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Publication Number
US-12303384-B2
Publication Date
2025-05-20
Expiration Date
Abstract
Methods and the resulting structures, like valve devices (e.g. heart or vessel) are provided made by electrospinning single shapes on mandrels with complex surface shapes. These single shapes are then shaped into valves with a plurality of leaflets. Three levels of complexity of shapes are described: 1) conical shapes, 2) a combination of conical and cylindrical shapes, and 3) a conical and/or cylindrical shape which has further complexity by one or more three-dimensional shapes. Heart valves resulting from these complex electrospun shaped mandrels have better mobility dynamics compared to heart valves electrospun on solely cylindrical mandrels.
Core Innovation
The invention relates to electrospinning a heart valve having a plurality of leaflets using a mandrel geometry that supports producing a single-piece electrospun scaffold and subsequently shaping it into the heart valve. The described mandrels include a conical shaped mandrel, a mandrel that additionally includes a cylindrical shaped section, and a complex shaped mandrel with one or more three-dimensional shapes. In each case, the conical shaped portion has a linear slope angle ranging from 1 to 12.5 degrees, with opposite ends both being circular shaped.
A single conically shaped electrospun scaffold, or a single cylindrical and conical shaped electrospun scaffold, or a single complex shaped electrospun scaffold is formed by electrospinning polymers onto the respective mandrel. The scaffold remains in one single piece during shaping into the heart valve shaped with the plurality of leaflets. The shaping is directed to produce a heart valve with two or three leaflets, and the scaffold geometry is matched to the mandrel geometry including one or more three-dimensional shapes.
The disclosed mandrel includes diameter constraints for the conical shaped portion or conical shaped section ranging from 16 mm to 28 mm. The complex shaped mandrel includes one or more three-dimensional shapes that correspond to local bulges or local lobes in the plurality of leaflets. The document further reports improved leaflet opening/closing dynamics versus valves made from purely cylindrical mandrels, including mobility quotient and a closing standard deviation.
Claims Coverage
The independent claims include 3 inventive methods. Across these methods, the core claim coverage centers on mandrel geometry defined by a conical linear slope angle, forming a single-piece electrospun scaffold by electrospinning polymers, and shaping that single piece into a heart valve with a plurality of leaflets while maintaining single-piece integrity during shaping.
Single conically shaped scaffold on conical mandrel with defined linear slope angle
Electrospinning polymers onto a conical shaped mandrel having opposite ends both being circular shaped, where the conical shaped mandrel has a linear slope angle ranging from 1 to 12.5 degrees, and forming a single conically shaped electrospun scaffold; shaping the single conically shaped electrospun scaffold into the heart valve shaped with the plurality of leaflets, wherein the single conically shaped electrospun scaffold remains in one single piece while shaping the plurality leaflets.
Single cylindrical and conical scaffold on mandrel with conical slope angle
Having a mandrel with a conical shaped section with opposite ends both being circular shaped and a cylindrical shaped section with opposite ends both being circular shaped, where the conical shaped section has a linear slope angle ranging from 1 to 12.5 degrees; forming a single cylindrical and conical shaped electrospun scaffold by electrospinning polymers onto both the conical shaped section and the cylindrical shaped section of the mandrel; shaping the single cylindrical and conical shaped electrospun scaffold into the heart valve shaped with the plurality of leaflets, wherein the single cylindrical and conical shaped electrospun scaffold remains in one single piece while shaping the plurality leaflets.
Single complex shaped scaffold on complex mandrel with three-dimensional shapes
Having a complex shaped mandrel with a complex surface comprising a conical shaped portion with opposite ends of the conical shaped portion both being circular shaped, where the complex surface further comprises one or more three-dimensional shapes, and where the conical shaped portion has a linear slope angle ranging from 1 to 12.5 degrees; forming a single complex shaped electrospun scaffold by electrospinning polymers onto the complex shaped mandrel including the one or more three-dimensional shapes; shaping the single complex shaped electrospun scaffold into the heart valve shaped with the plurality of leaflets, wherein the single complex shaped electrospun scaffold remains in one single piece while shaping the plurality leaflets.
Across the three independent claims, the claim coverage is directed to making heart valves with multiple leaflets by electrospinning polymers onto a mandrel defined by a conical linear slope angle of 1 to 12.5 degrees, while maintaining a single-piece electrospun scaffold during shaping into the heart valve shape. Two additional claim variations cover scaffolds formed on a conical mandrel alone and on a conical plus cylindrical mandrel, and a further variation covers a complex shaped mandrel with one or more three-dimensional shapes.
Stated Advantages
Improved leaflet opening/closing dynamics versus valves made from purely cylindrical mandrels.
Reported leaflet performance metrics include mobility quotient and closing standard deviation between leaflets.
Documented Applications
Prosthetic or transcatheter valve contexts are discussed, including optional flipping inside-out and support-frame assembly for prosthetic or transcatheter valve contexts [procedural detail omitted for safety].
Electrospun heart valves having a plurality of leaflets produced by shaping a single-piece electrospun scaffold are described for use as heart valve prosthetic structures [application limited to what is stated].
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