms reduce risks of thrombosis by closing sleeve openings after tool removal.
Documented Applications
Treatment and repair of native atrioventricular valves, particularly mitral and tricuspid valves, including cases of ischemic heart disease causing mitral regurgitation due to annulus dilatation.
Partial or full annuloplasty ring implantation for tightening and reshaping dilated valve annuli to improve valve function.
Use as a base ring for coupling prosthetic heart valves in valve replacement procedures.
Deployment via transcatheter, percutaneous, minimally invasive, or open heart procedures.
Post-implantation adjustability of the implant via contractile actuating mechanisms for long-term valve annulus size management.
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