Percutaneous valve, system and method

• US 10,226,344 B2
• Filed: 08/23/2016
• Issued: 03/12/2019
• Est. Priority Date: 02/05/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Eidenschink, Tracee, Thielen, Joseph M., Drasler, William J., Kveen, Craig L.
• Primary Examiner(s): Ganesan, Suba
• Application Number:
  US15/244,500
• Publication Number:
  US 20170165069A1
• Time in Patent Office: 931 Days
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Apparatus, systems, and methods for percutaneous valve replacement and/or augmentation are provided. The apparatus includes a valve having a valve frame, a valve leaflet coupled to the valve frame, and a leaflet transition member coupled to the valve leaflet. The valve leaflet and leaflet transition member can transition from a first position where the valve leaflet and leaflet frame are at least partially outside a lumen of the valve frame to a second position where the valve leaflet and the leaflet transition member are within the lumen of the valve frame.

Claims

1. A system, comprising:

an elongate delivery catheter including a distal end and a proximal end;

a retractable sheath positioned around at least a portion of the elongate delivery catheter;

a valve positioned around the distal end of the elongate delivery catheter and between the elongate delivery catheter and the retractable sheath,

wherein the valve comprises an expandable valve frame including a distal end, a proximal end, and a lumen therebetween and a plurality of valve leaflets pivotably coupled to the proximal end of the expandable valve frame and having a first position in which the plurality of valve leaflets extend proximally from the proximal end of the expandable valve frame and a second position in which the plurality of valve leaflets are within the lumen of the expandable valve frame; and

a number of elongate push members positioned around the elongate delivery catheter proximal of the valve;

wherein the valve is configured to shift from a delivery state to a deployed state following withdrawal of the retractable sheath from the valve;

wherein in the delivery state, the plurality of valve leaflets is in the first position extending away from the proximal end of the valve and the valve frame lumen, and wherein in the deployed state, the plurality of valve leaflets is in the second position disposed within the lumen of the valve.

2. The system of claim 1, further comprising an expandable balloon positioned around a distal portion of the elongate delivery catheter.

3. The system of claim 2, wherein the expandable balloon is configured to expand the expandable valve frame after the retractable sheath has been withdrawn from the valve.

4. The system of claim 2, wherein the elongate delivery catheter includes a distal tip disposed distal of the expandable balloon.

5. The system of claim 4, wherein an outer diameter of the distal tip decreases in a distal direction to a distal end of the elongate delivery catheter.

6. The system of claim 4, wherein the distal tip includes at least one proximally-extending member disposed proximate a perimeter of the distal tip.

7. The system of claim 1, wherein the number of elongate push members are configured to push the plurality of valve leaflets from the first position through the proximal end to the second position after the expandable valve frame has been expanded.

8. The system of claim 1, wherein in the second position, the plurality of valve leaflets forms a reversibly sealable opening configured to repeatedly move between an open state and a closed state for unidirectional flow of a liquid through the lumen of the valve.

9. The system of claim 1, further comprising a sealing material positioned on a periphery of the expandable valve frame.

10. The system of claim 9, wherein the sealing material is configured to swell when contacted by a liquid.