Penile prosthesis

• US 8,764,627 B2
• Filed: 09/10/2008
• Issued: 07/01/2014
• Est. Priority Date: 02/14/2000
• Status: Expired due to Fees

• Current Assignee: Obtech Medical AG
• Original Assignee: Obtech Medical AG
• Inventors: Forsell, Peter
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US12/232,090
• Publication Number:
  US 20090018388A1
• Time in Patent Office: 2,120 Days
• Field of Search: 600 38- 41, 128897-899
• US Class Current: 600/38
• CPC Class Codes: A61F 2/26 Penis implants
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants

Abstract

A male impotence treatment apparatus comprises an adjustable prosthesis device implanted in an impotent patient. The prosthesis device engages the corpus cavernosum or penile tissue of the patient to provide flaccid or erect state of the penis. An implanted adjustment device is adapted to adjust the prosthesis such that the penis can be temporarily erected. The prosthesis is preferably controlled with a remote control and an implanted powered operation device, which may include servo means, operates the adjustment device.

Claims

1. A male sexual impotence treatment apparatus, comprising:

an adjustable prosthesis device implantable in the corpora cavernosa or other parts of a male impotent patient'"'"'s penile tissue,

an implantable adjustment device for adjusting the prosthesis device to temporarily achieve erect status of the penis, and

an implantable powered operation device, capable of performing a reversible function, for operating the adjustment device,

wherein the apparatus further comprises a servo mechanism, a mechanism that transfers a weak force acting on a moving element having a long stroke into a strong force acting on another moving element having a short stroke, wherein the servo mechanism comprises a motor.

2. An apparatus according to claim 1 wherein the servo mechanism, comprise at least one of hydraulic means, electric control means, magnetic means, or mechanical means, which may be activated by manual manipulating means.

3. An apparatus according to claim 1, wherein the motor includes a gearing.

4. An apparatus according to claim 1 comprising an implantable hydraulic adjustment device, a reservoir implantable in the patient and containing hydraulic fluid, and a conduit providing fluid connection between the reservoir and the hydraulic adjustment device, wherein the operation device is adapted to operate the hydraulic adjustment device by distributing hydraulic fluid through the conduit between the reservoir and the hydraulic adjustment device, the conduit and hydraulic adjustment device being devoid of any non-return valve to permit free flow of hydraulic fluid in both directions in the conduit.

5. An apparatus according to claim 1, further comprising a reservoir implantable in the patient and containing hydraulic fluid, wherein the operation device is adapted to operate the adjustment device by using the hydraulic fluid of the reservoir.

6. An apparatus according to claim 5, wherein the reservoir contains a predetermined amount of hydraulic fluid.

7. An apparatus according to claim 6, wherein the adjustment device comprises an expandable cavity in the prosthesis device, the corpora cavernosa being filled upon expansion of the cavity and released upon emptying of the cavity, and the hydraulic operation device is adapted to distribute hydraulic fluid from the reservoir to expand the cavity, and to distribute hydraulic fluid from the cavity to the reservoir to fill up the cavity.

8. An apparatus according to claim 7, wherein the reservoir defines a chamber for said predetermined amount of fluid and the operation device is adapted to change the size of the chamber.

9. An apparatus according to claim 8, wherein 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).

10. An apparatus according to claim 9, wherein the operation device is adapted to provide said relative displacement in response to the pressure in the reservoir.

11. An apparatus according to claim 10, wherein the operation device comprises a pressure controlled hydraulic operation device.

12. An apparatus according to claim 11, 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.

13. An apparatus according to claim 9, wherein the first and second wall portions of the reservoir are displaceable relative to each other by magnetic means, hydraulic means, or electric control means, or a combination thereof.

14. An apparatus according to claim 7, 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.

15. An apparatus according to claim 7, wherein the operation device comprises a pump adapted to pump fluid between the reservoir and the cavity of the prosthesis device (2).

16. An apparatus according to claim 15, wherein the pump comprises a first activation member for activating the pump to pump fluid from the reservoir to the cavity of the prosthesis device and a second activation member for activating the pump to pump fluid from the cavity to the reservoir.

17. An apparatus according to claim 16, wherein at least one of the activation members is adapted to operate when subjected to a predetermined external pressure.

18. An apparatus according to claim 16, wherein at least one of the first and second activating members are operable by magnetic means, hydraulic means, electric control means or manual manipulation means, or a combination thereof.

19. An apparatus, according to claim 1, wherein the operation device includes the servo mechanism.

20. An apparatus according claim 1, the motor is an electric motor.

21. An apparatus according to claim 20, wherein the motor is adapted to be reversible.

22. An apparatus according to claim 19, further comprising a gearing connected between the motor and the adjustment device.

23. An apparatus according to claim 19, further comprising an implantable reservoir defining a chamber for hydraulic fluid, wherein the operation device is adapted to operate the adjustment device by using the hydraulic fluid of the reservoir.

24. An apparatus according to claim 23, wherein the reservoir contains a predetermined amount of hydraulic fluid.

25. An apparatus according to claim 23, wherein the reservoir comprises first and second wall portions and the reverse servo is adapted to provide relative displacement between the first and second wall portions of the reservoir, in order to change the volume of the reservoir.

26. An apparatus according to claim 19, wherein the servo mechanism comprises a pressure controlled servo mechanism.

27. An apparatus according to claim 26, 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 servo means exceeds a predetermined high value.

28. An apparatus according to claim 1, wherein the adjustment device comprises a hydraulic adjustment device, and further comprising a reservoir implantable in the patient and containing a predetermined amount of hydraulic fluid, and a conduit providing fluid connection between the reservoir and the hydraulic adjustment device, the operation device being adapted to operate the hydraulic adjustment device by distributing hydraulic fluid through the conduit between the reservoir and the hydraulic adjustment device, the conduit and hydraulic adjustment device being devoid of any non-return valve to permit free flow of hydraulic fluid in both directions in the conduit.

29. An apparatus according to claim 28, 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 adjustment device by reduction of the volume of the chamber and to withdraw fluid from the adjustment device by expansion of the volume of the chamber.

30. An apparatus according to claim 29, wherein the operation device comprises a motor.

31. An apparatus according to claim 29, wherein the operation device comprises a movable wall of the reservoir for changing the volume of the chamber.

32. An apparatus according to claim 31, wherein the operation device is adapted to change the volume of the chamber by moving the movable wall in response to the pressure in the chamber.

33. An apparatus according to claim 29, further comprising an injection port subcutaneously implantable in the patient and in fluid communication with the chamber.

34. An apparatus according to claim 33, wherein the injection port is integrated in the reservoir.

35. An apparatus according to claim 1, wherein the prosthesis device comprises an elongated prosthesis member and forming means for forming the prosthesis member into an implant in the corpora cavernosa or crura or the prolongations thereof, whereby the adjustment device is adapted to adjust the prosthesis member to change the size or length of the corpora cavernosa implant.

36. An apparatus according to claim 35, wherein the forming means forms the prosthesis member into a predetermined size or a size selected from several predetermined sizes.

37. An apparatus according to claim 35, wherein the adjustment device is adapted to change the size of the prosthesis such that the outer circumferential confinement surface of the prosthesis member is changed.

38. An apparatus according to claim 35, wherein the adjustment device is adapted to change the size of the prosthesis such that the outer circumferential confinement surface of the prosthesis member is unchanged.

39. An apparatus according to claim 35, wherein the adjustment device or prosthesis member is non-inflatable.

40. An apparatus according to claim 39, wherein the adjustment device mechanically adjusts the prosthesis member.

41. An apparatus according to claim 39, wherein the adjustment device hydraulically adjusts the non-inflatable prosthesis member.

42. An apparatus according to claim 35, wherein the elongated prosthesis member is flexible, and the adjustment device is adapted to pull a first portion of the flexible prosthesis member from a second portion of the flexible prosthesis member to achieve an erected status of the penis, and to move the first and second portion towards each other to achieve an flaccid status the penis.

43. An apparatus according to claim 1, wherein the adjustment device mechanically adjusts the prosthesis device.

44. An apparatus according to claim 40, wherein the mechanical adjustment device is hydraulically adjusted.

45. An apparatus according to claim 1, wherein the adjustment device is non-inflatable.

46. An apparatus according to claim 1, further comprising a corpus cavernosum implant, wherein the prosthesis device is adapted to bend a portion of the corpora cavernosa implant.

47. An apparatus according to claim 1, wherein the prosthesis device comprises at least one bending member and, wherein the corpora cavernosa implant is positioned in engagement with the bending member, and the adjustment device is adapted to move the bending members when the erected status of the penis should be achieved or released.

48. An apparatus according to claim 1, wherein the adjustment device is adapted to rotate a portion of the prosthesis device.

49. An apparatus according to claim 48, wherein the adjustment device is adapted to rotate a portion of the prosthesis device when the erected status of the penis should be achieved or released.

50. An apparatus according to claim 1, further comprising a wireless remote control for non-invasively controlling the hydraulic operation device.

51. An apparatus according to claim 49, wherein the remote control comprises an external wireless hand-held remote control unit which is manually operable by the patient to control the prosthesis device to achieve or release the erected status of the penis.

52. An apparatus according to claim 49, wherein the remote control comprises an external signal transmitter receiver or transceiver and a signal receiver transmitter or transceiver implantable in the patient.

53. An apparatus according to claim 52, wherein the signal receiver and/or transmitter comprises a control unit adapted to control the operation device in response to a control signal received from the signal.

54. An apparatus according to claim 53, further comprising an implantable energizer unit for providing energy to energy consuming implantable components of the apparatus.

55. An apparatus according to claim 54, wherein the control unit is adapted to power the motor with energy provided by the energizer unit in response to a control signal received from the signal transmitter.

56. An apparatus according to claim 50, wherein the remote control comprises wireless energy transfer means for transferring energy from outside the patient'"'"'s body to energy consuming implantable components of the apparatus.

57. An apparatus according to claim 56, wherein the energy transfer means comprises an implantable energizer unit, which is adapted to transform energy from the control signal, as it is transmitted to the signal receiver (into electric energy.

58. An apparatus according to claim 56, wherein the wireless energy transfer means is adapted to directly power the motor with transferred energy.

59. An apparatus according to claim 56, wherein the energy transferred by the wireless energy transfer means comprises a signal.

60. An apparatus according to claim 59, wherein the signal comprises a wave signal.

61. An apparatus according to claim 57, wherein the energy transferred by the wireless energy transfer means comprises an electric field or a magnetic field or a combination thereof.

62. An apparatus according to claim 59, wherein the signal is analog or digital or a combination thereof.

63. An apparatus according to claim 52, wherein the signal transmitter and signal receiver are adapted to transmit and receive an analog or digital signal or a combination thereof.

64. An apparatus according to claim 62, wherein the signal comprises analog or digital pulses.

65. An apparatus according to claim 62, wherein the analog or digital signal comprises a magnetic field or an electric field or a combination thereof.

66. An apparatus according to claim 52, wherein the signal transmitter and signal receiver are adapted to transmit and receive a wave signal.

67. An apparatus according to claim 66, wherein the wave signal comprises an electromagnetic wave signal, a sound wave signal or a carrier wave signal for a remote control signal or a combination thereof.

68. An apparatus according to claim 67, wherein the carrier signal is frequency, amplitude or frequency and amplitude modulated.

69. An apparatus according to claim 59 wherein the energy transfer means transfers the energy from the signal into a direct, pulsating direct or alternating current or a combination thereof.

70. An apparatus according to claim 52, wherein the remote control is capable of obtaining information related to important parameters of the apparatus from inside the patient'"'"'s body and of commanding the adjustment device to adjust the prosthesis device in response to obtained information.

71. An apparatus according to claim 52, wherein the remote control is capable of obtaining information related to the prosthesis device and of commanding the adjustment device to adjust the prosthesis device in response to obtained information.

72. An apparatus according to claim 1, further comprising an implantable source of energy for powering the operation device and/or for energizing other energy consuming components of the apparatus, wherein the energy from the source of energy is releasable from outside the patient'"'"'s body.

73. An apparatus according to claim 1 further comprising an energy transmission device for wireless transmission of energy.

74. An apparatus according to claim 73, wherein the energy transmission device transmits energy of a first form, and further comprising an energy transforming device implantable in the patient for transforming the energy of the first form into energy of a second form, to be supplied to;

the implantable source of energy for charging the same and/or other implantable energy consuming parts of the apparatus.

75. An apparatus according to claim 74, wherein the energy of the second form is different than the energy of the first form.

76. An apparatus according to claim 74, wherein the energy transmission device functions different from the energy transforming device.

77. An apparatus according to claim 73, further comprising an implantable motor or pump for operating the adjustment device, wherein the energy transmission device is adapted to transmit wireless energy in the form of an magnetic field or electromagnetic waves or field for direct power of the motor or pump, as the wireless energy is being transmitted.

78. An apparatus according to claim 74, wherein the energy transmission device transmits energy by at least one signal separate from the control signal.

79. An apparatus according to claim 74, further comprising an implantable stabiliser for stabilising the energy of the first or second form.

80. An apparatus according to claim 79, wherein the energy of the second form comprises electric current and the stabiliser comprises at least one capacitor.

81. An apparatus according to claim 72, wherein the source of energy comprises a battery, accumulator, capacitor or a combination thereof.

82. An apparatus according to claim 1, further comprising a control device adapted to produce wireless energy for directly powering the operation device and/or for energizing other energy consuming components of the apparatus.

83. An apparatus according to claim 1, further comprising an implantable energy transforming device for transforming wireless energy directly or indirectly into energy different than the wireless energy for operation of the prosthesis device.

84. An apparatus according to claim 82, wherein the wireless energy comprises a wave signal including 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 or a gamma radiation signal.

85. An apparatus according to claim 1, further comprising an energy transfer means for wireless transfer of energy from outside the patient'"'"'s body to the operation device or adjustment device and/or other energy consuming implantable components of the apparatus.

86. An apparatus according to claim 82, wherein the control device is adapted to produce wireless energy in the form of a train of energy pulses.

87. An apparatus according to claim 85, wherein the energy transfer means is adapted to intermittently transfer the energy in the form of a train of energy pulses for direct use in connection with the energising of the energy consuming components of the apparatus.

88. An apparatus according to claim 82, wherein the control device is adapted to control the energy transforming device to produce the energy of the second form in a train of energy pulses for direct use in connection with the operation of the adjustment device.

89. An apparatus according to claim 85, wherein the energy transfer device is adapted to transfer electric energy, and further comprising an implantable capacitor for producing the train of energy pulses.

90. An apparatus according to claim 89, wherein the capacitor has a capacity less than 0.1 μ

F.

91. An apparatus according to claim 85, further comprising an implantable motor or pump for operating the adjustment device wherein the energy transfer means is adapted to directly power the motor or pump with transferred energy.

92. An apparatus according to claim 91, wherein the pump is not a plunger type of pump.

93. An apparatus according to claim 1, wherein the adjustment device is adapted to adjust the prosthesis device in a non-manual, non-thermal or non-magnetic manner.

94. An apparatus according to claim 1, wherein the operation device is electrically powered.

95. An apparatus according to claim 1, wherein the operation device is unpowerable by static permanent magnetic energy.

96. An apparatus according to claim 1, wherein the operation device is adapted to non-invasively operate the adjustment device.

97. An apparatus according to claim 1, wherein the adjustment device is operable to adjust the prosthesis device to steplessly change the erected status of the penis.

98. An apparatus according to claim 1, wherein the operation device comprises a hydraulic operation device which uses hydraulic fluid, the viscosity of which changes when the hydraulic fluid is exposed to energy different than thermal energy.

99. An apparatus according to claim 98, wherein the viscosity of the hydraulic fluid changes when the fluid is exposed to electric energy.

100. An apparatus according to claim 1, wherein the adjustment device is adapted to mechanically adjust the prosthesis device, or adapted to hydraulically adjust the prosthesis device 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.

101. An apparatus according to claim 1, further comprising a control device for controlling the prosthesis device.

102. An apparatus according to claim 101, wherein the control device comprises an internal control unit implantable in the patient for controlling the prosthesis device.

103. An apparatus according to claim 102, wherein the internal control unit is programmable.

104. An apparatus according to claim 103, wherein the control device comprises an external control unit outside the patient'"'"'s body, the implantable internal control unit being programmable by the external control unit.

105. An apparatus according to claim 101, wherein the control device comprises an external control unit outside the patient'"'"'s body for wirelessly controlling the prosthesis device.

106. An apparatus according to claim 105, wherein the external control unit is programmable.

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

108. An apparatus according to claim 107, wherein the sensor is adapted to directly or indirectly sense as the physical parameter the horizontal position of the patient.

109. An apparatus according to claim 107, wherein the sensor comprises a pressure sensor for directly or indirectly sensing as the physical parameter the pressure against the prosthesis device or part of the human body.

110. An apparatus according to claim 109, wherein the adjustment device is adapted to change the prosthesis device in corpora cavernosa in response to the pressure sensor sensing a predetermined pressure.

111. An apparatus according to claim 107, further comprising a control device for controlling the prosthesis device in response to signals from the sensor.

112. An apparatus according to claim 111, wherein the control device comprises an internal control unit implantable in the patient and directly controlling the prosthesis device in response to signals from the sensor.

113. An apparatus according to claim 112, wherein the control device comprises an external control unit outside the patient'"'"'s body for controlling the prosthesis device in response to signals from the sensor.

114. An apparatus according to claim 113, wherein the control device comprises an external control unit outside the patient'"'"'s body for manually controlling the prosthesis device in response to information from the sensor.

115. An apparatus according to claim 101, further comprising an implantable source of energy, wherein the control device is operable from outside the patient'"'"'s body for controlling the source of energy to release energy for use in connection with the operation of the prosthesis, when the prosthesis is implanted.

116. An apparatus according to claim 115, wherein the source of energy is intended to be external to the patient'"'"'s body, and the 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.

117. An apparatus according to claim 115, wherein the control device controls the source of energy to release magnetic energy, non-magnetic energy, electromagnetic energy, non-electromagnetic energy, kinetic energy, non-kinetic energy, sonic energy, non-sonic energy, thermal energy or non-thermal energy.

118. An apparatus according to claim 1, wherein the operation device is powered by magnetic energy, non-magnetic energy, electromagnetic energy, non-electromagnetic energy, kinetic energy, non-kinetic energy, sonic energy, non-sonic energy, thermal energy or non-thermal energy.

119. An apparatus according to claim 115, wherein the control device controls the source of energy to release energy for a determined time period.

120. An apparatus according to claim 115, wherein the control device controls the source of energy to release energy in a determined number of energy pulses.

121. An apparatus according to claim 115, wherein the control device is adapted to control the source of energy to release energy in a non-invasive manner.

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

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

124. An apparatus according to claim 122, wherein the electrical components are devoid of any current detector and/or charge level detector.

125. An apparatus according to claim 122, 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.

126. An apparatus according to claim 53, wherein the control signal comprises a wave signal including 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 or a gamma radiation signal.

127. An apparatus according to claim 1, further comprising a switch implantable in the patient for directly or indirectly switching the operation of the prosthesis device.

128. An apparatus according to claim 127, further comprising a source of energy implantable in the patient for supplying energy for the operation of the prosthesis device, wherein the switch is operated by the energy supplied by the energy transmission device to switch from an off mode, in which the source of energy is not in use, to an on mode, in which the source of energy supplies energy for the operation of the prosthesis device.

129. An apparatus according to claim 127, further comprising a source of energy implantable in the patient for supplying energy for the operation of the prosthesis device, and a remote control for controlling the supply of energy of the implantable source of energy, wherein the switch is operated by the energy supplied by the energy transmission device to switch from an off mode, in which the remote control is prevented from controlling the source of energy and the source of energy is not in use, to a standby mode, in which the remote control is permitted to control the source of energy to supply energy for the operation of the prosthesis device.

130. An apparatus according to claim 127, further comprising a source of energy implantable in the patient for supplying energy for the operation of the prosthesis device, wherein the switch is operated by the energy supplied by the energy transforming device to switch from an off mode, in which the source of energy is not in use, to an on mode, in which the source of energy supplies energy for the operation of the prosthesis device.

131. An apparatus according to claim 127, further comprising a source of energy implantable in the patient for supplying energy for the operation of the prosthesis device, and a remote control for controlling the supply of energy of the implantable source of energy, wherein the switch is operated by the energy supplied by the energy transforming device to switch from an off mode, in which the remote control is prevented from controlling the source of energy and the source of energy is not in use, to a standby mode, in which the remote control is permitted to control the source of energy to supply energy for the operation of the prosthesis device.

132. An apparatus according to claim 101, wherein the prosthesis is operable to perform a reversible function.

133. An apparatus according to claim 132, further comprising a reversing device implantable in the patient for reversing the function performed by the prosthesis.

134. An apparatus according to claim 133, comprising a control device for controlling the reversing device to reverse the function performed by the prosthesis.

135. An apparatus according to claim 133, wherein the reversing device comprises hydraulic means including a valve for shifting the flow direction of a flowing fluid in the hydraulic means.

136. An apparatus according to claim 133, wherein the reversing device comprises a mechanical reversing device.

137. An apparatus according to claim 133, wherein the reversing device comprises a switch.

138. An apparatus according to claim 137, wherein the switch of the reversing device is operable by the released energy.

139. An apparatus according to claim 133, 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.

140. An apparatus according to claim 133, wherein the operation device comprises a motor, and the reversing device reverses the motor.

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

142. An apparatus according to claim 141, wherein the prosthesis device is embedded in a silicone material having hardness less than 20 Shore.

143. An apparatus according to claim 74, wherein the energy transforming means or device is designed to be implanted subcutaneously or in the abdomen, thorax or cephalic region of the patient.

144. An apparatus according to claim 107, wherein the prosthesis device is adapted to release the erection of the penis in response to the sensor sensing ejaculation.

145. An apparatus according to claim 1, wherein the prosthesis device is adapted to engage the corpora cavernosa or crura as a single unit.

146. An apparatus according to claim 1, wherein the prosthesis device further comprises two prosthesis members adapted to engage the respective corpora cavernosa or crura.

147. An apparatus according to claim 1, wherein the adjustment device is adapted to adjust the prosthesis device such that the prosthesis device provides a predetermined adjustment of the corpora cavernosa or crura or the prolongations thereof that is satisfactory for the patient.

148. An apparatus according to claim 1, wherein the adjustment device is adapted to adjust the prosthesis device in a non-flux magnetic or non-thermal manner or non-viscosity changing manner.