Coronary sinus mitral valve annuloplasty procedure and coronary artery and myocardial protection device
Inventors
Kim, June-Hong • Lederman, Robert J. • Kocaturk, Ozgur
Assignees
US Department of Health and Human Services
Publication Number
US-10687942-B2
Publication Date
2020-06-23
Expiration Date
2027-11-13
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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 annuloplasty device can be placed in the coronary sinus to reshape the mitral valve and reduce mitral valve regurgitation. A 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 the treatment or repair of regurgitant cardiac valves, particularly the mitral valve, by placing an annuloplasty device in the coronary sinus to reshape the mitral valve and reduce mitral valve regurgitation. A protective device is introduced between the annuloplasty device and an underlying coronary artery to inhibit compression of the artery by the annuloplasty device. This protective device can also inhibit compression of the coronary artery from inside the heart by prosthetic mitral valves exerting outward pressure.
The problem addressed is that existing trans-sinus mitral valve annuloplasty techniques risk compressing underlying coronary arteries because the coronary sinus often overlies the circumflex coronary artery and its branches. This compression can induce myocardial ischemia or infarction, limiting the usefulness and safety of these procedures. The disclosed protective device is designed as a rigid, arched support placed in the coronary sinus over a coronary artery to redistribute and inhibit pressure applied by the annuloplasty element, thereby protecting coronary arteries during mitral valve repair procedures using tensioning elements in the coronary sinus.
Claims Coverage
The claims include 14 claims with three independent claims focusing on a protective device configured for placement in the coronary sinus to shield coronary arteries during catheter-based mitral annuloplasty.
Device structure and configuration
The device is a surgically sterile implant with proximal and distal ends and an arched portion positioned in the coronary sinus. The arched portion straddles the left circumflex artery and defines a passageway along the implant through which an elongate tether extends entirely around the mitral valve and is placed under tension.
Pressure inhibition and orientation of the arch
The arched portion has sufficient rigidity and dimensions to inhibit pressure application to the left circumflex artery when the device with the tensioned tether is positioned in the coronary sinus. Tension causes the arch to orient away from the coronary artery, protecting it from compression.
Device dimensions and stabilizing features
The arched portion bridges a linear distance at its base of about 0.5 to 0.6 inches and is about 0.15 to 0.16 inches high. The implant includes proximal and distal ends collinear and extending oppositely with stabilizing regions configured to conform to the coronary sinus wall and maintain the arch position over the coronary artery.
Tubular structure with lumen for tension tether
The implant is a tubular protective device with a passageway extending from proximal to distal end adapted to receive the annuloplasty tension tether. The arch has a substantially uniform diameter along its length, including outer diameters from about 0.04 to 0.05 inches. The arch bridges about 0.5 to 0.6 inches at its base.
Material composition
The protective implant can be made of a shape memory material, such as nitinol, to allow deformation for delivery and recovery of the arched shape when deployed in the coronary sinus.
The independent claims cover a surgically sterile, arched protective device designed to fit within the coronary sinus over the coronary artery, providing a lumen to accommodate an annuloplasty tension tether, and having physical dimensions and rigidity to inhibit coronary artery compression during catheter-based mitral annuloplasty procedures.
Stated Advantages
Inhibits compression of underlying coronary arteries by the annuloplasty tension element, reducing the risk of myocardial ischemia or infarction.
Allows safer implementation of trans-sinus mitral valve annuloplasty techniques by protecting coronary blood flow during tensioning of annuloplasty devices.
Provides a structural support that redistributes compressive forces away from vulnerable coronary arteries, maintaining vessel patency during annuloplasty.
Use of shape memory materials permits minimally invasive percutaneous delivery and deployment within the coronary sinus.
Documented Applications
Treatment or repair of regurgitant mitral valves by placing an annuloplasty device in the coronary sinus to reduce mitral valve regurgitation using catheter-based percutaneous techniques.
Use with mitral valve cerclage annuloplasty procedures in which a tensioning element is applied around the mitral valve annulus through the coronary sinus.
Protection of coronary arteries specifically during transcatheter mitral valve implant procedures where both an implanted prosthetic valve and the annuloplasty device can exert compressive forces on the coronary arteries.
Integration or use in combination with other coronary sinus annuloplasty devices—whether catheter-based or open surgical—that risk compressing underlying coronary arteries.
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