Elliptical implantable device

• US 20070027528A1
• Filed: 07/26/2006
• Published: 02/01/2007
• Est. Priority Date: 07/29/2005
• Status: Abandoned Application

• Current Assignee: Cook Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Agnew, Charles
• Application Number:
  US11/493,061
• Publication Number:
  US 20070027528A1
• Time in Patent Office: Days
• US Class Current: 623/1.240
• 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 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Elliptical prosthetic valve devices are provided. The prosthetic valve device can include an elliptical support means having an elliptical cross-sectional shape and having an opening for fluid flow therethrough. The elliptical support is preferably characterized by a first radial axis and a second, shorter radial axis perpendicular thereto. A flexible valve member, such as a tube member portion or valve leaflet, can be operably connected to the elliptical support and the flexible member is adapted for regulating fluid flow through the opening. An attachment portion is desirably operably connected to the elliptical support for implanting the valve in the body vessel.

Claims

1. An elliptical prosthetic valve comprising:

an elliptical support means having a longitudinal axis, an interior surface and an outer surface, the interior surface defining an internal lumen containing the longitudinal axis, the elliptical support means configured to conduct fluid flow through the internal lumen, and the outer surface having an elliptical cross-sectional shape, the outer surface intersecting a first radial axis at a first distance and intersecting a second radial axis perpendicular to the first radial axis at a second distance that is less than the first distance, the first radial axis and the second radial axis being perpendicular to the longitudinal axis;

wherein the elliptical support means comprises an elliptical ring comprising a first pair of collapse points positioned at the points of intersection of the first radial axis with the elliptical ring;

the elliptical ring moveable from a planar configuration bisected by a first plane containing the first radial axis and the second radial axis, to a bent configuration by bending the planar elliptical ring at the first pair of collapse points while moving the points of intersection of the elliptical ring with the second radial axis out of the first plane; and

a means for regulating fluid flow through the internal lumen, the means for regulating fluid flow being attached to the elliptical ring.

2. The elliptical prosthetic valve of claim 1, wherein the elliptical ring further comprises a second pair of collapse points positioned at the points of intersection of the second radial axis with the elliptical ring.

3. The elliptical prosthetic valve of claim 1, wherein the elliptical support means further comprises a reinforcing frame portion bridging the points of intersection of the elliptical ring with the first radial axis and symmetrically bisected by a plane containing the longitudinal axis and first radial axis.

4. The elliptical prosthetic valve of claim 3, wherein each of the first pair of collapse points comprises a hinge in the planar elliptical ring.

5. The elliptical prosthetic valve device of claim 3, wherein the elliptical ring comprises a second pair of collapse points positioned at the points of intersection of the second radial axis with the elliptical support.

6. The elliptical prosthetic valve device of claim 1, where the elliptical prosthetic valve further comprises a support frame attached to the elliptical ring.

7. The elliptical prosthetic valve device of claim 1, further comprising at least one imageable element on said valve.

8. The elliptical prosthetic valve of claim 1, wherein the means for regulating fluid flow comprises a tubular flexible valve member defining a tubular lumen extending from an inlet end attached to the elliptical ring to a tapered end, the tubular lumen being contiguous with the internal lumen, the tubular lumen containing the longitudinal axis, and the tapered end defining a valve orifice having a cross sectional area that is less than the cross sectional area of the elliptical ring.

9. The elliptical prosthetic valve of claim 1, wherein the means for regulating fluid flow comprises a flexible valve leaflet attached to the elliptical ring, the flexible valve leaflet defining a valve orifice contiguous with the internal lumen, the valve orifice having an open configuration permitting fluid flow in a first direction along the longitudinal axis out of the internal lumen and a closed configuration substantially preventing fluid flow from entering the internal lumen along the longitudinal axis, the flexible valve leaflet being moveable relative to the elliptical ring in response to the fluid flow within the internal lumen contacting the flexible valve leaflet.

10. The elliptical prosthetic valve device of claim 9, wherein said flexible valve leaflet comprises a biocompatible polyurethane.

11. The elliptical prosthetic valve device of claim 8, wherein said tubular flexible valve member comprises small intestine submucosa.

12. The elliptical prosthetic valve device of claim 9, wherein said flexible valve leaflet comprises small intestine submucosa.

14. The elliptical prosthetic valve device of claim 9, wherein the elliptical support means is a planar elliptical ring bisected by a plane containing the first radial axis and the second radial axis.

15. A prosthetic valve device comprising:

an elliptical support ring bisected by a plane containing a first radial axis and a second radial axis perpendicular thereto;

said elliptical support ring further comprising a pair of collapse points aligned with one of said first axis or said second axis, the elliptical support ring comprising an attachment portion;

wherein said second radial axis is shorter than said first radial axis and wherein said attachment portion is adapted for securing said valve in a body vessel; and

at least one flexible valve leaflet operably connected to said elliptical support ring, the valve leaflet comprising a material selected from the group consisting of;

a biocompatible polyurethane and an extracellular matrix material.

16. The prosthetic valve device of claim 15, wherein the collapse points comprise a bioabsorbable material and dissipation of the bioabsorbable material increases the flexibility of the collapse points.

17. The prosthetic valve device of claim 15, wherein the attachment portion comprises an extracellular matrix material.

18. An elliptical prosthetic valve comprising:

an elliptical support ring having a longitudinal axis, an interior surface and an outer surface, the interior surface defining an internal lumen containing the longitudinal axis, the elliptical support ring configured to conduct fluid flow through the internal lumen, and the outer surface having an elliptical cross-sectional shape, the outer surface intersecting a first radial axis at a first distance and intersecting a second radial axis perpendicular to the first radial axis at a second distance that is less than the first distance, the first radial axis and the second radial axis being perpendicular to the longitudinal axis;

the elliptical support ring bisected by a plane containing the first radial axis and the second radial axis, the elliptical support ring comprising a first pair of collapse points positioned at the points of intersection of the first radial axis with the elliptical support ring; and

a flexible valve leaflet attached to the elliptical support ring, the flexible valve leaflet defining at least a portion of a valve orifice contiguous with the internal lumen, the valve orifice having an open configuration permitting fluid flow in a first direction along the longitudinal axis out of the internal lumen and a closed configuration substantially preventing fluid flow from entering the internal lumen along the longitudinal axis, the flexible valve leaflet being moveable relative to the elliptical support ring in response to the fluid flow contacting the flexible valve leaflet.

19. The elliptical prosthetic valve of claim 18, wherein the elliptical support ring is moveable from a planar configuration to a bent configuration by bending the planar elliptical ring at the first pair of collapse points while moving the points of intersection of the planar elliptical ring with the second radial axis out of the plane containing the first radial axis and the second radial axis.

20. The elliptical prosthetic valve of claim 18, further comprising a second flexible valve leaflet attached to the elliptical support ring, being configured and positioned to cooperatively define at least a portion of the value orifice, the value leaflets each comprising an extracellular matrix material.