Apparatus and method for replacing a diseased cardiac valve

• US 10,010,416 B2
• Filed: 03/31/2014
• Issued: 07/03/2018
• Est. Priority Date: 02/18/2006
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Navia, Jose L., Chen, Ji-Feng, Gao, Shengqiang, Davis, Brian L., Stucke, Samantha
• Primary Examiner(s): Pellegrino, Brian
• Application Number:
  US14/230,216
• Publication Number:
  US 20140214156A1
• Time in Patent Office: 1,555 Days
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/005 Rosette-shaped, e.g. star-shaped

Abstract

An apparatus for replacing a diseased cardiac valve is movable from a radially collapsed configuration to a radially expanded configuration. The apparatus comprises an expandable support member and a prosthetic valve secured therein. The main body portion extends between first and second end portions and includes an outer circumferential surface, a circumferential axis extending about the circumferential surface, and a plurality of wing members spaced apart from one another by an expandable region. Each of the wing members includes first and second end portions and a flexible middle portion extending between the end portions. The second end portion is integrally formed with the uyimain body portion. The first end portion is adjacent the circumferential axis and substantially flush with the outer circumferential surface in the radially collapsed configuration. The first end portion extends substantially radial to the outer circumferential surface in the radially expanded configuration.

Claims

1. A method for replacing a diseased cardiac valve, said method comprising the steps of:

providing an apparatus comprised of a prosthetic valve secured within a main body portion of an expandable support member having a first end portion and a second end portion, the main body portion including an outer circumferential surface, a circumferential axis extending about the circumferential surface, and a first and second plurality of wing members each integrally formed with the main body portion of the expandable support member and spaced apart from one another along the length of the circumferential axis of the main body portion, wherein the second plurality of wing members is circumferentially spaced around an upper portion of the expandable support member and wherein the second end portion of the expandable support member is comprised of at least two flexible arch members;

maintaining the expandable support member in a radially collapsed configuration;

loading the apparatus into a delivery catheter;

advancing the delivery catheter to the diseased cardiac valve; and

deploying the apparatus to a radially expanded configuration by extending both the first and second plurality wing members substantially radial to, and within the length of the axis of the outer circumferential surface of the main body portion, causing the first and second plurality of wing members to engage opposite sides of an annulus of the diseased native cardiac valve to secure the apparatus in place of the diseased cardiac valve; and

moving the at least two flexible arch members from a collapsed configuration to an expanded configuration to offset the at least two flexible arch members from the outer circumferential surface of the main body portion by about 90°

.

2. The method of claim 1, wherein said step of advancing the delivery catheter to the diseased cardiac valve further comprises the step of positioning the delivery catheter so that the apparatus is adjacent the valve annulus.

3. The method of claim 1, wherein said step of providing an apparatus further comprises providing a substantially dehydrated bioprosthetic valve.

4. The method of claim 3, wherein blood re-hydrates the substantially dehydrated bioprosthetic valve before the apparatus is deployed.

5. The method of claim 3, wherein blood re-hydrates the substantially dehydrated bioprosthetic valve after the apparatus is deployed.