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

• US 5,599,305 A
• Filed: 10/24/1994
• Issued: 02/04/1997
• Est. Priority Date: 10/24/1994
• Status: Expired due to Fees

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Cardiovascular Concepts, Inc. (Medtronic Plc)
• Inventors: Hermann, George D., Evans, Michael A., Lenker, Jay A., Kim, Steven W., Freislinger, Kirsten
• Primary Examiner(s): McDermott, Corrine M.
• Assistant Examiner(s): Gring, N. Kent
• Application Number:
  US08/330,140
• Time in Patent Office: 834 Days
• Field of Search: 604/95, 604/164, 604/167, 604/53, 604/256, 604/283, 604/280, 604/158, 604/169, 604/170, 604/171, 606/191, 606/198
• US Class Current: 604/95.04
• 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. A catheter introducing system comprising:

a flexible sheath having a proximal end, a distal end, and a lumen extending therebetween; and

an obturator removably receivable in the lumen of the flexible sheath, said 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;

wherein actuation of the deflecting mechanism manipulates the distal end of the sheath when the sheath extends over the distal portion of the obturator.

2. A catheter introducing system as in claim 1, wherein the obturator has an outer diameter which is at least 75% of the inner diameter of the sheath.

3. A catheter introducing system as in claim 2, wherein the obturator has a tapered distal end which defines a smooth transition with the distal end of the sheath.

4. A catheter introducing system as in claim 3, wherein the obturator has a length which is in the range from one to one and one-half times that of the flexible sheath.

5. A catheter introducing system as in claim 3, wherein the obturator has a length which is at least twice that of the flexible sheath.

6. A catheter introducing system as in claim 1, wherein the deflecting mechanism comprises a pull wire attached off center at a distal end of the obturator.

7. A catheter introducing system as in claim 1, wherein the deflecting mechanism of the obturator is capable of inducing a deflection with a 1 cm radius in the sheath.

8. A catheter introducing system comprising:

a flexible sheath having a proximal end, a distal end, and a lumen extending therebetween; and

an obturator removably receivable in the lumen of the flexible sheath, said 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;

wherein the flexible sheath has a length in the range from about 30 cm to 60 cm and a lumen diameter in the range from about 4 mm to 10 mm and wherein the obturator has a length in the range from 35 cm to 65 cm and an outer diameter in the range from about 4 mm to 9 mm; and

wherein actuation of the deflecting mechanism manipulates the distal end of the sheath when the sheath extends over the distal portion of the obturator.

9. A catheter introducing system as in claim 8, wherein the obturator comprises an elongate body having a region of enhanced flexibility over the distal length in the range from 3 cm to 6 cm.

10. A catheter introducing system as in claim 9, wherein the region of enhanced flexibility comprises an axial series of articulated elements.

11. A catheter introducing system as in claim 9, wherein the flexible sheath has a region of enhanced flexibility over a distal length in the range from 5 cm to 15 cm.

12. A catheter introducing system as in claim 11, wherein the flexible sheath comprises a tubular inner liner, a flat wire helical coil wrapped over an exterior surface of the tubular inner liner, and a plastic coating formed over the helical coil which penetrates into the space between adjacent turns of the coil and is bonded to the tubular inner liner, said coil having spaced-apart adjacent turns which extend distally over at least a portion of the region of enhanced flexibility.

13. A catheter introducing system as in claim 12, wherein the turns of the coil at the region of enhanced flexibility are separated by a greater distance than a proximal portion of the sheath.

14. A catheter introducing system as in claim 8, wherein the obturator has an outer diameter which is at least 75% of the inner diameter of the sheath.

15. A method for introducing a flexible sheath to a target location in a body lumen, said method comprising:

introducing the sheath to the body lumen;

advancing the sheath within the lumen toward the target location by laterally deflecting at least a distal portion of an obturator which is removably received in a lumen of the sheath so that the obturator deflects a distal portion of the sheath; and

removing the obturator from the sheath to provide an access lumen through the sheath after reaching the target location.

16. A method as in claim 15, wherein the sheath is advanced over the obturator after the obturator has been advanced toward the target location.

17. A method as in claim 15, wherein the target location is the aorta and sheath and obturator are advanced through the subclavian, external carotid, or axillary artery and the aortic arch to the aorta.

18. A method as in claim 17, wherein the sheath has a length in the range from 30 cm to 60 cm and an access lumen diameter in the range from about 5 mm to 10 mm.

19. A method as in claim 17, further comprising expanding a member on the exterior of the sheath within the aorta to partially occlude blood flow.

20. A method as in claim 17, further comprising introducing a vascular graft through the access lumen into the aorta, the right iliac, or the left iliac.

21. A method as in claim 20, further comprising expanding a member on the exterior of the sheath within the vascular graft after said graft has been positioned at the target location in order to anchor the graft at said target location.

22. A method for introducing a flexible sheath to a target location in a body lumen, said method comprising:

introducing the sheath to the body lumen;

advancing the sheath within the lumen toward the target location by laterally deflecting at least a distal portion of an obturator which is removably received in a lumen of the sheath;

manipulating a distal portion of the sheath by deflecting the distal portion of the obturator while the distal portion of the obturator is positioned within the distal portion of the sheath, and while the sheath and obturator are advanced together; and

removing the obturator from the sheath to provide an access lumen through the sheath after reaching the target location.

23. A hemostasis valve comprising:

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

a compressible insert disposed within the interior cavity of the housing, said insert including a polymeric foam body having an open axial lumen when the insert is unconfined and an exterior cross-section which is similar to but larger than an interior cross-section of 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.

24. A hemostasis valve as in claim 23, further comprising a second valve element in series with the compressible insert.

25. A hemostasis valve as in claim 24, wherein the second valve element is a duck bill or a slit disk structure.

26. A hemostasis valve as in claim 23, wherein the lumen is coated with a lubricant.

27. A hemostasis valve as in claim 23, wherein the lumen is coated with a protective layer.

28. A hemostasis valve as in claim 27, wherein the coating material is selected from the group consisting of polyurethane and silicone.

29. A hemostasis valve as in claim 23, wherein the housing is fixed.