Transcatheter dilatable biostable polymeric stented valved tube prosthesis

A system for installation of a transcatheter dilatable valve tube prosthesis comprising:

• a transcatheter dilatable valve tube prosthesis comprising
• a tubular member capable of plastic deformation from a first dimension to a second dimension;
• a valve component comprising a plurality of leaflets, the valve component capable of expansion from the first dimension to the second dimension, the valve component secured to an interior portion of the tubular member by an elastomeric glue at two circumferential portions defining an annular cavity therein, wherein the elastomeric glue is provided inside the annular cavity;
• and
• an expandable stent positioned in the annular cavity between the valve component and the tubular member and embedded in the elastomeric glue inside the annular cavity;
• and
• a balloon catheter insertable into the transcatheter dilatable valve tube prosthesis to expand the tubular member and the valve component from the first dimension to the second dimension.

A method of installing a transcatheter dilatable valve tube prosthesis in the body conduit of a patient comprising:

• providing a transcatheter dilatable valve tube prosthesis comprising a tubular member capable of plastic deformation from a dimension to a second dimension;
• a valve component comprising a plurality of leaflets, the valve component capable of expansion from the first dimension to the second dimension, the valve component secured to an interior portion of the tubular member by an elastomeric glue at two circumferential portions defining an annular cavity therein, wherein the elastomeric glue is provided inside the annular cavity;
• and an expandable stent positioned in the annular cavity between the valve component and the tubular member and embedded in the elastomeric glue inside the annular cavity;
• inserting the transcatheter dilatable valve tube prosthesis into the body conduit of the patient;
• securing the transcatheter dilatable valve tube prosthesis;
• inserting a balloon catheter into the transcatheter dilatable valve tube prosthesis;
• and
• expanding the balloon catheter, thereby expanding the tubular member from the first dimension to the second dimension.

A method of installing a transcatheter dilatable valve tube prosthesis in the body conduit of a patient comprising:

• providing a transcatheter dilatable valve tube prosthesis comprising a tubular member capable of plastic deformation from a dimension to a second dimension;
• a valve component comprising a plurality of leaflets, the valve component capable of expansion from the first dimension to the second dimension, the valve component secured to an interior portion of the tubular member by an elastomeric glue at two circumferential portions defining an annular cavity therein, wherein the elastomeric glue is provided inside the annular cavity;
• and an expandable stent positioned in the annular cavity between the valve component and the tubular member and embedded in the elastomeric glue inside the annular cavity;
• wherein the expandable stent comprises one or more struts defining a strut width (W) and strut thickness (T) and a number of circumferential patterns (NCP), selected from a set of parameters (χ) comprising strut width range, strut thickness range, number of circumferential patterns (NCP) range and stent material;
• wherein the strut width (W) and strut thickness (T) are determined by
• computing performance metrics comprising standard deviation of the descon dimension of the tubular conduit following plastic deformation (Dstddev), the peak radial force exerted by the stent to expand the tubular conduit (RF(χ), the Goodman metric for high cycle fatigue failure protection of the stent (GF(χ)) and the hydrostatic criterion for ductile failure prediction of the stent (DF(χ));
• constructing a surrogate model using the computed performance metrics to obtain a plurality of sets of Pareto-opitmal designs over all parameters (χ);
• and
• identifying the strut width (W) and strut thickness (T) by optimizing a normalized aggregate objection function with equal weighing of performance metrics;
• inserting the transcatheter dilatable valve tube prosthesis into the body conduit of the patient;
• securing the transcatheter dilatable valve tube prosthesis;
• inserting a balloon catheter into the transcatheter dilatable valve tube prosthesis;
• and
• expanding the balloon catheter, thereby expanding the tubular member from the first dimension to the second dimension.