Hydraulic urinary incontinence treatment apparatus

• US 6,953,429 B2
• Filed: 02/14/2001
• Issued: 10/11/2005
• Est. Priority Date: 02/14/2000
• Status: Expired due to Term

• Current Assignee: Obtech Medical AG (Johnson & Johnson)
• Original Assignee: Obtech Medical AG (Johnson & Johnson)
• Inventors: Forsell, Peter
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/203,211
• Publication Number:
  US 20030144648A1
• Time in Patent Office: 1,700 Days
• Field of Search: 6048901-892, 604/544, 604/346, 604/347, 604/349, 604/350, 600/29, 600/30, 128/DIG.25
• US Class Current: 600/29
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: A61F 2/26 Penis implants
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

A urinary incontinence treatment apparatus comprises an adjustable restriction device (234) implanted in a patient, who suffers from urinary incontinence. The restriction device engages the urethra (244) of the patient to restrict, i.e. to close the urine passageway. An implanted adjustment device is adapted to adjust the restriction device such that the urethra is temporarily released, in order to open the urine passageway when the patient wants to urinate. An implanted powered hydraulic operation device (246) operates the adjustment device.

Claims

1. A urinary incontinence treatment apparatus, comprising an adjustable restriction device adapted to engage the urethra or urine bladder of a patient, who suffers from urinary incontinence, to form a restricted urine passageway in the urethra or urine bladder, an implantable adjustment device for adjusting the restriction device to restrict the urethra or urine bladder to close the urine passageway, or release the urethra or urine bladder to open the urine passageway, when the restriction device is implanted in the patient, an implantable electrically powered operation device for operating the adjustment device, and a reservoir implantable in the patient and containing hydraulic fluid, wherein the operation device is adapted to operate the adjustment device by using the hydraulic fluid of the reservoir.

2. An apparatus according to claim 1, wherein the reservoir contains a predetermined amount of hydraulic fluid.

3. An apparatus according to claim 1, wherein the adjustment device comprises an expandable cavity in the restriction device, the urine passageway being closed upon expansion of the cavity and open upon contraction of the cavity, and the operation device is adapted to distribute hydraulic fluid from the reservoir to expand the cavity, and to distribute hydraulic fluid from the cavity to the reservoir to contract the cavity.

4. An apparatus according to claim 3, wherein the reservoir defines a chamber for said predetermined amount of fluid and the operation device is adapted to change the size of the chamber.

5. An apparatus according to claim 4, wherein the operation device comprises first and second wall portions of the reservoir and is adapted to provide relative displacement between the first and second wall portions of the reservoir, in order to change the volume of the chamber.

6. An apparatus according to claim 5, wherein the operation device is adapted to provide said relative displacement in response to the pressure in the reservoir.

7. An apparatus according to claim 6, wherein the operation device comprises a pressure controlled hydraulic operation device.

8. An apparatus according to claim 7, further comprising an alarm adapted to generate an alarm signal in response to the lapse of a predetermined time period during which the pressure controlling the hydraulic operation device exceeds a predetermined high value.

9. An apparatus according to claim 5, wherein the first and second wall portions of the reservoir are displaceable relative to each other by magnetic means, hydraulic means, or electric control means, or a combination thereof.

10. An apparatus according to claim 5, wherein the operation device is adapted to distribute fluid from the reservoir to the cavity of the restriction device in response to a predetermined first displacement of the first wall portion of the reservoir relative to the second wall portion of the reservoir and to distribute fluid from the cavity to the reservoir in response to a predetermined second displacement of the first wall portion relative to the second wall portion.

11. An apparatus according to claim 3, wherein the operation device comprises a pump adapted to pump fluid between the reservoir and the cavity of the restriction device.

12. An apparatus according to claim 11, wherein the pump comprises a first activation member for activating the pump to pump fluid from the reservoir to the cavity of the restriction device and a second activation member for activating the pump to pump fluid from the cavity to the reservoir.

13. An apparatus according to claim 12, wherein the first and second activation members are operable by manual manipulation.

14. An apparatus according to claim 12, wherein at least one of the activation members is adapted to operate when subjected to a predetermined external pressure.

15. An apparatus according to claim 12, wherein at least one of the first and second activating members are operable by magnetic means, hydraulic means, electric control means or manual manipulation means, or a combination thereof.

16. An apparatus according to claim 1, wherein the operation device comprises a servo means.

17. An apparatus according to claim 5 wherein the operation device comprises a reverse servo.

39. An apparatus according to claim 1, wherein the adjustment device comprises a hydraulic adjustment device, and further comprising a reservoir implantable in the patient and containing a predetermined amount of hydraulic fluid, and a conduit providing fluid connection between the reservoir and the hydraulic adjustment device, the operation device being adapted to operate the hydraulic adjustment device by distributing hydraulic fluid through the conduit between the reservoir and the hydraulic adjustment device, the conduit and hydraulic adjustment device being devoid of any non-return valve to permit free flow of hydraulic fluid in both directions in the conduit.

40. An apparatus according to claim 39, wherein the reservoir forms a fluid chamber with a variable volume, and the operation device is adapted to distribute fluid from the chamber to the adjustment device by reduction of the volume of the chamber and to withdraw fluid from the adjustment device by expansion of the volume of the chamber.

41. An apparatus according to claim 40, wherein the operation device comprises a motor or a pump.

42. An apparatus according to claim 40, wherein the operation device comprises a movable wall of the reservoir for changing the volume of the chamber.

43. An apparatus according to claim 42, wherein the operation device is adapted to change the volume of the chamber by moving the movable wall in response to the pressure in the chamber.

44. An apparatus according to claim 4, further comprising an injection port subcutaneously implantable in the patient and in fluid communication with the chamber.

45. An apparatus according to claim 44, wherein the injection port is integrated in the reservoir.

46. An apparatus according to claim 1, wherein the restriction device comprises an elongated restriction member and forming means for forming the restriction member into at least a substantially closed loop around the urethra or urine bladder, the loop defining a restriction opening, whereby the adjustment device is adapted to adjust the restriction member in the loop to change the size of the restriction opening.

47. An apparatus according to claim 46, wherein the forming means forms the restriction member into a loop having a predetermined size or a size selected from several predetermined sizes.

48. An apparatus according to claim 46, wherein the adjustment device is adapted to change the size of the restriction opening such that the outer circumferential confinement surface of the restriction member is changed.

49. An apparatus according to claim 46, wherein the adjustment device is adapted to change the size of the restriction opening such that the outer circumferential confinement surface of the restriction member is unchanged.

50. An apparatus according to claim 46, wherein the restriction member is non-inflatable, and the adjustment device is adapted to adjust the restriction member in said loop.

52. An apparatus according to claim 50, wherein the adjustment device hydraulically adjusts the non-inflatable restriction member.

54. An apparatus according to claim 1, wherein the adjustment device mechanically adjusts the restriction device.

55. An apparatus according to claim 1, wherein the restriction device comprises at least two elements to be placed on different sides of the urethra or urine bladder, and the adjustment device is adapted to squeeze the urethra or urine bladder between the elements to restrict the urine passageway in the urethra or urine bladder, and to release the urethra or urine bladder from the elements to enlarge the urine passageway.

56. An apparatus according to claim 1, wherein the restriction device comprises at least two articulated clamping elements to be positioned on opposite or different sides of the urethra or urine bladder, and the adjustment device is adapted to turn the clamping elements toward each other to clamp the urethra or urine bladder between the clamping elements to restrict the urine passageway in the urethra or urine bladder, and to turn the clamping elements away from each other to release the urethra or urine bladder from the elements to enlarge the urine passageway.

57. An apparatus according to claim 1, wherein the restriction device is adapted to bend a portion of the urethra or urine bladder.

58. An apparatus according to claim 41, wherein the restriction device comprises at least two bending members to be positioned on opposite sides of the urethra or urine bladder and to be displaced relative to each other along the urine passageway in the urethra or urine bladder, and the adjustment device is adapted to move the bending members against the urethra or urine bladder to bend the urethra or urine bladder to restrict the urine passageway in the urethra or urine bladder, and to move the bending members away from the urethra or urine bladder to release the urethra or urine bladder from the bending members to enlarge the urine passageway.

59. An apparatus according to claim 42, wherein the bending members comprise rollers.

60. An apparatus according to claim 1, wherein the restriction device is adapted to rotate a portion of the urethra or urine bladder.

61. An apparatus according to claim 1, further comprising a wireless remote control for non-invasively controlling the hydraulic operation device.

62. An apparatus according to claim 61, wherein the remote control comprises an external wireless hand-held remote control unit which is manually operable by the patient to control the restriction device to squeeze or release the urethra or urine bladder.

63. An apparatus according to claim 61, wherein the remote control comprises an external signal transmitter, receiver or transceiver and a signal receiver, transmitter or transceiver implantable in the patient.

64. An apparatus according to claim 63, wherein the signal receiver and/or transmitter comprises a control unit adapted to control the operation device in response to a control signal received from the signal transmitter.

65. An apparatus according to claim 64, further comprising an implantable energizer unit for providing energy to energy consuming implantable components of the apparatus.

66. An apparatus according to claim 1, wherein the operation device comprises a motor for operating the adjustment device.

67. An apparatus according to claim 65, wherein the operation device comprises a motor for operating the adjustment device and the control unit is adapted to power the motor with energy provided by the energizer unit in response to a control signal received from the signal transmitter.

68. An apparatus according to claim 61, wherein the remote control comprises a wireless energy transfer device for transferring energy from outside the patient'"'"'s body to energy consuming implantable components of the apparatus.

69. An apparatus according to claim 65, wherein the energizer unit is adapted to transform energy from the control signal, as it is transmitted to the signal receiver into electric energy.

70. An apparatus according to claim 68, wherein the operation device comprises a motor, and the wireless energy transfer device is adapted to directly power the motor with transferred energy.

71. An apparatus according to claim 69, wherein the energy transferred by the wireless energy transfer device comprises a signal.

72. An apparatus according to claim 71, wherein the signal comprises a wave signal.

73. An apparatus according to claim 69, wherein the energy transferred by the wireless energy transfer device comprises an electric field or a magnetic field or a combination thereof.

74. An apparatus according to claim 71, wherein the signal is analog or digital or a combination thereof.

75. An apparatus according to claim 63, wherein the signal transmitter and signal receiver are adapted to transmit and receive an analog or digital signal or a combination thereof.

76. An apparatus according to claim 74, wherein the signal comprises analog or digital pulses.

77. An apparatus according to claim 74, wherein the analog or digital signal comprises a magnetic field or an electric field or a combination thereof.

78. An apparatus according to claim 63, wherein the signal transmitter and signal receiver are adapted to transmit and receive a wave signal.

79. An apparatus according to claim 71, wherein the wave signal comprises an electromagnetic wave signal, a sound wave signal or a carrier wave signal for a remote control signal or a combination thereof.

80. An apparatus according to claim 79, wherein the carrier signal is frequency, amplitude or frequency and amplitude modulated.

81. An apparatus according to claim 71 wherein the energy transfer means transfers the energy from the signal into a direct, pulsating direct or alternating current or a combination thereof.

82. An apparatus according to claim 61, wherein the remote control is capable of obtaining information related to important parameters of the apparatus from inside the patient'"'"'s body and of commanding the adjustment device to adjust the restriction device in response to obtained information.

83. An apparatus according to claim 61, wherein the remote control is capable of obtaining information related to the urine passageway in the urethra or urine bladder and of commanding the adjustment device to adjust the restriction device in response to obtained information.

84. An apparatus according to claim 1, further comprising an implantable source of energy for powering the operation device and/or for energizing other energy consuming components of the apparatus, wherein the energy from the source of energy is releasable from outside the patient'"'"'s body.

85. An apparatus according to claim 1, further comprising an energy transmission device for wireless transmission of energy.

86. An apparatus according to claim 84, further comprising an energy transmission device for wireless transmission of energy and an energy transforming device implantable in the patient for transforming the energy of the first form into energy of a second form, to be supplied to the source of energy and/or other implantable energy consuming parts of the apparatus.

87. An apparatus according to claim 86, wherein the energy of the second form is different than the energy of the first form.

88. An apparatus according to claim 86, wherein the energy transmission device functions differently from the energy transforming device.

89. An apparatus according to claim 85, further comprising an implantable motor or pump for operating the adjustment device, wherein the energy transmission device is adapted to transmit wireless energy in the form of a magnetic field or electromagnetic waves or field for direct power of the motor or pump, as the wireless energy is being transmitted.

90. An apparatus according to claim 64, further comprising an energy transmission device for wireless transmission of energy by at least one signal separate from the control signal.

91. An apparatus according to claim 86, further comprising an implantable stabiliser for stabilising the energy of the first or second form.

92. An apparatus according to claim 91, wherein the energy of the second form comprises electric current and the stabiliser comprises at least one capacitor.

93. An apparatus according to claim 84, wherein the source of energy comprises a battery, accumulator, capacitor or a combination thereof.

94. An apparatus according to claim 1, further comprising a control device adapted to produce wireless energy for directly powering the operation device and/or for energizing other energy consuming components of the apparatus.

95. An apparatus according to claim 1, further comprising an implantable energy transforming device for transforming wireless energy directly or indirectly into energy different than the wireless energy for operation of the restriction device.

96. An apparatus according to claim 94, wherein the wireless energy comprises a wave signal including 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 or a gamma radiation signal.

97. An apparatus according to claim 1, further comprising an energy transfer device for wireless transfer of energy from outside the patient'"'"'s body to the operation device or adjustment device and/or other energy consuming implantable components of the apparatus.

98. An apparatus according to claim 94, wherein the control device is adapted to produce wireless energy in the form of a train of energy pulses.

99. An apparatus according to claim 68, wherein the energy transfer device is adapted to intermittently transfer the energy in the form of a train of energy pulses for direct use in connection with the energising of the energy consuming components of the apparatus.

100. An apparatus according to claim 94 further comprising a control device is adapted to control the energy transforming device to produce the energy of the second form in a train of energy pulses for direct use in connection with the operation of the adjustment device.

101. An apparatus according to claim 99, wherein the energy transfer device is adapted to transfer electric energy, and further comprising an implantable capacitor for producing the train of energy pulses.

102. An apparatus according to claim 92, wherein the capacitor has a capacity less than 0,1 μ

F.

103. An apparatus according to claim 97, further comprising an implantable motor or pump for operating the adjustment device, wherein the energy transfer device is adapted to directly power the motor or pump with transferred energy.

104. An apparatus according to claim 89, wherein the pump is not a plunger type of pump.

105. An apparatus according to claim 1, wherein the adjustment device is adapted to adjust the restriction device in a non-manual, non-thermal or non-magnetic manner.

106. An apparatus according to claim 62, further comprising a wireless remote control for non-invasively controlling the operation device.

107. An apparatus according to claim 1, wherein the operation device is unpowerable by static permanent magnetic energy.

108. An apparatus according to claim 1, wherein the operation device is adapted to non-invasively operate the adjustment device.

109. An apparatus according to claim 1, wherein the adjustment device is operable to adjust the restriction device to steplessly change the restriction of the urine passageway.

110. An apparatus according to claim 1, wherein the operation device comprises a hydraulic operation device which uses hydraulic fluid, the viscosity of which changes when the hydraulic fluid is exposed to energy different than thermal energy.

111. An apparatus according to claim 110, wherein the viscosity of the hydraulic fluid changes when the fluid is exposed to electric energy.

112. An apparatus according to claim 1, further comprising an adjustment device for adjusting the restriction device to change the restriction of the urine passageway, wherein the adjustment device is adapted to mechanically adjust the restriction device, or adapted to hydraulically adjust the restriction device by using hydraulic means which is devoid of hydraulic fluid of the kind having a viscosity that substantially increases when exposed to heat or a magnetic field.

113. An apparatus according to claim 1, further comprising a control device for controlling the restriction device.

114. An apparatus according to claim 113, wherein the control device comprises an internal control unit implantable in the patient for controlling the restriction device.

115. An apparatus according to claim 114, wherein the internal control unit is programmable.

116. An apparatus according to claim 115, wherein the control device comprises an external control unit outside the patient'"'"'s body, the implantable internal control unit being programmable by the external control unit.

117. An apparatus according to claim 113, wherein the control device comprises an external control unit outside the patients body for wirelessly controlling the restriction device.

118. An apparatus according to claim 117, wherein the external control unit is programmable.

119. An apparatus according to claim 1, further comprising at least one implantable sensor for sensing at least one physical parameter of the patient.

120. An apparatus according to claim 119, wherein the sensor is adapted to directly or indirectly sense as the physical parameter the horisontal position of the patient.

121. An apparatus according to claim 119, wherein the sensor comprises a pressure sensor for directly or indirectly sensing as the physical parameter the pressure against the restriction device or part of the human body.

122. An apparatus according to claim 121, wherein the restriction device is adapted to enlarge the urine passageway in the urethra or urine bladder in response to the pressure sensor sensing a predetermined pressure.

123. An apparatus according to claim 119, further comprising a control device for controlling the restriction device in response to signals from the sensor.

124. An apparatus according to claim 123, wherein the control device comprises an internal control unit implantable in the patient and directly controlling the restriction device in response to signals from the sensor.

125. An apparatus according to claim 124, wherein the control device comprises an external control unit outside the patient'"'"'s body for controlling the restriction device in response to signals from the sensor.

126. An apparatus according to claim 124, wherein the control device comprises an external control unit outside the patient'"'"'s body for manually controlling the restriction device in response to information from the sensor.

127. An apparatus according to claim 113, further comprising an implantable source of energy, wherein the control device is operable from outside the patient'"'"'s body for controlling the source of energyto release energy for use in connection with the operation of the restriction device, when the restriction device is implanted.

128. An apparatus according to claim 127, wherein the source of energy is intended to be external to the patient'"'"'s body, and the control device is adapted to control the external source of energy to release wireless energy for use in connection with the operation of the restriction device.

129. An apparatus according to claim 127, wherein the control device controls the source of energy to release magnetic energy, non-magnetic energy, electromagnetic energy, non-electromagnetic energy, kinetic energy, non-kinetic energy, sonic energy, non-sonic energy, thermal energy or non-thermal energy.

130. An apparatus according to claim 1, wherein the operation device is powered by magnetic energy, non-magnetic energy, electromagnetic energy, non-electromagnetic energy, kinetic energy, non-kinetic energy, sonic energy, non-sonic energy, thermal energy or non-thermal energy.

131. An apparatus according to claim 127, wherein the control device controls the source of energy to release energy for a determined time period.

132. An apparatus according to claim 98, wherein the control device controls the source of energy to release energy in a determined number of energy pulses.

133. An apparatus according to claim 127, wherein the control device is adapted to control the source of energy to release energy in a non-invasive manner.

134. An apparatus according to claim 1, further comprising implantable electrical components including at least one voltage level guard.

135. An apparatus according to claim 1, further comprising implantable electrical components including a single voltage level guard.

136. An apparatus according to claim 134, wherein the electrical components are devoid of any current detector and/or charge level detector.

137. An apparatus according to claim 84, further comprising an implantable capacitor or accumulator, wherein the charge or discharge of the capacitor or accumulator is controlled by use of the voltage level guard.

138. An apparatus according to claim 64, wherein the control signal comprises a wave signal including 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 or a gamma radiation signal.

139. An apparatus according to claim 1, further comprising a switch implantable in the patient for directly or indirectly switching the operation of the restriction device.

140. An apparatus according to claim 85, further comprising a source of energy implantable in the patient for supplying energy for the operation of the restriction device, and a switch operable by the energy supplied by the energy transmission device to switch from an off mode, in which the source of energy is not in use, to an on mode, in which the source of energy supplies energy for the operation of the restriction device.

141. An apparatus according to claim 84, further comprising a source of energy implantable in the patient for supplying energy for the operation of the restriction device, a remote control for controlling the supply of energy of the implantable source of energy, and a switch operable by the energy supplied by the energy transmission device to switch from an off mode, in which the remote control is prevented from controlling the source of energy and the source of energy is not in use, to a standby mode, in which the remote control is permitted to control the source of energy to supply energy for the operation of the restriction device.

142. An apparatus according to claim 86, further comprising a source of energy implantable in the patient for supplying energy for the operation of the restriction device, and a switch operable by the energy supplied by the energy transforming device to switch from an off mode, in which the source of energy is not in use, to an on mode, in which the source of energy supplies energy for the operation of the restriction device.

143. An apparatus according to claim 86, further comprising a source of energy implantable in the patient for supplying energy for the operation of the restriction device, a remote control for controlling the supply of energy of the implantable source of energy, and a switch operable by the energy supplied by the energy transforming device to switch from an off mode, in which the remote control is prevented from controlling the source of energy and the source of energy is not in use, to a standby mode, in which the remote control is permitted to control the source of energy to supply energy for the operation of the restriction device.

144. An apparatus according to claim 1, wherein the restriction device is operable to perform a reversible function.

145. An apparatus according to claim 66, further comprising a reversing device implantable in the patient for reversing the function performed by the restriction device.

146. An apparatus according to claim 145, wherein the control device controls the reversing device to reverse the function performed by the restriction device.

147. An apparatus according to claim 145, wherein the reversing device comprises hydraulic means including a valve for shifting the flow direction of a flowing fluid in the hydraulic means.

148. An apparatus according to claim 145, wherein the reversing device comprises a mechanical reversing device.

149. An apparatus according to claim 145, wherein the reversing device comprises a switch.

150. An apparatus according to claim 149, wherein the switch of the reversing device is operable by the released energy.

151. An apparatus according to claim 150, wherein the control device controls the operation of the switch of the reversing device by shifting polarity of the released energy supplied to the switch.

152. An apparatus according to claim 145, wherein the operation device comprises a motor, and the reversing device reverses the motor.

153. An apparatus according to claim 1, wherein the restriction device is embedded in a soft or gel-like material.

154. An apparatus according to claim 153, wherein the restriction device is embedded in a silicone material having hardness less than 20 Shore.

155. An apparatus according to claim 86, wherein the energy transforming means or device is designed to be implanted subcutaneously or in the abdomen, thorax or cephalic region of the patient.

156. An apparatus according to claim 1, wherein the adjustment device is adapted to adjust the restriction device such that the restriction device provides a predetermined contraction of the urine passageway that is satisfactory for the patient.

157. An apparatus according to claim 1, wherein the adjustment device is adapted to adjust the restriction device in a non-flux magnetic, non-thermal or non-viscosity changing manner.

18. A urinary incontinence treatment apparatus, comprising an adjustable restriction device adapted to engage the urethra or urine bladder of a patient, who suffers from urinary incontinence, to form a restricted urine passageway in the urethra or urine bladder, an implantable adjustment device for adjusting the restriction device to restrict the urethra or urine bladder to close the urine passageway, or release the urethra or urine bladder to open the urine passageway, when the restriction device is implanted in the patient, and an implantable operation device for operating the adjustment device, wherein characterised in that the operation device comprises a servo means operatively connected to the adjustment device.

19. An apparatus according to claim 18, wherein the operation device is powered.

20. An apparatus according to claim 18, wherein the operation device is manually operated.

21. An apparatus according to claim 18, wherein the servo means comprises a motor, preferably an electric motor.

22. An apparatus according to claim 21, wherein the motor is reversible.

23. An apparatus according to claim 21, further comprising a gearing connected between the motor and the adjustment device.

24. An apparatus according to claim 18, further comprising an implantable reservoir defining a chamber for hydraulic fluid, wherein the operation device is adapted to operate the adjustment device by using the hydraulic fluid of the reservoir.

25. An apparatus according to claim 24, wherein the reservoir contains a predetermined amount of hydraulic fluid.

26. An apparatus according to claim 18 wherein the servo means comprises a reverse servo.

27. An apparatus according to claim 24, further comprising a reverse servo, wherein the reservoir comprises first and second wall portions and the reverse servo is adapted to provide relative displacement between the first and second wall portions of the reservoir, in order to change the volume of the reservoir.

28. An apparatus according to claim 27, wherein the reverse servo device is adapted to provide said relative displacement in response to the pressure in the reservoir.

29. An apparatus according to claim 18, wherein the servo means comprises a pressure controlled servo means.

30. An apparatus according to claim 29, further comprising an alarm adapted to generate an alarm signal in response to the lapse of a predetermined time period during which the pressure controlling the servo means exceeds a predetermined high value.

31. An apparatus according to claim 26, wherein the reverse servo comprises magnetic means, electric means or manual manipulation means or a combination thereof.

32. An apparatus according to claim 27, wherein the reverse servo comprises hydraulic means.

33. An apparatus according to claim 32, wherein the reverse servo further comprises a servo reservoir defining a chamber containing servo fluid, and the operation device comprise first and second wall portions of the servo reservoir, which are displaceable relative to each other to change the volume of the chamber of the servo reservoir.

34. An apparatus according to claim 33, wherein the first and second wall portions of the servo reservoir are displaceable relative to each other by magnetic means, hydraulic means, or electric control means.

35. An apparatus according to claim 32, wherein the reverse servo comprises a servo reservoir and a fluid supply reservoir connected in a closed system and containing a further predetermined amount of fluid.

36. An apparatus according to claim 35, wherein the fluid supply reservoir defines a chamber for the further predetermined amount of fluid and the hydraulic operation device is adapted to change the volume of the chamber and thereby control the amount of fluid in the servo reservoir.

37. An apparatus according to claim 36, wherein the fluid supply reservoir comprises first and second wall portions, which are displaceable relative to each other to change the volume of the chamber of the fluid supply reservoir.

38. An apparatus according to claim 37, wherein the fluid supply reservoir increases the amount of fluid in the servo reservoir in response to a predetermined first displacement of the first wall portion of the fluid supply reservoir relative to the second wall portion of the fluid supply reservoir and decreases the amount of fluid in the servo reservoir in response to a predetermined second displacement of the first wall portion of the fluid supply reservoir relative to the second wall portion of the fluid supply reservoir.

51. An apparatus according to claim 34, wherein the adjustment device mechanically adjusts the restriction member.

53. An apparatus according to claim 51, wherein the elongated restriction member is flexible, and the adjustment device is adapted to pull a first portion of the flexible restriction member from a second portion of the flexible restriction member opposite the first portion in the loop to squeeze the urethra or urine bladder between two opposite lengths of the elongated flexible restriction member to restrict the passageway, and to release the urethra or urine bladder from the flexible restriction member to enlarge the passageway.