Trans-septal delivery system and methods of use

Patent metadata

Field	Value
Publication number	US-11612482-B2
Application number	US-202016807010-A
Country	US
Kind code	B2
Filing date	Mar 2, 2020
Priority date	Mar 6, 2019
Publication date	Mar 28, 2023
Grant date	Mar 28, 2023

Abstract

A delivery system for delivering a heart valve prosthesis includes a heart valve prosthesis and a delivery catheter. The heart valve prosthesis includes an anchoring member and an inner valve support, and further includes a radially collapsed configuration and a radially expanded configuration. The delivery catheter includes a handle, an outer shaft, an intermediate shaft, an inner shaft, and a distal tip component. The delivery catheter further includes a delivery configuration. In the delivery configuration, the outer shaft of the delivery catheter is configured to retain a first portion of the anchoring member, the intermediate shaft is configured to retain a first portion of the inner valve support, and the distal tip component is configured to retain a second end of the anchoring member and a second end of the inner valve support each in a radially compressed state.

First claim

What is claimed is:

1. A delivery system for percutaneously delivering a heart valve prosthesis to a site of a native valve, the delivery system comprising:
a heart valve prosthesis including an anchoring member at least partially surrounding and coupled to an inner valve support, the heart valve prosthesis having a radially collapsed configuration and a radially expanded configuration, and
a delivery catheter having a delivery configuration and a release configuration, the delivery catheter including:
an outer shaft, wherein in the delivery configuration the outer shaft retains the anchoring member of the heart valve prosthesis in a radially compressed state for delivery to a treatment site;
an intermediate shaft disposed through a lumen of the outer shaft, wherein in the delivery configuration the intermediate shaft retains at least a portion of the inner valve support of the heart valve prosthesis in a radially compressed state for delivery to a treatment site;
an inner shaft disposed through a lumen of the intermediate shaft; and
a distal tip component coupled to the inner shaft, the distal tip component including a distal shaft component extending proximally therefrom forming a recess between an inner surface of the distal shaft component and an outer surface of the inner shaft, wherein in the delivery configuration the distal shaft component retains a portion of the heart valve prosthesis in a radially compressed state in the recess for delivery to a treatment site.

2. The delivery system of claim 1 , wherein the inner shaft is axially slidable relative to a handle of the delivery catheter, the intermediate shaft and the outer shaft to advance the distal shaft component to release the portion of the heart valve prosthesis from the recess to enable the portion of the heart valve prosthesis to expand to a radially expanded state.

3. The delivery system of claim 1 , wherein the outer shaft is proximally retractable from the delivery configuration relative to the intermediate shaft and the inner shaft to release the anchoring member from the outer shaft to enable the anchoring member to expand to a radially expanded state.

4. The delivery system of claim 3 , wherein the intermediate shaft is proximally retractable from the delivery configuration relative to the inner shaft and the outer shaft to release the inner valve support from the intermediate shaft to enable the inner valve support to expand to a radially expanded state.

5. The delivery system of claim 1 , wherein the delivery catheter further comprises a spindle shaft disposed between in the inner shaft and the intermediate shaft, wherein the spindle shaft is configured to maintain the longitudinal positon of the heart valve prosthesis relative to a handle of the delivery catheter.

6. The delivery system of claim 1 , wherein in the delivery configuration, an inflow end of the heart valve prosthesis faces a proximal direction of the delivery catheter.

7. The delivery system of claim 6 , wherein the anchoring member is coupled to the inner valve support at an outflow portion of the heart valve prosthesis.

8. The delivery system of claim 1 , wherein in the delivery configuration the intermediate shaft encircles the inner valve support and is disposed radially within the anchoring member, and wherein in the delivery configuration the outer shaft encircles the anchoring member.

9. A delivery catheter for percutaneously delivering a heart valve prosthesis to a site of a native valve, the delivery catheter comprising:
a handle;
an outer shaft operably coupled to the handle such that the outer shaft is axially slidable relative to the handle;
an intermediate shaft disposed within a lumen of the outer shaft, wherein the intermediate shaft is operably coupled to the handle such that the intermediate shaft is axially slidable relative to the handle;
an inner shaft disposed within a lumen of the intermediate shaft and coupled to the handle; and
a distal tip component coupled to the inner shaft, the distal tip component including a distal shaft component extending proximally therefrom that forms a recess between an inner surface of the distal shaft component and an outer surface of the inner shaft,
wherein the outer shaft is axially slidable relative to the intermediate shaft and the inner shaft;
wherein the intermediate shaft is axially slidable relative to the outer shaft and the inner shaft; and
wherein the outer shaft and the intermediate shaft are configured in combination to retain a heart valve prosthesis in a radially compressed configuration.

10. The delivery catheter of claim 9 , wherein the inner shaft is operably coupled to the handle such that the inner shaft is movable relative to the handle, the outer shaft, and the intermediate shaft, wherein the outer shaft, the intermediate shaft, and the distal shaft component are configured in combination to retain the heart valve prosthesis in the radially compressed configuration such that the delivery catheter enables multi-stage deployment of the heart valve prosthesis.

11. The delivery catheter of claim 10 , wherein when the delivery catheter is in the delivery configuration, the outer shaft is configured to retain an outer member of the heart valve prosthesis in a radially compressed state, the intermediate shaft is configured to retain an inner member of the heart valve prosthesis in a radially compressed state, and the distal shaft component of the distal tip component is configured to retain a distal portion of the heart valve prosthesis in a radially compressed state within the recess.

12. The delivery catheter of claim 9 , wherein the delivery catheter further comprises a spindle shaft disposed between in the inner shaft and the intermediate shaft, wherein the spindle shaft is configured to maintain the longitudinal positon of the heart valve prosthesis relative to the handle of the delivery catheter.

13. A method of delivering and deploying a heart valve prosthesis at a site of a native heart valve, the method comprising the steps of:
positioning a delivery catheter at a site of a native heart valve with the heart valve prosthesis in a radially compressed configuration, wherein the heart valve prosthesis includes an outer member coupled to an inner member and a prosthetic valve component coupled to the inner member, wherein the delivery catheter includes an outer shaft, an intermediate shaft, and an inner shaft configured in combination to hold the heart valve prosthesis in the radially compressed configuration;
retracting the outer shaft to release the outer member of the heart valve prosthesis from the outer shaft such that the outer member radially expands;
after the step of retracting the outer shaft, retracting the intermediate shaft to release the inner member of the heart valve prosthesis from the intermediate shaft such that the inner member radially expands; and
after retracting the outer shaft and before retracting the intermediate shaft, advancing the delivery catheter such that a brim of the outer member engages an atrial side of an annulus of the mitral valve.

14. The method of claim 13 , wherein the native heart valve is a mitral valve.

15. The method of claim 14 , wherein the step of positioning the delivery catheter at the site of a native heart valve comprises advancing the delivery catheter from a right atrium to a left atrium via a puncture in a septal wall.

16. The method of claim 15 , wherein an inflow portion of the heart valve prosthesis faces a proximal portion of the delivery catheter.

17. The method of claim 13 , wherein the delive

Assignees

• Medtronic Inc

Inventors

• Keogh James
• Dwork Joshua

Classifications

• A61F2/9661

  the proximal portion of the stent or stent-graft is released first · CPC title

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2002/9665

  with additional retaining means · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2230/005

  Rosette-shaped, e.g. star-shaped · CPC title