This application is a divisional application with application number 01804891.9.
It is an object of the present invention to provide a simple male sexual impotence treatment apparatus, which is normally controlled by the patient.
The above object is achieved with an apparatus of the kind mentioned initially, which is characterized by an energy transmission device for wireless transmission of energy from outside the patient's body to inside the patient's body for use in connection with the operation of the restriction device, which operation comprises temporarily contracting said tissue portion for restricting penile outflow in the blood flow passageway for achieving erection.
Thus, the advantages can be obtained: the impotence treatment apparatus of the invention provides simple and effective energy transfer which ensures that the apparatus can function reliably for the remainder of the patient's life for an extended period of time, at least many years.
The restriction device preferably controls the cross-sectional area of the passageway through which blood flow leaves the penis, which gives the advantage that: the patient can adjust the restriction device to achieve the desired erection without feeling pain. This advantage should not be underestimated, since fine adjustments to restrict the cross-sectional area of the passageway will allow maximum erection with minimal restriction.
Generally, the apparatus comprises an energy transforming device implantable in the patient for transforming the energy wirelessly transmitted by the energy transmission device from a first form into a second form, preferably different from the first form.
The energy conversion device comprises at least one semiconductor component or a circuit of semiconductor components. The semiconductor component comprises a transistor or microchip or similar electronic assembly. However, the semiconductor device does not include a rectifier diode.
In accordance with a main embodiment of the invention, the energy transforming device comprises at least one element having a positive region and a negative region and adapted to form an energy field between the positive and negative regions when exposed to the energy of the first form transmitted by the energy transmission device, whereby the energy field provides the energy of the second form. Generally, the above-mentioned semiconductor component may comprise such an element.
In accordance with a preferred embodiment of the present invention the element comprises an electrical junction element which induces an electric field between the positive and negative regions when exposed to the energy of the first form transmitted by the energy transmission device, whereby the energy of the second form comprises electric energy.
Thus, the restriction device is suitably electrically controlled, such that the positive and negative regions of the electrical junction element provide electrical energy for operation of the restriction device. The device comprises implantable electrical conductors connected to the positive and negative regions of the electrical junction element in a suitable manner, so that the electrical junction element can supply an electrical current, such as a direct current, a pulsating direct current, a combination of a direct and pulsating direct current, an alternating current or a combination of a direct and alternating current, via the conductors. Furthermore, the electrical junction element can provide a frequency, amplitude or frequency and amplitude modulated analog, digital or a combination of analog and digital signals which are used to control the restriction device.
Preferably, the element in the form of an electrical semiconductor junction element is designed to generate an output current in excess of 1 mua when exposed to the energy of the first form transmitted by the energy transmission device. Suitably, the electrical junction element constitutes a flat and thin plate and has a thickness of less than 2000cm3Is suitable for subcutaneous implantation, and thus, the electrical junction element may be located subcutaneously in a patient. Alternatively, the above-described elements may be implanted in the thorax or cephalic region of a patient, or in an orifice in the body of a patient and in the mucosa or cavity outside the mucosa of the orifice. Of course, all components of the energy transforming device including the electrical junction element in contact with the patient's body should be of a biocompatible material.
In the case of extracorporeal devices, a special type of electrical semiconductor junction element, the so-called p-n (positive/negative) junction element, generally in the form of a solar cell, has been commonly used. Solar cells convert solar energy in the form of visible light into electrical energy in the form of direct current. For example, a P-n junction element may comprise two layers of semiconductor, one P-type (positive) and the other n-type (negative), which together form a "P-n junction". Such a p-n junction can induce an electric field across the element when absorbing light quanta (photons).
In particular, photons transfer their energy to some of the semiconductor electrons, which are able to move through the material. For such negatively charged electrons, corresponding positive charges- "holes" are formed. In a normal semiconductor, these electrons and holes are recombined after a short time, and their energy is wasted as heat. However, when electrons and holes are swept across the p-n junction in opposite directions by the electric field, the separation of the charges results in a voltage across the p-n junction element. By connecting the p-n junction element to an external circuit, electrons can flow, thereby forming a current.
It has been shown that although skin and subcutaneous tissue can absorb energy from an external light beam illuminating the portion of skin under which a suitably designed p-n junction element is placed, light energy transmitted through the skin can result in a current from the p-n junction element that is strong enough (1 μ A minimum) to enable the electrically controlled restriction device to operate. Thus, such p-n junction elements are currently used for the first time in vivo applications.
The apparatus may comprise an implantable pulse generator for generating electrical pulses from the energy of the second form generated by the energy field.
Generally, the energy transforming device is adapted to transform the energy of the first form directly or indirectly into the energy of the second form.
In accordance with a preferred embodiment of the invention, the energy of the second form comprises electric energy and the energy transforming device comprises a capacitor for generating electric pulses from the transformed electric energy. Preferably, the capacitor is adapted to produce the pulses when the energy transforming device transforms the energy of the first form transmitted by the energy transmission device into the electric energy of the second form. The capacitance should be small to facilitate implantation, i.e., not exceed 0.1 muf in capacitance.
The apparatus may comprise an implantable stabiliser for stabilising the energy of the second form. If the energy of the second form comprises a current, the stabilizer may comprise at least a capacitor of the type described above.
In most embodiments of the invention, the apparatus comprises implantable electrical components. If the electrical components comprise capacitors or accumulators of the type mentioned above, at least one, preferably individual, voltage level guard (voltage level guard) is preferably provided, wherein the charging and discharging of the capacitors or accumulators is controlled by the voltage level guard. Thus, there is no need for any implanted current detector and/or charge level detector for controlling the capacitance, which makes the aforementioned device simple and reliable.
In a particular embodiment of the invention, the wireless energy of the first form comprises sound waves and the energy of the second form comprises electric energy, wherein the energy transforming device is adapted to directly transform the sound waves into electric energy.
The apparatus may comprise an implantable motor or pump for operating the restriction device, wherein the motor or pump is powered by the transformed energy.
In accordance with a main aspect of the invention, the energy transforming device may be adapted to transmit wireless energy for direct use in connection with the operation of the restriction device. The advantage of using energy directly when transferring energy is that the device can be of a very simple construction and that the inclusion of a small number of components makes the device very reliable. For example, the energy transmission device may be used to directly power a motor or pump with wireless energy. The wireless energy may comprise a magnetic field or electromagnetic waves, suitably in the form of signals, to directly power the motor or pump. All of the functions of the motor and its associated components described herein may be used where applicable
As an alternative to the above-mentioned main aspect of the invention, the energy transforming device may be adapted to supply the energy of the second form for direct use in connection with the operation of the restriction device, as the energy of the first form is transformed into the energy of the second form. Thus, the energy transforming device may directly power the motor or pump with the energy of the second form.
Generally, the energy transforming device may directly operate the restriction device with the energy of the second form in a non-magnetic, non-thermal or non-mechanical manner.
If the apparatus comprises an electric motor for directly or indirectly operating the restriction device, the energy transforming device may power the electric motor with the energy of the second form. Suitably, the restriction device is operable to perform a reversible function, and the motor is operable to reverse the function.
In accordance with another embodiment of the invention, the restriction device comprises a hydraulic restriction device, and the apparatus comprises an implantable pump for operating the hydraulic restriction device, wherein the energy transforming device supplies the energy of the second form to drive the pump. Most preferably, the pump is not a piston pump, but includes a peristaltic pump or a diaphragm pump.
The energy transforming device is preferably capable of generating an electric current exceeding 1 μ A as the energy of the second form when delivering the energy of the second form transmitted by the energy transmission device.
The apparatus may comprise an implantable adjustment device for adjusting the restriction device to change the restriction of the faecal passageway. In accordance with a first alternative, the adjustment device is adapted to mechanically adjust the restriction device. In accordance with a second alternative, the adjustment device is adapted to hydraulically adjust the restriction device using implanted hydraulic means. The hydraulic device does not use hydraulic fluid of the kind having a viscosity that increases significantly when exposed to heat or a magnetic field.
The device of the present invention is not limited to the use of visible light for wireless transmission of energy. Thus, in accordance with a broad aspect of the invention, the energy transmission device transmits energy via at least one wireless signal preferably containing radiant energy.
The wireless signals may include waveform signals, including, for example, electromagnetic wave signals, such as infrared light signals, visible light signals, ultraviolet light signals, laser light signals, microwave signals, radio wave signals, x-ray radiation signals, and gamma radiation signals. Where applicable, one or more of the above may be combined. In addition, the waveform signal may include a sound wave signal such as an ultrasonic signal. Generally, the wireless signals may include digital, analog, or digital and analog signals.
The energy of the first form transmitted by the energy transmission device may comprise an electric or magnetic field transmitted in pulses, for example digital pulses. Furthermore, the energy transforming device may transform the energy of the first form comprising polarized energy into direct current, pulsed direct current, a combination of direct and pulsed direct current, alternating current or a combination of direct and alternating current. Additionally, the energy of the first form may comprise kinetic energy.
The energy of the second form may comprise frequency, amplitude or frequency and amplitude modulated analog, digital or combined analog and digital signals.
The restriction device is non-inflatable, i.e. without hydraulic fluid for adjusting the restriction device. This eliminates the problem of fluid leaking from the restriction device.
The apparatus may suitably comprise implantable electrical conductors connected to the energy transforming device such that the energy transforming device is capable of supplying an electric current, such as direct current, pulsating direct current, a combination of direct and pulsating direct current, alternating current or a combination of direct and alternating current, via the conductors. Furthermore, the energy transforming device may provide an analog, digital or a combination of analog and digital signal modulated in frequency, amplitude or frequency and amplitude, which signal may be used for controlling the restriction device.
In accordance with a main embodiment of the present invention, the apparatus comprises: an implantable operation device for operating the restriction device; and a control device for controlling the operation device; wherein the energy transforming device powers the operation device with the energy of the second form. The operating means preferably comprises a motor, for example comprising a linear motor or a rotor motor, which is controlled by said control means to rotate a predetermined number of revolutions. Optionally, an implantable gearing is connected to the motor. The motor may have a conductive portion made of plastic. Alternatively, the electric motor may comprise a hydraulic or pneumatic hydraulic motor, wherein the control device controls the fluid flow through the hydraulic motor. Currently commercially available motors are becoming smaller and smaller. In addition, there are various control methods and small-sized control devices. For example, the number of revolutions of the rotor motor can be analyzed with a hall element of only a few mm in size.
According to another embodiment of the invention, the restriction device comprises hydraulic means, and the operation device is adapted to conduct hydraulic fluid in the hydraulic means. The operation device includes: a fluid conduit connected to the hydraulic means of the restriction device; and a fluid reservoir, wherein the reservoir forms a portion of the conduit. The reservoir may form a fluid chamber having a variable volume, and the operation device may be adapted to distribute fluid from the chamber to the hydraulic means of the restriction device by reducing the volume of the chamber and to withdraw fluid from the hydraulic means to the chamber by expansion of the volume of the chamber. The operation device suitably comprises an implantable motor for reducing or expanding the volume of the fluid chamber. Also, the operation device may comprise a pump for pumping hydraulic fluid in the hydraulic means of the restriction device. All hydraulic components involved are preferably devoid of check valves. This is of great advantage, since, in the case of the valves concerned, there is a risk of malfunction due to improperly working valves, especially when a long time has elapsed between valve operations.
The control device may be operable to reverse the operation device by shifting polarity of the energy of the second form. If the operation device comprises an electric motor, the energy of the second form suitably comprises electric energy.
In accordance with another embodiment of the invention, the restriction device is operable to perform a reversible function, such as enlarging or restricting the blood flow passageway, and there is a reversing device implanted in the patient for reversing the function performed by the restriction device. Such a reversing function preferably comprises enlarging and restricting the blood flow passageway, suitably in a stepless manner, by the restriction device. In this respect, the control device suitably controls the reversing device, which comprises a switch, to reverse the function performed by the restriction device. The reversing device may comprise hydraulic means including a valve for reversing the direction of flow of fluid in the hydraulic means. Alternatively, the reversing device may comprise a mechanical reversing device such as a switch or gear box.
If the reversing device comprises a switch, the switch may be operated by the energy of the second form. In this case, the control means suitably controls the operation of the switch by shifting the polarity of the energy of the second form supplied to the switch. The switch may comprise an electrical switch and the energy source may provide electrical energy for operation of the switch.
In accordance with a preferred embodiment of the invention, the apparatus further comprises an energy storage device implanted in the patient for storing the energy of the second form and for supplying energy in connection with the operation of the restriction device. The implanted energy storage device preferably comprises a source of electric energy, such as an accumulator, a rechargeable battery or a combination of an accumulator and a rechargeable battery.
The apparatus further comprises: a switch implantable in the patient for switching the operation of the restriction device; and an energy source implantable in the patient. This embodiment is particularly suitable for applications where the energy transmission efficiency of the apparatus is insufficient, i.e. the implanted restriction device is to perform more advanced operations. The energy source is preferably a battery. Alternatively, the source of energy is an accumulator that stores the energy of the second form.
In accordance with a first alternative, the switch is operated by the energy of the second form supplied by the energy storage device to switch from an off mode, in which the source of energy is not in use, to an on mode, in which the source of energy supplies energy for the operation of the restriction device. In this case, the implanted source of energy may comprise a battery (preferably having a lifetime of at least 10 years) or an accumulator. However, other types of energy sources are also possible, such as a nuclear energy source or a chemical energy source (fuel cell).
In accordance with a second alternative, the apparatus further comprises a remote control for controlling the supply of energy of the implanted source of energy, wherein the switch is operated by the energy of the second form supplied by the energy storage device to switch from an off mode, in which the remote control is prevented from controlling the source of energy and the source of energy is not in use, to a standby mode, in which the remote control is permitted to control the source of energy to supply energy for the operation of the restriction device.
In accordance with a third alternative, the energy storage device is omitted, wherein the switch is operated by the energy of the second form supplied by the energy transforming device to switch from an off mode, in which the remote control is prevented from controlling the source of energy and the source of energy is not in use, to a standby mode, in which the remote control is permitted to control the source of energy to supply energy for the operation of the restriction device.
In accordance with a fourth alternative, the controller is omitted, wherein the switch is operated by the energy of the second form supplied by the energy transforming device to switch from an off mode, in which the source of energy is not in use, to an on mode, in which the source of energy supplies energy for the operation of the restriction device. Where applicable, in the above-described embodiments, the switch is preferably adapted to switch when the energy of the second form transmitted is stabilised by an implanted capacitor arranged to temporarily (for a few seconds) store the energy of the second form, while the energy transforming device is transmitting wireless energy.
In the third and fourth alternatives described above, the energy transmission device may replace the energy transforming device, such that the switch is operated by the energy of the first form.
The switch may comprise an electronic switch or, where applicable, a mechanical switch.
The advantage of using the above-mentioned switch is firstly that the safety of the control is increased, i.e. that interfering signals around the patient do not influence the implanted restriction device. Furthermore, the lifetime of the implanted source of energy may be significantly prolonged, since the energy consumption of the device may be minimized. During the standby mode, the remote control uses energy from the implanted source of energy. The energy transforming device may be adapted to transmit energy for activating the switch, so that the implanted source of energy is connected only when energy is required for the operation of the restriction device.
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 restriction device in response to signals from the sensor. Preferably, the sensor detects ejaculation and the restriction device releases the portion of tissue in response to the sensor detecting ejaculation.
The control device may comprise an internal controller implanted in the patient for controlling the restriction device, preferably directly, in response to signals from the sensor. The internal controller may send information about the sensors to outside the patient's body in response to signals from them, such as signals relating to pressure, the patient's position, or any other important physical parameter. The control device may also automatically control the restriction device in response to signals from the sensor. For example, the control device may control the restriction device to further restrict the blood flow passageway in response to the sensor detecting an increase in the patient's blood flow and blood pressure or to enlarge the blood flow passageway in response to the sensor detecting an abnormally high pressure against the restriction device or detecting ejaculation.
Alternatively, the control device may comprise an external controller outside the patient's body for directly controlling the restriction device, as appropriate, in response to signals from the sensor. The external controller may store information relating to the physical parameter sensed by the sensor and may be manually operated to control the restriction device in accordance with the stored information. Furthermore, there is at least one implantable transmitter for transmitting information related to the physical parameter detected by the sensor.
An external data communicator is provided external to the patient and an internal data communicator is implanted in the patient for communicating with the external communicator. The internal communicator may feed data related to the patient or related to the restriction device back to the external communicator. Additionally, or in combination, the external communicator may feed data to the internal communicator. The internal communicator may suitably feed data related to at least one physical signal of the patient.
The apparatus may further comprise an implantable programmable controller for controlling the restriction device, preferably over time, in accordance with an activity schedule. This will make the device more advanced and enable the device to be adapted to individual patients.
Most of the embodiments described above are remotely controlled in a suitable manner. Thus, the apparatus preferably comprises a wireless remote control transmitting at least one wireless control signal for controlling the restriction device. With such a remote control, the functionality of the device can be adapted to the needs of the patient. The control signal may comprise a frequency, amplitude or frequency or amplitude modulated signal. Also, the control signal may comprise an analog or digital signal or a combination of analog and digital signals.
The wireless remote control is capable of obtaining information about the status of the implanted restriction device and of controlling the restriction device in response to the information. Also, the remote control may be capable of transmitting information relating to the restriction device from inside the patient's body to outside the patient's body.
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 embodiment of the invention, 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.
The wireless remote control may transmit a carrier signal for carrying the control signal, wherein the carrier signal is modulated in frequency, amplitude or both. The carrier signal may also comprise digital, analog or a combination of digital and analog signals. Such signals may include waveform signals. Also, the control signal for use with the carrier signal may be frequency, amplitude, or frequency and amplitude modulated and digital, analog, or a combined digital and analog signal.
The control signal may include a waveform signal such as a sound wave signal such as an ultrasonic wave signal, an electromagnetic wave signal such as an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radio wave signal, an x-ray radiation signal, or a gamma radiation signal. Where feasible, two or more of the above signals may be combined.
The control signal may be digital or analog and may include an electric or magnetic field. Suitably, the wireless remote control may transmit an electromagnetic carrier wave signal for carrying the digital or analogue control signal. For example, the use of an analog carrier signal carrying a digital control signal can give secure communication. The control signal may be transmitted in pulses by a wireless remote control.
The energy transmission device may function in a different or similar manner as the energy transforming device. For example, in case the energy transmission device comprises-a coil for transmitting energy of the first form and the energy transforming device comprises an electrical junction element for transforming the transmitted energy into energy of the second form, the function of the energy transmission device and the function of the energy transforming device are different. Where the energy transmission device comprises a coil for transmitting energy of the first form and the energy transforming device also comprises a coil for transforming the transmitted energy into energy of the second form, the functions of the energy transmission device and the energy transforming device are similar to each other.
In accordance with another embodiment of the invention, the apparatus comprises an activatable source of energy implantable in the patient, wherein the source of energy is activatable by wireless energy transmitted by the energy transmission device to supply energy for the operation of the restriction device.
The implantable restriction device is suitably embedded within a soft or gel-like material, for example, a silicone material having a hardness of less than 20 Shore.
In different embodiments, all the above components, such as the motor, pump and capacitor, may be combined where feasible. Also, the various functions described in connection with the above-described embodiments of the invention may be used for different applications where feasible.
All of the various ways of transferring, transforming and controlling energy in this specification can be realized with all of the various components and solutions described above.
The invention also provides methods for implanting the apparatus of the invention and for treating impotence.
Accordingly, there is provided an implantation method comprising the steps of: providing the impotence treatment apparatus described above; cutting an opening in the mucosa in the opening in the patient's body; and implanting the energy transforming device into the patient through the opening. Alternatively, the cutting step may comprise cutting an opening in the patient's skin, and the implanting step comprises implanting the energy transforming device in the patient's body through the opening.
There is also provided a laparoscopic implantation method, comprising the steps of: providing the impotence treatment apparatus described above; placing at least two laparoscopic cannulas into a patient; and implanting the energy transforming device in the patient using the at least two laparoscopic cannulas.
In accordance with another alternative form there is provided a laparoscopic surgical method of implanting an impotence treatment apparatus, the method comprising the steps of: a) providing an impotence treatment apparatus as described above; b) placing at least two laparoscopic trocars within a patient; c) incising the penile tissue area or the prolongation thereof using at least one scalpel inserted through the laparoscopic trocar; d) an operable restriction device for introducing the apparatus through the trocar; e) arranging the restriction device in engagement with the penile pack or the prolongation thereof; and, f) implanting the energy transforming device of the apparatus in the patient's body for transforming the wireless energy into energy of a form suitable for operating the restriction device, thereby reducing the opening to restrict the flow of blood therethrough. The method of (a) - (f) above further comprising adjusting the reduced opening with a non-invasive procedure.
Also provided is a method of treating an impotent male, the method comprising: (a) a restriction device, which is engaged with male penile tissue or an extension thereof, is surgically implanted in a male patient to create a restrictable passageway for blood flow to exit the penis. (b) The operation device is surgically implanted in the male body and is responsive to the supplied energy to adjust the restricted access. And (c) providing energy from time to the operation device with non-invasive Post-operative treatment to restrict the passageway to reduce blood flow away from the male penis to achieve erection. In the above method, (c) may be performed by the patient when desired.
The invention is described in detail below with reference to the attached drawing figures, wherein:
FIGURE 1 diagrammatically shows the impotence apparatus of the invention in its simplest embodiment, with some parts implanted in the patient and other parts located outside the patient's body. Thus, in fig. 1, all parts arranged to the right of the patient's skin 2 are implanted, and all parts arranged to the left of the skin 2 are located outside the patient's body.
The apparatus of figure 1 comprises an implanted operable restriction device 4 which engages penile tissue or the prolongation thereof of the patient to form a restricted pathway for blood flow to exit the penis. The restriction device 4 may perform a reversible function, i.e. enlarging and reducing the passageway, so that the restriction device 4 may function as an artificial sphincter. The implanted energy transforming device 6 is adapted to supply energy to the energy consuming components of the restriction device 4 via the power supply line 12. The external energy transmission means 10 comprises a wireless remote control for transmitting wireless signals which are received by a signal receiver comprised in the implanted energy transforming means 6. The implanted energy transforming device 6 transforms energy from the signal to electric energy which is supplied to the restriction device 4 via the power supply line 12, and which energy is capable of moving a part of the restriction device 4 to thereby adjust the opening.
FIGURE 2 shows an embodiment of the invention identical to that of FIGURE 1, except that a reversing device in the form of an electric switch 14 also is implanted in the patient for reversing the restriction device 4. The wireless remote control of the external energy transmission device 10 transmits a wireless signal carrying energy, and the implanted energy transforming device 6 transforms the wireless signal into a current for operating the switch 14. When the polarity of the current is changed by the energy transforming device 6, the switch 14 reverses the function performed by the restriction device 4.
FIGURE 3 shows an embodiment of the invention identical to that of FIGURE 1, except that an operation device in the form of a motor 15 for operating the restriction device 4 also is implanted in the patient. When the remote control of the external energy transmission device 10 transmits a wireless signal to the receiver of the energy transforming device 6, the motor 15 is powered with energy from the energy transforming device 6.
FIGURE 4 shows an embodiment of the invention identical to that of FIGURE 1, except that an assembly 16 including a motor/pump unit 18 and a fluid reservoir 20 also is implanted in the patient. In this case the restriction device 4 is hydraulically controlled, i.e. the motor/pump unit 18 pumps hydraulic fluid from the reservoir 20 via the conduit 22 to the restriction device 4 to restrict the passage, and the motor/pump unit 18 pumps hydraulic fluid from the restriction device 4 back to the reservoir 20 to enlarge the cross-sectional area. The implanted energy transforming device 6 transforms the wireless energy into an electric current for powering the motor/pump unit 18 via the power supply line 24.
Fig. 5 shows an embodiment of the invention comprising the external energy transmission device 10 with the wireless remote control, the restriction device 4, in this case hydraulically controlled, and the implanted energy transforming device 6, and comprising an implanted hydraulic fluid reservoir 30, an implanted motor/pump unit 32 and an implanted reversing device in the form of a hydraulic valve shifting device 34. The motor of the motor/pump unit 32 is an electric motor. The implanted energy transforming device 6 powers the motor/pump unit 32 with energy carried by a control signal from the wireless remote control of the external energy transmission device 10 in response to the control signal, whereby the motor/pump unit 32 distributes hydraulic fluid between the reservoir 30 and the restriction device 4. The remote control of the energy transmission device 10 controls the shifting device 34 to shift the direction of the hydraulic fluid flow between one direction in which the motor/pump unit 32 draws fluid from the reservoir 30 to the restriction device 4 to reduce the passage and another opposite direction in which the motor/pump unit 32 draws fluid from the restriction device 4 back to the reservoir 30 to enlarge the cross-sectional area.
FIGURE 6 shows an embodiment of the invention identical to that of FIGURE 1, except that a control unit 36 controlled by the wireless remote control of the external energy transmission device 10, an accumulator 38 and a capacitor 40 also are implanted in the patient. The control unit 36 stores the electric energy received from the energy transforming device 6 in an accumulator 38, which supplies energy to the restriction device 4. The control device 6 is responsive to a control signal from the wireless remote control of the energy transmission device 10 either to cause electric energy to be discharged from the accumulator 38 and to transfer the discharged energy via the electric lines 42 and 44 or to transfer electric energy directly from the energy transforming device 6 via the electric line 46, the current stabilizing capacitor 40, the electric line 48 and the electric line 44 for operating the restriction device 4.
In accordance with an alternative, the capacitor 40 in the embodiment of fig. 6 may be omitted. According to another alternative, the accumulator 38 in this embodiment may be omitted.
FIGURE 7 shows an embodiment of the invention identical to that of FIGURE 1, except that a battery for supplying electric energy for operating the restriction device 4 and an electric switch 52 for switching the operation of the restriction device 4 also are implanted in the patient. The energy supplied by the energy transforming device 6 operates the switch 52 to switch from an off mode, in which the battery 50 is not in use, to an on mode, in which the battery 50 supplies energy for the operation of the restriction device.
FIGURE 8 shows an embodiment of the invention identical to that of FIGURE 7, except that a control unit 36 controlled by the wireless remote control of the external energy transmission device 10 also is implanted in the patient. In this case, the switch 52 is operated by the energy supplied by the energy transforming device 6 to switch from an off mode, in which the remote control is prevented from controlling the control device 36 and the battery is not in use, to a standby mode, in which the remote control is allowed to control the control device 36 to release electric energy from the battery 50 to operate the restriction device 4.
Fig. 9 shows an embodiment of the invention identical to that of fig. 8, except that the battery 50 is replaced by an accumulator 38 and the implanted components are interconnected differently. In this case, the accumulator 38 stores energy from the energy transforming device 6. The implanted control unit 36 controls the switch 52 in response to a control signal from the wireless remote control of the external energy transmission device 10 to switch from an off mode, in which the accumulator 38 is not in use, to an on mode, in which the accumulator 38 supplies energy for the operation of the restriction device 4.
FIGURE 10 shows an embodiment of the invention identical to that of FIGURE 9, except that a battery 50 also is implanted in the patient and the implanted components are interconnected differently. The implanted control unit 36 controls the accumulator 38 in response to a control signal from the wireless remote control of the external energy transmission device 10 to deliver energy for operating the switch 52 to switch from an off mode, in which the battery 50 is not in use, to an on mode, in which the battery 50 supplies energy for the operation of the restriction device.
In addition, the energy supplied by the accumulator 38 causes the switch 52 to be operated to switch from an off mode, in which the wireless remote control is prevented from controlling the battery 50 to supply energy and the wireless remote control is not in use, to a standby mode, in which the wireless remote control is allowed to control said battery 50 to supply energy to operate the restriction device 4.
FIGURE 11 shows an embodiment of the invention identical to that of FIGURE 7, except that a motor 15, a mechanical reversing device in the form of a gearbox 54 and a control unit 36 for controlling the gearbox 54 also are implanted in the patient. The implanted control unit 36 controls the gear box 54 to reverse the function performed by the (mechanically controlled) restriction device 4.
Fig. 12 shows the same embodiment of the invention as in fig. 10, except that the implanted components are interconnected differently. In this case, the battery 50 powers the control device 36 when the accumulator 38, suitably a capacitor, activates the switch 52 to switch to the on mode. When the switch 52 is in the on mode, the control device 36 is allowed to control the battery 50 to provide or not provide energy for the operation of the restriction device 4.
Figure 13 diagrammatically shows possible combinations of implanted components of the device for implementing various communication options. Basically, there is an implanted restriction device 4, a control device 36 and a motor/pump unit 18 as well as an external energy transmission device 10 comprising an external wireless remote control. As described above, the wireless remote control transmits control signals received by the implanted control unit 36, which in turn controls various implanted components of the apparatus.
A sensor 56 may be implantable in the patient for sensing a physical parameter of the patient, such as the pressure in the passageway, and the implanted control unit 36 or the external wireless remote control of the energy transmission device 10 may control the restriction device 4 in response to a signal from the sensor 56. A transceiver may be associated with the sensor 56 to transmit information relating to the sensed physical parameter to an external wireless remote control. The wireless remote control may include a signal transmitter or transceiver and the implanted control unit 36 may include a signal receiver or transceiver. Additionally, the wireless remote control may include a signal receiver or transceiver, and the implanted control unit 36 may include a signal receiver or transceiver. The above-mentioned transceiver, transmitter and receiver may be used for transmitting information or data relating to the restriction device 4 from inside the patient's body to outside the patient's body.
In the case where the motor/pump unit 18 and the battery 50 for powering the motor/pump unit 18 are implanted, the battery 50 may be equipped with a transceiver for sensing information related to the state of the battery 50.
Those skilled in the art will recognize that the various embodiments of fig. 1-13 described above may be combined in a number of different ways. For example, the energy-controlled switch 14 may be included in any of the embodiments of FIGS. 3, 6-12, the hydraulic shifting device 34 may be included in the embodiment of FIG. 4, and the transmission case 54 may be included in the embodiment of FIG. 3.
Fig. 14 shows an energy transforming device in the form of an electrical junction element 58 for use with the embodiments of fig. 1-13. Element 58 is a flat p-n junction element that includes a p-type semiconductor layer 60 and an n-type semiconductor layer 62 sandwiched together. A light bulb 64 is electrically connected to the opposite side of the element 58 to illustrate how the generated current is obtained. The current output from such a p-n junction element 58 is temperature dependent, see the following equation.
I＝I0(exp.(qV/kT)-1)
Wherein
I is the external current
I0 is reverse saturation current
q is a base charge of 1.602X 10-9 coulombs
V is the applied voltage
k is Boltzmann constant
T is the absolute temperature
At large negative pressures (reverse bias), the exponential term is negligible compared to 1.0, and I is about-I0. I0 is completely dependent on the temperature of the p-n junction and thus on the intrinsic carrier concentration. For materials with smaller bandgaps, I0 is greater than I0 for materials with larger bandgaps. In this particular embodiment, the rectifier action of the diode (i.e., limiting current flow to only one direction) is critical to the operation of the p-n junction element 58.
Another way of designing a p-n junction element is to deposit a thin layer of semiconductor onto a supporting material that does not absorb the energy used in the corresponding embodiment. Glass is a suitable material in terms of energy transmitted wirelessly by light waves. A variety of materials may be used on the semiconductor layer such as, but not limited to, cadmium telluride, copper indium diselenide, and silicon. A multilayer structure with several layers of p and n type materials may also be used in order to increase efficiency.
The electrical energy generated by the p-n junction element 58 may be of the same type as that generated by a solar cell, wherein the negative and positive electric fields generate direct current. In addition, the negative and positive semiconductor layers may change polarity with the transmitted waves, thereby generating an alternating current.
The p-n junction element 58 is designed to be suitable for implantation. Thus, all external surfaces of the element 58 that come into contact with the human body are made of non-repelling materials. The p-n junction semiconductor is designed to operate optimally at body temperature of 37 c because the current output greater than 1 ua is significantly dependent on temperature, as indicated above. Since the skin and subcutaneous tissue will absorb energy, the sensitivity or working area of the element 58 is considered in relation to the density and intensity of the wireless energy source. The P-n junction element 58 is preferably designed to be flat and small. Additionally, if the element 58 is made in larger sizes, the element should be flexible in order to accommodate the patient's movements. The volume of the element 58 should be less than 2000cm3。
FIGURE 15 generally illustrates how any of the above-described embodiments of the impotence treatment apparatus of the invention may be implanted in a patient. Thus, the restriction device 4 implanted in the patient engages the penile tissue or an extension thereof to form an artificial sphincter around the passageway through which blood flow exits the penis. An implanted operation device 68, such as a motor or a motor/pump assembly, also referred to as an adjustment device, operates the restriction device 4 via a transmission member 70, such as a mechanical transmission cord or a fluid tube. An energy transforming device in the form of an element 6 having a positive region and a negative region as described in detail above is placed under the skin of the patient. The external energy transmission device 10 is used for wireless energy transmission to the implanted component 6. The wireless remote controller includes: an external controller included within the energy transmission device 10; and an implanted controller 71 connected to element 6 and to manipulator 68.
The wireless energy carried by the signal transmitted by the wireless remote control of the external energy transmission device 10 at least partly enters the patient's skin and encounters the element 6. The energy encountering the element 6 is transformed into a different form of energy which is suitable for energizing the operating means 68. For example, if the operation device 68 is an electric motor, the element 6 comprises an electric p-n junction element, which transforms the wireless energy into an electric current for powering the motor. If the operation device 68 comprises a pump, the element 6 may transform the wireless energy into kinetic energy in order to power up the pump.
The transformed energy may be used for directly operating the restriction device 4, or, if the restriction device 4 is electrically controlled, the transformed energy may be stored in a capacitor and/or an accumulator for later or parallel use. Preferably, but not necessarily, the element 6 is controlled by a microprocessor. The wireless remote control of the external energy transmission device 10 may be used to control the use of the transmitted energy and the functions or commands to/from the implanted restriction device 4.
Fig. 16 shows the basic parts of a wireless remote control of the apparatus of the invention, comprising a motor 128 for operating a restriction member of the type described in fig. 15, for example. In this case the remote control is based on the transmission of high frequency electromagnetic wave signals, typically 100KHz-1gHz, through the patient's skin 130. In fig. 15, all the parts placed on the left side of the skin 130 are located on the outer side of the human body, and the parts placed on the right side of the skin 130 are implanted. Any suitable control remote control system may be used.
An external signal transmitting antenna 132 is positioned adjacent to a signal receiving antenna 134 implanted adjacent to the skin 130. As another alternative, the receiving antenna 134 may be disposed, for example, within the abdomen of the patient. The receiving antenna 134 comprises a coil, with a diameter of about 1-100mm, preferably 25mm, wound from a very thin wire and capacitively tuned to a specific high frequency. The small coil is selected if implanted under the patient's skin and the large coil is selected if implanted in the patient's abdomen. The transmitting antenna 132 comprises a coil having approximately the same dimensions as the coil of the receiving antenna 134, but wound with a thick wire capable of handling the necessary large currents. The turns of the transmitting antenna 132 are tuned to the same specific high frequency as the coil of the receiving antenna 134.
The external control device 136 includes a microprocessor, a high frequency electromagnetic wave signal generator, and a power amplifier. The microprocessor of the control device 136 is used to switch the generator on and off and to modulate signals generated by the generator so that digital information is sent to the implanted control device 138 via the power amplifier and the antennas 132,134. To avoid that occasional random high frequency fields trigger control commands, digital signal codes are used. A conventional keypad provided on the external control device 136 is connected to the microprocessor. The keypad is used to command the microprocessor to send digital signals to contract or expand the restriction device. The microprocessor starts the command by applying a high frequency signal to the antenna 132. After a short time, when the signal has powered the implanted part of the control system, commands are sent to contract or enlarge the restriction device in predetermined steps. The command is sent as a digital packet in the following form.
| Start mode 8 bits | Command 8 bit | Count 8 bits | Check sum of 8 bits |
The commands are sent continuously for a relatively long time, e.g., about 30 seconds or more. When a new contraction or expansion step is required, the count byte is incremented by one to allow the implanted control unit 138 to decode and understand that another step is required by the external control unit 136. If any part of the digital packet is in error, its content is simply ignored.
Through line 140, the implanted energiser unit 126 draws energy from the high frequency electromagnetic wave signals received by the receiving antenna 134. The energizer unit 126 stores energy in an energy storage device, such as a large capacitor, powers the control unit 138 and powers the motor 128 via a line 142.
The control device 138 includes a demodulator and a microprocessor. The demodulator demodulates a digital signal transmitted from the external control device 136. The microprocessor of the control unit 138 receives the data packet, decodes it and sends a signal to the motor 128 via signal line 144 in the event that the power supply of the energiser unit 126 has stored sufficient energy to contract or enlarge the restriction device in accordance with the received command code.
Additionally, the energy stored in the energy storage device of the energiser unit may be used only for powering the switch, and the energy for powering the motor 128 may be obtained from another implanted higher capacity energy source, e.g. a battery. In this case, the switch is used to connect the battery to the control unit 138 in the on mode when the switch is powered by the energy storage device and to disconnect the battery from the control unit in the standby mode when the switch is not powered.
The remote controller outlined above is described below in accordance with a more detailed embodiment with reference to fig. 17. The external control device 136 includes a microprocessor 146, a signal generator 148 and a power amplifier 150 connected thereto. The microprocessor 146 is used to switch the signal generator 148 and modulate the signal generated by the signal generator 148 with digital commands sent to the implanted components of the device. The power amplifier 150 amplifies the above signals and transmits them to the external signal transmitting antenna 132. The antenna 132 is connected in parallel with a capacitor 152 to form a resonant circuit tuned to the frequency generated by the signal generator 148.
The implanted signal receiving antenna coil 134 together with the capacitor 154 form a resonant circuit tuned to the same frequency as the transmitting antenna 132. The signal receiving antenna coil 134 induces a current in accordance with the received high frequency electromagnetic wave, and the rectifying diode 160 rectifies the induced current, which charges the storage capacitor 158. The coil 156 connected between the antenna coil 134 and the diode 160 prevents the capacitor 158 and the diode 160 from loading the circuitry of the signal receiving antenna 134 at higher frequencies. Thus, the coil 156 may charge the capacitor 158 and transmit digital information with amplitude modulation.
The parallel connection of the capacitor 162 and the resistor 164 and the diode 166 forms a detector for detecting the amplitude modulated digital information. Resistor 168 and capacitor 174 form a filter circuit, resistor 168 is connected in series with resistor 170, resistor 170 is connected in series with capacitor 172, capacitor 172 is connected in series with resistor 168 via ground, one end of capacitor 174 is connected between resistors 168, 170, and the other end is connected between diode 166 and the circuit formed by capacitor 162 and resistor 164. The filter circuit is used to filter out undesired low and high frequencies. The detected and filtered signal is fed to an implanted microprocessor 176 which decodes the digital information and controls the motor 128 via an H-bridge 178 comprising transistors 180,182, 184 and 186. The H-bridge 178 drives the motor 128 in two opposite directions.
The microprocessor 176 also monitors the amount of energy stored in the storage capacitor 158. Before sending a signal to start the motor 128, the microprocessor 176 checks whether the energy stored in the storage capacitor 158 is sufficient. If the stored energy is insufficient to perform the requested operation, the microprocessor 176 waits for the received signal to charge the storage capacitor 158 before activating the motor 128.