Mechanical anal incontinence

• US 20030032857A1
• Filed: 10/15/2002
• Published: 02/13/2003
• Est. Priority Date: 02/11/2000
• Status: Abandoned Application

• Current Assignee: Obtech Medical AG (Johnson & Johnson)
• Original Assignee: Obtech Medical AG (Johnson & Johnson)
• Inventors: Forsell, Peter
• Application Number:
  US10/269,949
• Publication Number:
  US 20030032857A1
• Time in Patent Office: Days
• US Class Current: 600/30
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An anal incontinence treatment apparatus comprises an adjustable restriction device implanted in a patient, who suffers from anal incontinence. The device engages a portion of the colon or rectum of the patient to restrict the fecal passageway. An adjustment device mechanically adjusts the restriction device to restrict or release the fecal passageway, i.e. to normally close the fecal passageway and open the fecal passageway when the patient wants to relieve himself or herself.

Claims

1. An anal incontinence treatment apparatus, comprising:

an adjustable restriction device implanted in a patient, who suffers from anal incontinence, and engaging a portion of the colon or rectum of the patient to restrict the fecal passageway therein, and

an adjustment device which mechanically adjusts said restriction device to restrict or release the fecal passageway.

2. The apparatus according to claim 1, wherein said adjustment device adjusts said restriction device in a non-magnetic manner.

3. The apparatus according to claim 1, further comprising a powered operation device for operating said adjustment device.

4. The apparatus according to claim 1, wherein said restriction device comprises at least one elongated restriction member and forming means for forming said restriction member into at least a substantially closed loop around said portion of the colon or rectum, said loop defining a restriction opening, whereby said adjustment device adjusts said restriction member in said loop to change the size of said restriction opening.

5. The apparatus according to claim 1, wherein said restriction device is implanted in the base of the rectum or the prolongation thereof.

6. The apparatus according to claim 1, wherein said restriction device comprises at least two elements on different sides of said portion of the colon or rectum, and said adjustment device squeezes said portion of the colon or rectum between said elements to decrease the fecal passageway.

7. The apparatus according to claim 1, wherein said restriction device comprises one element on one side of said portion of the colon or rectum, and said adjustment device squeezes said portion of the colon or rectum between said element and the human bone or tissue to decrease the fecal passageway.

8. The apparatus according to claim 4, wherein said restriction device comprises several elongated restriction members extending around the colon or rectum.

9. The apparatus according to claim 1, wherein said restriction device is non-inflatable.

10. The apparatus according to claim 4, wherein said adjustment device adjusts the longitudinal extension of said elongated restriction member.

11. The apparatus according to claim 10, wherein said restriction member comprises a main portion and two elongated end portions, and said adjustment device establishes a longitudinal relative displacement between said end portions of said restriction member, such that the size of said restriction opening is adjusted.

12. The apparatus according to claim 11, wherein said adjustment device comprises a movement transferring member in engagement with at least one of said end portions of said restriction member and operable to displace said one end portion relative to said other end portion of said restriction member.

13. The apparatus according to claim 12, further comprising a motor, which is fixed relative to said main portion of said restriction member and has a rotating drive shaft operatively connected to said movement transferring member.

14. The apparatus according to claim 13, wherein said motor is positioned relative to said elongated restriction member such that said drive shaft extends in parallel with a chord in said loop of the restriction member.

15. The apparatus according to claim 10, wherein said elongated restriction member is longitudinally resilient and said adjustment device comprises a contraction device, which longitudinally contracts said resilient restriction member.

16. The apparatus according to claim 15, wherein said elongated restriction member comprises a substantially nonresilient main portion and an end portion forming an elongated helical spring, which is contractable by said contraction device.

17. The apparatus according to claim 16, wherein said contraction device comprises an elongated flexible pulling member connected to said main portion of said restriction member and extending through said helical spring to contract said helical spring against an arresting member, which is fixed relative to said main portion of said restriction member.

18. The apparatus according to claim 10, wherein said restriction member comprises an elongated helical spring having a free end, and a body to which said spring is nonrotatably secured at its opposite end, said adjustment device rotates said helical spring in one direction to enlarge the coils of said helical spring to longitudinally contract said elongated helical spring and to rotate said helical spring in the opposite direction to reduce the size of the coils of said helical spring to longitudinally extend said helical spring.

19. The apparatus according to claim 18, wherein said restriction member comprises a further elongated helical spring having a free end and nonrotatably secured to said body at its opposite end, and said adjustment device comprises a drive shaft having two opposite end portions connected to said helical springs, respectively, at their free ends, said helical coils forming left and right hand helices, respectively.

20. The apparatus according to claim 19, wherein said restriction member comprises a further elongated helical spring having a free end and nonrotatably secured to said body at its opposite end, and said adjustment device comprises a gearing having an input shaft and two opposite aligned output shafts connected to said helical springs, respectively, at their free ends, said input shaft being connected to said output shafts such that said output shafts rotate in opposite directions upon rotation of said input shaft, said helical coils forming the same helices.

21. The apparatus according to claim 4, wherein said restriction member forms a radially innermost at least partly circumferential confinement surface of said restriction member, and said adjustment device mechanically adjusts said restriction member such that at least a portion of said confinement surface is substantially radially displaced in said loop.

22. The apparatus according to claim 21, wherein said adjustment device comprises an elongated voltage responsive element forming part of said confinement surface and capable of bending into a bow in response to a voltage applied across said element, the radius of curvature of said bow being adjustable by changing the level of said voltage.

23. The apparatus according to claim 21, wherein said restriction member comprises an elastic annular element forming said confinement surface, and said adjustment device changes the diameter of said elastic annular element.

24. The apparatus according to claim 21, wherein said forming means comprises a substantially rigid outer annular element, and said restriction member comprises an elongated helical spring extending internally along said outer annular element and contacting the latter, said helical spring forming part of said circumferential confinement surface and having a free end, and a body to which said helical spring is nonrotatably secured at its opposite end, and said adjustment device rotates said helical spring in one direction to enlarge the coils of said helical spring to contract said circumferential confinement surface and rotates said helical spring in the opposite direction to reduce the size of the coils of said helical spring to expand said circumferential confinement surface.

25. The apparatus according to claim 21, wherein said forming means comprises a substantially rigid outer annular element, and said restriction member comprises a first and a second elongated helical spring extending internally along said outer annular element and contacting the latter, said helical springs forming part of said circumferential confinement surface, said first and said second spring, respectively, having a free end, and a body to which said first and said second spring, respectively, is nonrotatably secured at its opposite end, and said adjustment device rotates said first and said second spring, respectively, in one direction to enlarge the coils of said spring to contract said circumferential confinement surface and rotates said first and said second spring, respectively, in the opposite direction to reduce the size of the coils of said spring to expand said circumferential confinement surface.

26. The apparatus according to claim 4, wherein said restriction member comprises at least two separate elements, at least one of which is pivoted such that it may turn in a plane in which said loop of said restriction member extends, and said adjustment device turns said pivoted element to change the size of said restriction opening.

27. The apparatus according to claim 1, wherein said restriction device comprises at least two frame elements, which are foldable towards each other by said adjustment device.

28. The apparatus according to claim 27, wherein said foldable frame elements comprise two substantially or partly semi-circular frame elements. which are hinged together such that said semi-circular elements are swingable relative to each other from a fully open state in which they substantially or partly form a circle to a fully folded state in which they substantially form a semi-circle.

29. The apparatus according to claim 4, wherein said elongated restriction member is elastic and varies in thickness as seen in a cross-section therethrough, and said adjustment device turns said restriction member around the longitudinal extension thereof.

30. The apparatus according to claim 1, further comprising a motor operatively connected to said adjustment device.

31. The apparatus according to claim 30, wherein said motor is fixed to said restriction device.

32. The apparatus according to claim 31, wherein said motor is remote from said restriction device and is connected to said adjustment device by a power transmission conduit.

33. The apparatus according to claim 1, further comprising a hydraulic device which operates said adjustment device.

34. The apparatus according to claim 33, further comprising a reservoir containing a predetermined amount of fluid for supplying said hydraulic device with fluid.

35. The apparatus according to claim 34, wherein said reservoir defines a chamber for said predetermined amount of fluid and said hydraulic device changes the size of said chamber.

36. The apparatus according to claim 34, wherein said hydraulic device comprises an activatable pump for pumping fluid between said reservoir and said adjustment device.

37. The apparatus according to claim 34, wherein said hydraulic device comprises a servo means.

38. The apparatus according to claim 37, wherein said hydraulic device comprises first and second wall portions of said reservoir, and said servo means provides relative displacement between said first and second wall portions of said reservoir.

39. The apparatus according to claim 1, further comprising a wireless remote control for controlling said adjustment device.

40. The apparatus according to claim 39, wherein said remote control comprises a separate signal transmitter and/or receiver and a signal receiver and/or transmitter implanted in the patient.

41. The apparatus according to claim 40, wherein said signal receiver comprises a control unit for controlling said adjustment device in response to a control signal received from said signal transmitter.

42. The apparatus according to claim 41, further comprising an energizer unit implanted in the patient for providing energy to energy consuming components of said restriction device.

43. The apparatus according to claim 42, further comprising a motor implanted in the patient for operating said adjustment device.

44. The apparatus according to claim 43, wherein said control unit powers said motor with energy provided by said energizer unit in response to a control signal received from said signal transmitter.

45. The apparatus according to claim 43, wherein said motor comprises an electric motor.

46. The apparatus according to claim 42, wherein said energizer unit transfers energy from said control signal, as the latter is transmitted to said signal receiver, into electric energy.

47. The apparatusaccording to claim 46, further comprising an electric motor implanted in the patient for operating said adjustment device, said energizer unit comprising a rechargeable electric power supply for storing said electric energy and said control unit powers said electric motor with energy from said rechargeable electric power supply in response to a control signal received from said signal transmitter.

48. The apparatus according to claim 42, wherein said energizer unit comprises a battery, an electrically operable switch for connecting said battery to said signal receiver in an “

on”

mode when said switch is powered and to keep said battery disconnected from said signal receiver means in a “

standby”

mode when said switch is unpowered, and a rechargeable electric power supply for powering said switch.

49. The apparatus according to claim 48, wherein said control unit powers said electric motor with energy from said battery in response to a control signal received from said signal transmitter, when said switch is in its “

on”

mode.

50. The apparatus according to claim 42, further comprising an external energy transmitter for transmitting wireless energy, wherein said energizer unit comprises a battery and an operable switch for connecting said battery to said signal receiver in an “

on”

mode when said switch is powered and to keep said battery disconnected from said signal receiver in a “

standby”

mode when said switch is unpowered, said external energy transmitter for powering said switch.

51. The apparatus according to claim 50, wherein said energy transmitter directly powers said switch with said wireless energy to switch into said “

on”

mode.

52. The apparatus according to claim 39, wherein said remote control comprises means for wireless transfer of energy from outside the patient'"'"'s body to energy consuming components of said restriction device.

53. The apparatus according to claim 52, wherein said means for wireless transfer of energy directly powers said energy consuming components of said restriction device.

54. The apparatus according to claim 52, further comprising a motor implanted in the patient for operating said adjustment device, wherein said means for wireless transfer of energy directly powers said motor with transferred energy.

55. The apparatus according to claim 52, wherein said energy transferred by said means for transfer of energy comprises a wave signal.

56. The apparatus according to claim 52, wherein said energy transferred by said means for transfer of energy comprises an electric or magnetic field.

57. The apparatus according to claim 40, wherein said signal transmitter and signal receiver transmit and receive a signals in the form of digital pulses.

58. The apparatus according to claim 57, wherein said digital pulses comprise an electric or magnetic field.

59. The apparatus according to claim 40, wherein said signal transmitter and signal receiver transmit and receive a wave signal.

60. The apparatus according to claim 59, wherein said wave signal comprises an electromagnetic wave signal, a sound wave signal or a carrier wave signal for a remote control signal.

61. The apparatus according to claim 42, wherein said energizer unit transfers said energy from said control signal into a direct or alternating current.

62. The apparatus according to claim 39, wherein said remote control is capable of obtaining information related to the pressure against the restriction device, directly or indirectly, and of commanding said adjustment device to directly or indirectly adjust said restriction device in response to obtained information.

63. The apparatus according to claim 4, wherein said adjustment device changes the size of said restriction opening such that the outer circumferential confinement surface of said restriction member is changed.

64. The apparatus according to claim 4, wherein said adjustment device changes the size of said restriction opening such that the outer circumferential confinement surface of the restriction member is unchanged.

65. The apparatus according to claim 4, wherein said forming means comprises a spring material forming said elongated restriction member into said loop, such that said restriction opening has a predetermined size, and said adjustment device adjusts said restriction member against the spring action of said spring material.

66. The apparatus according to claim 65, wherein said spring material is integrated in said restriction member.

67. The apparatus according to claim 4, wherein said forming means form said restriction member into a loop having a predetermined size.

68. The apparatus according to claim 4, wherein said elongated restriction member is flexible, and said adjustment device pulls a first portion of said flexible restriction member from a second portion of said flexible restriction member opposite said first portion in said loop to squeeze said portion of the rectum or colon between two opposite lengths of said elongated flexible restriction member to decrease the fecal passageway.

69. The apparatus according to claim 1, wherein said restriction device comprises at least two elements rotating in opposite direction thereof and being located spaced apart engaging the colon or rectum, and said adjustment device squeezes said portion of the colon or rectum between said elements when they are rotated to decrease the fecal passageway.

70. The apparatus according to claim 1, wherein said restriction device comprises at least two articulated clamping elements positioned on different sides of said portion of the colon or rectum, and said adjustment device moves said clamping elements towards each other to clamp said portion of the colon or rectum between said clamping elements to decrease the fecal passageway.

71. The apparatus according to claim 1, wherein said restriction device bends said portion of the colon or rectum.

72. The apparatus according to claim 71, wherein said restriction device comprises at least two bending members positioned on opposite or diferent sides of said portion of the colon or rectum, and said adjustment device moves said bending members against said portion of the colon or rectum in two opposite spaced apart directions to bend said portion of the colon or rectum to restrict the fecal passageway.

73. The apparatus according to claim 72, wherein said bending members comprise rollers.

74. The apparatus according to claim 1, wherein said restriction device rotates a portion of the colon or rectum.

75. The apparatus according to claim 1, wherein the colon or rectum form a fecal passageway and said restriction device controls the cross-sectional area of said fecal passageway.

76. The apparatus according to claim 75, wherein said restriction device is operable to open and close said fecal passageway to respectively allow, or substantially completely prevent, the passage of fecal material through said passageway.

77. The apparatus according to claim 76, wherein said restriction device steplessly controls the cross-sectional area of said fecal passageway.

78. The apparatus according to claim 1, further comprising a pressure sensor for directly or indirectly sensing the pressure against the restriction device.

79. The apparatus according to claim 78, wherein said restriction device is controlled in response to signals from said pressure sensor.

80. The apparatus according to claim 1, further comprising an implanted energy transfer device transferring wireless energy directly or indirectly into kinetic energy for operation of said restriction device.

81. The apparatus according to claim 1, further comprising a reversing device implanted in the patient, wherein said restriction device is capable of performing a reversible function and said reversing device reverses said function.

82. The apparatus according to claim 30, comprising a reversing device implanted in the patient for reversing said motor.

83. The apparatus according to claim 1, wherein said adjustment device or other energy consuming components of the apparatus are energised with wirelessly transmitted energy from outside the patient'"'"'s body.

84. The apparatus according to claim 1, further comprising an implanted accumulator or battery and means for controlling said accumulator or battery from outside the patient'"'"'s body to supply energy to said adjustment device or other implanted energy consuming components of the apparatus

85. The apparatus according to claim 42, wherein said energizer unit comprise an implanted battery or accumulator for providing energy to energy consuming components of said restriction device.

86. The apparatus according to claim 1, wherein said adjustment device adjusts said restriction device in a non-manual manner.

87. A method for treating anal incontinence, comprising:

surgically implanting in the body of a patient suffering from anal incontinence an adjustable restriction device which directly engages the colon or rectum to form a normally closed fecal passageway therein, and

when desired, mechanically adjusting the restriction device to temporarily open the fecal passageway to allow the passage of fecal material therethrough.

88. A surgical method as recited in claim 87, further comprising implanting the adjustable restriction device in the base or prolongation of the patient'"'"'s rectum.

89. A surgical method as recited in claim 87, further comprising implanting at least two restriction devices engaging the colon or rectum

90. A method for treating anal incontinence, comprising the steps of:

placing at least two laparascopical trocars in the body of a patient suffering from anal incontinence,

inserting a dissecting tool through the trocars and dissecting an area of the colon or rectum in the abdominal or pelvic or retoperitoneal surroundings,

placing at least one adjustable restriction device in the dissected area engaging the rectum or colon, and'"'"'

adjusting the restriction device to normally restrict the fecal passageway in the rectum or colon to substantially prevent the passage of fecal material therethrough, and when defaecation is needed release the fecal passageway to allow the passage of fecal material therethrough.

91. A surgical method as recited in claim 90, further comprising mechanically adjusting the restriction device.

92. A surgical method as recited in claim 90, further comprising adjusting the restriction device in a non-manual manner.

93. A surgical method as recited in claim 90, further comprising implanting a source of energy in the patient and providing a control device for controlling the source of energy from outside the patient'"'"'s body to supply energy to the restriction device