PROSTHETIC VALVES AND ASSOCIATED APPARTUSES, SYSTEMS AND METHODS

• US 20140330371A1
• Filed: 05/02/2014
• Published: 11/06/2014
• Est. Priority Date: 05/03/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gloss, Michael, Majkrzak, Carolyn, Rust, Matthew, Ryan, Timothy, Groen, Timothy, Weston, Matthew
• Granted Patent: US 9,375,311 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A valve prosthesis includes an expandable frame comprising an outflow portion and an inflow portion connected to the outflow portion. The frame defines a central lumen extending between the outflow portion and the inflow portion. The frame is generally cylindrical in a fully expanded configuration. When the frame is in the fully expanded configuration, an outer surface of the inflow portion is concave. The inflow portion has an upper inflow portion and a lower inflow portion. When the frame is in the fully expanded configuration, the upper inflow portion flares outwardly from the central lumen of the frame to greater extent than the lower inflow portion.

Claims

1. A valve prosthesis comprising:

an expandable frame comprising an outflow portion and an inflow portion connected to the outflow portion, the frame defining a central lumen extending between the outflow portion and the inflow portion, wherein the frame is generally cylindrical in a fully expanded configuration,

wherein, when the frame is in a fully expanded configuration, an outer surface of the inflow portion is concave, wherein the inflow portion has an upper inflow portion and a lower inflow portion, and wherein, when the frame is in the fully expanded configuration, the upper inflow portion flares outwardly from the central lumen of the frame to greater extent than the lower inflow portion.

2. A valve prosthesis according to claim 1, wherein the inflow portion of the frame further comprises a waist between the upper inflow portion and lower inflow portion, wherein the frame in the fully expanded configuration has a longitudinal axis, wherein the upper inflow portion flares outwardly away from the longitudinal axis at an angle that is greater than an angle at which the lower inflow portion flares.

3. A valve prosthesis according to claim 2, wherein the upper inflow portion flares outwardly from the longitudinal axis of the frame at an angle from about 40°

to about 60°

, and wherein the lower inflow portion flares outwardly from the longitudinal axis of the frame at an angle from about 10°

to about 30°

.

4. A valve prosthesis according to claim 2, wherein the upper inflow portion flares outwardly from the longitudinal axis of the frame at an angle from about 45°

to about 55°

, and wherein the lower inflow portion flares outwardly from the longitudinal axis of the frame at an angle from about 15°

to about 25°

.

5. A valve prosthesis according to claim 1, wherein the inflow portion of the frame further comprises a waist between the upper inflow portion and lower inflow portion, wherein the upper outflow portion forms an upper outflow edge defining a circumference and the lower outflow portion forms a lower edge defining a circumference, wherein the diameter of the upper inflow edge is from about 115% to about 135% of a diameter of the inflow waist and wherein the diameter of the lower inflow edge is from about 105% to about 120% of the diameter of the waist, provided that the diameter of the upper inflow edge is greater than the diameter of the lower inflow edge.

6. A valve prosthesis according to claim 5, wherein the upper inflow edge is from about 120% to about 130% of the diameter of the inflow waist and wherein the diameter of the lower inflow edge is from about 108% to about 117% of the diameter of the waist, provided that the diameter of the upper inflow edge is greater than the diameter of the lower inflow edge.

7. A valve prosthesis according to claim 1, wherein the upper outflow portion of the frame forms an upper outflow edge defining a circumference and the lower outflow portion forms a lower edge defining a circumference, wherein the diameter of the upper inflow edge is from about 105% to about 115% of the diameter of the lower inflow edge.

8. A valve prosthesis according to claim 1, wherein the inflow portion of the frame comprises a waist between the lower inflow portion and the upper inflow portion, and wherein the inflow region comprises a plurality of closed cells, wherein each cell is connected to an adjacent cell along the waist.

9. A valve prosthesis according to claim 1, wherein the outflow portion of the frame has an upper portion flared inwardly towards the central lumen.

10. A valve prosthesis according to claim 9, wherein the outflow portion of the frame has a lower portion and a middle portion that together are generally cylindrical, wherein the upper outflow portion defines an edge defining a circumference, and wherein the diameter of the edge of the upper outflow portion is from about 75% to about 97% of the diameter of the middle and lower outflow portions.

11. A valve prosthesis according to claim 10, wherein the diameter of the edge of the upper outflow portion is from about 80% to about 95% of the diameter of the middle and lower outflow portions.

12. A valve prosthesis according to claim 1, wherein the outflow portion comprises (i) an undulating upper outflow portion having peaks and valleys, (ii) an undulating middle outflow portion having peaks and valleys, and (iii) an undulating lower outflow portion having peaks and valleys, wherein the valleys of the undulating upper outflow portion are connected to the peaks of the undulating middle inflow portion, and wherein the valleys of the undulating middle outflow portion are connected to the peaks of the undulating lower outflow portion.

13. A valve prosthesis according to claim 12, wherein the height of the upper outflow portion is greater than the height of the lower outflow portion, and wherein the height of the upper outflow portion is less than the height of the middle outflow portion.

14. A valve prosthesis according to claim 12, wherein the inflow portion has a waist between the lower inflow portion and the upper inflow portion, wherein the lower inflow portion comprises a plurality of closed cells connected along the waist, and wherein the valleys of the undulating lower outflow portion are connected to the inflow portion along the waist between the closed cells.

15. A valve prosthesis according to claim 14, wherein the valleys of the undulating lower outflow portion are connected to the inflow portion along the waist via posts.

16. A valve prosthesis according to claim 1, wherein the frame comprises a plurality of enclosed wire form cells interconnected with one another.

17. A valve prosthesis according to claim 1, wherein the frame is a self-expanding frame.

18. A valve prosthesis according to claim 1, further comprising a valve body comprising a plurality of leaflets affixed to a skirt, wherein adjoining leaflets are affixed together to form commissures, and wherein the valve body is disposed in the central lumen of the frame and the commissures are affixed to the outflow portion.