Modular heart valve prosthesis
A modular heart valve prosthesis includes a first heart valve device and a second heart valve device. The first heart valve device includes a first valve support including a first prosthetic valve disposed within the valve support, and an anchoring frame surrounding the first valve support and coupled to the first valve support. The first prosthetic valve includes synthetic fabric leaflets having a first thickness. The second heart valve device includes a second valve support including a second prosthetic valve disposed within the second valve support. The second prosthetic valve includes tissue leaflets having a second thickness, wherein the second thickness is greater than the first thickness. In a first configuration, the second heart valve device is separate from the first heart valve device, and in a second configuration, the second heart valve device is disposed within the first valve support of the first heart valve device.
1. A modular heart valve prosthesis comprising:
a first heart valve device including,
a first valve support including a first prosthetic valve disposed within the valve support, the first prosthetic valve comprising synthetic fabric leaflets having a first thickness, and
an anchoring frame surrounding the first valve support and coupled to the first valve support, the anchoring frame including a first portion and a second portion; and
a second heart valve device including a second valve support and a second prosthetic valve disposed within the second valve support, the second prosthetic valve comprising tissue leaflets having a second thickness, wherein the second thickness is greater than the first thickness,
wherein in a first configuration the second heart valve device is separate from the first heart valve device and in a second configuration the second heart valve device is disposed within the first valve support of the first heart valve device.
2. The modular heart valve prosthesis of claim 1 , wherein the first heart valve device is self-expanding, and wherein the second heart valve device is balloon expandable.
3. The modular valve prosthesis of claim 1 , wherein the first heart valve device is self-expanding, and wherein the second heart valve device is self-expanding.
4. The modular heart valve prosthesis of claim 1 , wherein the synthetic fabric leaflets of the first prosthetic valve are formed from material selected from the group consisting of polyester, polyethylene terephthalate (PET, e.g. DACRON), polytetrafluoroethylene (PTFE), polyurethane, cloth materials, nylon blends, and polymeric materials.
5. The modular heart valve prosthesis of claim 1 , wherein the tissue leaflets of the second prosthetic valve are formed from material selected from the group consisting of bovine pericardium tissue and porcine pericardium tissue.
6. The modular valve prosthesis of claim 1 , wherein the first thickness is in a range of about 0.04 mm to about 0.10 mm.
7. The modular heart valve prosthesis of claim 6 , wherein the first thickness is about 0.07 mm.
8. The modular heart valve prosthesis of claim 1 , wherein the second thickness is in the range of about 0.35 mm to about 0.5 mm.
9. The modular heart valve prosthesis of claim 1 , wherein the first heart valve device has a crimped diameter of approximately 27 Fr.
10. The modular heart valve prosthesis of claim 9 , wherein the second heart valve device has a crimped diameter of approximately 14 Fr.
11. The modular heart valve prosthesis of claim 1 , wherein the first valve support and the second valve support are both generally cylindrical.
12. The modular valve prosthesis of claim 1 , wherein the first valve support has an hourglass shape with a first diameter at an inflow portion thereof, a second diameter at a central portion thereof, and a third diameter at an outflow portion thereof, wherein the first and third diameters are each larger than the second diameter, and wherein the second valve support has a corresponding hourglass shape.
13. The modular valve prosthesis of claim 1 , wherein the first valve support has a reverse hourglass shape with a first diameter at an inflow portion thereof, a second diameter at a central portion thereof, and a third diameter at an outflow portion thereof, wherein the first and third diameters are each smaller than the second diameter, and wherein the second valve support has a corresponding reverse hourglass shape.
14. The modular valve prosthesis of claim 1 , wherein the second valve support includes a brim at an inflow end thereof, wherein the brim is parallel to a central longitudinal axis of the second valve support with the second heart valve device in a radially compressed configuration, wherein the brim is disposed radially outward at a non-zero angle with respect to the central longitudinal axis with the second heart valve device in a radially expanded configuration, and wherein in the second configuration of the second heart valve device, the brim is proximal of an inflow end of the first valve support.
15. The modular valve prosthesis of claim 14 , wherein the non-zero angle is between 30 and 90 degrees.
16. The modular valve prosthesis of claim 1 , wherein the second heart valve device further includes barbs extending radially outward from an outer surface of the second valve support such that with the second heart valve device in the second configuration, the barbs engage the first valve support.
17. A modular heart valve prosthesis comprising:
a first heart valve device including,
a first valve support including a first prosthetic valve disposed within the valve support, the first valve support having a first end and a second end, and the first prosthetic valve comprising leaflets having a first thickness, and
an anchoring frame surrounding the first valve support and coupled to the first valve support at the first end of the first valve support and extending longitudinally at least to the second end of the first valve support, wherein at least a portion of an inner surface of the anchoring frame is radially spaced from an outer surface of the first valve support; and
a second heart valve device including a second valve support and a second prosthetic valve disposed within the second valve support, the second prosthetic valve comprising leaflets having a second thickness, wherein the second thickness is greater than the first thickness,
wherein in a first configuration the second heart valve device is separate from the first heart valve device and in a second configuration the second heart valve device is disposed within the first valve support of the first heart valve device.
18. The modular heart valve prosthesis of claim 17 , wherein the first heart valve device is self-expanding, and wherein the second heart valve device is balloon expandable.
19. The modular valve prosthesis of claim 17 , wherein the first heart valve device is self-expanding, and wherein the second heart valve device is self-expanding.
20. The modular valve prosthesis of claim 17 , wherein the second valve support includes a brim at an inflow end thereof, wherein the brim is parallel to a central longitudinal axis of the second valve support with the second heart valve device in a radially compressed configuration, wherein the brim is disposed radially outward at a non-zero angle with respect to the central longitudinal axis with the second heart valve device in a radially expanded configuration, and wherein in the second configuration of the second heart valve device, the brim is proximal of an inflow end of the first valve support.
21. The modular valve prosthesis of claim 20 , wherein the non-zero angle is between 30 and 90 degrees.
22. The modular valve prosthesis of claim 17 , wherein the second heart valve device further includes barbs extending radially outward from an outer surface of the second valve support such that with the second heart valve device in the second configuration, the barbs engage the first valve support.
23. A modular heart valve prosthesis comprising:
a first heart valve device including,
a first valve support including a first prosthetic valve disposed within the valve support, the first prosthetic valve comprising first leaflets having a first thickness in the range of about 0.04 mm to about 0.10 mm, and
an anchoring frame surrounding the first valve support and coupled to the first valve support, the anchoring frame including a first portion and a second portion; and
a second heart valve device including a second valve support and a second prosthetic valve disposed within the second valve support, the second prosthetic valve comprising second leaflets having a second thickness, wherein the second thickness is greater than the first thickness,
wherein in a first configuration the second heart valve device is separate from the first heart valve device and in a second configuration the second heart valve device is disposed within the first valve support of the first heart valve device.
24. The modular heart valve prosthesis of claim 23 , wherein the first thickness is about 0.07 mm.
25. The modular heart valve prosthesis of claim 23 , wherein the second thickness is in the range of about 0.35 mm to about 0.5 mm.
26. The modular heart valve prosthesis of claim 23 , wherein the first heart valve device has a crimped diameter of approximately 27 Fr.
27. The modular heart valve prosthesis of claim 26 , wherein the second heart valve device has a crimped diameter of approximately 14 Fr.
28. The modular valve prosthesis of claim 23 , wherein the first valve support has an hourglass shape with a first diameter at an inflow portion thereof, a second diameter at a central portion thereof, and a third diameter at an outflow portion thereof, wherein the first and third diameters are each larger than the second diameter, and wherein the second valve support has a corresponding hourglass shape.
29. The modular valve prosthesis of claim 23 , wherein the second valve support includes a brim at an inflow end thereof, wherein the brim is parallel to a central longitudinal axis of the second valve support with the second heart valve device in a radially compressed configuration, wherein the brim is disposed radially outward at a non-zero angle with respect to the central longitudinal axis with the second heart valve device in a radially expanded configuration, and wherein in the second configuration of the second heart valve device, the brim is proximal of an inflow end of the first valve support.
30. The modular valve prosthesis of claim 29 , wherein the non-zero angle is between 30 and 90 degrees.