Multiple anchor delivery tool
Inventors
Cabiri, Oz • GROSS, AMIR • Hammer, Tal • Reich, Tal • Aviv, Ehud
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-11723774-B2
Publication Date
2023-08-15
Expiration Date
2029-05-07
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Abstract
A tube and a set of anchors, are transluminally advanced toward a heart of a subject. Tabs are distributed axially along an anchor storage area of the tube, each of the tabs protruding medially from a circumferential wall of the tube. The anchors are disposed in the anchor storage area, a first anchor engaged and restrained by a first tab at a first axial location of the tube, and a second anchor engaged and restrained by a second tab at a second axial location of the tube proximal from the first axial location. The first anchor is engaged by the driver at the first axial location, advanced to a distal end of the tube, and anchored to tissue of the heart. Subsequently, the second anchor is engaged by the driver at the second axial location, advanced to the distal end of the tube, and anchored to the tissue.
Core Innovation
The invention provides an adjustable partial annuloplasty ring for repairing a dilated valve annulus of an atrioventricular valve, such as a mitral valve. The system includes a flexible sleeve containing a plurality of anchors that can be deployed through a wall of the sleeve and into cardiac tissue by an anchor deployment manipulator advanced within the sleeve. The anchors are typically deployed distally in a direction substantially parallel to the longitudinal axis of the deployment manipulator, and are screwed into the cardiac tissue to secure the sleeve around a portion of the valve annulus.
The anchor deployment manipulator comprises a flexible outer tube and an inner flexible shaft with a rotating deployment element at its distal end. The anchors are initially stored in an anchor storage area within the tube, restrained by tabs that prevent their distal movement until deployment. The deployment element sequentially engages and advances each anchor distally, deploying them into the cardiac tissue. The system allows deploying anchors one at a time while maintaining steerability and precision positioning within the anatomy.
The annuloplasty ring includes a flexible contracting member coupled to a contracting mechanism such as a spool, allowing the ring to be tightened circumferentially around the valve annulus after the anchors have been deployed. Tension is applied and maintained on the contracting member via the contracting mechanism. The deployment manipulator and the anchors enable minimally invasive or transcatheter implantation procedures that reduce risks in valve repair.
The problem being solved is the inadequacy of traditional surgical methods for repairing mitral regurgitation caused by dilatation of the mitral valve annulus due to ischemic heart disease. Conventional annuloplasty procedures can be invasive, and precise placement of multiple anchors around the valve annulus is challenging. Prior art devices for tissue anchoring do not provide an effective, minimally invasive means to deploy a series of anchors sequentially through a sleeve and to subsequently contract the annuloplasty ring, while maintaining steerable access and secure anchoring into cardiac tissue.
Claims Coverage
The patent claims encompass methods and apparatus for transluminal delivery of multiple anchors through an anchor deployment tool, including their deployment and subsequent annuloplasty ring contraction. There are several inventive features extracted from independent claims related to anchor storage, engagement, deployment, and annulus contraction.
Multiple-anchor storage with axial tabs for sequential deployment
The deployment tool includes a flexible tube with a series of tabs axially distributed along an anchor storage area. Each tab engages and restrains an anchor at distinct axial locations, allowing sequential engagement and distal advancement of each anchor for deployment.
Sequential anchor engagement and deployment with driver and flexible shaft
A driver with a flexible shaft and a deployment element at its distal end selectively engages anchors within the storage area one at a time. The deployment element advances the engaged anchor distally through the tube to tissue, enabling controlled anchoring at end locations.
Annuloplasty implant contraction by tensioning and locking elongate contracting member
Following anchor deployment, the elongate contracting member anchored via the anchors is tensioned to contract the annuloplasty implant. The tension is maintained by actuating a locking mechanism coupled to the contracting member, optionally including crimping and excess length removal.
Helical tissue coupling anchors with noncircular openings allowing shaft passage
Each anchor includes a helical tissue coupling element and a head forming a noncircular opening through which the flexible shaft of the driver passes. This configuration allows the distal end of the driver to slide through heads of other anchors during sequential engagement and deployment.
Deployment element with prongs inhibiting inward motion to engage anchors
The deployment element includes two prongs that expand to engage the anchor heads by inhibiting prong movement toward each other, facilitating stable engagement during deployment, rotation for screwing anchors into tissue, and withdrawal without disengagement.
The claims cover a comprehensive system for storing, sequentially engaging, advancing, and deploying multiple anchors through an anchor deployment tool with a flexible shaft and deployment element, enabling secure attachment of an annuloplasty implant. The system also incorporates mechanisms for contracting the implant and maintaining tension, while allowing minimally invasive transluminal procedures.
Stated Advantages
The annuloplasty system reduces the risk of accidental release of system elements into blood circulation and reduces tissue damage by containing tools and anchors within the sleeve.
The flexible sleeve guides re-access to previously deployed anchors to enable tightening, loosening, removal, or relocation, facilitated by helical screw anchors.
The deployment manipulator allows precise steerable delivery and placement of anchors with an angle between about 45 and 90 degrees relative to the sleeve wall, improving anchoring security by targeting thicker ventricular tissue.
The anchor deployment tool enables sequential deployment of multiple anchors stored within the tool, maintaining maneuverability by restricting to one anchor in the manipulation area at a time.
The contracting mechanism provides controlled circumferential tightening of the annuloplasty ring via a spool accessible within the sleeve lumen, enabling minimally invasive adjustment after anchor deployment.
Documented Applications
Repair of a dilated valve annulus of an atrioventricular valve, including mitral valve repair via partial or full annuloplasty ring implantation.
Deployment of anchors in cardiac tissue of the heart, specifically targeting anchoring around mitral valve annulus from the left atrium through the atrial wall into the ventricular wall.
Transcatheter, minimally invasive, or open heart surgical approaches to annuloplasty ring implantation and valve repair.
Application in treatment of other atrioventricular valves such as the tricuspid valve by deploying corresponding annuloplasty ring and anchors in the right atrium.
Deployment of tissue anchors via a working channel of an endoscope, such as securing a support mesh for hernia treatment.
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