Dual valve reinforced sheath and method

• US 5,653,697 A
• Filed: 09/27/1995
• Issued: 08/05/1997
• Est. Priority Date: 12/13/1991
• Status: Expired due to Term

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: EndoVascular Technologies Incorporated (Boston Scientific Corporation)
• Inventors: Sterman, Wesley D., Williams, Ronald G., Quiachon, Dinah B., Baker, Steven G., Dillow, David C.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US08/534,393
• Time in Patent Office: 678 Days
• Field of Search: 604/163, 604/171, 604/264, 604/104, 604/280, 604/282, 606/194
• US Class Current: 604/528
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0673 comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• 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
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

A large-diameter expandable sheath for use in introducing a catheter or other medical instrument into a vessel in the body of a patient. The expandable sheath comprises an elongate sheath tube formed of a flexible material which has proximal and distal extremities and a passage extending therethrough of a maximum predetermined diameter. The distal extremity of the elongate sheath tube is folded longitudinally to a smaller folded diameter. The sheath tube may be self-expanding or may be reinforced with a self-expanding wire or expandable stents. A backflow adapter is secured to the proximal extremity of the elongate sheath tube. The backflow adapter has a central opening therein in registration with the passage in the sheath tube. A normally closed primary valve is disposed in the central opening of the backflow adapter and is movable to an open position. A normally open secondary valve, movable to a closed position, may be configured in the backflow adapter proximal the sheath tube and distal the primary valve. The primary and secondary valves when open permit a catheter or other medical instrument to be inserted into the sheath, and when closed form a hemostatic seal about the catheter. A sheath introducer is provided for guiding the distal end of the sheath tube into a vessel and is configured to be positioned within the backflow adapter.

Claims

1. An expandable sheath for use in introducing a medical instrument into a body, the sheath comprising:

an elongate sheath tube having proximal and distal ends having an annular passage therethrough, said elongate sheath tube being formed of a flexible material; and

a self-expanding wire associated with the wall of said elongate sheath tube for causing radial expansion of said sheath tube to expand the annular passage such that a medical instrument can be inserted into the passage.

2. The expandable sheath of claim 1, wherein the self-expanding wire of said reinforcing means is sinusoidal in configuration.

3. The expandable sheath of claim 1, wherein the self-expanding wire of said reinforcing means is helical in configuration.

4. The expandable sheath of claim 1, wherein the self-expanding wire of said reinforcing means is configured to transverse a length of said sheath tube and to encircle the perimeter of the distal end of said sheath tube.

5. The expandable sheath of claim 1, wherein the self-expanding wire of said reinforcing means is configured to transverse the length of said sheath tube and to form a sinusoidal shape along the perimeter of the distal end of said sheath tube.