Steerable kink-resistant sheath

• US 8,721,826 B2
• Filed: 11/19/2010
• Issued: 05/13/2014
• Est. Priority Date: 11/15/2002
• Status: Expired due to Fees

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Hart, Charles C., Brustad, John R., Hilal, Nabil, Kahle, Henry, Gadberry, Donald L.
• Primary Examiner(s): BELL, WILLIAM P
• Application Number:
  US12/950,782
• Publication Number:
  US 20110066105A1
• Time in Patent Office: 1,271 Days
• Field of Search: 156/173, 156/143, 156/145, 156/175, 156/144, 156/244.11, 604/524, 604/525, 604/526, 604/527
• US Class Current: 156/244.11
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: B29C 53/58 helically
• CPC Class Codes: B29C 63/18 using tubular layers or sheathings B29C63/26 and B29C63/38 take precedence; placing tubular labels around rigid containers B65C3/065
• CPC Class Codes: B29D 23/18 Pleated or corrugated hoses
• CPC Class Codes: B29K 2019/00 Use of rubber not provided for in a single one of main groups B29K2007/00 - B29K2011/00, as moulding material
• CPC Class Codes: B29K 2083/00 Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
• CPC Class Codes: B29L 2031/7546 Surgical equipment
• CPC Class Codes: B32B 1/08 Tubular products

Abstract

A steerable kink resistant access device is provided having an elongated body and a steerable portion; methods for manufacturing the kink resistant device are also provided. The access sheath has an outside diameter sufficiently small so that it may be inserted into a body cavity or conduit. The access sheath typically has two internal lumen, a first lumen sized and configured as an access to a surgical site and a second lumen sized and configured to contain a tensioning device that, when acted upon, will deflect the steerable portion. The tensioning device may be directly or remotely attached to an actuation device that operates to control the tensioning and loosening of the tensioning device.

Claims

1. A method of manufacturing a thin-walled tube having a distal steerable portion, comprising:

coating a wire with a plastic material;

wrapping the coated wire around a mandrel forming a plurality of windings;

forming a primary lumen within the first wire windings;

the primary lumen having a longitudinal axis;

placing a first tube having a secondary lumen and a longitudinal axis on the first wire windings so that the longitudinal axis of the secondary lumen is spaced apart from the longitudinal axis of the primary lumen and the first tube and secondary lumen extend further in length than the first wire windings and primary lumen along the mandrel to form a distal steerable portion;

heating the wound coated wire and first tube until the plastic material melts and bonds the windings forming a wire-reinforced tube having a primary lumen and a secondary lumen;

inserting a pull-wire into the secondary lumen;

removing the mandrel;

forming an outer layer of plastic around the windings and the first tube; and

winding a second wire to encompass the windings, first tube and outer layer;

wherein the step of heating the wound coated wire and first tube includes heating the outer layer to bond the first tube, coated wire and outer layer together.

2. The method of claim 1, further including the steps of:

inserting a second tube into the first tube; and

extending the first tube and the outer layer beyond the distal end of the wire windings and distal end of the second tube to form a distal steerable region.

3. The method of claim 1, further including the steps of:

inserting a second tube into the first tube; and

extending the second tube and the outer layer beyond the distal end of the wire windings and distal end of the first tube to form a distal steerable region.

4. The method of claim 1, wherein the wire comprises at least one of a metallic material and a second plastic material.

5. The method of claim 1, wherein the wire is coated with the plastic material in a coextrusion process.

6. The method of claim 1, wherein the step of heating the wound coated wire and the first tube includes heating the outer layer and second wire to bond the first tube, coated wire, second wire and outer layer together.

7. The method of claim 1, wherein the wound coated tube is heated until the plastic material is formed above, below and between all the windings.

8. The method of claim 1, further including the step of forming a secondary lumen within the first tube, the step includes inserting a support wire into the first tube.

9. The method of claim 1, further including the step of inserting a third tube into the first tube.

10. A method of manufacturing a thin-walled tube having a distal steerable portion, comprising:

coating a wire with a plastic material;

wrapping the coated wire around a mandrel forming a plurality of windings;

forming a primary lumen within the first wire windings;

the primary lumen having a longitudinal axis;

placing a first tube having a secondary lumen and a longitudinal axis on the first wire windings so that the longitudinal axis of the secondary lumen is spaced apart from the longitudinal axis of the primary lumen and the first tube and secondary lumen extend further in length than the first wire windings and primary lumen along the mandrel to form a distal steerable portion;

heating the wound coated wire and first tube until the plastic material melts and bonds the windings forming a wire-reinforced tube having a primary lumen and a secondary lumen;

inserting a pull-wire into the secondary lumen;

removing the mandrel; and

winding a second wire to encompass the windings and first tube.

11. The method of claim 10, wherein the plastic material comprises at least one of polyurethane, a thermoplastic material and a thermoset material.

12. The method of claim 10, wherein the wire comprises at least one of a metallic material and a second plastic material.

13. The method of claim 10, wherein the wire is coated with the plastic material in a coextrusion process.

14. The method of claim 10, further comprising compressing the windings as the coated wire is being heated.

15. The method of claim 10, wherein the wound coated tube is heated until the plastic material is formed above, below and between all the windings.

16. The method of claim 10, further comprising dipping the thin-walled tube in a solvent based solution forming an outer layer of the thin-walled tube.

17. The method of claim 10, wherein the mandrel is tapered to provide the thin-walled tube with varying diameter throughout the length of the thin-walled tube.

18. The method of claim 10, further including the step of forming a secondary lumen within the first tube, the step includes inserting a support wire into the first tube.

19. The method of claim 10, further including the step of inserting a third tube into the first tube.

20. The method of claim 10 wherein the step of heating the wound coated wire and first tube includes heating heating the second wire to bond the first tube, coated wire and second wire together.