Ureteral stent

• US 7,470,247 B2
• Filed: 04/26/2004
• Issued: 12/30/2008
• Est. Priority Date: 04/26/2004
• Status: Active Grant

• Current Assignee: Gyrus ACMI, Inc. (Olympus Corporation)
• Original Assignee: Gyrus ACMI, Inc. (Olympus Corporation)
• Inventors: Nishtala, Vasu, Aliski, Peter, Tremaglio, Anthony, Shia, Benedict
• Primary Examiner(s): Sweet; Thomas J
• Application Number:
  US10/832,495
• Publication Number:
  US 20050240280A1
• Time in Patent Office: 1,709 Days
• Field of Search: None
• US Class Current: 604/8
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract

Abstract

A ureteral stent comprising an elongated tubular member having a body portion and opposed distal end portion and proximal end portion, the elongated tubular member defining a lumen therein; a retention disk comprising a plurality of generally axial, spaced-apart collapsable struts interconnected with a membrane to form a generalized tube with a retention disk lumen therein, the retention disk lumen in fluid communication with the lumen of the body portion, the struts and the membrane couple to the body portion proximal end at a retention disk distal end and terminate at a retention disk proximal end, each strut having a widthwise folding hinge substantially dividing the length of the strut, the struts adapted to have an expanded state wherein the struts are unfolded and substantially straight, as well as a free-resting state wherein each strut folds in upon itself at the folding hinge to form an inverted umbrella-like disk-shaped configuration; and a valve, wherein the inverted umbrella-like configuration provides a conformal shape to the ureteral orifice.

Claims

1. A stent comprising:

an elongated tubular member having a body portion, a proximate end portion and a distal end portion, the tubular member having an axial lumen therein adapted to provide fluid communication from the distal end portion to the proximal end portion; and

a retention disk comprising a first, pre-deployment configuration wherein a plurality of generally axial, spaced-apart collapsable struts interconnected with a membrane form a generalized tube with a retention disk lumen therein, the retention disk lumen in fluid communication with the lumen of the body portion, the struts and the membrane couple to the body portion proximal end at a retention disk distal end and terminate at a retention disk proximal end, each strut having a widthwise folding hinge substantially dividing the length of the strut, the struts adapted to have an expanded state wherein the struts are unfolded and substantially straight; and

a second, fully deployed, free state configuration wherein each strut folds in upon itself in a free resting state at the folding hinge to form an inverted umbrella-like disk-shaped configuration, and wherein the retention disk is biased to a fully deployed umbrella-like shaped configuration.

2. The stent of claim 1, wherein the inverted umbrella-like configuration is adapted to provide a conformal shape to the ureteral orifice.

3. The stent of claim 1, wherein the umbrella-like configuration substantially prevents the stent from irritating the trigone area of the bladder.

4. The stent of claim 1, wherein the umbrella-like configuration provides a seal between the ureteral orifice and the retention disk.

5. The stent of claim 1, wherein the struts comprise nickel-titanium alloy.

6. The stent of claim 1, wherein the membrane comprises a relatively low durometer material.

7. The stent of claim 1, wherein the membrane comprise a material that is elastic and allows for the radially expansion of the struts.

8. The stent of claim 1, further comprising a valve coupled to the retention disk proximal end, the valve comprising at least two valve lips that couple the retention disk proximal end and converge in engagement at a valve opening, the valve lips defining a lumen therebetween and in communication with the retention disk lumen.

9. The stent of claim 8, wherein the valve lips press together at the valve opening creating a tight seal against the passage of fluids up to a certain head pressure.

10. The stent of claim 8, wherein the valve lips are held elastically in a closed position by means of a force inherent in the shape and material of valve lips.

11. The stent of claim 8, wherein the valve lips open under the force due to the pressure of the fluid coming from the lumen, the force exceeding the force due to the elasticity of the materials.

12. The stent of claim 8, wherein the valve is functionally sealed by the valve lips when pressure in the bladder is increased, such as during voiding.

13. The stent of claim 8, wherein the valve opening remains slightly open in the relaxed state to permit fluid flow and closes tightly upon increased pressure in the bladder, such as during voiding.

14. The stent of claim 1, further comprising:

at least a portion of the proximal end portion comprises a flexible portion adapted to provide both longitudinal elasticity allowing for stretch and recoil, as well as radial elasticity allowing for bending and recovery.

15. The stent of claim 14, wherein the flexible portion is a region having material of differing material properties than the body portion.

16. The stent of claim 14, wherein the flexible portion is characterized as a region of thinning of a wall of the tubular member.

17. The stent of claim 14, wherein the flexible portion comprises a geometric change adapted to impart a more flexible property.

18. The stent of claim 14, further comprising:

a valve coupled to the retention disk proximal end, the valve comprising at least two valve lips that couple the retention disk proximal end and converge in engagement at a valve opening, the valve lips defining a lumen therebetween and in communication with the retention disk lumen; and

wherein the body portion is adapted to be positioned within the ureter, the stent thereby provides fluid communication along its length from the distal end portion to the proximal end portion, to the valve, and to the bladder.

19. A ureteral stent for maintaining drainage between the kidney and bladder comprising:

an elongated tubular member having a body portion, a proximate end portion and a distal end portion, the tubular member having an axial lumen therein adapted to provide fluid communication from the distal end portion to the proximal end portion; and

a retention disk comprising a first, pre-deployment configuration wherein a plurality of generally axial, spaced-apart collapsable struts interconnected with a membrane form a generalized tube with a retention disk lumen therein, the retention disk lumen in fluid communication with the lumen of the body portion, the struts and the membrane couple to the body portion proximal end at a retention disk distal end and terminate at a retention disk proximal end, each strut having a widthwise folding hinge substantially dividing the length of the strut, the struts adapted to have an expanded state wherein the struts are unfolded and substantially straight; and

a second, fully deployed, free state configuration wherein each strut folds in upon itself in a free resting state at the folding hinge to form an inverted umbrella-like disk-shaped configuration, and wherein the retention disk is biased to a fully deployed umbrella-like shaped configuration.

20. The stent of claim 19, further comprising a valve coupled to the retention disk proximal end, the valve comprising at least two valve lips that couple to the retention disk proximal end and converge in engagement at a valve opening, the valve lips defining a lumen therebetween and in communication with the retention disk lumen.

21. The stent of claim 19, further comprising:

at least a portion of the proximal end portion comprises a flexible portion adapted to provide both longitudinal elasticity allowing for stretch and recoil, as well as radial elasticity allowing for bending and recovery.

22. A ureteral stent for maintaining drainage between the kidney and bladder comprising:

an elongated tubular member having a body portion, a proximate end portion and a distal end portion, the tubular member having an axial lumen therein adapted to provide fluid communication from the distal end portion to the proximal end portion; and

a retention disk comprising a first, pre-deployment configuration wherein a plurality of generally axial, spaced-apart collapsable struts interconnected with a membrane form a generalized tube with a retention disk lumen therein, the retention disk lumen in fluid communication with the lumen of the body portion, the struts and the membrane couple to the body portion proximal end at a retention disk distal end and terminate at a retention disk proximal end, each strut having a widthwise folding hinge substantially dividing the length of the strut, the struts adapted to have an expanded state wherein the struts are unfolded and substantially straight; and

a second, fully deployed, free state configuration wherein each strut folds in upon itself in a free resting state at the folding hinge to form an inverted umbrella-like disk-shaped configuration, and wherein the retention disk is biased to a fully deployed umbrella-like shaped configuration; and

a valve coupled to the retention disk proximal end, the valve comprising at least two valve lips that couple to the retention disk proximal end and converge in engagement at a valve opening, the valve lips defining a lumen therebetween and in communication with the retention disk lumen.

23. A stent comprising:

an elongated tubular member having a body portion, a proximate end portion and a distal end portion, the tubular member having an axial lumen therein adapted to provide fluid communication from the distal end portion to the proximal end portion; and

a retention disk comprising a single integrated structure formed of a plurality of struts and membranes, the membranes coupled along the sides of the struts and spanning the area in between the struts, but not covering the struts, and the retention disk having first, pre-deployment configuration wherein the plurality of generally axial, spaced-apart collapsible struts interconnected with membranes in between the struts to form a generalized tube with a retention disk lumen therein, the retention disk lumen in fluid communication with the lumen of the body portion, the struts and the membranes couple to the body portion proximal end at a retention disk distal end and terminate at a retention disk proximal end, each strut having a widthwise folding hinge substantially dividing the length of the strut, the struts adapted to have an expanded state wherein the struts are unfolded and substantially straight; and

a second, fully deployed, free state configuration wherein each strut folds in upon itself in a free resting state at the folding hinge and the membranes expanding in between the struts to form an inverted umbrella-like disk-shaped configuration, and wherein the retention disk is biased to a fully deployed umbrella-like shaped configuration.

24. The stent of claim 23, further comprising a valve coupled to the retention disk proximal end, the valve comprising at least two valve lips that couple the retention disk proximal end and converge in engagement at a valve opening, the valve lips defining a lumen there between and in communication with the retention disk lumen.

25. The stent of claim 23, further comprising:

at least a portion of the proximal end portion comprises a flexible portion adapted to provide both longitudinal elasticity allowing for stretch and recoil, as well as radial elasticity allowing for bending and recovery.

26. A ureteral stent for maintaining drainage between the kidney and bladder comprising:

an elongated tubular member having a body portion, a proximate end portion and a distal end portion, the tubular member having an axial lumen therein adapted to provide fluid communication from the distal end portion to the proximal end portion;

a retention disk comprising a first, pre-deployment configuration wherein a plurality of generally axial, spaced-apart collapsible struts interconnected with edges that couple to a plurality of membranes, each membrane coupled to two struts along lengths of the edge of the strut and spanning the area in between the struts a to form a generalized tube with a retention disk lumen therein, the retention disk lumen in fluid communication with the lumen of the body portion, the struts and the membranes couple to the body portion proximal end at a retention disk distal end and terminate at a retention disk proximal end, each strut having a widthwise folding hinge substantially dividing the length of the strut, the struts adapted to have an expanded state wherein the struts are unfolded and substantially straight; and

a second, fully deployed, free state configuration wherein each strut folds in upon itself in a free resting state at the folding hinge and the struts and membranes form an inverted umbrella-like disk-shaped configuration, and wherein the retention disk is biased to a fully deployed umbrella-like shaped configuration;

wherein each membrane comprises a material that is elastic and allows for radial expansion of the struts; and

wherein the struts and membranes expand simultaneously while the retention disk is undergoing deployment.

27. A stent comprising:

an elongated tubular member having a body portion, a proximate end portion and a distal end portion, the tubular member having an axial lumen therein adapted to provide fluid communication from the distal end portion to the proximal end portion;

a retention disk comprising a first, pre-deployment configuration wherein a plurality of generally axial, spaced-apart collapsible struts with a plurality of distinct membranes affixed at the edges of the struts and spanning an area between the struts to form a generalized tube with a retention disk lumen therein, the retention disk lumen in fluid communication with the lumen of the body portion, the struts and the membranes couple to the body portion proximal end at a retention disk distal end and terminate at a retention disk proximal end, each strut having a widthwise folding hinge substantially dividing the length of the strut, the struts adapted to have an expanded state wherein the struts are unfolded and substantially straight; and

a second, fully deployed, free state configuration wherein each strut folds in upon itself in a free resting state at the folding hinge to form an inverted umbrella-like disk-shaped configuration, and wherein the retention disk is biased to a fully deployed umbrella-like shaped configuration.