Hydrophilic skirt for paravalvular leak mitigation and fit and apposition optimization for prosthetic heart valve implants
Inventors
Kumar, Saravana B. • Stone, Jeffrey R.
Assignees
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Publication Number
US-12544226-B2
Publication Date
2026-02-10
Expiration Date
Abstract
The present invention provides a prosthetic heart valve device with improved fit, apposition and/or paravalvular leakage mitigation. Thus, the prosthetic device comprises an anchoring structure for supporting prosthetic valve leaflets, wherein the anchoring structure comprises and/or is formed at least partially from a hydrophilic material designed to swell when contacted by the water solute in the patient's blood. Locating the hydrophilic material to provide swelling to improve the fit and/or apposition of the device to the patient's tissues results in, inter alia, improved paravalvular leakage mitigation. Some of the methods and mechanisms described herein may also be used to provide a seal against the septal hole created during transseptal delivery of the device.
Core Innovation
The disclosure describes a device for expanded implantation into a patient's heart chamber. The device includes an expandable anchoring structure with an expandable stent defining an upper portion with open cells and a base section having an outer surface. A valve support is integrally formed from the base section and disposed entirely within the base section, and at least one prosthetic valve is attached to an inner surface of the valve support.
The device further includes a skirt operatively attached to a portion of the outer surface of the base section. A bottom portion of the skirt comprises two layers of material, with an inner layer attached to the outer surface of the base section and an outer layer. Sub-pockets are defined between the two layers, and hydrophilic material is disposed within at least one sub-pocket.
To address paravalvular leakage, the skirt also includes a reserve pocket disposed on the skirt and spaced apart from the sub-pockets. The reserve pocket comprises a ring of material around a circumference of the skirt, and hydrophilic material is disposed within the reserve pocket. The disclosure also includes embodiments in which swelling of the hydrophilic material is localized using the two-layer skirt pocket/sub-pocket arrangement and may be delayed or protected using encapsulation or thin biodegradable films over hydrophilic regions.
Claims Coverage
The identified independent claim covers a prosthetic heart valve device with a specific expandable anchoring structure and a skirt architecture that places hydrophilic material in sub-pockets and in a spaced reserve pocket. The coverage is centered on the arrangement and placement of hydrophilic material in two-layer skirt sub-pockets and a spatially separated reserve pocket, with additional structural features of the stent and valve support.
Expandable anchoring structure with integrally formed valve support
An expandable anchoring structure comprising an expandable stent defining an upper portion with open cells and a base section having an outer surface, and a valve support integrally formed from the base section and disposed entirely within the base section, wherein at least one prosthetic valve is attached to the inner surface of the valve support.
Two-layer skirt defining sub-pockets with hydrophilic material
A skirt operatively attached to a portion of the outer surface of the base section, wherein a bottom portion of the skirt comprises two layers of material including an inner layer attached to the outer surface of the base section and an outer layer, sub-pockets defined between the two layers, and hydrophilic material disposed within at least one sub-pocket.
Spaced reserve pocket with hydrophilic material ring
A reserve pocket disposed on the skirt and spaced apart from the sub-pockets, wherein the reserve pocket comprises a ring of material around a circumference of the skirt, and hydrophilic material disposed within the reserve pocket.
Sub-pocket multi-level arrangement and reserve pocket at third level
Sub-pockets include first and second sub-pockets at first and second levels of the skirt, and a reserve pocket at a third level above the first and second levels.
Reserve pocket sealing relative to left atrial appendage
The reserve pocket is positioned to seal against and/or within the left atrial appendage when the device is implanted into the left atrium.
Overall claim coverage focuses on an expanded-implant prosthetic heart valve device using an expandable stent with open cells and an integrally formed valve support, combined with a skirt that uses two-layer skirt material to define sub-pockets containing hydrophilic material and a spatially separated reserve pocket also containing hydrophilic material, including multi-level positioning and an embodiment sealing relative to the left atrial appendage.
Stated Advantages
Improves fit and apposition of a prosthetic heart valve/anchoring structure.
Mitigates paravalvular leakage (PVL).
Provides localized swelling using two-layer skirt pockets/subpockets and/or a reserve pocket.
Can delay swelling of hydrophilic material using encapsulation or thin biodegradable films.
Documented Applications
Use in a patient's heart chamber, including an embodiment implanted into the left atrium where the reserve pocket seals against and/or within the left atrial appendage.
Use for mitigating paravalvular leakage (PVL) by swelling at portions vulnerable to paravalvular leakage.
Discussion includes potential sealing of a septal hole formed during transseptal delivery.
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