IP Library › Granted Patent US 12,727,993
Granted Patent B2
US 12,727,993 · App. 16/759,986 · Granted Sep 8, 2026

Expandable sealing skirt technology for leak-proof endovascular prostheses

Inventor: Ashish Mitra (Bondi, AU)
Assignee: Endoluminal Sciences Pty Ltd.
A61F2/2418A61F2/07A61F2/2433A61F2/2436A61F2230/0054A61F2250/0023A61F2250/0069
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Quick Facts
Patent No.
US 12,727,993
App. No.
16/759,986
Granted
Sep 8, 2026
Kind
B2
Abstract

Disclosed herein are device assemblies for endovascular prosthesis implantation in a human patient comprising a collapsed delivery configuration and an expanded deployed configuration comprising: a stent frame comprising a plurality of expandable stent cells arranged in more than one layer and stacked in a longitudinal direction; a valve attached to the stent frame; and an expandable sealing skirt coupled to the stent frame, the expandable sealing skirt comprising a protruding region configured to expand radially past the stent frame when the device assembly is in the expanded deployed configuration and a non-protruding region.

Claims (42)

1 . A device assembly for endovascular prosthesis implantation in a human patient, the device assembly comprising a collapsed delivery configuration and an expanded deployed configuration, and the device assembly comprising, when in the expanded deployed configuration:

a) a stent frame comprising

a first layer of first expandable stent cells and a second layer of second expandable stent cells;

b) a valve attached to the stent frame; and

c) an expandable sealing skirt coupled to the stent frame, the expandable sealing skirt comprising a protruding layer and a non-protruding layer integral with and backing the protruding layer in the radial direction, the protruding layer comprising an expandable material having an inner surface integral with and extending radially outward from an outer surface of the non-protruding layer, wherein the expandable material has a thickness in the radial direction, from the inner surface thereof to an outer surface thereof, greater than that of the non-protruding layer.

2 . The device assembly of claim 1 , wherein the thickness of the expandable material along the radial direction is spatially variable at least along a longitudinal direction.

3 . The device assembly of claim 1 , wherein the protruding layer comprises a plurality of protruding cells and connecting regions between the protruding cells, wherein the protruding cells comprise the expandable material of the protruding layer.

4 . The device assembly of claim 3 , wherein the protruding cells and connecting regions are arranged in a pattern reflecting a stent cell pattern of the stent frame.

5 . The device assembly of claim 3 , wherein the protruding cells extend through one or more of the first expandable stent cells in the first layer.

6 . The device assembly of claim 3 , wherein the connecting regions are coincident with one or more legs of said expendable stent cells, or are coincident with at least one or more inflections of said expendable stent cells, or a combination thereof.

7 . The device assembly of claim 3 , wherein the connecting regions are coincident with a portion of one or more legs of said expendable stent cells, or are coincident with a portion of at least one or more inflections of said expendable stent cells, or a combination thereof.

8 . The device assembly of claim 3 , wherein when the device assembly is in the expanded deployed configuration, one or more of the protruding cells comprises a cross section along a radial direction that is substantially a triangle or rectangle.

9 . The device assembly of 3 , wherein the protruding layer forms a protruding ring.

10 . The device assembly of claim 9 , wherein the protruding ring when viewed longitudinally from the proximal to distal end of the protruding layer, has protruding cells around an entire circumference of the protruding layer.

11 . The device assembly of claim 3 , wherein the protruding cells, the connecting region, or both, comprises foam.

12 . The device assembly of claim 11 , wherein the foam has an open pore structure, a closed pore structure, or a combination.

13 . The device assembly of claim 11 , wherein the foam has a controlled porosity.

14 . The device assembly of claim 11 , wherein the foam has a uniform porosity.

15 . The device assembly of claim 11 , wherein the foam has a variable porosity.

16 . The device assembly of claim 11 , wherein the foam has a porosity of about 5-500 μm.

17 . The device assembly of claim 1 , wherein the stent frame comprises a top or proximal portion, and a bottom or distal portion.

18 . The device assembly of claim 17 , wherein the top portion is more proximal than the bottom portion.

19 . The device assembly of claim 17 , wherein the stent frame comprises a cross section that is substantially circular at the bottom portion or at the first layer of stent cells.

20 . The device assembly of claim 3 , wherein the protruding cells are self-expanding.

21 . The device assembly of claim 1 , wherein the expandable material is self-expandable.

22 . The device assembly of claim 1 , wherein the expandable material of the protruding layer comprises a foam and the non-protruding layer comprises a mesh or foam mesh.

23 . The device assembly of claim 1 , wherein the protruding layer and the non-protruding layer are made of different materials.

24 . The device assembly of claim 1 , wherein the protruding layer and the non-protruding layer comprise the same material.

25 . The device assembly of claim 1 , wherein a maximal protruding thickness of the protruding layer along the radial direction is about 10% to about 3500% of a thickness of the non-protruding layer.

26 . The device assembly of claim 1 , wherein a maximal protruding thickness of the protruding layer along the radial direction is in a range of 0.1 mm to 10 cm.

27 . The device assembly of claim 1 , wherein the outer surface of the non-protruding layer is permanently integrated with the expandable material of the protruding layer.

28 . The device assembly of claim 1 , wherein the stent frame further comprises a plurality of rigid support beams of fixed length that extend longitudinally.

29 . The device assembly of claim 28 , wherein the valve is attached to the stent frame at the plurality of support beams.

30 . The device assembly of claim 28 , wherein the plurality of support beams are provided with bores for allowing attachment of the valve or the expandable sealing skirt thereto.

31 . The device assembly of claim 1 , wherein the expandable sealing skirt is coupled to the valve.

32 . The device assembly of claim 1 , wherein each expandable stent cell of the first or second expandable stent cells comprises a substantially diamond shape.

33 . The device assembly of claim 1 , wherein the stent frame comprises at least a third layer, and where the protruding layer does not extend beyond the first layer of first expandable stent cells, the second layer of second expandable stent cells, or both.

34 . The device assembly of claim 1 , wherein the expandable material of the protruding layer comprises a foam.

35 . The device assembly of claim 34 , wherein the foam has a porosity of about 5-500 μm.

36 . The device assembly of claim 1 , wherein the non-protruding layer is configured to prevent the expandable material of the protruding layer from bulging inward along the radial direction.

37 . The device assembly of claim 1 , wherein the non-protruding layer is configured to provide a flat backing of the protruding layer.

38 . The device assembly of claim 3 , wherein the non-protruding layer is configured to provide a flat backing of the plurality of protruding cells.

Continuity (7)
Provisional Application 62674522 · May 21, 2018
Provisional Application 62674519 · May 21, 2018
Provisional Application 62674517 · May 21, 2018
Provisional Application 62674515 · May 21, 2018
Provisional Application 62674510 · May 21, 2018
Provisional Application 62579005 · Oct 30, 2017
Related Publication 20200337837A1 · Oct 29, 2020
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