Modular valve prosthesis, delivery system, and method of delivering and deploying a modular valve prosthesis

Patent metadata

Field	Value
Publication number	US-12453632-B2
Application number	US-202318460634-A
Country	US
Kind code	B2
Filing date	Sep 4, 2023
Priority date	Jun 20, 2016
Publication date	Oct 28, 2025
Grant date	Oct 28, 2025

Abstract

A modular valve prosthesis includes an inflow stent, a valve component including a valve stent and a prosthetic valve, and an outflow stent. In a radially compressed delivery configuration, an inflow end of the valve stent is separated from an outflow end of the inflow stent and an outflow end of the valve stent is separated from an inflow end of the outflow stent. In a radially expanded deployed configuration, the inflow end of the valve stent is in contact with the outflow end of the inflow stent and the outflow end of the valve stent is in contact with the inflow end of the outflow stent. A delivery system includes a capsule including first, second and third sections and flexible first and second bands between respective sections. The modules of the modular valve prosthesis are aligned with the sections and gaps between the modules are aligned with the bands.

First claim

What is claimed is:

1. A method of delivering and deploying a modular valve prosthesis comprising the steps of:
manipulating a delivery system loaded with the modular valve prosthesis in a radially compressed delivery configuration to guide the modular valve prosthesis through a patient's vasculature to a treatment site, wherein the modular valve prosthesis comprises an inflow stent, a valve component, and an outflow stent, wherein the delivery system comprises an outer sheath including a capsule, wherein the capsule includes a first section, a second section, a third section, a first band disposed between the first section and the second section, and a second band disposed between the second section and the third section, wherein the modular valve prosthesis is loaded within the capsule with the inflow stent aligned with the first section, a first gap between the inflow stent and the valve component align with the first band, the valve component aligned with the second section, a second gap between the valve component and the outflow stent aligned with the second band, and the outflow stent aligned with third section, wherein the delivery system further includes a plurality of sutures coupled to a hub and extending through each of the inflow stent, the valve component, and the outflow stent;
retracting the capsule proximally to release the inflow stent from the capsule such that the inflow stent transitions from the radially compressed delivery configuration to a radially expanded deployed configuration;
retracting the hub such that the sutures are taut;
retracting the capsule proximally to release the valve component from the capsule such that the valve component transitions from the radially compressed delivery configuration to the radially expanded deployed configuration and the valve component couples with the inflow stent;
retracting the hub such that the sutures are taut; and
retracting the outer sheath proximally to release the outflow stent from the capsule such that the outflow stent transitions from the radially compressed delivery configuration to the radially expanded deployed configuration and the outflow stent couples with the valve component.

2. The method of claim 1 , wherein the delivery system further comprises a detaching mechanism, further comprising the step of manipulating the delivery system after the modular valve prosthesis is in the radially expanded deployed configuration to sever or detach a portion of the sutures from the hub.

3. The method of claim 1 , wherein the modular valve prosthesis further comprises a locking mechanism and the step of coupling the valve component with the inflow stent includes engaging the locking mechanism such that the locking mechanism locks the inflow stent and the valve component together.

4. The method of claim 3 , wherein the modular valve prosthesis further comprises a second locking mechanism and the step of coupling the outflow stent with the valve component includes engaging the second locking mechanism such that the second locking mechanism locks the valve component and the outflow stent together.

5. A method of delivering and deploying a modular valve prosthesis comprising the steps of:
manipulating a delivery system loaded with the modular valve prosthesis in a radially compressed delivery configuration to guide the modular valve prosthesis through a patient's vasculature to a native heart valve, wherein the modular valve prosthesis comprises a first stent and a valve component, the valve component including a valve stent and a prosthetic valve coupled to the valve stent, wherein the delivery system comprises an outer sheath including a capsule, wherein the modular valve prosthesis is loaded within the capsule with the first stent longitudinally separated from the valve component, wherein the delivery system further includes a plurality of sutures coupled to a hub and extending through each of the first stent and the valve component;
retracting the capsule proximally to release the first stent from the capsule such that the first stent transitions from the radially compressed delivery configuration to a radially expanded deployed configuration;
retracting the hub such that the sutures are taut; and
after retracting the hub, further retracting the capsule proximally to release the valve component from the capsule such that the valve component transitions from the radially compressed delivery configuration to the radially expanded deployed configuration; and
coupling the valve component with the first stent after the first stent is in the radially expanded configuration.

6. The method of claim 5 , wherein the modular valve prosthesis further comprises a locking mechanism and the step of coupling the valve component with the first stent includes engaging the locking mechanism such that the locking mechanism locks the first stent and the valve component together.

7. The method of claim 5 , wherein the first stent transitions from the radially compressed delivery configuration to the radially expanded deployed configuration at a native annulus of the native heart valve.

8. The method of claim 5 , wherein the native heart valve is a native aortic valve.

9. The method of claim 5 , wherein the modular valve prosthesis further comprises a second stent, wherein the second stent is loaded within the capsule during the manipulating step longitudinally separated from the valve component and the first stent.

10. The method of claim 9 , wherein the modular valve prosthesis is loaded within the capsule with the valve component disposed longitudinally between the first stent and the second stent.

11. The method of claim 10 , further comprising retracting the capsule proximally to release the second stent from the capsule such that the second stent transitions from the radially compressed delivery configuration to the radially expanded deployed configuration and the second stent couples with the valve component.

12. The method of claim 11 ,
wherein the modular valve prosthesis further comprises a first locking mechanism and a second locking mechanism,
wherein the step of coupling the valve component with the first stent includes engaging the first locking mechanism such that the first locking mechanism locks the first stent and the valve component together,
wherein the step of coupling the valve component with the second stent includes engaging the second locking mechanism such that the second locking mechanism locks the second stent and the valve component together.

13. The method of claim 10 , wherein the plurality of sutures also extend through the second stent, further comprising retracting the hub such that the sutures are taut prior to retracting the capsule to release the second stent.

14. A method of delivering and deploying a modular valve prosthesis comprising the steps of:
manipulating a delivery system loaded with the modular valve prosthesis in a radially compressed delivery configuration to guide the modular valve prosthesis through a patient's vasculature to a native heart valve, wherein the modular valve prosthesis comprises a first stent and a valve component, the valve component including a valve stent and a prosthetic valve coupled to the valve stent, wherein the delivery system comprises an outer sheath including a capsule, wherein the modular valve prosthesis is loaded within the capsule with the first stent longitudinally separated from the valve component;
retracting the capsule proximally to release the first stent from the capsule such that the first stent transitions from the radially compressed delivery configuration to a radially expanded deployed configurat

Assignees

• Medtronic Vascular Inc

Inventors

• Bell Rodney
• Costello Declan
• Duffy Niall
• Harewood Frank

Classifications

• A61F2250/0018

  differing in elasticity, stiffness or compressibility · CPC title

• A61F2250/006

  modular · CPC title

• A61F2/2418

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

• A61F2/852

  Two or more distinct overlapping stents · CPC title

• A61F2/2412

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