Mechanical impotence treatment apparatus

• US 7,367,938 B2
• Filed: 02/09/2001
• Issued: 05/06/2008
• Est. Priority Date: 02/10/2000
• Status: Expired due to Term

• Current Assignee: Obetch Medical AG, Obtech Medical AG
• Original Assignee: Obtech Medical AG
• Inventors: Forsell, Peter
• Primary Examiner(s): Gilbert; Samuel G
• Application Number:
  US10/203,086
• Publication Number:
  US 20030109771A1
• Time in Patent Office: 2,643 Days
• Field of Search: 600 38- 41, 600 29- 32, 128/DIG.25
• 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,

an operable adjustment device implantable in the patient for adjusting the restriction device 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, and to release said restricted blood flow to achieve a flaccid state of the penis, and

a powered operation device for operating the adjustment device,

wherein the adjustment device is adapted to mechanically adjust the restriction device, and

the operation device including a servo means operatively connected to the adjustment device, the servo means including 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.

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 said portion of the penile tissue comprises one or more of the exit veins from the penis.

4. An apparatus according to claim 3, 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.

5. An apparatus according to claim 4, wherein the restriction device is operable to open and close the blood flow passageway.

6. An apparatus according to claim 5, wherein the restriction device is adapted to steplessly control the cross-sectional area of the blood flow passageway.

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

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

9. An apparatus according to claim 8, 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.

10. An apparatus according to claim 9, wherein the servo means comprises 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.

11. An apparatus according to claim 1, 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.

12. An apparatus according to claim 11, 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.

13. An apparatus according to claim 12, 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.

14. An apparatus according to claim 11, 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.

15. An apparatus according to claim 11, 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.

16. An apparatus according to claim 11, wherein the adjustment device (12;

52;

66;

90;

104;

110;

434) is adapted to change the size of the restriction opening (3) such that the outer circumferential confinement surface of the restriction member (2;

48;

60;

62;

88;

110;

122;

126;

128;

130;

436) is unchanged.

17. An apparatus according to claim 1, wherein the servo means comprises a motor operatively connected to the adjustment device.

18. An apparatus according to claim 17, comprising an implantable reversing device for reversing the motor.

19. An apparatus according to claim 17, wherein the motor is fixed to the restriction device.

20. An apparatus according to claim 17, wherein the motor (22) is remote from the restriction member (2) and is connected to the adjustment device (14) by a power transmission conduit (24).

21. An apparatus according to claim 1, wherein the servo mechanism comprises an electric motor.

22. An apparatus according to claim 21, wherein the motor is reversible.

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

24. An apparatus according to claim 23, 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.

25. An apparatus according to claim 24, wherein the signal receiver comprises a control unit adapted to control the adjustment device in response to the control signal.

26. An apparatus according to claim 25, further comprising an implantable energiser unit for providing energy to energy consuming components of the apparatus to be implanted in the patient.

27. An apparatus according to claim 26, wherein the control unit is adapted to control the energiser unit to power the motor with energy in response to the control signal.

28. An apparatus according to claim 26, wherein the energiser unit is adapted to transform energy from the control signal, as it is transmitted to the signal receiver, into electric energy.

29. An apparatus according to claim 28, further comprising an implantable electric motor for operating the adjustment device, 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.

30. An apparatus according to claim 26, 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.

31. An apparatus according to claim 30, 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.

32. An apparatus according to claim 26, further comprising an external energy transmitter for transmitting wireless energy, wherein the energiser unit comprises a battery and a switch operable by the wireless energy transmitted by the external transmitter, 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.

33. An apparatus according to claim 32, wherein the external energy transmitter is adapted to directly power the switch with the wireless energy to switch into the “

on”

mode.

34. An apparatus according to claim 24, wherein the signal comprises analog or digital pulses.

35. An apparatus according to claim 34, wherein the analog or digital pulses comprise a magnetic field or an electric field.

36. An apparatus according to claim 24, wherein the signal comprises a wave signal.

37. An apparatus according to claim 36, wherein the wave signal comprises an electromagnetic wave signal, a sound wave signal or a carrier wave signal.

38. An apparatus according to claim 37, wherein the carrier signal is frequency, amplitude or frequency and amplitude modulated.

39. An apparatus according to claim 37, 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.

40. An apparatus according to claim 23, wherein the servo means is comprised of an implantable motor for operating the adjustment device.

41. An apparatus according to claim 40, wherein the motor is an electric motor.

42. An apparatus according to claim 23, 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.

43. 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.

44. An apparatus according to claim 43, further comprising an external energy transmitter for transmitting wireless energy, wherein the energiser unit is adapted to transform the wireless energy into electric energy.

45. An apparatus according to claim 44, wherein the servo means is comprised of an implantable electric motor for operating the adjustment device, wherein the energiser unit (326) is adapted to power the electric motor with the electric energy transformed from the wireless energy.

46. An apparatus according to claim 43, further comprising an external energy transmitter for transmitting wireless energy, wherein the energiser unit comprises a battery and a switch operable by the wireless energy transmitted by the external transmitter, 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.

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

48. An apparatus according to claim 47, wherein the electrical components are devoid of any current detector and/or charge level detector.

49. An apparatus according to claim 47, 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.

50. An apparatus according to claim 49, wherein the capacitor has a capacity less than 0, 1 μ

F.

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

52. 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 adjustment device and/or other energy consuming implantable components of the apparatus.

53. An apparatus according to claim 52, 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.

54. An apparatus according to claim 53, wherein the energy transfer means is adapted to transfer electric energy, and further comprising an implantable capacitor for producing the train of energy pulses.

55. An apparatus according to claim 52, wherein the servo means is comprised of 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.

56. An apparatus according to claim 52, wherein the energy transfer means is adapted to transfer wireless energy in the form of electromagnetic waves excluding radio waves.

57. An apparatus according to claim 52, wherein the energy transferred by the energy transfer means comprises an electric field or a magnetic field.

58. An apparatus according to claim 52, wherein the energy transferred by the energy transfer means comprises a signal.

59. An apparatus according to claim 52, wherein the energy transforming device comprises a capacitor.

60. An apparatus according to claim 59, wherein the capacitor is adapted to produce electric pulses from the transformed electric energy.

61. An apparatus according to claim 52, 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.

62. An apparatus according to claim 1, 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 a magnetic field or electromagnetic waves for direct power of the motor or pump, as the wireless energy is being transmitted.

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

64. An apparatus according to claim 63, wherein the restriction device is controlled in response to signals from the pressure sensor.

65. 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.

66. An apparatus according to claim 65, wherein the energy transforming device transforms the wireless energy into kinetic energy for operation of the restriction device.

67. An apparatus according to claim 65, wherein the energy transforming device transforms the wireless energy in the form of sound waves into electric energy for operation of the restriction device.

68. An apparatus according to claim 67, wherein the energy transforming device transforms the wireless energy in the form of sound waves directly into electric energy.

69. 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.

70. 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.

71. An apparatus according to claim 1, wherein the adjustment device is adapted to adjust the restriction device in a non-manual manner.

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

73. An apparatus according to claim 1, wherein the operation device further comprises a motor and wherein said motor is reversible and capable of performing a reversible function to open and close said restriction device to adjust the blood flow leaving the penis.

74. An apparatus according to claim 1, wherein the restriction device is designed for engagement with one or more of the patient'"'"'s penile exit veins, whereby the restriction device is operable to contract the penile exit veins to restrict the blood flow therein.

75. An apparatus according to claim 1, wherein the restriction device is designed for engagement with both of the corpora cavernosa or crura of the patient'"'"'s penis or the prolongations thereof as a single unit, whereby the restriction device is operable to contract the corpora cavernosa or crura or the prolongations thereof to restrict the blood flow leaving the penis.

76. An apparatus according to claim 1, wherein the restriction device is designed for engagement with each of the two corpora cavernosa or crura of the patient'"'"'s penis or the prolongations thereof as two separate units, whereby the restriction device is operable to contract each of the corpora cavernosa or crura or the prolongations thereof to restrict the blood flow leaving the penis.

77. A male sexual impotent treatment apparatus, comprising:

an adjustable, noninflatable 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, the restriction device comprising a loop around said portion of the penile tissue,

an operable adjustment device implantable in the patient for adjusting the restriction device 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, and

a powered operation device for operating the adjustment device,

the adjustment device being adapted to mechanically adjust the restriction device,

the operation device including a servo means operatively connected to the adjustment device, the servo means including 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,

the adjustment device comprising 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,

the servo means 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, and

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.