Softening expanding ureteral stent

• US 5,599,291 A
• Filed: 01/04/1993
• Issued: 02/04/1997
• Est. Priority Date: 01/04/1993
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Menlo Care, Inc. (Johnson & Johnson)
• Inventors: Balbierz, Daniel J., Bley, Robert S., Thomas, Joseph R., Walker, Jack M.
• Primary Examiner(s): RIMELL, SAMUEL G
• Application Number:
  US08/000,274
• Time in Patent Office: 1,492 Days
• Field of Search: 604/8, 604/9, 604/10, 604/175, 604/264, 604/283, 604/93, 604/95, 604/282, 604/281, 604/280
• US Class Current: 604/8
• 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 2002/041 Bile ducts
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract

Abstract

A ureteral stent comprising an elongated member having a proximal end portion and a distal end portion joined by a body portion. The elongated member has an initial outer diameter. A retention construction serves for retaining the member within the ureter. The member is formulated of a physiologically acceptable polymer capable of hydrating and expanding from the initial member outer diameter to form a final member outer diameter. The stent can assume differing shapes and can exhibit different degrees of softening at different places along its length.

Claims

1. A ureteral stent comprising an elongated member having a proximal end portion and a distal end portion joined by a body portion, the elongated member having an initial member outer diameter and including retention means for retaining the stent within a ureter, the member being formulated of a physiologically acceptable polymer capable of hydrating with concurrent softening and with concurrent expanding from the initial member outer diameter to form a final member outer diameter, the polymer being formulated such that upon hydration the member softens and expands to different degrees at different locations therealong, wherein the elongated member has an initial stiffness above about 100 Shore A and wherein upon hydration the initial stiffness of the distal end portion softens to a final softness which falls below 100 Shore A.

4. A ureteral stent as set forth in any one of claims 1, 2, or 3, wherein the retention means is formed upon hydration of the member.

5. A ureteral stent as set forth in any one of claims 1, 2, or 3, wherein the proximal end portion is tapered to a diameter smaller than the initial outer diameter of the body portion.

6. A ureteral stent as set forth in claim 5, wherein the tapered proximal end portion upon hydration expands to an outer diameter equal to the final outer diameter of the member.

7. A ureteral stent as set forth in any one of claims 1, 2, or 3, wherein the proximal retention means is formed upon hydration into the shape of a funnel.

8. A ureteral stent as set forth in any one of claims 1, 2, or 3, wherein the proximal end portion is flared outwardly to a diameter larger than the initial outer diameter of the body portion.

9. A ureteral stent as set forth in any one of claims 1, 2, or 3, wherein the retention means includes the proximal end portion formed upon hydration into the shape of a multipod.

10. A ureteral stent as set forth in any one of claims 1, 2, or 3, wherein the polymer comprises a hydrophilic component and a non-hydrophilic component and wherein the final cross ureteral member outer diameter decreases to a smaller cross ureteral member outer diameter a selectable time after hydration within a ureter.

11. A ureteral stent as set forth in claim 10, wherein the decrease results from the dissolving of all or a portion of the hydrophilic component after hydration.

12. A ureteral stent as set forth in claim 10 wherein the hydrophilic component is selected from the group consisting of poly(ethylene oxide), polyvinyl pyrrolidone, polyvinyl alcohol, poly(ethylene glycol), polyacrylamide, poly(hydroxy ethyl acrylate), poly(hydroxy ethyl methacrylate)., hydroxy ethyl cellulose, hydroxy propyl cellulose, methoxylated pectin gels, agar, starches, modified starches, alginates, hydroxy ethyl carbohydrates and mixtures and copolymers thereof and the non-hydrophilic component is selected from the group consisting of silicone, an aliphatic polyurethane, an aromatic polyurethane, a polyether polyurethane, a polyester polyurethane, an ethylene copolymer, a polyamide, an aliphatic polyester or mixtures or copolymers thereof.

13. A combination of a ureteral stent as set forth in any one of claims 1, 2, or 3 and insertion means, wherein the member is tubular and defines a lumen and wherein the insertion means comprises an elongated pusher having an outer diameter generally equal to the initial outer diameter of the member, the pusher having an engaging end portion joined by a handle portion, the engaging end portion having a shoulder from which a cylindrical post axially extends, the post being smaller in diameter than the diameter of the pusher and being adapted to engage with the lumen of the member so as to allow positive engagement between the post and the lumen of the member and to allow forward and backward manipulation of the member during insertion.

14. A combination of ureteral stent and insertion means as set forth in claim 13, wherein the post is threaded.

15. A combination of ureteral stent and insertion means as set forth in claim 13,including:

biasing means for biasing the post out of engagement with the lumen; and

removable locking means for preventing the biasing means from moving the post out of engagement with the lumen.

16. A combination of a ureteral stent as set forth in any one of claims 1, 2, or 3 and insertion means, wherein the insertion means comprises an elongated pusher mechanism which comprises:

a push rod having a far end portion for extending into a patient and a near end portion; and

a tubular member defining a bore and having far and near end portions, the push rod being positioned within the bore in slidable relation thereto, the far end portion of the bore having an inner diameter which is substantially equal to the outer diameter of the member so as to allow the distal end portion of the member to fit inside the bore.

17. A combination of ureteral stent and insertion means as set forth in claim 16, further including:

biasing means for normally biasing the push rod sufficiently away from the far end portion of the tubular member to allow the distal end portion of the member to be held in the bore; and

means for selectively overcoming the biasing means so as to expel the distal end portion of the member from the bore.

18. A combination of a ureteral stent as set forth in any one of claims 1, 2, or 3 and insertion means, wherein the insertion means comprises an elongated pusher bonded to the distal end portion of the member to form an assemblage.

19. A combination of ureteral stent and insertion means as set forth in claim 18, wherein the assemblage has an outer diameter substantially equal to the initial outer diameter of the member, the pusher being formulated of a dissolvable or biodegradable polymer which dissolves or biodegrades a selectable time following insertion of the assemblage into the ureter.

20. A combination of ureteral stent and insertion means as set forth in claim 18, wherein the assemblage has an outer diameter substantially equal to the initial outer diameter of the member, the assemblage further having a suture attached to and extending from the member, the suture being imbedded longitudinally along the pusher, the pusher being formulated of a dissolvable or biodegradable polymer which dissolves or biodegrades a selectable time following insertion of the assemblage into the ureter.

21. A combination of ureteral stent and insertion means as set forth in claim 19, wherein the dissolvable or biodegradable polymer is selected from the group consisting of the dissolvable polymers polyethylene oxides, polyvinylacetates, polyvinylpyrrolidones, polyethylene oxide based polyether urethanes and starch and cellulose derivatives, and of the biodegradable polymers polyorthoesters, polylactides, polyglycolides, copolymers thereof, collagen, polycaprolactones and polyglutonates.

22. A combination of ureteral stent and insertion means as set forth in claim 20, wherein the dissolvable or biodegradable polymer is selected from the group consisting of the dissolvable polymers polyethylene oxides, polyvinylacetates, polyvinylpyrrolidones, polyethylene oxide based polyether urethanes and starch and cellulose derivatives, and of the biodegradable polymers polyorthoesters, polylactides, polyglycolides, copolymers thereof, collagen, polycaprolactones and polyglutonates.

23. A ureteral stent as set forth in any one of claims 1, 2, and 3, wherein the member is tubular and defines a lumen which has internal ribs longitudinally along its length.

25. A ureteral stent as set forth in claim 23, wherein the elongated member has an initial stiffness above about 100 Shore A and wherein upon hydration the initial stiffness of the distal end portion softens to a final softness which falls below 100 Shore A.

2. A ureteral stent comprising an elongated member having a proximal end portion and a distal end portion joined by a body portion, the elongated member having an initial member outer diameter and including retention means for retaining the stent within a ureter, the member being formulated of a physiologically acceptable polymer capable of hydrating with concurrent softening and with concurrent expanding from the initial member outer diameter to form a final member outer diameter, the polymer being formulated such that upon hydration the member softens and expands to different degrees at different locations therealong, wherein upon hydration the proximal end portion softens to about 70 Shore A to about 70 Shore D, and wherein upon hydration the distal end portion softens to about 30 to about 100 Shore A.

3. A ureteral stent comprising an elongated member having a proximal end portion and a distal end portion joined by a body portion, the elongated member having an initial member outer diameter and including retention means for retaining the stent within a ureter, the member being formulated of a physiologically acceptable polymer capable of hydrating with concurrent softening and with concurrent expanding from the initial member outer diameter to form a final member outer diameter, the polymer being formulated such that upon hydration the member softens and expands to different degrees at different locations therealong wherein the polymer comprises a hydrophilic component and a non-hydrophilic component in a selected ratio, the ratio of hydrophilic to non-hydrophilic component being selected such that upon hydration the polymer softens and expands the initial member outer diameter by from about 5% up to about 300%, and wherein the hydrophilic component is selected from the group consisting of poly(ethylene oxide), polyvinyl pyrrolidone, polyvinyl alcohol, poly(ethylene glycol), polyacrylamide, poly(hydroxy ethyl acrylate), poly(hydroxy ethyl methacrylate), hydroxy ethyl cellulose, hydroxy propyl cellulose, methoxylated pectin gels, agar, starches, modified starches, alginates, hydroxy ethyl carbohydrates and mixtures and copolymers thereof and the non-hydrophilic component is selected from the group consisting of silicone, an aliphatic polyurethane, an aromatic polyurethane, a polyether polyurethane, a polyester polyurethane, an ethylene copolymer, a polyamide, an aliphatic polyester or mixtures or copolymers thereof.

24. A ureteral stent comprising an elongated member having a proximal end portion and a distal end portion joined by a body portion, the elongated member having an initial member outer diameter and including retention means for retaining the stent within a ureter, the member being formulated of a physiologically acceptable polymer capable of hydrating with concurrent softening and with concurrent expanding from the initial member outer diameter to form an enlarged final member outer diameter, the polymer being formulated such that a selectable time following hydration the final member outer diameter reduces in situ to a smaller diameter.

26. A ureteral stent as set forth in claim 24, wherein upon hydration the proximal end portion softens to about 70 Shore A to about 70 Shore D, and wherein upon hydration the distal end portion softens to about 30 to about 100 Shore A.

27. A ureteral stent as set forth in claim 24, wherein the polymer comprises a hydrophilic component capable of hydrating and the polymer upon hydration softens and expands the initial member outer diameter by from about 5% to about 300%.

28. A ureteral stent as set forth in claim 27, wherein the hydrophilic component is selected from the group consisting of poly(ethylene oxide), polyvinyl pyrrolidone, polyvinyl alcohol, poly(ethylene glycol), polyacrylamide, poly(hydroxy ethyl acrylate), poly(hydroxy ethyl methacrylate), hydroxy ethyl cellulose, hydroxy propyl cellulose, methoxylated pectin gels, agar, starches, modified starches, alginates, hydroxy ethyl carbohydrates and mixtures and copolymers thereof.

29. A ureteral stent as set forth in claim 24, wherein the polymer comprises a hydrophilic component and a non-hydrophilic component in a selected ratio, the ratio of hydrophilic to non-hydrophilic component being selected such that upon hydration the polymer softens and expands the initial member outer diameter by from about 5% up to about 300%.

30. A ureteral stent as set forth in claim 29, wherein the hydrophilic component is selected from the group consisting of poly(ethylene oxide), polyvinyl pyrrolidone, polyvinyl alcohol, poly(ethylene glycol), polyacrylamide, poly(hydroxy ethyl acrylate), poly(hydroxy ethyl methacrylate), hydroxy ethyl cellulose, hydroxy propyl cellulose, methoxylated pectin gels, agar, starches, modified starches, alginates, hydroxy ethyl carbohydrates and mixtures and copolymers thereof and the non-hydrophilic component is selected from the group consisting of silicone, an aliphatic polyurethane, an aromatic polyurethane, a polyether polyurethane, a polyester polyurethane, an ethylene copolymer, a polyamide, an aliphatic polyester or mixtures or copolymers thereof.

31. A ureteral stent as set forth in claim 24, wherein the retention means is formed upon hydration of the member.

32. A ureteral stent comprising an elongated member having a proximal end portion and a distal end portion joined by a body portion, the elongated member having an initial member outer diameter, the member being formulated of a physiologically acceptable polymer capable of hydrating with concurrent softening and with concurrent expanding from the initial member outer diameter to form a final member outer diameter, the polymer being formulated such that retention means for retaining the stent within a ureter forms upon hydration of the stent within the ureter.

33. A ureteral stent as set forth in claim 32, wherein the elongated member has an initial stiffness above about 100 Shore A and wherein upon hydration the initial stiffness of the distal end portion softens to a final softness which falls below 100 Shore A.

34. A ureteral stent as set forth in claim 32, wherein upon hydration the proximal end portion softens to about 70 Shore A to about 70 Shore D, and wherein upon hydration the distal end portion softens to about 30 to about 100 Shore A.

35. A ureteral stent as set forth in claim 32, wherein the polymer comprises a hydrophilic component capable of hydrating and the polymer upon hydration softens and expands the initial member outer diameter by from about 5% to about 300%.

36. A ureteral stent as set forth in claim 35, wherein the hydrophilic component is selected from the group consisting of poly(ethylene oxide), polyvinyl pyrrolidone, polyvinyl alcohol, poly(ethylene glycol), polyacrylamide, poly(hydroxy ethyl acrylate), poly(hydroxy ethyl methacrylate), hydroxy ethyl cellulose, hydroxy propyl cellulose, methoxylated pectin gels, agar, starches, modified starches, alginates, hydroxy ethyl carbohydrates and mixtures and copolymers thereof.

37. A ureteral stent as set forth in claim 32, wherein the polymer comprises a hydrophilic component and a non-hydrophilic component in a selected ratio, the ratio of hydrophilic to non-hydrophilic component being selected such that upon hydration the polymer softens and expands the initial member outer diameter by from about 5% up to about 300%.

38. A ureteral stent as set forth in claim 37, wherein the hydrophilic component is selected from the group consisting of poly(ethylene oxide), polyvinyl pyrrolidone, polyvinyl alcohol, poly(ethylene glycol), polyacrylamide, poly(hydroxy ethyl acrylate), poly(hydroxy ethyl methacrylate), hydroxy ethyl cellulose, hydroxy propyl cellulose, methoxylated pectin gels, agar, starches, modified starches, alginates, hydroxy ethyl carbohydrates and mixtures and copolymers thereof and the non-hydrophilic component is selected from the group consisting of silicone, an aliphatic polyurethane, an aromatic polyurethane, a polyether polyurethane, a polyester polyurethane, an ethylene copolymer, a polyamide, an aliphatic polyester or mixtures or copolymers thereof.

39. A ureteral stent as set forth in claim 32, wherein the retention means includes proximal retention means formed upon hydration of the proximal end portion.

40. A ureteral stent comprising an elongated member having a proximal end portion and a distal end portion joined by a body portion, the elongated member having an initial member outer diameter and including retention means for retaining the stent within a ureter, the member being formulated of an inner section surrounded by an outer layer, the inner section being formulated of a physiologically acceptable polymer capable of hydrating with concurrent softening and with concurrent expanding such that the initial member outer diameter expands to form an enlarged final member outer diameter, the outer layer being formulated such that a selectable time following hydration the outer layer degrades or dissolves such that the final member outer diameter reduces in situ to a smaller diameter.