SYSTEM, AN APPARATUS, AND A METHOD FOR TREATING A SEXUAL DYSFUNCTIONAL FEMALE PATIENT

• US 20110208231A1
• Filed: 10/09/2009
• Published: 08/25/2011
• Est. Priority Date: 10/10/2008
• Status: Active Grant

• Current Assignee: Kirk Promotion Ltd.
• Original Assignee: Milux Holding SA
• Inventors: Forsell, Peter
• Granted Patent: US 10,568,804 B2
• Time in Patent Office: Days
• US Class Current: 606/193
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61H 19/30 Devices for external stimulation of the genitals
• CPC Class Codes: A61H 19/34 For clitoral stimulation
• CPC Class Codes: A61H 19/40 Devices insertable in the genitals
• CPC Class Codes: A61H 2201/5097 wireless
• CPC Class Codes: A61H 23/0254 with rotary motor
• CPC Class Codes: A61H 23/04 with hydraulic or pneumatic drive hydraulic or Pneumatic massages, A61H9/00; underwater massages, A61H33/00
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A63B 2225/66 Cooled

Abstract

There is disclosed an apparatus, a system and a method for treating a sexual dysfunctional female patient. The apparatus comprises at least one expandable prosthesis adapted for implantation in female erectile tissue and adapted to be adjusted to temporarily achieve enlarged status of the female erectile tissue.

Claims

1. An apparatus for treating a sexual dysfunctional female patient comprising at least one expandable prosthesis adapted for implantation in female erectile tissue and adapted to be adjusted to temporarily achieve enlarged status of the female erectile tissue.

2. The apparatus according to claim 1, comprising at least one implantable operation device for operating the prosthesis.

3. The apparatus according to claim 2, where the operation device comprises an implantable reservoir defining a chamber containing hydraulic fluid, and a conduit providing a fluid connection between the chamber and the hydraulically operated prosthesis, the operation device operating the hydraulic fluid by distributing hydraulic fluid through the conduit between the chamber of the reservoir and the prosthesis.

4. The apparatus according to claim 3, wherein the conduit permits free flow of hydraulic fluid in both directions in the conduit, and the operation device comprises first and second wall portions of the reservoir and is adapted to provide relative displacement between the first and second wall portions of the reservoir, in order to change the volume of the chamber to distribute hydraulic fluid between the chamber and said hydraulically operated prosthesis.

5. The apparatus according to claim 3, wherein the chamber of the reservoir comprises a predetermined amount of hydraulic fluid.

6. The apparatus according to claim 3, wherein the operation device comprises an expandable cavity adapted to enlarge the female erectile tissue upon expansion of the cavity and released upon emptying of the cavity, and the operation device is adapted to distribute hydraulic fluid from the chamber of the reservoir to expand the cavity, and to distribute hydraulic fluid from the cavity to the chamber of the reservoir to contract the cavity.

7. The apparatus according to claim 3, wherein the operation device is adapted to provide said relative displacement in response to the pressure in the reservoir.

8. The apparatus according to claim 3, wherein the operation device comprises a pressure controlled hydraulic operation device.

9. The apparatus according to claim 3, further comprising an alarm adapted to generate an alarm signal in response to the lapse of a predetermined time period during which the pressure controlling the hydraulic operation device exceeds a predetermined high value.

10. The apparatus according to claim 4, wherein the first and second wall portions of the reservoir are displaceable relative to each other by at least one device selected from the group consisting of a magnetic device, an electromagnetic device, a hydraulic device, and an electric device.

11. The apparatus according to claim 4, wherein the operation device is adapted to distribute fluid from the reservoir to the cavity of the prosthesis device in response to a predetermined first displacement of the first wall portion of the reservoir relative to the second wall portion of the reservoir and to distribute fluid from the cavity to the reservoir in response to a predetermined second displacement of the first wall portion relative to the second wall portion.

12. The apparatus according to claim 2, wherein the operation device comprises a servo to reduce the amount of force needed by the operation device.

13. The apparatus according to claim 2, wherein the operation device is manually operated.

14. The apparatus according to claim 2, wherein the operation device comprises a motor.

15. The apparatus according to claim 2, wherein the operation device comprises an electric motor.

16. The apparatus according to claim 14, wherein the motor is reversible.

17. The apparatus according to claim 2, where the operation device comprises at least one gearing.

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

19. The apparatus according to claim 3, further comprising an injection port, subcutaneously implantable in the patient and in fluid communication with the chamber.

20. The apparatus according to claim 3, further comprising an injection port subcutaneously implantable in the patient and in fluid communication with the chamber, wherein said injection port is integrated in the reservoir.

21. The apparatus according to claim 1, wherein said at least one expandable prosthesis is adapted to be mechanically operated.

22. The apparatus according to claim 1, wherein the prosthesis device is embedded in a gel-like material.

23. A system comprising an apparatus according to claim 1.

24. The system according to claim 23, further comprising at least one switch implantable in the patient for manually and non-invasively controlling the apparatus.

25. The system according to claim 23, further comprising a hydraulic device having an implantable hydraulic reservoir, which is hydraulically connected to the apparatus, wherein the apparatus is adapted to be non-invasively regulated by manually pressing the hydraulic reservoir.

26. The system according to claim 23, further comprising a wireless remote control for non-invasively controlling the apparatus.

27. The system according to claim 26, 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.

28. The system according to claim 26, wherein the wireless remote control transmits at least one wireless control signal for controlling the apparatus.

29. The system according to claim 28, wherein the wireless control signal comprises a frequency, amplitude, or phase modulated signal or a combination thereof.

30. The system according to claim 28, wherein the wireless remote control transmits an electromagnetic carrier wave signal for carrying the control signal.

31. The system according to claim 23, further comprising a wireless energy-transmission device for non-invasively energizing implantable energy consuming components of the apparatus or the system with wireless energy.

32. The system according to claim 31, 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.

33. The system according to claim 31, wherein the wireless energy comprises one of the following:

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

34. The system according to claim 28, wherein the control signal comprises one of the following:

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

35. The system according to claim 28 or 32, wherein the signal comprises an analogue signal, a digital signal, or a combination of an analogue and digital signal.

36. The system according to claim 23, further comprising an implantable internal energy source for powering implantable energy consuming components of the apparatus.

37. The system according to claim 36, further comprising 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.

38. The system according to claim 37, further comprising 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.

39. The system according to claim 23, further comprising 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 apparatus.

40. The system according to claim 23, further comprising a sensor and/or a measuring device and an implantable internal control unit for controlling the apparatus 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 apparatus sensed by the sensor or measured by the measuring device.

41. The system according to claim 40, wherein the physical parameter is a pressure or a motility movement.

42. The system according to claim 23, further comprising 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 apparatus or the patient to the external data communicator and/or the external data communicator feeds data to the internal data communicator.

43. The system according to claim 23, further comprising a motor or a pump for operating the apparatus.

44. The system according to claim 23, further comprising a hydraulic operation device for operating the apparatus.

45. The system according to claim 23, further comprising an operation device for operating the apparatus, wherein the operation device comprises a servo designed to decrease the force needed for the operation device to operate the apparatus instead the operation device acting a longer way, increasing the time for a determined action.

46. The system according to claim 31, further comprising an operation device for operating the apparatus, 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 apparatus, as the wireless energy is being transmitted by the energy-transmission device.

47. The system according to claim 31, further comprising an energy-transforming device for transforming the wireless energy transmitted by the energy-transmission device from a first form into a second form energy.

48. The system according to claim 47, wherein the energy-transforming device directly powers implantable energy consuming components of the apparatus 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.

49. The system according to claim 47, wherein the second form energy comprises at least one of a direct current, pulsating direct current and an alternating current.

50. The system according to claim 47, further comprising an implantable accumulator, wherein the second form energy is used at least partly to charge the accumulator.

51. The system according to claim 47, 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.

52. The system according to claim 23, further comprising implantable electrical components including at least one voltage level guard and/or at least one constant current guard.

53. The system according to claim 31, further comprising 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 apparatus 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 used for the implantable energy consuming components of the apparatus, 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.

54. The system according to claim 53, 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.

55. The system according to claim 54, 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 apparatus, and the control device controls the transmission of wireless energy based on the detected energy difference.

56. The system according to claim 31, wherein the energy-transmission device comprises a coil placed externally to the human body, further comprising an implantable 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.

57. The system according to claim 56, wherein the electric circuit is adapted to deliver the electrical pulses to remain unchanged except varying the first and/or second time intervals.

58. The system according to claim 56, 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.

59. The system according to claim 39, comprising an implantable 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.

60. The system according to claim 39, comprising an implantable 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 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.

61. The system according to claim 60, wherein the transmitted energy may be regulated depending on the obtained coupling factor.

62. The system according to claim 60, 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.

63. The system according to claim 62, 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.

64. A method for treating a female sexually dysfunctional patient comprising the step of inserting an apparatus according to any one of claims 1-22.

65. The method according to claim 64 further comprising the step of postoperatively controlling the apparatus.

66. An operation method using an apparatus or system according to claim 1-63, further comprising the steps of:

d. creating an opening in the skin or vaginal wall of the female patient

e. dissecting at least one area of the female erectile tissue

f. placing at least one expandable prosthesis within said area, adapted to postoperatively erect said female erectile tissue on patient command.

67. The operation method according to claim 66, further comprising controlling said at least one prosthesis post-operatively and non-invasively from outside the body.

68. The operation method according to claim 66, further comprising placing a power source within the body.

69. The operation method according to claim 66, wherein the step of placing an expandable prosthesis comprising placing a pump and a reservoir, adapted to be filled with hydraulic fluid, remote from the at least one expandable prosthesis.

70. The operation method according to claim 66, wherein the step of placing a power source comprises the step of placing a control unit and a rechargeable battery remote from the at least one expandable prosthesis.

71. The operation method according to claim 66, wherein the step of placing at least one expandable prosthesis comprises placing hydraulic conduits connected to a hydraulic operation device.

72. An operation method using an apparatus or system according to claim 1-63, comprising the steps of:

inserting a tube or needle into the patients body,

filling the body through the tube or needle with a gas and thereby expanding a cavity within the female patients body,

inserting at least two key hole surgery trocars into said cavity,

inserting at least one camera trough at least one trocar,

inserting at least one dissecting tool through at least one trocar,

dissecting the area of the erectile tissue

placing at least one expandable prosthesis within said area, adapted to postoperatively erect said female erectile tissue on patient command.

73. The operation method according to claim 72, comprising controlling said at least one prosthesis post-operatively and non-invasively from outside the body.

74. The operation method according to claim 72, comprising placing a power source within the body.

75. The operation method according to claim 72, wherein the step of placing an expandable prosthesis comprises placing a pump and a reservoir, adapted to be filled with hydraulic fluid, remote from the at least one expandable prosthesis.

76. The operation method according to claim 72, wherein the step of placing a power source comprises the step of placing a control unit and a rechargeable battery remote from the at least one expandable prosthesis.

77. The operation method according to claim 66 or 72, comprising placing the expandable prosthesis including a vibrator in the body of a patient, and controlling said vibrator from outside the human body.

78. The operation method according to claim 66 or 72, comprising a reservoir placed in the body, controlling said at least one prosthesis post-operatively and non-invasively from outside the body by manually direct or indirect affecting said reservoir.

79. The apparatus according to claim 1, further comprising at least one implantable stimulation device adapted to stimulate at least a part of the sexually responsive tissue of the vulva of the patient by movement of said stimulation device and contact between said stimulation device and the at least one area of the sexually responsive tissue of the vulva.

80. The apparatus according to claim 79, where the at least one stimulating device is a vibrator and placed inside said expandable prosthesis.

81. The apparatus according to claim 79 or 80, wherein the at least one stimulating device is adapted to create movement with a frequency from 0.1 to 10 000 Hz.

82. The apparatus according to claim 79 or 80, wherein the at least one stimulating device is adapted to create movement with an amplitude of from 0.01 to 30 mm.

83. The apparatus according to claim 79 or 80, wherein the at least one stimulating device is adapted to create movements along more than one axis.

84. The apparatus according to claim 79 or 80, comprising a control device for independently controlling amplitude and frequency of the movement in the two different axes.

85. The apparatus according to claim 79 or 80, wherein the movement is achieved by a piezoelectric element

86. The apparatus according to claim 79 or 80, where the movement is achieved by an eccentric mechanism.