HEART VALVE REMODELING DEVICE

• US 20180153688A1
• Filed: 12/01/2017
• Published: 06/07/2018
• Est. Priority Date: 12/01/2016
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: O'Connor, Tim, O'Toole, Pat, O'Sullivan, Richard, Feeley, Marc, Gunning, Paul, Horgan, Fergal, Smyth, Coley, Shanley, Sean, Linke, Axel
• Granted Patent: US 10,702,381 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

A heart valve remodeling device may include a delivery device including an inner shaft slidably disposed over a guidewire and an outer shaft slidably disposed over the inner shaft, and a braided stent fixedly attached to the inner shaft and the outer shaft. The braided stent may be translatable between an elongated configuration and a deployed configuration by movement of the inner shaft relative to the outer shaft. The braided stent may include a valve having two or more leaflets disposed within the braided stent. Adjacent leaflets of the two or more leaflets may form longitudinally-oriented commissures proximate a perimeter of the valve, the commissures being fixedly secured to the braided stent along their length.

Claims

1. A heart valve remodeling device, comprising:

a delivery device including an inner shaft and an outer shaft slidably disposed over the inner shaft; and

a braided stent fixedly attached to the inner shaft at a distal end and fixedly attached to the outer shaft at a proximal end, the braided stent being translatable between an elongated configuration and a deployed configuration;

wherein the braided stent includes a valve having two or more leaflets disposed within the braided stent.

2. The heart valve remodeling device of claim 1, wherein the inner shaft extends through the valve.

3. The heart valve remodeling device of claim 1, wherein the valve is translatable between a collapsed configuration and an expanded configuration.

4. The heart valve remodeling device of claim 13, wherein the valve translates between the collapsed configuration and the expanded configuration as the braided stent translates between the elongated configuration and the deployed configuration, respectively.

5. The heart valve remodeling device of claim 1, wherein the valve is secured to the braided stent.

8. The heart valve remodeling device of claim 1, wherein free edges of the two or more leaflets are configured to contact each other and the inner shaft in a closed configuration during diastole and the free edges of the two or more leaflets are configured to spread apart in an open configuration during systole.

9. The heart valve remodeling device of claim 1, wherein the valve is formed of a polymer material.

10. The heart valve remodeling device of claim 1, wherein the valve includes an upstream cylindrical portion integrally formed with each of the two or more leaflets.

11. The heart valve remodeling device of claim 10, wherein the upstream cylindrical portion is disposed within the braided stent.

12. The heart valve remodeling device of claim 1, wherein in the deployed configuration, the braided stent defines a generally cylindrical central portion, a tapered proximal portion extending proximally from the central portion, and a tapered distal portion extending distally from the central portion.

13. The heart valve remodeling device of claim 12, wherein in the deployed configuration, a central portion of the braided stent has a greater outer extent than the proximal end of the braided stent and the distal end of the braided stent.

14. The heart valve remodeling device of claim 12, wherein the valve is disposed within the central portion of the braided stent.

6. The heart valve remodeling device of claim 6, wherein the valve is fixedly secured to the braided stent.

7. The heart valve remodeling device of claim 6, wherein the valve is bonded to a sealing layer disposed over at least a portion of an outer surface of the braided stent.

15. A heart valve remodeling device, comprising:

a delivery device including an inner shaft and an outer shaft slidably disposed over the inner shaft; and

a braided stent non-removably secured to the inner shaft and non-removably secured to the outer shaft, the braided stent being translatable between an elongated configuration and a deployed configuration by movement of the inner shaft relative to the outer shaft;

wherein the braided stent includes a valve having two or more leaflets disposed within the braided stent, wherein adjacent leaflets of the two or more leaflets form longitudinally-oriented commissures proximate a perimeter of the valve, the commissures being fixedly secured to the braided stent along their length.

16. The heart valve remodeling device of claim 15, wherein in the deployed configuration, the braided stent defines a generally cylindrical central portion, a tapered upstream portion extending from the central portion, and a tapered downstream portion extending from the central portion.

17. The heart valve remodeling device of claim 16, wherein the valve includes an upstream cylindrical portion integrally formed with each of the two or more leaflets, the two or more leaflets extending downstream from the cylindrical portion.

18. The heart valve remodeling device of claim 17, wherein the upstream cylindrical portion is fixedly attached to the braided stent.

19. The heart valve remodeling device of claim 15, wherein the commissures are embedded into the braided stent.

20. A heart valve remodeling device, comprising:

an elongate guidewire;

an inner shaft slidably disposed over the guidewire;

an outer shaft slidably disposed over the inner shaft, wherein the inner shaft extends distally of the outer shaft;

a braided wire frame configured to shift between an elongated delivery configuration and a deployed configuration as a result of relative longitudinal movement between the inner shaft and the outer shaft, the braided wire frame being fixedly attached to the inner shaft and the outer shaft; and

a polymer valve structure comprising a hollow cylindrical body and two or more leaflets integrally formed with the cylindrical body, the polymer valve structure being disposed within the braided wire frame with the two or more leaflets being radially spaced apart from the braided wire frame when the braided wire frame is in the deployed configuration and the leaflets are in a closed configuration.