Expandable percutaneous sheath

• US 9,241,735 B2
• Filed: 12/05/2003
• Issued: 01/26/2016
• Est. Priority Date: 12/05/2003
• Status: Active Grant

• 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
• Assistant Examiner(s): SIMPSON, SARAH A
• Application Number:
  US10/728,728
• Publication Number:
  US 20050124937A1
• Time in Patent Office: 4,435 Days
• Field of Search: 606/192, 604/104, 604/164.04
• US Class Current: 1/1
• 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 method of providing percutaneous access, said method comprising:

making an incision through skin;

inserting a guidewire through the incision in the skin and into or through the renal collection system,

percutaneously inserting a circumferentially continuous elongate tubular structure through the incision in the skin and over the guidewire and into the renal collection system, the elongate tubular structure comprising a distal region, a proximal region, and a tapered region between the distal region and the proximal region, the distal region having a first, folded, smaller cross-sectional profile and the proximal region having a second, greater cross-sectional profile;

inflating a balloon that is positioned within an interior lumen of said folded distal region of said elongate tubular structure to expand and unfold said distal region of said elongate tubular structure radially around its longitudinal axis from said first, smaller cross-sectional profile to said second, greater cross-sectional profile;

releasing the elongate tubular structure from a constraining tubular jacket, the constraining tubular jacket sharing the same longitudinal axis as the elongate tubular structure, wherein releasing the elongate tubular structure from the constraining tubular jacket comprises tearing said constraining tubular jacket along a perforation; and

removing said balloon from said distal region of said elongate tubular structure to open the interior lumen in said elongate tubular structure, the interior lumen open to an external environment outside the skin on its proximal end and open to the renal collection system on its distal end.

2. The method of claim 1, wherein the inflating a balloon is accomplished using a balloon catheter positioned within the interior lumen of the distal region of the elongate tubular structure.

3. The method of claim 1, wherein the inflating a balloon comprises radially expanding said balloon.

4. The method of claim 1, further comprising the step of separating said constraining tubular jacket from said elongate tubular structure.

5. A method of providing percutaneous access, said method comprising:

making an incision through skin;

inserting a guidewire through the incision in the skin and into or through the renal collection system,

percutaneously inserting a circumferentially continuous elongate tubular structure through the incision in the skin and over the guidewire and into the renal collection system, the elongate tubular structure comprising a distal region, a proximal region, and a tapered region between the distal region and the proximal region, the distal region having a first, folded, smaller cross-sectional profile and a beveled distal tip, the proximal region having a second, greater cross-sectional profile;

inflating a balloon that is positioned within an interior lumen of said folded distal region of said elongate tubular structure to expand and unfold said distal region of said elongate tubular structure from said first, smaller cross-sectional profile to said second, greater cross-sectional profile;

releasing the elongate tubular structure from a constraint, the constraint sharing the same longitudinal axis as the elongate tubular structure, wherein releasing the elongate tubular structure from the constraint comprises tearing said constraint along a perforation; and

removing said balloon from said distal region of said elongate tubular structure to open the interior lumen in said elongate tubular structure, the interior lumen open to an external environment outside the skin on its proximal end and open to the renal collection system through said beveled distal tip.

6. The method of claim 5, wherein the inflating a balloon is accomplished using a balloon catheter positioned within the interior lumen of the distal region of the enlongate tubular structure.

7. The method of claim 5, wherein the inflating a balloon comprises radially expanding said balloon.

8. The method of claim 5, further comprising the step of separating said constraint from said elongate tubular structure.

9. A method of providing percutaneous access, said method comprising:

making an incision through skin;

inserting a guidewire through the incision in the skin and into or through the renal collection system,

percutaneously inserting a circumferentially continuous elongate tubular structure over the guidewire and into the renal collection system, the elongate tubular structure comprising a distal region, a proximal region, and a tapered region between the distal region and the proximal region, the distal region having a first, folded, smaller cross-sectional profile and the proximal region having a second, unfolded, greater cross-sectional profile;

inflating a balloon that is positioned within an interior lumen of said folded distal region of said elongate tubular structure to expand and unfold said distal region of said elongate tubular structure from said first, smaller cross-sectional profile to said second, greater cross-sectional profile;

releasing the elongate tubular structure from a constraining tubular jacket, the constraining tubular jacket sharing the same longitudinal axis as the elongate tubular structure, wherein releasing the elongate tubular structure from the constraining tubular jacket comprises tearing said constraining tubular jacket along a score line; and

removing said balloon from said distal region of said elongate tubular structure to open the interior lumen in said elongate tubular structure, the interior lumen open to an external environment outside the skin on its proximal end and open to the renal collection system on its distal end.

10. The method of claim 9, wherein the inflating a balloon is accomplished using a balloon catheter positioned within the interior lumen of the distal region of the enlongate tubular structure.

11. The method of claim 9, wherein the inflating a balloon comprises radially expanding said balloon.

12. The method of claim 9, further comprising the step of separating said constraining tubular jacket from said elongate tubular structure.

13. A method of providing percutaneous access, said method comprising:

making an incision through skin;

inserting a guidewire through the incision in the skin and into or through the renal collection system,

percutaneously inserting a circumferentially continuous elongate tubular structure through the skin over the guidewire and into the renal collection system, the elongate tubular structure comprising a distal region, a proximal region, and a tapered region between the distal region and the proximal region, the distal region having a first, folded, smaller cross-sectional profile and a beveled distal tip, the proximal region having a second, greater cross-sectional profile;

inflating a balloon that is positioned within an interior lumen of said folded distal region of said elongate tubular structure to expand said distal region of said elongate tubular structure from said first, folded, smaller cross-sectional profile to said second, greater cross-sectional profile;

releasing the elongate tubular structure from a constraint, the constraint sharing the same longitudinal axis as the elongate tubular structure, wherein releasing the elongate tubular structure from the constraint comprises tearing said constraint along a score line; and

removing said balloon from said distal region of said elongate tubular structure to open the interior lumen in said elongate tubular structure, the interior lumen open to an external environment outside the skin on its proximal end and open to the renal collection system through said beveled distal tip.

14. The method of claim 13, wherein the inflating a balloon is accomplished using a balloon catheter positioned within the interior lumen of the distal region of the enlongate tubular structure.

15. The method of claim 13, wherein the inflating a balloon comprises radially expanding said balloon.

16. The method of claim 13, further comprising the step of separating said constraint from said elongate tubular structure.

17. A method of providing percutaneous access, said method comprising:

making an incision through skin;

inserting a guidewire through the incision in the skin and into or through the renal collection system,

percutaneously inserting a circumferentially continuous elongate tubular structure through the incision in the skin over the guidewire and into the renal collection system, the elongate tubular structure comprising a distal region, a proximal region, and a tapered region between the distal region and the proximal region, the distal region having a first, folded, substantially continuous, smaller cross-sectional profile, the proximal region having a second, unfolded, greater cross-sectional profile;

inflating a balloon positioned within an interior lumen of said folded distal region of said elongate tubular structure to expand and unfold said distal region of said elongate tubular structure from said first, folded, substantially continuous, smaller cross-sectional profile to said second, unfolded, greater cross-sectional profile; and

removing said balloon from the interior lumen of said distal region of said elongate tubular structure to open the interior lumen in said elongate tubular structure, the interior lumen open to an external environment outside the skin on its proximal end and open to the renal collection system on its distal end.

18. The method of claim 17, wherein the inflating a balloon is accomplished using a balloon catheter positioned within the interior lumen of the distal region of the elongate tubular structure.

19. The method of claim 17, wherein the inflating a balloon comprises radially expanding said balloon.