Adjustable annuloplasty devices and adjustment mechanisms therefor
Inventors
Cabiri, Oz • Sheps, Tal • Kutzik, Meir • GROSS, AMIR • Zipory, Yuval
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-12138168-B2
Publication Date
2024-11-12
Expiration Date
2028-12-22
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Abstract
An annuloplasty implant comprises a flexible member, helical anchors, and non-compressible portions. The helical anchors are configured to anchor the flexible member at least partway around the valve by being screwed into tissue of the heart of a subject. Each of the non-compressible portions comprises a helical coil having a plurality of turns, and at rest has a helix pitch that contacts each turn of the coil with an adjacent turn of the coil. The flexible member extends through the non-compressible portions. The implant is configured such that applying tension to the flexible member from one end thereof contracts the implant, thereby drawing the anchors closer to each other, the helical coil of each of the non-compressible portions inhibiting contraction of the implant at the non-compressible portion.
Core Innovation
The invention relates to an annuloplasty implant designed to repair a dilated mitral valve by comprising a flexible member, a plurality of helical anchors, and non-compressible portions. The helical anchors are configured to secure the flexible member at least partway around the valve by being screwed into the heart tissue of a subject. Non-compressible portions comprise a helical coil with multiple turns, where each turn contacts adjacent turns at rest, and the flexible member extends through these portions.
The implant is configured such that applying tension to the flexible member from one end contracts the implant, drawing the anchors closer. The helical coil in each non-compressible portion inhibits contraction at that portion, thereby controlling the shape and function of the implant during contraction.
The problem addressed is ischemic mitral regurgitation caused by ischemic dysfunction and annulus dilatation, leading to incomplete leaflet coaptation and decreased cardiac output. Existing devices lacked a flexible, adjustable annuloplasty implant that can be anchored via helical anchors and whose contraction is regulated by non-compressible portions to restore proper valve function.
Claims Coverage
The patent claims focus on the apparatus construction and functionality comprising flexible members, helical anchors, non-compressible portions, locking mechanisms, and the interaction of these elements in contracting and securing an annuloplasty implant.
Flexible member and helical anchors configuration
An annuloplasty implant comprising a flexible member anchored at least partway around a heart valve by helical anchors configured to be screwed into heart tissue.
Non-compressible portions structure
Inclusion of flexible non-compressible portions composed of helical coils with adjacent contacting turns that reside along the implant and inhibit contraction locally.
Locking mechanism with unlocked and locked states
A locking mechanism that facilitates contraction by allowing tension application in the unlocked state and maintains contraction by maintaining tension in the locked state.
Elongate tool interaction with locking mechanism
An elongate tool configured to maintain the locking mechanism in the unlocked state during contraction, with the locking mechanism comprising a compressible element biased toward the locked state; removal of the tool allows the compressible element to relax and lock the mechanism.
Anchor advancement tube
An anchor advancement tube configured to screw each of the helical anchors into the tissue to secure the implant.
Overall, the claims describe an adjustable annuloplasty implant with helical anchors, flexible and non-compressible portions regulating contraction, a locking mechanism that can be engaged and disengaged via a tool to control the tension and contraction state, and auxiliary components aiding implantation and anchoring.
Stated Advantages
Facilitates contraction of the implant by controlled tension application while maintaining the contracted state securely via a locking mechanism.
Enables adjustable and localized contraction control through non-compressible helical coil portions, improving conformity to anatomical features.
Allows minimally invasive implantation using helical anchors screwed into tissue with an anchor advancement tube.
Permits reversible adjustment of the implant's dimension through a locking mechanism releasable by an elongate tool.
Documented Applications
Repair of a dilated mitral valve of a patient by implantation of an annuloplasty device along the mitral valve annulus.
Use of the implant in transcatheter, minimally invasive, or open heart procedures to restore valve function in ischemic heart conditions.
Application to treat mitral regurgitation by controlling annulus size and shape.
Implantation of prosthetic heart valve assemblies comprising adjustable base rings for valve replacement procedures.
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