Prosthetic heart valve for natural blood flow
Inventors
Kumar, Saravana B. • Kruse, Steven D. • Diedering, Jason S.
Assignees
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Publication Number
US-12588998-B1
Publication Date
2026-03-31
Expiration Date
Abstract
A collapsible and expandable implant for implanting in a heart chamber on a side of a heart. The implant may include an outer section including a curved portion configured to be positioned in the heart chamber. The implant may be sized such that an ellipsoid conforming to the curved portion has a height greater than a length of the heart chamber by a percentage that is within a predetermined range of height percentage values. The implant may be sized such that the ellipsoid has a width greater than a width of the heart chamber by a percentage that is within a predetermined range of width percentage values. The length and width of the heart chamber may be defined in an image of the heart chamber.
Core Innovation
The invention relates to a method of manufacturing an implant for implantation in a heart chamber in a side of a heart by forming a curved portion so that an ellipsoid conforming to the curved portion has an ellipsoid height greater than a length of the heart chamber by a percentage within a predetermined range and an ellipsoid width greater than a width of the heart chamber by a percentage within a predetermined range. The length and width of the heart chamber are defined in an image of the heart chamber, including a length that extends between a level corresponding to an upper annular surface at a bottom of the heart chamber and a point on a roof of the heart chamber within 1.5 mm of a highest point on the roof in the image.
The method further defines the implant manufacturing using graphical models and ellipsoid-to-annulus relationships. An annular ring is formed such that it is positioned at a bottom of the ellipsoid, and the annular ring has a defined first height and a second cell structure. The method includes determining that a height of the annular ring is below a threshold value and increasing the first height to a second height, then forming the annular ring to have the second height.
The invention also relates to configuring the implant for collapsible and expandable behavior and for functional axis alignment during a heart cycle. The implant is formed from a superelastic material to have an atraumatic outer surface and to be collapsible for deployment into a heart chamber and then expandable to be anchorable by pressured contact without piercing heart tissue. As the curved portion expands in the heart chamber, movement in response to pressure from the chamber walls aligns an implant axis with the heart chamber’s central axis, including a conditional behavior that movement does not occur when the implant axis is aligned with the central axis of the heart chamber.
Claims Coverage
The independent claims identified in the provided material are clm-00001, clm-00029, clm-00056, clm-00082, and clm-00107. Across these independent claims, the inventive concept is centered on image-defined heart chamber geometry combined with a curved implant forming an ellipsoid whose height and width exceed chamber dimensions by percentage ranges, with further refinements that include annular ring formation using graphical models, cell density selection, CT image scaling, and geometric definitions for chamber measurement.
Image-defined ellipsoid-conforming curved portion with oversizing height and width
Forming a curved portion of the implant such that an ellipsoid conforming to the curved portion has an ellipsoid height greater than a length of the heart chamber by a percentage within a predetermined range of height percentage values, and an ellipsoid width greater than a width of the heart chamber by a percentage within a predetermined range of width percentage values, wherein the length and width of the heart chamber are defined in an image of the heart chamber.
Graphical-model-based annular ring formation with threshold height adjustment
Forming an annular ring of the implant by creating a first graphical model in which the ellipsoid has a first cell structure, creating a second graphical model in which the annular ring has a first height and a second cell structure, combining the first graphical model and the second graphical model such that the annular ring is positioned at a bottom of the ellipsoid, determining that a height of the annular ring is below a threshold value, increasing the first height to a second height, and forming the annular ring such that the annular ring has the second height.
Image-defined oversizing with cell density selection based on ellipsoid size thresholds
Selecting a first cell density of the implant when the ellipsoid height is less than a predetermined first value and the ellipsoid width is less than a predetermined second value, and selecting a second cell density of the implant when the ellipsoid height is greater than the predetermined first value and the ellipsoid width is greater than the predetermined second value.
CT image scaling and image-defined measurement for curved implant oversizing
Having the image include a computed tomography (CT) scan image, wherein the length and width of the heart chamber are defined in the image, the image has a scale that relates a dimension of the image to a corresponding dimension of the heart chamber, and the length and width are measured on the image.
Three-dimensional approximation level with acute-angle based length definition
Using a level that is a three-dimensional approximation of the upper annular surface, defining a cross-sectional plane such that an intersection of the level with the plane defines a segment and the length extends between a midpoint of the segment and the point, and defining an acute angle between a line extending from the midpoint to the highest point and a vertical axis extending from the midpoint to a top of the contour vertically above the midpoint.
Across the independent claims, the core inventive features are forming a curved implant portion with an ellipsoid that exceeds image-defined heart chamber length and width by predetermined percentage ranges, with chamber length defined from an upper annular surface level to a roof point near a highest roof point, and further manufacturing refinements that include annular ring formation via graphical models with a threshold-based height adjustment. Additional independent-claim refinements include cell density selection based on ellipsoid height and width thresholds, CT image scaling for measurement, and a three-dimensional approximation and acute-angle framework for defining chamber-derived length.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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