Artificial valve prosthesis with improved flow dynamics

• US 8,221,492 B2
• Filed: 04/21/2004
• Issued: 07/17/2012
• Est. Priority Date: 04/24/2003
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian C., Garrison, Michael L., Hoffa, Andrew, Schaeffer, Darin G., Flagle, Jacob A.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Wolf, Megan
• Application Number:
  US10/554,494
• Publication Number:
  US 20070260327A1
• Time in Patent Office: 3,009 Days
• Field of Search: 623/1.24, 623/2.1, 623/2.12, 623 214- 219, 623/23.68
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

An expandable venous valve having a support structure that configured to enlarge the area adjacent to the valve structure such that the flow patterns of retrograde flow are modified in a way that facilitates the flushing of the pockets at the base of the valve area to prevent stagnation of bodily fluid, which in the venous system, can lead to thrombus formation. The enlarged pocket areas can be created by forming an artificial sinus adjacent the valve structure in an unsupported section of vessel wall between two support frame section or the support frame can comprise an expanded-diameter intermediate or proximal section that forms an artificial sinus adjacent the valve structure. In another group of embodiments, the attachment pathway between opposing leaflets and the support frame and/or vessel wall comprises a proximal portion that places the leaflets in extended contact with one another and a distal portion forms a large angle with respect to the adjacent walls such that a large pocket is created at the base of the leaflets. In one embodiment, the attachment pathway extends distally along a pair of substantially parallel longitudinal attachment struts to create an extended leaflet contact area, then angles circumferentially and distally from the former along distal attachment struts to define the bottom edge of the leaflets.

Claims

1. A valve prosthesis for deployment in a bodily passage, said valve prosthesis having a longitudinal axis, a prosthesis length, and comprising:

a support structure having at least one longitudinal attachment strut generally aligned with said longitudinal axis and at least one distal attachment strut extending at an angle to said longitudinal axis; and

a valve structure comprising a first leaflet having first proximal and first distal portions, first and second outer lateral edges, a first free inner edge, and a first inner surface extending from the first outer lateral edge to the second outer lateral edge and including the first free inner edge, and a second leaflet having second proximal and second distal portions, third and fourth outer lateral edges, a second free inner edge, and a second inner surface extending from the third outer lateral edge to the fourth outer lateral edge and including the second free inner edge, the first and second proximal portions attached to the at least one longitudinal attachment strut and cooperatively defining a leaflet contact area comprising a longitudinal portion along the valve structure having a length that is greater than or equal to 10% of said prosthesis length and in which the first and second inner surfaces coapt from the first and third outer lateral edges to the second and fourth outer lateral edges while the valve structure is in a resting state, the first and second distal portions attached to the at least one distal attachment strut.

2. A valve prosthesis according to claim 1, wherein the leaflet contact area has a length that is between 10 and 80% of said prosthesis length.

3. A valve prosthesis according to claim 1, wherein the leaflet contact area has a length that is between 30 and 60% of said prosthesis length.

4. A valve prosthesis according to claim 1, wherein the leaflet contact area has a length that is between 35 and 55% of said prosthesis length.

5. A valve prosthesis according to claim 1, wherein the leaflet contact area has a length that is greater than 50% of said prosthesis length.

6. A valve prosthesis according to claim 1, wherein the at least one longitudinal attachment strut comprises first and second longitudinal attachment struts disposed on opposite sides of the support structure.

7. A valve prosthesis according to claim 1, wherein the at least one longitudinal attachment strut comprises first and second pairs of longitudinal attachment struts disposed on opposite sides of the support structure.

8. A valve prosthesis according to claim 7, wherein the first pair of longitudinal attachment struts comprises first and second members and the second pair of longitudinal attachment struts comprises third and fourth members;

and

wherein the first proximal portion is attached to the first and third members and the second proximal portion is attached to the second and fourth members.

9. A valve prosthesis according to claim 7, wherein at least one of the first and second pairs of longitudinal attachment struts defines an elongate closed cell in the support structure.

10. A valve prosthesis according to claim 9, wherein a portion of at least one of the first and second proximal portions is disposed in the elongate closed cell.

11. A valve prosthesis according to claim 9, wherein a portion of the first proximal portion and a portion of the second proximal portion are disposed in the elongate closed cell.

12. A valve prosthesis according to claim 1, wherein the at least one distal attachment strut comprises an extension of the at least one longitudinal attachment strut.

13. A valve prosthesis according to claim 1, wherein the at least one distal attachment strut extends laterally outward from the at least one longitudinal attachment strut.

14. A valve prosthesis according to claim 1, wherein the at least one longitudinal attachment strut and the at least one distal attachment strut define a leaflet attachment pathway that includes an obtuse angle.

15. A valve prosthesis for deployment in a bodily passage, said valve prosthesis having a longitudinal axis, a prosthesis length, and comprising:

a support structure having first and second longitudinal attachment struts and first and second distal attachment struts, the longitudinal attachment struts being generally aligned with said longitudinal axis and disposed on opposite sides of the support structure and each of the first and second distal attachment struts extending at an angle to said longitudinal axis; and

a valve structure comprising a first leaflet having first proximal and first distal portions, first and second outer lateral edges, a first free inner edge, and a first inner surface extending from the first outer lateral edge to the second outer lateral edge and including the first free inner edge, and a second leaflet having second proximal and second distal portions, third and fourth outer lateral edges, a second free inner edge, and a second inner surface extending from the third outer lateral edge to the fourth outer lateral edge and including the second free inner edge, the first and second proximal portions attached to the first and second longitudinal attachment struts and cooperatively defining a leaflet contact area comprising a longitudinal portion along the valve structure having a length that is greater than or equal to 10% of said prosthesis length and in which the first and second inner surfaces coapt from the first and third outer lateral edges to the second and fourth outer lateral edges while the valve structure is in a resting state, each of the first and second distal portions attached to one of the first and second distal attachment struts.

16. A valve prosthesis according to claim 15, wherein the leaflet contact area has a length that is between 10 and 80% of said prosthesis length.

17. A valve prosthesis according to claim 15, wherein the leaflet contact area has a length that is between 30 and 60% of said prosthesis length.

18. A valve prosthesis according to claim 15, wherein the leaflet contact area has a length that is between 35 and 55% of said prosthesis length.

19. A valve prosthesis according to claim 15, wherein the leaflet contact area has a length that is greater than 50% of said prosthesis length.