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-8211171-B2
Publication Date
2012-07-03
Expiration Date
2027-11-13
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Abstract
A protective device or bridge (20) comprising a central arch (24) 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
Mitral valve regurgitation, caused by primary valvular problems or functional issues such as dilated cardiomyopathy, leads to enlargement of the mitral annulus and left ventricular cavity causing valvular insufficiency. Traditional surgical mitral valve annuloplasty effectively reduces this insufficiency by reconstructing or augmenting the valve annulus with a ring, but requires open-heart surgery, which involves substantial morbidity, prolonged recovery, and high risk, often making it unsuitable for many patients.
Percutaneous mitral valve repair techniques, including coronary sinus annuloplasty and cerclage annuloplasty, offer less invasive alternatives by introducing prosthetic devices into the coronary sinus to exert forces that reduce annular dimensions without open-heart surgery. However, these methods face limitations such as inadequate reduction of septal-lateral separation of the mitral valve annulus and difficulty achieving circumferential tension comparable to surgical rings.
A major problem with trans-sinus annuloplasty techniques is that the coronary sinus and its branches commonly cross over major coronary arteries, such as the left circumflex artery, leading to compressive forces during annuloplasty that can constrict or occlude the underlying artery and cause myocardial ischemia. The invention addresses this problem by providing a protective device or bridge with a central arch of sufficient rigidity and dimensions, typically made from shape memory material like nitinol, placed between the annuloplasty tensioning element in the coronary sinus and the underlying coronary artery. This device supports and redistributes tension away from the artery, preventing application of compressive forces to the coronary artery during mitral valve repair procedures.
Claims Coverage
The patent includes one independent claim describing inventive features relating to a method of mitral valve repair with coronary artery protection.
Method of protecting coronary artery during mitral valve annuloplasty
A method comprising placing a circumferential annuloplasty tensioning element at least partially through the coronary sinus and over a coronary artery, determining where the coronary sinus passes over the coronary artery, interposing a protective support having a central arch made of shape memory material between the tensioning element and the coronary artery, and placing the tensioning element under tension. The protective support has sufficient rigidity and dimensions to inhibit pressure application to the coronary artery during tensioning, thereby protecting the coronary artery.
Introduction and positioning of annuloplasty tensioning element and protective support
The annuloplasty tensioning element is introduced through the coronary sinus via a transvascular catheter, which can be advanced antegrade or retrograde through various veins and myocardial tissue. The protective support is also introduced through the catheter and positioned between the tensioning element and the coronary artery, guided by imaging including angiography.
Percutaneous catheter-based annuloplasty procedure with guide wire exchange and tensioning
The method uses percutaneous insertion of a guiding catheter through vasculature to the coronary sinus, advancement of a wire through coronary sinuses and veins into cardiac chambers, exchange of the wire for tensioning material, and application of tension to remodel the mitral valve annulus while protecting underlying coronary arteries with the support device.
Protective support device structural features
The protective support device includes a central arch between proximal and distal ends forming stabilizers or feet that conform to the coronary sinus wall and retain the device in position over the coronary artery. The arch spans a linear distance from about 0.5 to 0.6 inches, with heights about 0.15 to 0.16 inches, outer diameter about 0.04 to 0.05 inches, inner diameter about 0.025 to 0.035 inches, and is tubular in shape.
Use of shape memory material in protective support
The protective support's central arch comprises shape memory material, such as nitinol, which allows the device to be deformed for vascular delivery and resume its protective shape upon deployment.
The claims cover a method of mitral valve repair using a circumferential annuloplasty tensioning element with an interposed protective support device made of shape memory material that prevents compressive injury to an underlying coronary artery during transcatheter annuloplasty, with defined structural and procedural features.
Stated Advantages
The protective device dramatically increases the safety and efficacy of trans-sinus mitral valve cerclage annuloplasty by preventing compression of underlying coronary artery branches, which can lead to myocardial ischemia.
The device allows for transcatheter annuloplasty procedures that avoid open-heart surgery morbidity and can be applied to a wider patient population, including those with less severe or advanced valvular dysfunction.
The protective support redistributes compressive forces away from coronary arteries, preserving coronary artery patency and myocardial perfusion during annuloplasty tensioning.
Made from shape memory materials, the device can be deployed in a minimally invasive manner through catheters and conform to cardiac anatomy to protect arteries effectively.
Documented Applications
Percutaneous mitral valve mitral valve repair via cerclage annuloplasty procedure using a tensioning element introduced through the coronary sinus and protected by the device to prevent coronary artery compression.
Use with any coronary sinus annuloplasty device that extends partially through the coronary sinus overlying coronary arteries, including catheter-based or surgical implants.
Use in procedures involving guide wire advancement through coronary veins and myocardial tissue to form annuloplasty pathways for tensioning material placement around the mitral valve annulus.
Protection of coronary arteries during application of compressive remodeling forces to the mitral valve annulus to reduce mitral regurgitation and improve valve function.
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