A METHOD OF CONSTRUCTING A PERICARDIAL HEART VALVE REPLACEMENT, A PERICARDIAL HEART VALVE REPLACEMENT CONSTRUCTED ACCORDING TO THIS METHOD, AND A DEVICE FOR THE IN VITRO CONDITIONING AND MODIFICATION OF TISSUE OF AUTOLOGOUS PERICARDIUM FOR THE CONSTRUCTION OF A PERICARDIAL HEART VALVE REPLACEMENT
The pericardial heart valve replacement (1) is constructed from living tissue of autologous pericardium containing living pericardial interstitial cells (PICs) and a living extracellular matrix (ECM) in the following way: in the first step the size and shape of the patients native pathological heart valve is determined using real-time three-dimensional transesophageal echocardiography (TEE) or computer tomography (CT angiography) or magnetic resonance imaging (MRI) in the next step a stented (2) or a stentless pericardial heart valve replacement (1) is constructed from a single sheet of living autologous pericardium obtained from the patient the size and shape of the pericardial heart valve replacement (1) corresponds to the size and shape of the patients native heart valve and aortic or pulmonary root. The subject matter of the invention also includes the development of a device (5) for the conditioning and modification of the living autologous pericardial heart valve replacement (1) consisting of a ipulsatile pump (6) driving the flow of culture medium in the device (5) to perfuse the cells in the pericardium, a reservoir (7) regulating the fluid capacitance and function of the pericardial heart valve replacement (1), a chamber (8) containing a holder (9) for the placement of the pericardial heart valve replacement (1) during dynamic conditioning, and a gas exchanger (10a, b) for perfusing C02 into the culture medium. The reservoir (7), the chamber (8) and the gas exchanger (10a, b) are placed in an incubator (11) with an inner atmosphere of air mixed with 5% C02 and a temperature of 36 to 37° C., the individual components of the device (5) being connected by tubing (12).
