Coiled sheet valve, filter or occlusive device and methods of use

• US 6,221,091 B1
• Filed: 05/25/1999
• Issued: 04/24/2001
• Est. Priority Date: 09/26/1997
• Status: Expired due to Term

• Current Assignee: Endotex Interventional Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Incept LLC
• Inventors: Khosravi, Farhad
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): Goldberg, Jonathan D.
• Application Number:
  US09/318,492
• Time in Patent Office: 700 Days
• Field of Search: 606/200, 606/190-198, 623/1.12, 623/1.24-1.26, 623/2.13-2.19, 623/23.64-23.7, 623/2, 3/1.5
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

Apparatus is provided comprising a coiled sheet having a plurality of flaps mounted on its interior surface that project radially inward into a lumen formed by the interior surface of the apparatus when it is deployed. The flaps lie parallel to the interior surface of the sheet during transluminal delivery, but project radially inward once the apparatus is deployed. The flaps may comprise a fine mesh for use as a filter, or alternatively may be covered with a biocompatible material that is substantially impermeable, so as to partially or completely occlude the lumen. In a further alternative embodiment, the flaps may comprise a resilient biocompatible plastic or polymer, so that the flaps move in response to the flow and function as a pressure-based or directional valve.

Claims

1. A method of altering flow through a vessel or body organ, the method comprising:

providing apparatus comprising a sheet having an interior surface, and a plurality of flaps disposed from the interior surface;

providing a delivery device comprising a sheath with a lumen, a shaft with an exterior surface, and an inflatable balloon disposed around the exterior surface of the shaft, the shaft and inflatable balloon disposed within the lumen;

rolling the sheet to form a tubular member in a delivery state of reduced diameter suitable for transluminal delivery, the interior surface defining a lumen of the tubular member, the flaps lying substantially parallel to the lumen;

placing the tubular member in the delivery state within the lumen and around an exterior surface of the balloon;

positioning the delivery device in the vessel or organ percutaneously and transluminally; and

expanding the apparatus, the tubular member assuming a deployed state of expanded diameter wherein the tubular member sealingly engages an interior wall of the vessel or organ, the flaps projecting radially inward into the lumen to alter flow through the vessel or organ.

2. The method of claim 1, wherein expanding the apparatus comprises retracting the sheath proximally to radially expand the tubular member to the deployed state.

3. The method of claim 1 further comprising:

inflating the balloon so that the tubular member sealingly engages the interior wall;

deflating the balloon; and

removing the delivery device from the vessel or organ, the flaps projecting radially inward.

4. The method of claim 3, wherein the sheet comprises first and second longitudinal edges, a plurality of teeth arranged along the first edge, and a plurality of openings arranged along the second edge.

5. The method of claim 4, wherein inflating the balloon further comprises engaging the plurality of openings with the plurality of teeth.

6. The method of claim 1, wherein the plurality of flaps comprise a fluid permeable mesh.

7. The method of claim 6, wherein expanding the apparatus further comprises:

spanning a cross section of the lumen of the tubular member with the plurality of flaps; and

filtering flow through the vessel or organ with the fluid permeable mesh.

8. The method of claim 7, wherein providing apparatus further comprises providing a coating of an anti-thrombogenic agent, the coating disposed on the plurality of flaps.

9. The method of claim 1, wherein the plurality of flaps comprise a fluid impermeable material.

10. The method of claim 9, wherein expanding the apparatus further comprises:

spanning a cross section of the lumen of the tubular member with the plurality of flaps; and

occluding flow through the vessel or organ with the fluid impermeable material.

11. The method of claim 10, wherein providing apparatus further comprises providing a coating of an anti-thrombogenic agent, the coating disposed on the plurality of flaps.

12. The method of claim 11, wherein expanding the apparatus further comprises:

defining an aperture with the plurality of flaps, the aperture having a smaller diameter than the expanded diameter of the lumen of the tubular member; and

regulating flow through the vessel or organ with the tips of the flaps.

13. The method of claim 9, wherein each of the plurality of flaps has a tip.

14. The method of claim 1 wherein the plurality of flaps comprise a resilient material capable of deflecting.

15. The method of claim 14, wherein expanding the apparatus further comprises forming a valve with the plurality of flaps, the valve opening when flow through the vessel or organ moves in a first direction and closing when flow moves in a second direction opposite the first direction.

16. The method of claim 1, wherein the flaps have a trapezoidal shape.

17. The method of claim 1, wherein:

each of the plurality of flaps has cut out areas near a point of attachment of the flap to the sheet; and

expanding the apparatus further comprises aligning the cutout areas along a curvature of the tubular member.

18. The method of claim 1, wherein the sheet comprises a nickel-titanium alloy.

19. The method of claim 1, wherein the sheet comprises first and second longitudinal edges, a plurality of teeth arranged along the first edge, and a plurality of openings arranged along the second edge.

20. The method of claim 19, wherein expanding the apparatus further comprises engaging the plurality of openings with the plurality of teeth.