Therapeutic device for the selective cytoreduction treatment of an obstruction in a natural lumen or passage of the human or animal body

• US 8,211,085 B2
• Filed: 12/22/2004
• Issued: 07/03/2012
• Est. Priority Date: 07/13/1994
• Status: Expired due to Term

• Current Assignee: Marian Devonec
• Original Assignee: Marian Devonec
• Inventors: Devonec, Marian
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): MEDWAY, SCOTT J
• Application Number:
  US11/018,508
• Publication Number:
  US 20050113748A1
• Time in Patent Office: 2,750 Days
• Field of Search: 424422-426, 424/430, 424/343, 514/511, 604/48, 604/93.01, 604/96.01, 604/101.01, 604104-109, 604/164.03, 604/265, 604/266, 604/287, 604/509, 604514-517, 604/523, 606/191, 606192-194, 606/198, 623/1.11, 623/1.15, 623/1.16, 623/1.42, 623/23.64, 623 2366- 2368, 623/23.7, 623/23.71, 623 2373- 2376
• US Class Current: 604/509
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2018/00547 Prostate
• 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 2002/047 Urethrae
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

Therapeutic device intended for the selective cytoreductive treatment of an obstruction in a natural lumen or passage of the human or animal body, said lumen being obstructed by the effect of a local cell proliferation, said device comprising a tubular element, in particular of cylindrical shape, intended to be placed in said natural lumen and sufficiently flexible to conform to said natural lumen, but sufficiently rigid to maintain an artificial channel in said lumen. The tubular element supports lengthwise a medicinal sleeve which is intended to come into line with, and into contact with, the obstruction once the natural lumen has been intubated, and is designed to deliver locally, at least in its outer surface portion, at least one therapeutic agent which is cytoreductive, in particular cytotoxic, through contact with the cells under whose effect said lumen is obstructed.

Claims

1. A method of treating an obstruction of a natural lumen through which a fluid naturally flows, comprising:

providing a device comprising a non-biodegradable element, an expandable sleeve positioned along the non-biodegradable element, a cytoreductive agent positioned along the expandable sleeve, and a withdrawal thread;

covering the expandable sleeve with a protective surface envelope to retain the sleeve in a non-expanded state;

inserting the device in the natural lumen so that the non-biodegradable element is positioned in contact with the obstruction;

breaking down and eliminating the protective surface envelope from the sleeve by direct contact of the envelope with an internal wall of the natural lumen, allowing the expandable sleeve to expand;

treating the obstruction by expanding the sleeve where the protective surface envelope has been eliminated to provide a reductive effect through direct contact of the sleeve with the cells of the obstruction;

ceasing reductive effect by ceasing direct contact between the sleeve and the cells of the obstruction; and

non-traumatically removing the device from the natural lumen by the withdrawal thread,

wherein the element is sufficiently flexible to conform to the natural lumen, but sufficiently rigid to maintain a channel for flow of the fluid in the lumen, said channel providing for passage of the fluid from upstream of the obstruction to downstream of the obstruction with respect to natural fluid flow;

thereby opening the obstructed natural lumen and allowing the normal passage of fluid.

2. The method of claim 1, wherein said natural lumen is the prostatic portion of a male urethra.

3. The method of claim 1, wherein said cytoreductive agent is cytotoxic.

4. The method of claim 2, wherein said cytoreductive agent is cytotoxic to prostatic cells.

5. The method of claim 1, wherein said non-biodegradable element is of cylindrical shape.

6. The method of claim 1, wherein said cytoreductive agent has a continuous surface both around the sleeve and along the length of the sleeve.

7. The method of claim 1, wherein said cytoreductive agent is non-selectively cytotoxic.

8. The method of claim 1, wherein said cytoreductive agent erodes the obstruction.

9. The method of claim 1, wherein the obstruction is a tumoral obstruction.

10. The method of claim 1, wherein said device is an intraurethral therapeutic device and wherein the fluid is urine, which is allowed to pass from upstream to downstream of the obstruction.

11. The method of claim 1, wherein said non-biodegradable element comprises a bottom end and a top end and wherein said cytoreductive agent is positioned between said bottom end and said top end of said element.

12. The method of claim 11, wherein said cytoreductive agent is positioned between 10 and 15 mm from both said bottom end and said top end of the non-biodegradable element.

13. The method of claim 2, wherein the device further comprises a tubular element intended to be arranged in the urethra on an opposite side of a sphincter to a side on which the non-biodegradable element is positioned, and the tubular element is attached to the non-biodegradable element with a connection means.

14. The method of claim 1, wherein said cytoreductive agent is selectively reductive to cells of the obstruction.

15. The method of claim 1, wherein said cytoreductive agent is cytotoxic to cells of a wall of said lumen.

16. The method of claim 1, wherein said cytoreductive agent is reductive to urethral mucosal cells.

17. The method of claim 1, wherein said cytoreductive agent extends around a perimeter of the sleeve.

18. The method of claim 1, wherein said cytoreductive agent is located in the sleeve.

19. The method of claim 1, wherein said cytoreductive agent is further incorporated in the non-biodegradable element.

20. The method of claim 1, wherein the sleeve comprises a biologically compatible substrate, and said cytoreductive agent is located on or in the biologically compatible substrate.

21. The method of claim 20, wherein said substrate is radially expandable.

22. The method of claim 20, wherein said substrate is hydrophilic and expandable under the effect of biological fluids present or circulating in the obstructed natural lumen.

23. The method of claim 1, wherein said device comprises a bacteriostatic agent.

24. The method of claim 1, wherein the device comprises a means for checking the correct positioning of said device.

25. The method of claim 1, wherein the device comprises an agent which is opaque vis-a-vis X-rays.

26. The method of claim 1, wherein said cytoreductive agent is not hydrosoluble.

27. The method of claim 1, wherein said cytoreductive agent comprises at least one medicament selected from the group consisting of antimitotic agents, cytolytic agents, enzymes, hormones, antienzymes, and metal salts.

28. The method of claim 1, further comprising temporarily maintaining said device in the natural lumen after treating the obstruction, and prior to removing said device from the lumen.

29. The method of claim 28, wherein said natural lumen is the prostatic portion of a male urethra.

30. The method of claim 28, wherein said cytoreductive agent is cytotoxic.

31. The method of claim 28, wherein said cytoreductive agent is cytotoxic to prostatic cells.

32. The method of claim 28, wherein said non-biodegradable element is of cylindrical shape.

33. The method of claim 28, wherein said cytoreductive agent has a continuous surface both around the sleeve and along the length of the sleeve.

34. The method of claim 28, wherein said cytoreductive agent is non-selectively cytotoxic.

35. The method of claim 28, wherein said cytoreductive agent erodes the obstruction.

36. The method of claim 28, wherein the obstruction is a tumoral obstruction.

37. The method of claim 28, wherein said device is an intraurethral therapeutic device and wherein the fluid is urine, which is allowed to pass from upstream to downstream of the obstruction.

38. The method of claim 28, wherein said non-biodegradable element comprises a bottom end and a top end and wherein said cytoreductive agent is positioned between said bottom end and said top end of said element.

39. The method of claim 38, wherein said cytoreductive agent is positioned between 10 and 15 mm from both said bottom end and said top end of the non-biodegradable element.

40. The method of claim 29, wherein the device further comprises a tubular element intended to be arranged in the urethra on an opposite side of a sphincter to a side on which the non-biodegradable element is positioned, and the tubular element is attached to the non-biodegradable element with a connection means.

41. The method of claim 28, wherein said cytoreductive agent is selectively reductive to cells of the obstruction.

42. The method of claim 28, wherein said cytoreductive agent is cytotoxic to cells of a wall of said lumen.

43. The method of claim 28, wherein said cytoreductive agent is reductive to urethral mucosal cells.

44. The method of claim 28, wherein said cytoreductive agent extends around a perimeter of the sleeve.

45. The method of claim 28, wherein said cytoreductive agent is located in the sleeve.

46. The method of claim 28, wherein said cytoreductive agent is further incorporated in the biodegradable element.

47. The method of claim 28, wherein the sleeve comprises a biologically compatible substrate, and said cytoreductive agent is located on or in the biologically compatible substrate.

48. The method of claim 47, wherein said substrate is radially expandable.

49. The method of claim 47, wherein said substrate is hydrophilic and expandable under the effect of biological fluids present or circulating in the obstructed natural lumen.

50. The method of claim 28, wherein said device comprises a bacteriostatic agent.

51. The method of claim 28, wherein the device comprises a means for checking the correct positioning of said device.

52. The method of claim 28, wherein the device comprises an agent which is opaque vis-a-vis X-rays.

53. The method of claim 28, wherein said cytoreductive agent is not hydrosoluble.

54. The method of claim 28, wherein said cytoreductive agent comprises at least one medicament selected from the group consisting of antimitotic agents, cytolytic agents, enzymes, hormones, antienzymes, and metal salts.

55. The method of claim 10, wherein removing said device is conducted once sufficient reduction of the obstruction has occurred that normal urine flow can be achieved in the absence of said device.

56. The method of claim 37, wherein removing said device is conducted once sufficient reduction has occurred that normal urine flow can be achieved in the absence of said device.

57. The method of claim 20, wherein said substrate comprises a plurality of radial channels.

58. The method of claim 47, wherein said substrate comprises a plurality of radial channels.