Expandable percutaneous sheath

• US 7,713,193 B2
• Filed: 05/02/2006
• Issued: 05/11/2010
• Est. Priority Date: 12/05/2003
• Status: Expired due to Term

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Onset Medical Corp. (Terumo Corporation)
• Inventors: Bishop, Joseph, Kick, George F., Nance, Edward J., Lenker, Jay, Tchulluian, Onnik
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Severson; Ryan J
• Application Number:
  US11/415,659
• Publication Number:
  US 20060200188A1
• Time in Patent Office: 1,470 Days
• Field of Search: 600/184, 606/108
• US Class Current: 600/184
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 31/005 for contrast media

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, the elongate tubular body comprising a distal region and a proximal region, wherein the distal region is expandable from a first, folded, substantially circular and continuous, smaller cross-sectional profile to a second, fully unfolded and greater cross-sectional profile, the first, folded profile including only two longitudinally extending creased outer sections that lie on a perimeter of the folded tubular body and face each other, and only two longitudinally extending creased inner sections that lie within the folded tubular body and face away from each other, wherein the proximal region does not include folds and has a cross-sectional profile that is larger than the first, folded, smaller cross-sectional profile of the distal region, and wherein the access sheath further comprises a transition region with a tapering profile between the proximal region and the first, folded, smaller cross-sectional profile of the distal region;

an expandable device positioned within the lumen of the elongate tubular body, said expandable device configured to radially expand said distal region of the elongate tubular body from said first profile to said second profile while said expandable device remains stationary along its longitudinal axis; and

a thin tubular jacket that substantially surrounds the access sheath to restrain at least a portion of the distal region of the elongate tubular body in the first, folded, smaller cross-sectional profile, said tubular jacket configured to tear upon said radial expansion of said distal region of the elongate tubular body;

wherein the elongate tubular body is sufficiently pliable to allow the passage of objects having a maximum cross-sectional dimension that is larger than an inner diameter of a circle corresponding to the cross-sectional area of the elongate tubular body when the distal region is in the second, fully unfolded and greater cross-sectional profile.

2. The percutaneous access system of claim 1, wherein, when the objects having a maximum cross-sectional dimension larger than the inner diameter of the elongate tubular body are passed through the lumen, the elongate tubular body reconfigures to change the cross-sectional shape of the lumen.

3. The percutaneous access system of claim 2, wherein, when the elongate tubular body reconfigures the cross-sectional shape of the lumen, the cross-sectional dimensions of the lumen increase in a first direction and decrease in a second direction.

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

5. The percutaneous access system of claim 4, wherein the elongate tubular body reconfigures by bending along the at least one crease of the distal region.

6. The percutaneous access system of claim 2, wherein the elongate tubular body is elastic and the elongate tubular body reconfigures, at least in part, by elastic deformation to increase the cross-sectional area of the lumen.

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

8. The percutaneous access system of claim 1, wherein said distal region has a beveled distal tip, the beveled distal tip comprising a leading edge and a trailing edge, and wherein said two longitudinally extending creased outer sections are positioned on the perimeter of the elongate tubular body generally opposite the side of the elongate tubular body on which the leading edge is positioned.

9. The percutaneous access sheath of claim 1, wherein the cross-sectional profile of the proximal region of the elongate tubular body has the same outside diameter as the second profile of the distal region of the elongate tubular body.

10. The percutaneous access sheath of claim 1, wherein the proximal region, the transition region, and the distal region are formed in one continuous length of tubing.

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

an access sheath comprising an elongate tubular body comprising an expandable distal region and a proximal region, the distal region and the proximal region both comprising a wall that defines a lumen, wherein the wall of the distal region is expandable from a first, folded, substantially continuous, smaller cross-sectional profile to a second, fully unfolded and greater cross-sectional profile, wherein in the first, folded, substantially continuous, smaller cross-sectional profile the wall of the distal region comprises only two longitudinally extending creased outer sections that lie on a perimeter of the folded tubular body and face each other, only two longitudinally extending creased inner sections that lie within the folded tubular body and face away from each other, and an outer section without opposing or facing creases that lies on the perimeter of the folded tubular body and extends continuously between the two creased outer sections, wherein the proximal region is without folds and has a larger cross-sectional profile than the distal region when the distal region is in its first, folded, substantially continuous, smaller cross-sectional profile, and wherein the access sheath further comprises a tapered transition region between the larger cross-sectional profile of the proximal region and the first, folded, substantially continuous, smaller cross-sectional profile of the distal region; and

an expandable device positioned within the lumen of the elongate tubular body, said expandable device configured to radially expand said distal region of the elongate tubular body from said first profile to said second profile while said expandable device remains stationary along its longitudinal axis.

12. The percutaneous access system of claim 11, wherein the wall of said distal region further comprises a beveled distal tip, the beveled distal tip comprising a leading edge and a trailing edge, and wherein said two longitudinally extending creased outer sections are positioned on the perimeter of the elongate tubular body generally opposite the side of the elongate tubular body on which the leading edge is positioned.

13. The percutaneous access sheath of claim 11, wherein the cross-sectional profile of the proximal region of the elongate tubular body has the same outside diameter as the second profile of the distal region of the elongate tubular body.

14. The percutaneous access sheath of claim 11, wherein the proximal region, the transition region, and the distal region are formed in one continuous length of tubing.

15. The percutaneous access sheath of claim 11, further comprising a thin tubular jacket that substantially surrounds the access sheath to restrain at least a portion of the wall of the distal region of the elongate tubular body in the first, folded, substantially continuous, smaller cross-sectional profile, said tubular jacket configured to tear upon said radial expansion of said distal region of the elongate tubular body.

16. The percutaneous access sheath of claim 15, wherein said tubular jacket is further configured to tear along a score line.

17. The percutaneous access sheath of claim 11, wherein said expandable device comprises a balloon.

18. The percutaneous access sheath of claim 11, wherein the elongate tubular body is sufficiently pliable to allow the passage of objects having a maximum cross-sectional dimension that is larger than an inner diameter of a circle corresponding to the cross-sectional area of the elongate tubular body when the wall of the distal region is in the second, fully unfolded and greater cross-sectional profile.

19. The percutaneous access sheath of claim 18, wherein, when the objects having a maximum cross-sectional dimension larger than the inner diameter of the elongate tubular body are passed through the lumen, the elongate tubular body reconfigures to change the cross-sectional shape of the lumen.

20. The percutaneous access sheath of claim 19, wherein the elongate tubular body reconfigures by bending along one or more of the creased sections of the wall of the distal region.