Expandable percutaneous sheath

• US 20070021768A1
• Filed: 06/05/2006
• Published: 01/25/2007
• Est. Priority Date: 06/03/2005
• Status: Active Grant

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Onset Medical Corp. (Terumo Corporation)
• Inventors: Bishop, Joseph, Lenker, Jay, Tchulluian, Onnik, Kick, George, Nance, Edward
• Granted Patent: US 8,092,481 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Disclosed is an expandable percutaneous sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion to a second, enlarged cross-sectional configuration. The sheath is maintained in the first, low cross-sectional configuration by a tubular restraint. In one application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as percutaneous nephrostomy or urinary bladder access.

Claims

1. A percutaneous access system for providing minimally invasive access, comprising:

an access sheath comprising an elongate tubular body that defines a lumen, at least a portion of the elongate tubular body being expandable from a first, folded, smaller cross-sectional profile to a second, greater cross-sectional profile, the access sheath having a distal end and a proximal end, the proximal end comprising an sheath hub, the sheath hub including an anti-rotation member;

a releasable jacket carried by the access sheath to restrain at least a portion of the elongate tubular structure in the first, folded, smaller cross-sectional profile; and

an expandable member positioned within the elongate tubular body and configured to expand the elongate tubular body from the first, smaller cross-sectional profile to the second, greater cross-sectional profile, the expandable member having a distal end and a proximal end, the proximal end including an expandable member hub with a complementary anti-rotational member configured to mate with the anti-rotational member of the sheath hub and limit rotation between the access sheath and the expandable member.

2. The percutaneous access system of claim 1, wherein the elongate tubular body includes at least one crease along which the elongate tubular body folds in the first, folded, smaller cross-sectional profile.

3. The percutaneous access system of claim 1, wherein the expandable device comprises an inflatable balloon.

4. The percutaneous access system of claim 1, wherein the anti-rotational member of the sheath hub comprises a tab and the corresponding anti-rotational member of the expandable member hub comprises a slot configured to receive the tab.

5. The percutaneous access system of claim 4, wherein the expandable member hub includes a cup like member that extends over the slot and tab when the expandable member hub is engaged with the sheath hub.

6. The percutaneous access system of claim 5, wherein the expandable member hub and the sheath hub engage each of other in a snap fit.

7. A percutaneous access system for providing minimally invasive access, comprising:

an access sheath comprising an elongate tubular body having a proximal end and a distal end and defining an axial lumen, at least a portion of the elongate tubular body being expandable from a first, smaller cross-sectional profile to a second, greater cross-sectional profile;

a releasable jacket carried by the access sheath to restrain at least a portion of the elongate tubular member in the first, smaller cross-sectional profile;

an expandable member positioned within the elongate tubular body and configured to expand the elongate tubular body from the first, smaller cross-sectional profile to the second, greater cross-sectional profile, the expandable member comprising an elongated shaft and a balloon having a distal end and a proximal and being positioned around the elongated shaft, the distal end of the balloon being bonded to an enlarged diameter portion of the elongated shaft, the enlarged diameter portion of the elongated shaft having a diameter greater than an average diameter of the elongated shaft positioned within the elongate tubular body.

8. A percutaneous access system for providing minimally invasive access, comprising:

an access sheath comprising an elongate tubular body having a proximal end and a distal end and defining an axial lumen, at least a portion of the elongate tubular body being expandable from a first, smaller cross-sectional profile to a second, greater cross-sectional profile;

a releasable jacket carried by the access sheath to restrain at least a portion of the elongate tubular member in the first, smaller cross-sectional profile; and

an expandable member positioned within the elongate tubular body and configured to expand the elongate tubular body from the first, smaller cross-sectional profile to the second, greater cross-sectional profile, the an expandable member having a distal end and a proximal end, the expandable member carrying at least one radiopaque member within the access sheath;

wherein the access sheath includes at least one opening in the elongate tubular body, the at least opening being positioned generally over the at least one radiopaque member.

9. The percutaneous access system of claim 8, wherein the expandable member includes a plurality of radiopaque members and the elongate tubular body includes a plurality of openings each aligned with one the plurality radiopaque members.

10. A percutaneous access system, for providing minimally invasive access, comprising:

an elongate tubular body that defines a lumen, at least a portion of the elongate tubular body being expandable from a first, folded, smaller cross-sectional profile to a second, greater cross-sectional profile;

a releasable jacket carried by the access sheath to restrain at least a portion of the elongate tubular structure in the first, smaller cross-sectional profile;

an expandable member positioned within the elongate tubular body and configured to expand the elongate tubular body from the first, smaller cross-sectional profile to the second, greater cross-sectional profile; and

means for preventing rotation about a longitudinal axis between the elongate tubular body and the expandable member.

11. A percutaneous access assembly for providing minimally invasive access, comprising:

an elongate tubular body that defines a lumen, at least a portion of the elongate tubular structure being expandable from a first, folded, smaller cross-sectional profile to a second, greater cross-sectional profile, the elongate tubular body has a distal end that forms a distal face which includes two beveled faces which are beveled with respect to a longitudinal axis of the elongate tubular body and form a point;

a releasable jacket carried by the access sheath to restrain at least a portion of the elongate tubular body in the first, smaller cross-sectional profile; and

an expandable member positioned within the elongate tubular body and configured to expand the elongate tubular body from the first, smaller cross-sectional profile to the second, greater cross-sectional profile.