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

• US 5,925,063 A
• Filed: 09/26/1997
• Issued: 07/20/1999
• 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): Buiz, Michael
• Assistant Examiner(s): PHAM, THUY D
• Application Number:
  US08/942,033
• Time in Patent Office: 662 Days
• Field of Search: 606/191, 606/200, 606/198, 606/157, 606/158, 606/213, 606/151, 623/12
• 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. Apparatus implantable within a body vessel or organ, the apparatus comprising:

a tubular member having an interior surface defining a lumen, the tubular member comprising a rolled sheet having a longitudinal edge, the tubular member having a reduced diameter for transluminal delivery wherein the sheet is coiled to form overlapping turns, and an expanded diameter when deployed in the body vessel or organ; and

a plurality of flaps disposed circumferentially adjacent to one another from the interior surface of the tubular member, each one of the flaps defining a substantially planar or curvilinear surface having side edges, the flaps projecting radially inward into the lumen so that the side edges overlap when the tubular member is in the deployed state.

2. The apparatus as defined in claim 1 wherein the plurality of flaps lie parallel to a longitudinal axis of the tubular member when the tubular member is contracted to the reduced diameter.

3. The apparatus as defined in claim 1 wherein the plurality of flaps comprise a fluid permeable mesh and span a cross-section of the lumen to form a filter.

4. The apparatus as defined in claim 3 further comprising a coating of an anti-thrombogenic agent disposed on the plurality of flaps.

5. The apparatus as defined in claim 1 wherein the plurality of flaps comprise a fluid impermeable material and span a cross-section of the lumen to occlude the lumen.

6. The apparatus as defined in claim 5 further comprising an coating of a thrombogenic agent disposed on the plurality of flaps.

7. The apparatus as defined in claim 1 wherein each one of the plurality of flaps has a tip and comprises a fluid impermeable material, the plurality of flaps arranged so that they do not span a cross-section of the lumen, the tips of the plurality of flaps defining an aperture that regulates flow through the lumen.

8. The apparatus as defined in claim 1 wherein each one of the plurality of flaps comprises a resilient material capable of deflecting, the plurality of flaps forming a valve that opens when a pressure differential across the flaps exceeds a predetermined value.

9. The apparatus as defined in claim 1 wherein each one of the plurality of flaps comprises a resilient material capable of deflecting, the plurality of flaps forming a valve that opens when the flow of biological fluids moves in a first direction, and closes when the biological fluid moves in a second direction opposite to the first direction.

10. The apparatus as defined in claim 1 wherein the flaps have a trapezoidal shape.

11. The apparatus as defined in claim 1 wherein each one of the plurality of flaps includes cut-out areas near a point of attachment of the flap to the tubular member and a portion of the flap includes an edge that approximates a curvature of the tubular member when deployed.

12. The apparatus as defined in claim 1 wherein the sheet comprises a nickel-titanium alloy.

13. The apparatus as defined in claim 1 wherein the sheet has first and second longitudinal edges, a plurality of teeth arranged along the first longitudinal edge and a plurality of openings arranged along the second longitudinal edge, the plurality of teeth engaging the plurality of openings in the second longitudinal edge when the tubular member is deployed.

14. Apparatus implantable within a body vessel or organ to provide a therapeutic result, the apparatus comprising:

a tubular member having an interior surface defining a lumen, the tubular member formed by rolling a sheet having first and second longitudinal edges, a plurality of teeth arranged along the first longitudinal edge and a plurality of openings arranged along the second longitudinal edge, the tubular member having a contracted state of reduced diameter for transluminal delivery wherein the sheet is rolled to form a series of overlapping turns, and a deployed state of expanded diameter wherein the plurality of teeth engage the plurality of openings in the second longitudinal edge; and

a plurality of flaps disposed from the interior surface of the tubular member, the flaps projecting radially inward into the lumen when the tubular member is in the deployed state.

15. The apparatus as defined in claim 14 wherein the plurality of flaps lie parallel to a longitudinal axis of the tubular member when the tubular member is in the contracted state.

16. The apparatus as defined in claim 14 wherein the vessel or organ forms a flowpath for a biological fluid, and wherein the plurality of flaps comprise a fluid permeable mesh and collectively span a cross-section of the lumen, so that when the apparatus is deployed in the flowpath, the apparatus provides a therapeutic result by filtering the biological fluid.

17. The apparatus as defined in claim 14 wherein the vessel or organ forms a flowpath for a biological fluid, and wherein the plurality of flaps comprise a fluid impermeable material and collectively span a cross-section of the lumen, so that when the apparatus is deployed in the flowpath, the apparatus provides a therapeutic result by occluding the flowpath of the biological fluid.

18. The apparatus as defined in claim 14 wherein the vessel or organ forms a flowpath for a biological fluid, and wherein each one of the plurality of flaps has a tip and comprises a fluid impermeable material, the plurality of flaps arranged so that they collectively do not span a cross-section of the lumen, the tips of the plurality of flaps defining an aperture, so that when the apparatus is deployed in the flowpath, the apparatus provides a therapeutic result by reducing flow of the biological fluid.

19. The apparatus as defined in claim 14 wherein the vessel or organ forms a flowpath for a biological fluid, and wherein each one of the plurality of flaps comprises a resilient material capable of deflecting, the plurality of flaps forming a valve that opens when a pressure differential across the flaps exceeds a predetermined value, so that when the apparatus is deployed in the flowpath, the apparatus provides a therapeutic result by regulating flow of the biological fluid.

20. The apparatus as defined in claim 14 wherein the vessel or organ forms a flowpath for a biological fluid, and wherein each one of the plurality of flaps comprises a resilient material capable of deflecting, the plurality of flaps forming a valve that opens when the flow of biological fluids moves in a first direction, and closes when the biological fluid moves in a second direction opposite to the first direction, so that when the apparatus is deployed in the flowpath, the apparatus provides a therapeutic result by regulating flow of the biological fluid.