Expandable percutaneous sheath

• US 10,349,976 B2
• Filed: 01/25/2016
• Issued: 07/16/2019
• 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: Kick, George F., Nguyen, Thanh Van, Shaolian, Samuel M.
• Primary Examiner(s): Holwerda, Kathleen S
• Assistant Examiner(s): Simpson, Sarah A
• Application Number:
  US15/006,025
• Publication Number:
  US 20160135840A1
• Time in Patent Office: 1,268 Days
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• 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 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• 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: A61B 2017/3486 Balloon
• 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 25/0668 splittable, tear apart
• 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 sheath assembly for providing minimally invasive access for percutaneous nephrostomy or bladder access comprising:

a balloon catheter having a balloon positioned on its distal end and which carries at least a first marker and a second marker;

a circumferentially continuous elongate tubular structure having an unfoldable and expandable distal region including a distal end that forms a distal face which is beveled with respect to a longitudinal axis of the elongate tubular structure, a proximal region, and a tapered region between the distal region and the proximal region, the distal region is configured to unfold and expand from a first, folded, smaller cross-sectional profile to a second, greater cross-sectional profile radially around a longitudinal axis of the elongate tubular structure by the balloon that is positioned within an interior lumen of the distal region and removable so as to allow access by devices within a patient, wherein the balloon catheter is arranged such that the first marker is aligned with a front edge of the distal face in an expanded position and the second marker is aligned with a rear edge of the distal face in an expanded position, and

a constraining releasable jacket sharing the same longitudinal axis as the elongate tubular structure and being carried by the percutaneous access sheath assembly to restrain at least a portion of said elongate tubular structure in said first, smaller cross-sectional profile;

the constraining releasable jacket being releasable by tearing the constraining releasable jacket along a perforation.

2. The percutaneous access sheath assembly of claim 1, wherein the balloon is capable of being expanded in a radial direction to radially expand said portion of said elongate tubular structure.

3. The percutaneous access sheath assembly of claim 1, wherein when said elongate tubular structure is in said first, smaller cross-sectional profile it has an outer diameter of about 10 French to about 30 French.

4. The percutaneous access sheath assembly of claim 3, wherein when said elongate tubular structure is in said second, greater cross-sectional profile it has an outer diameter of about 15 to about 40 French.

5. The percutaneous access sheath assembly of claim 1, wherein when said elongate tubular structure is in said second, greater cross-sectional profile it has an inner diameter of about 12 to about 37 French.

6. The percutaneous access sheath assembly of claim 1, wherein the distal face forms an angle of about 45 to about 75 degrees with respect to the longitudinal axis of the elongate tubular structure.

7. The percutaneous access sheath assembly of claim 1, wherein the balloon catheter is positioned within the elongate tubular structure, the balloon catheter carrying said balloon to expand said portion of said elongate tubular structure from said first, smaller cross-sectional profile to said second, greater cross-sectional profile.

8. The percutaneous access sheath assembly of claim 1, wherein the constraining releasable jacket is attached to the elongate tubular structure.

9. The percutaneous access sheath assembly of claim 8, wherein the constraining releasable jacket comprises a perforation.

10. The percutaneous access sheath assembly of claim 8, wherein the constraining releasable jacket comprises a score line.

11. The percutaneous access sheath assembly of claim 8, wherein the constraining releasable jacket is formed of a material that will separate along a longitudinal axis as the elongate tubular structure is expanded in a radial direction.

12. The percutaneous access sheath assembly of claim 1, wherein the constraining releasable jacket comprises a perforation.

13. The percutaneous access sheath assembly of claim 1, wherein the constraining releasable jacket comprises a score line.

14. The percutaneous access sheath assembly of claim 1, wherein the constraining releasable jacket is formed of a material that will separate along a longitudinal axis as the elongate tubular structure is expanded in a radial direction.

15. The percutaneous access sheath assembly of claim 1, wherein the constraining releasable jacket is not attached to the elongate tubular structure.

16. The percutaneous access sheath assembly of claim 1, wherein when said portion of said elongate tubular structure is in said first smaller cross-sectional profile it is folded into at least 2 sections.

17. The percutaneous access sheath assembly of claim 1, wherein when said portion of said elongate tubular structure is in said first smaller cross-sectional profile it is folded into 2 to 6 sections.

18. The percutaneous access sheath assembly of claim 1, wherein said portion of said elongate tubular structure is capable of being expanded in response to a radial force.

19. The percutaneous access sheath assembly of claim 1, wherein the entire elongate tubular structure is restrained by the constraining releasable jacket in said first, smaller cross-sectional profile.