Modular heart valve prosthesis

Patent metadata

Field	Value
Publication number	US-2021369451-A1
Application number	US-202016885553-A
Country	US
Kind code	A1
Filing date	May 28, 2020
Priority date	May 28, 2020
Publication date	Dec 2, 2021
Grant date	—

Abstract

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.

First claim

What is claimed:

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 heart valve prosthesis of claim 1 , wherein the first thickness is 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 method of delivering and deploying a modular heart valve prosthesis comprising the steps of:
delivering a first heart valve device in a radially compressed configuration to a site of a native heart valve, the first heart valve device including a first valve support including a first prosthetic valve comprising synthetic fabric leaflets disposed within the valve support and an anchoring frame surrounding the first valve support and coupled to the first valve support; deploying the first heart valve device by radially expanding the first heart valve device such that the anchoring frame is disposed within native leaflets of the native heart valve; after deploying the first heart valve device, delivering a second heart valve device in a radially compressed configuration to within the first valve support, the second heart valve device comprising a second valve support and a second prosthetic valve comprising tissue leaflets disposed within the second valve support; and deploying the second heart valve device by radially expanding the second valve support such that the second valve support engages the first prosthetic valve and the first valve support.

18 . The method of claim 17 , wherein the step of deploying the first heart valve device comprises releasing the first heart valve device from a sheath such that the first heart valve device self-expands.

19 . The method of claim 18 , wherein the step of deploying the second heart valve device comprises radially expanding the second valve support with a balloon.

20 . The method of claim 17 , wherein the first heart valve device is disposed in a first catheter for the step of delivering the first heart valve device.

21 . The method of claim 20 , wherein after the step of deploying the first heart valve device, the first catheter is withdrawn from the site of the native heart valve.

22 . The method of claim 21 , wherein after the step of withdrawing the first catheter, the second heart valve device is disposed in a second catheter for the step of delivering the second heart valve device to within the first valve support.

Assignees

• Medtronic Inc

Inventors

• Mcveigh Cahal

Classifications

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2250/0039

  differing in diameter · CPC title

• A61F2/2409

  Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442) · CPC title

• A61F2230/0063

  Three-dimensional shapes · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title