Techniques for facilitating heart valve tethering and chord replacement
Inventors
Assignees
Edwards Lifesciences Innovation Israel Ltd
Publication Number
US-11666442-B2
Publication Date
2023-06-06
Expiration Date
2039-01-22
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Abstract
A method is described, for use with a native valve of a heart of a subject, the valve being disposed between an atrium and a ventricle of the heart. A first radiopaque marker and a second radiopaque marker are percutaneously advanced to the heart. The first radiopaque marker is placed against a tissue site in the ventricle. The second radiopaque marker is placed against a leaflet of the valve. A distance is measured between the first radiopaque marker at the tissue site, and the second radiopaque marker at the leaflet. Responsively to the measured distance, a chord-length is determined. An artificial chord, selected based on the chord-length, is implanted in the heart. Other embodiments are also described.
Core Innovation
The invention provides techniques for determining an appropriate chord-length for an artificial chorda tendinea by placing radiopaque markers against tissue sites within a heart and calculating the distance between them. One marker is placed on a papillary muscle or a tissue site in the ventricle, and the other marker is placed against one or more valve leaflets. The chord-length is then based on the measured distance between these markers to facilitate implantation of an artificial chord with the correct length.
These techniques enable percutaneous implantation of the artificial chord, performed transluminally such as transfemorally or transseptally, without line-of-sight or direct visualization, by using imaging technologies including echocardiography and fluoroscopy. The method includes advancing markers percutaneously to the heart, placing them at specified tissue sites under echocardiographic guidance, measuring the distance via fluoroscopy or computer-assisted software, and determining the chord-length responsively, followed by implanting the chord accordingly.
The problem being solved is the difficulty in determining the optimal length of artificial chordae tendineae to repair native heart valves, particularly due to conditions like ischemic heart disease that cause mitral regurgitation through papillary muscle displacement and leaflet tethering. Existing challenges include the need for precise chord-length measurement to restore proper valve function, especially when direct visualization is limited during minimally invasive procedures.
Claims Coverage
The patent includes several independent claims covering methods for advancing radiopaque markers to a heart, measuring distances to determine chord-length or tether-length, and implanting artificial chords or tethers with features related to tool configurations, imaging guidance, and implantation techniques.
Percutaneous placement and measurement of radiopaque markers for chord-length determination and chord implantation
Advancing an elongate tool with a first radiopaque marker and a second separate radiopaque marker through vasculature to a heart; placing the first marker against a tissue site in the ventricle and the second against a leaflet of the native valve; measuring the distance between markers; determining chord-length responsively; anchoring a tissue anchor coupled to an elongate guide member to the tissue site without removing the tool; and implanting an artificial chord by advancing it along the guide member and attaching its ends to the anchor and leaflet.
Simulated heart and vasculature model method for planning chord implantation
Advancing radiopaque markers along a physical or computer-simulated model of vasculature to a simulated heart; placing markers at tissue sites; measuring the distance; determining tether-length; anchoring a tissue anchor to the tissue site; and implanting a tether based on the measured length.
Using a first and second elongate tool that are slidably coupled for marker placement and chord-length determination
Advancing a first radiopaque marker on a first elongate tool and a second radiopaque marker on a second elongate tool that is slidably coupled to the first; sliding the second tool relative to the first to place markers against tissue sites; measuring distance between markers and determining chord-length responsively.
Laterally expandable appendage on a second elongate tool for marker placement on leaflets
A second elongate tool including a longitudinal shaft and a laterally expandable appendage on which the second radiopaque marker is disposed; expanding the appendage inside the heart to abut a leaflet; using this configuration to place the second marker against the leaflet for distance measurement.
The independent claims cover the main inventive features of percutaneous placement and measurement of radiopaque markers to determine chord-length or tether-length, the use of elongate tools with sliding and expandable features to facilitate marker positioning, and the implantation of artificial chords or tethers accordingly, including applications on simulated models for procedure planning.
Stated Advantages
The techniques facilitate percutaneous implantation of artificial chords without the need for direct visualization.
Using radiopaque markers and fluoroscopy allows accurate distance measurement within the heart.
The methods may reduce the total amount of contrast agent needed during procedures.
The use of imaging guidance like echocardiography and fluoroscopy improves the precision of marker placement.
The invention enables customization of artificial chord length based on patient-specific measurements.
Simulated heart and vasculature models facilitate training and personalized procedural planning.
Documented Applications
Repair of native heart valves, such as mitral or tricuspid valves, by determining and implanting artificial chordae tendineae percutaneously.
Percutaneous implantation of artificial chords or tethers in a living animal or a non-living heart, including cadaver or simulator.
Use with simulated hearts and vasculature, either physical models or computer-simulated, for training or planning patient-specific procedures.
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