Urinary incontinence treatment apparatus

• US 6,709,385 B2
• Filed: 11/19/2002
• Issued: 03/23/2004
• Est. Priority Date: 02/11/2000
• Status: Expired due to Term

• Current Assignee: Obtech Medical AG (Johnson & Johnson), Li Gao Xiong
• Original Assignee: Obtech Medical AG (Johnson & Johnson)
• Inventors: Forsell, Peter
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US10/203,092
• Publication Number:
  US 20030144575A1
• Time in Patent Office: 490 Days
• Field of Search: 600/29-32, 128/DIG.25
• US Class Current: 600/29
• CPC Class Codes: A61B 17/132 Tourniquets sphygmomanometer A61B5/022
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

A urinary incontinence treatment apparatus includes an adjustable non-inflatable restriction device implanted in a patient suffering from urinary incontinence. The restriction device engages the urethra or urine bladder to restrict the urine passageway. An adjustment device mechanically adjusts the restriction device to restrict the urine passageway or temporarily release the urine passageway to allow the patient to urinate.

Claims

1. An urinary incontinence treatment apparatus for treatment of a patient, who suffers from urinary incontinence, comprising;

an adjustable restriction device implantable in the patient for contracting a portion of the urethra or urine bladder to form a restricted urine passageway therein, and

an operable adjustment device implantable in the patient for adjusting the restriction device to change the restriction of the urine passageway,

wherein the restriction device is non-inflatable, and the adjustment device is inoperable by permanent static magnetic energy and mechanically adjusts the restriction device to restrict the urine passageway to prevent urine from passing therethrough and enlarge the urine passageway to allow urine to pass therethrough.

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

3. An apparatus according to claim 1, wherein the adjustment device is powered.

4. An apparatus according to claim 1, wherein the restriction device is adapted to control the cross-sectional area of the urine passageway.

5. An apparatus according to claim 4, wherein the restriction device is operable to open and close the urine passageway.

6. An apparatus according to claim 5, wherein the restriction device is adapted to steplessly control the cross-sectional area of the urine passageway.

7. An apparatus according to claim 1, further comprising a powered operation device for operating the adjustment device.

8. An apparatus according to claim 1, wherein the restriction device comprises an element to be placed on one side of said portion of the urethra or urine bladder, and the adjustment device squeezes said portion of the urethra or urine bladder between the element and the human bone or tissue to restrict the urine passageway.

9. An apparatus according to claim 1, wherein the restriction device comprises at least one elongated restriction member and forming means for forming the restriction member into at least a substantially closed loop around said portion of 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.

10. An apparatus according to claim 9, wherein the restriction device comprises several elongated restriction members to be formed into at least substantially closed loops around the urethra or urine bladder.

11. An apparatus according to claim 9, wherein, the adjustment device is adapted to adjust a longitudinal extension of the elongated restriction member in said loop to change the size of the restriction opening.

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

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

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

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

16. An apparatus according to claim 11, wherein the elongated restriction member is longitudinally resilient and the adjustment device comprises a contraction means adapted to longitudinally contract the resilient restriction member.

17. An apparatus according to claim 16, wherein the elongated restriction member comprises a substantially nonresilient main portion and an end portion forming an elongated helical spring, which is contractible by the contraction means.

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

19. An apparatus according to claim 9, wherein the restriction member comprises an elongated helical spring having a free end, and a body to which said spring is nonrotatably secured at its opposite end, the adjustment device being adapted to rotate the helical spring in one direction to enlarge the coils of the helical spring to longitudinally contract the elongated helical spring and to rotate the helical spring in the opposite direction to reduce the size of the coils of the helical spring to longitudinally extend the helical spring.

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

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

22. An apparatus according to claim 9, wherein the restriction member forms a radially innermost circumferential confinement surface in said loop of the restriction member, and the adjustment device is adapted to mechanically adjust the restriction member such that at least a portion of the confinement surface is substantially radially displaced in said loop.

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

24. An apparatus according to claim 22, wherein the restriction member comprises an elastic annular element forming the confinement surface, and the adjustment device is adapted to change the diameter of the elastic annular element.

25. An apparatus according to claim 22, wherein the forming means comprises a substantially rigid outer annular element, and the restriction member comprises an elongated helical spring extending internally along the outer annular element and contacting the latter, the helical spring forming part of the circumferential confinement surface and having a free end, and a body to which the helical spring is nonrotatably secured at its opposite end, the adjustment device being adapted to rotate the helical spring in one direction to enlarge the coils of the helical spring to contract the circumferential confinement surface and to rotate the helical spring in the opposite direction to reduce the size of the coils of the helical spring to expand the circumferential confinement surface.

26. An apparatus according to claim 22, wherein the forming means comprises a substantially rigid outer annular element, and the restriction member comprises a first and a second elongated helical spring extending internally along the outer annular element and contacting the latter, the helical springs forming part of the circumferential confinement surface, the first and the second spring, respectively, having a free end, and a body to which the first and the second spring, respectively, is nonrotatably secured at its opposite end, the adjustment device being adapted to rotate the first and the second spring, respectively, in one direction to enlarge the coils of the spring to contract the circumferential confinement surface and to rotate the first and the second spring, respectively, in the opposite direction to reduce the size of the coils of the spring to expand the circumferential confinement surface.

27. An apparatus according to claim 9, wherein the restriction member comprises at least two separate elements, at least one of which is pivoted such that it is pivoted in a plane in which said loop of the restriction member extends, and the adjustment device is adapted to turn said pivoted element to change the size of said restriction opening.

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

29. An apparatus according to claim 28, wherein the foldable frame elements comprise two substantially semi-circular frame elements, which are hinged together such that the semicircular elements are swingable relative to each other from a fully open state in which they substantially form a circle to a fully folded state in which they form a semicircle.

30. An apparatus according to claim 9, wherein the elongated restriction member is elastic and varies in thickness as seen in a cross-section therethrough, and the adjustment device is adapted to turn the restriction member around the longitudinal extension thereof.

31. An apparatus according to claim 9, wherein the forming means comprises a spring material forming the elongated restriction member into the loop, such that the restriction opening has a predetermined size, and the adjustment device is adapted to adjust the restriction member against the spring action of the spring material.

32. An apparatus according to claim 31, wherein the spring material is integrated in the restriction member.

33. An apparatus according to claim 9, wherein the forming means is adapted to form the restriction member into a loop having a predetermined size or a size selected from several predetermined sizes.

34. An apparatus according to claim 9, 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.

35. An apparatus according to claim 9, 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.

36. An apparatus according to claim 9, 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 said portion of the urethra or urine bladder between two opposite lengths of the elongated flexible restriction member to restrict the urine passageway in said portion of the urethra or urine bladder, and to release said portion of the urethra or urine bladder from the flexible restriction member to enlarge the urine passageway (FIGS. 36A,36B).

37. An apparatus according to claim 1, wherein the restriction device comprises at least two elements to be placed on different sides of said portion of the urethra or urine bladder, and the adjustment device is adapted to squeeze said portion of the urethra or urine bladder between the elements to restrict the urine passageway in said portion of the urethra or urine bladder, and to release said portion of the urethra or urine bladder from the elements to enlarge the urine passageway (FIGS. 37A, 37B).

38. 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 said portion of the urethra or urine bladder, and the adjustment device is adapted to turn the clamping elements toward each other to clamp said portion of the urethra or urine bladder between the clamping elements to restrict the urine passageway in said portion of the urethra or urine bladder, and to turn the clamping elements away from each other to release said portion of the urethra or urine bladder from the clamping elements to enlarge the urine passageway (FIG. 38).

39. An apparatus according to claim 1, wherein the restriction device bends a portion of said portion of the urethra or urine bladder.

40. An apparatus according to claim 39, wherein the restriction device comprises at least two bending members to be positioned on opposite or different sides of said portion of the urethra or urine bladder and to be displaced relative to each other along the urine passageway in said portion of the urethra or urine bladder, and the adjustment device is adapted to move the bending members against said portion of the urethra or urine bladder to bend it to restrict the urine passageway, and to move the bending members away from said portion of the urethra or urine bladder to release it from the bending members to enlarge the urine passageway.

41. An apparatus according to claim 40, wherein the bending members comprise rollers.

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

43. An apparatus according to claim 7, wherein the operation device comprises a motor operatively connected to the adjustment device.

44. An apparatus according to claim 43, wherein the operation device comprises a reverse servo connected between the motor and the adjustment device.

45. An apparatus according to claim 43, comprising an implantable reversing device for reversing the motor.

46. An apparatus according to claim 43, wherein the motor is fixed to the restriction device.

47. An apparatus according to claim 43, wherein the motor is remote from the restriction member and is connected to the adjustment device by a power transmission conduit.

48. An apparatus according to claim 7, wherein the operation device comprises a servo means.

49. An apparatus according to claim 48, wherein the servo means comprises a motor, preferably an electric motor.

50. An apparatus according to claim 49, wherein the motor is reversible.

51. An apparatus according to claim 7, wherein the operation device comprises hydraulic means for operating the adjustment device.

52. An apparatus according to claim 51, further comprising a reservoir containing a predetermined amount of fluid for supplying the hydraulic means with fluid.

53. An apparatus according to claim 52, wherein the reservoir defines a chamber for the predetermined amount of fluid and the hydraulic means is adapted to change the volume of the chamber.

54. An apparatus according to claim 52, wherein the hydraulic means comprises a pump for pumping fluid between the reservoir and the adjustment device.

55. An apparatus according to claim 52, wherein the hydraulic means is devoid of any non-return valve.

56. An apparatus according to claim 52, wherein the hydraulic means comprises a reverse servo.

57. An apparatus according to claim 56, wherein the reverse servo is manually operated.

58. An apparatus according to claim 56, wherein the reverse servo is powered.

59. An apparatus according to claim 56, wherein the hydraulic means comprises first and second wall portions of the reservoir, and the reverse servo is adapted to provide relative displacement between the first and second wall portions of the reservoir.

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

61. An apparatus according to claim 60, wherein the remote control comprises a separate signal transmitter and/or receiver and an implantable signal receiver and/or transmitter, for transmitting and/or receiving a control signal.

62. An apparatus according to claim 61, wherein the signal receiver comprises a control unit adapted to control the adjustment device in response to the control signal.

63. An apparatus according to claim 62, further comprising an implantable energiser unit for providing energy to energy consuming components of the apparatus to be implanted in the patient.

64. An apparatus according to claim 60, further comprising an implantable motor for operating the adjustment device.

65. An apparatus according to claim 63, wherein the control unit is adapted to control the energiser unit to power the motor with energy in response to the control signal.

66. An apparatus according to claim 64, wherein the motor is an electric motor.

67. An apparatus according to claim 63, wherein the energiser unit is adapted to transform energy from the control signal, as it is transmitted to the signal receiver, into electric energy.

68. An apparatus according to claim 63, wherein the energiser unit is adapted to transform energy from the control signal into a direct or alternating current.

69. An apparatus according to claim 67, further comprising an implantable electric motor for operating the adjustment device, wherein the energiser unit comprises a rechargeable electric power supply for storing the electric energy and the control unit is adapted to power the electric motor with energy from the rechargeable electric power supply in response to the control signal.

70. An apparatus according to claim 63, wherein the energiser unit comprises a battery, an electrically operable switch adapted to connect the battery to the signal receiver in an “

on”

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

standby”

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

71. An apparatus according to claim 70, wherein the control unit is adapted to power the electric motor with energy from the battery in response to a control signal received from the signal transmitter, when the switch is in its “

on”

mode.

72. An apparatus according to claim 63, further comprising an external energy transmitter for transmitting wireless energy, wherein the energiser unit comprises a battery and a switch operable by the wireless energy transmitted by the external transmitter, for connecting the battery to the signal receiver in an “

on”

mode when the switch is powered by the wireless energy and to keep the battery disconnected from the signal receiver in a “

standby”

mode when the switch is unpowered.

73. An apparatus according to claim 1, further comprising an implantable energiser unit for providing energy to energy consuming components of the apparatus to be implanted in the patient.

74. An apparatus according to claim 73, further comprising an external energy transmitter for transmitting wireless energy, wherein the energiser unit is adapted to transform the wireless energy into electric energy.

75. An apparatus according to claim 74, further comprising an implantable electric motor for operating the adjustment device, wherein the energiser unit is adapted to power the electric motor with the electric energy transformed from the wireless energy.

76. An apparatus according to claim 73, further comprising an external energy transmitter for transmitting wireless energy, wherein the energiser unit comprises a battery and a switch operable by the wireless energy transmitted by the external transmitter, for connecting the battery to the implantable energy consuming components of the apparatus in an “

on”

mode when the switch is powered by the wireless energy and to keep the battery disconnected from the energy consuming components in a “

standby”

mode when the switch is unpowered.

77. An apparatus according to claim 72, wherein the external energy transmitter is adapted to directly power the switch with the wireless energy to switch into the “

on”

mode.

78. An apparatus according to claim 60, wherein the remote control is capable of obtaining information from implantable components of the apparatus and of commanding the adjustment device to adjust the restriction device in response to obtained information.

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

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

81. An apparatus according to claim 79, wherein the electrical components are devoid of any current detector and/or charge level detector.

82. An apparatus according to claim 79, 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.

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

84. An apparatus according to claim 83, wherein the energy transfer means 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.

85. An apparatus according to claim 84, wherein the energy transfer means is adapted to transfer electric energy, and further comprising an implantable capacitor for producing the train of energy pulses.

86. An apparatus according to claim 82, wherein the capacitor has a capacity less than 0,1 μ

F.

87. An apparatus according to claim 83, further comprising an implantable motor or pump for operating the adjustment device, wherein the energy transfer means is adapted to directly power the motor or pump with transferred energy.

88. An apparatus according to claim 1, further comprising an implantable motor or pump for operating the adjustment device, and an energy transmission device adapted to transmit wireless energy in the form of an magnetic field or electromagnetic waves for direct power of the motor or pump, as the wireless energy is being transmitted.

89. An apparatus according to claim 88, wherein the pump is not a plunger pump.

90. An apparatus according to claim 83, wherein the energy transfer means is adapted to transfer wireless energy in the form of electromagnetic waves excluding radio waves.

91. An apparatus according to claim 83, wherein the energy transferred by the energy transfer means comprises an electric field or a magnetic field.

92. An apparatus according to claim 83, wherein the energy transferred by the energy transfer means comprises a signal.

93. An apparatus according to claim 61, wherein the signal comprises digital or analog pulses.

94. An apparatus according to claim 93, wherein the digital or analog pulses comprise a magnetic field or an electric field.

95. An apparatus according to claim 61, wherein the signal comprises a wave signal.

96. An apparatus according to claim 95, wherein the wave signal comprises an electromagnetic wave signal, a sound wave signal or a carrier wave signal.

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

98. An apparatus according to claim 97, wherein the restriction device is controlled in response to signals from the pressure sensor.

99. 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.

100. An apparatus according to claim 99, wherein the energy transforming device transforms the wireless energy into kinetic energy for operation of the restriction device.

101. An apparatus according to claim 99, wherein the energy transforming device transforms the wireless energy in the form of sound waves into electric energy for operation of the restriction device.

102. An apparatus according to claim 1, further comprising an implantable reversing device, wherein the restriction device is capable of performing a reversible function and the reversing device reverses the reversible function.

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

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

105. An apparatus according to claim 7, further comprising an implantable gear transmission operatively connecting the operation device and adjustment device.

106. An apparatus according to claim 101, wherein the energy transforming device transforms the wireless energy in the form of sound waves directly into electric energy.

107. An apparatus according to claim 101, wherein the energy transforming device comprises a capacitor.

108. An apparatus according to claim 107, wherein the capacitor is adapted to produce electric pulses from the transformed electric energy.

109. An apparatus according to claim 58, wherein the reverse servo comprises a motor, preferably an electric motor.

110. An apparatus according to claim 109, wherein the motor is reversible.

111. An apparatus according to claim 96, wherein the carrier signal is frequency, amplitude or frequency and amplitude modulated.

112. An apparatus according to claim 96, wherein the 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.

113. An apparatus according to claim 52, wherein the hydraulic means of the operation device comprises a fluid conduit, the reservoir forming part of the conduit.

114. An apparatus according to claim 113, wherein the hydraulic means including the conduit are devoid of any non-return valve.

115. An apparatus according to claim 83, wherein the energy transfer means is adapted to transfer 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.