System and method for transcatheter heart valve platform

• US 10,398,549 B2
• Filed: 03/15/2016
• Issued: 09/03/2019
• Est. Priority Date: 03/15/2016
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Krone, Ryan T.
• Primary Examiner(s): Tyson, Melanie R
• Application Number:
  US15/071,077
• Publication Number:
  US 20170265994A1
• Time in Patent Office: 1,267 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A method for delivering a platform for reinforcing an annulus of a mitral valve: Passing a catheter having a sheath covering a tube formed from a metal into the left atrium, the tube including: an annular portion defining at least one opening, a plurality of upper elements attached to an upper perimeter of the annular portion and extending axially, and a plurality of lower elements attached to a lower perimeter of the annular portion. Inserting the tube into the annulus of the mitral valve; withdrawing the sheath, but leaving the sheath covering the annular portion and the upper elements; bending the lower elements until the lower elements extend radially so as to be positioned beneath the mitral valve; then withdrawing the sheath from covering the annular portion and the upper elements; bending the upper elements until the upper elements extend radially so as to be positioned above the mitral valve.

Claims

1. A system for delivering a platform to support a prosthetic mitral valve in a patient'"'"'s heart, the system comprising:

a delivery catheter that includes a slidable sheath;

a tube positioned within the slidable sheath defining a structure that includes;

an annular portion defining a bore and an axis that extends along the bore, and further defining at least one opening in a circumferential surface of the annular portion,

a plurality of upper elements attached to an upper perimeter of the annular portion and extending axially, and

a plurality of lower elements attached to a lower perimeter of the annular portion and extending axially; and

a piston configured to slide within the tube, the piston defining a lumen that receives at least one pin configured to slide out of the lumen so as to pass through the at least one opening; and

wherein the slidable sheath includes a resilient ring at a distal end of the slidable sheath.

2. The system of claim 1, wherein the at least one pin includes two pins, and the two pins are separated from each other by a spring configured to urge the two pins apart from each other.

3. The system of claim 2, wherein each pin is attached to a retraction wire that extends inside the lumen, the retraction wire being attached to each of the two pins, whereby the two pins are urged towards each other when the retraction wire is pulled proximally.

4. The system of claim 1, wherein the resilient ring is made of metal.

5. The system of claim 1, wherein the annular portion occupies a first cylindrical profile having a first diameter, and the plurality of lower elements occupy a second cylindrical profile having a second diameter smaller than the first diameter.

6. The system of claim 5, wherein the piston has an outer circumferential surface having a third diameter that is smaller than the first diameter but larger than the second diameter, whereby distal movement of the piston applies a force against the plurality of lower elements thus to urge each of the plurality of lower elements to bend away from the axis.

7. The system of claim 1, wherein the piston includes a means for causing the circumferential surface to expand.

8. The system of claim 1, further including a means for applying a distal force against a proximal end of each of the plurality of upper elements and thus to urge the plurality of upper elements to bend away from the axis.

9. A method for delivering a platform for reinforcing an annulus of a mitral valve in a heart of a patient, the heart including a right atrium, a left atrium, and a septum separating the right atrium from the left atrium, the method comprising:

providing a delivery system having;

a delivery catheter that includes a slidable sheath,

a tube positioned within the slidable sheath defining a structure that includes;

an annular portion defining a bore and an axis that extends along the bore, and further defining at least one opening in a circumferential surface of the annular portion,

a plurality of upper elements attached to an upper perimeter of the annular portion and extending axially, and

a plurality of lower elements attached to a lower perimeter of the annular portion and extending axially, and

a piston configured to slide within the tube, the piston defining a lumen that receives at least one pin configured to slide out of the lumen so as to pass through the at least one opening,

wherein the slidable sheath includes a resilient ring at a distal end of the slidable sheath;

passing, via a femoral artery of a patient, the catheter into the right atrium, then through the septum into the left atrium,

withdrawing the sheath from covering the plurality lower elements, but leaving the sheath covering the annular portion and the plurality of upper elements;

bending the plurality of lower elements by imparting a plastic deformation to the metal until the plurality of lower elements extend radially so as to be positioned beneath the mitral valve;

then withdrawing the sheath from covering the annular portion and the plurality of upper elements; and

bending the plurality of upper elements by imparting a plastic deformation to the metal until each of the plurality of upper elements extends radially so as to be positioned above the mitral valve.

10. The method of claim 9, wherein the annular portion occupies a first cylindrical profile having a first diameter, and the plurality of lower elements prior to being bent occupy a second cylindrical profile having a second diameter smaller than the first diameter, and wherein bending the plurality of lower elements includes moving the piston distally through the annular portion and engaging each of the plurality of lower elements with the piston, the piston having a third diameter greater than the second diameter.

11. The method of claim 10, wherein moving the piston distally through the annular portion and engaging each of the plurality of lower elements with the piston is simultaneously accompanied by restraining the first diameter of the annular portion against expansion.

12. The method of claim 11, wherein restraining the annular portion against expansion of the first diameter includes positioning the resilient ring around the lower perimeter of the annular portion.

13. The method of claim 12, wherein positioning the resilient ring includes positioning a distal end of the sheath around the lower perimeter of the annular portion.

14. The method of claim 10, further including expanding the first diameter of the annular portion by imparting a plastic deformation to the metal.

15. The method of claim 14, wherein expanding the first diameter of the annular portion includes expanding the first diameter until the annular portion is in contact with the annulus of the mitral valve along a continuous circumference of the annular portion.

16. The method of claim 14, wherein expanding the first diameter of the annular portion includes expanding the third diameter of the piston.

17. The method of claim 9, wherein bending the plurality of upper elements includes applying an axially oriented force on each of the plurality of upper elements.

18. The method of claim 17 further including applying a force having a radially outward component to each of the plurality of upper elements.

19. The method of claim 18, wherein applying a force having a radially outward component to each of the plurality of upper elements includes applying a moving force to a proximal extremity of each of the plurality of upper elements.

20. The method of claim 17, wherein applying an axially oriented force includes applying a force to a proximal extremity of each of the plurality of upper elements.

21. The method of claim 17, wherein applying an axially oriented force includes restraining the annular portion against distal movement.

22. The method of claim 21, wherein restraining the annular portion against distal movement includes inserting a pin into the at least one opening.