Transcatheter valve prosthesis and a concurrently delivered sealing component

• US 9,456,897 B2
• Filed: 02/21/2013
• Issued: 10/04/2016
• Est. Priority Date: 02/21/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Krivoruchko, Michael, Shipley, Adam
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): SCHWIKER, KATHERINE H
• Application Number:
  US13/772,676
• Publication Number:
  US 20140236287A1
• Time in Patent Office: 1,321 Days
• Field of Search: 606/2.11
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

A method of preventing paravalvular leakage includes concurrent delivery of a heart valve prosthesis and an annular sealing component. During delivery, the sealing component is moved from a first position to a second position of the heart valve prosthesis which is longitudinally spaced apart from the first position of the heart valve prosthesis. The sealing component is secured around the heart valve prosthesis at the second position by a contoured outer surface of the heart valve prosthesis. The sealing component may be a flexible ring or may be a cylindrical flexible sleeve having a plurality of ribs longitudinally extending over the cylindrical sleeve. The ribs operate to deploy the sealing component such that at least a portion of the cylindrical sleeve buckles outwardly away from the outer surface of the heart valve prosthesis.

Claims

1. A method of preventing paravalvular leakage, the method comprising the steps of:

percutaneously advancing a catheter to a target site, wherein the catheter includes a heart valve prosthesis and an annular sealing component,

wherein the heart valve prosthesis includes a self-expanding tubular stent component defining a lumen therethrough and a prosthetic valve component disposed within and secured to the stent component, the stent component including a first portion, a second portion, and an intermediate waist portion positioned between the first and second portions,

wherein the sealing component is not coupled to the heart valve prosthesis and is positioned around an outer surface of the heart valve prosthesis at a first position on the first portion of the heart valve prosthesis;

deploying at least a portion of the heart valve prosthesis against native valve tissue at a target site;

moving the sealing component relative to the heart valve prosthesis from the first position to a second position on the intermediate waist portion of the heart valve prosthesis which is longitudinally spaced apart from the first position of the heart valve prosthesis, wherein the sealing component is secured around the heart valve prosthesis at the second position by a contoured outer surface of the heart valve prosthesis and the sealing component prevents gaps between the valve prosthesis and the native valve tissue to prevent paravalvular leakage;

wherein a deployed diameter of the intermediate waist portion is less than a deployed diameter of the first portion and is less than a deployed diameter of the second portion and the contoured outer surface of the heart valve prosthesis includes a gradual and continuous taper between the first portion and the intermediate waist portion;

wherein the step of deploying at least a portion of the heart valve prosthesis includes radially expanding the stent component wherein the radial expansion of the stent component causes the sealing component to slide along the taper of the contoured outer surface.

2. The method of claim 1, wherein the sealing component is formed from a material selected from a group consisting of cloth, foam, or a polymer.

3. The method of claim 1, wherein the prosthetic valve component is disposed within the intermediate portion of the stent component.

4. A method of preventing paravalvular leakage, the method comprising the steps of:

percutaneously advancing a catheter to a target site, wherein the catheter includes a heart valve prosthesis and an annular sealing component, the heart valve prosthesis including a self-expanding tubular stent component including a first portion, a second portion, and an intermediate waist portion positioned between the first and second portions and a prosthetic valve component disposed within and secured to the stent component, wherein the sealing component is not coupled to the heart valve prosthesis and is positioned around an outer surface of the heart valve prosthesis at the first portion of the stent component; and

deploying the heart valve prosthesis by radially expanding the stent component against native valve tissue at the target site, wherein a deployed diameter of the intermediate waist portion is less than a deployed diameter of the first portion and is less than a deployed diameter of the second portion and a contoured outer surface of the stent component includes a gradual and continuous taper between the first portion and the intermediate waist portion, and

wherein radial expansion of the stent component causes the sealing component to move relative to the heart valve prosthesis and slide in a longitudinal direction along the taper of the contoured outer surface from the first portion of the stent component to the intermediate waist portion of the stent component.

5. The method of claim 4, wherein the sealing component is secured around the heart valve prosthesis at the intermediate waist portion of the stent component due to the contoured outer surface of the stent component.