Transcatheter dilatable biostable polymeric stented valved tube prosthesis
Inventors
Kalfa, David • Kysar, Jeffrey W. • Russ, Jonathan B. • LI, Richard L. • HERSCHMAN, Abigail R. • WAISMAN, Haim • VEDULA, Vijay
Assignees
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Publication Number
US-12611299-B2
Publication Date
2026-04-28
Expiration Date
Abstract
A transcatheter dilatable valve tube prosthesis is provided including a tubular member capable of plastic deformation from a first dimension to a second dimension; a valve component having a plurality of leaflets. The valve component is capable of expansion from the first dimension to the second dimension, and the valve component is secured to an interior portion of the tubular member by an elastomeric glue at two circumferential portions defining an annular cavity therein. An expandable stent is positioned in the annular cavity between the valve component and the tubular member.
Core Innovation
A transcatheter dilatable valve tube prosthesis includes a tubular member capable of plastic deformation from a first dimension to a second dimension and a valve component comprising a plurality of leaflets. The valve component is capable of expansion from the first dimension to the second dimension and is secured to an interior portion of the tubular member by an elastomeric glue at two circumferential portions defining an annular cavity therein, with the elastomeric glue provided inside the annular cavity.
An expandable stent is positioned in the annular cavity between the valve component and the tubular member and embedded in the elastomeric glue inside the annular cavity. This arrangement counters elastomeric glue/tube retraction and enables durable expansion of the tubular member and valve component, while supporting valve competence after dilation.
The prosthesis is characterized by use of an expandable stent for growth accommodation, where expansion is described as plastic deformation from a first dimension to a second dimension. The stent parameter selection is connected to performance metrics for expansion durability and failure protection, including standard deviation of permanent diameter and peak radial force, as well as Goodman fatigue and a hydrostatic ductile failure criterion.
Claims Coverage
The document contains four independent claims, covering the prosthesis structure, a system for installation using a balloon catheter, a method of installing the prosthesis, and a method where stent strut geometry is determined using performance metrics with surrogate-model Pareto design and objective optimization. The main inventive features are distributed across these claims, with the most detailed inventive workflow for stent design in the last independent claim.
Transcatheter dilatable valve tube prosthesis with embedded expandable stent in annular glue cavity
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.
System for installation using balloon catheter to expand prosthesis from first to second dimension
A system for installation of a transcatheter dilatable valve tube prosthesis comprising the prosthesis structure 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.
Method of installing prosthesis with balloon catheter expansion from first to second dimension
A method of installing a transcatheter dilatable valve tube prosthesis in the body conduit of a patient comprising providing the prosthesis structure, 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.
Stent strut width and thickness selection using performance metrics, surrogate model, and Pareto optimization
A method comprising determining strut width and strut thickness for an expandable stent with one or more struts and a number of circumferential patterns by computing performance metrics comprising standard deviation of the dimension of the tubular conduit following plastic deformation, peak radial force, the Goodman metric for high cycle fatigue failure protection, and the hydrostatic criterion for ductile failure prediction; constructing a surrogate model using the computed performance metrics to obtain a plurality of sets of Pareto-optimal designs over the parameters; and identifying the strut width and strut thickness by optimizing a normalized aggregate objective function with equal weighing of performance metrics.
Across the independent claims, the prosthesis structure is anchored by a tubular member, a plurality-of-leaflets valve component secured with elastomeric glue inside an annular cavity, and an expandable stent embedded in that glue. Installation is performed using a balloon catheter to expand the prosthesis from a first dimension to a second dimension. The most specific claimed inventive content for design selection is the determination of stent strut width and strut thickness using computed performance metrics, construction of a surrogate model, generation of Pareto-optimal designs, and equal-weight normalized aggregate objective optimization.
Stated Advantages
Counters elastomeric glue/tube retraction and enables durable expansion.
Enables valve competence after dilation.
Supports a sutureless/glue bonding arrangement for securing components.
Associated with reduced reoperations.
Documented Applications
Installation of the transcatheter dilatable valve tube prosthesis in the body conduit of a patient using a balloon catheter to expand the tubular member and valve component from the first dimension to the second dimension.
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