Annuloplasty procedures, related devices and methods
Inventors
Rafiee, Nasser • MacDonald, Stuart • Rafiee, Koosha • Busold, Rany • Lederman, Robert J. • Rogers, Toby
Assignees
National Institutes of Health NIH • Transmural Systems LLC • US Department of Health and Human Services
Publication Number
US-10433962-B2
Publication Date
2019-10-08
Expiration Date
2037-05-08
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Abstract
Devices and methods are disclosed for the treatment or repair of regurgitant cardiac valves, such as a mitral valve. An illustrative annuloplasty device can be placed in the coronary sinus to reshape the mitral valve and reduce mitral valve regurgitation. An improved protective device can be placed between the annuloplasty device and an underlying coronary artery to inhibit compression of the underlying coronary artery by the annuloplasty device in the coronary sinus. In addition, the protective device can inhibit compression of the coronary artery from inside the heart, such as from a prosthetic mitral valve that exerts radially outward pressure toward the coronary artery. The annuloplasty device can also create an artificial inner ridge or retaining feature projecting into the native mitral valve region to help secure a prosthetic mitral valve.
Core Innovation
The invention relates to devices and methods for treating or repairing regurgitant cardiac valves, such as the mitral valve, particularly through percutaneous annuloplasty procedures. An illustrative annuloplasty device is placed in the coronary sinus to reshape the mitral valve and reduce mitral valve regurgitation by exerting compressive tensile remodeling forces, including the use of tensioning elements like tethers. The invention addresses the limitation that trans-sinus annuloplasty can compress underlying coronary arteries, especially the left circumflex artery, leading to myocardial ischemia or infarction.
To solve this problem, the invention provides an improved protective device configured as an arch-shaped support or bridge placed between the annuloplasty device and an underlying coronary artery within the coronary sinus. This protection device has sufficient rigidity and dimension to support the annuloplasty tensioning element over the coronary artery, redistributing tension away from the artery to inhibit compression. The bridge is typically made from shape memory materials such as nitinol and configured to fit anatomically, with additional features like elongated landing zones to facilitate securing prosthetic mitral valves.
Claims Coverage
The patent includes one independent claim which covers an implant comprising distinct structural components and a lock mechanism.
Implant structure with arched bridge and elongate inner tether
The implant includes a bridge with proximal and distal ends and an arched portion between them, an elongate inner tether coupled to the bridge, and an outer sheath material circumferentially surrounding both the bridge and inner tether.
Inclusion of an implant lock to secure sheath ends
The first and second ends of the outer sheath material are directed through an implant lock that maintains tension and positioning when installed in the heart.
Radiopacity along tether and sheath material
At least one of the elongate inner tether or the outer sheath includes radiopaque material disposed along its length, such as a radiopaque wire within the inner tether inside a heat shrunk polymeric tube.
Strain relief sections to transition implant stiffness
Polymeric tubes shrunk around the bridge and inner tether extend axially beyond the bridge ends forming strain relief regions that provide a transition in stiffness from the bridge to the sheath material.
Shape memory material for bridge with deformable height
The bridge is made from shape memory material configured to alter its shape from a first height to a lower height to facilitate percutaneous delivery.
Implant lock with tubular limbs guiding sheath through anatomical pathways
The implant lock defines distal openings connected to two distally extending tubular limbs which permit the outer sheath to pass through, configured to traverse the tricuspid valve (with an atraumatic distal tip) and the coronary sinus, each preformed with a curvature matching vascular anatomy.
Adjustable length tubular limb in the implant lock
At least one tubular limb of the implant lock has an adjustable length and can be adjusted while urged against native anatomy to optimize placement.
Outer sheath with varying transverse dimensions
The outer sheath material has varying transverse dimensions along its length, with an enlarged width in the region where the bridge is present to accommodate structural features.
The claims cover an implant incorporating an arched bridge and elongate inner tether surrounded by an outer sheath, secured in the heart by a specialized lock featuring anatomically configured limbs for tension maintenance and strain relief. Features include radiopaque components, shape memory materials for deployment, and adaptability to anatomical constraints.
Stated Advantages
The protective device increases the safety and efficacy of trans-sinus mitral cerclage annuloplasty by preventing compression of underlying coronary arteries, notably the left circumflex artery, thereby avoiding myocardial ischemia or infarction.
The arch-shaped protective bridge redistributes compressive forces from the annuloplasty device to the coronary sinus wall, reducing the risk of arterial compression during mitral valve repair.
The shape memory materials allow the protection device to be deformed during delivery and to return automatically to the intended shape within the heart for effective protection.
The device facilitates anchoring of prosthetic mitral valves by providing a reinforced landing zone and retaining structure within the heart.
Documented Applications
Treatment and repair of regurgitant cardiac valves, particularly mitral valve regurgitation, via percutaneous mitral valve cerclage annuloplasty procedures.
Placement of annuloplasty devices in the coronary sinus to reshape the mitral valve and reduce regurgitation.
Use of the protective device in combination with prosthetic mitral valves to inhibit coronary artery compression from both inside (prosthetic valve expansion) and outside (annuloplasty tensioning).
Use of the implant with its protective bridge and lock mechanism for transcatheter delivery and securement in mitral valve repair procedures.
Capture and retrieval of guidewires via improved snare catheters to facilitate implant delivery during annuloplasty procedures.
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