Transcatheter aortic valvuloplasty device

• US 10,583,006 B2
• Filed: 01/26/2017
• Issued: 03/10/2020
• Est. Priority Date: 06/19/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Flanagan, Aiden
• Primary Examiner(s): Shi, Katherine M
• Application Number:
  US15/416,704
• Publication Number:
  US 20170143487A1
• Time in Patent Office: 1,139 Days
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A valvuloplasty device comprises an expandable anchor and an expansion member mounted about an outer surface of the expandable anchor. The expansion member is either an annular balloon or a sleeve. The valvuloplasty device can be used for valvuloplasty and for valve implantation.

Claims

1. A method of performing valvuloplasty, comprising:

advancing a valvuloplasty device to a deployment location within a vascular system;

wherein the valvuloplasty device comprises;

an expandable anchor having a proximal end, a distal end, an outer surface extending between the proximal end and the distal end, and an inner surface extending between the proximal end and the distal end, the inner surface defining a lumen; and

an expansion member comprising;

an annular expandable balloon having an inner surface and an outer surface, the annular expandable balloon disposed around the outer surface of the expandable anchor such that at least a portion of the inner surface of the annular expandable balloon is affixed directly to the outer surface of the expandable anchor;

deploying the expandable anchor from a delivery state to a deployed state, thereby permitting fluid flow through the lumen of the expandable anchor;

expanding the expansion member; and

removing the valvuloplasty device from the vascular system.

2. The method of claim 1, wherein the expansion member extends axially over at least a portion of the expandable anchor.

3. The method of claim 2, wherein the distal end of the expandable anchor is radially aligned with a distal end of the expansion member.

4. The method of claim 1, wherein the valvuloplasty device has:

a delivery configuration wherein the expandable anchor is in the delivery state and the expansion member is in a delivery state;

a deployed configuration, wherein the expandable anchor is in the deployed state and the expansion member is in a deployed state.

5. The method of claim 4, the annular expandable balloon being inflatable, the annular expandable balloon in the delivery state being uninflated, the annular expandable balloon in the deployed state being inflated.

6. The method of claim 5, the valvuloplasty device further having a partially deployed configuration wherein the anchor is in the deployed state and the annular expandable balloon is in the delivery state.

7. The method of claim 5, wherein the annular expandable balloon has a plurality of folds when the expandable anchor is in the delivery state.

8. The method of claim 5, wherein the annular expandable balloon has a plurality of spines engaged to an inner wall of the annular expandable balloon, the plurality of spines being positioned about a circumference of the inner wall of the annular expandable balloon.

9. The method of claim 1, further comprising deploying a replacement valve implant within the lumen of the expandable anchor.

10. A method of performing valvuloplasty, comprising:

advancing a valvuloplasty device to a deployment location within a vascular system;

wherein the valvuloplasty device comprises;

an expandable anchor having a proximal end, a distal end, an outer surface extending between the proximal end and the distal end, and an inner surface extending between the proximal end and the distal end, the inner surface defining a lumen having open ends; and

an annular expandable balloon having an inner surface and an outer surface, the annular expandable balloon disposed around the outer surface of the expandable anchor such that at least a portion of the inner surface of the annular expandable balloon is affixed directly to the outer surface of the expandable anchor;

deploying the expandable anchor from a delivery state to a deployed state, thereby permitting fluid flow through the lumen of the expandable anchor;

thereafter, inflating the expandable annular balloon; and

removing the valvuloplasty device from the vascular system.

11. The method of claim 10, wherein the expandable anchor is self-expanding, and deploying the expandable anchor includes withdrawing a delivery sheath relative to the expandable anchor to expose the expandable anchor at the deployment location.

12. The method of claim 10, wherein the valvuloplasty device includes an expansion balloon mounted on an inner member disposed within the lumen of the expandable anchor, and deploying the expandable anchor includes inflating the expansion balloon within the lumen of the expandable anchor.

13. The method of claim 10, wherein after deploying the expandable anchor to the deployed state, the expandable anchor engages a wall of the vascular system at the deployment location.

14. The method of claim 13, wherein in the deployed state the lumen of the expandable anchor has an effective orifice area greater than 1 square millimeter.

15. The method of claim 10, wherein the valvuloplasty device includes an inflation mechanism detachably connected to the expandable annular balloon.

16. The method of claim 10, wherein inflating the expandable annular balloon includes expanding the expandable annular balloon from a delivery state to a deployed state, the outer surface of the expandable annular balloon engaging a wall of the vascular system at the deployment location preventing fluid flow between the wall of the vascular system and the outer surface of the expandable anchor.

17. The method of claim 10, further comprising deploying a replacement valve implant within the lumen of the expandable anchor.

18. The method of claim 10, wherein at least a portion of the inner surface of the annular expandable balloon is affixed directly to the outer surface of the expandable anchor at the distal end of the expandable anchor.

19. The method of claim 10, wherein the expandable annular balloon is only affixed to the expandable anchor at a distal end of the expandable annular balloon.