Ureteral stent for improved patient comfort

• US 6,991,614 B2
• Filed: 04/04/2003
• Issued: 01/31/2006
• Est. Priority Date: 11/07/1995
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Whitmore, Willet F. III, McWeeney, John O., Rubin, Stephanie
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/406,876
• Publication Number:
  US 20040059279A1
• Time in Patent Office: 1,033 Days
• Field of Search: 604 8- 9, 604/19, 604/93.01, 604/164.01, 604/264, 604/523, 604/525, 604/534, 604/537, 604540-544, 604/385.18, 604/904, 606/108, 623/23.64, 623/23.66, 623/23.7, 264/176.1
• US Class Current: 604/8
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2018/00148 with metal
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2002/048 Ureters
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract

Abstract

A ureteral stent for assisting the movement of urine along a patient'"'"'s ureter and into the patient'"'"'s bladder. The stent includes an elongated tubular segment extending toward the bladder from a kidney end region for placement in the renal cavity to a bladder end region. A central lumen connects at least one opening at the first end region to at least one opening in the bladder end region. Thin flexible tail(s) are attached to the bladder end region of the tubular segment at a point outside the bladder so as to receive urine from the opening in the bladder end region of the tubular segment and to transport urine from there across the ureter/bladder junction and into the bladder. The tails include an elongated external urine-transport surface sized and configured to transport urine along the ureter. The urine transporting surface(s) are sized and configured to extend along at least part of the ureter, across the ureter/bladder junction, and from there into the bladder. In some embodiments, the distal region includes a tubular body with a lumen in fluid communication with an interstitial area defined by one or more flexible filaments of the proximal region forming at least one loop.

Claims

1. A ureteral stent, comprising:

a distal region including a tubular body defining a lumen, the distal region including a retention structure configured to help retain the ureteral stent within a kidney of a patient, the distal region including a proximal end; and

a proximal region including a first loop and a second loop, the first loop and the second loop each extending monolithically from the proximal end of the distal region, the first loop and the second loop each being configured to be at least partially positioned in a bladder of the patient.

2. The ureteral stent of claim 1, wherein the proximal end of the distal region defines an opening, the opening being in communication with the lumen, the first loop having a first portion and a second portion, the second loop having a first portion and a second portion, the first portion of the first loop extending from the distal region at a first location, the second portion of the first loop extending from the distal region at a second location, the first location and the second location associated with the first loop defining an axis, the first portion of the second loop extending from the distal region at a first location, the second portion of the second loop extending from the distal region at a second location, the first location and the second location associated with the second loop defining an axis, the axis associated with the first loop and the axis associated with the second loop intersect within an area defined by the opening.

3. The ureteral stent of claim 1, wherein the first loop is continuous and unitary.

4. The ureteral stent of claim 1, wherein the first loop has a retention force insufficient to maintain the ureteral stent within the bladder.

5. The ureteral stent of claim 1, wherein a distal end of the first loop extends distally from a ureteral orifice of the patient about 3 centimeters or more.

6. The ureteral stent of claim 1, wherein the first loop includes a pliable portion, the pliable portion being softer than the distal region.

7. The ureteral stent of claim 1, wherein the first loop includes a pliable portion, the pliable portion is compressible upon an exertion of a pressure by a ureteral orifice of the patient.

8. The ureteral stent of claim 1, wherein the first loop includes a pliable portion, the pliable portion collapses sufficiently to inhibit urine reflux.

9. The ureteral stent of claim 1, wherein the first loop is sufficiently resilient to provide drainage along an interstitial space defined by the loop.

10. The ureteral stent of claim 1, wherein the first loop is sufficiently resilient to provide drainage along an interstitial space defined by the first loop, the interstitial space being at least partially collapsible upon exertion of body pressure.

11. The ureteral stent of claim 1, wherein the first loop and the second loop are each continuous and unitary.

12. The ureteral stent of claim 1, wherein the distal region has a hardness greater than the proximal region.

13. The ureteral stent of claim 1, wherein a hardness of the ureteral stent gradually decreases from the distal portion of the distal region to a proximal end of the proximal region.

14. The ureteral stent of claim 1, wherein the proximal region has a hardness of about 60–

80 Shore A.

15. The ureteral stent of claim 1, wherein the distal region has a hardness of at least about 80–

110 Shore A.

16. The ureteral stent of claim 1, wherein a length of the first loop is sufficient to maintain at least a portion of the first loop within the bladder after intubation, including upon routine movement of the kidney and the bladder.

17. The ureteral stent of claim 1, wherein the first loop has sufficient tensile strength to provide for extubation of the stent via the bladder.

18. The ureteral stent of claim 1, further comprising a lubricious coating.

19. The ureteral stent of claim 1, further comprising one or more openings disposed along the tubular body.

20. The ureteral stent of claim 1, wherein the first loop has a first portion and a second portion, the second loop has a first portion and a second portion, the first portion of the first loop extending from the distal region at a first location, the second portion of the first loop extending from the distal region at a second location, a first portion of a perimeter of the opening being located between the first location associated with the first portion of the first loop and the second location associated with the second portion of the first loop, a second portion of the perimeter of the opening being located between the first location associated with the first portion of the first loop and the second location associated with the second portion of the first loop, the first portion of the perimeter of the opening being different than the second portion of the perimeter of the opening, the first portion of the second loop extending from the first portion of the perimeter of the opening, the second portion of the second loop extending from the second portion of the perimeter of the opening.

21. A ureteral stent, comprising:

a distal region including a tubular body defining a lumen, the distal region including a retention structure configured to help retain the ureteral stent within a kidney of a patient, the distal region including a proximal end; and

a proximal region including a first loop and a second loop, the first loop and the second loop each extending from the distal region, the first loop and the second loop each being configured to be at least partially positioned in a bladder of the patient, the distal region and the first loop and the second loop being constructed of substantially the same material.

22. The ureteral stent of claim 21, wherein the proximal end of the distal region defines an opening, the opening being in communication with the lumen, the first loop having a first portion and a second portion, the second loop having a first portion and a second portion, the first portion of the first loop extending from the distal region at a first location, the second portion of the first loop extending from the distal region at a second location, the first location and the second location associated with the first loop defining an axis, the first portion of the second loop extending from the distal region at a first location, the second portion of the second loop extending from the distal region at a second location, the first location and the second location associated with the second loop defining an axis, the axis associated with the first loop and the axis associated with the second loop intersect within an area defined by the opening on the proximal end of the distal region.

23. The ureteral stent of claim 21, wherein the first loop is continuous and unitary.

24. The ureteral stent of claim 21, wherein the first loop has a first portion and a second portion, the second loop has a first portion and a second portion, the first portion of the first loop extending from the distal region at a first location, the second portion of the first loop extending from the distal region at a second location, a first portion of a perimeter of the opening being located between the first location associated with the first portion of the first loop and the second location associated with the second portion of the first loop, a second portion of the perimeter of the opening being located between the first location associated with the first portion of the first loop and the second location associated with the second portion of the first loop, the first portion of the perimeter of the opening being different than the second portion of the perimeter of the opening, the first portion of the second loop extending from the first portion of the perimeter of the opening, the second portion of the second loop extending from the second portion of the perimeter of the opening.