Geometrically-accommodating heart valve replacement device

Patent metadata

Field	Value
Publication number	US-12004948-B2
Application number	US-202016890905-A
Country	US
Kind code	B2
Filing date	Jun 2, 2020
Priority date	Nov 16, 2017
Publication date	Jun 11, 2024
Grant date	Jun 11, 2024

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 expandable to permit an increase in the diameter of the opening, wherein the first leaflet is moveable between the open and closed configurations as the diameter of the opening expands from 5 mm to 50 mm, and wherein the opening expands while keeping a perimeter length of the valve frame constant.

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 and second leaflets are moveable between the open and closed configurations over the diameter size range of the opening.

3. The valve replacement device of claim 1 , further comprising an outer frame support coupled to the valve frame.

4. The valve replacement device of claim 1 , wherein the valve frame can be reduced to a contracted form for catheter delivery.

5. The valve replacement device of claim 3 , wherein the outer frame support and valve frame are balloon-expandable.

6. The valve replacement device of claim 1 , wherein the first leaflet maintains a constant surface area with expansion or contraction of the valve frame.

7. The valve replacement device of claim 2 , 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.

8. The valve replacement device of claim 1 , wherein the first leaflet has a Young's Modulus of between 30 MPa to 4 GPa.

9. The valve replacement device of claim 8 , wherein the first leaflet is made of a material selected from the group consisting of a bioabsorbable polymer, a tissue-engineered construct, a decellularized homologous tissue engineered leaflet, a thin film nitinol, an expanded PTFE membrane, a gluteraldehyde-treated bovine pericardium, a gluteraldehyde-treated porcine pericardium, a photo-oxidized bovine pericardium, and a bovine jugular vein valve.

10. The valve replacement device of claim 1 , wherein the opening is circular.

11. The valve replacement device of claim 1 , wherein the opening is elliptical.

12. The valve replacement device of claim 1 , wherein the valve frame comprises first and second frame sections connected by a pair of commissures.

13. The valve replacement device of claim 12 , 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.

14. The valve replacement device of claim 13 , wherein the intermediate section is planar.

15. The valve replacement device of claim 12 , wherein each of the first and second frame sections comprises an arc shape.

16. 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 valve frame expands, the height decreases as the diameter increases, and wherein a free edge of the leaflets are 1.5 to 3.5 times the diameter of the opening.

17. The valve replacement device of claim 16 , further comprising a second leaflet coupled to the frame.

18. The valve replacement device of claim 16 , wherein the height to diameter ratio ranges from 1:1 to 2.5:1.

19. The valve replacement device of claim 16 , wherein the first leaflet is expandable.

20. The valve replacement device of claim 16 , wherein the valve frame includes first and second frame sections configured to move laterally apart from each other as the valve frame expands.

21. The valve replacement device of claim 16 , wherein a height of the first leaflet in the open position ranges between 0.2 to 0.8 times a height of the valve frame.

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

23. The valve replacement device of claim 22 , 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.

24. The valve replacement device of claim 20 , wherein at least one of the first and second frame sections have a curve profile defined by an elliptical quadrant projected upon a cylinder.

25. The valve replacement device of claim 24 , 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.

26. The valve replacement device of claim 12 , further comprising a first reinforcement feature that connects the pairs of commissures.

27. The valve replacement device of claim 26 , further comprising a second reinforcement feature that connects the first and second frame sections.

28. The valve replacement device of claim 27 , wherein at least one of the first and second reinforcement features are configured to expand with the frame.

29. The valve replacement device of claim 28 , wherein the at least one of the first and second reinforcement features have a length that is at least equal to a perimeter of the valve opening when the valve opening has been expanded to its maximum size.

30. The valve replacement device of claim 20 , wherein the first and second frame sections are connected at a pair of commissures, and further comprising a first reinforcement feature that connects the pair of commissures.

31. The valve replacement device of claim 30 , further comprising a second reinforcement feature that connects the first and second frame sections.

32. The valve replacement device of claim 31 , wherein at least one of the first and second reinforcement features are configured to expand with the frame.

33. The valve replacement device of claim 16 , wherein a height of the leaflets ranges from 1.5 to 3.5 times the diameter of the opening.

34. The valve replacement device of claim 31 , wherein at least one of the first and second reinforcement features is of a different thickness than the other of the first and second reinforcement features.

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

• A61F2250/0004

  adjustable · CPC title

• A61F2250/0082

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

• A61F2250/0065

  telescopic · CPC title

• A61F2230/0013

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

• A61F2230/0008

  elliptical or oval · CPC title