Mechanical impotence treatment apparatus

• US 8,602,966 B2
• Filed: 04/25/2008
• Issued: 12/10/2013
• Est. Priority Date: 02/10/2000
• Status: Expired due to Fees

• Current Assignee: Obtech Medical AG (Johnson & Johnson)
• Original Assignee: Obtech Medical AG (Johnson & Johnson)
• Inventors: Forsell, Peter
• Primary Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US12/149,020
• Publication Number:
  US 20080275296A1
• Time in Patent Office: 2,055 Days
• Field of Search: 600 29- 32, 600 37- 41
• US Class Current: 600/40
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/26 Penis implants
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants

Abstract

A male sexual impotence treatment apparatus comprises an adjustable non-inflatable restriction device (434) implanted in a male impotent patient. The restriction device directly engages a portion of the normal penile tissue of the patient, such as both of the corpora cavernosa as a single unit or one or more of the exit veins from the penis, to affect the blood flow leaving the penis. An adjustment device (436) mechanically adjusts the restriction device to temporarily restrict the blood flow leaving the penis when the patient wishes to achieve erection.

Claims

1. A male sexual impotence treatment apparatus comprising:

an adjustable restriction device implantable in a male impotent patient for directly engaging a portion of the normal penile tissue or the prolongation thereof of the patient to temporarily contract said portion of the normal penile tissue or the prolongation thereof to restrict the blood flow leaving the penis, when the patient desires to achieve erection;

an operation device for operating the restriction device;

an energy transmission device for wireless transmission of energy from outside the patient'"'"'s body to inside the patient'"'"'s body for use in connection with the operation of the restriction device including powering the operation device, wherein the operation device comprises;

(i) a motor implantable in the patient, wherein the energy transmitted by the energy transmission device (10) is used for powering the motor, which operates the restriction device;

or

(ii) a pump implantable in the patient, wherein the energy transmitted by the energy transmission device is used for powering the pump to operate the restriction device to change restriction of the exit blood flow passageway;

and wherein

the apparatus further comprises electrical components including at least one implantable voltage level guard.

2. An apparatus according to claim 1, wherein the restriction device is operable to contract said portion of the patient'"'"'s penile tissue or the prolongation thereof, when the patient desires to achieve erection, such that the penile arterial blood flow is at least substantially unrestricted, whereas the penile venous blood flow is substantially restricted.

3. An apparatus according to claim 1, wherein the restriction device is designed for engagement with both of the corpora cavernosa or crura of the penis or the prolongations thereof as a single unit, or for engagement with each of the two corpora cavernosa or crura or the prolongation thereof as two separate units.

4. An apparatus according to claim 1, wherein said portion of the penile tissue comprises one or more of the exit veins from the penis.

5. An apparatus according to claim 4, wherein the restriction device is adapted to control the cross-sectional area of a blood flow passageway formed by the patient'"'"'s penile exit veins.

6. An apparatus according to claim 5, wherein the restriction device is operable to open and close the blood flow passageway.

7. An apparatus according to claim 6, wherein the restriction device is adapted to steplessly control the cross-sectional area of the blood flow passageway.

8. An apparatus according to claim 1, comprising an adjustment device adapted to adjust the restriction device.

9. An apparatus according to claim 8, wherein the adjustment device is powered.

10. An apparatus according to claim 8, wherein the adjustment device is adapted to adjust the restriction device in a non-manual manner.

11. An apparatus according to claim 8, wherein the operation device operates the adjustment device.

12. An apparatus according to claim 11, wherein the restriction device comprises an element to be placed on one side of said portion of the penile tissue, and the adjustment device is adapted to squeeze said portion of the penile tissue between the element and the human bone or tissue to decrease the blood flow leaving the penis.

13. An apparatus according to claim 11, wherein the restriction device comprises at least one elongated restriction member and forming means for forming the restriction member into at least a substantially closed loop around said portion of the penile tissue, the loop defining a restriction opening, whereby the adjustment device is adapted to adjust the restriction member in the loop to change the size of the restriction opening.

14. An apparatus according to claim 13, wherein the restriction device comprises several elongated restriction members to be formed into at least substantially closed loops around the penile tissue.

15. An apparatus according to claim 13, wherein, the adjustment device) is adapted to adjust the longitudinal extension of the elongated restriction member in said loop to change the size of the restriction opening.

16. An apparatus according to claim 15, wherein the restriction member comprises a main portion and two elongated end portions and the adjustment device is adapted to establish longitudinal relative displacement between the end portions of the restriction member, such that the size of the restriction opening (is adjusted.

17. An apparatus according to claim 16, wherein the adjustment device ( ) comprises a movement transferring member) in engagement with at least one of the end portions of the restriction member and operable to displace said one end portion relative to the other end portion of the restriction member.

18. An apparatus according to claim 17, further comprising a motor which is fixed relative to the main portion of the restriction member and has a rotating drive shaft operatively connected to the movement transferring member.

19. An apparatus according to claim 18, wherein the motor is positioned relative to the elongated restriction member such that the drive shaft extends in parallel with a chord in said loop of the restriction member.

20. An apparatus according to claim 15, wherein the elongated restriction member (is longitudinally resilient and the adjustment device comprises a contraction means adapted to longitudinally contract the resilient restriction member.

21. An apparatus according to claim 20, wherein the elongated restriction member comprises a substantially non-resilient main portion and an end portion forming an elongated helical spring, which is contractible by the contraction means.

22. An apparatus according to claim 21, wherein the contraction means comprises an elongated flexible pulling member connected to the main portion of the restriction member and extending through the helical spring to contract the helical spring against an arresting member, which is fixed relative to the main portion of the restriction member.

23. An apparatus according to claim 13, wherein the restriction member comprises an elongated helical spring having a free end, and a body to which said spring is nonrotatably secured at its opposite end, the adjustment device being adapted to rotate the helical spring in one direction to enlarge the coils of the helical spring to longitudinally contract the elongated helical spring and to rotate the helical spring in the opposite direction to reduce the size of the coils of the helical spring to longitudinally extend the helical spring.

24. An apparatus according to claim 23, wherein the restriction member comprises a further elongated helical spring having a free end and nonrotatably secured to the body at its opposite end, and the adjustment device comprises a drive shaft having two opposite end portions connected to the helical springs, respectively, at their free ends, the helical coils forming left and right hand helices, respectively.

25. An apparatus according to claim 24, wherein the restriction member comprises a further elongated helical spring having a free end and nonrotatably secured to the body at its opposite end, and the adjustment device comprises a gearing having an input shaft and two opposite aligned output shafts (74,76) connected to the helical springs (60,62), respectively, at their free ends, the input shaft being connected to the output shafts such that the output shafts rotate in the opposite directions upon rotation of the input shaft, the helical coils forming the same helices.

26. An apparatus according to claim 13, wherein the restriction member forms a radial innermost circumferential confinement surface in said loop of the restriction member, and the adjustment device is adapted to mechanically adjust the restriction member such that at least a portion of the confinement surface is substantially radially displaced in said loop.

27. An apparatus according to claim 26, wherein the adjustment device comprises an elongated voltage responsive element (forming part of the confinement surface and capable of bending into a bow in response to a voltage applied across the element, the radius of curvature of said bow being adjustable by changing the level of the voltage.

28. An apparatus according to claim 26, wherein the restriction member comprises an elastic annular element forming the confinement surface, and the adjustment device is adapted to change the diameter of the elastic annular element.

29. An apparatus according to claim 26, wherein the forming means comprises a substantially rigid outer annular element, and the restriction member comprises an elongated helical spring extending internally along the outer annular element and contacting the latter, the helical spring forming part of the circumferential confinement surface and having a free end, and a body to which the helical spring is nonrotatably secured at its opposite end, the adjustment device being adapted to rotate the helical spring in one direction to enlarge the coils of the helical spring to contract the circumferential confinement surface and to rotate the helical spring in the opposite direction to reduce the size of the coils of the helical spring to expand the circumferential confinement surface.

30. An apparatus according to claim 26, wherein the forming means comprises a substantially rigid outer annular element, and the restriction member comprises a first and a second elongated helical spring extending internally along the outer annular element and contacting the latter, the helical springs forming part of the circumferential confinement surface, the first and the second spring, respectively, having a free end, and a body to which the first and the second spring, respectively, is nonrotatably secured at its opposite end, the adjustment device being adapted to rotate the first and the second spring, respectively, in one direction to enlarge the coils of the spring to contract the circumferential confinement surface and to rotate the first and the second spring, respectively, in the opposite direction to reduce the size of the coils of the spring to expand the circumferential confinement surface.

31. An apparatus according to claim 13, wherein the restriction member comprises at least two separate elements, at least one of which is pivoted such that it is turnable in a plane in which said loop of the restriction member extends, and the adjustment device is adapted to turn said pivoted element to change the size of said restriction opening.

32. An apparatus according to claim 13, wherein the elongated restriction member is elastic and varies in thickness as seen in a cross-section thereof, and the adjustment device is adapted to turn the restriction member around the longitudinal extension thereof.

33. An apparatus according to claim 13, wherein the forming means comprises a spring material forming the elongated restriction member into the loop, such that the restriction opening has a predetermined size, and the adjustment device is adapted to adjust the restriction member against the spring action of the spring material.

34. An apparatus according to claim 33, wherein the spring material is integrated in the restriction member.

35. An apparatus according to claim 13, wherein the forming means is adapted to form the restriction member into a loop having a predetermined size or a size selected from several predetermined sizes.

36. An apparatus according to claim 13, wherein the adjustment device is adapted to change the size of the restriction opening such that the outer circumferential confinement surface of the restriction member is changed.

37. An apparatus according to claim 13, wherein the adjustment device is adapted to change the size of the restriction opening such that the outer circumferential confinement surface of the restriction member is unchanged.

38. An apparatus according to claim 13, wherein the elongated restriction member is flexible, and the adjustment device is adapted to pull a first portion of the flexible restriction member from a second portion of the flexible restriction member opposite the first portion in the loop to squeeze said portion of the penile tissue between two opposite lengths of the elongated flexible restriction member to restrict the blood flow leaving the penis, and to release said portion of the penile tissue from the flexible restriction member to increase the blood flow leaving the penis.

39. An apparatus according to claim 11, wherein the restriction device comprises at least two elements to be placed on different sides of said portion of the penile tissue, and the adjustment device is adapted to squeeze said portion of the penile tissue (406) between the elements to restrict the blood flow leaving the penis, and to release said portion of the penile tissue (406) from the elements to increase the blood flow leaving the penis.

40. An apparatus according to claim 11 wherein the restriction device comprises at least two articulated clamping elements to be positioned on opposite or different sides of said portion of the penile tissue, and the adjustment device is adapted to turn the clamping elements toward each other to clamp said portion of the penile tissue between the clamping elements to restrict the blood flow leaving the penis, and to turn the clamping elements away from each other to release said portion of the penile tissue from the clamping elements to increase the blood flow leaving the penis.

41. An apparatus according to claim 11, wherein the restriction device is adapted to bend a portion of said portion of the penile tissue.

42. An apparatus according to claim 41, wherein the restriction device (comprises at least two bending members to be positioned on opposite or different sides of said portion of the penile tissue and to be displaced relative to each other along the penile tissue, and the adjustment device is adapted to move the bending members against said portion of the penile tissue to bend it to restrict the blood flow leaving the penis, and to move the bending members away from said portion of the penile tissue to release it from the bending members to increase the blood flow leaving the penis.

43. An apparatus according to claim 42, wherein the bending members comprise rollers.

44. An apparatus according to claim 11, wherein the restriction device is adapted to rotate a portion of the penile tissue.

45. An apparatus according to claim 11, the motor is operatively connected to the adjustment device.

46. An apparatus according to claim 45, wherein the operation device comprises a reverse servo connected between the motor and the adjustment device.

47. An apparatus according to claim 45, comprising an implantable reversing device for reversing the motor.

48. An apparatus according to claim 45, wherein the motor is fixed to the restriction device.

49. An apparatus according to claim 45, wherein the motor is remote from the restriction device and is connected to the adjustment device by a power transmission conduit.

50. An apparatus according to claim 11, wherein the operation device comprises a servo means transferring weak force acting on a moving element having a long stroke into strong force acting on an element with a short stroke.

51. An apparatus according to claim 50, wherein the servo means comprises a motor, preferably an electric motor.

52. An apparatus according to claim 51, wherein the motor is reversible.

53. An apparatus according to claim 11, wherein the operation device comprises hydraulic means for operating the restriction device.

54. An apparatus according to claim 53, further comprising a reservoir containing a predetermined amount of fluid for supplying the hydraulic means with fluid.

55. An apparatus according to claim 54, wherein the reservoir defines a chamber for the predetermined amount of fluid and the hydraulic means is adapted to change the volume of the chamber.

56. An apparatus according to claim 54, wherein a pump is adapted to pump fluid between the reservoir and the adjustment device.

57. An apparatus according to claim 54, wherein the hydraulic means comprises a reverse servo) transferring a strong force acting on a moving element with a short stroke into a weak force acting on moving element with a long stroke.

58. An apparatus according to claim 57, wherein the reverse servo is manually operated.

59. An apparatus according to claim 57, wherein the reverse servo is powered.

60. An apparatus according to claim 59, wherein the reverse servo comprises a motor, preferably an electric motor.

61. An apparatus according to claim 60, wherein the motor is reversible.

62. An apparatus according to claim 57, wherein the hydraulic means comprises first and second wall portions of the reservoir, and the reverse servo is adapted to provide relative displacement between the first and second wall portions of the reservoir.

63. An apparatus according to claim 54, wherein the hydraulic means of the operation device comprises a fluid conduit, the reservoir forming part of the conduit.

64. An apparatus according to claim 63, wherein the hydraulic means including the conduit are devoid of any non-return valve.

65. An apparatus according to claim 53, wherein the hydraulic means is devoid of any non-return valve.

66. An apparatus according to claim 1, wherein the restriction device comprises at least two frame elements, which are foldable towards each other by the adjustment device.

67. An apparatus according to claim 66, wherein the foldable frame elements comprise two substantially semi-circular frame elements, which are hinged together such that the semicircular elements are swingable relative to each other from a fully open state in which they substantially form a circle to a fully folded state in which they form a semicircle.

68. An apparatus according to claim 1, wherein the restriction device is non-inflatable.

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

70. An apparatus according to claim 69, wherein the remote control comprises a separate signal transmitter and/or receiver and an implantable signal receiver and/or transmitter), for transmitting and/or receiving a control signal.

71. An apparatus according to claim 70, wherein the signal receiver (comprises a control unit adapted to control the adjustment device in response to the control signal.

72. An apparatus according to claim 71, further comprising an implantable energiser unit for providing energy to energy consuming components of the apparatus to be implanted in the patient.

73. An apparatus according to claim 72, wherein the energiser unit is adapted to transform energy from the control signal, as it is transmitted to the signal receiver into electric energy.

74. An apparatus according to claim 73, wherein the implantable motor is an electrical motor that operates the adjustment device, and wherein the energiser unit comprises a rechargeable electric power supply for storing the electric energy and the control unit is adapted to power the electric motor with energy from the rechargeable electric power supply in response to the control signal.

75. An apparatus according to claim 72, wherein the energiser unit (is adapted to transform energy from the control signal into a direct or alternating current.

76. An apparatus according to claim 72, wherein the energiser unit comprises a battery, an electrically operable switch adapted to connect the battery to the signal receiver in an “

on”

mode when the switch is powered and to keep the battery disconnected from the signal receiver in a “

standby”

mode when the switch is not powered, and a rechargeable electric power supply for powering the switch.

77. An apparatus according to claim 76, wherein the control unit is adapted to power the electric motor with energy from the battery in response to a control signal received from the signal transmitter, when the switch is in its “

on”

mode.

78. An apparatus according to claim 72, wherein the energiser unit comprises a battery and a switch operable by the wireless energy transmitted by the energy transmission device, for connecting the battery to the signal receiver in an “

on”

mode when the switch is powered by the wireless energy and to keep the battery disconnected from the signal receiver in a “

standby”

mode when the switch is not powered.

79. An apparatus according to claim 78, wherein the energy transmission device is adapted to directly power the switch with the wireless energy to switch into the “

on”

mode.

80. An apparatus according to claim 69, wherein the implantable motor operates the adjustment device.

81. An apparatus according to claim 80, wherein the control unit is adapted to control the energiser unit to power the motor with energy in response to the control signal.

82. An apparatus according to claim 80, wherein the motor is an electric motor.

83. An apparatus according to claim 69, wherein the remote control is capable of obtaining information from implantable components of the apparatus and of commanding the adjustment device to adjust the restriction device in response to obtained information.

84. An apparatus according to claim 1, further comprising an implantable energiser unit for providing energy to energy consuming components of the apparatus to be implanted in the patient.

85. An apparatus according to claim 84, wherein the energiser unit is adapted to transform the wireless energy into electric energy.

86. An apparatus according to claim 85, the implantable motor is an electric motor that operates adjustment device, wherein the energiser unit is adapted to power the electric motor with the electric energy transformed from the wireless energy.

87. An apparatus according to claim 85, wherein the energiser unit comprises an implantable accumulator or battery, and the electric energy is adapted to charge the accumulator or battery.

88. An apparatus according to claim 87, wherein the energy transforming device comprises a capacitor.

89. An apparatus according to claim 84, wherein the energiser unit comprises a battery and a switch operable by the wireless energy transmitted by the energy transmission device, for connecting the battery to the implantable energy consuming components of the apparatus in an “

on”

mode when the switch is powered by the wireless energy and to keep the battery disconnected from the energy consuming components in a “

standby”

mode when the switch is not powered.

90. An apparatus according to claim 1, comprising a single voltage level guard.

91. An apparatus according claim 90, 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.

92. An apparatus according to claim 91, wherein the capacitor has a capacity less than 0.1 μ

F.

93. An apparatus according to claim 1, wherein the electrical components are devoid of any current detector and/or charge level detector.

94. 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 energy consuming implantable components of the apparatus.

95. An apparatus according to claim 94, 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.

96. An apparatus according to claim 95, wherein the energy transfer means is adapted to transfer electric energy, and further comprising an implantable capacitor for producing the train of energy pulses.

97. An apparatus according to claim 94, wherein the energy transfer means is adapted to directly power the motor or pump with transferred energy.

98. An apparatus according to claim 94, wherein the energy transferred by the energy transfer means comprises an electric field or a magnetic field.

99. An apparatus according to claim 94, wherein the energy transferred by the energy transfer means comprises a signal.

100. An apparatus according to claim 99, wherein the signal comprises analog or digital pulses.

101. An apparatus according to claim 100, wherein the analog or digital pulses comprise a magnetic field or an electric field.

102. An apparatus according to claim 99, wherein the signal comprises a wave signal.

103. An apparatus according to claim 102, wherein the wave signal comprises an electromagnetic wave signal, a sound wave signal or a carrier wave signal.

104. An apparatus according to claim 103, wherein the carrier signal is frequency, amplitude or frequency and amplitude modulated.

105. An apparatus according to claim 103, 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.

106. An apparatus according to claim 94, wherein the energy transforming device comprises a capacitor.

107. An apparatus according to claim 106, wherein the capacitor is adapted to produce electric pulses from the transformed electric energy.

108. An apparatus according to claim 94, wherein the energy transfer means is adapted to transfer 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.

109. An apparatus according to claim 1, wherein the energy transmission device is adapted to transmit 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 transmitted.

110. An apparatus according to claim 109, wherein the pump is not a plunger type of pump.

111. An apparatus according to claim 110, wherein the energy transfer means is adapted to transfer wireless energy in the form of electromagnetic waves excluding radio waves.

112. An apparatus according to claim 1, further comprising a pressure sensor for directly or indirectly sensing the pressure against the restriction device.

113. An apparatus according to claim 112, wherein the restriction device is controlled in response to signals from the pressure sensor.

114. 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 restriction device.

115. An apparatus according to claim 114, wherein the energy transforming device transforms the wireless energy into kinetic energy for operation of the restriction device.

116. An apparatus according to claim 114, wherein the energy transforming device transforms the wireless energy in the form of sound waves into electric energy for operation of the restriction device.

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 1, further comprising an implantable accumulator or battery and means for controlling the accumulator or battery from outside the patient'"'"'s body to supply energy to the adjustment device and/or other implantable energy consuming components of the apparatus.

119. An apparatus according claim 1, wherein the restriction device is designed for implantation in the base of the patient'"'"'s penis or its prolongation.

120. An apparatus according to claim 1, further comprising an adjustment device for adjusting the restriction device to change the restriction of the blood flow passageway, wherein the adjustment device is adapted to mechanically adjust the restriction device, or adapted to hydraulically adjust the restriction 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.

121. An apparatus according to claim 1, further comprising an implantable reversing device, wherein the restriction device is capable of performing a reversible function and the reversing device reverses the reversible function.