Actively controllable stent, stent graft, heart valve and method of controlling same

Patent metadata

Field	Value
Publication number	US-11707356-B2
Application number	US-202017118382-A
Country	US
Kind code	B2
Filing date	Dec 10, 2020
Priority date	Oct 21, 2011
Publication date	Jul 25, 2023
Grant date	Jul 25, 2023

Abstract

A prosthetic heart valve includes a frame, a valve, and an expansion element. The frame is movable between contracted and expanded configurations and includes first struts and second struts non-hingedly coupled together. The second struts are configured to pivot relative to the first struts as the frame moves between the contracted and expanded configurations. The valve is coupled to the frame and includes leaflets. The expansion element extends through a lumen of the first struts. The expansion element is slidable relative to the lumen of the first struts and is configured to move the frame incrementally from the contracted configuration and the expanded configuration and from the expanded configuration to the contracted configuration.

First claim

The invention claimed is:

1. A prosthetic heart valve comprising:
a stent assembly radially movable between a contracted configuration and an expanded configuration and comprising a plurality of longitudinally extending struts and a plurality of laterally extending arms, wherein the longitudinally extending struts and the laterally extending arms are formed from one integral piece of shape memory metal and are fixedly coupled together, wherein one or more of the longitudinally extending struts comprises a bore extending longitudinally therethrough, and wherein the laterally extending arms are configured to flex relative to the longitudinally extending struts as the stent assembly moves between the contracted configuration and the expanded configuration;
a valve assembly coupled to the stent assembly and comprising a plurality of leaflets, wherein the leaflets are coupled together and are configured to move between an open configuration and a closed configuration, wherein in the open configuration blood can flow through the prosthetic heart valve in a first direction, and wherein in the closed configuration blood is restricted from flowing through the prosthetic heart valve in a second direction, which is opposite the first direction; and
an expansion shaft coupled to the one or more of the longitudinally extending struts of the stent assembly, wherein the expansion shaft extend through the bore of the one or more of the longitudinally extending struts, wherein the expansion shaft is slidable relative to a portion of the bore of the one or more of the longitudinally extending struts, and wherein the expansion shaft is configured to actively control movement of the stent assembly between the contracted configuration and the expanded configuration.

2. The prosthetic heart valve of claim 1 , wherein the stent assembly is shape set to an intermediate configuration, and wherein the intermediate configuration is radially larger than the contracted configuration and radially smaller than the expanded configuration.

3. The prosthetic heart valve of claim 2 , wherein the stent assembly is configured to self-expand from the contracted configuration to the intermediate configuration.

4. The prosthetic heart valve of claim 2 , wherein the expansion shaft is configured to forcibly-expand the stent assembly from the intermediate configuration to the expanded configuration.

5. The prosthetic heart valve of claim 1 , wherein the longitudinally extending struts comprise first portions and second portions, and wherein the stent assembly is configured such that the first portions and the second portions move longitudinally away from each other when the stent assembly is moved from the expanded configuration to the contracted configuration and such that the first portions and the second portions move toward each other when the stent assembly is moved from the contracted configuration to the expanded configuration.

6. The prosthetic heart valve of claim 5 , wherein the first portions and the second portions of the longitudinally extending struts are configured to abut each other when the stent assembly is in a maximum expanded configuration.

7. The prosthetic heart valve of claim 1 , wherein the stent assembly further comprises a plurality of intermediate struts extending parallel to and circumferentially between adjacent pairs of the longitudinally extending struts, and wherein the laterally extending arms extend from the longitudinally extending struts to the intermediate struts.

8. The prosthetic heart valve of claim 7 , wherein the leaflets of the valve assembly are coupled to the intermediate struts via opening formed in the intermediate struts.

9. The prosthetic heart valve of claim 7 , wherein the intermediate struts, the longitudinally extending struts, and the laterally extending arms are formed from the one integral piece of shape memory metal.

10. A prosthetic heart valve comprising:
a frame radially movable between a contracted configuration and an expanded configuration and comprising a plurality of first struts and a plurality of second struts, wherein the first struts and the second struts are non-hingedly coupled together, wherein one or more first struts comprise a lumen extending longitudinally therethrough, and wherein the second struts are configured to pivot relative to the first struts as the frame moves between the contracted configuration and the expanded configuration;
a valve structure coupled to the frame and comprising three leaflets, wherein the leaflets are coupled together and are configured to move between an open configuration and a closed configuration, wherein in the open configuration blood can flow through the prosthetic heart valve in a first direction, and wherein in the closed configuration blood is restricted from flowing through the prosthetic heart valve in a second direction, which is opposite the first direction; and
an expansion rod coupled to the one or more first struts of the frame, wherein the expansion rod extends through the lumen of the one or more first struts, wherein the expansion rod is slidable relative to the lumen of the one or more first struts, and wherein the expansion rod is configured to move the frame incrementally from the contracted configuration and the expanded configuration and from the expanded configuration to the contracted configuration.

11. The prosthetic heart valve of claim 10 , wherein the frame is shape set to a partially-expanded configuration, and wherein the partially-expanded configuration is radially larger than the contracted configuration and radially smaller than the expanded configuration.

12. The prosthetic heart valve of claim 11 , wherein the frame is configured to self-expand from the contracted configuration to the partially-expanded configuration.

13. The prosthetic heart valve of claim 11 , wherein the expansion rod is configured to forcibly-expand the frame from the partially-expanded configuration to the expanded configuration.

14. The prosthetic heart valve of claim 10 , wherein the first struts comprise distal portions and proximal portions, and wherein the frame is configured such that the distal portions and the proximal portions move longitudinally away from each other when the frame is moved from the expanded configuration to the contracted configuration and such that the distal portions and the proximal portions move longitudinally toward each other when the frame is moved from the contracted configuration to the expanded configuration.

15. The prosthetic heart valve of claim 14 , wherein the distal portions and the proximal portions of the first struts are configured to abut each other when the frame is in a maximum expanded configuration.

16. The prosthetic heart valve of claim 10 , wherein the frame further comprises a plurality of third struts extending parallel to and circumferentially between adjacent pairs of the first struts, and wherein the second struts extend between the first struts and the third struts.

17. The prosthetic heart valve of claim 16 , wherein the third struts comprise bores formed therein, and wherein the bores are configured for coupling the leaflets of the valve structure to the third struts.

18. A prosthetic heart valve comprising:
a frame radially movable between a contracted configuration and an expanded configuration and comprising a plurality of first struts and a plurality of second struts, wherein the first struts and the second struts are flexibly coupled together, wherein one or more first struts comprise a lumen extending longitudinally therethrough, an

Assignees

• Edwards Lifesciences Cardiaq Llc

Inventors

• Cartledge Richard George
• Smith Kevin W
• Bales Jr Thomas O
• Deville Derek Dee
• Kline Korey
• Mendez Max Pierre
• Palmer Matthew A
• Kirk Michael Walter
• Rivera Carlos
• Petersen Eric
• Mcbrayer M Sean

Classifications

• A61F2/2418 Primary

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

• A61B5/6862

  Stents · CPC title

• A61F2/243

  Deployment by mechanical expansion · CPC title

• A61F2/2412

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

• A61F2/2436

  Deployment by retracting a sheath · CPC title