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

• US 6,338,725 B1
• Filed: 09/23/1998
• Issued: 01/15/2002
• Est. Priority Date: 10/24/1994
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Hermann, George D., Lenker, Jay A., Kim, Steven W., Evans, Michael A., Freislinger, Kirsten
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Weiss, Jr., Joseph F.
• Application Number:
  US09/158,777
• Time in Patent Office: 1,210 Days
• Field of Search: 604/95, 604/164, 604/167, 604/53, 604/200, 604/169, 604/170, 604/264, 604/256, 604/96, 604/101, 604/912, 604/919, 604/523, 604/527, 604/526, 604/537, 604/164.01, 604/164.09, 604/164.12, 604/164.13, 604/528, 251/149.2, 251/149.6, 251/149.1, 251/149.4, 251/149.5, 251/149.11, 137/844
• 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. An aortic introducer catheter and an obturator assembly comprising:

an obturator having a proximal end, a distal portion, and a deflecting mechanism actuable from the proximal end for laterally deflecting at least the distal portion; and

an aortic introducer catheter including a flexible sheath, the sheath having a proximal end, a distal end, and a lumen extending therebetween for removably receiving the obturator,

wherein when the obturator and the catheter are simultaneously introduced into a tortuous blood vessel, the obturator is disposed within the lumen of the sheath, and wherein the distal end of the sheath is laterally deflectable by the deflecting mechanism of the obturator so that the obturator can steer the sheath within the tortuous blood vessel.

2. An aortic introducer catheter and obturator assembly as in claim 1, wherein the flexible sheath has a region of enhanced flexibility over a distal length in the range from 5 cm to 15 cm.

3. An aortic introducer catheter and obturator assembly as in claim 1, further comprising an expandable member on the exterior of the sheath located at from 1 cm to 10 cm from the distal end of the sheath, wherein said expandable member partially occludes blood flow when expanded inside the aorta.

4. An aortic introducer catheter and obturator assembly as in claim 1, further comprising an expandable member at the distal end of the sheath, wherein said expandable member can be positioned within an aortic prosthesis for internal expansion.

5. An aortic introducer catheter and obturator assembly as in claim 1, 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.

6. An aortic introducer catheter and obturator assembly as in claim 1, 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.

7. An aortic introducer catheter and obturator assembly as in claim 1, further comprising a hemostasis valve secured to the proximal end of the sheath.

8. An aortic introducer catheter and obturator assembly as in claim 7, 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.

9. An aortic introducer catheter and obturator assembly comprising:

an obturator having a proximal end, a distal portion, and a deflecting mechanism actuable from the proximal end for laterally deflecting at least the distal portion;

an aortic introducer catheter including a flexible sheath, the sheath having a proximal end, a distal end, and a lumen extending therebetween for removably receiving the obturator,

wherein when the obturator and the catheter are simultaneously introduced into a tortuous blood vessel, the obturator is disposed within the lumen of the sheath, and wherein the distal end of the sheath is laterally deflectable by the deflecting mechanism of the obturator so that the obturator can steer the sheath within the tortuous blood vessel; and

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

10. An aortic introducer catheter and obturator assembly as in claim 9, wherein the hemostasis valve comprises:

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

an elastomeric insert disposed within the interior cavity of the valve body, the insert having a forwardly disposed conical face;

an annular ring disposed proximally of the forwardly disposed conical face, the conical face radially split to allow passage of a tubular sheath therethrough.