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-9943409-B2
Publication Date
2018-04-17
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
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 treating or repairing regurgitant cardiac valves, particularly the mitral valve. The core innovation involves placing an annuloplasty device in the coronary sinus to reshape the mitral valve and reduce mitral valve regurgitation. Additionally, a protective device is positioned between the annuloplasty device and an underlying coronary artery to inhibit compression of the coronary artery caused by the annuloplasty device. This protective device can also inhibit compression from inside the heart, such as compression exerted by a prosthetic mitral valve.
The problem addressed is that traditional surgical mitral valve annuloplasty requires open-heart surgery, which has substantial morbidity and long recovery. Percutaneous approaches that introduce prostheses via catheters into the coronary sinus avoid open surgery but have limited efficacy. A significant drawback identified is that the coronary sinus and its branches frequently cross over coronary arteries, and coronary sinus-based annuloplasty devices can compress these arteries, risking myocardial ischemia or infarction.
The disclosed protective device has sufficient rigidity and shape to support and bridge over the coronary artery within the coronary sinus, redistributing compressive forces from the annuloplasty tensioning element away from the artery, thus protecting coronary blood flow during mitral valve annuloplasty. The protective device can be tubular with an internal lumen for the annuloplasty tensioning element and may include stabilizing feet to retain its position in the coronary sinus. The device may be made of shape memory materials such as nitinol for deployment through vascular catheters and assumes the protective shape upon release.
Claims Coverage
The patent includes one main independent claim defining a system with a protection device, an annuloplasty tensioning element, and a transcatheter prosthetic mitral valve, with additional claims specifying various features and configurations of the system.
Protection device configured to inhibit coronary artery compression
A protective member designed to be implanted in the coronary sinus where it passes over a coronary artery, comprising two feet and an arched portion. The arched portion has sufficient rigidity and dimensions to bridge over the coronary artery and prevent compression by a prosthetic mitral valve exerting outward force and an annuloplasty tension element under tension.
Annuloplasty tensioning element and prosthetic mitral valve integration
An annuloplasty tensioning element suitable for use with the protection device to apply inward compressive force around the native mitral valve. The transcatheter prosthetic mitral valve is configured to be implanted within the native mitral valve region when the annuloplasty tensioning element and protection device are positioned over the coronary artery, applying inward and outward forces respectively.
Protection device dimensions and configuration to optimize protection
The arched portion height is at least 3.5 mm and can bridge about 0.6 inches. The device’s feet can be curved to match heart wall curvature and oriented to receive expansion force from the prosthetic valve, reducing force on the artery. The device may have asymmetric chirality, helical, corkscrew, or spiral shapes to cross the artery nearly perpendicularly.
Tubular and non-tubular protection device embodiments
The protection device can be fully tubular, partially tubular, or non-tubular, accommodating different configurations while still providing protection against coronary artery compression.
Prosthetic mitral valve features and interaction with protection device
The transcatheter prosthetic mitral valve may be self-expanding or expandable via applied force, and it is configured to secure to the retaining structure created by inward annuloplasty tension to prevent migration. The protection device protects the coronary artery from the combined inward and outward forces.
The claims cover a comprehensive system combining a protection device positioned in the coronary sinus with annuloplasty tensioning and a transcatheter prosthetic mitral valve, where the protection device architecture and materials inhibit coronary artery compression while accommodating mechanical interactions between the valve and annuloplasty components.
Stated Advantages
The protective device prevents compression of underlying coronary arteries during trans-sinus mitral valve annuloplasty, thereby avoiding myocardial ischemia or infarction risks.
Use of the protective device increases the safety and efficacy of trans-sinus mitral cerclage annuloplasty and other coronary sinus annuloplasty devices.
The protective device permits use of percutaneous catheter-based mitral valve repair approaches in a wider range of patients by mitigating a key complication.
The shape memory materials and structural design enable minimally invasive device deployment and accurate positioning over coronary arteries to redistribute compressive forces effectively.
Documented Applications
Treatment and repair of regurgitant cardiac valves, particularly mitral valve regurgitation, by reshaping the mitral valve annulus with an annuloplasty device placed in the coronary sinus.
Percutaneous mitral valve cerclage annuloplasty procedures employing tensioning material introduced via catheters into the coronary sinus to apply circumferential tension for valve repair.
Use of the protective device in combination with transcatheter prosthetic mitral valve implantation to protect coronary arteries from compression by both inward annular tension and outward prosthetic valve expansion.
Adaptation of the protective device for use in coronary sinus annuloplasty devices other than cerclage annuloplasty, including devices implanted by open-chest surgery or other catheter-based approaches.
Interested in licensing this patent?