VAGINAL OPERATION METHOD FOR THE TREATMENT OF URINARY INCONTINENCE IN WOMEN

• US 20110015473A1
• Filed: 07/19/2010
• Published: 01/20/2011
• Est. Priority Date: 07/17/2009
• Status: Active Grant

• Current Assignee: Kirk Promotion Ltd.
• Original Assignee: Teslux Holdings S.A.
• Inventors: Forsell, Peter
• Granted Patent: US 10,952,836 B2
• Time in Patent Office: Days
• US Class Current: 600/31
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2250/0002 for data transfer

Abstract

There is disclosed a method for treating urinary incontinence in women. The method comprises accessing the urethra though an incision in the vagina and implanting a restriction device on the urethra or the neck of the urinary bladder. There are also disclosed methods for energizing and controlling the restriction device.

Claims

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

a) accessing any of the urethra and the neck of the urinary bladder trough an opening in the vaginal wall of the patient,

b) dissecting in the patient at least a part of any of the urethra and the neck of the urinary bladder,

c) implanting at least one restriction device in a position that enables it to decrease the cross-sectional area of the urine passageway to at least partially restrict the flow of urine through any of the urethra and the neck of the urinary bladder.

2. The method according to claim 1, comprising implanting an energy receiver for powering an adjustment procedure of the restriction device for adjusting the restriction device, being powered.

3. The method according to claim 2, comprising the additional step of postoperatively adjusting said restriction device to control the urine passageway.

4. The method according to claim 2, comprising the additional step of implanting a switch and the additional step of adjusting said restriction device using said implantable switch.

5. The method according to claim 2, comprising the additional step of adjusting said restriction device from outside the body of the patient.

6. The method according to claim 5, wherein the method comprises the step of adjusting said restriction device postoperatively using a remote control.

7. 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 sensor being adapted to sending an alarm signal to the patient.

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

12. The method according to claim 1, wherein the method comprises implanting at least two restriction devices.

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

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

15. The method according to claim 1, further comprising the additional step of using a cytoscopic method for calibrating said restriction device.

17. The method according to claim 7, 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.

18. The method according to claim 1, wherein the device is adapted to be powered by an energy source, the method comprising the additional step of implanting said energy source in the body of the patient and using said energy source to power any energy consuming parts of the device or attached components.

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

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

21. The method according to claim 1, further comprising using a wireless remote control for non-invasively controlling the restriction device.

22. The method according to claim 21, wherein the wireless remote control comprises at least one external signal transmitter and/or receiver, further comprising an internal signal receiver and/or transmitter implantable in the patient for receiving signals transmitted by the external signal transmitter or transmitting signals to the external signal receiver.

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

24. The method according to claim 23, wherein the wireless control signal comprises a frequency, amplitude, or phase modulated signal or a combination thereof.

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

26. The method according to claim 1, further comprising the step of using a wireless energy-transmission device for non-invasively energizing implantable energy consuming components of the 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 23, wherein the control signal comprises one of the following:

an electric field, a magnetic field, a combined electric and magnetic field.

30. The method according to claim 23, wherein the signal comprises an analogue signal, a digital signal, or a combination of an analogue and digital signal

31. The method according to claim 1, further comprising the additional step of implanting an internal energy source for powering implantable energy consuming components of the restriction device.

32. The method according to claim 31, further comprising using an external energy source for transferring energy in a wireless mode, wherein the internal energy source is chargeable by the energy transferred in the wireless mode.

33. The method according to claim 32, further comprising the additional step of implanting a sensor or measuring device 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.

34. 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 restriction device.

35. The method according to claim 1, further comprising implanting a sensor and/or a measuring device and an implantable internal control unit for controlling the restriction device in response to information being related to at least one of a physical parameter of the patient sensed by the sensor or measured by the measuring device and a functional parameter related to the restriction device sensed by the sensor or measured by the measuring device.

36. The method according to claim. 35, wherein the physical parameter is a pressure or a motility movement.

37. 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 restriction device or the patient to the external data communicator and/or the external data communicator feeds data to the internal data communicator.

38. The method according to claim 1, further comprising implanting a motor or a pump for operating the restriction device.

39. The method according to claim 1, further comprising implanting a hydraulic operation device for operating the restriction device.

40. The method according to claim 1, further comprising an implanting an operation device for operating the restriction device, wherein the operation device comprises a servo designed to decrease the force needed for the operation device to operate the restriction device instead the operation device acting a longer way, increasing the time for a determined action.

41. The method according to claim 26, further comprising the additional step of implanting an operation device for operating the 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 restriction device, as the wireless energy is being transmitted by the energy-transmission device.

42. 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.

43. The method according to claim 42, wherein the energy-transforming device directly powers implantable energy consuming components of the restriction device with the second form energy, as the energy-transforming device transforms the first form energy transmitted by the energy-transmission device into the second form energy.

44. The method according to claim 42, wherein the second form energy comprises at least one of a direct current, pulsating direct current and an alternating current.

45. The method according to claim 42, further comprising implanting an accumulator, wherein the second form energy is used at least partly to charge the accumulator.

46. The method according to claim 42, wherein the energy of the first or second form comprises at least one of magnetic energy, kinetic energy, sound energy, chemical energy, radiant energy, electromagnetic energy, photo energy, nuclear energy thermal energy, non-magnetic energy, non-kinetic energy, non-chemical energy, non-sonic energy, non-nuclear energy and non-thermal energy.

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

48. The method according to claim 26, further comprising implanting a control device for controlling the transmission of wireless energy from the energy-transmission device, and an implantable internal energy receiver for receiving the transmitted wireless energy, the internal energy receiver being connected to implantable energy consuming components of the restriction device for directly or indirectly supplying received energy thereto, the system method further comprising determining by means of a determination device an energy balance between the energy received by the internal energy receiver and the energy used by the implantable energy consuming components of the restriction device, wherein the control device controls the transmission of wireless energy from the external energy-transmission device, based on the energy balance determined by the determination device.

49. The method according to claim 48, wherein the determination device is adapted to detect a change in the energy balance, and the control device controls the transmission of wireless energy based on the detected energy balance change.

50. The method according to claim 48, wherein the determination device is adapted to detect a difference between energy received by the internal energy receiver and energy used for the implantable energy consuming components of the restriction device, and the control device controls the transmission of wireless energy based on the detected energy difference.

51. The method according to claim 26, wherein the energy-transmission device comprises a coil placed externally to the human body, further comprising implanting an 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 and/or second time intervals between successive trailing and leading edges of the electrical pulses to vary the power of the transmitted wireless energy, the energy receiver receiving the transmitted wireless energy having a varied power.

52. The method according to claim 51, wherein the electric circuit is adapted to deliver the electrical pulses to remain unchanged except varying the first and/or second time intervals.

53. The method according to claim 51, wherein the electric circuit has a time constant and is adapted to vary the first and second time intervals only in the range of the first time constant, so that when the lengths of the first and/or second time intervals are varied, the transmitted power over the coil is varied.

54. The method according to claim 34, further comprising implanting an 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 system 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.

55. The method according to claim 34, further comprising implanting an 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 method further comprising implanting a feedback device for communicating out the amount of energy received in the first coil as a feedback information, and wherein the second electronic circuit includes a determination device for receiving the feedback information and for comparing the amount of transferred energy by the second coil with the feedback information related to the amount of energy received in the first coil to obtain the coupling factors between the first and second coils.

56. The method according to claim 55, wherein the energy transmitter regulates the transmitted energy in response to the obtained coupling factor.

57. The method according to claim 55, wherein 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.

58. The method according to claim 57, wherein the external second coil is adapted to calibrate the amount of transferred energy to achieve the feedback information in the determination device, before the coupling factor is maximized.

59. The method according to claim 26, further comprising implanting a control device for controlling the transmission of wireless energy from the energy-transmission device, and an implantable internal energy receiver for receiving the transmitted wireless energy, the internal energy receiver being connected to implantable energy consuming components of the restriction device and components connected to said restriction device, for directly or indirectly supplying received energy thereto, the system further comprising a determination device adapted to determine an energy balance between the energy received by the internal energy receiver and the energy consumed by the energy consuming components of the restriction device and its connected components, wherein the control device controls the transmission of wireless energy from the external energy-transmission device, based on the energy balance determined by the determination device

60. The method according to claim 1 where a laparoscopic method is used.

61. The method according to claim 1 wherein at least one trocar is used.

62. The method according to claim 1 wherein at least two trocars are used.

64. 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.

65. The method according to claim 1 wherein the site surrounding the urethra and the neck of the urine bladder is accessed after said surgical site has been insufflated with a gas.

67. The method according to claim 1, comprising the additional step of fixating said restriction device.

68. The method according to claim 1, comprising the additional step of fixating said 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 said organs, being placed in a tunnel of fibrotic tissue surrounding said organs.

69. The method according to claim 1, comprising the additional step of suturing the tissue in layers.

70. 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.

71. 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 said organs and d) the muscles surrounding said organs;

by using electricity.

72. The method according to claim 71, comprising the additional step of stimulating in more than one location on the restriction device.

73. The method according to claim 1, wherein the step of implanting a restriction device comprises the implantation of an enrgy receiver.

74. The method according to claim 2, comprising the additional step of adjusting said restriction device manually.

75. The method according to claim 2, comprising the additional step of adjusting said restriction device non-manually.

76. The method according to claim 2, wherein the energy receiver is implanted in the abdominal cavity.

77. The method according to claim 2, wherein the energy receiver is implanted subcutaneously.

78. The method according to claim 2, wherein the energy receiver is implanted in the pelvic region.

79. The method according to any one of claim 2, 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 restriction device.

80. The method according to claim 2, where the energy receiver comprises an energy transforming device transforming wireless energy to non-wireless energy.

81. The method according to claim 80, wherein the energy transforming device is powering a motor or pump directly during said wireless energy transfer.

82. The method according to claim 80, wherein the energy transforming device is used for charging an energy storage device, indirectly supplying energy to any energy consuming parts of the device.

83. The method according to claim 2, wherein said method comprises the step of adjusting said restriction device mechanically.

84. The method according to claim 2, wherein said method comprises the step of adjusting said restriction device hydraulically.

85. The method according to claim 2, wherein said method comprises the step of adjusting said restriction device electrically.

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

mounting the restriction device inside said introductionary hose,

introducing said restriction device around the urethra or the neck of the urine bladder by using said introductionary hose,

releasing said restriction device from said introductionary hose, and

withdrawing said hose from the device.

87. The method according to claim 86, wherein said hose comprising a holding part, adapted to allow an instrument to hold said hose at the first introductionary end to ease the introduction of the device, wherein the method step of introducing said restriction device by using said introductionary hose comprises;

inserting said instrument via vagina around the urethra or the neck of the urine bladder,

attaching said holding part of said introductionary hose to said instrument,and

introducing said hose around the urethra or the neck of the urine bladder.

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

entering the retroperitoneal space from the vaginal opening,

placing said device in the retroperitoneal cavity,

fixating said device by the a tunnel created in the fibrotic tissue in said space.

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

entering the fibrotic tissue surrounding the urinary channel from the vaginal opening,

placing said device in a tunnel of said fibrotic tissue,

fixating said device by said tunnel.

90. The method according to claim 88, comprising the additional step of;

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

placing an electrical wire between the energy receiver and the device using said vaginal opening as an intermediate passage or using a instrument therefore through said vaginal opening,

tunnelating the wire subcutaneously from the energy receiver to the device.

91. The method according to claim 88, comprising the additional step of;

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

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

tunnelating a hydraulic tube subcutaneously from the pump to the device using said vaginal opening as an intermediate passage or using a instrument therefore in said opening.

92. The method according to claim 88, comprising the additional step of;

introducing a camera through said vaginal opening.

93. The method according to claim 88, comprising the additional step of;

when introducing a camera through said vaginal opening,

using said camera to go around the urinary passageway and

attaching said device to said camera to thereby,

passing said device around the urinary passageway using said camera.

9. The method according to claim I 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 restriction device, said sensor being adapted to sending an alarm signal to the patient.

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

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

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

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

66. The method involving a vaginal approach for operating urinary incontinence comprising the steps of:

a. inserting a tube or needle trough an opening in the vaginal wall of the patient into the body of the patient,

b. using said tube or needle to insufflate a site in a surrounding of at least one organ selected from group consisting of;

a) the urethra, b)the neck of the urinary bladder c) fibrotic tissue surrounding said organs and d) the muscles surrounding said organs, of the body of the patient with a gas,

c. inserting at least two laparoscopic trocars into said site,

d. inserting at least one camera trough at least one of said at least two laparoscopic trocars, and

e. inserting at least one dissecting tool through at least one of said at least two laparoscopic trocars

f. dissecting in the patient at least one organ selected from the group consisting of;

a) the urethra, b)the neck of the urinary bladder c) fibrotic tissue surrounding said organs and d) the muscles surrounding said organs,

g. implanting at least one powered restriction device in a position that enables it to decrease the cross-sectional area of a) the urethra, b)the neck of the urinary bladder c) fibrotic tissue surrounding said organs and d) the muscles surrounding said organs in order to at least decrease the movement of urine through said passageway.