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

• US 20050113748A1
• Filed: 12/22/2004
• Published: 05/26/2005
• Est. Priority Date: 07/13/1994
• Status: Active Grant

• Current Assignee: Marian Devonec
• Original Assignee: Marian Devonec
• Inventors: Devonec, Marian
• Granted Patent: US 8,211,085 B2
• Time in Patent Office: Days
• US Class Current: 604/96.10
• 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 therapeutic device intended for substantially fully intracorporeal insertion for treatment of an obstruction in the prostatic portion of a male urethra, comprising:

a non-biodegradable element that is designed to be placed and retained in a prostatic portion of the male urethra to maintain a channel, said element being sufficiently flexible to conform to the urethra, but sufficiently rigid to maintain the channel for urine flow in the prostatic portion, the channel providing for passage of urine from upstream of the obstruction to downstream of the obstruction; and

a cytoreductive agent that causes reduction of the obstruction, said cytoreductive agent being positioned along said element, so as to treat the obstruction of the prostatic portion of the male urethra when said element is retained in the prostatic portion of the male urethra,

wherein the reductive effect is through direct contact of said element with cells of the obstruction and even without removing the device from the urethra, the reductive effect ceases when the direct contact ceases, and

wherein said device further comprises a withdrawal thread and is non-traumatically removable from the male urethra by said withdrawal thread following treatment of the obstruction.

2. The device of claim 1, wherein said device is configured to be self-stabilizing.

3. The device of claim 1, wherein said element is of cylindrical shape.

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

5. The device of claim 1, wherein said cytoreductive agent is cytotoxic to prostatic cells.

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

7. The device of claim 1, wherein said cytoreductive agent extends around a perimeter of said element.

8. The device of claim 1, wherein said cytoreductive agent is supported by said element.

9. The device of claim 1, wherein said cytoreductive agent is distinct from said element and covers said element.

10. The device of claim 1, wherein said cytoreductive agent is located on or in a sleeve, which is positioned along said non-biodegradable element.

11. The device of claim 1, wherein said cytoreductive agent is incorporated in said element.

12. The device of claim 1, wherein said element comprises (i) a core made of a biocompatible material and (ii) a biologically active zone, and wherein in the biologically active zone of said element, said biocompatible material of said core incorporates said cytoreductive agent, at least on a surface of said biologically active zone.

13. The device of claim 12, wherein said core made of biocompatible material is made of silicone rubber.

14. The device of claim 1, wherein said element comprises an internal core made of a biocompatible material, and said cytoreductive agent is located on or in a biologically compatible substrate covering at least a portion of said internal core.

15. The device of claim 14, wherein said internal core is made of silicone rubber.

16. The device of claim 14, wherein said substrate and said internal core are off-centered in relation to one another.

17. The device of claim 14,

wherein said element has an outer surface,

wherein said substrate is radially expandable, and

wherein said substrate has an outer surface that is inscribed within said outer surface of said element, and, in the expanded position, emerges from said outer surface of said element.

18. The device of claim 14, wherein said substrate is hydrophilic and expandable under the effect of biological fluids present or circulating in the obstructed prostatic portion of the male urethra.

19. The device of claim 14, further comprising a sheath made of a synthetic foam between said substrate and said internal core.

20. The device of claim 14, wherein said substrate comprises a plurality of radial channels.

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

22. The device of claim 1, comprising means for checking the correct positioning of said device.

23. The device of claim 1, comprising an agent which is opaque vis-a-vis X-rays.

24. The device of claim 1, wherein said cytoreductive agent is not hydrosoluble.

25. The device 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.

26. The device of claim 1, wherein said 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.

27. The device of claim 1, wherein said cytoreductive agent is cytotoxic to urethral mucosal cells.

28. A method of treating an obstruction of the prostatic portion of the male urethra, comprising inserting said device of claim 1 into the obstructed portion of the male urethra, thereby opening the obstructed urethra and allowing normal passage of urine from the bladder.

29. The method of claim 28, wherein said cytoreductive agent causes a reduction in the obstruction.

30. The method of claim 29, further comprising removing said device once sufficient reduction has occurred that normal urine flow can be achieved in the absence of said device.

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

32. The method of claim 31, wherein said cytoreductive agent erodes the tumoral obstruction.

33. The method of claim 28, further comprising temporarily maintaining said device in the male urethra and then removing said device from the male urethra.

34. A therapeutic device intended for substantially fully intracorporeal insertion for treatment of an obstruction in a natural lumen through which a fluid naturally flows, comprising:

a non-biodegradable element that is designed to be placed and retained in the natural lumen to maintain a channel, said element being sufficiently flexible to conform to the natural lumen, but sufficiently rigid to maintain the channel for flow of the fluid in the lumen, the channel providing for passage of the fluid from upstream of the obstruction to downstream of the obstruction with respect to natural fluid flow; and

a cytoreductive agent that causes reduction of the obstruction, said cytoreductive agent being positioned along said element, so as to treat the obstruction of the natural lumen when said element is retained in the natural lumen,

wherein the reductive effect is through direct contact of said element with cells of the obstruction and, even without removing the device from the lumen, the reductive effect ceases when the direct contact ceases, and

wherein said device further comprises a withdrawal thread and is non-traumatically removable from the natural lumen by said withdrawal thread following treatment of the obstruction.

35. The device of claim 34, wherein said device is configured to be self-stabilizing.

36. The device of claim 34, wherein said element is of cylindrical shape.

37. The device of claim 34, wherein said cytoreductive agent is selectively reductive to cells of the obstruction.

38. The device of claim 34, wherein said cytoreductive agent is cytotoxic to cells of a wall of said lumen.

39. The device of claim 34, wherein said cytoreductive agent is reductive to urethral mucosal cells.

40. The device of claim 34, wherein said cytoreductive agent extends around a perimeter of said element.

41. The device of claim 34, wherein said cytoreductive agent is supported by said element.

42. The device of claim 34, wherein said cytoreductive agent is distinct from said element and covers at least a portion of said element.

43. The device of claim 34, wherein said cytoreductive agent is located on or in a sleeve, which is positioned along said non-biodegradable element.

44. The device of claim 34, wherein said cytoreductive agent is incorporated in said element.

45. The device of claim 34, wherein said element comprises (i) a core made of a biocompatible material, and (ii) a biologically active zone, and wherein in the biologically active zone of said element, said biocompatible material of the core incorporates said cytoreductive agent.

46. The device of claim 45, wherein said core made of biocompatible material is made of silicone rubber.

47. The device of claim 34, wherein said element comprises an internal core made of a biocompatible material, and said cytoreductive agent is located on or in a biologically compatible substrate covering at least a portion of said internal core.

48. The device of claim 47, wherein said internal core is made of silicone rubber.

49. The device of claim 47, wherein said cytoreductive agent and said internal core are off-centered in relation to one another.

50. The device of claim 47,

wherein said element has an outer surface,

wherein said substrate is radially expandable, and

wherein said substrate has an outer surface that is inscribed within said outer surface of said element, and, in the expanded position, emerges from said outer surface of said first element.

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

52. The device of claim 47, comprising a sheath made of a synthetic foam between said cytoreductive agent and said internal core.

53. The device of claim 47, wherein said substrate comprises a plurality of radial channels.

54. The device of claim 34, wherein said device comprises a bacteriostatic agent.

55. The device of claim 34, comprising means for checking the correct positioning of said device.

56. The device of claim 34, comprising an agent which is opaque vis-a-vis X-rays.

57. The device of claim 34, wherein said cytoreductive agent is not hydrosoluble.

58. The device of claim 34, 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.

59. The device of claim 34, wherein said 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.

60. The device of claim 59, wherein said cytoreductive agent is positioned between 10 and 15 mm from both said bottom end and said top end of said element.

61. A method of treating an obstruction of a natural lumen, comprising inserting said device of claim 34 into the obstructed natural lumen so that said element is positioned in contact with the obstruction, thereby opening the obstructed natural lumen and allowing the normal passage of the fluid.

62. A therapeutic device intended for substantially fully intracorporeal insertion for reduction of a pre-existing obstruction in a natural lumen for flow of a fluid, the lumen being obstructed by the effect of a local cell proliferation, said device comprising:

a non-biodegradable element adapted to be placed and retained in the natural lumen to maintain a channel, and sufficiently flexible to conform to the natural lumen, but sufficiently rigid to maintain the channel for flow of the fluid in the natural lumen, the channel providing for passage of the fluid from upstream to downstream of the obstruction with respect to the natural fluid flow; and

a sleeve which is supported by said element and which is positioned along said element so as to come into contact with the obstruction when said element is retained in the natural lumen, wherein said sleeve supports or comprises a cytoreductive agent that causes reduction of the pre-existing obstruction,

wherein the reductive effect is through direct contact of said sleeve with cells of the obstruction and, even without removing the device from the lumen, the reductive effect ceases when the direct contact ceases.

63. The device of claim 62, wherein said cytoreductive agent is selectively reductive to cells of the obstruction.

64. The device of claim 62, 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.

65. A method of treating a pre-existing obstruction of a natural lumen, comprising inserting said device of claim 62 into the obstructed natural lumen so that said element is positioned in contact with the obstruction, thereby opening the obstructed natural lumen and allowing normal passage of the fluid.

66. A method for treating a pre-existing obstruction in the prostatic portion of a male urethra, comprising inserting said device of claim 64 into the obstructed portion of the male urethra, thereby opening the obstructed urethra and allowing normal passage of urine.

67. The method of claim 65, wherein the obstruction is a tumoral obstruction.

68. The method of claim 67, wherein said agent erodes the obstruction.

69. A therapeutic device intended for substantially fully intracorporeal insertion for treatment of an obstruction in a natural lumen through which a fluid naturally flows, comprising:

a non-biodegradable element that is designed to be placed and retained in the natural lumen to maintain a channel, said element being sufficiently flexible to conform to the natural lumen, but sufficiently rigid to maintain the channel for flow of the fluid in the lumen, the channel providing for passage of the fluid from upstream of the obstruction to downstream of the obstruction with respect to natural fluid flow; and

a cytoreductive agent that causes reduction of the obstruction, said cytoreductive agent being positioned along said element, so as to treat the obstruction of the natural lumen when said element is retained in the natural lumen,

wherein said cytoreductive agent is non-selectively cytotoxic, and

wherein the reductive effect is through direct contact of said element with cells of the obstruction and, even without removing the device from the lumen, the reductive effect ceases when the direct contact ceases.

70. The device of claim 69, wherein said natural lumen is the prostatic portion of a male urethra.

71. A method of treating an obstruction of a natural lumen, comprising inserting said device of claim 69 into the obstructed natural lumen so that said element is positioned in contact with the obstruction, thereby opening the obstructed natural lumen and allowing the normal passage of the fluid.

72. A method for treating an obstruction in the prostatic portion of a male urethra, comprising inserting said device of claim 70 into the obstructed portion of the male urethra, thereby opening the obstructed urethra and allowing normal passage of urine.

73. A therapeutic device intended for substantially fully intracorporeal insertion for treatment of an obstruction in a natural lumen through which a fluid naturally flows, comprising:

a non-biodegradable element that is designed to be placed and retained in the natural lumen to maintain a channel, said element being sufficiently flexible to conform to the natural lumen, but sufficiently rigid to maintain the channel for flow of the fluid in the lumen, the channel providing for passage of the fluid from upstream of the obstruction to downstream of the obstruction with respect to natural fluid flow; and

a cytoreductive agent that causes reduction of the obstruction, said cytoreductive agent being positioned along said element, so as to treat the obstruction of the natural lumen when said element is retained in the natural lumen,

wherein said reductive effect is through direct contact of said element with cells of the obstruction and, even without removing the device from said lumen, the reductive effect ceases when the direct contact ceases.

74. The device of claim 73, wherein said natural lumen is the prostatic portion of a male urethra.

75. A method of treating an obstruction of a natural lumen, comprising inserting said device of claim 73 into the obstructed natural lumen so that said element is positioned in contact with the obstruction, thereby opening the obstructed natural lumen and allowing the normal passage of the fluid.

76. A method for treating an obstruction in the prostatic portion of a male urethra, comprising inserting said device of claim 74 into the obstructed portion of the male urethra, thereby opening the obstructed urethra and allowing normal passage of urine.

77. A therapeutic device intended for substantially fully intracorporeal insertion for treatment of an obstruction in a natural lumen through which a fluid naturally flows, comprising:

a non-biodegradable element that is designed to be placed and retained in the natural lumen to maintain a channel, said element being sufficiently flexible to conform to the natural lumen, but sufficiently rigid to maintain the channel for flow of the fluid in the lumen, the channel providing for passage of the fluid from upstream of the obstruction to downstream of the obstruction with respect to natural fluid flow; and

a cytoreductive agent that causes reduction of the obstruction, said cytoreductive agent being positioned along a length of said element, so as to treat the obstruction of the natural lumen when said element is retained in the natural lumen;

wherein said cytoreductive agent has a continuous surface both around said element and along said length of said element.

78. The device of claim 77, wherein said natural lumen is the prostatic portion of the male urethra.

79. A method of treating an obstruction of a natural lumen, comprising inserting said device of claim 77 into the obstructed natural lumen so that said element is positioned in contact with the obstruction, thereby opening the obstructed natural lumen and allowing the normal passage of the fluid.

80. A method for treating an obstruction in the prostatic portion of a male urethra, comprising inserting said device of claim 78 into the obstructed portion of the male urethra, thereby opening the obstructed urethra and allowing normal passage of urine.

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

inserting, in the natural lumen, a device comprising a non-biodegradable element and a cytoreductive agent positioned along said element, so that the element is positioned in contact with the obstruction,

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 the fluid, and

wherein the cytoreductive agent causes reduction of the obstruction through direct contact of said element with cells of the obstruction, the reductive effect ceasing when the direct contact ceases even without removal of the device from the lumen.

82. The method of claim 81, wherein said natural lumen is the prostatic portion of a male urethra.

83. The method of claim 81, wherein said cytoreductive agent is cytotoxic.

84. The method of claim 82, wherein said cytoreductive agent is cytotoxic to prostatic cells.

85. The method of claim 81, wherein said non-biodegradable element is of cylindrical shape.