Methods and devices for transcatheter cerclage annuloplasty
Inventors
Lederman, Robert J. • Kocaturk, Ozgur
Assignees
US Department of Health and Human Services
Publication Number
US-9579200-B2
Publication Date
2017-02-28
Expiration Date
2031-09-15
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Abstract
Devices, apparatus, and methods for catheter-based repair of cardiac valves, including transcatheter-mitral-valve-cerclage annuloplasty and transcatheter-mitral-valve reapposition. In particular, a target and capture device is provided for guiding a cerclage traversal catheter system through a cerclage trajectory, particularly through a reentry site of the cerclage trajectory. The target and capture device provides the user with a target through which the cerclage traversal catheter system must be guided, particularly under imaging guidance, so as to properly traverse the cerclage trajectory at any desired location, particularly at a reentry site. The target and capture device can, further, ensnare and externalize the cerclage traversal catheter system.
Core Innovation
The invention provides methods, devices, and apparatuses for minimally invasive, transcatheter repair of cardiac valves, specifically focusing on mitral valve cerclage annuloplasty. The core aspect involves a target and capture device that guides a cerclage traversal catheter system through a cerclage trajectory, particularly through a challenging reentry site where the catheter passes through the septal myocardial tissue into the right heart chamber. This device offers a precise, imageable target to facilitate accurate traversal and capture or ensnaring of the catheter system during the procedure.
The problem addressed is the technical difficulty and risk involved in percutaneous cerclage annuloplasty procedures, particularly the challenge of positioning tensioning elements in the correct anatomical plane and preventing entrapment of subvalvular or ventricular structures, such as trabeculae, chordae tendineae, and moderator bands. Entrapment can lead to serious damage to the tricuspid valve or right ventricle, causing procedural failure and adverse outcomes. Existing percutaneous techniques have limitations in achieving effective annuloplasty tension and avoiding complications associated with catheter traversal through myocardial and valvular structures.
The invention solves these challenges by providing a target and capture device that is positionable at the desired site, especially the reentry site of the cerclage trajectory. The device can conform to the curvature of the right ventricle, be imageable under various modalities, displace vulnerable structures safely, and ensnare or capture the traversal catheter system for retrieval or exchange with tensioning elements. The invention encompasses various device embodiments including shafts with loops, expandable and collapsible meshes, and vertebrated skeleton catheters, all designed to guide, protect, and retrieve the traversal system during cerclage annuloplasty.
Claims Coverage
The claims include two independent claims directed to a target and capture device for transcatheter cerclage annuloplasty, focusing on novel structural and functional features of an expandable and collapsible mesh.
Expandable and collapsible mesh conforming to right ventricle curvature
The device comprises an expandable and collapsible mesh made of a plurality of criss-crossing wire-like members formed of a shape memory material. The mesh is configured to conform to the curvature of the right ventricle and forms a U-shape or J-shape that conforms to the right ventricular outflow tract and/or infundibulum when expanded, while being insertable through a catheter when collapsed.
Incorporation of an imageable target within the mesh
The mesh includes an imageable target incorporated within its structure, facilitating precise imaging guidance for positioning and manipulation during the procedure.
Mesh configured to displace and apply pressure on cardiac structures
The mesh is adapted to displace the valvar chordae and true and false trabecular muscles against the endocardial border of the right ventricular septum and to apply pressure upon expansion to achieve this displacement, thereby protecting these structures during traversal.
Push member for controlled expansion and collapse of the mesh
The device features a push member positioned to expand and collapse the mesh during delivery and retrieval, allowing controlled manipulation of the mesh state.
Presence of movable ring-like and horizontal wire elements
The mesh comprises a plurality of ring-like wire members interwoven along horizontal wire-like members, wherein the ring-like elements are movable along the wires to independently vary opening sizes within the mesh structure.
Inclusion of electrophysiological electrodes
The device further includes unipolar or bipolar electrode sets for determining the target and capture device's position relative to functional electrophysiological fiducial markers, such as performing His electrocardiograms.
Capability to capture and ensnare a traversal catheter system
The mesh is configured to capture and/or ensnare a catheter, specifically a cerclage traversal catheter system, inserted through or within the mesh during the procedure.
The independent claims cover a sophisticated, shape-adaptive mesh device with imageable targeting, cardiac structure displacement capability, integrated electrophysiological localization, and the ability to capture and retrieve catheter systems, thereby providing improved safety and guidance in transcatheter cerclage annuloplasty.
Stated Advantages
Facilitates precise guidance and positioning of the cerclage traversal catheter system through difficult cerclage trajectories, especially at reentry sites.
Reduces the risk of entrapment and injury to trabecular and subvalvular structures by displacing these anatomical elements safely during catheter traversal.
Enables capture and retrieval of the traversal catheter system, enhancing procedural control and safety.
Conforms anatomically to the right ventricle curvature, improving device apposition and effectiveness of guidance.
Allows imaging under multiple modalities to provide real-time positioning and targeting during the procedure.
Documented Applications
Percutaneous or transcatheter repair of cardiac valves, particularly mitral valve and tricuspid valve annuloplasty using cerclage techniques.
Guiding cerclage traversal catheter systems through complex myocardial trajectories including coronary sinus, great cardiac vein, and basal septal perforator vein paths to reenter right heart chambers.
Prevention of trabecular and subvalvular structure entrapment during cerclage annuloplasty procedures.
Use in conjunction with imaging modalities such as X-ray fluoroscopy, MRI, echocardiography, and electroanatomic positioning for catheter navigation and device placement.
Application of tensioning elements around mitral or tricuspid valve annuli to treat valvular regurgitation with minimally invasive transcatheter methods.
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