Transcatheter 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-9271833-B2
Publication Date
2016-03-01
Expiration Date
2027-11-13
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Abstract
A protective device or bridge comprising a central arch is suitable to be placed between an annuplasty device placed in the coronary sinus and an underlying coronary artery to inhibit transmission of compressive force on the coronary artery by the annuplasty device.
Core Innovation
The invention relates to a protective device or bridge comprising a central arch, which is designed to be placed between an annuloplasty device positioned in the coronary sinus and an underlying coronary artery, in order to inhibit the transmission of compressive force on the coronary artery by the annuloplasty device. The device has sufficient rigidity and dimensions to support the annuloplasty tension element over the coronary artery, redistribute tension away from the artery, and prevent pressure application that could constrict the vessel during mitral valve annuloplasty procedures performed via the coronary sinus.
Mitral valve regurgitation often requires mitral valve repair, such as annuloplasty, which conventionally involves open-heart surgery and carries significant morbidity. Percutaneous procedures, including those using the coronary sinus to place tensioning elements, offer less invasive alternatives but have limitations. A key problem is that the coronary sinus commonly lies superficial to major coronary arteries, particularly the left circumflex artery, resulting in compression of these arteries by annuloplasty devices and causing myocardial ischemia or infarction. This restricts the usefulness and safety of trans-sinus annuloplasty.
The invention solves this problem by providing a surgically sterile protective device, introduced percutaneously through a catheter into the coronary sinus, where it acts as a bridge over the coronary artery. The central arch of the device supports the tensioning annuloplasty element so that compressive forces from the tension element are distributed on the protective device and not transmitted to the coronary artery beneath. This approach enables effective mitral valve annuloplasty via the coronary sinus while preventing coronary artery compression and preserving myocardial perfusion.
Claims Coverage
The patent claims cover a protective device for coronary artery protection during catheter-based mitral annuloplasty, detailing its structural features, configurations, and materials. There are multiple independent claims that focus on the protective member's shape, rigidity, dimensions, and functional positioning with respect to the coronary sinus and annuloplasty tension element.
Protective device with central arch and passageway for annuloplasty tension element
A surgically sterile protective member with proximal and distal free ends and a central arch, configured to fit within the coronary sinus at a location over a coronary artery, including a passageway extending through it to allow a circumferential annuloplasty tension element to extend entirely around the mitral valve. The arch has sufficient rigidity and dimensions to inhibit pressure on the coronary artery by orienting away from it under tension.
Protective device with stabilizing ends conforming to coronary sinus wall
Proximal and distal free ends of the protective member form stabilizers (such as support feet) that conform to the coronary sinus wall and maintain the arch positioned bridging over the coronary artery within the coronary sinus.
Protective device dimensions for effective coronary artery protection
The arch bridges a linear distance at its base approximately 0.5 to 0.6 inches and has a height of about 0.15 to 0.16 inches, with substantially uniform width along its length to optimize support over the coronary artery.
Protective device made of shape memory material
The protective member comprises a shape memory material, such as nitinol, enabling it to be deformed for catheter delivery and to recover the arched configuration upon deployment within the coronary sinus.
Tubular protective device with enclosed passageway for annuloplasty tension element
A surgically sterile tubular protective member with a uniform diameter along its length, including an enclosed lumen through which the annuloplasty tension element passes, with the arch positioned centrally to inhibit application of pressure to the underlying coronary artery and oriented away from the artery when under tension.
The independent claims collectively describe a protective device for coronary artery compression prevention during catheter-based mitral annuloplasty, characterized principally by a central arch structure that supports an annuloplasty tension element within the coronary sinus. The device's stabilizing ends, specific dimensional ranges, and material composition (shape memory alloys) are inventive features that enable secure positioning, effective protection against arterial compression, and compatibility with catheter-based delivery.
Stated Advantages
The device prevents constriction or occlusion of underlying coronary arteries during percutaneous mitral valve annuloplasty performed via the coronary sinus, thereby avoiding myocardial ischemia or infarction.
It increases the safety and efficacy of trans-sinus mitral valve annuloplasty by distributing compressive forces away from the coronary artery.
The device can be delivered percutaneously through a transvascular catheter and is compatible with existing annuloplasty techniques, facilitating minimally invasive repair procedures.
Use of shape memory materials enables deployment through tortuous anatomy and recovery to the protective arched shape upon release.
Documented Applications
Protection of coronary arteries during percutaneous transcatheter mitral valve cerclage annuloplasty procedures.
Use in coronary sinus shortening or coronary sinus mitral valve annuloplasty methods to prevent coronary artery compression.
Integration with catheter-based delivery systems for mitral valve repair in patients with mitral regurgitation.
Use with various annuloplasty elements, including tensioning elements such as sutures or wires, extending at least partially through the coronary sinus.
Use with open-chest surgical annuloplasty devices implanted in the coronary sinus to prevent coronary artery compression.
Interested in licensing this patent?