Prosthesis intended for the treatment of a natural lumen or tract, in particular an endo-urethral prosthesis

• US 6,290,666 B1
• Filed: 03/02/1998
• Issued: 09/18/2001
• Est. Priority Date: 02/19/1993
• Status: Expired due to Term

• Current Assignee: Marian A. Devonec
• Original Assignee: Marian A. Devonec
• Inventors: Devonec, Marian A.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): BIANCO, PATRICIA
• Application Number:
  US09/032,978
• Time in Patent Office: 1,296 Days
• Field of Search: 623/1, 623/11, 623/12, 128/878, 128/898, 604/8-10, 604/523, 604/264, 604/540, 604/541, 604/543-44
• US Class Current: 623/1.16
• 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 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A prosthesis intended for the treatment of a natural lumen or tract of a human or animal body through which a flow is effected on either side of a sphincter is disclosed. The prosthesis comprises at least one tubular element, in particular of cylindrical shape which is sufficiently flexible to conform to the natural lumen, but sufficiently rigid to maintain an artificial passage in the lumen, and is intended to be placed in the natural lumen. The wall of the tubular element comprises a relatively smooth and soft biocompatible material, such as silicone rubber, at least in its outer part.

Claims

1. A prosthesis capable of being inserted in a biological lumen or tract, comprising:

first and second elements that are locatable on either side of a sphincter surrounding the lumen or tract, wherein at least one of said first and second elements is sufficiently flexible to conform to the lumen or tract and sufficiently rigid to maintain a passage through the lumen or tract against a force that tends to obstruct the lumen or tract, and

a connecting element comprising a first end that is connected to said first element, a second end that is connected to said second element, and a flexible middle portion joining said first and second ends, wherein said flexible middle portion is locatable in the sphincter and is deformable by the sphincter to allow the sphincter to close naturally and thereby close the lumen or tract to natural fluid flows;

wherein a removal thread is attached to at least one of said first and second elements.

2. The prosthesis of claim 1, wherein said first and second elements are tubular.

3. The prosthesis of claim 1, wherein the biological lumen or tract is a male urethra.

4. The prosthesis of claim 3, wherein said first element forms a conduit that maintains an endo-urethral passage where the male urethra traverses a prostate.

5. The prosthesis of claim 3, wherein said first element has a sufficient length to extend into a bladder from the male urethra.

6. The prosthesis of claim 1, wherein at least one of said first and second elements comprises a substantially smooth outer layer.

7. The prosthesis of claim 1, wherein at least one of said first and second elements includes a reinforcing element.

8. The prosthesis of claim 1, wherein at least one of said first and second elements comprises a wall that includes a coiled metallic reinforcing element.

9. The prosthesis of claim 1, wherein at least one of said first and second elements comprises a wall that includes a coiled non-metallic reinforcing element.

10. The prosthesis of claim 1, wherein at least one of said first and second elements comprises a wall that includes a reinforcing element that extends over only a portion of said wall.

11. The prosthesis of claim 1, wherein an end of at least one of said first and second elements opposite said connecting element is closed and has a convex shape, and wherein at least one aperture is formed in a wall of said at least one element adjacent said closed end.

12. The prosthesis of claim 1, wherein said flexible middle portion comprises a flexible sleeve.

13. The prosthesis of claim 1, wherein at least one of said first and second elements is perforated.

14. The prosthesis of claim 1, wherein at least of of said first and second elements is notched.

15. The prosthesis of claim 1, wherein at least one of said first and second elements each have a continuous and substantially uniform external profile.

16. The prosthesis of claim 1, wherein abutment of said first and second elements against the sphincter can inhibit movement of said elements into the sphincter.

17. The prosthesis of claim 1, wherein at least one of said first and second elements comprises an outer portion that is biodegradable.

18. The prosthesis of claim 1, wherein apertures are formed in at least said middle portion of said connecting element.

19. The prosthesis of claim 1, wherein a plurality of apertures or undulations is distributed along a length of at least one of said first and second elements.

20. The prosthesis of claim 1, wherein an external surface of at least one of said first and second elements is coated with a therapeutic substance.

21. The prosthesis of claim 1, wherein at least one of said first and second elements has a pre-formed angulation that mimics a natural angulation of the lumen or tract into which said prosthesis is to be inserted.

22. The prosthesis of claim 21, wherein said first element has a pre-formed angulation of about 140 to 160 degrees.

23. The prosthesis of claim 22, wherein said first element angulation is about 150 degrees.

24. The prosthesis of claim 21, wherein said second element has a pre-formed angulation of about 110 to 130 degrees.

25. The prosthesis of claim 24, wherein said second element angulation is about 120 degrees.

26. The prosthesis of claim 21, wherein said angulation can change upon introduction of a stress on at least one of said first and second elements, but returns to said pre-formed angulation upon relief of the stress.

27. A method of treating an obstruction of a male urethra using the prosthesis of claim 1, wherein said obstruction is due to an external force that tends to close said urethra, and wherein said prosthesis is located in said urethra such that said first and second elements are located on either side of said sphincter and said connecting element extends through said sphincter, comprising the steps of:

supporting an interior of said urethra at said obstruction with at least one of said first and second elements so that a passage through said urethra is open despite said external force that tends to close said urethra; and

allowing said sphincter to naturally contract to block fluid flow through said urethra, and to naturally relax to permit fluid flow through said urethra.

28. A method of treating an obstruction of a male urethra, comprising:

supporting said male urethra at a site of said obstruction with the prosthesis of claim 1 by inserting said prosthesis into said male urethra so that said first element supports said male urethra at said site of said obstruction.

29. An assembly for treating a male urethra, comprising:

a prosthesis according to claim 1;

a cylindrical mandrel having a first end with an outer diameter that is adapted to pass inside an inner diameter of said prosthesis to engage said prosthesis, and wherein a second, opposite end of said mandrel has an outer limit stop; and

a hollow cylindrical pusher having inner and outer diameters, said inner diameter allowing said mandrel to pass inside said pusher, wherein said pusher acts as a spacer between said engaged prosthesis and said outer limit stop.

30. The prosthesis of claim 1, wherein at least one of said elements has an angulation along its axis.

31. The prosthesis of claim 30, wherein said angulation can be suppressed upon introduction of a stress on at least one of said first and second elements, but returns to said angulation upon relief of the stress.

32. The prosthesis of claim 30, wherein said angulation is proximate to the distal end of at least one of said first and second elements.

33. The prosthesis of claim 13, wherein at least one of said first and second elements contains more than one perforation.

34. The prosthesis of claim 1, wherein the biological lumen or tract is human.

35. A prosthesis capable of being inserted in a biological lumen or tract, comprising:

first and second elements that are locatable on either side of a sphincter surrounding the lumen or tract, wherein at least one of said first and second elements is sufficiently flexible to conform to the lumen or tract and sufficiently rigid to maintain a passage through the lumen or tract against a force that tends to obstruct the lumen or tract, and

a connecting element comprising at least one thread, wherein first and second ends of each said thread are connected to said first and second elements, respectively.

36. The prosthesis of claim 35, wherein abutment of the first and second elements against the sphincter can inhibit movement of said elements into the sphincter.

37. The prosthesis of claim 35, wherein said connecting element comprises a plurality of threads, wherein first and second ends of each of the plurality of threads are connected to said first and second elements, respectively.

38. A method of treating an obstruction of a male urethra, comprising:

supporting said male urethra at a site of said obstruction with the prosthesis of claim 35 by inserting said prosthesis into said male urethra so that said first element supports aid male urethra at said site of said obstruction.

39. A prosthesis, comprising a first tubular element, a second tubular element, and a connecting element, said connecting element comprising a plurality of threads, wherein first and second ends of each of the plurality of threads are connected to said first and second elements, respectively.

40. A method of treating an obstruction of a male urethra, comprising:

supporting said male urethra at a site of said obstruction with the prosthesis of claim 39 by inserting said prosthesis into said male urethra so that said first element supports said male urethra at said site of said obstruction.

41. An intraurethral therapeutic device, comprising:

(i) a first tubular element made of a flexible, biocompatible material having a proximal end and a distal end and a central portion with a substantially constant inner diameter,

wherein said proximal end is open to allow passage of fluid,

wherein said distal end is perforated to allow urine to enter said first tubular element from the bladder, and

wherein said first tubular element comprises a therapeutic agent;

(ii) a second tubular element made of a flexible, biocompatible material having a proximal end and a distal end and a central portion,

wherein said second tubular element has a substantially constant inner diameter that is substantially the same as said inner diameter of said first tubular element, and

wherein said proximal end of said second tubular element has at least one thread attached to it for removal of said intraurethral therapeutic device; and

(iii) a connecting element connecting said proximal end of said first element to said distal end of said second element, said connecting element comprising a plurality of threads, wherein first and second ends of each of the plurality of threads are connected to said first and second elements, respectively.

42. A method of treating an obstruction of a male urethra, comprising:

supporting said male urethra at a site of said obstruction with the prosthesis of claim 41 by inserting said prosthesis into said male urethra so that said first element supports said male urethra at said site of said obstruction.

43. An intraurethral prosthetic device, comprising:

first and second elements, at least one of said first and second elements having a continuous and substantially uniform external profile,

a connecting element that connects said first and second elements and that is flexible, and

a removal thread attached to at least one of said first and second elements.

44. A method of treating an obstruction of a male urethra, comprising:

supporting said male urethra at a site of said obstruction with the prosthesis of claim 43 by inserting said prosthesis into said male urethra so that said first element supports said male urethra at said site of said obstruction.