Vaginal operation method for the treatment of urinary incontinence in women

1. A method for treating a female urinary incontinent patient, the method comprising the steps of:

incising one opening in the vaginal wall of the patient;

accessing the urethra or the neck of the urinary bladder through the opening in the vaginal wall of the patient with an instrument having a flexible tip capable of bending around at least one of the urethra or the neck of urinary bladder;

dissecting an area in the patient surrounding the urethra or the neck of the urinary bladder with the instrument;

implanting with the instrument at least one powered restriction device around the urethra or the neck of urinary bladder, the at least one powered restriction device comprising an elongated restriction member and forming means for forming the restriction member into at least a substantially closed loop around the urethra or the neck of urinary bladder, wherein the loop defines a restriction opening, whereby an adjustment device is configured to adjust the restriction member in the loop to change the size of the restriction opening, the at least one powered restriction device being further adapted to be connected to a rechargeable energy source or an energy receiver and thereby power the at least one powered restriction device to change the size of the restriction opening and thereby decrease the flow of urine through any of the urethra and the neck of the urinary bladder;

implanting one or both of the rechargeable energy source or the energy receiver, using a vaginal approach or using a vaginal approach in combination with a skin incision; and

connecting the at least one powered restriction device directly or indirectly to the rechargeable energy source or the energy receiver, to power any energy consuming parts of the at least one powered restriction device.

2. The method according to claim 1 , comprising the additional step of postoperatively adjusting said at least one powered restriction device to control the flow of urine through any of the urethra and the neck of the urinary bladder.

3. The method according to claim 1 , comprising the additional step of implanting a switch and the additional step of adjusting said at least one powered restriction device using said implantable switch.

4. The method according to claim 1 , comprising the additional step of adjusting said at least one powered restriction device from outside the body of the patient.

5. The method according to claim 4 , wherein the method comprises the step of adjusting said at least one powered restriction device postoperatively using a remote control.

6. The method according to claim 1 comprising the additional step of implanting in the body of the patient at least one sensor adapted to measure at least one physiological parameter of the patient, said at least one sensor being adapted to send an alarm signal to the patient.

7. The method according to claim 6 wherein said at least one physiological parameter is selected from the group consisting of; pressure, volume, diameter, stretching, elongation, extension, movement, elasticity, muscle contraction, temperature or nerve impulse.

8. The method according to claim 6 , further comprising the additional step of measuring at least one parameter from the list consisting of pressure, volume, diameter, stretching, elongation, extension, movement, elasticity, muscle contraction, temperature, flow and nerve impulse.

9. The method according to claim 1 comprising the additional step of implanting in the body of the patient at least one sensor that measures at least one functional parameter of said at least one powered restriction device, said at least one sensor being adapted to send an alarm signal to the patient.

10. The method according to claim 9 wherein said at least one functional parameter is an electrical parameter.

11. The method according to claim 9 wherein said at least one functional parameter is selected from the group consisting of: pressure, volume, diameter, stretching, elongation, extension, movement and elasticity, temperature or flow.

12. The method according to claim 9 , further comprising the additional step of measuring an electrical parameter.

13. The method according to claim 1 , wherein the method comprises implanting at least one further restriction device.

14. The method according to claim 1 , further comprising the step of using cytoscopic observation of the patient.

15. The method according to claim 1 , further comprising the additional step of using a cytoscopic method for placing a sensor in the patient.

16. The method according to claim 1 , further comprising the additional step of using a cytoscopic method for calibrating said at least one powered restriction device.

17. The method according to claim 1 , further comprising implanting at least one switch in the patient for manually and non-invasively controlling the at least one powered restriction device.

18. The method according to claim 1 , further comprising implanting a hydraulic device having an implantable hydraulic reservoir, which is hydraulically connected to the at least one powered restriction device, wherein the at least one powered restriction device is adapted to be non-invasively regulated by manually pressing the hydraulic reservoir.

19. The method according to claim 1 , further comprising using a wireless remote control for non-invasively controlling the at least one powered restriction device.

20. The method according to claim 19 , wherein the wireless remote control comprises at least one external signal transmitter or receiver or both, and further comprising an internal signal receiver or transmitter or both implantable in the patient for receiving signals transmitted by the external signal transmitter or transmitting signals to the external signal receiver.

21. The method according to claim 19 , wherein the wireless remote control transmits at least one wireless control signal for controlling the at least one powered restriction device.

22. The method according to claim 21 , wherein the wireless control signal comprises a frequency, amplitude, or phase modulated signal or a combination thereof.

23. The method according to claim 21 , wherein the wireless remote control transmits an electromagnetic carrier wave signal for carrying the control signal.

24. The method according to claim 21 , wherein the control signal comprises one of the following: an electric field, a magnetic field, a combined electric and magnetic field.

25. The method according to claim 21 , wherein the signal comprises an analogue signal, a digital signal, or a combination of an analogue and digital signal.

26. The method according claim 1 , further comprising the step of using a wireless energy-transmission device for non-invasively energizing implantable energy consuming components of the at least one powered restriction device and components connected thereto with wireless energy.

27. The method according to claim 26 , wherein the wireless energy comprises a wave signal selected from the following: 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.

28. The method according to claim 26 , wherein the wireless energy comprises one of the following: an electric field, a magnetic field, a combined electric and magnetic field.

29. The method according to claim 26 , further comprising the additional step of implanting an operation device for operating the at least one powered restriction device, wherein the wireless energy is used in its wireless state to directly power the operation device to create kinetic energy for the operation of the at least one powered restriction device, as the wireless energy is being transmitted by the energy-transmission device.

30. The method according to claim 26 , further comprising the additional step of implanting an energy-transforming device for transforming the wireless energy transmitted by the energy-transmission device from a first form into a second form energy.

31. The method according to claim 26 , wherein the energy-transmission device comprises a coil placed externally to the human body, further comprising implanting the energy receiver to be placed internally in the human body and an electric circuit connected to power the external coil with electrical pulses to transmit the wireless energy, the electrical pulses having leading and trailing edges, the electric circuit adapted to vary first time intervals between successive leading and trailing edges or second time intervals between successive trailing and leading edges of the electrical pulses or both to vary the power of the transmitted wireless energy, the energy receiver receiving the transmitted wireless energy having a varied power.

32. The method according to claim 31 , wherein the electric circuit is adapted to deliver the electrical pulses to remain unchanged except varying the first or second time intervals or both.

33. The method according to claim 31 , wherein the electric circuit has a time constant and is adapted to vary the first and second time intervals only in the range of a first time constant, so that when the lengths of the first or second time intervals or both are varied, the transmitted power over the coil is varied.

34. The method according to claim 1 , further comprising using an external energy source for transferring energy in a wireless mode, wherein the rechargeable energy source is chargeable by the energy transferred in the wireless mode.

35. The method according to claim 34 , further comprising the additional step of implanting a sensor or measuring device for sensing or measuring a functional parameter correlated to the transfer of energy for charging the internal energy source, and a feedback device for sending feedback information from inside the patient's body to the outside thereof, the feedback information being related to the functional parameter sensed by the sensor or measured by the measuring device.

36. The method according to claim 1 , further comprising implanting a feedback device for sending feedback information from inside the patient's body to the outside thereof, the feedback information being related to at least one of a physical parameter of the patient and a functional parameter related to the at least one powered restriction device.

37. The method according to claim 36 , further comprising implanting the internal energy receiver for receiving wireless energy, the energy receiver having an internal first coil and a first electronic circuit connected to the first coil, and an external energy transmitter for transmitting wireless energy, the energy transmitter having an external second coil and a second electronic circuit connected to the second coil, wherein the external second coil of the energy transmitter transmits wireless energy which is received by the first coil of the energy receiver, the first electronic circuit further comprising a power switch for switching the connection of the internal first coil to the first electronic circuit on and off, such that feedback information related to the charging of the first coil is received by the external energy transmitter in the form of an impedance variation in the load of the external second coil, when the power switch switches the connection of the internal first coil to the first electronic circuit on and off.

38. The method according to claim 37 , wherein the energy transmitter regulates the transmitted energy in response to an obtained coupling factor.

39. The method according to claim 37 , wherein the external second coil is adapted to be moved in relation to the internal first coil to establish the optimal placement of the second coil, in which the coupling factor is maximized.

40. The method according to claim 1 , further comprising implanting an external data communicator and an implantable internal data communicator communicating with the external data communicator, wherein the internal communicator feeds data related to the at least one powered restriction device or the patient to the external data communicator or the external data communicator feeds data to the internal data communicator or both.

41. The method according to claim 1 , further comprising implanting a motor or a pump for operating the at least one powered restriction device.

42. The method according to claim 1 , further comprising implanting a hydraulic operation device for operating the at least one powered restriction device.

43. The method according to claim 1 , further comprising implanting an operation device for operating the at least one powered restriction device, wherein the operation device comprises a servo designed to decrease the force needed for the operation device to operate the at least one powered restriction device thereby increasing the time for a determined action.

44. The method according to claim 1 , further comprising the additional step of implanting electrical components including at least one voltage level guard or at least one constant current guard or both.

45. The method according to claim 1 wherein the steps of incising and accessing include a laparoscopic method.

46. The method according to claim 1 wherein the step of accessing includes using at least one trocar.

47. The method according to claim 46 wherein at least one trocar with a diameter from 5 to 12 mm is used.

48. The method according to claim 1 wherein the step of accessing includes using at least two trocars.

49. The method according to claim 1 , comprising inserting at least one laparoscopic trocar through the vaginal wall of the patient, and wherein said dissection is performed using at least one dissecting tool, which dissecting tool is inserted through at least one laparoscopic trocar.

50. The method according to claim 1 , comprising dissecting a surgical site surrounding the urethra and the neck of the urine bladder to be accessed after said surgical site has been insufflated with a gas.

51. The method according to claim 1 , comprising the additional step of fixating said at least one powered restriction device.

52. The method according to claim 1 , comprising the additional step of fixating said at least one powered restriction device in adjacent tissue or in at least one of: an area of a) the urethra; b) the neck of the urinary bladder; c) the muscles surrounding the urethra or the neck of the urinary bladder; or d) in a tunnel of fibrotic tissue surrounding the urethra or the neck of the urinary bladder.

53. The method according to claim 52 , comprising the additional step of suturing the tissue in layers.

54. The method according to claim 1 , wherein the restriction is carried out at several different parts of any of the urethra and the neck of the urinary bladder.

55. The method according to claim 1 , comprising the additional step of stimulating contraction in at least one of a) the urethra; b) the neck of the urinary bladder;

c) fibrotic tissue surrounding the urethra or the neck of the urinary bladder; or d) the muscles surrounding the urethra or the neck of the urinary bladder; by using electricity from the energy source.

56. The method according to claim 55 , comprising the additional step of stimulating in more than one location on the at least one powered restriction device.

57. The method according to claim 1 , comprising the additional step of adjusting said at least one powered restriction device manually.

58. The method according to claim 1 , comprising the additional step of adjusting said at least one powered restriction device non-manually.

59. The method according to claim 1 , wherein the energy receiver is implanted in the abdominal cavity.

60. The method according to claim 1 , wherein the energy receiver is implanted subcutaneously.

61. The method according to claim 1 , wherein the energy receiver is implanted in the pelvic region.

62. The method according to claim 1 , wherein the energy receiver comprises a motor or a pump that is able to use wireless energy directly to create kinetic energy to adjust the at least one powered restriction device.

63. The method according to claim 1 , where the energy receiver comprises an energy transforming device transforming wireless energy to non-wireless energy.

64. The method according to claim 63 , wherein the energy transforming device is powering a motor or pump directly during said wireless energy transfer.

65. The method according to claim 63 , wherein the energy transforming device is used for charging an energy storage device, indirectly supplying energy to any energy consuming parts of the at least one powered restriction device.

66. The method according to claim 1 further including adjusting said at least one powered restriction device mechanically by operating a gear box and an internal control unit.

67. The method according to claim 1 further including adjusting said at least one powered restriction device hydraulically by operating a servo reservoir and a regulation reservoir.

68. The method according to claim 1 further including adjusting said at least one powered restriction device electrically by operating a motor or pump.

69. The method according to claim 1 , wherein said at least one powered restriction device is implanted by a system for implantation of said at least one powered restriction device, wherein said system comprising an introductionary hose, being hollow and having at least partially a conical shape, adapted to hold said at least one powered restriction device inside the hollow space to compact the at least one powered restriction device and make it smaller and conical at a first introductionary end to ease the introduction of the at least one powered restriction device, wherein the method comprises;

mounting the at least one powered restriction device inside said introductionary hose,

introducing said at least one powered restriction device around the urethra or the neck of the urinary bladder by using said introductionary hose,

releasing said at least one powered restriction device from said introductionary hose, and

withdrawing said hose from the at least one powered restriction device.

70. The method according to claim 1 , comprising the additional step of;

entering the retroperitoneal space from the vaginal opening,

placing said at least one powered restriction device in the retroperitoneal cavity,

fixating said at least one powered restriction device by a tunnel created in the fibrotic tissue in said space.

71. The method according to claim 70 , comprising the additional steps of:

placing the energy receiver for receiving wireless energy subcutaneously just above the symphysis bone;

placing an electrical wire between the energy receiver and the at least one powered restriction device using said vaginal opening as an intermediate passage or using an instrument therefor through said vaginal opening; and

tunnelating the wire subcutaneously from the energy receiver to at least one powered restriction device.

72. The method according to claim 70 , comprising the additional steps of:

placing the energy receiver for receiving wireless energy subcutaneously just above the symphysis bone;

placing a pump and reservoir above the symphysis bone in the abdominal cavity; and

tunnelating a hydraulic tube subcutaneously from the pump to the at least one powered restriction device using said vaginal opening as an intermediate passage or using an instrument therefor in said opening.

73. The method according to claim 70 , comprising the additional step of;

introducing a camera through said vaginal opening.

74. The method according to claim 70 , comprising the additional step of;

when introducing a camera through said vaginal opening,

using said camera to go around the urethra and

attaching said at least one powered restriction device to said camera to thereby,

passing said at least one powered restriction device around the urinary passageway using said camera.

75. The method according to claim 1 , comprising the additional step of;

entering the fibrotic tissue surrounding the urethra from the vaginal opening,

placing said at least one powered restriction device in a tunnel of said fibrotic tissue,

fixating said at least one powered restriction device by said tunnel.

76. The method according to claim 1 further including stimulating muscle tissue surrounding the urethra or neck of the urinary bladder.

77. A method involving a vaginal approach for operating urinary incontinence comprising the steps of:

incising one opening in the vaginal wall of the patient;

inserting a tube or needle through the opening in the vaginal wall of the patient into the body of the patient;

using said tube or needle to insufflate a site surrounding at least one organ selected from group consisting of: a) the urethra, b) the neck of the urinary bladder c) fibrotic tissue surrounding the urethra or the neck of the urinary bladder and d) the muscles surrounding the urethra or the neck of the urinary bladder, of the body of the patient with a gas;

inserting at least two laparoscopic trocars into said site;

inserting at least one camera through at least one of said at least two laparoscopic trocars;

inserting at least one dissecting tool having a flexible tip capable of bending around at least one of the urethra or the neck of urinary bladder through at least one of said at least two laparoscopic trocars;

dissecting in the patient an area around at least one organ selected from the group consisting of: a) the urethra, b) the neck of the urinary bladder c) fibrotic tissue surrounding the urethra or the neck of the urinary bladder and d) the muscles surrounding the urethra or the neck of the urinary bladder;

implanting at least one powered restriction device in a position around the urethra or the neck of the urinary bladder that enables it to decrease the cross-sectional area of the urethra or the neck of the urinary bladder in order to stop the movement of urine through the urethra or the neck of the urinary bladder;

implanting a rechargeable energy source, an energy receiver, or a rechargeable energy source and an energy receiver, using a vaginal approach or using a vaginal approach in combination with a skin incision; and

connecting the at the least one powered restriction device directly or indirectly to the rechargeable energy source or the energy receiver.