Expandable percutaneous sheath

• US 8,092,481 B2
• Filed: 06/05/2006
• Issued: 01/10/2012
• Est. Priority Date: 06/03/2005
• Status: Active Grant

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Onset Medical Corp. (Terumo Corporation)
• Inventors: Nance, Edward J., Bishop, Joseph, Lenker, Jay, Tchulluian, Onnik, Kick, George F.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): BLATT, ERIC D
• Application Number:
  US11/447,232
• Publication Number:
  US 20070021768A1
• Time in Patent Office: 2,045 Days
• Field of Search: 606/108, 606/191, 606/192, 606/194, 606/195, 606/198, 600/585
• 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 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 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 one opening being positioned generally over the at least one radiopaque member.

2. The percutaneous access system of claim 1, wherein the expandable member includes a plurality of radiopaque members and the elongate tubular body includes a plurality of openings each aligned with one of the plurality of radiopaque members.

3. The percutaneous access system of claim 1, wherein the proximal end of the elongate tubular body includes a sheath hub.

4. The percutaneous access system of claim 3, wherein the sheath hub includes an anti-rotational member, and the proximal end of the expandable member includes 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 elongate tubular body and the expandable member.

5. The percutaneous access system of claim 4, wherein the sheath hub is engaged to the expandable member hub.

6. The percutaneous access system of claim 5, wherein the expandable member hub and the sheath hub are releasably affixed in a snap fit.

7. The percutaneous access system of claim 5, wherein the anti-rotational member of the sheath hub comprises a tab and the complementary anti-rotational member of the expandable member hub comprises a slot configured to receive the tab.

8. The percutaneous access system of claim 7, wherein the expandable member hub includes a cup-like member that extends over the slot and tab when the expandable member is engaged with the sheath hub.

9. The percutaneous access system of claim 5, wherein the engagement comprises releasable affixation, preventing lateral relative motion between the sheath hub and the expandable member hub, at every point around substantially the full perimeters of the sheath hub and the expandable member hub.

10. The percutaneous access system of claim 9, wherein the releasable affixation comprises a snap fit.

11. 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, smaller cross-sectional profile.

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