Contraction of an annuloplasty structure
Inventors
Peleg, Carmel • Cohen, Yehuda • Brauon, Haim • Zipory, Yuval
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-11779463-B2
Publication Date
2023-10-10
Expiration Date
2039-01-23
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Abstract
An annuloplasty structure includes a flexible sleeve and an elongate contraction wire. The sleeve has a first sleeve-end-portion, a second sleeve-end-portion, and a circumferential wall that defines a longitudinal lumen between the first and second sleeve-end-portions. The contraction wire has a first wire-end and a second wire-end, the first wire-end being attached to the sleeve at the first sleeve-end-portion. The wire extends, in association with the circumferential wall, from the first sleeve-end-portion to the second sleeve-end-portion. The wire is arranged with respect to the sleeve such that increasing a longitudinal proportion of the wire that is disposed within the lumen longitudinally contracts the sleeve. Other embodiments are also provided.
Core Innovation
The invention relates to an annuloplasty structure comprising a flexible sleeve with a longitudinal lumen and an elongate contraction wire extending from a first sleeve-end to a second sleeve-end in association with the sleeve's circumferential wall. The contraction wire has a first wire-end attached to the sleeve at the first sleeve-end and a second wire-end at the opposite end. The wire arrangement is such that increasing the longitudinal portion of the wire disposed within the lumen longitudinally contracts the sleeve, thereby adjusting the shape of a heart valve annulus, such as to treat atrioventricular valve regurgitation.
The problem being addressed arises from ischemic heart disease, which causes valve regurgitation due to the dilatation of the valve annulus and displacement of papillary muscles. This dilation impairs valve leaflet coaptation, leading to regurgitation of blood, increased stroke volume, decreased cardiac output, and weakening of the ventricle due to volume and pressure overload of the atrium. Existing annuloplasty devices aim to improve leaflet coaptation but optimizing and maintaining precise contraction of such implants after implantation poses challenges, particularly in delivering contraction adjustments and securely locking them.
The invention provides various embodiments of a system for reshaping the heart valve annulus using the adjustable annuloplasty band. Contraction is achieved by increasing the longitudinal proportion of the contraction wire disposed within the lumen, typically by pulling the wire into the lumen. The contraction can be maintained by locking mechanisms that prevent the wire from reducing the contracted state. Various tools are described for engaging the wire internally or externally, adjusting the contraction wire, and locking the contraction state, some of which are transluminally advanceable. Moreover, the excess wire after contraction is contained within the lumen, obviating the need for removal or cutting, enhancing safety and convenience.
Claims Coverage
The patent includes multiple independent claims covering the annuloplasty apparatus and related mechanisms, with inventive features involving the implant structure, means of contraction, anchoring systems, contraction tools, locking mechanisms, and adjustment systems.
Annuloplasty implant structure with contraction wire
A flexible sleeve defining a longitudinal lumen with an elongate contraction wire extending from a first sleeve-end to a second sleeve-end in association with the circumferential wall, with the first wire-end attached at the first sleeve-end.
Anchoring mechanism with independently advanceable anchors
A plurality of anchors independently advanceable into the sleeve lumen and configured to anchor the sleeve to tissue by being driven through the circumferential wall and into tissue.
Contraction wire arrangement for lumen-based contraction
The contraction wire's second wire-end disposed within the lumen, and movement of this end toward the first sleeve-end increases the longitudinal proportion of wire within the lumen for longitudinal contraction.
Contraction wire woven along circumferential wall
The contraction wire extends from the first sleeve-end to the second sleeve-end by weaving along the circumferential wall between these portions.
One-way mechanism to maintain contraction
A one-way mechanism coupled to the wire and sleeve that allows one-way movement of the wire increasing the implanted portion within the lumen and inhibits reduction, maintaining contraction.
Contraction tool movable through lumen to engage wire
A tool comprising a wire-engaging element movable longitudinally into and through the lumen past anchor heads, reversibly couplable within the lumen to the second wire-end, enabling pulling of the wire into the lumen to contract the sleeve.
Locking mechanism with unlocked and locked states
A locking mechanism that allows movement of wire through it in an unlocked state to increase wire portion within the lumen, and inhibits movement in a locked state to maintain contraction.
Locking mechanism integrated with implant and transluminal delivery
The locking mechanism is a component of the annuloplasty implant, coupled to the sleeve, and the implant is transluminally advanceable with the locking mechanism coupled.
Lock tool for transitioning locking mechanism state
A lock tool configured to engage the locking mechanism and transition it from the unlocked state to the locked state, possibly by disengagement and biasing of the locking mechanism.
Adjustment mechanism feeding wire into lumen
An adjustment mechanism coupled to the sleeve and wire, configured to feed the wire into the lumen upon actuation, increasing the longitudinal proportion of wire disposed within the lumen.
Adjustment mechanism featuring a capstan and guide tube
The adjustment mechanism includes a capstan and may include a guide tube extending from the adjustment mechanism into the lumen, with wire feeding occurring into the tube upon actuation.
The independent claims cover an annuloplasty apparatus with a flexible sleeve and contraction wire arranged to achieve longitudinal contraction by increasing the wire portion within the lumen, use of anchors for tissue attachment, tools for engaging the contraction wire internally for contraction, locking mechanisms to maintain contraction, and adjustment mechanisms including capstans and guide tubes for controlled wire feeding to safely and effectively contract the implant.
Stated Advantages
The excess contraction wire is disposed within the lumen, obviating the need for removal or cutting of the wire, improving safety and convenience.
The arrangement allows for longitudinal contraction of the annuloplasty band by drawing the wire into the lumen, providing precise control of contraction.
Locking mechanisms provide secure maintenance of the contracted state, preventing undesirable loosening of the implant after adjustment.
Adjustment mechanisms such as capstans do not collect wire upon actuation, maintaining consistent contraction per adjustment step.
Use of one-way mechanisms inhibits reverse movement of the contraction wire, ensuring durable contraction.
Documented Applications
Treatment of native heart valves, such as mitral and tricuspid valves, by reshaping and contracting the valve annulus to improve leaflet coaptation and reduce regurgitation.
Percutaneous implantation and adjustment of annuloplasty devices via transluminal delivery to heart valve annuli.
Use in ischemic heart disease to counteract dilation of the atrioventricular valve annulus caused by ischemic dysfunction and ventricular dilation.
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