Implantation of repair chords in the heart
Inventors
Miller, Eran • Cabiri, Oz • Gross, Yosef • GROSS, AMIR • Reich, Tal
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-11766327-B2
Publication Date
2023-09-26
Expiration Date
2029-05-04
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Abstract
Systems and apparatuses herein include a longitudinal member having opposite first and second end portions, a tension of the longitudinal member being adjustable to repair an atrioventricular valve of the patient. A delivery tool can be configured to couple the first end portion of the longitudinal member to a first portion of heart tissue, couple the second end portion of the longitudinal member to the leaflet, adjust tension of the longitudinal member, assume a first diameter at a portion of the delivery tool that passes between the leaflets of the atrioventricular valve, during coupling of the first end portion of the longitudinal member to the first portion of heart tissue, and assume a second diameter that is smaller than the first diameter, at the portion of the delivery tool that passes between the leaflets of the atrioventricular valve, during adjusting of the tension of the longitudinal member.
Core Innovation
The invention provides systems and apparatuses comprising at least one adjustable longitudinal member and a delivery tool to repair atrioventricular valves of a patient. The longitudinal member, which can function as an artificial chordae tendineae or adjust distances between ventricular wall portions, is coupled at one end to an adjusting mechanism such as a spool assembly implanted in heart tissue like a papillary muscle or ventricular wall portion. The opposite end is coupled to heart tissue such as a leaflet of an atrioventricular valve or another ventricular wall portion. The tension of the longitudinal member is adjustable to restore or improve valve function.
The delivery tool is configured to couple each end portion of the longitudinal member to the respective portions of heart tissue and then adjust the tension by rotating the spool to wind the longitudinal member, thereby shortening it and drawing the coupled heart tissues together. The tool includes a multilumen shaft with a primary lumen housing a torque-delivering mechanism and secondary lumens for the longitudinal members. During implantation, the tool passes between valve leaflets, initially having a first diameter to facilitate coupling. After coupling, the tool is retracted to a smaller diameter that reduces interference with the beating valve while adjusting tension.
This invention solves the problems caused by ischemic heart disease, such as mitral regurgitation due to papillary muscle dysfunction and ventricular dilation. These conditions prevent proper leaflet coaptation, leading to regurgitation and decreased cardiac output. Existing technologies either lack adjustable tensioning after implantation or cause significant interference during the heart’s beating. By enabling adjustable, minimally interfering implantation and tensioning of repair chords through a delivery tool that changes diameter intracardially, the invention addresses these issues and improves valve repair outcomes.
Claims Coverage
The patent presents two independent apparatus claims focusing on adjustable longitudinal members implanted in the heart, and a delivery tool allowing for coupling and tension adjustment between heart tissue portions and valve leaflets. The inventive features pertain to the structure, function, and configuration that facilitate implantation, adjustment, and reduced interference during procedures.
Longitudinal member with adjustable tension for valve repair
An apparatus including at least one longitudinal member having opposite ends couplable between heart tissue surrounding a ventricular space and a valve leaflet, wherein tension of the longitudinal member is adjustable to repair the valve.
Delivery tool with intracardially variable diameter
A delivery tool reversibly coupled to the longitudinal member, configured to deliver and adjust tension by coupling the first and second end portions to heart tissue and leaflets respectively, that assumes a first diameter during coupling and is intracardially changed to a smaller second diameter during subsequent tension adjustment to minimize interference with valve leaflets.
Helical tissue anchor implantation at papillary muscle
The first end portion of the longitudinal member is coupled to a helical tissue anchor implantable at a papillary muscle for anchoring.
Leaflet engagement via clips and piercing
The second end portion of the longitudinal member is coupled to at least one clip configured to engage both atrial and ventricular surfaces of a leaflet, with the delivery tool configured to couple this by puncturing the leaflet.
Delivery tool structure enabling diameter adjustment by sliding tube
The delivery tool comprises a handle defining a lumen, a longitudinal member-adjusting tool, and a surrounding tube slidable along the adjusting tool and into the handle lumen to achieve diameter reduction of the tool portion passing between valve leaflets during tension adjustment.
Maintaining distal adjusting tool position during tension adjustment
During tension adjustment, the distal end of the adjusting tool is maintained within the ventricle and reversibly coupled to the tissue anchor, ensuring stable positioning.
Leaflet-engaging element holder coupled to distal tube end
The distal end of the tube includes a leaflet-engaging element holder reversibly coupled to the leaflet-engaging element for engaging the leaflet while the distal end of the adjusting tool remains within the ventricle.
Engaging leaflets by driving elements through leaflets
The delivery tool is configured to engage the leaflet-engaging element with the leaflet by driving the element from an upstream side through to a downstream side of the leaflet.
The claims cover an apparatus and delivery tool system for implanting adjustable longitudinal members coupled between heart tissues and valve leaflets, featuring a delivery tool with an intracardially variable diameter, helical tissue anchors, leaflet engagement via clips or piercing, and mechanisms ensuring stable positioning and manipulability during implantation and tension adjustment.
Stated Advantages
Reduced interference of the delivery tool on the beating heart during adjustment by intracardially reducing the tool diameter between valve leaflets.
Ability to adjust the tension of repair chords both during implantation and post-operatively from outside the patient's body to restore valve function.
Bidirectional adjustment of the artificial chordae tendineae allows both tightening and relaxing to accommodate physiological conditions.
Improved implantation accuracy and stability by utilizing a helical tissue anchor coupled to a spool assembly implanted in heart tissue such as papillary muscle.
Facilitates minimally-invasive, open-heart, and transcatheter procedures with atraumatic delivery and adjustable repair.
Documented Applications
Repair of atrioventricular valves, particularly mitral and tricuspid valves, by replacing or supplementing native chordae tendineae with adjustable artificial chords.
Adjusting distances between two portions of the ventricular wall to restore physiological dimensions of the heart in cases of ventricular dilation or papillary muscle displacement.
Procedures applicable during open-heart surgery, minimally-invasive surgery, and transcatheter interventions to implant and adjust repair chords.
Use of delivery tools and implant assemblies to facilitate implantation of adjustable repair chords, coupling to leaflets via clips, hooks, rings, or direct suturing, and adjustment of tension post implantation.
Application of energy (radiofrequency or ultrasound) from outside the patient's body for adjusting chord length after implantation.
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