INTRODUCER SHEATH HAVING DUAL REINFORCING ELEMENTS

• US 20100049168A1
• Filed: 08/20/2008
• Published: 02/25/2010
• Est. Priority Date: 08/20/2008
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Crabtree, Christopher B., Parker, Fred T.
• Granted Patent: US 9,731,094 B2
• Time in Patent Office: Days
• US Class Current: 604/527
• 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 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid

Abstract

An introducer sheath for deploying a stent to a target site within a body passageway of a patient. The introducer sheath includes a tubular inner liner having a proximal portion, a distal portion, and an outer surface. A first reinforcing element, and a second reinforcing element are positioned along the outer surface of the inner liner. The first reinforcing element comprises a braid the second reinforcing element comprises a coil. The braid is positioned at the proximal portion of the inner liner and extends distally therefrom. The coil is positioned at the distal portion longitudinally adjacent the braid. The braid has a length that may extend about 90% of the length of the sheath. An outer jacket is positioned longitudinally around the reinforcing elements, and is connected to the inner liner between the respective wires of the braid and the coil.

Claims

1. An introducer sheath comprising:

a tubular inner liner having a proximal portion, a distal portion, and an outer surface;

a first reinforcing element and a second reinforcing element disposed along said outer surface of said inner liner, said first reinforcing element comprising a braid and said second reinforcing element comprising a coil, said braid disposed at said proximal portion of said inner liner and extending distally therefrom, said coil disposed at said distal portion longitudinally adjacent said braid, said braid having a length that extends at least about 50% of a length of the sheath; and

an outer jacket positioned longitudinally around said reinforcing elements, and connected to said inner liner.

2. The introducer sheath of claim 1, wherein said braid comprises a plurality of interwoven filaments and said coil comprises a plurality of coil turns, and said outer jacket is connected to said inner liner between said interwoven filaments and said coil turns, said braid having a length that extends at least 70% of the length of the sheath.

3. The introducer sheath of claim 2, wherein said braid extends at least 90% of the length of the sheath, and wherein said coil begins substantially at a distal end of said braid and extends to a distal end of said sheath.

4. The introducer sheath of claim 1, further comprising a radiopaque marker disposed along said sheath length distal to said braid.

5. The introducer sheath of claim 1, wherein said inner liner comprises a lubricious fluoropolymer.

6. The introducer sheath of claim 5, wherein said lubricious fluoropolymer comprises PTFE, and wherein said inner liner has a substantially uniform inner diameter ranging up to 30 French.

7. The introducer sheath of claim 6, wherein the tubular inner liner has a roughened outer surface, and wherein said outer jacket is bonded to said inner tubular liner at said roughened outer surface.

8. The introducer sheath of claim 1, wherein the outer jacket comprises at least two discrete longitudinal segments differing in durometer from a higher durometer proximal segment to a lower durometer distal segment.

9. The introducer sheath of claim 1, wherein said outer jacket comprises a heat formable polyamide material.

10. The introducer sheath of claim 1, wherein at least the distal end of the outer surface of the sheath is coated with a hydrophilic compound.

11. The introducer sheath of claim 2, wherein said braid comprises round wire, and said coil comprises flat wire.

12. An introducer sheath for use in deploying a medical interventional device to a target site within a body passageway of a patient, comprising:

a tubular inner liner having a proximal portion, a distal portion, and an outer surface, said tubular inner liner comprising a fluoropolymer, said inner liner having a passageway extending therethrough, said passageway sized for receiving said medical interventional device therein, said distal portion defining a nesting area for maintaining said medical interventional device prior to deployment thereof;

a first reinforcing element positioned along said outer surface of said inner liner, said first reinforcing element disposed at said proximal portion of said inner liner and extending in a distal direction therefrom, said first reinforcing element comprising a braid formed of a plurality of interwoven filaments, said braid having a length that extends at least about 70% of a length of the introducer sheath;

a second reinforcing element positioned longitudinally adjacent and distal to said first reinforcing element along said outer surface of said inner liner, said second reinforcing element comprising a helical coil, said helical coil having a length substantially equal to a length of said nesting area; and

an outer jacket positioned longitudinally around said first and second reinforcing elements, and connected to the outer surface of said inner liner between said interwoven filaments and said coil turns.

13. The introducer sheath of claim 12, wherein said braid extends at least 90% of a length of the introducer sheath.

14. The introducer sheath of claim 12, wherein said braid comprises round wire, and said coil comprises flat wire.

15. The introducer sheath of claim 12, wherein said tubular inner liner comprises PTFE having a roughened outer surface, and said outer jacket comprises a polyamide, said polyamide being bonded to said roughened outer surface.

16. A method of delivering a medical interventional device to a target area in a body passageway of a patient, comprising:

providing an introducer sheath, said introducer sheath comprising a tubular inner liner having a proximal portion, a distal portion, and an outer surface, said tubular inner liner comprising a fluoropolymer, said inner liner having a passageway extending therethrough, said passageway sized for receiving said medical interventional device therein, said distal portion defining a nesting area for maintaining said medical interventional device prior to deployment thereof a first reinforcing element positioned along said outer surface of said inner liner, said first reinforcing element disposed at said proximal portion of said inner liner and extending in a distal direction therefrom, said first reinforcing element comprising a braid formed of a plurality of interwoven filaments, said braid having a length that extends at least about 70% of a length of the introducer sheath;

a second reinforcing element positioned longitudinally adjacent and distal to said first reinforcing element along the outer surface of the inner liner, said second reinforcing element comprising a helical coil, said helical coil having a length substantially equal to a length of said nesting area; and

an outer jacket positioned longitudinally around said first and second reinforcing elements, and connected to the outer surface of said inner liner between said interwoven filaments and said coil turns;

positioning a medical interventional device in said passageway at said nesting area;

inserting said sheath into said body passageway such that a sheath distal end portion is disposed at said target area; and

delivering said medical interventional device to said target area from said sheath distal end portion.

17. The method of claim 16, wherein said braid extends at least 90% of a length of the introducer sheath.

18. The method of claim 17, wherein said inner liner comprises PTFE having a roughened outer surface, and said outer jacket is bonded to said roughened outer surface of said inner liner.

19. The method of claim 16, wherein said braid comprises round wire and said coil comprises flat wire.

20. The method of claim 16, wherein inner liner comprises PTFE, said sheath further comprising a radiopaque marker disposed at said sheath distal end portion, and having a hydrophilic coating over at least said sheath distal end portion.