Expandable transluminal sheath

• US 8,348,892 B2
• Filed: 01/14/2011
• Issued: 01/08/2013
• Est. Priority Date: 09/09/2004
• Status: Active Grant

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Onset Medical Corp. (Terumo Corporation)
• Inventors: Lenker, Jay, Nance, Edward J., Bishop, Joseph, Kick, George F.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US13/007,280
• Publication Number:
  US 20110306843A1
• Time in Patent Office: 725 Days
• Field of Search: 604104-109, 604/96.01, 604/101.01, 604/103.05, 606/192, 606/198
• US Class Current: 604/103.05
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 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: A61B 2017/0225 flexible, e.g. fabrics, meshes, or membranes
• 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 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract

Abstract

Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The distal end of the sheath is maintained in the first, low cross-sectional configuration and expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as ureteroscopy or stone removal.

Claims

1. A method of instrumenting a body lumen or cavity comprising the steps of:

inserting a sheath with a pre-inserted dilator, and advancing the sheath to a treatment or diagnostic site within the body lumen or cavity, wherein the sheath comprises a distal region which is collapsed in diameter, the sheath further comprising distorted proximal and distal chevrons,

dilating the distal region of the sheath so that the distal region of the sheath is expanded, wherein the proximal and distal chevrons become undistorted such that a full-size lumen exists within the sheath and extending from the proximal end to the distal end,

collapsing the dilator by an action applied at the proximal end of said dilator,

removing the dilator from the sheath,

inserting instrumentation through the lumen of the sheath,

performing therapy or diagnosis with the instrumentation, and

removing the sheath from the patient.

2. The method of claim 1 wherein the dilation step is performed by inflating a balloon on the dilator.

3. The method of claim 1 wherein the dilation step is performed by attaching a liquid-filled inflation device to a balloon inflation port at the distal end of the dilator and infusing liquid under pressure into the dilator.

4. The method of claim 1 wherein the step of collapsing the dilator comprises withdrawing a plunger on the inflation device to withdraw liquid from the dilator.

5. The method of claim 1 wherein a guidewire is advanced to the treatment site prior to inserting the sheath and dilator into the body lumen or cavity.

6. The method of claim 1 wherein the sheath is advanced over a previously placed guidewire, which is routed through a lumen in the dilator.

7. The method of claim 1 wherein the sheath is advanced to a point in the body lumen or cavity which is anatomically distal to the site where therapy or diagnosis will be carried out by the instrumentation.

8. The method of claim 1 wherein the full-size lumen created by the dilator comprises a final sheath configuration where the distal sheath lumen circumference is substantially the same as the proximal lumen of the sheath.

9. The method of claim 1 wherein the full-size lumen created by the dilator comprises a final sheath configuration where the distal sheath lumen has a shape different from that of the proximal sheath lumen.

10. The method of claim 1 wherein the body lumen or cavity is the mammalian urinary tract.

11. The method of claim 1 wherein the target site for therapy or diagnosis is the mammalian ureter.

12. The method of claim 1 wherein the sheath further comprises a transition zone comprising the proximal and distal chevrons, the chevrons forming a substantially even zig-zag pattern with a substantially smooth gradual transition when undistorted.

13. The method of claim 1 wherein the sheath further comprises a non-expandable proximal region and a transition zone between the non-expandable proximal region and the expandable distal region, the regions being fused together along edges of the chevrons.

14. The method of claim 1 wherein the sheath further comprises longitudinal running flutes.

15. The method of claim 14 wherein the flutes reduce friction between an inner layer of the sheath and the instrumentation.