Expandable transluminal sheath

• US 9,801,619 B2
• Filed: 05/23/2014
• Issued: 10/31/2017
• 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:
  US14/286,944
• Publication Number:
  US 20140257042A1
• Time in Patent Office: 1,257 Days
• Field of Search: 604 9601, 60416403, 604104-109
• 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 providing access to a body lumen comprising the steps of:

inserting a sheath into a body lumen;

the sheath having an axially elongate sheath tube with a proximal region, a distal region, and a central through lumen;

advancing the sheath to a desired site within the body lumen;

occluding the central through lumen with a central obturator during the inserting and advancing of the sheath within the body lumen;

dilating the distal region of the sheath to an expanded diameter by inflating a balloon on the central obturator, thereby forming a substantially uniform diameter of the central through lumen throughout an entire length of the central through lumen, including the proximal region and the distal region;

collapsing the balloon of the central obturator by an action applied at the proximal end of said central obturator,

removing the central obturator from the sheath,

inserting a device into the central through lumen of the sheath and advancing it to the desired site,

performing a desired operation with the device, and

removing the sheath from the patient.

2. The method of claim 1 wherein the dilating is performed by attaching a liquid-filled inflation device to a balloon inflation port at the distal end of the central obturator and infusing fluid under pressure into the central obturator.

3. The method of claim 1 wherein the step of collapsing the central obturator comprises withdrawing a plunger on an inflation device to withdraw fluid from the central obturator.

4. The method of claim 1 wherein a guidewire is advanced to the desired site prior to inserting the sheath into the body lumen.

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

6. The method of claim 1 wherein the desired site is anatomically distal to the region where the desired operation is intended to be performed.

7. The method of claim 1 wherein the body lumen is a mammalian urinary tract.

8. The method of claim 1 wherein the desired site is the mammalian ureter.

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

10. 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 distal region, the regions being fused together along edges of chevrons.

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

12. The method of claim 11 wherein the flutes reduce friction between an inner layer of the sheath and the instrumentation.