Cardiac prostheses and their deployment

• US 10,226,340 B2
• Filed: 10/08/2014
• Issued: 03/12/2019
• Est. Priority Date: 10/08/2013
• Status: Active Grant

• Current Assignee: The Medical Research, Infrastructure And Health Services Fund Of The Tel Aviv Medical Center
• Original Assignee: The Medical Research, Infrastructure And Health Services Fund Of The Tel Aviv Medical Center
• Inventors: Keren, Gad
• Primary Examiner(s): Tanner, Jocelin
• Application Number:
  US15/027,699
• Publication Number:
  US 20160242901A1
• Time in Patent Office: 1,616 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

A method of replacing a native cardiac valve with a prosthetic cardiac valve, the method comprising: expanding a wire mesh scaffolding in a chamber of the heart on a retrograde side of the native cardiac valve; while the scaffolding is expanded on the retrograde side of the valve positioning the prosthetic cardiac valve at the site of the native cardiac valve; expanding the prosthetic cardiac valve to replace the native cardiac valve; and collapsing the scaffolding to a collapsed state and removing the collapsed scaffolding from the chamber of the heart.

Claims

1. Apparatus for replacing a native cardiac valve, the apparatus comprising:

a wire mesh cardiac valve prosthesis having a cylindrical collapsed state and an expanded state and leaflets that operate to control blood flow;

a wire mesh scaffolding having a collapsed state and at least one expanded deployed state configured to contact walls of a chamber in a heart on a retrograde side of the native cardiac valve and substantially fill the heart chamber;

a delivery system comprising at least one tube in which the prosthesis and the scaffolding are mounted in their collapsed state that is controllable to;

deploy the scaffolding in its expanded state on the retrograde side of the native valve;

deploy the prosthesis in its expanded state; and

remove the scaffolding in the collapsed state from the site of the native cardiac valve to leave the deployed prosthesis replacing the native valve.

2. The apparatus according to claim 1 wherein the at least one tube comprises a scaffolding housing tube formed having exit holes at a distal end thereof and in the collapsed state the wire mesh scaffolding comprises a plurality of scaffolding wires housed in the scaffolding housing tube, each of which scaffolding wires extends out from the scaffolding housing tube through two of the exit holes to form a small loop outside of the scaffolding housing tube.

3. The apparatus according to claim 2 and comprising a push rod inside the scaffolding housing tube that is connected to the scaffolding wires and is slidable inside the scaffolding housing tube to push and pull on the scaffolding wires to respectively increase or decrease the size of the loops outside of the scaffolding housing tube.

4. The apparatus according to claim 3 wherein the push rod is operable to push the scaffolding wires through the exit holes out from the scaffolding housing tube to form loops that cooperate to form the at least one expanded deployed state of the wire mesh scaffolding.

5. The apparatus according to claim 4 wherein the at least one expanded deployed state of the wire mesh scaffolding comprises a plurality of different expanded deployed states that the loops cooperate to form as a function of the size of the loops.

6. The apparatus according to claim 5 wherein the plurality of different expanded deployed states comprises a state in which the loops have an envelope in a shape of a discus.

7. The apparatus according to claim 5 wherein the plurality of different expanded deployed states comprise a state in which the loops have an envelope in a shape of a lampshade.

8. The apparatus according to claim 2 wherein the at least one tube comprises a prosthesis delivery tube that surrounds the scaffolding housing tube and to which prosthesis delivery tube the cardiac valve prosthesis is mounted in the collapsed state.

9. The apparatus according to claim 8 wherein the at least one tube comprises a release tube surrounding the prosthesis delivery tube that constrains at least a portion of the cardiac valve prosthesis to prevent the cardiac valve prosthesis from self expanding to the expanded state.

10. The apparatus according to claim 9 wherein the release tube is translatable relative to the prosthesis delivery tube to cease constraining the at least portion of the cardiac valve prosthesis.

11. The apparatus according to claim 9 wherein the at least one tube comprises a control sheath surrounding the release tube that constrains at least a portion of the cardiac valve prosthesis to prevent the cardiac valve prosthesis from self expanding to the expanded state.

12. The apparatus according to claim 11 wherein the control sheath is translatable relative to the prosthesis delivery tube to cease constraining the at least portion of the cardiac valve prosthesis.

13. The apparatus according to claim 1 wherein the prosthesis in the expanded state comprises:

a mesh crown;

a plurality of tails attached to the mesh crown that are splayed out and comprise hooks configured to puncture and anchor into tissue on the antegrade side of the native valve; and

a plurality of support struts attached to the crown that support the leaflets and are substantially not splayed out.

14. The apparatus according to claim 13 wherein the tails and support struts are located at substantially same angular locations on the crown.

15. The apparatus according to claim 13 wherein the tails and support struts are located at different angular locations on the crown.

16. The apparatus according to claim 1 wherein the cardiac valve prosthesis has a cinch-girdle expanded state in which the prosthesis comprises upper and lower cups joined at a relatively narrow waist and when deployed the upper cup and lower cups are located respectively on retrograde and antegrade sides of the native cardiac valve.

17. The apparatus according to claim 16 wherein the at least one tube comprises a delivery tube to which the scaffolding and prosthesis are mounted.

18. The apparatus according to claim 17 wherein in their collapsed states a portion of the prosthesis overlaps a portion of the scaffolding.

19. The apparatus according to claim 18 and comprising a prosthesis control tube concentric with the delivery tube that constrains a portion of the prosthesis to its constrained state and is translatable along the delivery tube to release the constrained portion to expand towards the expanded state.

20. The apparatus according to claim 19 and comprising a control sheath concentric with the delivery tube and the prosthesis control tube that constrains the scaffolding and the portion of the prosthesis that overlies the scaffolding to their collapsed states and is translatable along the prosthesis control tube to release the scaffolding and the portion of the prosthesis overlying the scaffolding to expand towards their expanded states.