Spiral ureteral stent

• US 4,813,925 A
• Filed: 04/21/1987
• Issued: 03/21/1989
• Est. Priority Date: 04/21/1987
• Status: Expired due to Term

• Current Assignee: Cabot Corporation
• Original Assignee: Medical Engineering Corporation
• Inventors: Maerzke, James T., Anderson, Donald L. Jr.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US07/040,959
• Time in Patent Office: 700 Days
• Field of Search: 604/8, 604/21, 604/93, 604/164-170, 604/264, 604/280-282
• 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: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract

Abstract

A spiral ureteral stent is positioned in the ureter to aid in infusion of the renal pelvis and to maintain fluid drainage between the renal pelvis and the bladder. The stent includes a helical coiled section having retaining means at the distal and proximal ends for reception in the bladder and the renal pelvis. The retaining means enable the stent to resist movement in the ureter. A lumen extends the entire length of the stent to form a fluid passageway for infusion of fluid from an external source into the renal pelvis. The stent is flexible and may be straightened by means of a wire stylet inserted in the lumen, to faciliate placement of the stent in the ureter. The retention means and helical coiled section reform upon withdrawal of the stylet from the lumen. As the helical coiled section reforms to its coil shape, it bears agains the walls of the ureter to reduce any restriction and to reinforce the walls of the ureter. The stent thus helps to redefine the ureteral passage from the renal pelvis to the bladder through which fluids and other matter may readily flow.

Claims

1. A stent for placement in a ureter comprising,

(a) a relatively flexible, helically-shaped coiled section selectively deformable into an approximately straight configuration, said coiled section having a diameter substantially the same of that of a normal unimpaired ureter to support said ureter,

(b) a first curved retention means for holding said stent in a fixed position in the ureter formed at a distal end of said coiled section and adapted to be received in the bladder,

(c) a second curved retention means for holding said stent in a fixed position in a ureter, formed at a proximal end of said coiled section and adapted to be received in the renal pelvis,

(d) a lumen extending through the entire length of said stent to provide a fluid passage and to permit the use of a straightening member to straighten the coiled section and the first and second retention means such that the stent can be inserted to a predetermined position within the ureter, said straightening member being removable from the stent when the stent is in said predetermined position, to permit the coiled section to return to the helical configuration to support the wall of said ureter, and to permit said first and second retention means to reform and prevent said stent from migrating from said predetermined position.

2. The stent as claimed in claim 1 wherein said first retention means comprises a loop-shaped formation integral with said coiled section.

3. The stent as claimed in claim 2 wherein said loop-shaped formation has a predetermined outer diameter greater than the passage diameter of said ureter where said ureter enters said bladder, to enable said loop-shaped formation to resist movement into said ureter.

4. The stent as claimed in claim 2 wherein said loop-shaped formation lies in an axial plane of the helix of coils of said coiled section.

5. The stent as claimed in claim 1 wherein said second retention means comprises a curl-shaped formation integral with said coiled section.

6. The stent as claimed in claim 5 wherein said curl-shaped formation extends less than 360°

.

7. The stent as claimed in claim 5 wherein said curl-shaped formation has a curvature of predetermined magnitude greater than the passage diameter of said ureter where said ureter enters said renal pelvis, to enable said curl-shaped formation to resist movement into said ureter.

8. The stent as claimed in claim 7 wherein said first retention means comprises a loop-shaped formation integral with said coiled section and having an outer diameter of predetermined magnitude greater than the passage diameter of said ureter where said ureter enters said bladder, to enable said loop-shaped formation to resist movement into said ureter, whereby said loop-shaped formation and said curl-shaped formation, upon respective positioning in the bladder and in the renal pelvis, prevent migration of said stent in said ureter.

9. The stent as claimed in claim 5 wherein said curl-shaped formation lies in an axial plane of the helix of coils of said coiled section.

10. The stent as claimed in claim 9 wherein said first retention means comprises a loop-shaped formation integral with said coiled section and said loop shaped formation and said curl shaped formation lie in the same plane.

11. The stent as claimed in claim 1 further including a fluid infusion member joined to said distal end portion for connection to an external fluid source to permit fluid from the fluid source to pass through the infusion tube into said lumen and into said renal pelvis, drainage of said fluid from said pelvis occurring through said ureter as supported by said coiled section.

12. A ureteral infusion and drainage system comprising,

(a) A stylet, and

(b) a spiral ureteral stent comprising a relatively flexible, helically shaped, coiled section selectively formable into an approximate straight configuration, said coiled section having a diameter substantially equivalent to that of a normal, unimpaired ureter, to support said ureter, a first retention means for holding said stent in a fixed position in the ureter, at the distal end of said coil section adapted to be received in the bladder, a second retention means for holding said stent in a fixed position in a ureter, at the proximal end of said coiled section adapted to be received in the renal pelvis, and a lumen extending through the entire length of the stent to provide a fluid passage and to permit the use of the stylet to straighten said coiled section and said first and second retention means to facilitate the placement of the stent in the ureter.

13. The system as claimed in claim 12 further including an infusion member joined to the distal end of said stent for connection with an external fluid source to infuse fluid through said stent.

14. The system as claimed in claim 13 wherein said infusion member is detachably secured to said distal end.

15. A ureteral infusion and drainage system comprising,

(a) a flexible stent having a proximal free end portion and a distal free end portion,

(b) a lumen in said stent extending from the free end of said proximal end portion to the free end of said distal end portion,

(c) said stent having a normally coiled section constituted by a plurality of coils in a form of a helix, said proximal and distal end portions extending from opposite portions of said coiled section,

(d) retaining means for retaining said stent in a ureter respectively formed at said proximal and distal end portions, said retaining means normally having respective curved configurations at said proximal and distal end portions, and

(e) an elongated straightening member having a predetermined stiffness, insertable in said lumen for straightening the normally curved configurations of said retaining means and for straightening the normally coiled section such that said stent has a relatively straight, substantially uncoiled and uncurved configuration to facilitate insertion of said stent in a ureter, said straightening member being removable from said stent after said stent is positioned in said ureter to permit the coiled section and the curved configuration of the retaining means to reform.

16. The system as claimed in claim 15 wherein said elongated straightening member comprises a wire stylet.

17. The system as claimed in claim 15 wherein the proximal end portion has an opening of reduced size relative to the size of said lumen to prevent projection of said straightening member out of said opening.

18. The system as claimed in claim 15 wherein an infusion member is joined to one of said retaining means for infusing fluid through said stent.

19. A method of infusing and draining the renal pelvis comprising:

(a) forming a stent of a flexible biocompatible material with curved retaining means at the distal and proximal ends of the stent for respective placement in the bladder and renal cavity to prevent movement of the stent in the ureter,

(b) including a lumen in the stent extending the full length of the stent,

(c) forming a flexible helically-shaped coiled section of the stent intermediate the proximal and distal ends of the stent, with a coil diameter substantially the same as that of a normal unimpaired ureter, to support the ureter,

(d) rendering the stent selectively deformable into an approximately straight configuration by inserting a stylet in the lumen to straighten the coiled section and the retaining means at the proximal and distal ends,

(e) positioning the straightened stent and stylet assembly within the ureter,

(f) withdrawing the stylet from the lumen to reform the coiled section and the first and second retaining means, such that the coiled section exerts an outward pressure on any collapsed areas in the ureter to restore the ureter passage to its more normal dimension, and

(g) permitting drainage of fluid from the renal pelvis through the ureter as supported by the coiled section.

20. The method as claimed in claim 19 including infusing fluid from an external source through the lumen into the renal pelvis.