Urethral device with anchoring system

• US 6,221,060 B1
• Filed: 10/04/1999
• Issued: 04/24/2001
• Est. Priority Date: 08/19/1997
• Status: Expired due to Fees

• Current Assignee: AbbeyMoor Medical, Inc.
• Original Assignee: AbbeyMoor Medical, Inc.
• Inventors: Willard, Lloyd K.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/411,491
• Time in Patent Office: 568 Days
• Field of Search: 604/264, 604/175, 604/93, 604/500, 604/508, 604/523, 600/29, 600/30
• US Class Current: 604/264
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A device that comprises a tubular-shaped body that is insertable into a body passageway or cavity, in particular the urethra, and that has an exterior surface having one or more anchors located thereon that aid in movement of the device with a minimum of trauma during placement and that aid in securing the device within the passageway or cavity during use. The device may be inserted into either the urethra, bladder neck, or bladder. The anchors can vary in height, length, number, compressiveness, axial placement, material characteristics, and helix angle. According to a further aspect, the one or more anchors are in the form of partial spiral helixes that function to move and secure the device within the human urethra. The partial spiral helixes have structures that allow for the longitudinal movement of the device during positioning procedures.

Claims

1. A device for placement in a urethra comprising:

a tubular body sized for placement in said urethra, said tubular body having a proximal portion adapted for placement toward a bladder end of said urethra and a distal portion opposite from said proximal portion, said tubular body having an exterior surface; and

an anchor extending outward from said exterior surface, wherein said anchor extends less than 360°

around said exterior surface.

2. The invention of claim 1 wherein said anchor extends less than 180°

around said exterior surface.

3. The invention of claim 1 wherein said anchor extends less than 90°

around said exterior surface.

4. The invention of claim 1 wherein said anchor has associated therewith tapered end portions extending from a main portion thereof and tapering toward said exterior surface of said tubular body.

5. The invention of claim 1 wherein said anchor comprises an elongate ridge having a height extending in a radial direction relative to an axis of said tubular body, and a length extending in a direction generally around a circumference of said tubular body, and wherein said height varies along said length tapering from a maximum height located along said length of said ridge.

6. The invention of claim 1 wherein said anchor extends helically around said exterior surface.

7. The invention of claim 1 wherein said tubular body comprises a wall that defines a passageway extending from said proximal portion to said distal portion and further wherein said tubular body has a proximal opening located in said proximal portion and communicating with said passageway and a distal opening located in said distal portion and communicating with said passageway.

8. The invention of claim 7 wherein a distal portion of said passageway includes a recess for receiving an insertion tool.

9. The invention of claim 7 wherein the proximal opening comprises an open through-lumen.

10. The invention of claim 7 wherein the proximal opening comprises a port.

11. The invention of claim 7 further comprising a valve located in said passageway.

12. The invention of claim 1 wherein said tubular body has a length such that said distal portion extends outside the urethra during use.

13. The invention of claim 1 wherein said tubular body has a length such that a distal end is retained inside the urethra during use.

14. The invention of claim 1 wherein said tubular body has a length such that a proximal end is positioned in the bladder during use.

15. The invention of claim 1 wherein said anchor has a maximum height of approximately 100% of a base diameter of said tubular body.

16. The invention of claim 1 wherein said device has a size between 6 and 24 French.

17. The invention of claim 1 wherein said exterior surface is constructed of a material selected from a group consisting of:

molded silicone, latex, polyurethane, polyethylene, and polycarbonate.

18. The invention of claim 1 further comprising:

at least one sealer ring located on said proximal portion and extending around said tubular body.

19. The invention of claim 18 wherein said at least one sealer ring is formed of a pliable material.

20. The invention of claim 1 further comprising:

at least one sealer ring located on said distal portion and extending around said body.

21. The invention of claim 1 further comprising:

a plurality of sealer rings located on said proximal portion and extending around said body.

22. The invention of claim 1 wherein said body is formed of silicone rubber.

23. The invention of claim 1 wherein said body is formed of a material having a Durometer hardness in a range between approximately 20 and 80 Shore A.

24. The invention of claim 1 wherein said body is formed of a material having a Durometer hardness of between approximately 60 and 80 Shore A.

25. The invention of claim 1 further comprising a marker located at said proximal portion.

26. The invention of claim 1 wherein said tubular body comprises a wall that defines a passageway extending from said proximal portion to said distal portion and further wherein said tubular body has a proximal opening located in said proximal portion and communicating with said passageway and a distal opening located in said distal portion and communicating with said passageway, and further wherein a magnetically-actuatable valve is located in said passageway.

27. A device for placement in a urethra comprising:

a tubular body sized for placement in said urethra, said tubular body having a cylindrical-shaped wall having an exterior surface, said tubular body having a proximal portion adapted for placement toward a bladder end of said urethra and a distal portion opposite from said proximal portion; and

an anchor located on said exterior surface, said anchor comprising an elongate ridge having a height extending in a radial direction relative to an axis of said tubular body, a length extending in a direction generally around a circumference of said tubular body, and a width perpendicular to said length and parallel to said axis, and wherein said ridge has a middle portion along its length where its height defines a distally-oriented surface that engages a wall of said urethra to anchor said tubular body therein, wherein said middle portion extends less than 360°

around said exterior surface of said tubular body.

28. The invention of claim 27 wherein said tubular body defines a passageway extending from said proximal portion to said distal portion, said tubular body having a proximal opening located in said proximal portion and communicating with said passageway and a distal opening located in said distal portion and communicating with said passageway.

29. A tubular device for placement in a urethra to provide a passageway therein comprising:

a tubular body sized for placement in the urethra, said tubular body having a cylindrical-shaped wall having an exterior surface, said tubular body defining a lumen extending from a proximal portion to a distal portion thereby providing a passageway through said tubular body, said proximal portion adapted for placement toward a bladder end of the urethra;

said tubular body having a proximal opening located in said proximal portion and communicating with said lumen and a distal opening located in said distal portion and communicating with said lumen;

an anchoring ridge, wherein said anchoring ridge extends from said exterior surface and has a distally-facing surface, and

wherein said anchoring ridge extends less than 360°

around said exterior surface.

30. The invention of claim 29 wherein said distally-facing surface forms an acute angle with said exterior surface of said tubular body.

31. The invention of claim 29 wherein said distally-facing surface forms an angle of at least approximately 30°

with said exterior surface of said tubular body.

32. The invention of claim 29 wherein said anchoring ridge deflects radially when pressure is applied to said tubular body.

33. The invention of claim 29 wherein said anchoring ridge has a proximally-facing surface, and wherein said proximally-facing surface forms an obtuse angle with said exterior surface of said tubular body.

34. The invention of claim 29 wherein said anchoring ridge is longitudinally displaced from one another along said exterior surface.

35. A device for placement in a urethra comprising:

a tubular body sized for placement in said urethra, said tubular body having a proximal portion adapted for placement toward a bladder end of said urethra and a distal portion opposite from said proximal portion, said tubular body having an exterior surface; and

an anchor extending outward from said exterior surface wherein said anchor forms a sinusoidal protrusion along a side of the exterior surface.

36. A device according to claim 35 wherein said anchor extends 360°

around said exterior body.

37. A device according to claim 35 wherein said anchor extends less than 360°

around said exterior body.

38. A device according to claim 35 wherein the sinusoidal protrusion along the side of the exterior surface is offset from a sinusoidal protrusion along a second side of the exterior surface.

39. A device according to claim 35 wherein the sinusoidal protrusion along the side of the exterior surface is aligned with a sinusoidal protrusion along a second side of the exterior surface.

40. The invention of claim 35 wherein said anchor extends less than 180°

around said exterior surface.

41. The invention of claim 35 wherein said anchor extends less than 90°

around said exterior surface.

42. The invention of claim 35 wherein each of said plurality of anchors extends helically around said exterior surface.

43. The invention of claim 35 wherein said tubular body comprises a wall that defines a passageway extending from said proximal portion to said distal portion and further wherein said tubular body has a proximal opening located in said proximal portion.

44. The invention of claim 43 wherein the proximal opening comprises an open through-lumen.

45. The invention of claim 43 wherein the proximal opening comprises a port.

46. The invention of claim 35 further comprising a valve located in said passageway.

47. The invention of claim 35 wherein said tubular body has a length such that said distal portion extends outside the urethra during use.

48. The invention of claim 35 wherein said tubular body has a length such that a distal end is retained inside the urethra during use.

49. The invention of claim 35 wherein said tubular body has a length such that a proximal end is positioned in the bladder during use.

50. The invention of claim 35 wherein said device has a size between 6 and 24 French.

51. The invention of claim 35 wherein said exterior surface is constructed of a material selected from a group consisting of:

molded silicone, latex, polyurethane, polyethylene, and polycarbonate.

52. The invention of claim 35 further comprising:

at least one sealer ring located on said proximal portion and extending around said tubular body.

53. The invention of claim 52 wherein said at least one sealer ring is formed of a pliable material.

54. The invention of claim 35 further comprising:

at least one sealer ring located on said distal portion and extending around said body.

55. The invention of claim 35 further comprising:

a plurality of sealer rings located on said proximal portion and extending around said body.

56. The invention of claim 35 wherein said body is formed of silicone rubber.

57. The invention of claim 35 wherein said body is formed of a material having a Durometer hardness in a range between approximately 29 and 80 Shore A.

58. The invention of claim 35 wherein said body is formed of a material having a Durometer hardness of between approximately 60 and 80 Shore A.

59. The invention of claim 35 further comprising a marker located at said proximal portion.

60. The invention of claim 35 wherein said tubular body comprises a wall that defines a passageway extending from said proximal portion to said distal portion and further wherein said tubular body has a proximal opening located in said proximal portion and communicating with said passageway and a distal opening located in said distal portion and communicating with said passageway, and further wherein a magnetically-actuatable valve is located in said passageway.

61. A device for placement in a urethra comprising:

a tubular body sized for placement in said urethra, said tubular body having a proximal portion adapted for placement toward a bladder end of said urethra and a distal portion opposite from said proximal portion, said tubular body having an exterior surface; and

an anchor extending outward from said exterior surface wherein said anchor forms an undulating pattern along said exterior surface.

62. A device according to claim 61 wherein said anchor extends 360°

around said exterior body.

63. A device according to claim 61 wherein said anchor extends less than 360°

around said exterior body.

64. A device according to claim 61 wherein said anchor extends less than 180°

around said exterior surface.

65. The invention of claim 61 wherein said anchor extends less than 90°

around said exterior surface.

66. The invention of claim 61 wherein said anchor extends helically around said exterior surface.

67. The invention of claim 61 wherein said tubular body comprises a wall that defines a passageway extending from said proximal portion to said distal portion and further wherein said tubular body has a proximal opening located in said proximal portion.

68. The invention of claim 67 wherein the proximal opening comprises an open through-lumen.

69. The invention of claim 67 wherein the proximal opening comprises a port.

70. The invention of claim 67 further comprising a valve located in said passageway.

71. The invention of claim 61 wherein said tubular body has a length such that said distal portion extends outside the urethra during use.

72. The invention of claim 61 wherein said tubular body has a length such that a distal end is retained inside the urethra during use.

73. The invention of claim 61 wherein said tubular body has a length such that a proximal end is positioned in the bladder during use.

74. The invention of claim 61 wherein said device has a size between 6 and 24 French.

75. The invention of claim 61 wherein said exterior surface is constructed of a material selected from a group consisting of molded silicone, latex, polyurethane, polyethylene, and polycarbonate.

76. The invention of claim 61 further comprising:

at least one sealer ring located on said proximal portion and extending around said tubular body.

77. The invention of claim 76 wherein said at least one sealer ring is formed of a pliable material.

78. The invention of claim 61 further comprising:

at least one sealer ring located on said distal portion and extending around said body.

79. The invention of claim 61 further comprising:

a plurality of sealer rings located on said proximal portion and extending around said body.

80. The invention of claim 61 wherein said body is formed of silicone rubber.

81. The invention of claim 61 wherein said body is formed of a material having a Durometer hardness in a range between approximately 29 and 80 Shore A.

82. A device for placement in a urethra comprising:

a tubular body sized for placement in said urethra, said tubular body comprising;

a proximal portion adapted for placement toward a bladder end of said urethra;

a distal portion opposite from said proximal portion;

an exterior surface;

a wall that defines a passageway extending from said proximal portion to said distal portion; and

a valve located in said passageway, wherein said valve is movable from a closed position that blocks access to said passage way to an open position where said passageway is accessible and said valve automatically moves to said open position when said valve encounters a predetermined fluid pressure.

83. The device of claim 82, wherein said predetermined pressure is greater than approximately 40 cm of water.

84. The device of claim 82, wherein said valve automatically moves to said open position when said valve encounters said predetermined fluid pressure for at least a predetermined amount of time.

85. The device of claim 84, wherein said predetermined amount of time is several seconds.

86. The device of claim 83, wherein said valve automatically moves to said open position when said valve encounters said predetermined fluid pressure for at least a predetermined amount of time.

87. The device of claim 86, wherein said predetermined amount of time is several seconds.

88. The device of claim 82, comprising an anchor extending from said exterior surface.

89. The device of claim 88, wherein said anchor forms an undulating pattern along said exterior surface.

90. The device of claim 89, wherein said undulating pattern comprises a sinusoidal pattern.

91. The device of claim 88 wherein said anchor extends 360°

around said exterior body.

92. The device of claim 88 wherein said anchor extends less than 360°

around said exterior body.

93. The device of claim 88 wherein said anchor extends less than 180°

around said exterior surface.

94. The device of claim 88 wherein said anchor extends less than 90°

around said exterior surface.

95. The device of claim 82, wherein said valve is magnetically-actuatable.

96. The device of claim 82 wherein said valve is latched at said closed position in that said valve opens after solely overcoming minimal frictional forces.

97. The device of claim 95 wherein said valve is latched at said closed position in that said valve opens after solely overcoming minimal frictional forces.