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-11925558-B2
Publication Date
2024-03-12
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
Devices and methods are disclosed for treating or repairing regurgitant cardiac valves, such as 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 can be positioned between the annuloplasty device and an underlying coronary artery to prevent compression of the coronary artery caused by the annuloplasty device. Additionally, 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 disclosed protective device features a bridge with sufficient rigidity and dimensions to support the tensioning element within the coronary sinus and redistribute tension away from the coronary artery, thereby inhibiting application of pressure to the underlying artery during mitral valve annuloplasty. The device may have guides such as an internal lumen to retain and support the annuloplasty device. The protective device can be tubular and include stabilizing feet that retain the device in position over the coronary artery. It can also be constructed from shape memory materials like nitinol, allowing it to be introduced in a linear form and to assume the protective arch shape after deployment.
The problem solved is that conventional trans-sinus mitral valve annuloplasty techniques risk compressing the underlying coronary artery since the coronary sinus crosses superficial to the coronary artery in most humans. This compression can induce myocardial ischemia or infarction, limiting the usefulness and safety of coronary sinus annuloplasty methods. The invention addresses the need to avoid constricting coronary artery branches during trans-sinus annuloplasty by providing a protection device that prevents coronary artery compression from devices placed in the coronary sinus.
Claims Coverage
The claims present two independent methods focusing on the use and placement of a tensioning device with a protective bridge in the coronary sinus to repair the mitral valve.
Use of a tensioning device with a bridge to protect coronary artery during mitral valve repair
A tensioning device is introduced through the coronary sinus over a coronary artery, wherein the device includes a bridge shaped to direct tension away from the coronary artery. The method involves determining the pathway of the coronary sinus over the coronary artery, locating the bridge over the artery to reduce pressure, and applying tension to effect mitral valve repair.
Formation of a closed loop tensioning device traversing specific heart structures for mitral valve repair
An elongate tensioning device is introduced at least partially through the coronary sinus and over the coronary artery to surround the mitral valve, forming a closed loop tensioning device. Tension is applied to effect changes in mitral valve function, with the device traversing a septal tricuspid valve commissure after loop formation.
The claims cover methods employing a tensioning device having a protective bridge placed within the coronary sinus to protect the underlying coronary artery during annuloplasty, including specific procedural steps for introduction, placement, and tension application for mitral valve repair.
Stated Advantages
The protective device increases the safety and efficacy of trans-sinus mitral cerclage annuloplasty by preventing compression of underlying coronary artery branches.
It enables percutaneous mitral valve repair methods to be used in a broader range of patients, including those with less severe or more severe valvular dysfunction.
The device supports the annuloplasty tensioning element and redistributes compressive forces away from the coronary artery, protecting myocardial blood flow.
Documented Applications
Treatment or repair of regurgitant cardiac valves, specifically mitral valve repair by coronary sinus mitral valve annuloplasty.
Percutaneous mitral valve cerclage annuloplasty procedures to reduce mitral valve regurgitation.
Use in conjunction with prosthetic mitral valves to create a retaining structure for secure prosthetic valve implantation while protecting coronary arteries from compression.
Protection of coronary arteries during various coronary sinus annuloplasty devices including those delivered via catheter or implanted using open surgery.
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