Medical implant preform produced using an inside out flipping method
Inventors
Miedema, Jurgen Sander • Cox, Martijn Antonius Johannes • Naz, Christophe Pierre Edouard
Assignees
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Publication Number
US-11767613-B2
Publication Date
2023-09-26
Expiration Date
Abstract
A method of making a medical implant is provided by electrospinning a polymer solution to form a preform around a mandrel. The formed preform distinguishes an inner surface and an outer surface. The formed preform is removed from the mandrel and flipped inside-out resulting in the inner surface of the formed preform becoming the outer surface of the inside-out flipped preform, and the outer surface of the formed preform becoming the inner surface of the inside-out flipped preform. At least part of the inside-out flipped preform forms the medical implant such as e.g. an artificial heart valve, an artificial leaflet, an artificial graft, or an artificial vessel. The products made according to the method of this invention greatly improve the performance and durability of the medical implant.
Core Innovation
The invention relates to a method of making a medical implant using a polymer solution to form a preform with a desired thickness around the surface of a mandrel. The mandrel includes a plurality of three-dimensional convex shapes so that the formed preform distinguishes an inner surface and an outer surface.
After forming the preform, the formed preform is removed from the mandrel and flipped inside-out. In the inside-out flipped preform, the inner surface of the formed preform becomes the outer surface, and the outer surface becomes the inner surface, with at least part of the inside-out flipped preform forming the medical implant having a plurality of three-dimensional concave shapes.
The method further maintains the concave shapes of the plurality of three-dimensional concave shapes as the medical implant. Electro-spinning of the polymer solution onto the mandrel is used to form the preform, and the medical implant is selected from an artificial heart valve, an artificial leaflet, an artificial graft, or an artificial vessel.
Claims Coverage
The independent claim coverage is based on one independent method claim, with refinements recited in dependent claims. Across these claims, the core inventive features center on forming a polymer preform on a mandrel having three-dimensional convex shapes, removing the preform, and performing an inside-out flip to produce a medical implant with three-dimensional concave shapes, followed by maintaining the concave shapes.
Polymer preform on mandrel with three-dimensional convex shapes
Using a polymer solution to form a preform with a desired thickness around the surface of a mandrel, wherein the mandrel has a plurality of three-dimensional convex shapes, and the formed preform distinguishes an inner surface and an outer surface.
Inside-out flipping to convert surfaces and form concave shapes
Removing the formed preform from the mandrel and flipping it inside-out so that the inner surface becomes the outer surface and the outer surface becomes the inner surface, wherein at least part of the inside-out flipped preform forms the medical implant with a plurality of three-dimensional concave shapes.
Maintaining the three-dimensional concave shapes as the medical implant
Maintaining the concave shapes of the plurality of three-dimensional concave shapes as the medical implant.
Electro-spinning the polymer solution to form the preform
Forming the preform with electro-spinning of the polymer solution onto the mandrel.
Selecting the medical implant from specified artificial implant types
The medical implant is selected from an artificial heart valve, an artificial leaflet, an artificial graft, or an artificial vessel.
Overall, the claim set covers an inside-out flipping approach in which a polymer preform formed on a mandrel having three-dimensional convex shapes is removed and flipped so the resulting implant includes three-dimensional concave shapes, with a requirement to maintain those concave shapes; dependent claims further refine the preform formation to electro-spinning and specify particular artificial implant types.
Stated Advantages
Preferential inwards bending and reduced local strains when the preform is used as a heart valve.
Enables electrospinning of complex geometries including concave regions on the implant.
Enables predictable folding behavior when crimped for certain multi-lobe preforms.
Documented Applications
Normally closed heart valve scaffolds, including heart valve scaffold geometries that form as a medical implant with concave shapes when flipped inside-out.
Tubular/transcatheter valve geometries as medical implants formed by the method.
Multi-lobe preforms forming predictable folding behavior when crimped.
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