Transcatheter delivery of a replacement heart valve

• US 8,092,524 B2
• Filed: 12/03/2008
• Issued: 01/10/2012
• Est. Priority Date: 02/05/2004
• Status: Active Grant

• Current Assignee: Children's Medical Center Corporation
• Original Assignee: Children's Medical Center Corporation
• Inventors: Nugent, Alan, Lock, James E.
• Primary Examiner(s): Matthews, William H.
• Application Number:
  US12/326,979
• Publication Number:
  US 20090082858A1
• Time in Patent Office: 1,133 Days
• Field of Search: 623 21- 219, 623/2.38
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0002 for data transfer
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A replacement heart valve apparatus. The heart valve apparatus includes a stent and a valve frame having a substantially cylindrical body defining a lumen. The valve frame includes a plurality of curved wire pairs attached to the substantially cylindrical body. Each curved wire pair includes an inner curved wire and an outer curved wire. The wire frame further having a plurality of leaflets. Each leaflet is attached to a respective inner curved wire and extends over a respective outer curved wire, so as to position the body of the leaflet within the lumen of the valve frame.

Claims

1. A replacement heart valve comprising:

a valve frame comprising a body defining a lumen, wherein the body of the valve frame comprises;

a substantially cylindrical body portion, wherein one end of the substantially cylindrical body portion comprises a serpentine edge comprising a plurality of troughs and vertices;

one or more exterior serpentine rings at a distance away from the substantially cylindrical body portion;

a plurality of valve attachment wires between the one or more exterior serpentine rings and the substantially cylindrical body portion, the plurality of valve attachment wires comprising a plurality of curved wire pairs, wherein each curved wire pair comprises an inner curved wire and an outer curved wire; and

a plurality of standoff wires attached to the one or more exterior serpentine rings and the substantially cylindrical body portion; and

a plurality of valve leaflets attached to the valve attachment wires;

wherein the ends of each inner curved wire is attached to spaced apart vertices of the serpentine edge, and the ends of each outer curved wire is attached to spaced apart troughs of the serpentine edge, wherein the serpentine edge is constructed and arranged such that, in use, each vertex points to a direction opposite blood flow, and each trough points to the direction of blood flow.

2. The replacement heart valve of claim 1, wherein the inner curved wire and the outer curved wire are separate from each other by a space that is substantially constant.

3. The replacement heart valve of claim 1, wherein the inner curved wire and the outer curved wire are parabolic in curvature.

4. The replacement heart valve of claim 1, wherein each valve leaflet comprises a leaflet body and one or more leaflet projections, wherein the one or more leaflet projections are curved around a respective inner wire and attached to itself, and the leaflet body extends over a respective outer curved wire.

5. The replacement heart valve of claim 4, wherein each leaflet is positioned such that the leaflet body is located within the lumen of the valve frame, the portion of the leaflet body nearest the one or more leaflet projections is pulled away from the lumen over a respective outer curved wire and toward a respective inner curved wire to position the one or more leaflet projections such that they are extended toward the lumen and curved around the respective inner curved wire.

6. The replacement heart valve of claim 1, comprising one or more radiopaque markers at the one or more exterior serpentine rings.

7. The replacement heart valve of claim 1, comprising one or more radiopaque markers at the substantially cylindrical body portion.

8. The replacement heart valve of claim 1, wherein the substantially cylindrical body portion is constructed of a plurality of serpentine curved wires.

9. The replacement heart valve of claim 8, wherein each serpentine curved wire is composed of nickel-titanium.

10. The replacement heart valve of claim 1, wherein each standoff wire is sufficiently long to prevent contact between the valve leaflets and the exterior serpentine rings when the valve frame is in a compressed state.