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

Patent metadata

Field	Value
Publication number	US-9566178-B2
Application number	US-201213656717-A
Country	US
Kind code	B2
Filing date	Oct 21, 2012
Priority date	Jun 24, 2010
Publication date	Feb 14, 2017
Grant date	Feb 14, 2017

Abstract

Sealable and repositionable implant devices are provided with features that increase the ability of implants such as endovascular grafts and valves to be precisely deployed or re-deployed, with better in situ accommodation to the local anatomy of the targeted recipient anatomic site, and/or with the ability for post-deployment adjustment to accommodate anatomic changes that might compromise the efficacy of the implant. A surgical implant includes an implant body and a selectively adjustable assembly attached to the implant body, the assembly having adjustable elements and being operable to cause a configuration change in a portion of the implant body and, thereby, permit implantation of the implant body within an anatomic orifice to effect a seal therein under normal physiological conditions.

First claim

What is claimed is:

1. A surgical implant, comprising:
a deformable stent of a shape-memory material set to a given shape, the stent having a plurality of lumens comprising first and second segments, wherein the first segments have interior threads; and
a selectively adjustable assembly at the stent having adjustable elements with first and second portions and being operable to force a configuration change in at least a portion of the stent from the given shape to a different deformed shape, the first portions of the adjustable elements having exterior threads that threadably engage the interior threads of respective first segments of the lumens when the stent is in a crimped configuration and when the stent is in an expanded configuration, and the second portions of the adjustable elements being axially slidable through respective ones of the second segments of the lumens.

2. The surgical implant according to claim 1 , wherein the adjustable elements are located substantially within a wall of the stent having a wall thickness.

3. The surgical implant according to claim 1 , wherein the adjustable elements are located within a wall of the stent having a wall thickness.

4. The surgical implant according to claim 3 , wherein:
the stent has an outer surface and an inner surface;
the outer surface of the stent and the inner surface of the stent define the wall thickness; and
the adjustable elements are located between the outer and inner surfaces.

5. The surgical implant according to claim 3 , wherein:
the wall thickness has a radial extent; and
the adjustable elements longitudinally pass through the radial extent of the wall thickness.

6. The surgical implant according to claim 3 , wherein the adjustable elements are located entirely within the wall thickness of the stent.

7. The surgical implant according to claim 1 , wherein the selectively adjustable assembly is attached to the stent.

8. The surgical implant according to claim 1 , wherein the adjustable elements are operable to force at least one of a diameter, a circumference, and a perimeter change in at least the portion of the stent.

9. The surgical implant according to claim 1 , wherein the adjustable elements are operable to force a configuration change in the stent.

10. The surgical implant according to claim 1 , wherein the stent is shaped substantially as a cylinder and the configuration change is an expansion in at least one of a diameter, a circumference, and a perimeter of the cylinder.

11. The surgical implant according to claim 1 , wherein, after forcing a configuration change in at least the portion of the stent, the adjustable elements retain the configuration change.

12. The surgical implant according to claim 1 , wherein the shape-memory material is heat set to the given shape and is at least one of:
operable to self-expand back to the given shape after being compressed and released; and
operable to self-contract back to the given shape after being expanded and released.

13. The surgical implant according to claim 1 , wherein the second segments of the lumens are axially aligned and spaced relative to respective ones of the first segments.

14. The surgical implant according to claim 13 , wherein the second segments of the lumens and the second portions of the adjustable elements are non-threaded.

15. A surgical implant, comprising:
a deformable stent of a shape-memory material set to a given shape, the stent having a wall with a wall thickness and a longitudinal extent, the wall defining at least one drive screw lumen within the wall thickness along the longitudinal extent, wherein at least a portion of the at least one drive screw lumen has interior threads; and
a selectively adjustable assembly at the stent, having adjustable elements comprising at least one drive screw with a non-threaded portion and a threaded portion, and being operable to force a configuration change in at least a portion of the stent from the given shape to a different deformed shape, the non-threaded portion of the at least one drive screw being slidably movable within the at least one drive screw lumen, and the threaded portion of the at least one drive screw being rotationally movable within the at least one drive screw lumen and having exterior threads configured to engage the interior threads of the at least one drive screw lumen when the stent is in a delivery state and when the stent is in an expanded state.

16. The surgical implant according to claim 15 , wherein:
the at least one drive screw has a proximal end and a longitudinal axis; and
the adjustable elements comprise at least one drive screw coupler fixed at the proximal end and extending away therefrom along the longitudinal axis.

17. The surgical implant according to claim 16 , wherein the at least one drive screw coupler is spaced from a proximal end of the stent when the stent is in delivery state, and the at least one drive screw coupler is in contact with the proximal end of the stent when the stent is in a fully expanded state.

18. The surgical implant according to claim 15 , wherein the at least one drive screw coupler has a couple shaped to engage a tool for rotating the at least one drive screw.

19. The surgical implant according to claim 15 , wherein the at least one drive screw lumen is located substantially within the wall thickness of the stent.

20. The surgical implant according to claim 15 , wherein the at least one drive screw lumen is located within the wall thickness.

21. The surgical implant according to claim 15 , wherein:
the stent has an outer surface and an inner surface;
the outer surface of the stent and the inner surface of the stent define the wall thickness; and
the at least one drive screw lumen is located between the outer and inner surfaces.

22. The surgical implant according to claim 15 , wherein:
the wall thickness has a radial extent; and
the adjustable elements longitudinally pass through the radial extent of the wall thickness.

23. The surgical implant according to claim 15 , wherein the at least one drive screw lumen is located entirely within the wall thickness of the stent.

24. The surgical implant according to claim 15 , wherein:
the at least one drive screw lumen is a pair of axially aligned and longitudinally separate lumen portions including a distal lumen portion and a proximal lumen portion; and
the at least one drive screw is operable to move the two portions at least one of:
towards one another; and
away from one another.

25. The surgical implant according to claim 24 , wherein:
the wall thickness defines a plurality of the drive screw lumens each having a pair of the axially aligned and longitudinally separate lumen portions including the distal lumen portion and the proximal lumen portion; and
the adjustable elements comprise a plurality of drive screws rotationally movable in the plurality of the drive screw lumens.

26. The surgical implant according to claim 15 , wherein the at least one drive screw has exterior threads frictionally holding the at least one drive screw rotationally still until a torque is imparted on the at least one drive screw.

27. The surgical implant according to claim 15 , wherein, after forcing a configuration change in at least the portion of the stent, the adjustable elements retain the configuration change.

28. The surgical implant according to

Assignees

• Edwards Lifesciences Cardiaq Llc

Inventors

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

Classifications

• A61F2/9517

  handle assemblies therefor · CPC title

• A61F2/95

  Instruments specially adapted for placement or removal of stents or stent-grafts · CPC title

• A61F2002/075

  the stent being loosely attached to the graft material, e.g. by stitching · CPC title

• A61F2/2439

  Expansion controlled by filaments · CPC title

• A61F2002/9505

  having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument · CPC title