Pinnate Assembly of Artificial Chordae for Heart Valve Cleft Repair
A surgical implant based on artificial chordae, that can effectively close cleft cardiac valves
Background
Aortic valve cleft is a rare disease that can be degenerative, congenital, or age-related. It may be present with or without other heart defects and can lead to serious aortic insufficiency that will require surgical interventions. Although in some cases a surgery can restore the normal valve function by sewing close the cleft, in many cases the sewn valve will not open adequately. In other cases, the surgeon may decide to leave the cleft open or to only partially sew the cleft. This will leave the patient with serious complications such as regurgitation and outflow restriction. Therefore, there is a need for more effective remedies for aortic valve cleft.
One potential solution involves the use of artificial chordae. Artificial chordae products have been successfully developed for treatment of prolapsing leaflet and isolated chordal rupture.
Technology Overview
BCH researchers have invented a surgical implant based on artificial chordae, that can effectively close cleft cardiac valves. It consists of an assembly of artificial chordae that are arranged in a feather-like pattern. The central spine of the assembly extends from a papillary muscle to the valve annulus. A set of pairs of arms connect this central spine to points on the cleft edges in a branching pattern. In different embodiments of the invention, the spine and the arms can have numerous different forms. For instance, the spine can be a monofilament suture or it can be made from braid or a flexible or rigid strip of material. The wide angle between the pairs of arms enables them to develop sufficient tension to pull the edges of the cleft together and help close the valve. As a result, this design enables the valve to close without leaking and open without flow restriction.
Figure 1
In an in-vitro experiment, the native chordae structure of the anterior and posterior leaflets of the porcine heart valve were surgically excised and the invention implanted. Passive testing showed that adequate valve coaptation was restored. In an in-vivo experiment, the invention was implanted in a pig’s heart. Passive testing showed that the invention supported the cleft closure and resulted in a good functioning of the valve with minimal regurgitation. Another set of in-vivo experiments with six swine models showed minimal or no leakage after implanting the invention, assessed using epicardial echocardiography.
Benefits
- Restores normal valve function
- Eliminates leakage when the valve closes and flow restriction when the valve opens
Applications
- Surgical repair of congenitally cleft aortic valves
- Ischemic mitral regurgitation
- Any congenital or acquired valve disease that involves valvular regurgitation through a cleft or commissure
IP Status
