Hydraulic anal incontinence treatment

• US 20030045775A1
• Filed: 10/15/2002
• Published: 03/06/2003
• Est. Priority Date: 08/12/1999
• Status: Active Grant

• Current Assignee: Obtech Medical AG (Johnson & Johnson)
• Original Assignee: Obtech Medical AG (Johnson & Johnson)
• Inventors: Forsell, Peter
• Granted Patent: US 7,235,044 B2
• Time in Patent Office: Days
• US Class Current: 600/31
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61F 2/0018 magnetic
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/004 inflatable
• 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 and method includes and uses an adjustable restriction device implanted in a patient, who suffers from anal incontinence. The restriction device engages the rectum of the patient to restrict the fecal passageway. An adjustment device is adapted to adjust the restriction device such that the rectum is temporarily released, in order to open the fecal passageway when the patient wishes to achieve defaecation.

Claims

1. An anal incontinence treatment apparatus, comprising:

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

an adjustment device which adjusts said restriction device to restrict the colon or rectum to close the fecal passageway, or release the colon or rectum to open the fecal passageway, and

a powered hydraulic operation device for operating said adjustment device.

2. The apparatus according to claim 1, wherein said restriction device controls the size of the area of the fecal passageway in the colon or rectum.

3. The apparatus according to claim 2, wherein said restriction device controls said size of the area of the fecal passageway to change steplessly.

4. The apparatus according to claim 2, wherein said adjustment device adjusts said restriction device to the colon or rectum such that the area of the fecal passageway in the colon or rectum assumes a preselected size that is satisfactory for the patient.

5. The apparatus according to claim 1, further comprising a control device for controlling said restriction device.

6. The apparatus according to claim 5, wherein said control device comprises an internal control unit implanted in the patient for controlling said restriction device.

7. The apparatus according to claim 6, wherein said internal control unit is programmable.

8. The apparatus according to claim 7, wherein said control device comprises an external control unit outside the patient'"'"'s body, said implanted internal control unit being programmable by said external control unit.

9. The apparatus according to claim 5, wherein said control device comprises an external control unit outside the patient'"'"'s body for wirelessly controlling said restriction device.

10. The apparatus according to claim 9, wherein said external control unit is programmable.

11. The apparatus according to claim 1, further comprising at least one implanted sensor for sensing at least one physical parameter of the patient.

12. The apparatus according to claim 11, wherein said sensor senses the pressure against the restriction device, direct or indirect, and said restriction device releases the restriction in the fecal passageway in the colon or rectum in response to said sensor sensing a predetermined value.

13. The apparatus according to claim 11, further comprising a control device controlling said restriction device in response to signals by said sensor.

14. The apparatus according to claim 13, wherein said control device comprises an internal control unit implanted in the patient and directly controlling said restriction device in response to signals by said sensor.

15. The apparatus according to claim 13, wherein said control device comprises an external control unit outside the patient'"'"'s body controlling said restriction device in response to signals by said sensor.

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

17. The apparatus according to claim 1, wherein said restriction device comprises an elongated restriction member and forming means for forming said restriction member into at least a substantially closed loop around colon or rectum or it'"'"'s prolongation, said locp defining a restriction opening, whereby said adjustment device adjusts said restriction member in said loop to change the size of said restriction opening.

18. The apparatus according to claim 17, wherein said forming means forms said restriction member into a loop having a predetermined size.

19. The apparatus according to claim 17, 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 the colon or rectum between two opposite lengths of said elongated flexible restriction member to restrict the fecal passageway.

20. The apparatus according to claim 19, wherein said elongated restriction member is non-inflatable, and said adjustment device mechanically adjusts said restriction member in said loop.

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

22. The apparatus according to claim 1, wherein said restriction device comprises at least two articulated clamping elements positioned on opposite sides of the colon or rectum or it'"'"'s prolongation, and said adjustment device moves said clamping elements toward each other to clamp the colon or rectum or it'"'"'s prolongation between said clamping elements to restrict the fecal passageway.

23. The apparatus according to claim 1, wherein said restriction device bends the the colon or rectum or it'"'"'s prolongation.

24. The apparatus according to claim 23, wherein said restriction device comprises at least two bending members positioned on opposite sides of the colon or rectum or it'"'"'s prolongation, and said adjustment device moves said bending members against the colon or rectum or it'"'"'s prolongation in two opposite spaced apart directions to bend the colon or rectum to restrict the fecal passageway.

25. The apparatus according to claim 24, wherein said bending members comprise rollers.

28. The apparatus according to claim 1, further comprising a reservoir implanted in the patient and containing a predetermined amount of hydraulic fluid, wherein said hydraulic operation device operates said adjustment device by using said hydraulic fluid of said reservoir.

29. The apparatus according to claim 28, wherein said adjustment device comprises an expandable cavity in said restriction device, the colon or rectum or prolongation thereof being squezeed upon expansion of said cavity and released upon contraction of said cavity, and said hydraulic operation device distributes hydraulic fluid from said reservoir to expand said cavity, and distributes hydraulic fluid from said cavity to said reservoir to contract said cavity.

30. The apparatus according to claim 29, wherein said reservoir defines a chamber for said predetermined amount of fluid and said hydraulic operation device changes the size of said chamber.

31. The apparatus according to claim 30, wherein said hydraulic operation device comprises first and second wall portions of said reservoir, which are displaceable relative to each other to change the size of said chamber of said reservoir.

32. The apparatus according to claim 31, wherein said first and second wall portions of said reservoir are displaceable relative to each other by non-manual manipulation thereof.

33. The apparatus according to claim 31, wherein said first and second wall portions of said reservoir are displaceable relative to each other by magnetic means, hydraulic means, or electric control means.

34. The apparatus according to claim 31, wherein said hydraulic operation device distributes fluid from said reservoir to said cavity in response to a predetermined first displacement of said first wall portion of said reservoir relative to said second wall portion of said reservoir and distributes fluid from said cavity to said reservoir in response to a predetermined second displacement of said first wall portion relative to said second wall portion.

35. The apparatus according to claim 29, wherein said hydraulic operation device comprises a pump for pumping fluid between said reservoir and said cavity.

36. The apparatus according to claim 35, wherein said pump comprises a first activation member for activating said pump to pump fluid from said reservoir to said cavity and a second activation member for activating said pump to pump fluid from said cavity to said reservoir.

37. The apparatus according to claim 36, wherein said first and second activation members are operable by manual manipulation thereof.

38. The apparatus according to claim 36, wherein at least one of said activation members operates when subjected to an external predetermined pressure.

39. The apparatus according to claim 36, wherein at least one of said first and second activating members are operable by magnetic means, hydraulic means, or electric control means.

40. The apparatus according to claim 35, wherein said operation device comprises a fluid conduit between said pump and said cavity, said reservoir forming part of said conduit.

41. The apparatus according to claim 40, wherein said conduit, hydraulic operation device or pump is devoid of any non-return valve.

42. The apparatus according to claim 41, wherein said reservoir forms a fluid chamber with a variable volume, and said pump distributes fluid from said chamber to said cavity by reduction of the volume of said chamber and withdraws fluid from said cavity by expansion of the volume of said chamber.

43. The apparatus according to claim 42, wherein said operation device comprises a motor for driving said pump.

44. The apparatus according to claim 43, wherein said pump comprises a movable wall of said reservoir for changing the volume of said chamber.

45. The apparatus according to claim 17, wherein said adjustment device changes the size of said restriction opening such that the outer circumferential confinement surface of said restriction member is changed.

46. The apparatus according to claim 17, wherein said adjustment device changes the size of said restriction opening such that the outer circumferential confinement surface of said restriction member is unchanged.

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

59. The apparatus according to claim 58, wherein said remote control comprises an external wireless hand-held remote control unit which is manually operable by the patient to control said restriction device to squeeze or release the colon or rectum or it'"'"'s prolongation.

60. The apparatus according to claim 58, wherein said remote control comprises an external signal transmitter or receiver and a signal receiver or transmitter implanted in the patient.

61. The apparatus according to claim 60, wherein said signal receiver comprises a control unit for controlling said restriction device in response to a control signal received from said signal transmitter.

62. The apparatus according to claim 61, further comprising an energizer unit implanted in the patient for providing energy to energy consuming implanted components of the apparatus.

63. The apparatus according to claim 62, further comprising a motor implanted in the patient for operating said adjustment device.

64. The apparatus according to claim 63, 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.

65. The apparatus according to claim 62, wherein said energizer unit transfers energy from said control signal, as the latter is transmitted to said signal receiver, into electric energy.

66. The apparatus according to claim 58, wherein said remote control comprises means for wireless transfer of energy from outside the patient'"'"'s body to energy consuming implanted components of the apparatus.

67. The apparatus according to claim 66, 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.

68. The apparatus according to claim 67, wherein the energy transferred by said means for transfer of energy comprises a wave signal.

69. The apparatus according to claim 67, wherein the energy transferred by said means for transfer of energy comprises an electric field or a magnetic field.

70. The apparatus according to claim 60, wherein said signal transmitter and signal receiver transmit and receive a signal in the form of digital pulses.

71. The apparatus according to claim 70, wherein said digital pulses comprise a magnetic field or an electric field.

72. The apparatus according to claim 60, wherein said signal transmitter and signal receiver transmit and receive a wave signal.

73. The apparatus according to claim 72, wherein said wave signal comprises an electromagnetic wave signal, a sound wave signal or a carrier wave signal for a remote control signal.

74. The apparatus according to claim 62 or 65, wherein said energizer unit transfers the energy from said signal into a direct or alternating current.

75. The apparatus according to claim 58, wherein said remote control is capable of obtaining information related to important parameters from inside the patients body and of commanding said adjustment device to adjust said restriction device in response to obtained information.

84. The apparatus according to claim 58, wherein said remote control is capable of obtaining information from implanted components of the apparatus and of commanding said adjustment device to adjust said restriction device in response to obtained information.

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

86. The apparatus according to claim 1, further comprising an implanted energy transfer device and said energy transfer device transfers wireless energy direct or indirect into kinetic energy for operation of said restriction device.

87. The apparatus according to claim 1, wherein said adjustment device comprises a motor and a reversing device implanted in the patient for reversing said motor.

88. 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.

89. The apparatus according to claim 1, wherein said adjustment device or other energy consuming components of the apparatus are energised with an implanted battery or accumulator and the energy is released from outside the patient'"'"'s body.

26. An anal incontinence treatment apparatus, comprising:

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

an adjustment device which adjusts said restriction device to squeeze the colon or rectum to restrict the fecal passageway or release the colon or rectum to open the fecal passageway, wherein said adjustment device comprises servo means.

27. The apparatus according to claim 26, further comprising an operation device implanted in the patient for operating said adjustment device, wherein said operation device comprises a powered hydraulic operation device.

47. The apparatus according to claim 26, wherein said servo means comprises a hydraulic operation device.

48. The apparatus according to claim 47, wherein said hydraulic operation 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 to change the volume of said chamber of said reservoir.

49. The apparatus according to claim 26, wherein said servo means comprises magnetic means, or electric means.

50. The apparatus according to claim 26, wherein said servo means comprises hydraulic means.

51. The apparatus according to claim 50, wherein said servo means comprises a servo reservoir defining a chamber containing servo fluid, and said hydraulic operation device comprises first and second wall portions of said servo reservoir, which are displaceable relative to each other to change the volume of said chamber of said servo reservoir.

52. The apparatus according to claim 51, wherein said first and second wall portions of said servo reservoir are displaceable relative to each other by manual manipulation.

53. The apparatus according to claim 51, wherein said first and second wall portions of said servo reservoir are displaceable relative to each other by magnetic means, hydraulic means, or electric control means.

54. The apparatus according to claim 47, wherein said servo means comprises a servo reservoir and a fluid supply reservoir connected in a closed system and containing a further predetermined amount of fluid.

55. The apparatus according to claim 54, wherein said fluid supply reservoir defines a chamber for the further predetermined amount of fluid and said hydraulic operation device changes the volume of said chamber of said supply reservoir and thereby control the amount of fluid in said servo reservoir.

56. The apparatus according to claim 55, wherein said fluid supply reservoir comprises first and second wall portions, which are displaceable relative to each other to change the volume of said chamber of said fluid supply reservoir.

57. The apparatus according to claim 56, wherein said fluid supply reservoir increases the amount of fluid in said servo reservoir in response to a predetermined first displacement of said first wall portion of said fluid supply reservoir relative to said second wall portion of said fluid supply reservoir and decreases the amount of fluid in said servo reservoir in response to a predetermined second displacement of said first wall portion of said fluid supply reservoir relative to said second wall portion of said fluid supply reservoir.

90. The apparatus according to claim 26, wherein said adjustment device is non-inflatable.

76. An anal incontinence treatment apparatus, comprising:

an adjustable restriction device implanted in a patient, who suffers from anal incontinence, said restriction device having at least one restriction member engaging colon or rectum or it'"'"'s prolongation of the patient to affect the fecal passageway,

a hydraulic adjustment device operated in a non-manual manner for adjusting said restriction device to restrict the colon or rectum or the prolongation thereof to close the fecal passageway.

81. The apparatus according to claim 76, wherein said operation device is electrically powered.

82. Apparatus according to claim 76, comprising a reservoir implanted in the patient and containing a predetermined amount of hydraulic fluid, a conduit providing fluid connection between said reservoir and said hydraulic adjustment device, and an operation device implanted in the patient for operating said hydraulic adjustment device by distributing hydraulic fluid through said conduit between said reservoir and said hydraulic adjustment device, wherein said conduit, hydraulic adjustment device and operation device are devoid of any non-return valve to permit free flow of hydraulic fluid in both directions in said conduit.

77. An anal incontinence treatment apparatus, comprising:

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

an adjustment device which adjusts said restriction device to restrict the colon or rectum to close the fecal passageway or release the colon or rectum to open the fecal passageway, a reservoir implanted in the patient and containing a predetermined amount of hydraulic fluid,

a conduit providing fluid connection between said reservoir and said hydraulic adjustment device, and

an operation device implanted in the patient for operating said hydraulic adjustment device by distributing hydraulic fluid through said conduit between said reservoir and said hydraulic adjustment device,

wherein said conduit, hydraulic adjustment device and operation device are devoid of any non-return valve to permit free flow of hydraulic fluid in both directions in said conduit.

78. The apparatus according to claim 77, wherein said reservoir forms a fluid chamber with a variable volume, and said pump distributes fluid from said chamber to said cavity by reduction of the volume of said chamber and withdraws fluid from said cavity by expansion of the volume of said chamber.

79. The apparatus according to claim 78, wherein said operation device comprises a motor for driving said pump.

80. The apparatus according to claim 79, wherein said pump comprises a movable wall of said reservoir for changing the volume of said chamber.

92. The apparatus according to claim 77, further comprising a wireless remote control for controlling said restriction device.

93. The apparatus according to claim 77, wherein said adjustment device or other energy consuming components of the apparatus are energised with wirelessly transmitted energy from outside the patient'"'"'s body.

94. The apparatus according to claim 77, wherein said adjustment device or other energy consuming components of the apparatus are energised with an implanted battery or accumulator and the energy is released from outside the patient'"'"'s body.

83. An anal incontinence treatment apparatus, comprising:

an adjustable restriction device implanted in a patient, who suffers from anal incontinence, said restriction device having at least one restriction member engaging the colon, rectum or the prolongation thereof of the patient to engage the fecal passageway,

an adjustment device for adjusting said restriction device to restrict the colon, rectum or the prolongation thereof by means of said restriction member to close the fecal passageway or release the colon or rectum to open the fecal passageway, and

an electrically powered operation device which operates said adjustment device.

91. The apparatus according to claim 83, further comprising a wireless remote control for controlling said restriction device.

95. The apparatus according to claim 83, wherein said adjustment device or other energy consuming components of the apparatus are energised with wirelessly transmitted energy from outside the patients body.

96. The apparatus according to claim 83, wherein said adjustment device or other energy consuming components of the apparatus are energised with an implanted battery or accumulator and the energy is released from outside the patients body.

97. A method for treating anal incontinence, comprising:

surgically implanting in the body of a patient suffering from anal incontinence an adjustable powered restriction device engaging the colon or rectum or the prolongation thereof to restrict the fecal passageway therein, and

when desired to achieve defaecation adjusting the adjustable powered restriction device to temporarily release the fecal passageway.

98. A surgical method as recited in claim 97, further comprising implanting an elongated restriction member of the restriction device around the the colon or rectum or the prolongation thereof.

99. A surgical method as recited in claim 97, further comprising implanting the restriction device in the distal part of the rectum of the patient.

100. A surgical method as recited in claim 97, further comprising adjusting said powered restriction device in a non-manual manner.

101. A surgical method as recited in claim 97, further comprising;

implanting a servo means for operating said restriction device.

102. A method for treating anal incontinence according to claim 97, 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.

103. A method for treating anal incontinence according to claim 97, further comprising using a wirelessly transmitted energy to providing energy to the energy consuming parts of said apparatus and providing a control device for controlling the source of energy from outside the patient'"'"'s body to supply energy to the restriction device.

104. A method for treating anal incontinence as recited in claim 97, comprising implanting a reservoir in the patient containing a predetermined amount of hydraulic fluid, implanting a conduit providing fluid connection between said reservoir and said hydraulic adjustment device, and implanting an operation device in the patient for operating said hydraulic adjustment device by distributing hydraulic fluid through said conduit between said reservoir and said hydraulic adjustment device, wherein said conduit, hydraulic adjustment device and operation device are devoid of any non-return valve to permit free flow of hydraulic fluid in both directions in said conduit.

105. A method as rected in claim 97, comprising surgically implanting in the body of the patient at least two adjustable restriction devices in engagement with the colon or rectum or the prolongation thereof to restrict the fecal passageway therein.

106. A method for treating anal incontinence, comprising:

laparoscopicly implanting in the body of a patient suffering from anal incontinence an adjustable restriction device which directly engages a portion of the normal tissue in the colon or rectum or prolongation thereof, comprising;

placing at least two laparascopical trocars in the human'"'"'s or animal'"'"'s body, inserting a dissecting tool through the trocars and dissecting an area of the colon or rectum or the prolongation thereof,

implanting an operable restriction device in the dissected area in engagement with the colon or rectum or the prolongation thereof to restrict the fecal passageway, and

when desired to achieve defaecation adjusting said restriction device to temporarily release the fecal passageway.

107. A method for treating anal incontinence as recited in claim 106, wherein said adjusting step is operated in a non-manual manner.

108. A method for treating anal incontinence as recited in claim 106, comprising implanting a conduit providing fluid connection between said reservoir and said hydraulic adjustment device, and implanting an operation device in the patient for operating said hydraulic adjustment device by distributing hydraulic fluid through said conduit between said reservoir and said hydraulic adjustment device, wherein said conduit, hydraulic adjustment device and operation device being devoid of any non-return valve to permit free flow of hydraulic fluid in both directions in said conduit.

109. A method for treating anal incontinence according to claim 106, further comprising implanting a servo means for operating said restriction device.

110. A method for treating anal incontinence according to claim 106, 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.

111. A method for treating anal incontinence according to claim 106, further comprising using a wirelessly transmitted energy to providing energy to the energy consuming parts of said apparatus and providing a control device for controlling the source of energy from outside the patient'"'"'s body to supply energy to the restriction device.