Expandable stent valve

• US 10,478,290 B2
• Filed: 11/26/2014
• Issued: 11/19/2019
• Est. Priority Date: 11/26/2013
• Status: Active Grant

• Current Assignee: Children's Medical Center Corporation
• Original Assignee: Children's Medical Center Corporation
• Inventors: Emani, Sitaram, Lock, James E., del Nido, Pedro J., Marshall, Audrey C.
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US15/039,510
• Publication Number:
  US 20170014228A1
• Time in Patent Office: 1,819 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0067 conical
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

An expandable valve (100) and valve frame device that may be implanted within the body, for example, at a position of the heart. The device may be surgically implanted and subsequently expanded at a later time. The device may include an expandable sewing member (160) surrounding the valve frame (130) at a region between upstream and downstream ends of the device, for attaching the device to surrounding tissue. The device may include a membrane (140) for blocking leakage out the side of the valve frame between opposite ends. However, the membrane may include a side opening (170) for guiding fluid flow toward an appropriate anatomical outflow tract. The device may include a hood-like covering attached to a tissue wall, for smoothly receiving and guiding fluid flow along a perpendicular bend. The device may further include a flared opening at a downstream end, providing adequate space for device attachment.

Claims

1. A device for implantation at a position of a heart, the device comprising:

a valve frame defining a lumen, the valve frame having an upstream end and a downstream end;

a plurality of valve leaflets attached to and disposed within the valve frame;

a sewing member surrounding the valve frame at a region between the upstream end and the downstream end, for forming an attachment to tissue at the position of the heart; and

a membrane disposed about the valve frame for obstructing fluid flow between the lumen and an external region surrounding the valve frame,

wherein the valve frame is expandable, and a portion of the membrane at a side region of the downstream end of the valve frame comprises an opening that permits fluid flow through the side region.

2. The device of claim 1, wherein the valve frame is expandable from a first diameter between 9 mm and 18 mm to a second diameter between 10 mm and 22 mm.

3. The device of claim 1, wherein the sewing member is expandable.

4. The device of claim 1, wherein the sewing member is attached to the valve frame.

5. The device of claim 1, wherein the opening comprises a cut out of the membrane extending along a plane that is parallel to or forms an angle with respect to a longitudinal axis of the valve frame.

6. The device of claim 5, wherein a downstream end of the membrane comprises a cut out extending along a plane that is substantially perpendicular to the longitudinal axis of the valve frame.

7. The device of claim 1, wherein the sewing member comprises a corrugated cuff.

8. The device of claim 1, wherein the valve frame is expandable from a first diameter between 11 mm and 13 mm to a second diameter between 13 mm and 15 mm.

9. The device of claim 1, wherein an edge of at least one of the upstream end and the downstream end of the valve frame has a level surface.

10. The device of claim 1, further comprising an attachment region proximate to the downstream end of the valve frame, for forming an attachment to tissue at a wall of the heart.

11. The device of claim 1, wherein the valve frame has a length of between 1.0 cm and 2.5 cm.

12. The device of claim 1, wherein the sewing member is located substantially concentric with the plurality of valve leaflets.

13. The device of claim 1, wherein the position comprises a mitral valve position of the heart.

14. The device of claim 1, wherein the sewing member surrounds the valve frame at approximately a midpoint between the upstream end and the downstream end.

15. A method of implanting a device at a position of the heart, the device including a valve frame defining a lumen, the valve frame having an upstream end and a downstream end, a plurality of valve leaflets attached to and disposed within the valve frame, and a membrane disposed about the valve frame for obstructing fluid flow between the lumen and an external region surrounding the valve frame, wherein the valve frame is expandable, and a portion of the membrane at a side region of the downstream end of the valve frame comprises an opening that permits fluid flow through the side region, the method comprising:

positioning the valve frame at the position of the heart; and

attaching a sewing member surrounding the valve frame at a region between the upstream end and the downstream end to tissue at the position of the heart.