Large-diameter introducer sheath having hemostasis valve and removable steering mechanism

• US 5,843,031 A
• Filed: 10/21/1996
• Issued: 12/01/1998
• Est. Priority Date: 10/24/1994
• Status: Expired due to Fees

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hermann, George D., Evans, Michael A., Lenker, Jay A., Kim, Steven W., Freislinger, Kirsten
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/735,401
• Time in Patent Office: 771 Days
• Field of Search: 604/95, 604/164, 604/167, 604/53, 604/200, 604/169, 604/170, 604/264, 251/149.2, 251/149.6, 251/149.1, 251/149.4, 251/149.5, 251/149.11
• US Class Current: 604/95.01
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61M 2025/0046 Coatings for improving slidability
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/0646 Duckbill-valve
• CPC Class Codes: A61M 2039/066 Septum-like element
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 2210/127 Aorta
• 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 25/0051 made from fenestrated or weakened tubing layer
• 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
• CPC Class Codes: A61M 25/0138 : having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0144 : having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 39/0606 : without means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A catheter introducing system includes an introducer catheter comprising a flexible sheath having a hemostasis valve and an obturator having a steering mechanism operated by a proximal actuator handle. The catheter introducer system will usually be introduced with the obturator inside of the flexible sheath so that the obturator can effect steering by laterally deflecting the distal end of the combined sheath and obturator. Such catheter introducing systems are particularly useful for large diameter sheaths which are not readily introduced over guide wires. A first exemplary hemostasis valve comprises a compressed foam insert having an axial lumen therein. A second exemplary hemostasis valve comprises an elastomeric insert which receives and seals over the catheter.

Claims

1. An aortic introducer catheter for use with an obturator having a proximal end, a distal portion, and a deflecting mechanism actuable from the proximal end of the obturator for laterally deflecting at least the distal portion, the aortic introducer catheter comprising:

a flexible sheath having a proximal end, a distal end, and a lumen extending therebetween for removably receiving the obturator, wherein the length between the proximal and distal ends is in the range from 30 cm to 60 cm and the lumen diameter is in the range from 5 mm to 10 mm; and

a hemostasis valve secured to the proximal end of the sheath;

wherein the distal end of the sheath is sufficiently flexible so as to be laterally deflectable by the deflecting mechanism of the obturator when the obturator is within the lumen of the sheath, so that the obturator can steer the sheath within a tortuous blood vessel, and

wherein the flexible sheath comprises;

a tubular inner liner having a proximal end, a distal end, and a lumen therebetween;

a flat wire helical coil wrapped over an exterior surface of the tubular inner liner, said coil having spaced-apart adjacent turns; and

a plastic coating formed over the helical coil, penetrating into the space between adjacent turns of the coil, and bonded to the tubular inner liner.

2. An aortic introducer catheter for use with an obturator having a proximal end, a distal portion, and a deflecting mechanism actuable from the proximal end of the obturator for laterally deflecting at least the distal portion, the aortic introducer catheter comprising:

a flexible sheath having a proximal end, a distal end, and a lumen extending therebetween for removably receiving the obturator, wherein the length between the proximal and distal ends is in the range from 30 cm to 60 cm and the lumen diameter is in the range from 5 mm to 10 mm, and

a hemostasis valve secured to the proximal end of the sheath;

wherein the distal end of the sheath is sufficiently flexible so as to be laterally deflectable by the deflecting mechanism of the obturator when the obturator is within the lumen of the sheath, so that the obturator can steer the sheath within a tortuous blood vessel, and

wherein the hemostasis valve comprises;

a housing having an interior and axially aligned inlet and outlet ports; and

a compressible insert disposed within the interior of the housing, said insert including a polymeric foam body having an open axial lumen and an exterior geometry which is similar to but larger than the cavity in the housing, wherein the insert is confined within the cavity to close the lumen with said closed lumen being aligned between the inlet and outlet ports.

3. A catheter sheath for use with an obturator having a proximal end, a distal portion, and a deflecting mechanism actuable from the proximal end of the obturator for laterally deflecting at least the distal portion, the sheath comprising:

a tubular inner liner having a proximal end, a distal end, and a lumen therebetween for removably receiving the obturator, the distal end having a region of enhanced flexibility;

a flat wire helical coil wrapped over an exterior surface of the tubular inner liner, said coil having consistently spaced-apart adjacent turns; and

a plastic coating formed over the helical coil, penetrating into the space between adjacent turns of the coil, and bonded to the tubular inner liner;

wherein the distal end of the sheath is laterally deflectable by the deflecting mechanism of the obturator when the obturator is within the lumen of the sheath.

4. A catheter sheath as in claim 3, wherein the tubular liner is composed of a material selected from the group consisting of polyurethane, polytetrafluoroethylene, fluorinated ethylene-propylene polymer, polyether block amide copolymer, polyamide, and polyethylene and has a wall thickness in the range from 0.08 mm to 0.15 mm.

5. A catheter sheath as in claim 3, wherein the helical coil comprises a stainless steel ribbon having a width in the range from 0.5 mm to 1.5 mm and thickness in the range from 0.08 mm to 0.15 mm, wherein the ribbon is wrapped at from 5 turns to 15 turns per cm and wherein the spacing between adjacent turns is in the range from 0.5 mm to 1 mm.

6. A catheter sheath as in claim 3, wherein the plastic coating is composed of a material selected from the group consisting of polyurethane, polyether block amide copolymer, polyethylene, and polyamide, and has a thickness measured from tubular inner liner in the range from 0.08 mm to 0.15 mm.

7. A catheter sheath as in claim 3;

having a region of enhanced flexibility over a distal length in the range from about 5 cm to 15 cm.

8. A catheter sheath as in claim 3, having a soft tip free from the helical coil over a distal length in the range of 2 mm to 10 mm.

9. A catheter sheath as in claim 3, further comprising a hemostasis valve secured to the proximal end of the sheath.

10. A catheter sheath as in claim 3, wherein the lumen diameter is in the range from 5 mm to 10 mm, and wherein the region of enhanced flexibility accepts a 1 cm radius curve without kinking or collapse of the lumen.

11. A steerable obturator for use with a flexible catheter sheath having a proximal end, a distal end, and a lumen extending therebetween, said obturator comprising:

a flexible body having a proximal end and tapered distal tip, the flexible body removably receivable in the lumen of the sheath; and

a deflecting mechanism actuable from the proximal end of the flexible body for laterally deflecting at least a distal portion of the flexible body;

wherein the distal portion of the flexible body is capable of redirecting axial advancement of the sheath by actuating the deflecting mechanism while the sheath advances distally over the obturator.

12. A steerable obturator as in claim 11, wherein the deflecting mechanism can induce a bend in a catheter body having a length in the range from 45 cm to 60 cm and an outer diameter in the range from 4 mm to 5 mm by laterally deflecting the distal portion within the lumen.

13. A steerable obturator as in claim 12, wherein the flexible body has a region of enhanced flexibility over a distal length in the range from about 5 cm to 10 cm.

14. A steerable obturator as in claim 13, wherein the region of enhanced flexibility comprises an axial series of elements connected by pivoting joints.

15. A steerable obturator as in claim 11, wherein the deflecting means comprises a pull wire attached off center at the distal end of the flexible body.

16. A steerable obturator as in claim 15, wherein the deflecting means further comprises a handle assembly attached to the proximal end of the flexible body, wherein said handle assembly includes a first portion attached to the pull wire and a second portion attached to the flexible body, whereby relative movement of the two portions causes lateral deflection of the distal portion.

17. A steerable obturator as in claim 11, wherein the deflecting mechanism of the obturator induces a deflection with a 1 cm radius in the sheath.

18. A steerable obturator as in claim 11, wherein the obturator has an outer diameter which is at least 75% of an inner diameter of the sheath.

19. A hemostasis valve for use with a catheter having an outer surface, the hemostasis valve comprising:

a housing having an interior cavity and axially aligned inlet and outlet ports;

an elastomeric insert within the interior cavity of the housing, said insert having a forwardly disposed conical face, wherein the face is radially split to permit passage of a catheter therethrough and

an annular ring disposed proximally of the face, the annular ring having an open lumen which is adapted to form a sliding seal with the outer surface of the catheter.

20. A hemostasis valve as in claim 19, wherein the annular ring is formed integrally with the insert.

21. A hemostasis valve as in claim 19, wherein the face is radially split along at least three lines.

22. A hemostasis valve as in claim 19, wherein the lumen is coated with a lubricant.

23. A hemostasis valve as in claim 22, wherein the lubricant is selected from the group consisting of polyurethane and silicone.

24. A hemostasis valve as in claim 19, wherein the housing adjacent the ring is fixed.