Anal incontinence treatment with energy transfer device

• US 6,454,698 B1
• Filed: 02/10/2000
• Issued: 09/24/2002
• Est. Priority Date: 08/12/1999
• Status: Expired due to Fees

• Current Assignee: Obtech Medical AG (Johnson & Johnson)
• Original Assignee: Obtech Medical AG (Johnson & Johnson)
• Inventors: Forsell, Peter
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): Cadugan, Joseph A
• Application Number:
  US09/502,073
• Time in Patent Office: 957 Days
• Field of Search: 128/897-899, 600/29-32, 600/37, 600/593, 604/27-28, 606/139-141, 606/151, 606/157, 606/201-203, 606/213, 606/228, 607/41, 623/23.65, 623/23.67
• US Class Current: 600/30
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An anal incontinence treatment apparatus and method include or use an operable restriction device implanted in a patient and engaging the colon or rectum to form a restricted passageway. An energy transmission device for wireless transmission of energy of a first form from outside the patient'"'"'s body is provided. An implanted energy transfer device transfers the energy of the first form transmitted by the energy transmission device into energy of a second form, which is used to control the operation of the restriction device to vary the size of the restricted passageway. The energy transfer device includes at least one element having a positive region and a negative region, the element being capable of creating an energy field between the positive and negative regions when exposed to the first form energy transmitted by the energy transmission device, so that the energy field provides the second form energy.

Claims

1. An anal incontinence treatment apparatus, comprising:

an energy transmission device for wireless transmission of energy of a first form from outside a patient'"'"'s body;

an operable restriction device adapted to be implanted in the patient to engage the colon or rectum to form a restricted fecal passageway in the colon or rectum, said restriction device operable in response to a second energy form different than the first form energy to vary the restricted passageway; and

an energy transfer device adapted to be implanted in the patient for transferring energy of the first form transmitted by said energy transmission device into energy of the second form,

wherein said energy transfer device comprises at least one element having a positive region and a negative region, and creating an energy field between said positive and negative regions when exposed to the first form energy transmitted by said energy transmission device, so that said energy field produces the energy of the second form.

2. The apparatus according to claim 1, wherein said element comprises an electrical junction element capable of inducing an electric field between said positive and negative regions when exposed to the energy of the first form transmitted by said energy transmission device, whereby said energy of the second form comprises electric energy.

3. The apparatus according to claim 2, wherein said restriction device is electrically operated, and said positive and negative regions of said electrical junction element supply electric energy for the operation of said restriction device.

4. The apparatus according to claim 3, further comprising electric conductors connected to said positive and negative regions of said electrical junction element, whereby said electrical junction element is capable of supplying an electric current via said conductors.

5. The apparatus according to claim 4, wherein said electrical junction element is capable of supplying a direct current or pulsating direct current via said conductors.

6. The apparatus according to claim 4, wherein said electrical junction element is capable of supplying an alternating current or a combination of a direct and alternating current via said conductors.

7. The apparatus according to claim 3, wherein said electrical junction element is capable of supplying a frequency or amplitude modulated signal.

8. The apparatus according to claim 3, wherein said electrical junction element is capable of supplying an analog or digital signal.

9. The apparatus according to claim 2, wherein said electrical junction element comprises at least one semiconductor.

10. The apparatus according to claim 2, wherein said electrical junction element generates an output current exceeding 1 μ

A when exposed to the energy of the first form transmitted by said energy transmission device.

11. The apparatus according to claim 1, further comprising an operation device adapted to be implanted in the patient for operating said restriction device, wherein said element powers said operation device with the energy of the second form.

12. The apparatus according to claim 11, wherein said operation device comprises a motor.

13. The apparatus according to claim 12, further comprising a control device, wherein said motor comprises a rotary motor, and said control device controls said rotary motor to rotate a desired number of revolutions.

14. The apparatus according to claim 12, wherein said motor comprises a linear motor.

15. The apparatus according to claim 12, further comprising a control device, wherein said motor comprises a hydraulic or pneumatic fluid motor, and said control device controls said fluid motor.

16. The apparatus according to claim 10, wherein said motor comprises an electric motor having electrically conductive parts made of plastics.

17. The apparatus according to claim 11, wherein said restriction device comprises hydraulic means and said operation device comprises a pump for pumping a fluid in said hydraulic means.

18. The apparatus according to claim 17, wherein said operation device comprises a motor for driving said pump.

19. The apparatus according to claim 17, wherein said operation device comprises a fluid conduit between said pump and said hydraulic means of said restriction device, and a reservoir for fluid, said reservoir forming part of said conduit.

20. The apparatus according to claim 19, wherein said hydraulic means, pump and conduit are devoid of any non-return valve.

21. The apparatus according to claim 20, wherein said reservoir forms a fluid chamber with a variable volume, and said pump distributes fluid from said chamber to said hydraulic means of said restriction device by reduction of the volume of said chamber and withdraws fluid from said hydraulic means to said chamber by expansion of the volume of said chamber.

22. The apparatus according to claim 11, further comprising a control device for controlling said operation device.

23. The apparatus according to claim 22, wherein said control device shifts polarity of the energy of the second form to reverse said operation device.

24. The apparatus according to claim 23, wherein said operation device comprises an electric motor and the energy of the second form comprises electric energy.

25. The apparatus according to claim 22, wherein said restriction device is operable to perform a reversible function.

26. The apparatus according to claim 25, further comprising a reversing device adapted to be implanted in the patient for reversing said function performed by said restriction device.

27. The apparatus according to claim 26, wherein said control device controls said reversing device to reverse said function performed by said restriction device.

28. The apparatus according to claim 26, wherein said reversing device comprises hydraulic means including a valve for shifting the flow direction of a fluid flow in said hydraulic means.

29. The apparatus according to claim 26, wherein said reversing device comprises a mechanical reversing device.

30. The apparatus according to claim 29, wherein said reversing device comprises a gear box.

31. The apparatus according to claim 26, wherein said reversing device comprises a switch.

32. The apparatus according to claim 31, wherein said switch is operable by the energy of the second form.

33. The apparatus according to claim 32, wherein said control device controls the operation of said switch by shifting polarity of the energy of the second form.

34. The apparatus according to claim 32, wherein said switch comprises an electric switch and the energy of the second form comprises electric energy.

35. The apparatus according to claim 11, wherein said operation device comprises hydraulic means and at least one valve for controlling a fluid flow in said hydraulic means.

36. The apparatus according to claim 35, further comprising a wireless remote control for controlling said valve.

37. The apparatus according to claim 1, wherein said element forms a flat and thin sheet, and has a volume of less than 2000 cm³.

38. The apparatus according to claim 1, further comprising an energy storage device adapted to be implanted in the patient for storing the energy of the second form and for supplying energy in connection with the operation of said restriction device.

39. The apparatus according to claim 38, wherein said energy storage device comprises an accumulator.

40. The apparatus according to claim 39, wherein the energy of the second form comprises electric energy and said energy storage device comprises an electric accumulator.

41. The apparatus according to claim 40, wherein said electric accumulator comprises at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery.

42. The apparatus according to claim 38, further comprising a switch adapted to be implanted in the patient for directly or indirectly switching the operation of said restriction device.

43. The apparatus according to claim 42, further comprising a source of energy adapted to be implanted in the patient, wherein said switch is operated by the energy of the second form supplied by said energy storage device to switch from an off mode, in which said source of energy is not in use, to an on mode, in which said source of energy supplies energy for the operation of said restriction device.

44. The apparatus according to claim 42, further comprising a source of energy adapted to be implanted in the patient, and a remote control for controlling the supply of energy of said implantable source of energy, wherein said switch is operated by the energy of the second form supplied by said energy storage device to switch from an off mode, in which said remote control is prevented from controlling said source of energy and said source of energy is not in use, to a standby mode, in which said remote control is permitted to control said source of energy to supply energy for the operation of said restriction device.

45. The apparatus according to claim 1, further comprising a switch adapted to be implanted in the patient for switching the operation of said restriction device.

46. The apparatus according to claim 45, further comprising a source of energy adapted to be implanted in the patient for supplying energy for the operation of said restriction device, wherein said switch is operated by the energy of the second form supplied by said energy transfer device to switch from an off mode, in which said source of energy is not in use, to an on mode, in which said source of energy supplies energy for the operation of said restriction device.

47. The apparatus according to claim 45, further comprising a source of energy adapted to be implanted in the patient for supplying energy for the operation of said restriction device, and a remote control for controlling the supply of energy of said implanted source of energy, wherein said switch is operated by the energy of the second form supplied by said energy transfer device to switch from an off mode, in which said remote control is prevented from controlling said source of energy and said source of energy is not in use, to a standby mode, in which said remote control is permitted to control said source of energy to supply energy for the operation of said restriction device.

48. The apparatus according to claim 1, wherein said energy transmission device transmits the energy of the first form by at least one wireless signal.

49. The apparatus according to claim 48, wherein said signal comprises a wave signal.

50. The apparatus according to claim 49, wherein said wave signal comprises an electromagnetic wave signal including one of an infrared light signal, a visible light signal, an ultra violet light signal, a laser signal, a micro wave signal, a radio wave signal, an x-ray radiation signal, and a gamma radiation signal.

51. The apparatus according to claim 49, wherein said wave signal comprises a sound wave signal.

52. The apparatus according to claim 48, wherein said signal contains radiant energy.

53. The apparatus according to claim 48, wherein said signal comprises a digital or analog signal, or a combination of a digital and analog signal.

54. The apparatus according to claim 1, wherein the energy of the first form transmitted by said energy transmission device comprises an electric field.

55. The apparatus according to claim 54, wherein said electric field is transmitted in pulses or digital pulses by said energy transmission device.

56. The apparatus according to claim 1, wherein the energy of the first form transmitted by said energy transmission device comprises a magnetic field.

57. The apparatus according to claim 56, wherein said magnetic field is transmitted in pulses or digital pulses by said energy transmission device.

58. The apparatus according to claim 1, wherein said energy of a first form comprises polarized energy.

59. The apparatus according to claim 1, wherein said energy transfer device transfers the energy of the first form into a direct current or pulsating direct current, or a combination of a direct current and a pulsating direct current.

60. The apparatus according to claim 1, wherein said energy transfer device transfers the energy of the first form into an alternating current or a combination of a direct and alternating current.

61. The apparatus according to claim 1, wherein the energy of the second form comprises a frequency or amplitude modulated signal, or a combination of a frequency and amplitude modulated signal.

62. The apparatus according to claim 1, wherein the energy of the second form comprises an analog or a digital signal, or a combination of an analog and digital signal.

63. The apparatus according to claim 1, further comprising a pulse generator adapted to be implanted in the patient for generating electrical pulses from the energy of the second form rendered by said energy field.

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

65. The apparatus according to claim 64, wherein said sensor comprises a pressure sensor for directly or indirectly sensing the pressure in the fecal passageway.

66. The apparatus according to claim 64, further comprising a control device for controlling said restriction device in response to signals from said sensor.

67. The apparatus according to claim 66, wherein said control device comprises an internal control unit adapted to be implanted in the patient for controlling said restriction device in response to signals from said sensor.

68. The apparatus according to claim 66, wherein said internal control unit directly controls said restriction device in response to signals from said sensor.

69. The apparatus according to claim 66, wherein said control device comprises an external control unit outside the patient'"'"'s body for controlling said restriction device in response to signals from said sensor.

70. The apparatus according to claim 69, wherein said external control unit stores information on said physical parameter sensed by said sensor and is manually operated to control said restriction device based on said stored information.

71. The apparatus according to claim 64, further comprising at least one sender adapted to be implanted in the patient for sending information on said physical parameter sensed by said sensor.

72. The apparatus according to claim 1, further comprising a wireless remote control transmitting at least one wireless control signal for controlling said restriction device.

73. The apparatus according to claim 72, wherein said remote control is capable of obtaining information on the condition of said restriction device and to control said restriction device in response to said information.

74. The apparatus according to claim 72, wherein said remote control comprises a control unit adapted to be implanted in the patient for controlling said restriction device.

75. The apparatus according to claim 74, wherein said control unit comprises a microprocessor.

76. The apparatus according to claim 72, wherein said wireless remote control comprises at least one external signal transmitter or transceiver and at least one internal signal receiver or transceiver adapted to be implanted in the patient.

77. The apparatus according to claim 72, wherein said wireless remote control comprises at least one external signal receiver or transceiver and at least one internal signal transmitter or transceiver adapted to be implanted in the patient.

78. The apparatus according to claim 72, wherein said remote control is capable of sending information related to said restriction device from inside the patient'"'"'s body to the outside thereof.

79. The apparatus according to claim 78, wherein said remote control controls said restriction device in response to said information.

80. The apparatus according to claim 72, wherein said remote control comprises a control signal transmitter for transmitting said control signal, and said energy transmission device comprises said control signal transmitter, whereby the energy of the first form is transmitted by said control signal.

81. The apparatus according to claim 72, wherein said energy transmission device transmits the energy of the first form by at least one signal separate from said control signal.

82. The apparatus according to claim 72, wherein said remote control transmits a carrier signal for carrying said control signal.

83. The apparatus according to claim 72, wherein said energy transmission device transmits the energy of the first form by at least one signal, which is used as a carrier signal for said control signal transmitted by said remote control.

84. The apparatus according to claim 83, wherein said carrier signal is frequency or amplitude modulated, or frequency and amplitude modulated.

85. The apparatus according to claim 83, wherein said carrier signal comprises digital or analog waves, or a combination of digital and analog waves.

86. The apparatus according to claim 83, wherein said control signal used with said carrier signal is frequency or amplitude modulated, or frequency and amplitude modulated.

87. The apparatus according to claim 83, wherein said control signal used with said carrier signal is digital or analog, or digital and analog.

88. The apparatus according to claim 72, wherein said control signal comprises a wave signal comprising one of a sound wave signal including an ultrasound wave signal, an electromagnetic wave signal including an infrared light signal, a visible light signal, an ultra violet light signal and a laser light signal, a micro wave signal, a radio wave signal, an x-ray radiation signal, and a gamma radiation signal.

89. The apparatus according to claim 72, wherein said control signal comprises an electric or magnetic field, or an electric and magnetic field.

90. The apparatus according to claim 72, wherein said control signal comprises a digital or analog control signal, or a digital and analog control signal.

91. The apparatus according to claim 90, wherein said remote control transmits an electromagnetic carrier wave signal for carrying said digital or analog control signal.

92. The apparatus according to claim 1, wherein the energy of the second form used for operating said restriction device is wirelessly transmitted by said energy transfer device.

93. The apparatus according to claim 1, wherein said restriction device controls the size of the stoma opening.

94. The apparatus according to claim 1, further comprising a control unit adapted to be implanted in the patient for controlling said restriction device.

95. The apparatus according to claim 94, wherein said control unit is programmable for controlling said restriction device in accordance with a program.

96. The apparatus according to claim 95, wherein said control unit controls said restriction device over time in accordance with an activity schedule program.

97. The apparatus according to claim 95, further comprising an external wireless remote control for programming said control unit.

98. The apparatus according to claim 1, further comprising an external data communicator and a data communicator adapted to be implanted in the patient communicating with said external communicator, wherein said implantable data communicator feeds data related to said restriction device back to said external communicator or said external communicator feeds data to said implantable data communicator.

99. The apparatus according to claim 98, wherein said implantable data communicator feeds data related to at least one physical signal of the patient.

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

101. The apparatus according to claim 1, wherein said restriction device is directly operated with the energy of the second form, as said energy transmission device transmits the energy of the first form.

102. The apparatus according to claim 101, wherein said restriction device is directly operated with the energy of the second form in a non-magnetic manner.

103. The apparatus according to claim 101, wherein said restriction device is adapted for direct operation with the energy of the second form, when said restriction device is implanted in the patient, without externally touching components of the apparatus that are adapted to be subcutaneously implanted in the patient.

104. The apparatus according to claim 1, wherein the energy of the first form comprises kinetic energy.

105. The apparatus according to claim 1, wherein said energy transfer device is adapted to be implanted subcutaneously or in the abdomen of the patient.

106. The apparatus according to claim 1, wherein said energy transfer device is adapted to be implanted in the thorax or in the cephalic region of the patient.

107. The apparatus according to claim 1, wherein said energy transfer device is adapted to be implanted in an orifice of the patient'"'"'s body and under the mucosa or intraluminar outside the mucosa of the orifice.

111. An implanting method, comprising the steps of:

providing an anal incontinence treatment apparatus according to claim 1,

cutting an opening in a patient'"'"'s mucosa in an orifice of the patient'"'"'s body, and

implanting the energy transfer device in the patient'"'"'s body through the opening.

112. An implanting method, comprising the steps of:

providing an anal incontinence disease treatment apparatus according to claim 1,

cutting an opening in a patient'"'"'s skin, and

implanting the energy transfer device in the patient'"'"'s body through the opening.

113. A laparascopical implanting method, comprising the steps of:

providing an anal incontinence treatment apparatus according to claim 1,

placing at least two laparascopic cannula within a patient'"'"'s body, and

implanting the energy transfer device in the patient'"'"'s body by using the at least two laparascopic cannula.

108. An anal incontinence treatment apparatus, comprising:

an energy transmission device for wireless transmission of energy of a first form from outside a patient'"'"'s body;

an operable restriction device adapted to be implanted in the patient to engage the colon or rectum to form a restricted fecal passageway in the colon or rectum, said restriction device operable in response to a second energy form different than the first form energy to vary the restricted passageway; and

an energy transfer device adapted to be implanted in the patient for transferring energy of the first form transmitted by said energy transmission device into energy of the second form,

wherein said energy transfer device comprises at least one semiconductor circuitry creating an energy field when exposed to the first form energy transmitted by said energy transmission device, and said energy field provides the second form energy.

109. An anal incontinence treatment apparatus, comprising:

an energy transmission device for wireless transmission of energy of a first form from outside a patient'"'"'s body;

an operable restriction device adapted to be implanted in the patient to engage the colon or rectum to form a restricted fecal passageway in the colon or rectum, said restriction device operable in response to a second energy form different than the first form energy to vary the restricted passageway; and

an energy transfer device adapted to be implanted in the patient for transferring energy of the first form transmitted by said energy transmission device into energy of the second form,

wherein said energy transfer device comprises at least one transistor circuitry creating an energy field when exposed to the first form energy transmitted by said energy transmission device, and said energy field provides the second form energy.

110. An anal incontinence treatment apparatus, comprising:

an energy transmission device for wireless transmission of energy of a first form from outside a patient'"'"'s body;

an operable restriction device adapted to be implanted in the patient to engage the colon or rectum to form a restricted fecal passageway in the colon or rectum, said restriction device operable in response to a second energy form different than the first form energy to vary the restricted passageway; and

an energy transfer device adapted to be implanted in the patient for transferring energy of the first form transmitted by said energy transmission device into energy of the second form,

wherein said energy transfer device comprises at least one microchip creating an energy field when exposed to the first form energy transmitted by said energy transmission device, and said energy field provides the second form energy.

114. A laparoscopic surgical method of implanting in a patient an anal incontinence treatment apparatus, comprising the steps of:

a) placing at least two laparoscopic trocars within the patient'"'"'s body,

b) using a dissecting tool inserted through the laparoscopic trocar, dissecting the region of the colon or rectum,

c) introducing a restriction device of the apparatus through the trocar,

d) placing the restriction device in engagement with the colon or rectum to create a restricted fecal passageway therein,

e) implanting in the patient an energy transfer device of the apparatus including at least one element having a positive region and a negative region, and creating an energy field between the positive and negative regions when exposed to wireless energy of a first form,

f) exposing the at least one element to the first form energy so that the energy field produces energy of a second form different than the first form energy, and

g) operating the restriction device with the energy of the second form produced by the energy transfer device to close the restricted passageway to prevent feces to pass therethrough and to enlarge the restricted passageway to allow feces to readily pass therethrough.

115. A method of treating a human or animal having anal incontinence, comprising:

(a) surgically implanting in the human or animal a restriction device engaging the human'"'"'s or animal'"'"'s colon or rectum, to form a restricted passageway in the colon or rectum;

(b) surgically implanting in the human or animal an electric operation device which can adjust the restricted passageway in response to supplied energy;

(c) surgically implanting in the human or animal an energy transfer device for transferring wireless energy into electric energy for powering the electric operation device, and

(d) in a non-invasive post-operative procedure, from time to time, powering the electric operation device with electric energy transferred by the energy transfer device so as to enlarge the restricted passageway to allow feces to readily pass therethrough.

116. A method as recited in claim 115, wherein (d) is practiced at least once a day.

117. A method as recited in claim 115, wherein (d) is practiced several times a day.