INTRODUCER SHEATH HAVING PROFILED REINFORCING MEMBER

• US 20140046138A1
• Filed: 08/08/2012
• Published: 02/13/2014
• Est. Priority Date: 08/08/2012
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Merk, James C., Hiatt, Mark J., Baker, Melissa Dawn
• Granted Patent: US 9,393,380 B2
• Time in Patent Office: Days
• US Class Current: 600/206
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/0059 having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
• CPC Class Codes: A61M 25/0012 with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: B29C 53/12 helically, e.g. for making springs for textile fibres D02G1/00
• CPC Class Codes: B29C 63/0069 of tubular articles
• CPC Class Codes: B29K 2075/00 Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2077/00 Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B29L 2031/7542 Catheters

Abstract

An introducer sheath includes an inner liner having a passageway extending longitudinally therethrough, a coil positioned over the inner liner, and an outer jacket positioned over the liner and the coil. The outer jacket is bonded to the inner liner between the coil turns. The coil turns have a cross-section comprising opposing end portions, and a center portion disposed between the opposing end portions. The center portion has a thickness not exceeding about one-third of a thickness of the end portions for reducing a bending modulus of the coil, and the end portions have a generally curved outer surface. At least a distal end portion of the outer jacket has a durometer between about 70 and 90 on the Shore D scale.

Claims

1. An introducer sheath comprising:

an inner liner having a passageway extending longitudinally therethrough;

a reinforcing member positioned longitudinally over the inner liner, the reinforcing member comprising a coil having adjacent coil turns, each of said coil turns having a cross-section comprising opposing end portions and a center portion, wherein a thickness of said coil turns at said end portions is greater than a thickness at said center portion; and

an outer jacket positioned longitudinally over said inner liner and said coil, said outer jacket bonded to said inner liner between said coil turns.

2. The introducer sheath of claim 1, wherein at least a distal end portion of the outer jacket has a durometer between about 70 and 90 on the Shore D scale.

3. The introducer sheath of claim 1, wherein said thickness of said coil turn center portion does not exceed about one-third of said thickness of said end portions.

4. The introducer sheath of claim 1, wherein said coil turn cross-section has an upper and lower surface, and wherein up to about 40% of said coil turn thickness is removed from said center portion at each of said upper and lower surfaces when compared to the thickness of said end portions.

5. The introducer sheath of claim 1, wherein said coil turn cross-section has an upper and lower surface, and wherein between about 10 and 30% of said coil turn thickness is removed from said center portion of at least one of said upper and lower surfaces.

6. The introducer sheath of claim 1, wherein said end portions have a generally curved outer surface.

7. The introducer sheath of claim 6, wherein at least one of said coil end portions has a radius r and a thickness t, said end portion generally curved surface being defined by the formula r=t/2.

8. The introducer sheath of claim 6, wherein at least one of said coil end portions has a radius r and a thickness t, said end portion generally curved surface not exceeding r=t/4.

9. The introducer sheath of claim 1, wherein at least a distal end portion of the outer jacket has a durometer between about 70 and 90 on the Shore D scale, wherein the thickness of the center portion is about one-third of the thickness of the end portions, and wherein said end portions have a generally curved outer surface.

10. The introducer sheath of claim 1, wherein the thickness of the coil turn center portion is about one-third of the thickness of the end portions.

11. The introducer sheath of claim 1, wherein said inner liner comprises a lubricious fluoropolymer, and said outer jacket comprises at least one of a polyether block amide, a polyamide, and a polyurethane.

12. An introducer sheath comprising:

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

a coil positioned longitudinally over the inner liner, the coil having adjacent coil turns, each of said coil turns having a cross-section comprising opposing end portions and a center portion disposed between said opposing end portions, said center portion having a thickness not exceeding about one-third of a thickness of said end portions for reducing a bending modulus of said coil, said end portions having a generally curved outer surface; and

an outer jacket positioned longitudinally over said inner liner and said coil, said outer jacket bonded to said inner liner between said coil turns, at least a distal end portion of the outer jacket having a durometer between about 70 and 90 on the Shore D scale.

13. The introducer sheath of claim 12, wherein at least one of said coil end portions has a radius r and a thickness t, said end portion generally curved surface being defined by the formula r=t/2.

14. The introducer sheath of claim 12, wherein at least one of said coil end portions has a radius r and a thickness t, said end portion generally curved surface not exceeding r=t/4.

15. The introducer sheath of claim 12, wherein said coil turn cross-section comprises about one-third of said thickness of said end portions.

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

positioning an inner liner over a mandrel, the inner liner having a passageway extending therethrough, and having an outer surface;

positioning a reinforcing member longitudinally over the inner liner, the reinforcing member comprising a coil having adjacent coil turns, each of said coil turns having a cross-section comprising opposing end portions and a center portion disposed between said opposing end portions, said end portions having a greater thickness than a thickness of said center portion;

positioning a polymeric outer jacket longitudinally over said inner liner and said coil; and

exposing an assembly comprising the mandrel, inner liner, reinforcing member and outer jacket to sufficient heat to at least partially melt the outer jacket such that a melted portion of said outer jacket flows between said coil turns and bonds to an outer surface of said inner liner.

17. The method of claim 16, wherein said coil turn cross-section has an upper and lower surface, and wherein up to about 40% of said coil turn thickness is removed from said center portion at each of said upper and lower surfaces when compared to the thickness of said end portions,

18. The method of claim 16, wherein said coil turn cross-section has an upper and lower surface, and wherein between about 10 and 30% of said coil turn thickness is removed from said center portion of at least one of said upper and lower surfaces.

19. The method of claim 16, wherein said coil end portions have a generally curved outer surface, and wherein the thickness of the coil turn center portion is about one-third of the thickness of the end portions.

20. The method of claim 19, wherein said inner liner comprises a lubricious fluoropolymer having a roughened outer surface, and said outer jacket comprises at least one of a polyether block amide, a polyamide, and a polyurethane, and wherein at least a distal end portion of the outer jacket has a durometer between about 70 and 90 on the Shore D scale.