Deployment techniques for annuloplasty structure
Inventors
Zipory, Yuval • Cabiri, Oz • Gross, Yosef • Hammer, Tal • GROSS, AMIR • Maisano, Francesco • Miller, Eran • Weitzman, Yoseph • Ayvazian, Aram
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-11844665-B2
Publication Date
2023-12-19
Expiration Date
2029-05-04
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Abstract
A first part of an annuloplasty structure is anchored to an annulus of a valve of a heart by using a driver to screw a tissue-coupling element of a first anchor into a first site of the annulus, such that the tissue-coupling element enters cardiac tissue in a direction parallel to a central longitudinal axis of the driver through the distal end of the anchor driver. The same is subsequently done for second and third parts of the annuloplasty structure using second and third anchors at second and third sites of the annulus, mutatis mutandis. Between anchors, the driver is retracted out of the heart. Subsequently, the valve is treated by reducing a distance between the first site and the second site, and a distance between the second site and the third site, by tightening a flexible and elongate contracting member of the annuloplasty structure.
Core Innovation
The invention provides an implant structure comprising a contracting mechanism arranged to contract the implant upon rotation of a rotatable structure within the mechanism. The implant includes a longitudinal member coupled to the contracting mechanism, and a rotation tool configured to be guided along the longitudinal member to engage and rotate the rotatable structure in response to applied rotational force. This implant structure is exemplified in embodiments such as an adjustable partial annuloplasty ring comprising a flexible sleeve, multiple anchors, and a flexible elongated contracting member which tightens the ring by winding around a spool.
A key innovation lies in a method and apparatus for anchoring the annuloplasty structure to a valve annulus using an anchor deployment manipulator advanced into the lumen of the sleeve. Anchors are deployed from the distal end of the manipulator through the sleeve wall into cardiac tissue, at specific angles, typically between 45 and 90 degrees relative to the tissue surface or lines defined between anchor sites. The anchors enter cardiac tissue parallel to the manipulator's longitudinal axis, enabling secure implantation into regions such as the upper ventricular wall near the atrium, enhancing anchoring security.
The contracting mechanism comprises features including a spool housed within a housing, coupled to the flexible contracting member, which is tightened by rotating the spool via the rotation tool. The tool comprises multiple tubes passing concentrically over the longitudinal member; one tube engages and rotates the spool, another rotates the longitudinal member to decouple it from the contracting mechanism. A locking mechanism prevents unwinding after contraction. The implant delivery and adjustment system includes a steerable outer tube for precise anchor deployment and may incorporate a pusher element or tube to assist in maneuvering within the sleeve during implantation.
Claims Coverage
The patent includes multiple independent claims focusing on a method of anchor deployment and valve treatment using an annuloplasty structure, with specific anchoring steps and apparatus configurations. The main inventive features relate to anchor deployment angles, catheter-based deployment techniques, and sequential engagement of anchors to the valve annulus.
Transfemoral catheter-based anchor deployment and sequential anchoring
A method comprising advancing a catheter transfemorally to the atrium, using a transfemoral anchor driver engaged with a coupling head of successive anchors of an elongate annuloplasty structure, advancing each anchor into the atrium, and anchoring each part of the annuloplasty structure to defined sites of the valve annulus by screwing tissue-coupling elements into cardiac tissue in a direction parallel to a central longitudinal axis of the anchor driver through its distal end. The method includes retracting the driver after each anchor deployment with remaining parts inside the catheter.
Angle-specific anchor deployment relative to annulus sites
Deploying anchors such that the central longitudinal axis of the anchor driver through its distal end forms angles between 45 and 90 degrees with lines defined between adjacent anchor deployment sites on the annulus, ensuring proper geometric deployment in the atrial vicinity for secure anchoring.
Valve treatment by tightening a flexible contracting member
After anchoring multiple parts of the annuloplasty structure, the valve is treated by reducing distances between adjacent anchor sites of the annulus through tightening a flexible and elongate contracting member incorporated into the annuloplasty structure, thereby reducing annular dilation.
Catheter steering during anchor deployment
The method includes optionally employing catheter steering functionality to direct the anchor driver toward specific anchor sites on the annulus during the procedure, allowing precise anatomical placement of the anchors.
Locking mechanism to maintain contracting member tension
Subsequent to tightening the contracting member, a locking mechanism is engaged to maintain tautness in the contracting member, preventing loss of valve annulus contraction.
The independent claims cover a catheter-based method of sequentially deploying anchors into the atrial side of a valve annulus via a transfemoral approach, securing an annuloplasty structure by screwing anchors in with angular control, retracting the deployment tool between anchor deployments, and tightening the annulus by contracting a flexible member coupled to the anchors. Additional claimed features include catheter steering and locking of the contraction mechanism.
Stated Advantages
Reduces the risk that system elements are accidentally released into blood circulation or damage surrounding tissue by containing all tools and elements introduced into the heart within the sleeve lumen.
The sleeve lumen provides a guide for re-accessing previously deployed anchors for potential tightening, loosening, removal, or relocation.
Use of helical screws facilitates anchor adjusting or removing, minimizing force applied during deployment and enhancing secure engagement.
The flexible sleeve being configured to assume a straight shape helps surgeons locate subsequent anchoring sites and manage distances between anchors accurately.
Steering capabilities of the deployment manipulator allow precise six-degree freedom positioning of deployment sites in complex cardiac anatomy.
Documented Applications
Repair of dilated atrioventricular valves, such as the mitral valve, through placement of an adjustable partial annuloplasty ring anchored to the valve annulus.
Treatment of tricuspid valve regurgitation by placing and contracting the annuloplasty ring in the right atrium.
Minimally invasive, percutaneous, or open heart procedures for placing the annuloplasty device, typically via a transfemoral transseptal approach into the left atrium for mitral valve repair.
Use of repair chords to pull separate portions of heart tissue toward one another, facilitating leaflet coaptation for valve repair.
Valve prosthesis assemblies comprising an annuloplasty base ring and prosthetic valve leaflets, where the ring can be contracted to secure the prosthetic valve in place during valve replacement.
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