Urinary Dysfunction Treatment Apparatus

• US 7,499,753 B2
• Filed: 11/10/2003
• Issued: 03/03/2009
• Est. Priority Date: 06/28/2001
• Status: Expired due to Term

• Current Assignee: Urologica AG
• Original Assignee: Urologica AG
• Inventors: Forsell, Peter
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Malamud; Deborah
• Application Number:
  US10/703,444
• Publication Number:
  US 20040172087A1
• Time in Patent Office: 1,940 Days
• Field of Search: 607 40- 41
• US Class Current: 607/41
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

An apparatus for treating urinary incontinence comprises an electrically powered stimulation device that electrically stimulates the urethral sphincter of a urinary incontinent patient and a hand-held wireless remote control that controls the stimulation device. A stress or urge incontinent patient operates the remote control to: i) switch off the electrically powered stimulation device, when the patient wants to urinate, and switch on the electrically powered stimulation device, when the patient has finished urinating; and ii) control the stimulation device as needed at any time over the course of a day to promptly adjust the intensity of the electric stimulation of the urethral sphincter to quickly increase the tonus of the urethral sphincter.

Claims

1. An apparatus for treating urinary incontinence, comprising

an electrically powered stimulation device implantable in a urinary incontinent patient and adapted to electrically stimulate the patient'"'"'s natural urethral sphincter all the time, except when the patient wants to urinate, to maintain a sufficient tonus of the patient'"'"'s natural urethral sphincter that prevents urine from passing past the patient'"'"'s natural urethral sphincter, and

a control device that controls said stimulation device, said control device including a hand-held wireless remote control that generates a control signal to control said stimulation device from outside the patient'"'"'s body to:

i) switch off said electrically powered stimulation device, when the patient wants to urinate, and switch on said electrically powered stimulation device, when the patient has finished urinating; and

ii) control said stimulation device as needed at any time over the course of a day to promptly adjust the intensity of the electric stimulation of the patient'"'"'s natural urethral sphincter, so that the tonus of the patient'"'"'s natural urethral sphincter is instantly increased, whereby the patient is able to maintain continence.

2. An apparatus according to claim 1, wherein said wireless remote control is adapted to be operated to control said stimulation device to temporarily increase the intensity of the electric stimulation of the urethral sphincter, so that the tonus of the urethral sphincter is increased, when the patient expects an abrupt increase in the abdominal pressure.

3. An apparatus according to claim 1, wherein said wireless remote control is adapted to be operated to control said stimulation device to adjust the intensity of the electric stimulation of the urethral sphincter to one of a plurality of different preselected intensity levels.

4. An apparatus according to claim 1, further comprising a source of energy, wherein said control device also controls said source of energy to supply energy for operating said stimulation device.

5. An apparatus according to claim 4, wherein said source of energy comprises an electric source of energy and said control device is adapted to control said electric source of energy to supply said stimulation device with electric energy.

6. An apparatus according to claim 5, wherein said stimulation device comprises electrodes adapted to engage with the urethral sphincter, said electric source of energy is adapted to provide a current through said electrodes, and said control device is adapted to control said electric source of energy to release electric energy such that the intensity of the current through said electrodes amounts to a predetermined value.

7. An apparatus according to claim 6, wherein said control device is adapted to control said electric source of energy to release electric energy in the form of an alternating current.

8. An apparatus according to claim 5, wherein said control device is adapted to control said electric source of energy to continuously supply said stimulation device with electric energy to keep the urethral sphincter closed, except when the patient operates said wireless remote control to stop the stimulation of the urethral sphincter.

9. An apparatus according to claim 4, wherein said source of energy is intended to be external to the patient'"'"'s body when said stimulation device is implanted therein, and said control device is adapted to control the external source of energy to supply wireless energy.

10. An apparatus according to claim 9, further comprising an energy storage device implantable in the patient for storing said wireless energy supplied by said external source of energy.

11. An apparatus according to claim 10, wherein said energy storage device comprises an accumulator.

12. An apparatus according to claim 11, wherein said accumulator comprises an electric accumulator.

13. An apparatus according to claim 12, wherein said electric accumulator comprises at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery.

14. An apparatus according to claim 9, wherein said control device is adapted to control said external source of energy to supply wireless energy for direct use in connection with the operation of said stimulation device.

15. An apparatus according to claim 14, further comprising an activatable source of energy implantable in the patient, wherein said implantable source of energy is activated by wireless energy supplied by said external source of energy, to supply energy which is used in connection with the operation of said stimulation device.

16. An apparatus according to claim 14, wherein said control device is adapted to control said external source of energy to intermittently supply wireless energy in the form of a train of energy pulses for direct use in connection with the operation of said stimulation device.

17. An apparatus according to claim 16, wherein said control device is adapted to control said source of energy to release electric energy, and further comprising an implantable capacitor for producing said train of energy pulses from the released energy.

18. An apparatus according to claim 17, wherein said capacitor has a capacity less than 0.1 μ

F.

19. An apparatus according to claim 9, further comprising an implantable stabiliser for stabilising said energy supplied by said external source of energy.

20. An apparatus according to claim 19, wherein said energy supplied by said external source of energy comprises electric energy and said stabiliser comprises at least one capacitor.

21. An apparatus according to claim 9, wherein said wireless energy comprises said control signal.

22. An apparatus according to claim 9, further comprising an implantable energy transforming device for transforming said wireless energy directly or indirectly into electric energy for operating said stimulation device, as said energy transforming device transforms said wireless energy.

23. An apparatus according to claim 22, wherein said energy transforming device comprises a capacitor.

24. An apparatus according to claim 23, wherein said capacitor is adapted to produce electric pulses from said transformed electric energy.

25. An apparatus according to claim 9, further comprising an implantable energy transforming device for transforming said wireless energy in the form of sound waves into kinetic energy.

26. An apparatus according to claim 9, further comprising an implantable energy transforming device for transforming said wireless energy in the form of sound waves directly or indirectly into electric energy.

27. An apparatus according to claim 4, wherein said source of energy comprises an implantable internal source of energy.

28. An apparatus according to claim 27, wherein said internal source of energy comprises an electric source of energy.

29. An apparatus according to claim 28, wherein said internal electric 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.

30. An apparatus according to claim 4, further comprising a switch implantable in the patient for directly or indirectly switching the operation of said stimulation device.

31. An apparatus according to claim 30, wherein said source of energy comprises an internal electric source of energy implantable in the patient for supplying electric energy to said stimulation device, wherein said switch directly or indirectly affects the supply of electric energy from said internal electric source of energy.

32. An apparatus according to claim 31, wherein said wireless remote control controls said internal electric source of energy.

33. An apparatus according to claim 31, wherein said source of energy further comprises an external source of energy and said control device is adapted to control said external source of energy to supply wireless energy, and further comprising an energy transforming device implantable in the patient for transforming said wireless energy into storable energy and an energy storage device implantable in the patient for storing said storable energy.

34. An apparatus according to claim 33, wherein said switch is adapted to be operated by energy from said implantable energy storage device to switch between an “

off”

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

on”

mode, in which said internal electric source of energy supplies electric energy to said stimulation device.

35. An apparatus according to claim 34,wherein said control device controls said energy storage device to operate said switch.

36. An apparatus according to claim 31, wherein said source of energy further comprises an external source of energy and said control device is adapted to control said external source of energy to supply wireless energy, the apparatus further comprising an energy transforming device implantable in the patient for transforming said wireless energy into electric energy, which is stored by said internal electric source of energy.

37. An apparatus according to claim 36, wherein said switch switches from an “

off”

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

on”

mode, in which said internal source of electric energy supplies energy to said stimulation device.

38. An apparatus according to claim 37, wherein said control device controls said switch to switch between said “

on” and

“

off”

modes.

39. An apparatus according to claim 4, wherein said control device controls said source of energy to supply energy for a determined time period.

40. An apparatus according to claim 4, wherein said control device controls said source of energy to supply energy in a determined number of energy pulses.

41. An apparatus according to claim 4, wherein said control device is adapted to control said source of energy to supply energy in a non-invasive manner.

42. An apparatus according to claim 1, wherein said control device is adapted to control said stimulation device to vary the intensity of the electric stimulation of the urethral sphincter over time.

43. An apparatus according to claim 1, wherein said remote control is adapted to be operated to control said stimulation device to increase the intensity of the electric stimulation of the urethral sphincter so that the tonus of the urethral sphincter is increased, when the patient feels need but does not want to urinate.

44. An apparatus according to claim 1, further comprising at least one implantable sensor for sensing at least one physical parameter of the patient, wherein said control device controls said stimulation device in response to said sensor.

45. An apparatus according to claim 44, wherein said sensor is adapted to sense as the physical parameter the pressure against the urethral sphincter exerted by the urine bladder.

46. An apparatus according to claim 45, wherein said control device is adapted to control said electric stimulation device to increase the stimulation on the urethral sphincter in response to said sensor sensing an abrupt increase in pressure caused by bladder contraction or increased abdominal pressure.

47. An apparatus according to claim 44, wherein said sensor is adapted to sense as the physical parameter the patient'"'"'s orientation.

48. An apparatus according to claim 47, wherein said control device is adapted to control said electric stimulation device to decrease the stimulation intensity on the urethral sphincter in response to said sensor sensing that the patient is lying down.

49. An apparatus according to claim 44, wherein said sensor comprises a pressure sensor for directly or indirectly sensing as the physical parameter the pressure in the urine bladder.

50. An apparatus according to claim 44, wherein said control device comprises an external control unit outside the patient'"'"'s body, said external control unit controlling said stimulation device in response to signals from said sensor.

51. An apparatus according to claim 44, wherein said control device comprises an internal control unit implantable in the patient, said internal control unit controlling said stimulation device in response to signals from said sensor.

52. An apparatus according to claim 51, wherein said external control unit stores information on said physical parameter sensed by said sensor and is manually operated to control said stimulation device based on said stored information.

53. An apparatus according to claim 44, further comprising at least one implantable sender for sending information on said physical parameter sensed by said sensor.

54. An apparatus according to claim 1, wherein said stimulation device comprises electrodes adapted to engage with the urethral sphincter, and a band for application around the urethral sphincter and provided with said electrodes.

55. An apparatus according to claim 1, wherein said stimulation device comprises electrodes provided with hooks adapted to be inserted into the urethral sphincter.

56. An apparatus according to claim 1, wherein said control device comprises an internal control unit implantable in the patient for controlling said stimulation device.

57. An apparatus according to claim 56, wherein said internal control unit is programmable.

58. An apparatus according to claim 57, wherein said control device comprises an external control unit intended to be outside the patient'"'"'s body, said internal control unit being programmable by said external control unit.

59. An apparatus according to claim 58, wherein said external control unit controls said internal control unit in accordance with a doctor mode only authorised for a doctor.

60. An apparatus according to claim 58, wherein said external control unit controls said internal control unit in accordance with a patient mode permitted for the patient.

61. An apparatus according to claim 57, wherein said internal control unit is programmable for controlling said stimulation device over time.

62. An apparatus according to claim 61, wherein said internal control unit comprises a microprocessor.

63. An apparatus according to claim 1, further comprising an external data communicator intended to be outside the patient'"'"'s body, an internal data communicator implantable in the patient for communicating with said external communicator, and means for generating data related to the patient, wherein said internal data communicator feeds said data related to the patient back to said external data communicator.

64. An apparatus according to claim 63, wherein said means generates data related to at least one physical signal of the patient.

65. An apparatus according to claim 1, further comprising an external data communicator intended to be outside the patient'"'"'s body, an internal data communicator implantable in the patient for communicating with said external communicator, and means for generating data related to said stimulation device, wherein said internal data communicator feeds said data related to said stimulation device.

66. An apparatus according to claim 1, further comprising information generating means for generating information on the condition of said stimulation device when said stimulation device is implanted, wherein said remote control is capable of obtaining said generated information and of controlling said stimulation device in response to said information.

67. An apparatus according to claim 1, wherein said wireless remote control comprises at least one external signal transmitter or transceiver and at least one internal signal receiver or transceiver implantable in the patient.

68. An apparatus according to claim 1, wherein said wireless remote control comprises at least one external signal receiver or transceiver and at least one internal signal transmitter or transceiver implantable in the patient.

69. An apparatus according to claim 1, wherein the control device controls the stimulation device by means of a control signal, and wherein said remote control transmits a carrier signal for carrying said control signal.

70. An apparatus according to claim 69, wherein said carrier signal is frequency, amplitude or frequency and amplitude modulated.

71. An apparatus according to claim 69, wherein said carrier signal is digital, analogue or digital and analogue.

72. An apparatus according to claim 69, wherein said control signal used with said carrier signal is frequency, amplitude or frequency and amplitude modulated.

73. An apparatus according to claim 1, wherein the control device controls the stimulation device by means of a control signal, and 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.

74. An apparatus according to claim 1, wherein the control device controls the stimulation device by means of a control signal, and wherein said control signal comprises an electric, magnetic or electric and magnetic field.

75. An apparatus according to 1, wherein the control device controls the stimulation device by means of a control signal, and wherein said control signal is digital, analogue or digital and analogue.

76. An apparatus according to claim 75, wherein said remote control transmits an electromagnetic carrier wave signal for carrying the digital or analogue control signal.

77. An apparatus according to claim 1, wherein the control device controls the stimulation device by means of a control signal, and wherein said control signal is transmitted in pulses by said wireless remote control.

78. An apparatus according to claim 1, wherein said stimulation device is embedded in a soft material.

79. An apparatus according to claim 1, wherein said stimulation device is embedded in a silicone material having hardness less than 20 Shore.

80. An apparatus according to claim 1, wherein said control device controls said stimulation device to cyclically alternate between an operation mode, in which the urethral sphincter is stimulated, and a rest mode, in which the urethral sphincter is not stimulated.

81. An apparatus according to claim 80, wherein the urethral sphincter is stimulated with energy pulses when the stimulation device is in an operation mode.

82. A method for treating a patient suffering from urinary incontinence, comprising:

implanting in the patient an electrically powered stimulation device in direct engagement with the urethral sphincter,

electrically stimulating the urethral sphincter by the stimulation device to increase the tonus thereof,

providing a hand-held wireless remote control adapted to control the stimulation device from outside the patient'"'"'s body, and

operating the wireless remote control by the patient holding it to;

i) switch off the electrically powered stimulation device, when the patient wants to urinate;

ii) switch on the electrically powered stimulation device, when the patient has finished urinating; and

iii) control the stimulation device when various needs arise over the course of a day to promptly adjust the intensity of the electric stimulation of the urethral sphincter so that the tonus of the urethral sphincter is instantly increased.

83. A method according to claim 82, wherein the patient operates the wireless remote control to control the stimulation device to temporarily increase the intensity of the electric stimulation of the urethral sphincter, so that the tonus of the urethral sphincter is increased, when the patient expects an abrupt increase in the abdominal pressure.

84. A method according to claim 82, further comprising:

providing an external source of energy for transmitting wireless energy,

implanting in the patient an energy storage device,

transmitting wireless energy from the external source of energy,

loading the implanted energy storage device with the transmitted wireless energy, and

controlling the implanted energy storage device to supply energy for operating the stimulation device.