Methods and devices for transcatheter cerclage annuloplasty
Inventors
Assignees
US Department of Health and Human Services
Publication Number
US-10751179-B2
Publication Date
2020-08-25
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 devices, apparatus, and methods for catheter-based repair of cardiac valves, particularly focusing on transcatheter-mitral-valve-cerclage annuloplasty and transcatheter-mitral-valve reapposition. Central to the innovation is a target and capture device that guides a cerclage traversal catheter system along a cerclage trajectory, especially through a reentry site. This device offers a target to properly guide and capture the catheter system, assisting the precise positioning of a tensioning element around the mitral valve annulus.
The background describes the problem that conventional surgical valve repairs require open-heart surgery, which carries significant risks and morbidity, limiting their use. Percutaneous methods, such as coronary sinus shortening and other leaflet procedures, have been developed but present technical challenges and limited success, especially in establishing circumferential tension characteristic of surgical annuloplasty. Percutaneous cerclage annuloplasty offers promise but remains technically demanding, particularly at the reentry site where subvalvular trabecular entrapment can cause serious complications. Thus, the invention addresses the need for improved techniques and devices that facilitate precise positioning of tensioning systems during cerclage procedures and prevent trabecular entrapment.
Claims Coverage
The patent includes one independent method claim and one independent kit claim, each covering inventive features related to the target and capture device and the cerclage traversal catheter system in performing transcatheter cerclage annuloplasty.
Expandable and collapsible mesh target and capture device
The device comprises an expandable and collapsible mesh configured to conform to the curvature of the right ventricle when expanded, providing a plurality of openings and an imageable target to guide the cerclage traversal catheter system. The mesh can ensnare the catheter system and includes an expanding slotted tube with slots varying in size upon expansion or compression.
Magnet-assisted guidance and capture
The target and capture device is provided with a magnet to assist in guiding and capturing the cerclage traversal catheter system.
Insertion and deployment features of the mesh device
The mesh is collapsible for insertion through a catheter in the patient's vasculature and can displace valvar chordae and trabecular muscles against the endocardial border of the right ventricular septum. It applies pressure upon expansion to displace these structures.
Deployment mechanism with push member
The device includes a push member positioned to move the expandable mesh to expand or collapse it as needed during deployment and retrieval.
Catheter system and method of use
The method involves inserting the cerclage traversal catheter into the vasculature, positioning the expandable, imageable mesh at a desired right ventricular reentry site, guiding the catheter system through the mesh target, exchanging it with a tensioning element, and applying tension.
Device configurations and materials
The device can be formed of shape memory materials and may comprise hollow center disc shaped elements interconnected to allow adjustment of shape and spacing. It can form U-shapes or J-shapes conforming to ventricular outflow tract geometry.
Additional device features for imaging and functional guidance
The target and capture device can include unipolar or bipolar electrode sets to determine its position relative to electrophysiological fiducial markers, including performing His electrocardiograms.
Loop and shaft component
The target and capture device may have a shaft with a loop at the distal end, fabricated to conform to the right ventricle curvature, which is imageable and collapsible for deployment and capture.
Deployment system control
The mesh is supported and deployed via a deployment catheter and push element configured to control expansion and collapse, enabling gripping and ensnaring of the catheter system when compressed.
The inventive features focus on a specially designed target and capture device, particularly an expandable and collapsible mesh or loop configured to conform anatomically to the right ventricle, provide an imageable guiding target for the cerclage traversal catheter system, and capture or ensnare the system during transcatheter cerclage annuloplasty procedures. These features facilitate safe, precise, and effective deployment of annuloplasty tensioning elements while reducing risks such as trabecular entrapment.
Stated Advantages
Facilitation of proper positioning of the tensioning system during demanding and complex cerclage procedures.
Prevention of trabecular entrapment and injury to cardiac subvalvular or trabecular structures.
Provision of an imageable target that improves guidance and placement accuracy of the cerclage traversal catheter system.
Ability to conform to the right ventricular curvature to ensure stable apposition and enhanced procedural targeting.
Capability to capture, ensnare, retrieve, and externalize the cerclage traversal catheter system, simplifying procedure and reducing complications.
Documented Applications
Catheter-based repair of mitral valve regurgitation via transcatheter-mitral-valve-cerclage annuloplasty.
Catheter-based repair of tricuspid valve regurgitation using cerclage annuloplasty techniques.
Minimally invasive and percutaneous procedures to treat valvular insufficiency where surgical options are risky or contraindicated.
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