INTRODUCER SHEATH WITH ENCAPSULATED REINFORCING MEMBER

• US 20100057051A1
• Filed: 08/26/2008
• Published: 03/04/2010
• Est. Priority Date: 08/26/2008
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Lentz, David Christian, Howat, William L.
• Granted Patent: US 8,343,136 B2
• Time in Patent Office: Days
• US Class Current: 604/526
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

An introducer sheath and a method for making the sheath. The sheath includes a fluoropolymer liner having a passageway extending longitudinally therethrough. An inner jacket is positioned longitudinally over the liner, and the inner surface of the inner jacket is bonded to the outer surface of the liner. An outer jacket is positioned longitudinally over the inner jacket, and the inner surface of the outer jacket is bonded to the outer surface of the inner jacket. A reinforcing coil is encapsulated within the inner jacket and the outer jacket.

Claims

1. An introducer sheath comprising:

a liner having a passageway extending longitudinally therethrough, said liner having an outer surface;

an inner jacket positioned longitudinally over said liner, said inner jacket having an inner surface and an outer surface, said inner surface engaged with said outer surface of said liner;

an outer jacket positioned longitudinally over said inner jacket, said outer jacket having an inner surface bonded to said outer surface of said inner jacket; and

a reinforcing member encapsulated in said inner jacket and said outer jacket.

2. The introducer sheath of claim 1, wherein said reinforcing member comprises a coil.

3. The introducer sheath of claim 2, wherein said reinforcing member comprises a flat wire coil.

4. The introducer sheath of claim 2, wherein said inner jacket extends substantially the length of said liner outer surface, said inner jacket having a wall thickness between about 0.0001 and 0.001 inch (0.0025 and 0.025 mm).

5. The introducer sheath of claim 4, wherein said inner jacket has a generally constant wall thickness of about 0.001 inch (0.025 mm) along said length.

6. The introducer sheath of claim 1, wherein said liner comprises a lubricious fluoropolymer, said inner jacket and outer jacket comprise at least one of a polyether block amide, nylon, and polyurethane, and said reinforcing member comprises a flat wire coil.

7. The introducer sheath of claim 6, wherein said lubricious fluoropolymer comprises PTFE.

8. The introducer sheath of claim 6, wherein said inner jacket and said outer jacket are formed from the same polymer composition.

9. The introducer sheath of claim 1, wherein said outer surface of said inner liner is roughened, and said inner jacket is bonded to said roughened outer surface.

10. The introducer sheath of claim 1, wherein the reinforcing member is completely encapsulated within the inner jacket and the outer jacket.

11. A method for forming an introducer sheath, comprising:

providing an inner liner, said inner liner having a passageway extending therethrough, and having an outer surface;

applying a solution comprising a polymer dissolved in a solvent to said outer surface of said inner liner;

evaporating the solvent, leaving a layer of the polymer on the outer surface of the inner liner, said layer comprising an inner polymer layer;

positioning a reinforcing member around the inner polymer layer;

applying an outer polymer layer over the reinforcing member; and

exposing an assembly comprising the mandrel, inner polymer layer, reinforcing member and outer polymer layer to sufficient heat to at least partially melt the inner polymer layer and outer polymer layer such that a bond is formed therebetween, and such that said inner polymer layer is bonded to said liner outer surface, said reinforcing member being encapsulated within said inner and outer polymer layers.

12. The method of claim 11, wherein said inner liner is positioned over a mandrel when said solution is applied thereto, said solution being applied to said liner outer surface by at least one of submersion of the liner and mandrel into the solution, spraying the solution onto the outer surface of the liner, and coating the solution on the outer surface of the liner.

13. The method of claim 12, wherein said layer of polymer on the outer surface of the inner liner has a thickness between about 0.0001 and 0.001 inch (0.0025 and 0.025 mm) after evaporation of the solvent.

14. The method of claim 13, wherein said thickness is about 0.001 inch (0.025 mm).

15. The method of claim 12, wherein said liner comprises a lubricious fluoropolymer having a roughened outer surface, and said inner polymer layer bonds with said roughened outer surface upon said exposure to heat.

16. The method of claim 12, wherein said dissolved polymer comprises at least one of a polyether block amide, nylon, and polyurethane.

17. The method of claim 16, wherein said inner liner comprises a fluoropolymer, and said solvent comprises a non-polar solvent.

18. The method of claim 16, wherein said solvent comprises a phenolic solvent.

19. The method of claim 12, wherein each of said inner and outer polymer layer comprises at least one of a polyether block amide, nylon, and polyurethane, and wherein said reinforcing member comprises a helical coil.

20. An introducer sheath comprising:

a lubricious liner formed of PTFE, said liner having a passageway extending longitudinally therethrough, said liner having a roughened outer surface;

an inner jacket formed of a polyether block amide, nylon, or polyurethane, said inner jacket positioned longitudinally over said lubricious liner, said inner jacket having an inner surface and an outer surface, said inner surface bonded to said roughened outer surface of said liner, said inner jacket having a thickness of about 0.001 inch (0.025 mm);

an outer jacket formed of the same composition as said inner jacket, said outer jacket positioned longitudinally over said inner jacket, said outer jacket having an inner surface bonded to said outer surface of said inner jacket; and

a flat wire coil having a length, said flat wire coil encapsulated in said inner jacket and said outer jacket along said length.