Low profile transseptal catheter and implant system for minimally invasive valve procedure

• US 10,231,834 B2
• Filed: 02/08/2016
• Issued: 03/19/2019
• Est. Priority Date: 02/09/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Keidar, Yaron
• Primary Examiner(s): Louis, Richard G
• Application Number:
  US15/018,781
• Publication Number:
  US 20160228252A1
• Time in Patent Office: 1,135 Days
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets

Abstract

A low profile transseptal catheter and implant system is disclosed. Access to the mitral valve can be obtained using femoral catheterization with a fluoroscopically guided, low-profile catheter. For example, the right atrium is accessed and the interatrial septum punctured to access the left atrium, and the mitral valve is approached through the left atrium. Advantageously, this approach avoids contact with the left ventricular outflow tract and the chordae tendinae. Two leaflet braces are extended over guide wires to form semicircular loops that circumnavigate the anterior and posterior mitral valve leaflets. Tension is applied to the catheter from the atrial direction to keep the leaflet braces tightly wedged under the leaflets for the remainder of the procedure. A fastener joins the ends of each loop to create one annular ring encircling the valve under the anterior and posterior leaflets.

Claims

1. A method of supporting a heart valve, the method comprising:

looping a first guide wire around a first leaflet of the heart valve;

looping a second guide wire around a second leaflet of the heart valve;

extending a first leaflet brace over the first guide wire and around the first leaflet; and

extending a second leaflet brace over the second guide wire and around the second leaflet.

2. The method of claim 1, further comprising applying tension to the first leaflet via the first guide wire and applying tension to the second leaflet via the second guide wire.

3. The method of claim 1, further comprising extending at least one guide catheter into the heart and wherein the first guide wire is advanced through the at least one guide catheter into the heart so that it can be looped around the first leaflet.

4. The method of claim 3, wherein the second guide wire is advanced through the at least one guide catheter into the heart so that it can be looped around the second leaflet.

5. The method of claim 1, wherein the first and second guide wires each include a snare loop and wherein looping the first and second guide wires around the first and second leaflets includes snaring the snare loop of the first and second guide wires.

6. The method of claim 1, further comprising securing adjacent ends of the first leaflet brace and second leaflet brace to each other to form a closed loop.

7. The method of claim 6, wherein securing adjacent ends includes attaching a first fastener to a first pair of adjacent ends of the first and second leaflet braces and attaching a second fastener to a second pair of adjacent ends of the first and second leaflet braces.

8. The method of claim 1, further comprising applying tension to the first and second leaflets via the first and second leaflet braces.

9. The method of claim 1, further comprising expanding a replacement heart valve within the heart valve.

10. The method of claim 9, wherein expanding is performed while applying tension to the first and second leaflets.

11. A method of supporting a native heart valve comprising:

positioning a first leaflet brace around a first leaflet of the native heart valve, the first leaflet brace having first and second end portions;

positioning a second leaflet brace around a second leaflet of the native heart valve, the second leaflet brace having first and second end portions, wherein the first leaflet brace and the second leaflet brace are separate components;

fastening the first end portion of the first leaflet brace to the first end portion of the second leaflet brace; and

fastening the second end portion of the first leaflet brace to the second end portion of the second leaflet brace;

wherein after the acts of fastening, the first and second leaflet braces form an enclosed ring encircling the first and second leaflets of the native heart valve.

12. The method of claim 11, further comprising an expanding a prosthetic heart valve within the native heart valve such that the first and second leaflets of the native heart valve are captured radially between the enclosed ring and the prosthetic heart valve.

13. The method of claim 11, wherein:

the act of fastening the first end portion of the first leaflet brace to the first end portion of the second leaflet brace comprises positioning a first fastener over the first end portions, thereby retaining the first end portions relative to each other; and

the act of fastening the second end portion of the first leaflet brace to the second end portion of the second leaflet brace comprises positioning a second fastener over the second end portions, thereby retaining the second end portions relative to each other.

16. The method of claim 13, wherein the first fastener comprises first and second openings through which the first end portions of the leaflet braces extend.

17. The method of claim 16, wherein the first fastener includes a plurality of locking tabs extending around the first and second openings.

18. The method of claim 13, wherein the first and second fasteners are mounted on a fastening hoop.

14. A method of supporting a native heart valve comprising:

positioning a first leaflet brace around a first leaflet of the native heart valve, the first leaflet brace having first and second end portions;

positioning a second leaflet brace around a second leaflet of the native heart valve, the second leaflet brace having first and second end portions;

fastening the first end portion of the first leaflet brace to the first end portion of the second leaflet brace;

fastening the second end portion of the first leaflet brace to the second end portion of the second leaflet brace;

wherein after the acts of fastening, the first and second leaflet braces form an enclosed ring encircling the first and second leaflets of the native heart valve;

wherein the act of fastening the first end portion of the first leaflet brace to the first end portion of the second leaflet brace comprises positioning a first fastener over the first end portions, thereby retaining the first end portions relative to each other; and

wherein the act of fastening the second end portion of the first leaflet brace to the second end portion of the second leaflet brace comprises positioning a second fastener over the second end portions, thereby retaining the second end portions relative to each other;

wherein the act of positioning the first fastener comprises;

advancing a first fastening catheter and the first fastener over the first end portions of the first and second leaflet braces; and

releasing the first fastener from the first fastening catheter.

15. The method of claim 14, wherein the act of positioning the second fastener comprises:

advancing a second fastening catheter and the second fastener over the second end portions of the first and second leaflet braces; and

releasing the second fastener from the second fastening catheter.