Anal incontinence disease treatment with controlled wireless energy supply

• US 8,545,384 B2
• Filed: 02/01/2010
• Issued: 10/01/2013
• Est. Priority Date: 08/12/1999
• Status: Expired due to Fees

• Current Assignee: Obtech Medical AG
• Original Assignee: Obtech Medical AG
• Inventors: Forsell, Peter
• Primary Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US12/656,513
• Publication Number:
  US 20100217067A1
• Time in Patent Office: 1,338 Days
• Field of Search: 600 29- 32, 600/37, 128/897, 128/898, 128/DIG.25
• US Class Current: 600/29
• CPC Class Codes: A61F 2/0009 placed in or outside the body opening close to the surface of the body plugging an opening in the wall of a hollow or tubular organ A61B17/0057
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A anal incontinence disease treatment apparatus and method include and use an operable restriction device implanted in a patient and engaging the colon or engaging the rectum to form a restricted fecal passageway in the colon or the rectum. A source of energy external to the patient'"'"'s body and a control device for releasing wireless energy from the source of energy from outside the patient'"'"'s body are provided. The released wireless energy is used in connection with the operation of the restriction device, to enlarge or contract the restricted fecal passageway.

Claims

1. A anal incontinence disease treatment apparatus, comprising:

a restriction device implantable in a patient that is operable to perform a reversible function involving enlarging and restricting the patient'"'"'s fecal passageway,

a source of energy implantable in the patient,

a control device operable from outside the patient'"'"'s body for releasing energy from said source of energy, said released energy being used in connection with the operation of said restriction device,

an operation device implantable in the patient comprising a motor or a pump, wherein the source of energy is adapted to power the motor or the pump to operate the restriction device, and wherein the apparatus further comprises;

an external data communicator intended to be outside the patient'"'"'s body and an internal data communicator implantable in the patient for communicating with said external communicator, wherein said internal communicator feeds data related to the patient back, or data related to the implanted restriction device, to said external communicator, or said external communicator feeds data to said internal communicator,

wherein the control device comprises an external control unit adapted to load an internal control unit with data in accordance with a loading mode only authorized for a doctor.

2. The apparatus according to claim 1, wherein said control device controls said restriction device.

3. The apparatus according to claim 2, wherein the internal control unit is adapted to be implanted in the patient for controlling the operation device.

4. The apparatus according to claim 3, wherein said internal control unit is programmable.

5. The apparatus according to claim 4, wherein the external control unit is adapted to be placed outside the patient'"'"'s body, said internal control unit being programmable by said external control unit.

6. The apparatus according to claim 5, wherein said external control unit loads said internal control unit with data in accordance with a loading mode only authorized for a doctor.

7. The apparatus according to claim 5, wherein said external control unit controls said internal control unit in accordance with a doctor mode only authorized for a doctor.

8. The apparatus according to claim 5, wherein said external control unit controls said internal control unit in accordance with a patient mode permitted for the patient.

9. The apparatus according to claim 4, wherein said internal control unit is programmable for controlling said restriction device over time.

10. The apparatus according to claim 9, wherein said internal control unit controls said restriction device over time in accordance with an activity schedule program.

11. The apparatus according to claim 9, wherein said internal control unit comprises a microprocessor.

12. The apparatus according to claim 1, wherein said control device controls said operation device to operate said restriction device.

13. The apparatus according to claim 12, wherein said operation device further comprises hydraulic means and at least one valve for controlling a fluid flow in said hydraulic means.

14. The apparatus according to claim 13, wherein said control device comprises a wireless remote control for controlling said valve.

15. The apparatus according to claim 12, wherein said restriction device comprises hydraulic means and said operation device comprises a reservoir forming a fluid chamber with a variable volume connected to said hydraulic means, and said operation device distributes fluid from said chamber to said hydraulic means 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.

16. The apparatus according to claim 12, wherein said restriction device comprises hydraulic means and said operation device comprises a pump for pumping a fluid in said hydraulic means.

17. The apparatus according to claim 16, wherein said operation device comprises a motor for driving said pump.

18. 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.

19. The apparatus according to claim 18, wherein said hydraulic means, pump and conduit is devoid of any non-return valve.

20. The apparatus according to claim 19, 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.

21. The apparatus according to claim 12, wherein said control device releases polarized energy from said source of energy.

22. The apparatus according to claim 21, wherein the operation device comprises an electric motor and said released energy comprises electric energy.

23. The apparatus according to claim 12, wherein said control device shifts polarity of said released energy to reverse said operation device.

24. The apparatus according to claim 1, wherein the source of energy is intended to be external to the patient and the control device is adapted to control the external source of energy to release wireless energy, said wireless energy released from said external source of energy is directly or indirectly used for operation of said restriction device.

25. The apparatus according to claim 24, wherein said wireless energy is directly used for operation of said restriction device in a non-magnetic manner.

26. The apparatus according to claim 24, wherein said wireless energy is directly used for operation of said restriction device in a non-mechanical manner.

27. The apparatus according to claim 24, wherein said wireless energy directly or indirectly powers said operation device.

28. The apparatus according to claim 27, wherein said control device controls said operation device.

29. The apparatus according to claim 24, further comprising an energy transfer device implanted in the patient for transferring said wireless energy into storable energy and an energy storage device implanted in the patient for storing said storable energy.

30. The apparatus according to claim 29, comprising an implantable switch, wherein said switch is operable by energy from said implanted energy storage device to switch between an “

off”

mode, in which said internal source of energy is not in use, and an “

on”

mode, in which said internal source of energy supplies energy for the operation of said restriction device.

31. The apparatus according to claim 30, wherein said control device controls said energy storage device to operate said switch.

32. The apparatus according to claim 31, wherein said control device comprises a wireless remote control.

33. The apparatus according to claim 24, comprising an energy transfer device, wherein the energy transfer device is adapted to transform the wireless energy of a first form directly or indirectly into the energy of a second form.

34. The apparatus according to claim 33, wherein the motor or pump is powered by the energy of the second form.

35. The apparatus according to claim 34, wherein the energy transfer device is adapted to directly power the motor or pump by the transferred energy, as the energy of the second form is being transferred from the energy of the first form.

36. The apparatus according to claim 33, wherein the wireless energy of the fist form comprises sound waves and the energy of the second form comprises electric energy.

37. The apparatus according to claim 33, wherein the energy transfer device comprises a capacitor and the energy of the second form comprises electric energy.

38. The apparatus according to claim 37, wherein the capacitor is adapted to produce electric pulses from the transferred electric energy.

39. The apparatus according to claim 33, further comprising an implantable stabiliser for the energy of the second form.

40. The apparatus according to claim 39, wherein the energy of the second form comprises electric current and the stabiliser comprises at least one capacitor.

41. The apparatus according to claim 33, further comprising an activatable source of energy implantable in the patient, wherein the source of energy is activated by wireless energy transmitted by the external source of energy, to supply energy which is used in connection with the operation of the restriction device.

42. The apparatus according to claim 33, comprising an external source of energy for transmitting the energy of the first form, wherein said external source of energy comprises an electric, an electromagnetic or a magnetic field, or a combination thereof.

43. The apparatus according to claim 42, wherein the electric, electromagnetic or magnetic field, or the combination thereof is transmitted in pulses or digital pulses, or a combination of pulses and digital pulses by the energy transmission device.

44. The apparatus according to claim 42, wherein the electric, electromagnetic or magnetic field, or the combination thereof is transmitted in waves or analog pulses or a combination thereof by the energy transmission device.

45. The apparatus according to claim 33, wherein the energy transfer device transforms the energy of the first form into a direct current or pulsating direct current, or a combination of a direct current and pulsating direct current.

46. The apparatus according to claim 33, wherein the energy transfer device transforms the energy of the first form into an alternating current or a combination of a direct and alternating current.

47. The apparatus according to claim 24, external source of energy transmits energy by at least one wireless signal.

48. The apparatus according to claim 47, wherein the signal contains radiant energy.

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

50. The apparatus according to claim 49, wherein the 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 50, wherein the signal comprises a digital or analog signal, or a combination of a digital and analog signal.

52. The apparatus according to claim 49, wherein the wave signal comprises a sound or ultrasound wave signal.

53. The apparatus according to claim 24, comprising;

an external source of energy for transmitting wireless energy,

a receiving coil antenna adapted to receive said transmitted wireless energy, wherein

said receiving coil antenna comprises a resonant circuit comprising a capacitor and a coil which together form said resonant circuit tuned to the same frequency as the external source of energy.

54. The apparatus according to claim 1, wherein the motor comprises a gear box.

55. The apparatus according to claim 1, wherein said motor comprises a rotary motor, and said control device controls said rotary motor to rotate a desired number of revolutions.

56. The apparatus according to claim 1, wherein said motor comprises a linear motor.

57. The apparatus according to claim 1, wherein said motor comprises a hydraulic or pneumatic fluid motor, and said control device controls the fluid flow through said fluid motor.

58. The apparatus according to claim 1, wherein said motor comprises an electric motor having electrically conductive parts made of plastics.

59. The apparatus according to claim 1, wherein said restriction device is operable to perform a reversible function.

60. The apparatus according to claim 59, further comprising a reversing device implanted in the patient for reversing said function performed by said restriction device.

61. The apparatus according to claim 60, wherein said control device controls said reversing device to reverse said function performed by said restriction device.

62. The apparatus according to claim 60, wherein said reversing device comprises hydraulic means including a valve for shifting the flow direction of a fluid in said hydraulic means.

63. The apparatus according to claim 60, wherein said reversing device comprises a mechanical reversing device.

64. The apparatus according to claim 63, wherein said mechanical reversing device comprises a switch.

65. The apparatus according to claim 63, wherein said reversing device comprises a gear box.

66. The apparatus according to claim 60, wherein said reversing device comprises a switch.

67. The apparatus according to claim 66, wherein said switch is operated by said released energy.

68. The apparatus according to claim 67, wherein said control device controls the operation of said switch by shifting polarity of said released energy operating said switch.

69. The apparatus according to claim 67, wherein said switch comprises an electric switch and said source of energy supplies electric energy for the operation of said switch.

70. The apparatus according to claim 66, wherein said reversing device reverses said motor.

71. The apparatus according to claim 1, further comprising a switch implanted in the patient for directly or indirectly switching the operation of said restriction device.

72. The apparatus according to claim 71, wherein the source of energy is an internal source of energy implanted in the patient for supplying energy for the operation of said restriction device, wherein said switch directly or indirectly affects the supply of energy from said internal source of energy.

73. The apparatus according to claim 72, wherein said switch switches between an “

off”

mode, in which said internal source of energy is not in use, and an “

on”

mode, in which said internal source of energy supplies energy for the operation of said restriction device.

74. The apparatus according to claim 73, wherein said switch is operable by energy released from said internal source of energy.

75. The apparatus according to claim 73, wherein said internal source of energy comprises a nuclear source of energy.

76. The apparatus according to claim 73, wherein said internal source of energy comprises a chemical source of energy.

77. The apparatus according to claim 72, further comprising a source of energy intended to be external to the patient and wherein the control device is adapted to control the external source of energy to release wireless energy to operate said switch.

78. The apparatus according to claim 77, wherein said control device comprises a wireless remote control.

79. The apparatus according to claim 72, wherein said control device comprises a wireless remote control for controlling said internal source of energy.

80. The apparatus according to claim 79, wherein said switch is operable by said wireless energy from said external source of energy to switch between an “

off”

mode, in which said internal source of energy and remote control are not in use, and a “

standby”

mode, in which said remote control is permitted to control said internal source of energy to supply energy for the operation of said restriction device.

81. The apparatus according to claim 72, further comprising an energy transfer device implanted in the patient for transferring said wireless energy into storable energy, wherein said internal source of energy is capable of storing said storable energy.

82. The apparatus according to claim 81, wherein said switch switches from an “

off”

mode, in which said internal 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.

83. The apparatus according to claim 82, wherein said control device controls said switch to switch between said “

on” and

“

off”

modes.

84. The apparatus according to claim 83, wherein said control device comprises a wireless remote control.

85. The apparatus according to claim 1, wherein said source of energy comprises an internal source of energy adapted to be implanted in the body.

86. The apparatus according to claim 85, wherein said source of energy comprises at least one accumulator, at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery.

87. The apparatus according to claim 85, wherein said source of energy comprises an accumulator or a battery having a life-time of at least 10 years.

88. The apparatus according to claim 1, wherein the control device is adapted to supply a control signal, wherein the control signal comprises a wave signal comprising one of a sound wave signal, an ultrasound wave signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, an ultra violet light signal, 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 88, wherein the control signal comprises an electric or magnetic field, or a combined electric and magnetic field.

90. The apparatus according to claim 88, comprising a remote control, wherein the remote control transmits an electromagnetic carrier wave signal for carrying a digital or analog control signal.

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

92. The apparatus according to claim 91, wherein said sensor comprises a pressure sensor for directly or indirectly sensing the pressure in said fecal passageway.

93. The apparatus according to claim 91, wherein said control device controls said restriction device in response to signals from said sensor.

94. The apparatus according to claim 93, wherein said control device comprises an internal control unit implanted in the patient, said internal control unit controlling said restriction device in response to signals from said sensor.

95. The apparatus according to claim 93, wherein said control device comprises an external control unit outside the patient'"'"'s body, said external control unit controlling said restriction device in response to signals from said sensor.

96. The apparatus according to claim 95, 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.

97. The apparatus according to claim 95, further comprising at least one implanted sender for sending information on said physical parameter sensed by said sensor.

98. The apparatus according to claim 1, wherein said internal communicator feeds data related to said implanted restriction device.

99. The apparatus according to claim 1, wherein said internal communicator feeds data related to at least one physical signal of the patient.

100. The apparatus according to claim 1, wherein said restriction device controls the cross-sectional area of said fecal passageway.

101. The apparatus according to claim 100, wherein said restriction device is operable to open and close said fecal passageway.

102. The apparatus according to claim 100, wherein said restriction device steplessly controls the cross-sectional area of said fecal passageway.

103. The apparatus according to claim 1, wherein the source of energy is intended to be external to the patient and the control device is adapted to control the external source to energy to release wireless energy, further comprising an implanted energy transfer device, for transferring said wireless energy into kinetic energy for operation of said restriction device.

104. The apparatus according to claim 103, wherein said restriction device is directly operated with said kinetic energy, as said energy transfer device transfers said wireless energy into said kinetic energy.

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

106. The apparatus according to claim 1, wherein said control device releases energy for a determined time period.

107. The apparatus according to claim 1, wherein said control device releases energy in a determined number of energy pulses.

108. The apparatus according to claim 1, wherein said control device releases energy from said source of energy in a non-invasive manner.

109. The apparatus according to claim 1, wherein said control device comprises a wireless remote control transmitting at least one wireless control signal for controlling said restriction device.

110. The apparatus according to claim 109, wherein said remote control is capable of obtaining information on the condition of said implanted restriction device and to control said restriction device in response to said information.

111. The apparatus according to claim 109, wherein said wireless remote control comprises at least one external signal transmitter or transceiver and at least one internal signal receiver or transceiver implanted in the patient.

112. The apparatus according to claim 111, wherein said wireless remote control comprises at least one external signal receiver or transceiver and at least one internal signal transmitter or transceiver implanted in the patient.

113. The apparatus according to claim 106, wherein said remote control is capable of sending information related to said restriction device from inside the patient'"'"'s body to the outside thereof.

114. The apparatus according to claim 113, wherein said remote control controls said restriction device in response to said information.

115. The apparatus according to claim 109, wherein said remote control transmits a carrier signal for carrying said control signal.

116. The apparatus according to claim 115, wherein said carrier signal is frequency, amplitude or frequency and amplitude modulated.

117. The apparatus according to claim 115, wherein said carrier signal is digital, analog or digital and analog.

118. The apparatus according to claim 117, wherein said control signal used with said carrier signal is frequency, amplitude or frequency and amplitude modulated.

119. The apparatus according to claim 109, 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.

120. The apparatus according to claim 109, wherein said control signal comprises an electric, magnetic or electric and magnetic field.

121. The apparatus according to claim 109, wherein said control signal is digital, analog or digital and analog.

122. The apparatus according to claim 121, wherein said remote control transmits an electromagnetic carrier wave signal for carrying said digital or analog control signal.

123. The apparatus according to claim 109, wherein said control signal is transmitted in pulses by said wireless remote control.

124. The apparatus according to claim 1, further comprising an implanted stabilizer for stabilizing the energy released by said control device.

125. The apparatus according to claim 124, wherein the energy released by said control device comprises electric energy and said stabilizer comprises at least one capacitor.

126. The apparatus according to claim 1, wherein said control device releases energy from said source of energy in a non-invasive manner.

127. The apparatus according to claim 1, wherein said control device releases magnetic energy.

128. The apparatus according to claim 1, wherein said control device releases electromagnetic energy.

129. The apparatus according to claim 1, wherein said control device releases kinetic energy.

130. The apparatus according to claim 1, wherein said control device releases thermal energy.

131. The apparatus according to claim 1, wherein said control device releases energy from said external source of energy in a mechanical manner.

132. The apparatus according to claim 1, wherein said control device releases non-magnetic energy.

133. The apparatus according to claim 1, wherein said control device releases non-electromagnetic energy.

134. The apparatus according to claim 1, wherein said control device releases non-kinetic energy.

135. The apparatus according to claim 1, wherein said control device releases or non-thermal energy.

136. The apparatus according to claim 1, wherein said control device releases energy from said source of energy in a non-mechanical manner.

137. The apparatus according to claim 1, further comprising an implantable control unit for controlling the restriction device and wherein the control unit is programmable for controlling the restriction device in accordance with a program.

138. The apparatus according to claim 137, wherein the control unit controls the restriction device over time in accordance with an activity schedule program.

139. The apparatus according to claim 137, further comprising an external wireless remote control for programming the implantable control unit.

140. The apparatus according to claim 1, wherein the control device for controlling the restriction device comprising:

a first control unit operable from the outside of the patients body for providing a control signal, and

a second control unit implantable in the patient adapted to control the restriction device in response to the control signal.

141. The apparatus according to claim 140, wherein the energy source comprising:

a rechargeable internal energy source adapted to be recharged by wireless energy transformed into storable energy, wherein said apparatus comprises,

an energy transfer device adapted to receive wireless energy and transform wireless energy to storable energy for charging said rechargeable internal energy source.

142. The apparatus according to claim 1, wherein the control device is capable of obtaining information related to the anal passageway or the pressure against the restriction device, or anal passageway, or other important physical parameters and of commanding the adjustment device to adjust the restriction device in response to obtained information.