Collapsible and re-expandable prosthetic heart valve cuff designs and complementary technological applications

• US 9,351,832 B2
• Filed: 04/17/2015
• Issued: 05/31/2016
• Est. Priority Date: 07/15/2008
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., Ashworth, Paul Edward, Schraut, Julia Ann
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Shipmon, Tiffany
• Application Number:
  US14/689,618
• Publication Number:
  US 20150216663A1
• Time in Patent Office: 410 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.

Claims

1. A method of implanting a prosthetic heart valve within a native valve annulus of a patient, the method comprising:

introducing a delivery device to the vicinity of the native valve annulus, the delivery device carrying a prosthetic heart valve in a collapsed condition, the prosthetic heart valve including a stent body, a valve element mounted within the stent body and operative to allow flow in an antegrade direction through the stent body but to substantially block flow in a retrograde direction through the stent body, and a cuff connected to the stent body and including an inner wall adjacent the stent body and an outer wall outside the stent and outside the inner wall so as to define a pocket between the inner wall and the outer wall, the inner wall projecting in the antegrade direction beyond the outer wall; and

expanding the prosthetic heart valve so that the prosthetic heart valve moves from the collapsed condition to an expanded condition and so that in the expanded condition the outer wall of the cuff is disposed within the native valve annulus and a flow of blood outside of the stent body in the retrograde direction will fill the pocket with blood and bias the outer wall outwardly into engagement within the native valve annulus.

2. The method as claimed in claim 1, wherein the stent body is self-expandable.

3. The method as claimed in claim 1, wherein the stent body is balloon expandable.

4. The method as claimed in claim 1, wherein the stent body includes a flared region.

5. The method as claimed in claim 1, wherein the delivery device includes an outer sheath surrounding the prosthetic heart valve, the method further comprising withdrawing the sheath to deploy the prosthetic heart valve from the delivery device.

6. The method as claimed in claim 1 wherein, in the expanded condition, an edge of the outer wall facing in the antegrade direction is in proximity to the inner wall at first locations spaced apart from one another in a circumferential direction around the stent body and the edge of the outer wall is radially spaced apart from the inner wall at a second location disposed between the first locations so that the inner wall and the edge of the outer wall cooperatively define an opening for entry of blood into the pocket at the second location.

7. The method as claimed in claim 6 wherein, in the expanded condition, the edge of the outer wall is radially spaced apart from the inner wall at a plurality of second locations so that the inner wall and the outer wall cooperatively define a plurality of openings.

8. The method as claimed in claim 7 wherein all of the openings are arranged in a single row extending in the circumferential direction around the stent body.