Atraumatic ureteral access sheath

• US 8,235,968 B2
• Filed: 04/13/2005
• Issued: 08/07/2012
• Est. Priority Date: 04/13/2004
• Status: Active Grant

• Current Assignee: Gyrus ACMI, Inc. (Olympus Corporation)
• Original Assignee: Gyrus ACMI, Inc. (Olympus Corporation)
• Inventors: Tremaglio, Anthony
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US11/105,808
• Publication Number:
  US 20050228361A1
• Time in Patent Office: 2,673 Days
• Field of Search: 604/525, 604/524, 604/529, 604/534, 604/523
• US Class Current: 604/525
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• 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 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers

Abstract

A ureteral access sheath having nonuniform axial-stiffness adapted for proximal pushability needed for placement while also having distal flexibility to minimize trauma to the body lumen and ureter. Embodiments in accordance with the present invention provide a nonuniform axial-stiffness ureteral access sheath comprising a nonuniform axial-stiffness jacket encapsulating the reinforcement layer with the inner liner. Other embodiments in accordance with the present invention provide a nonuniform axial-stiffness ureteral access sheath comprising a nonuniform axial-stiffness reinforcement layer encapsulated between a single axial-stiffness jacket and the inner liner. Other embodiments in accordance with the present invention provide a nonuniform axial-stiffness ureteral access sheath comprising a nonuniform axial-stiffness jacket encapsulating a nonuniform axial-stiffness reinforcement layer with the inner liner.

Claims

1. A nonuniform axial-stiffness ureteral access sheath, comprising:

a tubular inner liner;

a reinforcement layer coaxially located over the inner liner; and

an outer jacket coaxially located over the reinforcement layer, the outer jacket having a jacket proximal portion and a jacket distal portion, the jacket proximal portion having a higher durometer than the jacket distal portion, wherein along a length of the sheath, spanning the jacket distal portion and jacket proximal portion, there are spaces between the tubular inner liner and the outer jacket that are void of reinforcement layer structure.

2. The sheath of claim 1, wherein the outer jacket comprises at least two coaxial tube portions tandemly disposed over the reinforcement layer, the tube portions having dissimilar axial-stiffness.

3. The sheath of claim 1, wherein the outer jacket comprises a butt-joint transition region between the jacket proximal portion and a jacket distal portion.

4. The sheath of claim 1, wherein the outer jacket comprises a tapered transition region between the jacket proximal portion and a jacket distal portion.

5. The sheath of claim 1, wherein the reinforcement layer comprises a reinforcement layer proximal portion and a reinforcement layer distal portion, the reinforcement layer proximal portion having a higher axial stiffness than the reinforcement layer distal portion.

6. The sheath of claim 1, wherein the outer jacket extends beyond the reinforcement layer distal portion defining a distal tip.

7. The sheath of claim 1, further comprising a radiopaque element, wherein the outer jacket and the inner liner extend beyond the reinforcement layer distal portion defining a distal tip, the radiopaque element disposed adjacent the reinforcement layer distal portion at the distal tip between the extended inner liner and outer jacket.

25. The nonuniform axial-stiffness ureteral access sheath of claim 1, wherein the reinforcement layer comprises a coil configured to provide a non-uniform axial stiffness.

8. A nonuniform axial-stiffness ureteral access sheath, comprising:

a tubular inner liner;

a reinforcement layer coaxially located over the inner liner, the reinforcement layer comprising a reinforcement layer proximal portion and a reinforcement layer distal portion, the reinforcement layer proximal portion having a higher axial stiffness than the reinforcement layer distal portion; and

an outer jacket coaxially located over the reinforcement layer wherein along a length of the sheath, spanning the reinforcement layer proximal portion and the reinforcement layer distal portion, there are spaces between the tubular inner liner and the outer jacket that are void of reinforcement layer structure.

9. The sheath of claim 8, wherein the outer jacket has a jacket proximal portion and a jacket distal portion, the jacket proximal portion having a higher durometer than the jacket distal portion.

10. The sheath of claim 9, wherein the outer jacket comprises at least two coaxial tube portions tandemly disposed over the reinforcement layer, the tube portions having dissimilar axial-stiffness.

11. The sheath of claim 9, wherein the outer jacket comprises a butt-joint transition region between the jacket proximal portion and a jacket distal portion.

12. The sheath of claim 9, wherein the outer jacket comprises a tapered transition region between the jacket proximal portion and a jacket distal portion.

13. The sheath of claim 9, wherein the outer jacket extends beyond the reinforcement layer distal portion defining a distal tip.

14. The sheath of claim 9, further comprising a radiopaque element, wherein the outer jacket and the inner liner extend beyond the reinforcement layer distal portion defining a distal tip, the radiopaque element disposed adjacent the reinforcement layer distal portion at the distal tip between the extended inner liner and the outer jacket.

26. The nonuniform axial-stiffness ureteral access sheath of claim 8, wherein the reinforcement layer comprises a coil configured to provide a non-uniform axial stiffness.

15. A method of constructing a nonuniform axial-stiffness ureteral access sheath comprising:

providing an elongated tubular inner liner having a liner proximal portion and a liner distal portion;

providing an outer jacket disposed over the inner liner, the outer jacket comprising a jacket proximal portion having a higher durometer and a jacket distal portion having a lower durometer; and

providing a reinforcement layer coaxially disposed between the inner liner and outer jacket, and wherein along a length of the sheath, spanning the jacket distal portion and jacket proximal portion, there are spaces between the tubular inner liner and the outer jacket that are void of reinforcement layer structure.

16. The method of claim 15, wherein providing an outer jacket disposed over the inner liner comprises providing an outer jacket disposed over the inner liner extending from the liner proximal portion to the liner distal portion, and

wherein providing a reinforcement layer coaxially disposed between the inner liner and outer jacket comprises providing a reinforcement layer coaxially disposed between the inner liner and outer jacket extending from the liner proximal portion to the liner distal portion.

17. The method of claim 15, wherein providing an outer jacket disposed over the inner liner comprises providing an outer jacket disposed over the inner liner extending from the liner proximal portion to beyond the liner distal portion forming a distal tip.

18. The method of claim 15, wherein providing a reinforcement layer coaxially disposed between the inner liner and outer jacket comprises providing a reinforcement layer coaxially disposed between the inner liner and outer jacket extending from the liner proximal portion and spaced from the liner distal portion, the method further comprising:

disposing a radiopaque element at the distal tip adjacent the reinforcement layer between the liner distal end and the outer jacket.

19. The method of claim 15, wherein providing a reinforcement layer coaxially disposed between the inner liner and outer jacket comprises providing a reinforcement layer coaxially disposed between the inner liner and outer jacket, the reinforcement layer comprising a reinforcement layer proximal portion having a higher axial stiffness and a reinforcement layer distal portion having a lower axial stiffness.

27. The method of claim 15, wherein the reinforcement layer comprises a coil configured to provide a non-uniform axial stiffness.

20. A method of constructing a nonuniform axial-stiffness ureteral access sheath comprising:

providing an elongated tubular inner liner having a liner proximal portion and a liner distal portion;

providing an outer jacket disposed over the inner liner; and

providing a reinforcement layer coaxially disposed between the inner liner and outer jacket, the reinforcement layer comprising a reinforcement layer proximal portion having a higher axial stiffness and a reinforcement layer distal portion having a lower axial stiffness and wherein along a length of the sheath, spanning the reinforcement layer distal portion and the reinforcement layer proximal portion, there are spaces between the tubular inner liner and the outer jacket that are void of reinforcement layer structure.

21. The method of claim 20, wherein providing an outer jacket disposed over the inner liner comprises providing an outer jacket disposed over the inner liner extending from the liner proximal portion to the liner distal portion, and

wherein providing a reinforcement layer coaxially disposed between the inner liner and outer jacket comprises providing a reinforcement layer coaxially disposed between the inner liner and outer jacket extending from the liner proximal portion to the liner distal portion.

22. The method of claim 20, wherein providing an outer jacket disposed over the inner liner comprises providing an outer jacket disposed over the inner liner extending from the liner proximal portion to beyond the liner distal portion forming a distal tip.

23. The method of claim 20, wherein providing a reinforcement layer coaxially disposed between the inner liner and outer jacket comprises providing a reinforcement layer coaxially disposed between the inner liner and outer jacket extending from the liner proximal portion and spaced from the liner distal portion, the method further comprising:

disposing a radiopaque element at the distal tip adjacent the reinforcement layer between the liner distal end and the outer jacket.

24. The method of claim 20, wherein providing an outer jacket disposed over the inner liner comprises providing an outer jacket disposed over the inner liner, the outer jacket comprising a jacket proximal portion having a higher durometer and a jacket distal portion having a lower durometer.

28. The method of claim 20, wherein the reinforcement layer comprises a coil configured to provide a non-uniform axial stiffness.