Geometrically-accommodating heart valve replacement device

Patent metadata

Field	Value
Publication number	US-10966826-B2
Application number	US-201816764763-A
Country	US
Kind code	B2
Filing date	Nov 16, 2018
Priority date	Nov 16, 2017
Publication date	Apr 6, 2021
Grant date	Apr 6, 2021

Abstract

A replacement heart valve device is disclosed. In some embodiments, the device includes a frame coupled to one or more leaflets that are moveable between open and closed configurations. In some embodiments, the frame comprises at least two frame sections that join at a pair of commissural posts. In some embodiments, the device may be geometrically accommodating to adapt to different vasculature shapes and sizes and/or to be able to change size while implanted within a growing patient.

First claim

What is claimed is:

1. A valve replacement device, comprising:
a valve frame defining an opening for passage of fluid, the opening having a diameter along a largest dimension of the opening, the valve frame being expandable to permit an increase in the diameter of the opening from 5 mm to 50 mm; and
a first leaflet coupled to the valve frame, the first leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first leaflet at least partially covers the opening,
wherein the valve frame is configured to expand to permit an increase in the diameter of the opening, and wherein the first leaflet is configured to be moveable between the open and closed configurations as the diameter of the opening expands from 5 mm to 50 mm,
wherein the first leaflet maintains a constant surface area with expansion or contraction of the valve frame,
wherein the valve frame includes first and second frame sections configured to move laterally apart from each other as the valve frame expands, and
wherein at least one of the first and second frame sections have a curve profile defined by an elliptical quadrant projected upon a cylinder.

2. The valve replacement device of claim 1 ,
further comprising a second leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first and second leaflets contact one another to at least partially cover the opening, wherein the first leaflet and second leaflets are configured to be moveable between the open and closed configurations over the diameter size range of the opening,
wherein in the closed configuration, the first and second leaflets permit a regurgitant fraction of no more than 0 to 20% over a diameter size range of the opening of 5 mm to 50 mm.

3. The valve replacement device of claim 1 , wherein the valve frame expands asymmetrically by expanding faster in a first lateral direction than an opposing lateral direction.

4. The valve replacement device of claim 1 , wherein the valve frame expands asymmetrically by expanding further in a first lateral direction than an opposing lateral direction.

5. The valve replacement device of claim 1 , wherein the opening is asymmetric.

6. The valve replacement device of claim 1 ,
wherein the valve frame comprises first and second frame sections connected by a pair of commissures, and
wherein the valve frame is asymmetric such that the first and second frame sections are different from one another.

7. A valve replacement device, comprising:
a valve frame defining an opening for passage of fluid, the opening having a diameter along a largest dimension of the opening, the valve frame being expandable to permit an increase in the diameter of the opening from 5 mm to 50 mm; and
a first leaflet coupled to the valve frame, the first leaflet having an open configuration in which the opening is exposed, and a closed configuration in which the first leaflet at least partially covers the opening,
wherein the valve frame is configured to expand to permit an increase in the diameter of the opening, and wherein the first leaflet is configured to be moveable between the open and closed configurations as the diameter of the opening expands from 5 mm to 50 mm,
wherein the valve frame comprises first and second frame sections connected by a pair of commissures, and
wherein the first frame section forms a U-shape having two arms extending away from an intermediate section, the intermediate section forming a base of the first frame section.

8. The valve replacement device of claim 7 , wherein the intermediate section is planar.

9. The valve replacement device of claim 7 , wherein the intermediate section is non-planar.

10. A valve replacement device comprising:
a valve frame defining an opening for passage of fluid, the valve frame having a diameter along a largest dimension of the opening, the valve frame having a height in a direction perpendicular to the diameter, the valve frame being expandable to increase the diameter in an operational configuration and contractible to decrease the diameter in a contracted configuration and having a height to diameter ratio ranging from 0.5:1 to 2.5:1 in the operational configuration; and
a first leaflet coupled to the frame,
wherein as the frame expands, the height decreases as the diameter increases,
wherein the valve frame includes first and second frame sections configured to move laterally apart from each other as the valve frame expands, and
wherein at least one of the first and second frame sections have a curve profile defined by an elliptical quadrant projected upon a cylinder.

11. The valve replacement device of claim 10 , wherein the valve frame can expand in a length perpendicular to the diameter and preserve the height to diameter ratio at different diameters.

12. The valve replacement device of claim 1 , wherein the valve frame comprises first and second frame sections connected by a pair of commissures, and
wherein at least one of the first and second frame sections have a curve profile defined by an elliptical quadrant projected upon a cylinder.

13. The valve replacement device of claim 12 , wherein a center of an ellipse from which the elliptical quadrant is derived coincides with a point along a circumference of an axial end of the cylinder, and a minor axis and a major axis of the ellipse are co-axial with edges of a cross-section of the cylinder.

14. The valve replacement device of claim 10 , wherein a center of an ellipse from which the elliptical quadrant is derived, coincides with a point along a circumference of an axial end of the cylinder, and a minor and major axis of the ellipse are co-axial with edges of a cross-section of the cylinder.

15. The valve replacement device of claim 1 ,
wherein the valve frame comprises first and second frame sections connected by a pair of commissures,
further comprising a first reinforcement feature that connects the pair of commissures,
further comprising a second reinforcement feature that connects the first and second frame sections, and
wherein the second reinforcement feature is used as a fixation site for transcatheter deployment or for fixation to native structures.

16. The valve replacement device of claim 10 , wherein the valve frame includes first and second frame sections configured to move laterally apart from each other as the valve frame expands,
wherein the first and second frame sections are connected at a pair of commissures,
further comprising a first reinforcement feature that connects the pair of commissures,
and further comprising a second reinforcement feature that connects the first and second frame sections, and
wherein the second reinforcement feature is used as a fixation site for transcatheter deployment or for fixation to native structures.

17. The valve replacement device of claim 10 ,
wherein the valve frame includes first and second frame sections configured to move laterally apart from each other as the valve frame expands,
wherein the first and second frame sections are connected at a pair of commissures,
further comprising a first reinforcement feature that connects the pair of commissures,
further comprising a second reinforcement feature that connects the first and second frame sections, and
wherein at least one of the first and second reinforcement features is of a different shape than the other of the first and second reinforcement features.

18. The valve replacement device of claim 1 ,
wherein the valve frame comprises first and second

Assignees

• Childrens Medical Center
• Harvard College
• Massachusetts Inst Technology

Inventors

• Hofferberth Sophie-Charlotte
• Del Nido Pedro J
• Edelman Elazer R
• Hammer Peter E
• Payne Christopher

Classifications

• A61F2250/0082

  specially designed for children, e.g. having means for adjusting to their growth · CPC title

• A61F2250/001

  for adjusting a diameter · CPC title

• A61F2250/0004

  adjustable · CPC title

• A61F2230/0013

  Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped · CPC title

• A61F2230/0008

  elliptical or oval · CPC title