SYSTEM FOR TRICUSPID VALVE REPAIR

• US 20180021133A1
• Filed: 07/20/2016
• Published: 01/25/2018
• Est. Priority Date: 07/20/2016
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Barbarino, Casey M.
• Granted Patent: US 10,058,426 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A system for repairing a tricuspid valve in a patient'"'"'s heart; a first shaft; a first disc removably mounted on the first shaft; a second shaft coaxially aligned with, and slideable in relation to, the first shaft; a second disc removably mounted on the second shaft, wherein the second disc is positioned proximal of the first disc; and wherein the first disc includes a plurality of openings positioned on an outer perimeter of the first disc, and a first cinch wire extending through the plurality of openings and thence through the catheter to the proximal end, the first cinch wire being tensionable for reducing the outer perimeter of the first disc.

Claims

1. A system for repairing a tricuspid valve in a patient'"'"'s heart, the system being positioned at a distal end of a catheter having a proximal end and a distal end and comprising:

a first shaft;

a first disc removably mounted on the first shaft, the first disc being in a compressed condition which has a cylindrical profile for delivery, the first disc being formed to adopt, for deployment, an expanded condition that has a concave surface facing towards the proximal end of the catheter;

a second shaft coaxially aligned with, and slideable in relation to, the first shaft;

a second disc removably mounted on the second shaft, the second disc being in a compressed condition which has a cylindrical profile for delivery, the second disc being formed from shape memory metal to adopt, for deployment, an expanded condition that has a convex surface facing towards the distal end of the catheter;

wherein the second disc is positioned proximal of the first disc; and

wherein the first disc includes a plurality of openings positioned on an outer perimeter of the first disc, and a first cinch wire extending through the plurality of openings and thence through the catheter to the proximal end, the first cinch wire being tensionable from the proximal end for reducing the outer perimeter of the first disc.

2. The system of claim 1, wherein the first cinch wire includes a zip tie.

3. The system of claim 2, wherein the first cinch wire includes a frangible portion having a reduced dimension and configured to break when the first cinch wire is pulled from the proximal end of the catheter.

4. The system of claim 1, further including a sheath which is slideably mounted to surround the second disc when in the compressed condition.

5. The system of claim 1, wherein the first shaft includes:

a first rod and a first tube that slideably surrounds the first rod; and

a first annulus positioned at a distal end of the first shaft to surround the first rod, and being formed of compressible material that, upon being compressed in a major direction expands in a minor direction perpendicular to the major direction;

wherein a distal end of the first tube is in operable contact with the first annulus, whereby distal movement of the first tube in relation to the first rod compresses the first annulus.

6. The system of claim 1, wherein the second shaft includes:

a second rod and a second tube that slideably surrounds the second rod; and

a second annulus positioned at a distal end of the second shaft to surround the second rod, and being formed of compressible material that, upon being compressed in a major direction expands in a minor direction perpendicular to the major direction;

wherein a distal end of the second tube is in operable contact with the second annulus, whereby distal movement of the second tube in relation to the second rod compresses the second annulus.

7. The system of claim 1, wherein the second shaft defines an inner bore and the first shaft is slidingly positioned within the inner bore.

8. The system of claim 7, wherein the first disc, when in the compressed condition, is positioned within the inner bore.

9. The system of claim 1, wherein the second disc includes a plurality of openings positioned on an outer perimeter of the second disc, and a second cinch wire extending through the plurality of openings, the second cinch wire being tensionable from the proximal end of the catheter for reducing the outer perimeter of the second disc.

10. The system of claim 1, wherein the first disc is formed by being cut from a sheet of shape memory metal alloy.

11. The system of claim 1, wherein the second disc is formed by being cut from a sheet of shape memory metal alloy.

12. A method of repairing a tricuspid valve having three leaflets in a heart of a patient, the method comprising:

inserting into the heart via transcatheter delivery a first disc having a cylindrical shape in a compressed condition and a concave surface with a first circumferential perimeter in an expanded condition, and a second disc having a cylindrical shape in a compressed condition, and a convex surface with a second circumferential perimeter in an expanded condition;

positioning the first disc in a right ventricle of the heart,

passing the first disc in the compressed condition through an opening in the second disc;

expanding the first disc from the compressed condition to the expanded condition, and locating the concave surface adjacent to and facing the three leaflets of the tricuspid valve;

positioning the second disc in a right atrium of the heart,

expanding the second disc from the compressed condition to the expanded condition, and locating the convex surface adjacent to and facing the three leaflets of the tricuspid valve;

moving the first disc towards the second disc, thereby trapping a portion of each of the three leaflets between the concave surface of the first disc and the convex surface of the second disc;

tensioning the three leaflets to provide a seal along opposing edges of the leaflets during systole of the heart and thereby causing the tricuspid valve to have three separate orifices for blood flow during diastole of the heart;

reducing the first circumferential perimeter of the first disc to a third circumferential perimeter that is smaller than the first circumferential perimeter; and

locking the third circumferential perimeter of the first disc in a fixed dimension.

13. The method of claim 12, wherein reducing the first circumferential perimeter of the first disc includes applying tension to a cinching element extending along the first circumferential perimeter.

14. The method of claim 13, wherein applying tension to a cinching element includes applying tension to a zip tie.

15. The method of claim 12, wherein reducing the first circumferential perimeter of the first disc includes reducing the second circumferential perimeter of the second disc to a fourth circumferential perimeter that is smaller than the second circumferential perimeter.

16. The method of claim 12, wherein positioning the first disc in a right ventricle includes passing the first disc, while located within a bore of a shaft in the compressed condition, through the tricuspid valve from the right atrium.

17. The method of claim 16, wherein expanding the first disc from the compressed condition to the expanded condition includes pushing the first disc from the bore of the shaft.

18. The method of claim 12, wherein moving the first disc towards the second disc includes withdrawing a shaft through the tricuspid valve, wherein the first disc is attached to the shaft.

19. The method of claim 12, wherein expanding the second disc from the compressed condition to the expanded condition includes retracting a sheath covering the second disc thereby exposing the second disc.