US20030100929A1 - Controlled penile prosthesis - Google Patents

Abstract

A male sexual impotence treatment prosthesis apparatus comprises an operable prosthesis (48) implanted in the cavities of the corpora cavernose 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 (60). A control device (62and64) 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.

Description

• The present invention relates to a male sexual impotence treatment prosthesis apparatus, comprising an operable penile prosthesis implantable in the cavities of the corpora cavernosa of a patient's penile tissue to provide erect penile condition, when the prosthesis is operated.[0001]
• Male sexual impotence is a widespread problem. Many different solutions to this problem have been tried. In accordance with a prior system currently practised a hydraulic inflatable/contractible silicon prosthesis is implanted in the cavities of the corpora cavernosa of the penis. In fluid connection with this prosthesis is a reservoir implanted retroperitonially and a pump therefore in the scrotum. By manually pumping the pump the prosthesis is filled with fluid from the reservoir to achieve erect penile condition or is emptied of fluid, which returns to the reservoir, to achieve flaccid penile condition. However, there are several more or less severe disadvantages of this solution. A problem that often occurs is that thick, hard fibrosis is created around the pump which makes the system useless sooner or later.[0002]
• Another solution to achieve erection is to restrict the blood flow leaving the penis. For example, U.S. Pat. Nos. 4,829,990, 4,958,630 and 5,048,511 disclose two hydraulically operated inflatable cuffs wrapped around the respective crura or penile exit veins. A disadvantage of such a solution is that it involves complicated surgery. U.S. Pat. No. 4,828,544 discloses' another example on this solution, in which an artificial fistula system is surgically implanted and provides a primary fistula between the femoral artery and the femoral vein and a secondary fistula for leading blood from the primary fistula to the penis. An inflatable balloon engages the primary fistula between the secondary fistula and the vein. The balloon is in fluid connection with a manually compressible reservoir implanted in the scrotum. Again, implantation of this artificial fistula system requires delicate surgery.[0003]
• Yet another solution is to inject a substance in the penile vein system to achieve erection. However, injections are painful and complicated for the patient.[0004]
• Various impotence treatment devices in which fluid is distributed from a reservoir to an inflatable implanted prosthesis are disclosed in U.S. Pat. Nos. 3,855,122, 3,954,102, 4,009,711, 4,201,202, 4,235,227, 4,318,396 and 5,250,020.[0005]
• U.S. Pat. No 4,424,807 discloses another solution in which inflatable hydraulic cylindrical elements are implanted relatively deep into the corpus cavernosum.[0006]
• The object of the present invention to provide a simple male sexual impotence treatment prosthesis apparatus which is conveniently controlled by the patient.[0007]
• This object is obtained by an apparatus of the kind described initially, which is characterised in that a source of energy is provided, and a control device operable from outside the patient's body is provided for controlling the source of energy to release energy for use in connection with the operation of the prosthesis, when the prosthesis is implanted.[0008]
• As a result, the advantage is achieved that the prosthesis can be operated without need for touching subcutaneously implanted components of the apparatus. Furthermore, the apparatus of the invention provides simple and effective control of the energy supplied to implanted components of the apparatus which ensures an extended and reliable functionality of the apparatus, possibly for the rest of the patient's natural life, and at least many years.[0009]
• Generally, the prosthesis is adapted to control the penis to change, preferably steplessly, between flaccid and erect penile condition. This gives the advantage that the patient is enabled to make fine adjustments of the prosthesis to achieve the desired erection without feeling pain.[0010]
• The control device may also control the prosthesis. The control device may comprise an internal control unit, preferably including a microprocessor, implanted in the patient for controlling the prosthesis. The control device may further comprise an external control unit outside the patient's body, wherein the internal control unit is programmable by the external control unit, for example for controlling the prosthesis over a short period of time. Alternatively, the internal control unit may control the prosthesis over time in accordance with an activity schedule program, which may be adapted to the patient's needs. For example to avoid a too long duration of the penis in erect condition.[0011]
• Conveniently, the external control unit may load the internal control unit with data in accordance with a loading mode only authorized for a doctor: For specialized controls of the implanted prosthesis, the external control unit may control the internal control unit in accordance with a doctor mode only authorized for the doctor. For simple controls of the implanted prosthesis, the external control unit may control the internal control unit in accordance with a patient mode permitted for the patient. Thus, by using the external control unit in accordance with different modes it is possible to have certain functions of the implanted prosthesis controlled by the patient and other more advanced functions controlled by the doctor, which enables a flexible post-operation treatment of the patient.[0012]
• The control device may be adapted to control the source of energy to release energy, for instance to intermittently release energy in the form of a train of energy pulses, for direct use in connection with the operation of the prosthesis. In accordance with a suitable embodiment the control device controls the source of energy to release electric energy, and the apparatus further comprises an implantable capacitor for producing the train of energy pulses from the released energy. In this case the term “direct” is used to mean, on one hand, that the released energy is used while it is being released by the control device, on the other hand, that the released energy may be somewhat delayed, in the order of seconds, by for instance an energy stabiliser before being used in connection with the operation of the prosthesis. The prosthesis may be operable in non-manual, a non-magnetic or non-mechanical manner by use of the released energy.[0013]
• In accordance with a preferred embodiment of the invention, the apparatus comprises implantable electrical components including at least one, or only one single voltage level guard and a capacitor or accumulator, wherein the charge and discharge of the capacitor or accumulator is controlled by use of the voltage level guard. As a result, there is no need for any implanted current detector and/or charge level detector for the control of the capacitor, which makes the apparatus simple and reliable.[0014]
• Generally, the apparatus further comprises an operation device implantable in the patient for operating the prosthesis, wherein the control device controls the operation device to operate the prosthesis. The control device may directly power the operation device with energy released from the source of energy and/or power other energy consuming components of the apparatus to be implanted. In this case the term “directly” is used to mean, on one hand, that the operation device is powered with released energy while the latter is being released by the control device, on the other hand, that the released energy may be somewhat delayed, in the order of seconds, by for instance an energy stabiliser before powering the operation device. The advantage of directly using energy as it is released is that the apparatus can be of a very simple design and the few components involved makes the apparatus reliable.[0015]
• It should be understood that the energy consuming parts of the apparatus for example a motor or pump may be or may not be energised with the unchanged wirelessly transmitted energy as this being transmitted as well as being or not being energised with energy different than the transmitted energy for example transformed into electrical energy but still directly used for energising the energy consuming parts of the apparatus as the transmitted energy is transmitted. Alternatively the energy consuming parts of the apparatus may be energised from a implanted source of energy or storage device, which still may be loaded with wireless energy. In all these aspects it is preferable to be able to wirelessly control the release of energy and get an feedback of the result of the performed function of the device. Direct use of transmitted energy may be unrelaible without a feedback what has happened, has the energy reached it's goal?[0016]
• The prosthesis may be non-inflatable, i.e. with no hydraulic fluid involved for the adjustments of the prosthesis. This eliminates problems with fluid leaking from the prosthesis.[0017]
• The operation device may comprise hydraulic means and at least one valve for controlling a fluid flow in the hydraulic means. The control device may suitably comprise a wireless remote control for controlling the valve. The prosthesis may comprise hydraulic means and the operation device may comprise a reservoir forming a fluid chamber with a variable volume connected to the hydraulic means. The operation device may distribute fluid from the chamber to the hydraulic means by reduction of the volume of the chamber and withdraw fluid from the hydraulic means to the chamber by expansion of the volume of the chamber.[0018]
• In accordance with a first main aspect of the invention, the source of energy is external to the patient's body and the control device controls the source of energy to release wireless energy. The external source of energy may be of any conceivable kind, such as a nuclear source of energy or a chemical source of energy.[0019]
• An energy storage device, preferably an electric accumulator, may be implanted in the patient for storing the wireless energy released from the external source of energy. The electric accumulator may comprise at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery. Alternatively, a battery may be implanted in the patient for supplying electric energy to implanted electric energy consuming components of the apparatus, in addition to the supply of wireless energy. Where the control device comprises an implantable control unit the electronic circuit thereof and the prosthesis may be directly powered with transformed wireless energy, or energy from either the implanted energy storage device or battery.[0020]
• In accordance with a second main aspect of the invention, the wireless energy is directly used for operation of the prosthesis, i.e. the prosthesis is operated as the wireless energy is released from the external source of energy by the control device. In this case the term “directly” is used to mean, on one hand, that the prosthesis is promptly operated by using the released energy whithout first storing the latter, on the other hand, that the released energy may be somewhat delayed, in the order of seconds, by for instance an energy stabiliser before being used for the operation of the prosthesis. As a result, a very simple control of the prosthesis is achieved and there are only a few implanted components of the apparatus. For example, there is no implanted source of energy, such as a battery, nor any implanted complicated signal control system. This gives the advantage that the apparatus will be extremely reliable.[0021]
• Generally, the control device controls and directly or indirectly powers the operation device with wireless energy released from the source of energy and/or powers other implanted energy consuming components of the apparatus.[0022]
• In a first particular embodiment in accordance with the first and second main aspects of the invention, the operation device comprises a motor, preferably an electric motor, which may have electrically conductive parts made of plastics. The motor may include a rotary motor, wherein the control device is adapted to control the rotary motor to rotate a desired number of revolutions. Alternatively, the motor may include a linear motor, or a hydraulic or pneumatic fluid motor, wherein the control device is adapted to control the fluid flow through the fluid motor. Motors currently available on the market are getting smaller and smaller. Furthermore, there is a great variety of control methods and miniaturized control equipment available. For example, a number of revolutions of a rotary motor may be analyzed by a Hall-element just a few mm in size.[0023]
• In a second particular embodiment in accordance with the first and second main aspects of the invention, the control device is adapted to shift polarity of the released energy to reverse the operation device. The operation device may suitably comprise an electric motor and the released energy may comprise electric energy.[0024]
• In a third particular embodiment in accordance with the first and second main aspects of the invention there is a reversing device implantable in the patient for reversing the function performed by the prosthesis, i.e. to change from erect to flaccid penile condition, suitably in a stepless manner. In this connection, the control device suitably controls the reversing device, which may include a switch, to reverse the function performed by the prosthesis. The reversing device may comprise hydraulic means including a valve for shifting the flow direction of a fluid in the hydraulic means. Alternatively, the reversing device may comprise a mechanical reversing device, such as a switch or a gearbox.[0025]
• Where the reversing device comprises a switch the control device suitably controls the operation of the switch by shifting polarity of released energy supplied to the switch. The switch may comprise an electric switch and the source of energy may supply electric energy for the operation of the switch. The switch mentioned above may comprise an electronic switch or, where applicable, a mechanical switch.[0026]
• In accordance with the third particular embodiment, the operation device preferably comprises a motor, wherein the reversing device reverses the motor.[0027]
• In a fourth particular embodiment in accordance with the first and second main aspects of the invention, the prosthesis comprises hydraulic means, for example including an expansible/contractible cavity for fluid. Preferably, the operation device is adapted to conduct hydraulic fluid in the hydraulic means, and comprises a motor, a valveless fluid conduit connected to the hydraulic means of the prosthesis, and a reservoir for fluid, wherein the reservoir forms part of the conduit. The operation device suitably comprises a pump operated by the motor. All of the hydraulic components involved are preferably deviod of any non-return valve. This is of great advantage, because with valves involved there is always a risk of malfunction due to inproperly working valves, especially when long time periods pass between valve operations. The reservoir may form a fluid chamber with a variable volume, and the pump may distribute fluid from the chamber to the hydraulic means of the prosthesis by reduction of the volume of the chamber and withdraw fluid from the hydraulic means to the chamber by expansion of the volume of the chamber.[0028]
• In accordance with a third main aspect of the invention, the source of energy is implantable in the patient. Thus, when the source of energy is implanted in a patient the control device controls it from outside the patient's body to release energy. This solution is advantageous for embodiments of the apparatus that have a relatively high consumption of energy which cannot be satisfied by direct supply of wireless energy.[0029]
• The implantable source of energy may comprise an accumulator, preferably an electric source of energy, such as a battery having a lifetime of at least 10 years.[0030]
• In accordance with a fourth main aspect of the invention, the apparatus comprises a switch implanted in the patient for directly or indirectly switching the operation of the prosthesis and an internal source of energy, such as a battery, implanted in the patient for supplying energy for the operation of the prosthesis, wherein the switch directly or indirectly affects the supply of energy from the internal source of energy. This solution is advantageous for embodiments of the apparatus that have a relatively high energy consumption which cannot be met by direct supply of wireless energy.[0031]
• In a first particular embodiment in accordance with the fourth main aspect of the invention, 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 prosthesis. In this case, the switch is conveniently operated by the wireless energy released from the external source of energy to switch between the on and off modes. The control device, preferably comprising a wireless remote control, may control the external source of energy to release the wireless energy. The advantage of this embodiment is that the lifetime of the implanted source of energy, such as a battery, can be significantly prolonged, since the implanted source of energy does not supply energy when the switch is in its off mode.[0032]
• In a second particular embodiment in accordance with the fourth main aspect of the invention, the control device comprises a wireless remote control for controlling the internal source of energy. In this case, 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 prosthesis.[0033]
• In a third particular embodiment in accordance with the fourth main aspect of the invention, the apparatus further comprises an energy transforming device implanted in the patient for transforming the wireless energy into storable energy, wherein the internal source of energy is capable of storing the storable energy. The internal source of energy preferably comprises an electric 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. In this case, the switch switches from an off mode, in which the internal source of energy is not in use, to an on mode, in which the internal source of energy supplies energy for the operation of the prosthesis.[0034]
• The control device, preferably comprising a wireless remote control, may control the switch to switch between the on and off modes.[0035]
• Alternatively, in this third particular embodiment an energy storage device may be implanted in the patient for storing the storable energy instead of the internal source of energy, wherein the switch is operable by energy from the implanted energy storage device to switch 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 prosthesis. In this case, the control device (the wireless remote control) controls the energy storage device to operate the switch.[0036]
• The internal source of energy preferably comprises an electric source of energy, such as an accumulator or a battery having a lifetime of at least 10 years. However, other kinds of sources are also conceivable, such as a nuclear source of energy or a chemical source of energy.[0037]
• The above first, second, third and fourth particular embodiments described in connection with the first and second main aspects of the invention are also applicable in accordance with the third main aspect of the invention, i.e. where the source of energy is to be implanted, and in accordance with the fourth main aspect of the invention, i.e. where the apparatus comprises an implantable switch.[0038]
• All of the above embodiments may be combined with at least one implantable sensor for sensing at least one physical parameter of the patient, wherein the control device may control the prosthesis in response to signals from the sensor. For example, the sensor may directly or indirectly sense ejaculation or the pressure against the prosthesis or the pressure in the urethra or any other important physical parameter. The pressure sensor may be any suitable known or conventional pressure sensor such as shown in U.S. Pat. Nos. 5,540,731, 4,846,181, 4,738,267, 4,571,749, 4,407,296 or 3,939,823; or an NPC-102 Medical Angioplasty Sensor.[0039]
• Advantageously, the sensor may sense ejaculation and the prosthesis may make the penis flaccid in response to the sensor sensing that ejaculation has occurred.[0040]
• Where the control device comprises an internal control unit to be implanted in the patient, the internal control unit may suitably directly control the prosthesis in response to signals from the sensor. In response to signals from the sensor, for example pressure or any other important physical parameter, the internal control unit may send information thereon to outside the patient's body. The control unit may also automatically control the prosthesis in response to signals from the sensor, such as signals corresponding to ejaculation. For example, the control unit may control the prosthesis to make the penis flaccid in response to the sensor sensing an abnormally high pressure against the prosthesis.[0041]
• Where the control device comprises an external control unit outside the patient's body, the external control unit may, suitably directly, control the prosthesis in response to signals from the sensor. The external control unit may store information on the physical parameter sensed by the sensor and may be manually operated to control the prosthesis based on the stored information. In addition, there may be at least one implantable sender for sending information on the physical parameter sensed by the sensor.[0042]
• An external data communicator may be provided outside the patient's body and an internal data communicator to be implanted in the patient may be provided for communicating with the external data communicator. The internal data communicator may feed data related to the patient, or related to the prosthesis, back to the external data communicator. Alternatively or in combination, the external data communicator may feed data to the internal data communicator. The internal data communicator may suitably feed data related to at least one physical signal of the patient.[0043]
• The apparatus may comprise an implantable energy transforming device, wherein the control device releases electric energy and the energy transforming device transforms the electric energy into kinetic energy for, preferably direct, operation of the prosthesis. Suitably, an implantable stabiliser, such as a capacitor or a rechargeable accumulator, or the like, may be provided for stabilising the electric energy released by the control device. In addition, the control device may control the source of energy to release energy for a determined time period or in a determined number of energy pulses. Finally, the prosthesis may be non-inflatable.[0044]
• All of the above embodiments are preferably remote controlled. Thus, the control device advantageously comprises a wireless remote control transmitting at least one wireless control signal for controlling the prosthesis. With such a remote control it will be possible to adapt the function of the apparatus to the patient's need.[0045]
• The wireless remote control may be capable of obtaining information on the condition of the prosthesis and of controlling the prosthesis in response to the information. Also, the remote control may be capable of sending information related to the prosthesis from inside the patient's body to the outside thereof.[0046]
• In a particular embodiment of the invention, 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. In another particular embodiment of the invention, the wireless remote control comprises at least one external signal reciever or transceiver and at least one internal signal transmitter or transceiver implantable in the patient.[0047]
• The remote control may transmit a carrier signal for carrying the control signal, wherein the carrier signal is frequency, amplitude or frequency and amplitude modulated and is digital, analog or digital and analog. Also the control signal used with the carrier signal may be frequency, amplitude or frequency and amplitude modulated.[0048]
• The control signal may comprise a wave signal, for example, a sound wave signal, such as an ultrasound wave signal, an electromagnetic wave signal, such as an infrared light signal, a visible light signal, an ultra violet light signal, a laser signal, a micro wave signal, a radio wave signal, an x-ray radiation signal, or a gamma radiation signal. Where applicable, two or more of the above signals may be combined.[0049]
• The control signal may be digital or analog, and may comprise an electric or magnetic field. Suitably, the wireless remote control may transmit an electromagnetic carrier wave signal for carrying the digital or analog control signal. For example, use of an analog carrier wave signal carrying a digital control signal would give safe communication. The control signal may be transmitted in pulses by the wireless remote control.[0050]
• In all of the above solutions, the control device advantageously releases energy from the source of energy in a non-invasive, magnetic, non-magnetic, mechanical or non-mechanical manner.[0051]
• The control device may release magnetic, electromagnetic, kinetic, sonic or thermal energy, or non-magnetic, non-sonic, non-thermal, non-electromagnetic or non-kinetic energy.[0052]
• The control device may be activated in a manual or non-manual manner to control the source of energy to release energy.[0053]
• The operation device may be powered by magnetic energy, non-magnetic energy, electromagnetic energy, non-electromagnetic energy, kinetic energy, non-kinetic energy, thermal energy or non-thermal energy. However, preferably the operation device comprises an electrical operation device.[0054]
• Typically the apparatus of the invention comprises an adjustment device for adjusting the prosthesis between erect and flaccid penile conditions. The adjustment device may be adapted to mechanically adjust the prosthesis. Alternatively, the adjustment device may be adapted to hydraulically adjust the 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, i.e. the hydraulic fluid would not become more viscous when exposed to heat or influenced by magnetic forces.[0055]
• The above-presented embodiments of the invention may be modified in accordance with the following suggestions. The released energy may comprise electric energy and an implantable capacitor having a capacity less than 0.1 μF may be provided for producing the above-mentioned train of energy pulses.[0056]
• An implantable motor or pump may be provided 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. Specifically, the control device may be adapted to release wireless energy in the form of a magnetic field or electromagnetic waves (excluding radio waves) for direct power of the motor or pump, as the wireless energy is being released. Where a pump is used it preferably is not a plunger type of pump.[0057]
• Generally, the wireless energy comprises a signal.[0058]
• The apparatus may further comprise implantable energy transforming device for transforming wireless energy directly or indirectly into energy different than the wireless energy, for operation of the penile prosthesis. For example, the motor or pump may be powered by the transformed energy.[0059]
• The energy transforming device may transform the wireless energy in the form of sound waves, preferably directly, into electric energy for operation of the penile prosthesis. The energy transforming device may comprise a capacitor adapted to produce electric pulses from the transformed electric energy.[0060]
• The motor mentioned in the present specification may also be directly powered with wirelessly transmitted electromagnetic or magnetic energy in the form of signals, as the energy is transmitted. Furthermore, all the various functions of the motor and associated components described in the present specification may be used where applicable.[0061]
• Preferable the present invention provides an a male sexual impotence treatment prosthesis, comprising an prosthesis device implanted in the corpora cavernosa of the patients penis, who suffers from impotence and an adjustment device which temporarely achieve an ereccted status of the penis and an powered operation device which is able to perform a reversible function to adjust said adjustment device.[0062]
• In another embodiment of the invention the male sexual impotence treatment apparatus, comprising a hydraulic adjustment device, and further comprising a reservoir implantable in the patient and containing hydraulic fluid, and a conduit providing fluid connection between the reservoir and the hydraulic adjustment device, characterised in that 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.[0063]
• Alternatively, or in combination with a powered operation device, the servo means may be used, which enables manual manipulation without need for strong manipulation forces. The servo means may comprise hydraulic means, electric control means, magnetic means, or mechanical means, which may be activated by manual manipulating means. Using a servo system will save the use of force when adjusting the adjustment device, which may be of importance in many applications.[0064]
• The term “servo means” encompasses the normal definition of a servo mechanism, i.e. an automatic device that controls large amounts of power by means of very small amounts of power, but may alternatively or additionally encompass the definition of 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 servo means may comprise a motor, preferably an electric motor, which may be reversible and/or include a gearing.[0065]
• In accordance with another particular embodiment of the invention, the operation device comprises a pump for pumping fluid between the reservoir and the adjustment device. A mechanical solution is proposed in which it is possible to pump fluid from the reservoir to the adjustment device and vice versa just by pushing an activation member in one direction. The pump preferably comprises a first activation member for activating the pump to pump fluid from the reservoir to the adjustment device, and a second activation member for activating the pump to pump fluid from the adjustment device to the reservoir. At least one of the first and second activation members may be operable by manual manipulation, preferably to permit manual pushing, pulling or rotation thereof in one direction, or by a device powered magnetically, hydraulically, or electrically (e.g. by an electric motor), or be operable by a combination of these methods. Suitably, at least one of the activation members may be adapted to operate when subjected to an external pressure exceeding a predetermined magnitude.[0066]
• Another alternative is a pump pumping in only one direction and an adjustable valve to change the direction of fluid to either increase or decrease the amount of fluid in the reservoir. This valve may be manipulated either manually, mechanically, magnetically, or hydraulically.[0067]
• The main embodiment of the invention described above including the reservoir may alternatively be equipped with a servo means comprising a reverse servo. The term “reverse servo” is to be understood as a mechanism that transfers a strong force acting on a moving element having a short stroke into a weak force acting on another moving element having a long stroke; i.e. the reverse function of the above-defined alternative mechanism of a normal servo mechanism. A first closed hydraulic system that controls another closed hydraulic system in which hydraulic means of the adjustment device is incorporated may be used. Minor changes in the amount of fluid in a smaller reservoir of the first system could then be transferred by the reverse servo into major changes in the amount of fluid in a larger reservoir in the second system. In consequence, the change of volume in the larger reservoir of the second system affects the hydraulic means of the adjustment device. For example, a short stroke that decreases the volume of the smaller reservoir will cause the larger reservoir to supply the adjustment device with a large amount of hydraulic fluid, which in turn results in a long mechanical adjustment stroke on the restriction device.[0068]
• The great advantage of using such a reverse servo is that the larger volume system could be placed inside the abdomen or retroperitoneum where there is more space and still it would be possible to use manual manipulation means of the smaller system subcutaneously. The smaller reservoir could be controlled directly or indirectly by a fluid supply means. The fluid supply means may include another small reservoir, which may be placed subcutaneously and may be activated by manual manipulation means. Both the normal servo means and the specific reverse servo may be used in connection with all of the various components and solutions described in the present specification.[0069]
• Thus, the reverse servo may be adapted to provide relative displacement between the first and second wall portions of the reservoir, suitably in response to the pressure in the reservoir, in order to change the volume of the chamber of the reservoir.[0070]
• Generally, the servo means, including the reverse servo, comprises a pressure controlled servo means. The alarm mentioned above may alternatively be 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.[0071]
• The reverse servo may comprise magnetic means, electric means or manual manipulation means or a combination thereof. Preferably, however, the reverse servo comprises hydraulic means.[0072]
• In accordance with a particular embodiment of the invention, the reverse servo further comprises a servo reservoir defining a chamber containing servo fluid, and the operation device comprise first and second wall portions of the servo reservoir, which are displaceable relative to each other to change the volume of the chamber of the servo reservoir. The first and second wall portions of the servo reservoir may be displaceable relative to each other by magnetic means, hydraulic means, or electric control means.[0073]
• Where the reverse servo comprises hydraulic means it may further comprise a fluid supply reservoir connected to the servo reservoir in a closed system and containing a further predetermined amount of fluid. The fluid supply reservoir defines a chamber for the further predetermined amount of fluid and the operation device is adapted to change the volume of the chamber and thereby control the amount of fluid in the servo reservoir. The fluid supply reservoir comprises first and second wall portions, which are displaceable relative to each other to change the volume of the chamber of the fluid supply reservoir. Suitable, the fluid supply reservoir increases the amount of fluid in the servo reservoir in response to a predetermined first displacement of the first wall portion of the fluid supply reservoir relative to the second wall portion of the fluid supply reservoir and decreases the amount of fluid in the servo reservoir in response to a predetermined second displacement of the first wall portion of the fluid supply reservoir relative to the second wall portion of the fluid supply reservoir.[0074]
• Generally, the penile prosthesis advantageously is embedded in a soft or gel-like material, such as a silicone material having hardness less than 20 Shore.[0075]
• Of course, the penile prosthesis preferably is adjustable in a non-manual manner.[0076]
• All the above described various components, such as the motor, pump and capacitor, may be combined in the different embodiments where applicable. Also the various functions described in connection with the above embodiments of the invention may be used in different applications, where applicable.[0077]
• All the various ways of transferring energy and controlling the energy presented in the present specification may be practised by using all of the various components and solutions described.[0078]
• The present invention also provides a method of treating an impotent male patient, comprising: (a) surgically implanting an operable prosthesis in the corpora cavernosa of the male patient. (b) Providing a source of energy. (c) Controlling the source of energy to release energy for use in connection with the operation of the prosthesis.[0079]
• Steps (b) and (c) may further comprise providing the source of energy external to the patient's body and controlling the external source of energy from outside the patient's body to release wireless energy for use in connection with the operation of the prosthesis.[0080]
• The method may further comprise (d) implanting in the patient an operation device which can adjust the prosthesis in response to supplied energy, and (f) using the released wireless energy to operate the implanted operation device to achieve erect or flaccid penile condition.[0081]
• In accordance with an alternative method, there is provided a method of treating an impotent male patient, comprising the steps of placing at least two laparascopical trocars in the patient's body, inserting a tool through the trocars and using the tool to place an operable prosthesis in the cavities of the corpora cavernosa, providing a source of energy outside or inside the male patient's body, controlling the source of energy from outside the patient's body to release energy, which may comprise wireless energy where the source of energy is external to the patient's body, and using the released energy in connection with the operation of the prosthesis.[0082]
• In accordance with another alternative method, there is provided a method of treating an impotent male patient, comprising the steps of placing at least two laparascopical trocars in the male patient's body, inserting a tool through the trocars and using the tool to place an operable prosthesis in the cavities of the corpora cavernosa, implanting an energy transforming device, providing an external source of energy, controlling the external source of energy to release wireless energy, and transforming the wireless energy by the energy transforming device into energy different than the wireless energy for use in connection with the operation of the prosthesis. This method may further comprise implanting a stabiliser in the patient's body to stabilize the energy transformed by the energy transforming device.[0083]
• It is the primary object of the present invention to provide a simple yet effective apparatus for treating male sexual impotence. This and other objects of the invention will become clear from an inspection of the detailed description of the invention and from the appended claims.[0084]
• The invention is described in more detail in the following with reference to the accompanying drawings, in which[0085]
• FIGS.[0086]1 to6 are schematic block diagrams illustrating six embodiments, respectively, of the invention, in which wireless energy released from an external source of energy is used for direct operation of a prosthesis implanted in the penile tissue of a patient;
• FIGS.[0087]7 to10 are schematic block diagrams illustrating four embodiments, respectively, of the invention, in which energy is released from an implanted source of energy;
• FIGS.[0088]11 to15 are schematic block diagrams illustrating five embodiments, respectively, of the invention, in which a switch is implanted in the patient for directly or indirectly switching the operation of the prosthesis;
• FIG. 16 is a schematic block diagram illustrating conceivable combinations of implantable components for achieving various communication options;[0089]
• FIG. 17 illustrates the apparatus in accordance with the invention implanted in a patient;[0090]
• FIG. 18 is a block diagram illustrating remote control components of an embodiment of the invention; and[0091]
• FIG. 19 is a schematic view of exemplary circuitry used for the components of the block diagram of FIG. 18.[0092]
• Referring to the drawing figures, like reference numerals designate identical or corresponding elements throughout the several figures.[0093]
• FIG. 1 schematically shows an embodiment of the male sexual impotence treatment prosthesis apparatus of the invention having some parts implanted in a patient and other parts located outside the patient's body. Thus, in FIG. 1 all parts placed to the right of the patient's[0094]skin2 are implanted and all parts placed to the left of theskin2 are located outside the patient's body.
• The apparatus of FIG. 1 comprises an implanted[0095]operable prosthesis4, which is placed in the cavities of the corpora cavernosa of the patient's penis. The implantedprosthesis4 is capable of performing a reversible function, i.e. to erect the penis or to make the penis flaccid. An implantedcontrol unit6 controls the implantedprosthesis4 via a control line8 to achieve an adequate erection. Anexternal control unit10 includes an external source of energy and a wireless remote control transmitting a control signal generated by the external source of energy. The control signal is received by a signal receiver incorporated in the implantedcontrol unit6, whereby thecontrol unit6 controls the implantedprosthesis4 in response to the control signal. The implantedcontrol unit6 also uses energy from the control signal for directly operating the implantedprosthesis4 via apower supply line12, as the control signal is transmitted.
• FIG. 2 shows an embodiment of the invention identical to that of FIG. 1, except that a reversing device in the form of a[0096]switch14 also is implanted in the patient for reversing the implantedprosthesis4. Thecontrol unit6 uses theswitch14 to reverse the function performed by the implantedprosthesis4. More precisely, theexternal control unit10 releases energy carried by a wireless signal and the implantedcontrol unit6 transforms the wireless energy into a current for operating theswitch14. When thecontrol unit6 shifts the polarity of the current theswitch14 reverses the function performed by the implantedprosthesis4.
• FIG. 3 shows an embodiment of the invention identical to that of FIG. 1, except that an operation device in the form of a[0097]motor16 also is implanted in the patient. The implantedcontrol unit6 powers themotor16 with wireless energy released from the external source of energy of theexternal control unit10. The implantedcontrol unit6 controls the operation of themotor16 in response to a control signal from the remote control of theexternal control unit10.
• FIG. 4 shows an embodiment of the invention identical to that of FIG. 1, except that an[0098]assembly16 including a motor/pump unit18 and a fluid reservoir20 also is implanted in the patient. In this case theprosthesis4 is hydraulically operated, i.e. hydraulic fluid is pumped by the motor/pump unit18 from the reservoir20 through aconduit22 to theprosthesis4 to erect the penis, and hydraulic fluid is pumped by the motor/pump unit18 back from theprosthesis4 to the reservoir20 to make the penis flaccid. Theexternal control unit10 releases energy carried by a wireless signal and the implantedcontrol unit6 transforms the wireless energy into a current, for example a current, for powering the motor/pump unit18 via an electricpower supply line24. The implantedcontrol unit6 controls the motor/pump unit16 and theprosthesis4 viacontrol lines26 and27.
• FIG. 5 shows an embodiment of the invention comprising the[0099]prosthesis4, hydraulically operated, and the implantedcontrol unit6, and further comprising ahydraulic fluid reservoir230, a motor/pump unit232 and a reversing device in the form of a hydraulic valve shifting device234, all of which are implanted in the patient. The motor of the motor/pump unit232 is an electric motor.
• FIG. 6 shows an embodiment of the invention identical to that of FIG. 1, except that an[0100]accumulator28 also is implanted in the patient. Thecontrol unit6 stores energy received from theexternal control unit10 in theaccumulator28. In response to a control signal from theexternal control unit10 the implantedcontrol unit6 releases energy from theaccumulator28 via apower line30 for the operation of theprosthesis4.
• FIG. 7 shows an embodiment of the invention comprising the[0101]prosthesis4, hydraulically operated, and the implantedcontrol unit6, and further comprising a source of energy in the form of abattery32, ahydraulic fluid reservoir34, a motor/pump unit36 and a reversing device in the form of a hydraulicvalve shifting device38, all of which are implanted in the patient. The motor of the motor/pump unit36 is an electric motor. Anexternal control unit40 includes a wireless remote control transmitting a control signal which is received by the signal receiver incorporated in the implantedcontrol unit6.
• In response to a control signal from the[0102]external control unit40 the implantedcontrol unit6 powers the motor/pump unit36 with energy from thebattery32, whereby the motor/pump unit36 distributes hydraulic fluid between thereservoir34 and theprosthesis4. Thecontrol unit6 controls the shiftingdevice38 to shift the hydraulic fluid flow direction between one direction in which the fluid is pumped by the motor/pump unit36 from thereservoir34 to theprosthesis4 to erect the penis, and another opposite direction in which the fluid is pumped by the motor/pump unit36 back from theprosthesis4 to thereservoir34 to make the penis flaccid.
• FIG. 8 shows an embodiment of the invention identical to that of FIG. 6, except that a[0103]battery42 is substituted for theaccumulator28, theexternal control unit40 of the embodiment of FIG. 5 is substituted for theexternal control unit10 and anelectric motor44 is implanted in the patient for operating theprosthesis4. In response to a control signal from theexternal control unit40 the implantedcontrol unit6 powers themotor44 with energy from thebattery42, whereby themotor44 operates theprosthesis4.
• FIG. 9 shows an embodiment of the invention identical to that of FIG. 8, except that the motor/[0104]pump unit36 of the embodiment of FIG. 7 is substituted for themotor44 and afluid reservoir46 also is implanted in the patient. Thereservoir46 is viafluid conduits48 and50 connected to the motor/pump unit36 andprosthesis4, which in this case is hydraulically operated. In response to a control signal from theexternal control unit40, the implantedcontrol unit6 powers the electric motor of the motor/pump unit36 with energy from thebattery42, whereby the motor/pump unit36 distributes hydraulic fluid between thefluid reservoir46 and theprosthesis4.
• FIG. 10 shows an embodiment of the invention identical to that of FIG. 8, except that a mechanical reversing device in the form of[0105]a-gearbox52 also is implanted in the patient. The implantedcontrol unit6 controls thegearbox52 to reverse the function performed by the prosthesis4 (mechanically operated).
• FIG. 11 shows an embodiment of the invention comprising the[0106]prosthesis4, theexternal control unit10, an implanted source ofenergy236 and an implantedswitch238. Theswitch238 is operated by wireless energy released from the external source of energy of theexternal control unit6 to switch between an off mode, in which the implanted source ofenergy236 is not in use, and an on mode, in which the implanted source ofenergy236 supplies energy for the operation of theprosthesis4.
• FIG. 12 shows an embodiment of the invention identical to that of FIG. 11, except that also the[0107]control unit6 is implanted, in order to receive a control signal from the wireless remote control of theexternal control unit10. Theswitch238 is operated by the wireless energy from the external source ofenergy10 to switch between an off mode, in which the implanted source ofenergy236 and the wireless remote control of theexternal control unit10 are not in use, i.e. thecontrol unit6 is not capable of receiving the control signal, and a standby mode, in which the wireless remote control is permitted to control the internal source ofenergy236, via the implantedcontrol unit6, to supply energy for the operation of theprosthesis4.
• FIG. 13 shows an embodiment of the invention identical to that of FIG. 12, except that an energy transforming device for transforming the wireless energy into storable energy is incorporated in the implanted[0108]control unit6 and that the implanted source ofenergy236 is of a type that is capable of storing the storable energy. In this case, in response to a control signal from theexternal control unit10, the implantedcontrol unit6 controls theswitch238 to switch from an off mode, in which the implanted source ofenergy236 is not in use, to an on mode, in which the source ofenergy36 supplies energy for the operation of theprosthesis4.
• FIG. 14 shows an embodiment of the invention identical to that of FIG. 13, except that an[0109]energy storage device240 also is implanted in the patient for storing the storable energy transformed from the wireless energy by the transforming device of thecontrol unit6. In this case, the implantedontrol unit6 controls theenergy storage device240 to operate theswitch238 to switch between an off mode, in which the implanted source ofenergy236 is not in use, and an on mode, in which the implanted source ofenergy236 supplies energy for the operation of theprosthesis4.
• FIG. 15 shows an embodiment of the invention identical to that of FIG. 13, except that a[0110]motor242 and a mechanical reversing device in the form of agearbox244 also are implanted in the patient. The implantedcontrol unit6 controls thegearbox244 to reverse the function performed by the prosthesis4 (mechanically operated), i.e. erecting the penis and making the penis flaccid.
• FIG. 16 schematically shows conceivable combinations of implanted components of the apparatus for achieving various communication possibilities. Basically, there are the implanted[0111]prosthesis4, the implantedcontrol unit6 and theexternal control unit10 including the external source of energy and the wireless remote control. As already described above the remote control transmits a control signal generated by the external source of energy, and the control signal is received by a signal receiver incorporated in the implantedcontrol unit6, whereby thecontrol unit6 controls the implantedprosthesis4 in response to the control signal.
• A sensor[0112]54 may be implanted in the patient for sensing a physical parameter of the patient, such as the pressure in the stomach. Thecontrol unit6, or alternatively theexternal control unit10, may control theprosthesis4 in response to signals from the sensor54. A transceiver may be combined with the sensor54 for sending information on the sensed physical parameter to theexternal control unit10. The wireless remote control of theexternal control unit10 may comprise a signal transmitter or transceiver and the implantedcontrol unit6 may comprise a signal receiver or transceiver. Alternatively, the wireless remote control of theexternal control unit10 may comprise a signal receiver or transceiver and the implantedcontrol unit6 may comprise a signal transmitter or transceiver. The above transceivers, transmitters and receivers may be used for sending information or data related to the prosthesis from inside the patient's body to the outside thereof.
• The[0113]motor44 may be implanted for operating theprosthesis4 and also thebattery32 may be implanted for powering themotor44. Thebattery32 may be equipped with a transceiver for sending information on the charge condition of the battery.
• Those skilled in the art will realize that the above various embodiments according to FIGS.[0114]1-15 could be combined in many different ways. For example, the energy operatedswitch14 could be incorporated in any of the embodiments of FIGS.4,6,8-10. Thehydraulic shifting device38 could be incorporated in any of the embodiments of FIGS. 4 and 9. Thegearbox52 could be incorporated in any of the embodiments of FIGS. 1,6 and8.
• FIG. 17 illustrates how any of the above-described embodiments of the impotence treatment prosthesis apparatus of the invention may be implanted in a patient. Thus, the apparatus comprises a prosthesis including two[0115]elongated balloon elements56 implanted in the cavities of the corpora cavernosa of the patient'spenile tissue58, and an implantedhydraulic operation device60 for operating theprosthesis elements56. A control device in the form of a wireless remote control comprises an implantedcontrol unit62, which includes a signal receiver, for controlling theoperation device60, and anexternal control unit64 including a signal transmitter for transmitting a control signal to the signal receiver of the implantedcontrol unit62. The implantedcontrol unit62 is capable of transforming signal energy from the control signal into electric energy for powering theoperation device60 and for energizing electric energy consuming implanted components of the apparatus. When the patient desires to achieve erection, he uses theexternal control unit64 to activate theoperation device60 to distribute hydraulic fluid into the twoballoon elements56, whereby eachelement56 is inflated and assumes the shape of a straight rod as indicated in FIG. 17.
• FIG. 18 shows the basic parts of a wireless remote control of the apparatus of the invention including an[0116]electric motor128 for operating a prosthesis, for example of the type illustrated in FIG. 17. In this case, the remote control is based on the transmission of electromagnetic wave signals, often of high frequencies in the order of 100 kHz-1 gHz, through theskin130 of the patient. In FIG. 18, all parts placed to the left of theskin130 are located outside the patient's body and all parts placed to the right of theskin130 are implanted. Any suitable remote control system may be used.
• An external[0117]signal transmitting antenna132 is to be positioned close to a signal receiving antenna134 implanted close to theskin130. As an alternative, the receiving antenna134 may be placed for example inside the abdomen of the patient. The receiving antenna134 comprises a coil, approximately 1-100 mm, preferably 25 mm in diameter, wound with a very thin wire and tuned with a capacitor to a specific high frequency. A small coil is chosen if it is to be implanted under the skin of the patient and a large coil is chosen if it is to be implanted in the abdomen of the patient. The transmittingantenna132 comprises a coil having about the same restriction as the coil of the receiving antenna134 but wound with a thick wire that can handle the larger currents that is necessary. The coil of the transmittingantenna132 is tuned to the same specific high frequency as the coil of the receiving antenna134.
• An[0118]external control unit136 comprises a microprocessor, a high frequency electromagnetic wave signal generator and a power amplifier. The microprocessor of thecontrol unit136 is adapted to switch the generator on/off and to modulate signals generated by the generator to send digital information via the power amplifier and theantennas132,134 to an implantedcontrol unit138. To avoid that accidental random high frequency fields trigger control commands, digital signal codes are used. A conventional keypad placed on theexternal control unit136 is connected to the microprocessor thereof. The keypad is used to order the microprocessor to send digital signals to activate the prosthesis to either restrict or enlarge the blood flow passageway. The microprocessor starts a command by applying a high frequency signal on theantenna132. After a short time, when the signal has energized the implanted parts of the control system, commands are sent to restrict or enlarge the blood flow passageway in predefined steps. The commands are sent as digital packets in the form illustrated below.

  	Start pattern,	Command,	Count,	Checksum,
  	8 bits	8 bits	8 bits	8 bits

• The commands are sent continuously during a rather long time period (e.g. about 30 seconds or more). When a new restrict or enlarge step is desired the Count byte is increased by one to allow the implanted[0119]control unit138 to decode and understand that another step is demanded by theexternal control unit136. If any part of the digital packet is erroneous, its content is simply ignored.
• Through a[0120]line140, an implantedenergizer unit126 draws energy from the high frequency electromagnetic wave signals received by the receiving antenna134. Theenergizer unit126 stores the energy in a power supply, such as a large capacitor, powers thecontrol unit138 and powers theelectric motor128 via aline142.
• The[0121]control unit138 comprises a demodulator and a microprocessor. The demodulator demodulates digital signals sent from theexternal control unit136. The microprocessor of thecontrol unit138 receives the digital packet, decodes it and, provided that the power supply of theenergizer unit126 has sufficient energy stored, sends a signal via asignal line144 to themotor128 to operate the prosthesis to either erect the penis or make the penis flaccid depending on the received command code.
• Alternatively, the energy stored in the power supply of the energizer unit may only be used for powering a switch, and the energy for powering the[0122]motor128 may be obtained from another implanted power source of relatively high capacity, for example a battery. In this case the switch is adapted to connect the battery to thecontrol unit138 in an on mode when the switch is powered by the power supply and to keep the battery disconnected from the control unit in a standby mode when the switch is unpowered.
• With reference to FIG. 19, the remote control schematically described above will now be described in accordance with a more detailed embodiment. The[0123]external control unit136 comprises amicroprocessor146, asignal generator148 and apower amplifier150 connected thereto. Themicroprocessor146 is adapted to switch thesignal generator148 on/off and to modulate signals generated by thesignal generator148 with digital commands that are sent to implanted components of the apparatus. Thepower amplifier150 amplifies the signals and sends them to the externalsignal transmitting antenna132. Theantenna132 is connected in parallel with acapacitor152 to form a resonant circuit tuned to the frequency generated by thesignal generator148.
• The implanted signal receiving antenna coil[0124]134 forms together with a capacitor154 a resonant circuit that is tuned to the same frequency as the transmittingantenna132. The signal receiving antenna coil134 induces a current from the received high frequency electromagnetic waves and a rectifyingdiode160 rectifies the induced current, which charges astorage capacitor158. Acoil156 connected between the antenna coil134 and thediode160 prevents thecapacitor158 and thediode160 from loading the circuit of the signal receiving antenna134 at higher frequencies. Thus, thecoil156 makes it possible to charge thecapacitor158 and to transmit digital information using amplitude modulation.
• A[0125]capacitor162 and aresistor164 connected in parallel and adiode166 forms a detector used to detect amplitude modulated digital information. A filter circuit is formed by aresistor168 connected in series with aresistor170 connected in series with acapacitor172 connected in series with theresistor168 via ground, and acapacitor174, one terminal of which is connected between theresistors168,170 and the other terminal of which is connected between thediode166 and the circuit formed by thecapacitor162 andresistor164. The filter circuit is used to filter out undesired low and high frequencies. The detected and filtered signals are fed to an implanted microprocessor176 that decodes the digital information and controls themotor128 via an H-bridge178 comprisingtransistors180,182,184 and186. Themotor128 can be driven in two opposite directions by the H-bridge178.
• The microprocessor[0126]176 also monitors the amount of stored energy in thestorage capacitor158. Before sending signals to activate themotor128, the microprocessor176 checks whether the energy stored in thestorage capacitor158 is enough. If the stored energy is not enough to perform the requested operation, the microprocessor176 waits for the received signals to charge thestorage capacitor158 before activating themotor128.

Claims (142)

1. A male sexual impotence treatment prosthesis apparatus, comprising an operable penile prosthesis implantable in the cavities of the corpora cavernosa of a patient to provide erect penile condition, when the prosthesis is operated, characterised in that a source of energy is provided, and a control device operable from outside the patient's body is provided for controlling the source of energy to release energy for use in connection with the operation of the prosthesis, when the prosthesis is implanted.

2. An apparatus according toclaim 1, 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.

3. An apparatus according toclaim 1 or2, wherein the control device controls the prosthesis.

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

5. An apparatus according toclaim 4, wherein the internal control-unit is programmable.

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

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

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

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

10. An apparatus according toclaim 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 toclaim 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 toclaim 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 toclaim 1, wherein the source of energy is implantable in the patient.

14. An apparatus according toclaim 13, 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.

15. An apparatus according toclaim 14, wherein the implantable source of energy comprises an electric source of energy.

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

17. An apparatus according to any of claims1-16, wherein the control device controls the penile prosthesis.

18. An apparatus according toclaim 2, further comprising an energy storage device implantable in the patient for storing the wireless energy released from the external source of energy.

19. An apparatus according toclaim 18, wherein the energy storage device comprises an accumulator.

20. An apparatus according toclaim 19, wherein the accumulator comprises an electric accumulator.

21. An apparatus according toclaim 20, wherein the electric accumulator comprises at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery.

22. An apparatus according toclaim 1 or2, further comprising a battery implantable in the patient for supplying electric energy to implantable electric energy consuming components of the apparatus.

23. The apparatus according toclaim 2, 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.

24. The apparatus according toclaim 23, 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.

25. The apparatus according toclaim 23 or24, wherein the penile prosthesis is operable in a non-magnetic, non-thermal or non-mechanical manner by use of said released wireless energy.

26. The apparatus according to any of claims1,2 and17, further comprising a switch implantable in the patient for directly or indirectly switching the operation of the penile prosthesis.

27. The apparatus according toclaim 26, further comprising an internal source of energy implantable in the patient for supplying energy for the operation of the penile prosthesis, wherein the switch directly or indirectly affects the supply of energy from the internal source of energy.

28. The apparatus according toclaim 27, 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.

29. The apparatus according toclaim 2 and28, wherein the switch is operable by the wireless energy released from the external source of energy.

30. The apparatus according toclaim 29, wherein the control device controls the external source of energy to release the wireless energy.

31. The apparatus according to any of claims1,2 and30, wherein the control device comprises a wireless remote control.

32. The apparatus according toclaim 27, wherein the control device comprises a wireless remote control for controlling the internal source of energy.

33. The apparatus according toclaim 32, 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.

34. The apparatus according toclaim 27, further comprising an energy transforming device implantable in the patient for transforming the wireless energy into storable energy and an energy storage device implantable in the patient for storing the storable energy.

35. The apparatus according toclaim 34, wherein the switch is operable by energy from the implantable energy storage device to switch 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.

36. The apparatus according toclaim 35, wherein the control device controls the energy storage device to operate the switch.

37. The apparatus according toclaim 17 or36, wherein the control device comprises a wireless remote control.

38. The apparatus according toclaim 27, further comprising an energy transforming device implantable in the patient for transforming the wireless energy into storable energy, wherein the internal source of energy is capable of storing the storable energy.

39. The apparatus according toclaim 38, wherein the switch switches from an “off” mode, in which the internal source of energy is not in use, to an “on” mode, in which the source of energy supplies energy for the operation of the penile prosthesis.

40. The apparatus according toclaim 39, wherein the control device controls the switch to switch between the “on” and “off” modes.

41. The apparatus according toclaim 40, wherein the control device comprises a wireless remote control.

42. The apparatus according toclaim 27, wherein the internal source of energy comprises an electric source of energy.

43. The apparatus according toclaim 42, wherein the electric 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.

44. The apparatus according toclaim 42, wherein the electric source of energy comprises an accumulator or a battery having a lifetime of at least 10 years.

45. The apparatus according toclaim 1, wherein the source of energy comprises a nuclear source of energy.

46. The apparatus according toclaim 1, wherein the source of energy comprises a chemical source of energy.

47. An apparatus according to any one of claims1,2,13 or26, further comprising an operation device implantable in the patient for operating the penile prosthesis.

48. An apparatus according toclaim 2 or23, further comprising an operation device implantable in the patient for operating the penile prosthesis, wherein the wireless energy directly or indirectly powers the operation device.

49. An apparatus according toclaim 47 or48, wherein the control device controls the operation device to operate the penile prosthesis.

50. An apparatus according toclaim 49, wherein the operation device comprises hydraulic means and at least one valve for controlling a fluid flow in the hydraulic means.

51. An apparatus according toclaim 50, wherein the control device comprises a wireless remote control for controlling the valve.

52. An apparatus according toclaim 49, 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.

53. An apparatus according toclaim 47 or49, wherein the operation device comprises a motor.

54. An apparatus according toclaim 53, wherein the motor comprises a rotary motor, and the control device controls the rotary motor to rotate a desired number of revolutions.

55. An apparatus according toclaim 53, wherein the motor comprises a linear motor.

56. An apparatus according toclaim 53, wherein the motor comprises a hydraulic or pneumatic fluid motor, and the control device controls the fluid motor.

57. An apparatus according toclaim 53, wherein the motor comprises an electric motor having electrically conductive parts made of plastics.

58. An apparatus according to any one of claims1,47-49, wherein the control device releases polarized energy from the source of energy.

59. An apparatus according to any one of claims47-49, wherein the control device shifts polarity of the released energy to reverse the operation device.

60. An apparatus according to any one of claims47-49, wherein the operation device comprises an electric motor and the released energy comprises electric energy.

61. An apparatus according to any one of claims1,13,47-49 and53, wherein the penile prosthesis is operable to perform a reversible function.

62. An apparatus according toclaim 61, further comprising a reversing device implantable in the patient for reversing the function performed by the penile prosthesis.

63. An apparatus according toclaim 62, wherein the control device controls the reversing device to reverse the function performed by the penile prosthesis.

64. An apparatus according toclaim 62, wherein the reversing device comprises hydraulic means including a valve for shifting the flow direction of a fluid in the hydraulic means.

65. An apparatus according toclaim 62, wherein the reversing device comprises a mechanical reversing device.

66. An apparatus according toclaim 65, wherein the mechanical reversing device comprises a switch.

67. An apparatus according toclaim 65, wherein the reversing device comprises a gearbox.

68. An apparatus according toclaim 62, wherein the reversing device comprises a switch.

69. An apparatus according toclaim 68, wherein the switch of the reversing device is operable by the released energy.

70. An apparatus according toclaim 69, 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.

71. An apparatus according toclaim 68, wherein the switch comprises an electric switch and the source of energy supplies electric energy for the operation of the switch.

72. An apparatus according toclaim 68, wherein the operation device comprises a motor, and the reversing device reverses the motor.

73. An apparatus according to any of claims1,2,13,47-49, wherein the penile prosthesis comprises hydraulic means and the operation device is adapted to conduct a hydraulic fluid in the hydraulic means.

74. An apparatus according toclaim 73, wherein the operation device comprises a motor.

75. An apparatus according toclaim 73 or74, 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.

76. An apparatus according toclaim 75, wherein the hydraulic means and conduit are devoid of any non-return valve.

77. An apparatus according toclaim 76, 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.

78. An apparatus according to any of the preceding claims, further comprising at least one implantable sensor for sensing at least one physical parameter of the patient.

79. An apparatus according toclaim 78, wherein the sensor is adapted to directly or indirectly sense as the physical parameter ejaculation or the pressure in the urethra.

80. An apparatus according toclaim 78 or79, wherein the control device controls the penile prosthesis in response to signals from the sensor.

81. An apparatus according toclaim 80, 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.

82. An apparatus according toclaim 81, 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.

83. An apparatus according toclaim 82, 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.

84. An apparatus according to any of claims78-83, further comprising at least one implantable sender for sending information on the physical parameter sensed by the sensor.

85. An apparatus according to any of the preceding claims, further comprising an external data communicator intended to be outside the patient's body and an internal data communicator implantable in the patient for communicating with the external communicator, wherein the internal data communicator feeds data related to the patient back to the external data communicator or the external data communicator feeds data to the internal data communicator.

86. An apparatus according toclaim 85, wherein the internal data communicator feeds data related to the penile prosthesis.

87. An apparatus according toclaim 85 or86, wherein the implantable communicator feeds data related to at least one physical signal of the patient.

88. An apparatus according to any of the preceding claims, wherein the prosthesis is adapted to control the penis to change between flaccid and erect penile condition.

89. An apparatus according toclaim 88, wherein the prosthesis is operable to erect the penis or to make it flaccid.

90. An apparatus according toclaim 88 or89, wherein the prosthesis is adapted to control the penis to steplessly change between flaccid and erect penile condition.

91. An apparatus according to any of the preceding claims, further comprising an implantable energy transforming device, wherein the control device is adapted to control the 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.

92. An apparatus according toclaim 91, wherein the prosthesis is directly operated with the kinetic energy, as the energy transforming device transforms the electric energy into the kinetic energy.

93. An apparatus according to any of the preceding claims, 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.

94. An apparatus according to any of the preceding claims, wherein the prosthesis is non-inflatable.

95. An apparatus according to any of the preceding claims, wherein the control device controls the source of energy to release energy for a determined time period.

96. An apparatus according to any of claims1-94, wherein the control device controls the source of energy to release energy in a determined number of energy pulses.

97. An apparatus according to any of the preceding claims, wherein the control device is adapted to control the source of energy to release energy in a non-invasive manner.

98. An apparatus according to any of the preceding claims, wherein the control device comprises a wireless remote control for transmitting at least one wireless control signal for controlling the prosthesis.

99. An apparatus according toclaim 98, 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.

100. An apparatus according toclaim 98 or99, 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.

101. An apparatus according toclaim 98 or99, 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.

102. An apparatus according to any of claims98-101, wherein the remote control is capable of sending information related to the prosthesis from inside the patient's body to the outside thereof.

103. An apparatus according toclaim 102, wherein the remote control controls the prosthesis in response to the information.

104. An apparatus according to any of claims98-103, wherein the remote control transmits a carrier signal for carrying the control signal.

105. An apparatus according toclaim 104, wherein the carrier signal is frequency, amplitude or frequency and amplitude modulated.

106. An apparatus according toclaim 104 or105, wherein the carrier signal is digital, analog or digital and analog.

107. An apparatus according to any of claims104-106, wherein the control signal used with the carrier signal is frequency, amplitude or frequency and amplitude modulated.

108. An apparatus according to any of claims98-107, 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.

109. An apparatus according to claim98-107, wherein the control signal comprises an electric, a magnetic or an electric and magnetic field.

110. An apparatus according to any of claims98-108, wherein the control signal is digital, analog or digital and analog.

111. An apparatus according toclaim 110, wherein the remote control transmits an electromagnetic carrier wave signal for carrying the digital or analog control signal.

112. An apparatus according to any of claims98-111, wherein the control signal is transmitted in pulses by the wireless remote control.

113. An apparatus according to any of claims2,23-25,89-91, further comprising an implantable stabiliser for stabilising the energy released by the control device.

114. An apparatus according toclaim 113, wherein the energy released by the control device comprises electric energy and the stabiliser comprises at least one capacitor.

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

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

117. An apparatus according toclaim 23 or24, 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.

118. An apparatus according toclaim 1, further comprising an adjustment device for adjusting the penile prosthesis to change the size of the stoma opening, 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.

119. An apparatus according toclaim 47, wherein the operation device comprises an electrical operation device.

120. An apparatus according toclaim 47, 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.

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

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

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

124. An apparatus according toclaim 122 or123, wherein the electrical components are devoid of any current detector and/or charge level detector.

125. An apparatus according to any of claims121-124, 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 toclaim 23, wherein the released energy comprises electric energy and further comprising an implantable capacitor for producing the train of energy pulses.

127. An apparatus according toclaim 125 or126, wherein the capacitor has a capacity less than 0.1 μF.

128. An apparatus according to any of claims1,2,23 and24, 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.

129. An apparatus according toclaim 23, wherein the wireless energy comprises electromagnetic waves excluding radio waves.

130. An apparatus according to any of claims2,23 and24, 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.

131. An apparatus according toclaim 130, wherein the pump is not a plunger type of pump.

132. An apparatus according to any of claims2,23 or24, wherein the wireless energy comprises a signal.

133. An apparatus according toclaim 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 penile prosthesis.

134. An apparatus according toclaim 133, wherein the energy transforming device transforms the wireless energy in the form of sound waves into electric energy for operation of the penile prosthesis.

135. An apparatus according toclaim 134, wherein the energy transforming device transforms the wireless energy in the form of sound waves directly into electric energy.

136. An apparatus according toclaim 134 or135, wherein the energy transforming device comprises a capacitor.

137. An apparatus according toclaim 136, wherein the capacitor is adapted to produce electric pulses from the transformed electric energy.

138. An apparatus according to any of claims133-137, further comprising an implantable motor or pump for operating the penile prosthesis, wherein the motor or pump is powered by the transformed energy.

139. An apparatus according toclaim 1, wherein the penile prosthesis is adjustable in a non-manual manner.

140. An apparatus according to any of the preceding claims, wherein the penile prosthesis is embedded in a soft or gel-like material.

141. An apparatus according to any of the preceding claims, wherein the penile prosthesis is embedded in a silicone material having hardness less than 20 Shore.

142. An apparatus according toclaim 23, further comprising an activatable source of energy implantable in the patient, wherein the implantable 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 restriction device.

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