Transcatheter heart valve with micro-anchors

#The disclosed technology relates generally to methods and devices for improving valve function of a heart. For instance, embodiments of the disclosed technology can be used to treat aortic insufficiency in a human heart.

#The aortic valve in the human heart is a one-way valve that separates the left ventricle from the aorta. The aorta is a large artery that carries oxygen-rich blood out of the left ventricle to the rest of the body. Aortic insufficiency is a condition in which the aortic valve does not fully close during ventricular diastole, thereby allowing blood to flow backward from the aorta into the left ventricle. This leakage of blood through the aortic valve back into the left ventricle is often referred to as aortic valve regurgitation.

#Aortic insufficiency is typically caused by aortic root dilatation (annuloaortic ectasia), which is idiopathic in over 80% of the cases. Aortic insufficiency may also result from other factors, such as aging and hypertension. In any case, the regurgitation of blood resulting from aortic insufficiency substantially reduces the pumping efficiency of the left ventricle. Therefore, even during periods of rest, the heart must work hard simply to maintain adequate circulation through the body. Over time, this continuous strain on the heart can damage the left ventricle. For example, the additional strain on the heart may result in a thickening of the heart muscle (hypertrophy). When heart-wall thickening occurs due to aortic insufficiency, the geometry of the heart can be adversely affected and the heart can be permanently damaged.

#FIG. 1 is an anatomic anterior view of a human heart, with portions broken away and in section to view the interior heart chambers and adjacent structures.

#FIG. 2 is a perspective view of a transcatheter heart valve formed with a shape-memory stent in accordance with an embodiment of the disclosed technology.

#FIG. 3 is a perspective view of another embodiment of a transcatheter heart valve formed with a shape memory support structure according to the disclosed technology.

#As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.

#In vertebrate animals, the heart is a hollow muscular organ having four pumping chambers as seen in FIG. 1. The left and right atria 2, 4 and the left and right ventricles 6, 8, are each provided with their own one-way valve. The natural heart valves are identified as the aortic 10, mitral (or bicuspid) 12, tricuspid 14, and pulmonary 16, and are each mounted in an annulus comprising dense fibrous rings attached either directly or indirectly to the atrial and ventricular muscle fibers. Each annulus defines a flow orifice.

#The atria 2, 4 are the blood-receiving chambers, which pump blood into the ventricles 6, 8. The ventricles 6, 8 are the blood-discharging chambers. The synchronous pumping actions of the left and right sides of the heart constitute the cardiac cycle. The cycle begins with a period of ventricular relaxation, called ventricular diastole. The cycle ends with a period of ventricular contraction, called ventricular systole. The four valves 10, 12, 14, 16 ensure that blood does not flow in the wrong direction during the cardiac cycle; that is, to ensure that the blood does not back flow from the ventricles 6, 8 into the corresponding atria 2, 4, or back flow from the arteries into the corresponding ventricles 6, 8. The mitral valve 12 is between the left atrium 2 and the left ventricle 6, the tricuspid valve 14 between the right atrium 4 and the right ventricle 8, the pulmonary valve 16 is at the opening of the pulmonary artery, and the aortic valve 10 is at the opening of the aorta. As discussed, in aortic insufficiency, the aortic valve 10 can become dilated, thus preventing the valve from fully closing. Embodiments of the present disclosure can be deployed to the aortic valve, specifically to the area of the aortic valve annulus, to treat aortic insufficiency.