Percutaneous mitral valve replacement device

• US 10,441,416 B2
• Filed: 04/20/2016
• Issued: 10/15/2019
• Est. Priority Date: 04/21/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Oba, Travis Zenyo, Yi, Seung-Beom, Freschauf, Lauren R., Valencia, Juan
• Primary Examiner(s): Pellegrino, Brian E
• Application Number:
  US15/134,172
• Publication Number:
  US 20160310268A1
• Time in Patent Office: 1,273 Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

In one representative embodiment, a prosthetic valve assembly for replacing a native heart valve comprises a radially expandable and compressible support structure, the support structure comprising an annular frame having a lumen extending from an inflow end to an outflow end, the support structure further comprising an annular sealing member extending radially inwardly into the lumen of the frame and having an inner peripheral portion defining an orifice, and a radially expandable and compressible valve component, the valve component comprising an annular frame and a valve structure supported inside of the frame for permitting the flow blood through the valve component in one direction and blocking the flow of blood in the opposite direction, wherein the valve component is configured to expand within the orifice of the sealing member and engage the inner peripheral portion of the sealing member when radially expanded.

Claims

1. A prosthetic valve assembly for replacing a native heart valve, comprising:

a radially expandable and compressible support structure, the support structure comprising an annular metal frame having a lumen extending from an inflow end to an outflow end, the support structure further comprising an annular sealing member extending radially inwardly into the lumen of the frame and having an inner peripheral edge spaced radially inwardly of the lumen of the frame and defining an orifice, wherein the support structure comprises a plurality of projections secured to the frame of the support structure and configured to penetrate tissue of native heart valve leaflets, wherein the projections have first portions and second portions, wherein the first portions extend radially outwardly from the frame of the support structure and axially toward the inflow end of the frame of the support structure, and wherein the second portions extend radially inwardly from the first portions and axially toward the outflow end of the frame of the support structure;

a radially expandable and compressible valve component, the valve component comprising an annular metal frame with an inflow end and an outflow end and a valve structure supported inside of the frame for permitting flow of blood through the valve component in one direction and blocking the flow of blood in the opposite direction; and

a flexible, tubular connector connected at one end to the support structure and at another end to the valve component, the connector permitting the valve assembly to transition from a first, axially-extended configuration wherein the valve component is outside of the support structure to a second, axially-contracted configuration wherein the valve component is disposed within the support structure,

wherein the valve component is configured to expand within the orifice of the sealing member and engage the inner peripheral edge of the sealing member when radially expanded such that there is a gap void of material of the prosthetic valve assembly, wherein the gap extends radially between the frames of the support structure and the valve component at the inflow ends of the frames and extends axially toward the outflow ends of the frames, and

wherein the inner peripheral edge of the sealing member is disposed axially within the support structure when the valve assembly is in the first, axially-extended configuration and when the valve assembly is in the second, axially-contracted configuration.

2. The prosthetic valve assembly of claim 1, wherein the sealing member comprises a fabric.

3. The prosthetic valve assembly of claim 1, wherein the gap extends axially along the valve component for a distance greater than a majority of the length of the valve component.

4. The prosthetic valve assembly of claim 1, wherein there are no metal components connecting the frames to each other when the valve component is radially expanded within the support structure.

5. The prosthetic valve assembly of claim 1, wherein the frames are connected to each other only by fabric when the valve component is radially expanded within the support structure.

6. The prosthetic valve assembly of claim 1, wherein the inflow and outflow ends of the valve component are disposed axially between the inflow and outflow ends of the support structure when the valve component is expanded within the support structure.

7. The prosthetic valve assembly of claim 1, wherein the connector comprises one or more apertures configured to allow blood flow through the connector when the connector is in the first, axially-extended configuration.

8. The prosthetic valve assembly of claim 1, wherein the connector comprises one or more flaps configured to allow blood flow through the connector when the connector is in the first, axially-extended configuration.

9. The prosthetic valve assembly of claim 1, wherein the prosthetic valve assembly is configured for replacing a native mitral valve.

10. A prosthetic valve assembly for replacing a native heart valve, comprising:

a radially expandable and compressible support structure, the support structure comprising an annular metal frame having a lumen extending from an inflow end to an outflow end, wherein the frame comprises a plurality of projections configured to penetrate tissue of native heart valve leaflets, wherein the projections have first portions and second portions, wherein the first portions extend radially outwardly from the support structure and axially toward the inflow end, and wherein the second portions extend radially inwardly from the first portions and axially toward the outflow end;

an annular sealing member extending radially inwardly into the lumen of the frame and having an inner free edge defining an orifice;

a radially expandable and compressible tubular valve component coupled to the sealing member inside of the support structure, the valve component comprising inflow and outflow ends and a plurality of leaflets configured to permit flow of blood through the valve component in one direction and block the flow of blood in the opposite direction; and

a flexible, tubular connector connected at one end to the support structure and at another end to the valve component, wherein the connector permits the valve assembly to transition from an axially-extending configuration, wherein the inflow and outflow ends of the valve component are disposed outside of the outflow end of the support structure to an axially-contracted configuration, and wherein the inflow and outflow ends of the valve component are axially disposed between the inflow and outflow ends of the support structure,

wherein the valve component is configured to expand within the orifice of the sealing member in the axially-contracted configuration such that a radially outwardly facing surface of the valve component engages the free edge of the sealing member and such that the valve component is radially spaced apart from the frame of the support structure at the inflow end of the valve component by the sealing member.

11. The prosthetic valve assembly of claim 10, wherein the valve component comprises an annular metal frame and the leaflets are mounted inside of the frame of the valve component.

12. The prosthetic valve assembly of claim 10, wherein the radial space between the valve component and the frame of the support structure extends axially along at least a majority of the length of the valve component.

13. The prosthetic valve assembly of claim 10, wherein there are no metal components connecting the frame of the support structure to the valve component.

14. The prosthetic valve assembly of claim 10, wherein the frame of the support structure and the valve component are connected to each other only by fabric.

15. The prosthetic valve assembly of claim 10, wherein the prosthetic valve assembly is configured for replacing a native mitral valve.

16. A prosthetic valve assembly for replacing a native mitral valve, comprising:

a radially expandable and compressible support structure, the support structure comprising an annular frame having a main body, an atrial flange extending radially outwardly from the main body, a plurality of leaflet-engaging projections, and a lumen extending from an inflow end to an outflow end, the support structure further comprising an annular sealing member extending radially inwardly from the atrial flange and the main body into the lumen of the frame and having an inner peripheral edge radially spaced apart from the atrial flange and the main body and defining an orifice, wherein the projections are distributed across the main body and comprise fixed end portions and free end portions, wherein the fixed end portions are secured to the main body, extend radially outwardly and axially toward an inflow end of the support structure, and wherein the free end portions comprise barbs extending radially inwardly and axially toward an outflow end of the support structure;

a radially expandable and compressible valve component, the valve component comprising an annular frame and a valve structure supported inside of the frame for permitting flow of blood through the valve component in one direction from an inflow end to an outflow end and blocking the flow of blood in an opposite direction from the outflow end to the inflow end, wherein an outer diameter of the frame of the valve component in a fully radially expanded configuration is less than an inner diameter of the frame of the valve component in a fully radially expanded configuration; and

a flexible, tubular connector connected at one end to the outflow end of the support structure and at another end to the inflow end of the valve component, wherein the connector permits the valve assembly to transition from an axially-extending configuration, wherein the inflow and outflow ends of the valve component are disposed outside of the outflow end of the support structure to an axially-contracted configuration, and wherein the inflow and outflow ends of the valve component are axially disposed between the inflow and outflow ends of the support structure, and

wherein when the frame of the support structure and the frame of the valve component are in the fully radially expanded configuration and the connector is in the axially-contracted configuration, the valve component is disposed within the orifice of the sealing member and engages the inner peripheral edge of the sealing member such that there is a gap void of material of the prosthetic valve assembly between the valve component and the frame of the support structure, wherein the gap extends radially between a radially-inwardly facing surface of the support structure and a radially-outwardly facing surface of the valve component and extends axially from an inflow end of the valve component toward an outflow end of the valve component.