Expandable transluminal sheath

• US 8,764,704 B2
• Filed: 12/11/2012
• Issued: 07/01/2014
• 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 A., Nance, Edward J., Bishop, Joseph, Kick, George F.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US13/710,762
• Publication Number:
  US 20130261399A1
• Time in Patent Office: 567 Days
• Field of Search: 604/96.01, 60416401-16403, 604523-527, 604/103.05, 606191-194
• 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. An expandable transluminal access sheath adapted for providing minimally invasive access to body lumens or cavities, comprising:

an axially elongate sheath tube with a proximal and a distal end and a central through lumen;

a distal region of the sheath which is expandable in circumference in response to pressure applied therein,

a hub affixed to the proximal end of the sheath tube, the hub adapted to form a tapered internal lumen to facilitate the passage of instrumentation;

a central obturator, which serves to occlude the central lumen of the sheath during insertion; and

a guidewire lumen within the obturator, capable of passing standard medical guidewires;

wherein the obturator is a balloon dilator capable of expanding the distal region of the sheath.

2. The transluminal sheath of claim 1 wherein the sheath tube comprises an outer layer, an inner layer, and a reinforcing layer wherein the outer layer and the inner layer comprises a polymer.

3. The transluminal sheath of claim 2 wherein the polymeric material is polyolefin.

4. The transluminal sheath of claim 2 wherein the polyolefin is selected from a blend of high-density and low-density polyethylene.

5. The transluminal sheath of claim 2 wherein the inner and outer layer are fabricated from different polymers.

6. The transluminal sheath of claim 2 wherein the inner or outer layer are fabricated from a blend of high-density and low-density polyethylene wherein the ratio is 25% of one polymer and 75% of the other polymer.

7. The transluminal sheath of claim 2 wherein the sheath bends predominantly by plastic deformation rather than elastic deformation.

8. The transluminal sheath of claim 2 wherein the sheath bends predominantly by plastic deformation, said deformation being enhanced by subjecting the sheath to temperatures substantially near those of body temperature.

9. The transluminal sheath of claim 2 wherein the reinforcing layer is a braided structure fabricated from polymeric materials.

10. The transluminal sheath of claim 2 wherein the reinforcing layer is a braided structure fabricated from polyethylene napthalate.

11. The transluminal sheath of claim 2 wherein the reinforcing layer is a braided structure fabricated from polyethylene terephthalate.

12. The transluminal sheath of claim 2 wherein the reinforcing layer is a braided structure fabricated from a blend of PET and PEN, wherein the ratio of PET to PEN varies from 0.1 to 0.9.

13. The transluminal sheath of claim 2 wherein the reinforcing layer is a braided structure fabricated from polyamide.

14. The transluminal sheath of claim 2 wherein the reinforcing layer is a braided structure with a pick count ranging between 10 and 30 picks per inch and between 8 and 42 carriers of strand.

15. The transluminal sheath of claim 2 wherein the reinforcing layer is a braided structure comprising fibers with primary diameters between 0.001 inches and 0.010 inches.

16. The transluminal sheath of claim 2 wherein the reinforcing layer is substantially deformable in cross-section.

17. The transluminal sheath of claim 2 wherein the sheath tube is substantially deformable in cross-section in response to irregularly shaped objects being advanced or withdrawn therethrough.

18. The transluminal sheath of claim 2 wherein the reinforcing layer is a coil of flat wire.

19. The transluminal sheath of claim 2 wherein the inner member, the reinforcing layer, and the outer member are fabricated from polymeric materials.

20. The transluminal sheath of claim 2 wherein the sheath comprises a radiopaque marker.