Expandable percutaneous sheath

• US 7,780,692 B2
• Filed: 07/02/2004
• Issued: 08/24/2010
• Est. Priority Date: 12/05/2003
• Status: Active Grant

• 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): Simpson; Sarah A
• Application Number:
  US10/884,017
• Publication Number:
  US 20050125021A1
• Time in Patent Office: 2,244 Days
• Field of Search: 606/192, 606/198, 604/104, 604/164.05
• US Class Current: 606/198
• 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 method of providing percutaneous access, the method comprising:

inserting a guidewire into a patient,

percutaneously inserting an elongate tubular body having a first, smaller cross-sectional profile over the guidewire to a treatment site within the patient, wherein the treatment site is the patient'"'"'s renal pelvis, the elongate tubular body comprising a distal region, the distal region comprising at least one longitudinal crease and a beveled distal face, the beveled distal face comprising a leading edge and a trailing edge, the at least one longitudinal crease positioned on the distal region generally opposite the side on which the leading edge is positioned wherein the at least one longitudinal crease comprises only two creased outer sections positioned on the perimeter of the distal region and only two creased inner sections positioned within the perimeter of the distal region, wherein the two creased outer sections generally face each other and the two creased inner sections generally face away from each other;

expanding the elongate tubular body from the first, smaller cross-sectional profile to a second, greater cross-sectional profile by applying radial force by an expandable member positioned within the elongate tubular body;

removing the expandable member from the elongate tubular body to open a working lumen within the elongate tubular body, the working lumen providing access to the treatment site from outside the patient;

performing one or more therapeutic procedures at the treatment site through the working lumen;

collapsing the elongate tubular body to a cross-sectional profile smaller than the second, greater cross-sectional profile; and

removing the elongate tubular body from the patient.

2. The method as in claim 1, wherein the step of collapsing the elongate tubular body comprises pulling the elongate tubular body in a radially inward direction.

3. The method as in claim 1, wherein the step of collapsing the elongate tubular body comprises inserting a collapsible device into the elongate tubular body and collapsing the collapsible device.

4. The method as in claim 3, further comprising engaging complementary retention structures between the collapsible device and the elongate tubular structure.

5. The method as in claim 3, wherein the step of collapsing the collapsible device comprises deflating a balloon.

6. The method as in claim 3, wherein the expandable member is a balloon.

7. The method as in claim 3, wherein the collapsible device comprises the expandable member.

8. The method as in claim 1, further comprising releasing the elongate tubular body from a constraining tubular jacket, wherein the releasing is accomplished in response to the step of expanding.

9. The method as in claim 1, wherein the therapeutic procedures comprise one or more of a biopsy, stone extraction, antegrade endopyelotomy, resection of transitional cell carcinoma, removal of strictures, and delivery of drugs.

10. The method as in claim 1, wherein the performing one or more therapeutic procedures comprises passing one or more instruments through the working lumen.

11. The method as in claim 10, wherein the one or more instruments comprise a surgical retractor.

12. The method as in claim 10, wherein the second, greater cross-sectional profile of the elongate tubular body reconfigures in response to the passing one or more instruments through the working lumen.

13. The method as in claim 4, wherein the complementary retention structures comprise a track and a rail.

14. The method as in claim 1, wherein percutaneously inserting the elongate tubular body comprises inserting the elongate tubular body and the expandable member positioned within the elongate tubular body as one unit.

15. The method as in claim 14, wherein the elongate tubular body further comprises a proximal hub at its proximal end and the expandable member comprises an inflation hub at its proximal end, the proximal hub and the inflation hub configured to be releaseably engaged, and wherein the removing the expandable member from the elongate tubular body comprises disengaging the proximal hub and the inflation hub.