Delivery systems having a temporary valve and methods of use

Patent metadata

Field	Value
Publication number	US-11833044-B2
Application number	US-202017068869-A
Country	US
Kind code	B2
Filing date	Oct 13, 2020
Priority date	Nov 20, 2017
Publication date	Dec 5, 2023
Grant date	Dec 5, 2023

Abstract

A delivery system for percutaneously delivering a heart valve prosthesis to a site of a native heart valve includes a delivery catheter and a heart valve prosthesis. The delivery catheter includes an outer sheath, an inner shaft, and an orifice restriction mechanism. The heart valve prosthesis has a valve member and a docking member. When the orifice restriction mechanism is positioned within the docking member within an annulus of the native heart valve, the orifice restriction mechanism temporarily replicates the operation of the native heart valve until the valve member is positioned within the docking member.

First claim

What is claimed is:

1. A delivery system for percutaneously delivering a heart valve prosthesis to a site of a native heart valve, the delivery system comprising:
a delivery catheter including:
an outer sheath;
an inner shaft slidably disposed within the outer sheath; and
an orifice restriction mechanism attached to a distal portion of the inner shaft, wherein the orifice restriction mechanism has a first state and a radially expanded second state, and wherein the orifice restriction mechanism moves with the inner shaft in both the first state and the radially expanded second state; and

a heart valve prosthesis having a radially collapsed configuration and a radially expanded configuration, the heart valve prosthesis disposed within the outer sheath in the radially collapsed configuration in a delivery configuration of the delivery system,
wherein the orifice restriction mechanism is configured to be positioned within the native heart valve and is configured to temporarily replicate the operation of the native heart valve until the heart valve prosthesis is deployed within the native heart valve.

2. The delivery system of claim 1 , wherein the orifice restriction mechanism is configured to temporarily replicate the operation of the native heart valve by alternating between the first state and the radially expanded second state.

3. The delivery system of claim 1 , wherein the heart valve prosthesis is a mitral heart valve prosthesis and the native heart valve is a native mitral valve.

4. The delivery system of claim 3 , wherein the orifice restriction mechanism is configured to temporarily replicate the operation of the native valve by transitioning to the first state during diastole and transitioning to the radially expanded second state during systole of the cardiac cycle of a heart.

5. The delivery system of claim 1 , wherein the orifice restriction mechanism comprises a balloon attached to the inner shaft.

6. The delivery system of claim 5 , wherein:
the heart valve prosthesis comprises a docking member and a valve member;
the docking member is balloon expandable and is mounted on the balloon in the delivery configuration; and
the balloon is configured to radially expand the docking member and then temporarily replicate the operation of the native heart valve within the docking member until the valve member is deployed within the docking member.

7. The delivery system of claim 1 , wherein the orifice restriction mechanism comprises a plurality of flaps attached to the inner shaft.

8. The delivery system of claim 7 , wherein:
the heart valve prosthesis comprises a docking member and a heart valve member, the docking member is configured to be deployed at the site of the native heart valve; and
the orifice restriction member is configured to be disposed within the deployed docking member to replicate the operation of the native heart valve within the docking member until the valve member is deployed within the docking member.

9. A method of delivering, positioning and deploying a heart valve prosthesis at a site of a native heart valve, the method comprising the steps of:
advancing a delivery catheter with a heart valve prosthesis in a radially collapsed configuration retained therein and an orifice restriction member attached to the delivery catheter in a first state to the site of the native heart valve of a patient;
locating the orifice restriction member within the native heart valve;
cyclically alternating the orifice restriction mechanism between the first state and a radially expanded second state in synchronization with the cardiac cycle of the heart while the orifice restriction member is attached to the delivery catheter and located within the native heart valve;
deploying the heart valve prosthesis at the site of the native heart valve; and
removing the delivery catheter from the patient, thereby removing the orifice restriction member from the patient.

10. The method of claim 9 , wherein the heart valve prosthesis includes a docking member and a valve member, wherein deploying the heart valve prosthesis comprises first deploying the docking member within the native heart valve and later deploying the valve member within the deployed docking member, wherein locating the orifice restriction member within the native heart valve comprises locating the orifice restriction member within the deployed docking member.

11. The method of claim 9 , wherein the orifice restriction member comprises a balloon, and wherein cyclically alternating the orifice restriction member comprises inflating and deflating the balloon in synchronization with the cardiac cycle of the heart.

12. The method of claim 9 , wherein the orifice restriction mechanism comprises a plurality of flaps attached to an inner shaft of the delivery catheter, wherein cyclically alternating the orifice restriction member comprises blood flow cyclically alternating the flaps between the first state and the second radially expandable state.

13. The method of claim 12 , wherein each of the plurality of flaps comprises a first end pivotably coupled to the inner shaft and a second, free end opposite the first end, wherein the first state comprises the second end disposed adjacent the inner shaft, and the second radially expanded state comprises each flap pivotably rotating about the first end such that the second end is disposed radially outward of the first end such that a longitudinal axis of each flap is transverse to a central longitudinal axis of the inner shaft.

14. The method of claim 12 , wherein locating the orifice restriction member comprises locating the orifice restriction member within a native mitral heart valve, and wherein the plurality of flaps pivot to the second radially expanded state during systole of the heart and to the first state during diastole of the heart.

15. The method of claim 9 , wherein the orifice restriction mechanism is a radially expandable tube having a first end coupled to a distal end portion of a first inner shaft and a second end coupled to a distal end portion of a second inner shaft, wherein the second inner shaft is slidably received within a lumen of the first inner shaft, and wherein cyclically alternating the orifice restriction member comprises telescopically moving the first inner shaft relative to the second inner shaft.

16. The method of claim 15 , wherein telescopically moving the first inner shaft relative to the second inner shaft such that the first end and the second end of the tube to move closer together causes the tube to radially expand and telescopically moving the first inner shaft relative to the second inner shaft such that the first end and the second end of the tube move farther apart causes the tube to radially collapse.

Assignees

• Medtronic Vascular Inc

Inventors

• Lally Marian
• Keogh James R
• Quill Jason

Classifications

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61B17/1204

  temporary occlusion · CPC title

• A61B17/12136

  Balloons · CPC title

• A61F2/2409

  Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442) · CPC title

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title