Controlled penile prosthesis

• US 8,126,558 B2
• Filed: 05/22/2006
• Issued: 02/28/2012
• Est. Priority Date: 02/14/2000
• Status: Expired due to Term

• Current Assignee: Obtech Medical AG
• Original Assignee: Obtech Medical AG
• Inventors: Forsell, Peter
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US11/437,771
• Publication Number:
  US 20060235482A1
• Time in Patent Office: 2,108 Days
• Field of Search: 600/40, 607/39
• US Class Current: 607/39
• CPC Class Codes: A61F 2/26 Penis implants
• CPC Class Codes: A61F 5/41 Devices for promoting penis erection penis implants A61F2/26; massage of the genitals A61H19/00

Abstract

A male sexual impotence prosthesis apparatus comprises an operable prosthesis implanted in the cavities of the corpora cavemosa of a patient'"'"'s penile tissue for providing erect penile condition, when the prosthesis is operated. The prosthesis is operable by an implanted operation device. A control device is provided for controlling a source of energy, which may or may not be implanted, from outside the patient'"'"'s body, to release energy for use in connection with the operation of the prosthesis, i.e., to power the operation device. The patient uses the control device to operate the prosthesis to achieve erection.

Claims

1. A male sexual impotence treatment prosthesis apparatus comprising:

an operable prosthesis implantable in the cavities of the corpora cavernosa of an impotent patient to provide erect penile condition, when the prosthesis is operated;

an external source of energy adapted to release wireless energy for use in connection with the operation of the prosthesis;

an implantable energy transforming device for transforming the wireless energy to storable energy;

an internal, implantable source of energy adapted to store the energy released from the external source of energy; and

a control device operable from the outside of patient'"'"'s body is provided for controlling the internal source of energy for use in connection with the operation of the prosthesis, when the prosthesis is implanted,

wherein the apparatus further comprises an external data communicator to be provided outside the patient'"'"'s body and an internal data communicator to be implanted in the patient for communicating with the external data communicator, said internal data communicator is capable of feeding data related to the patient or related to the prosthesis, back to the external data communicator and said external data communicator is capable of feeding data to said internal data communicator.

2. An apparatus according to claim 1, wherein control device is adapted to control the external source of energy to release wireless energy for use in connection with the operation of the prosthesis.

3. An apparatus according to claim 1, wherein the control device controls the prosthesis.

4. An apparatus according to claim 3, wherein the control device comprises an internal control unit implantable in the patient for controlling the prosthesis.

5. An apparatus according to claim 4, wherein the internal control unit is programmable.

6. An apparatus according to claim 5, wherein the control device comprises an external control unit intended to be outside the patient'"'"'s body, the internal control unit being progranunable by the external control unit.

7. An apparatus according to claim 5, wherein the internal control unit is programmable for controlling the prosthesis over time.

8. An apparatus according to claim 7, wherein the internal control unit controls the prosthesis over time in accordance with an activity schedule program.

9. An apparatus according to claim 7, wherein the internal control unit comprises a microprocessor.

10. An apparatus according to claim 6, wherein the external control unit loads the internal control unit with data in accordance with a loading mode only authorized for a doctor.

11. An apparatus according to claim 6, wherein the external control unit controls the internal control unit in accordance with a doctor mode only authorized for a doctor.

12. An apparatus according to claim 6, wherein the external control unit controls the internal control unit in accordance with a patient mode permitted for the patient.

13. An apparatus according to claim 1, wherein the implantable 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.

14. An apparatus according to claim 13, wherein the implantable source of energy comprises an electric source of energy.

15. An apparatus according to claim 14, wherein the electric source of energy comprises an accumulator, or a battery having a lifetime of at least 10 years.

16. An apparatus according to claim 1, wherein the control device controls the penile prosthesis.

17. An apparatus according to claim 1, wherein the implantable source of energy comprises an accumulator.

18. An apparatus according to claim 17, wherein the accumulator comprises an electric accumulator.

19. An apparatus according to claim 18, wherein the electric accumulator comprises at least one capacitor, or a combination of at least one capacitor and at least one rechargeable battery.

20. An apparatus according to claim 1, further comprising a battery implantable in the patient for supplying electric energy to implantable electric energy consuming components of the apparatus.

21. The apparatus according to claim 1, wherein the control device is adapted to control the external source of energy to release wireless energy for direct use in connection with the operation of the penile prosthesis.

22. The apparatus according to claim 21, wherein the control device is adapted to control the external source of energy to intermittently release wireless energy in the form of a train of energy pulses for direct use in connection with the operation of the penile prosthesis.

23. The apparatus according to claim 21, wherein the penile prosthesis is operable in a non-magnetic, non-thermal or non-mechanical manner by use of said released wireless energy.

24. The apparatus according to claim 1, further comprising a switch implantable in the patient for directly or indirectly switching the operation of the penile prosthesis.

25. The apparatus according to claim 24, wherein the switch directly or indirectly affects the supply of energy from the internal source of energy.

26. The apparatus according to claim 25, wherein the switch switches between an “

off”

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

on”

mode, in which the internal source of energy supplies energy for the operation of the penile prosthesis.

27. The apparatus according to claim 1, further comprising a switch implantable in the patient for directly or indirectly switching the operation of the penile prosthesis, wherein the switch is operable by the wireless energy released from the external source of energy.

28. The apparatus according to claim 27, wherein the control device controls the external source of energy to release the wireless energy.

29. The apparatus according to claim 1, wherein the control device comprises a wireless remote control.

30. The apparatus according to claim 29, wherein the wireless remote is adapted to control the internal source of energy.

31. The apparatus according to claim 30, further comprising a switch implantable in the patient for directly or indirectly switching the operation of the penile prosthesis, wherein the switch is operable by the wireless energy from the external source of energy to switch between an “

off”

mode, in which the internal source of energy and remote control are not in use, and a “

standby”

mode, in which the remote control is permitted to control the internal source of energy to supply energy for the operation of the penile prosthesis.

32. The apparatus according to claim 29, wherein the control device controls the switch to switch between the “

on” and

“

off”

modes.

33. An apparatus according to claim 1, further comprising an operation device implantable in the patient for operating the penile prosthesis.

34. An apparatus according to claim 33, wherein the control device controls the operation device to operate the penile prosthesis.

35. An apparatus according to claim 33, wherein the operation device comprises hydraulic means and at least one valve for controlling a fluid flow in the hydraulic means.

36. An apparatus according to claim 35, wherein the control device comprises a wireless remote control for controlling the valve.

37. An apparatus according to claim 34, wherein the penile prosthesis comprises hydraulic means and the operation device comprises a reservoir forming a fluid chamber with a variable volume connected to the hydraulic means, and the operation device is adapted to distribute fluid from the chamber to the hydraulic means by reduction of the volume of the chamber and to withdraw fluid from the hydraulic means to the chamber by expansion of the volume of the chamber.

38. An apparatus according to claim 1, wherein the operation device comprises a motor.

39. An apparatus according to claim 38, wherein the motor comprises a rotary motor, and the control device controls the rotary motor to rotate a desired number of revolutions.

40. An apparatus according to claim 38, wherein the motor comprises a linear motor.

41. An apparatus according to claim 38, wherein the motor comprises a hydraulic or pneumatic fluid motor, and the control device controls the fluid motor.

42. An apparatus according to claim 38, wherein the motor comprises an electric motor having electrically conductive parts made of plastics.

43. An apparatus according to claim 1, wherein the control device releases polarized energy from the internal source of energy.

44. An apparatus according to claim 34, wherein the control device shifts polarity of the released energy to reverse the operation device.

45. An apparatus according to claim 33, wherein the operation device comprises an electric motor and the released energy comprises electric energy.

46. An apparatus according to claim 1, wherein the penile prosthesis is operable to perform a reversible function.

47. An apparatus according to claim 46, further comprising a reversing device implantable in the patient for reversing the function performed by the penile prosthesis.

48. An apparatus according to claim 47, wherein the control device controls the reversing device to reverse the function performed by the penile prosthesis.

49. An apparatus according to claim 48, wherein the reversing device comprises hydraulic means including a valve for shifting the flow direction of a fluid in the hydraulic means.

50. An apparatus according to claim 48, wherein the reversing device comprises a mechanical reversing device.

51. An apparatus according to claim 50, wherein the mechanical reversing device comprises a switch.

52. An apparatus according to claim 50, wherein the reversing device comprises a gearbox.

53. An apparatus according to claim 52, wherein the reversing device comprises a switch.

54. An apparatus according to claim 53, wherein the switch of the reversing device is operable by the released energy.

55. An apparatus according to claim 54, wherein the control device controls the operation of the switch of the reversing device by shifting polarity of the released energy supplied to the switch.

56. An apparatus according to claim 55, wherein the switch comprises an electric switch and the source of energy supplies electric energy for the operation of the switch.

57. An apparatus according to claim 53, wherein the operation device comprises a motor, and the reversing device reverses the motor.

58. An apparatus according to claim 1, further comprising an operation device implantable in the patient for operating the penile prosthesis.

59. An apparatus according to claim 58, wherein the penile prosthesis comprises hydraulic means and the operation device is adapted to conduct a hydraulic fluid in the hydraulic means.

60. An apparatus according to claim 59, wherein the operation device comprises a motor.

61. An apparatus according to claim 59, wherein the operation device comprises a fluid conduit connected to the hydraulic means of the penile prosthesis, and a reservoir for fluid, the reservoir forming part of the conduit.

62. An apparatus according to claim 61, wherein the hydraulic means and conduit are devoid of any non-return valve.

63. An apparatus according to claim 61, wherein the reservoir forms a fluid chamber with a variable volume, and the operation device is adapted to distribute fluid from the chamber to the hydraulic means of the penile prosthesis by reduction of the volume of the chamber and to withdraw fluid from the hydraulic means to the chamber by expansion of the volume of the chamber.

64. An apparatus according to claim 1, further comprising at least one implantable sensor for sensing at least one physical parameter of the patient.

65. An apparatus according to claim 64, wherein the sensor is adapted to directly or indirectly sense as the physical parameter ejaculation or the pressure in the urethra.

66. An apparatus according to claim 64, wherein the control device controls the penile prosthesis in response to signals from the sensor.

67. An apparatus according to claim 66, wherein the control device comprises an internal control unit implantable in the patient, the internal control unit controlling the penile prosthesis in response to signals from the sensor.

68. An apparatus according to claim 67, wherein the control device comprises an external control unit outside the patient'"'"'s body, the external control unit controlling the penile prosthesis in response to signals from the sensor.

69. An apparatus according to claim 68, wherein the external control unit stores information on the physical parameter sensed by the sensor and is manually operated to control the penile prosthesis based on the stored information.

70. An apparatus according to claim 64, further comprising at least one implantable sender for sending information on the physical parameter sensed by the sensor.

71. An apparatus according to claim 1, wherein the internal data communicator feeds data related to at least one physical signal of the patient.

72. An apparatus according to claim 1, wherein the prosthesis is adapted to control the penis to change between flaccid and erect penile condition.

73. An apparatus according to claim 72, wherein the prosthesis is operable to erect the penis or to make it flaccid.

74. An apparatus according to claim 72, wherein the prosthesis is adapted to control the penis to steplessly change between flaccid and erect penile condition.

75. An apparatus according to claim 1, wherein the control device is adapted to control the external source of energy to release wireless electric energy and the energy transforming device is adapted to transform the electric energy into kinetic energy for operation of the prosthesis.

76. An apparatus according to claim 75, wherein the prosthesis is directly operated with the kinetic energy, as the energy transforming device transforms the electric energy into the kinetic energy.

77. An apparatus according to claim 1, wherein the prosthesis is non-inflatable.

78. An apparatus according to claim 1, wherein the control device controls the internal source of energy to release energy for a determined time period.

79. An apparatus according to claim 1, wherein the control device controls the source of energy to release energy in a determined number of energy pulses.

80. An apparatus according to claim 1, wherein the control device is adapted to control the internal source of energy to release energy in a non-invasive manner.

81. An apparatus according to claim 1, wherein the control device comprises a wireless remote control for transmitting at least one wireless control signal for controlling the prosthesis.

82. An apparatus according to claim 81, wherein the remote control is capable of obtaining information on the condition of the prosthesis when the prosthesis is implanted and of controlling the prosthesis in response to the information.

83. An apparatus according to claim 81, wherein the 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.

84. An apparatus according to claim 81, wherein the 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.

85. An apparatus according to claims 82, wherein the remote control is capable of sending information related to the prosthesis from inside the patient'"'"'s body to the outside thereof.

86. An apparatus according to claim 85, wherein the remote control controls the prosthesis in response to the information.

87. An apparatus according to any of claims 81, wherein the remote control transmits a carrier signal for carrying the control signal.

88. An apparatus according to claim 87, wherein the carrier signal is frequency, amplitude or frequency and amplitude modulated.

89. An apparatus according to claim 87, wherein the carrier signal is digital, analog or digital and analog.

90. An apparatus according to claim 87, wherein the control signal used with the carrier signal is frequency, amplitude or frequency and amplitude modulated.

91. An apparatus according to claim 81, wherein the control signal comprises a wave signal comprising one of a sound wave signal including an ultrasound wave signal, an electromagnetic wave signal including an infrared light signal, a visible light signal, an ultra violet light signal and a laser light signal, a micro wave signal, a radio wave signal, an x-ray radiation signal, and a gamma radiation signal.

92. An apparatus according to claim 81, wherein the control signal comprises an electric, a magnetic or an electric and magnetic field.

93. An apparatus according to claims 81, wherein the control signal is digital, analog or digital and analog.

94. An apparatus according to claim 93, wherein the remote control transmits an electromagnetic carrier wave signal for carrying the digital or analog control signal.

95. An apparatus according to claims 81, wherein the control signal is transmitted in pulses by the wireless remote control.

96. An apparatus according to claim 1, further comprising an implantable stabilizer for stabilizing the energy released by the control device.

97. An apparatus according to claim 96, wherein the energy released by the control device comprises electric energy and the stabilizer comprises at least one capacitor.

98. An apparatus according to claim 1, wherein the penile prosthesis is operable by the released energy in a manual, mechanical, thermal or magnetic manner.

99. An apparatus according to claim 1, wherein the penile prosthesis is operable by the released energy in a non-manual, non-mechanical, non-thermal or non-magnetic manner.

100. An apparatus according to claim 1, wherein the control device is adapted to control the source of energy to release electric energy, and further comprising an implantable capacitor for producing the train of energy pulses from the released energy.

101. An apparatus according to claim 1, further comprising an adjustment device for adjusting the penile prosthesis, wherein the adjustment device is adapted to mechanically adjust the penile prosthesis, or adapted to hydraulically adjust the penile prosthesis by using hydraulic means which is devoid of hydraulic fluid of the kind having a viscosity that substantially increases when exposed to heat or a magnetic field.

102. An apparatus according to claim 33, wherein the operation device comprises an electrical operation device.

103. An apparatus according to claim 33, wherein the operation device is powered by magnetic energy, non-magnetic energy, electromagnetic energy, non-electromagnetic energy, kinetic energy, non-kinetic energy, thermal energy or non-thermal energy.

104. An apparatus according to claim 1, wherein the control device is activated in a manual or non-manual manner to control the source of energy to release energy.

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

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

107. An apparatus according to claim 105, wherein the electrical components are devoid of any current detector and/or charge level detector.

108. An apparatus according to claim 105, further comprising an implantable capacitor or accumulator, wherein the charge or discharge of the capacitor or accumulator is controlled by use of the voltage level guard.

109. An apparatus according to claim 21, wherein the released energy comprises electric energy and further comprising an implantable capacitor for producing the train of energy pulses.

110. An apparatus according to claim 108, wherein the capacitor has a capacity less than 0,1 μ

F.

111. An apparatus according to claim 1, further comprising an implantable motor or pump for operating the penile prosthesis, wherein the control device is adapted to control the source of energy to directly power the motor or pump with the released energy.

112. An apparatus according to claim 21, wherein the wireless energy comprises electromagnetic waves excluding radio waves.

113. An apparatus according to claim 1, further comprising an implantable motor or pump for operating the penile prosthesis, wherein the control device is adapted to release wireless energy in the form of a magnetic field or electromagnetic waves for direct power of the motor or pump, as the wireless energy is being released.

114. An apparatus according to claim 113, wherein the pump is not a plunger type of pump.

115. An apparatus according to claim 1, wherein the wireless energy comprises a signal.

116. An apparatus according to claim 1, wherein the energy transforming device transforms the wireless energy in the form of sound waves into electric energy for operation of the penile prosthesis.

117. An apparatus according to claim 116, wherein the energy transforming device transforms the wireless energy in the form of sound waves directly into electric energy.

118. An apparatus according to claim 116, wherein the energy transforming device comprises a capacitor.

119. An apparatus according to claim 118, wherein the capacitor is adapted to produce electric pulses from the transformed electric energy.

120. An apparatus according to claim 116, further comprising an implantable motor or pump for operating the penile prosthesis, wherein the motor or pump is powered by the transformed energy.

121. An apparatus according to claim 1, wherein the penile prosthesis is adjustable in a non-manual manner.

122. An apparatus according to claim 1, wherein the penile prosthesis is embedded in a soft or gel-like material.

123. An apparatus according to claim 122, wherein the penile prosthesis is embedded in a silicone material having hardness less than 20 Shore.

124. An apparatus according to claim 21, further comprising an activatable source of energy implantable in the patient, wherein the internal source of energy is activated by wireless energy released from the external source of energy, to supply energy which is used in connection with the operation of the prosthesis.

125. An apparatus according to claim 1, wherein the prosthesis is reversibly adjustable between flaccid and erect penile conditions by displacing a hydraulic fluid into or from the cavities of copora cavernosa.

126. An apparatus according to claim 18, wherein the electric accumulator comprises at least one rechargeable battery.