Valve apparatus, system and method

• US 7,867,274 B2
• Filed: 02/23/2005
• Issued: 01/11/2011
• Est. Priority Date: 02/23/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Hill, Jason P., Drasler, William J., Shoemaker, Susan M.
• Primary Examiner(s): Matthews; William H
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US11/063,681
• Publication Number:
  US 20060190074A1
• Time in Patent Office: 2,148 Days
• Field of Search: 623 123- 126, 623/2.17, 623/2.16
• US Class Current: 623/1.24
• 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 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: Y10T 137/0402 Cleaning, repairing, or assembling
• CPC Class Codes: Y10T 29/49405 Valve or choke making

Abstract

A venous valve with a frame and a cover on the frame for unidirectional flow of a liquid through the valve.

Claims

1. A valve, comprising:

a frame having an inner frame surface, an outer frame surface opposite the inner frame surface, a first leaflet connection a second leaflet connection region, a tubular radial support member that includes a first frame end and extends from the first leaflet connection region and the second leaflet connection region, a tubular ring that includes a second frame end, a first member, a second frame member, a third frame member, and a fourth frame member, where the frame members define openings across the frame and each of the frame members immediately extend from the tubular ring towards the tubular radial support member such that the first frame member merges with the second frame member to form the first leaflet connection region and the third frame member merges with the fourth frame member to form the second leaflet connection region, where the first leaflet connection region and the second leaflet connection region immediately extend from the tubular radial support member; and

a frame cover having integrated flexible support members, a frame cover interior, a frame cover exterior opposite the frame cover interior, a first frame cover terminus proximate to the first frame end, a second frame cover terminus proximate to the second frame end where the frame cover provides;

a first leaflet coupled to the first leaflet connection region and the second leaflet connection region;

a second leaflet coupled to the first leaflet connection region and the second leaflet connection region, where the first leaflet and the second leaflet have surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve and where the first valve leaflet and the second valve leaflet pass through the openings defined by the frame members to radially-expand and radially-collapse; and

an area defined by the frame cover exterior at the second frame cover terminus that is less than an area defined by the inner frame surface at the second frame end and less than an area defined by the frame cover at the first frame cover terminus so as to provide a space between the frame cover exterior at the second frame cover terminus and the inner frame surface of the radial support member when the frame cover is in an open position.

2. The valve of claim 1, wherein the first leaflet and the second leaflet are formed of a first material and the integrated flexible support members are formed of a second material.

3. The valve of claim 2, wherein the integrated flexible support members are laminated between at least two layers of the first material.

4. The valve of claim 3, wherein the first material of the first leaflet and the second leaflet includes a thermoplastic.

5. The valve of claim 1, wherein the first leaflet and the second leaflet include a predetermined shape and the flexible support members stabilize the predetermined shape in the first leaflet and the second leaflet.

6. The valve of claim 1, wherein the second material of the integrated flexible support members includes spun-fibers of a ceramic.

7. The valve of claim 6, wherein the ceramic includes basalt.

8. The valve of claim 1, wherein the integrated flexible support members are oriented to provide circumferential support to the first leaflet and the second leaflet.

9. The valve of claim 8, wherein the integrated flexible support members are in a configuration selected from the group consisting of woven, matted, coiled, rings, braided and knitted.

10. The valve of claim 1, wherein the first leaflet has a first leaflet first major face on the frame cover interior and a first leaflet second major face on the frame cover exterior and the second leaflet has a second leaflet first major face on the frame cover interior and a second leaflet second major face on the frame cover exterior, such that when the valve is in the open position:

a first space is present between the inner surface of the tubular radial support member and the first leaflet second major face, so that a line perpendicular to the longitudinal axis of the frame that passes through the first space and the first leaflet second major face passes through the frame cover at only two points; and

second space is present between the inner surface of the tubular radial support member and the second leaflet second major face, so that a line perpendicular to the longitudinal axis of the frame that passes through the second space and the second leaflet major face passes through the frame cover at only two points.