Patent Description:
Inflatable medical implants with manually operated pumps and reversing switches placed in the male scrotum or female labia, which transfer fluid back and forth between an abdominal reservoir and inflatable penile cylinders, urethra cuffs and anal cuffs, are known for treatment of erectile dysfunction, urinary incontinence and fecal incontinence. Some patients, particularly older people with arthritis, find it difficult to operate the implanted manual pump and reversing switch, and there is not a comfortable place to implant the pump in females. Therefore, many patients elect not to have treatment.

More recent concepts replace the implanted manual pump and reversing switch with an electrically driven pump which may be controlled and powered from an external source. In operation, an external unit sends energy and control signals wirelessly to an internal unit, which then activates a separately placed pump unit. Signals may also be fed back from the internal unit to the external unit to control energy flow.

In certain systems, external alternating current power is transmitted transdermally by close-coupled magnetic induction typically operating in the band from <NUM> to <NUM> and forming an air core electrical transformer with its primary winding external to the patient and its secondary winding internal to the patient. Due to the low permeability of air and body tissue, few magnetic flux linkages connect between these primary and secondary windings; not like in an iron core transformer where most of the magnetic flux is coupled between primary and secondary windings. Therefore the primary and secondary windings must be placed within a few millimeters of each other to safely transmit any appreciable power, which means the implanted transformer secondary may be implanted in the dermis, a physically and cosmetically uncomfortable situation.

In some systems, this placement problem is alleviated with an internal rechargeable battery or capacitor to accumulate enough energy over time from a magnetic induction source so that when needed, the pump gets enough power to transfer the required fluid. Other systems use high voltages to increase power transmission over longer distances, however increasing the transmitted voltage increases the risk of electric shock. In all these systems, the voltage induced in the internal secondary winding can vary widely due to the patient's placement of the external primary windings with respect to the implanted secondary winding.

Full-wave Schottky diode bridge rectifiers with electromagnetic interference filters are known to convert the secondary winding's varying alternating current voltage into varying direct current voltage. However these full-wave bridge rectifiers have two diode voltage drops in their current delivery path, which set a limit on their efficiency.

In many of these systems, one or more linear voltage regulators are used to convert the varying direct current voltage to stable direct current voltage to power the electronics and the motor. These linear voltage regulators waste transmitted energy and can generate significant heat in the implant.

Technology to limit linear voltage regulator inefficiency is known in the form of a transdermal voltage feedback loop which limits how much voltage is applied to the external primary winding and reaches the internal regulator through the secondary winding, and therefore limits how much power is transmitted and must be dissipated in the linear regulator. Other systems use switch mode power supplies, which can achieve <NUM>-<NUM>% efficiency.

In some systems, brushed direct current and brushless direct current motors are known to drive the pump. Both brushed and brushless direct current motors have rotors and stators containing ferrous material and are MR-Unsafe. Brushed direct current motors may be connected to switch mode power supply's output though a solid state forward-off-reversing switch.

Brushless direct current motors are comprised of a direct current to <NUM>-phase inverter and a <NUM>-phase induction motor. Such inverters generate <NUM>-phase pulse width modulated signals to drive a metal-oxide-semiconductor field-effect transistor <NUM>-phase half control bridge circuit, which then feeds the motor.

Positive displacement rotating internal gear fluid pumps, which can be built in millimeter diameters, are also known. For submerged operation, such pumps use a hermetically sealed motor magnetically coupled to the pump to prevent fluid from entering the motor. This magnetic coupling is MR-Unsafe.

What is needed is a MR-Safe or MR-Conditional apparatus without reduction gears and with efficient power transmission and conversion, which will transmit enough power transdermally to inflate and deflate medical implants in less time and with greater efficiency, higher reliability, lower implant voltage, in a small implant volume and with minimal surgical impact for men by not involving the scrotum, and, especially for incontinent women, where there is not a comfortable place to implant a separate pump unit.

<CIT> discloses a male impotence prosthesis apparatus comprising an operable penile prosthesis (<NUM>) implanted in an impotent patient's corpus cavenosum to provide flaccid or erect states of the patient's penis. An energy transmission device (<NUM>) for wireless transmission of energy from outside the patient's body to inside the patient's body is provided body for use in connection with the operation of the penile prosthesis.

<CIT> discloses a wireless controlled inflatable medical implant system including an external control module and an implantable module. The external control module may transmit wireless power and control signals, which are received by circuitry on a flexible printed circuit board in the implantable module. In response to the received signals, circuitry in the flexible printed circuit board may cause a motor and pump combination to transfer fluid from a reservoir in the implantable device, through tubing, and into inflatable medical implant located in the penis. The flexible printed circuit board, motor, and pump may be placed within the fluid reservoir, which provides a heat sink that prevents overheating of the implant.

The present invention is directed to an apparatus for treating erectile dysfunction, urinary and fecal incontinence, and other medical problems treated with inflatable medical implants. In particular, the present disclosure relates to a MR-Safe or MR-Conditional apparatus that can transfer enough transdermal energy to power a nonferrous motor, fluid pump and valve combination submerged in a reservoir that is small enough to fit into a patient's abdomen and capable of inflating and deflating multiple inflatable medical implants, such as dual penile cylinders, anal cuffs and urethra cuffs, in a short amount of time. For example, the apparatus may inflate or deflate the medical implants in less than <NUM> seconds.

MR-safe means there are no MRI restrictions for a patient with such an implant. MR-Conditional means a patient with a MR-Conditional implant can have a MRI study conducted in specific MRI machines, such as <NUM>-tesla MRI machines. The apparatus disclosed has an implant which is comprised of nonferrous motors, pumps and valves; however, the implant may contain electronic components or conductors which may be MR-Conditional.

The apparatus includes a medical provider software application, a patient external controller, and a MR-safe or MR-Conditional pump in reservoir implant. The medical provider software application, running on any computing device, such as a tablet, PC or MAC, allows the medical provider to individually program each patient's patient external controller for their personal use, to monitor each patient's pump in reservoir implant usage, and to perform statistical analysis of usage across patients. The medical provider software application communicates with the patient external controller via wired or wireless communications, such as Ethernet, radio, Wi-Fi or Bluetooth.

The patient external controller contains a rechargeable battery power source, such as a Lithium Ion battery; a patient display, such as a touch panel liquid crystal display, and control switches, such as pushbuttons; a microcontroller; a transdermal power transmitter which generates a high frequency, evanescent electromagnetic field from a power amplifier and resonant antenna; a bidirectional radio link with the pump in reservoir implant; and a bidirectional link with the medical provider software application.

In operation, the medical provider uses the medical provider software application to program the patient external controller for use by the specific patient. The patient then activates a control on the patient external controller to transmit control signals, data and power to the pump in reservoir implant to inflate or deflate one or more inflatable medical implants. The pump in reservoir implant sends performance data back to the patient external controller so the patient may monitor implant operation on the display. The patient external controller stores the data for later transmission back to the medical provider software application so the medical provider can monitor and, if necessary, update pump in reservoir implant operation.

The pump in reservoir implant includes a biocompatible case enclosing a reservoir containing an isotonic fluid, such as normal saline, which is pumped into and out of one or more inflatable medical implants to cause inflation and deflation. The fluid also acts as a heat sink for a submerged cylinder containing circular electronic circuit boards and a nonferrous pump assembly comprising a <NUM>-phase squirrel cage motor, an internal gear pump, and one or more piezoelectric valves. The amount of fluid transferred by the pump may be controlled by powering the pumps for a fixed number of rotations or by pump output pressure.

One or more independently controlled piezoelectric valves achieve independent control of one or more inflatable medical implants to treat multiple medical problems and to prevent leakage through the pump. That is, when multiple medical implants are included, each medical implant is connected to a dedicated piezoelectric valve. A pressure relief tube, with its top under the dermis, is provided for deflation by the medical provider should the pump in reservoir implant fail.

Sensors in the pump in reservoir implant measure pumping parameters for optimizing pump performance and monitoring for implant failures. Sensor data may include reservoir and inflatable medical implant pressure, pump speed, motor current and voltage, temperature, leaks, and electrical shorts.

The data from the sensors is also sent to the patient external controller for monitoring by the patient and for storage for later analysis by the medical provider. The medical provider may then noninvasively change inflation parameters by reprogramming the patient external controller via the medical provider software application.

No power is stored internally in the pump in reservoir implant, so the implant is completely passive at all times except when powered by the patient external controller. A data link handshake and foreign object detection is provided to prevent the implant from being powered by the MRI machine's radio frequency transmitter or other sources, or for power to be transmitted to foreign objects.

The present invention is directed to an apparatus for treating erectile dysfunction, urinary and fecal incontinence and other conditions treated by inflatable medical implants. The apparatus includes an MR-Safe or MR-Conditional transdermally powered inflator for inflatable medical implants. As shown in <FIG>, the apparatus includes a medical provider software application <NUM>, a patient external controller <NUM>, and a pump in reservoir implant <NUM>, which can inflate and deflate one or more inflatable medical implants <NUM><NUM> in a short time period by transferring isotonic fluid at a particular or varying pressure. For example, the implants may be inflated or deflated in <NUM> second by transferring <NUM> milliliters of isotonic fluid at <NUM> pounds per square inch pressure.

The pump in reservoir implant <NUM> is surgically placed in a patient's <NUM> abdomen <NUM>, and a flexible tube <NUM> is run from it to the inflatable medical implant <NUM>. The pump in reservoir implant contains all the pumping components, which obviates the need for surgeons to enter the scrotum in males or providing uncomfortable pump locations in females. As shown in <FIG>, a pressure relief tube143 is placed in the abdomen <NUM> close to the dermis <NUM> for pump in reservoir implant <NUM> deflation by the medical provider should the apparatus fail.

The medical provider software application <NUM>, executed on a computing device <NUM>, such as a desktop, laptop, smartphone, or tablet, allows the medical provider to set, monitor and noninvasively change inflatable medical implant <NUM> inflation parameters stored in the patient external controller <NUM> for transmission to the pump in reservoir implant <NUM>. Inflation parameters may originate from the medical provider, the apparatus provider or from performance data received from sensors placed in the pump in reservoir implant <NUM>. The medical provider software application <NUM> also collects patient external controller <NUM> data from multiple patients so trends in usage and performance may be analyzed for determining settings and for scientific papers.

A block diagram of the software modules contained in the medical provider software application <NUM> is shown in <FIG>. The implant parameter module <NUM> provides the medical provider with the capability to set and update the patient external controller's <NUM> software and inflation parameters, and to monitor implant operation. The medical provider may set parameters including the amount of fluid that the pump transfers and at what speed for inflation and deflation. The medical provider may set the amount of fluid and speed parameters as constant values, or may set the parameters to change depending on particular times of the day. For example, to increase anal and urinary artificial sphincter life, the medical provider may want to apply less pressure to the artificial sphincter at night, when less pressure is needed in supine patients, thereby reducing tissue wear. Pump operating time and output pressure data fed back to the module is then available to assist the medical provider in finding this minimum, and noninvasively adjusting it over time, as tissue atrophies.

Data from the implant parameter module <NUM> is stored in an encrypted patient data base module <NUM>. The patient data base module <NUM> may store patient implant data for all the medical provider's patients. An analytics module <NUM> provides the medical provider with the capability to study trends in patient data contained in the patient data base <NUM>. Analysis may include looking at atrophy rates of artificial sphincter patients with specific devices, and warning that a particular device is about to fail.

An executive module <NUM> controls and oversees the use of other modules by providing services such as such a logon, logoff and module selection. A graphic user interface module <NUM> provides the displays and controls for the medical provider to interface with the application's modules.

When in range, such as during office visits or hospitalizations, a communications module <NUM> provides for computer instructions and data transfer between the medical provider software application <NUM> and the patient external controller <NUM> using encrypted transmissions over a standard communications network <NUM>, such as Ethernet, USB drive, Bluetooth or Wi-Fi, as shown in <FIG>. The communications module <NUM> may also retrieve implant performance data stored in the patient external controller <NUM>. A security module <NUM> provides data encryption and medical provider authentication. And, a multiplatform interface module <NUM> provides application operation across different medical provider computing devices <NUM> with different screen sizes. All module software may be updated from time to time by the apparatus provider via disk and over the internet.

A patient external controller <NUM>, in communication with the medical provider software application <NUM> and the pump in reservoir implant <NUM>, receives and stores inflation data and computer instruction updates from the medical provider software application <NUM>, and sends data, power and computer instructions to the pump in reservoir implant <NUM>. It also receives data back from the pump in reservoir implant <NUM> which may be viewed by the patient and stored for retransmission to the medical provider software application <NUM>, thus allowing the patient to transdermally activate, control and power the implant and for the medical provider to reprogram and monitor implant usage and performance, respectively.

<FIG> illustrates an example of a hand-held patient external controller. As shown in the Figure, the patient external controller includes an external controller case <NUM> with a touch screen display <NUM> and patient control <NUM> buttons. Patient controls <NUM> may be provided via push buttons, a touch screen display 311or both. They may include "On, Off, Inflate, and Deflate. " Multiple controls are provided for implants operating more than one inflatable medical implant <NUM>. For example, the buttons may control inflation and deflation of three inflatable medical implants <NUM>. The center button is a "Power On and Off" button. The patient external controller <NUM> may also have a lanyard <NUM> which allows patients to hang the controller from the neck while in use. In operation, the patient may place the external controller case <NUM> or the transmitter resonator pad <NUM> on, or in proximity to, the dermis <NUM>, over the pump in reservoir implant <NUM>, and then operate the desired patient control <NUM>.

<FIG> is a block diagram representation of the patient external controller's130 electronic circuitry. It contains a rechargeable battery power source <NUM>, such as Lithium Ion or Nickel Metal Hydride batteries, to power the apparatus. When not in use, the patient external controller <NUM> may sit in a battery charging station <NUM>, which provides direct current power to charge the rechargeable battery power source <NUM>. Overcurrent, short circuit and over temperature protection may be provided. The battery charging station <NUM> may be powered from <NUM>-<NUM> volt (V), <NUM>-<NUM> hertz (Hz) wall outlet connections or <NUM> V storage batteries.

When the "On" patient control <NUM> is selected, the rechargeable battery power source <NUM> supplies power to the patient external controller <NUM> to energize its functions and await commands from the patient via patient controls <NUM> or from the medical provider via the communications port <NUM>. Upon activating another control, a signal is sent to a controller microcontroller <NUM>, such as a TMS <NUM> series microcontroller, which contains a nonvolatile memory for storing its executable computer instructions, medical provider's settings, and implants usage data, to institute and control apparatus actions. Should an action include operation of the pump in reservoir implant <NUM>, a handshake is first conducted with the pump in reservoir implant140 over the bidirectional communications link132 to ensure it is ready for operation, and foreign object detection is initiated for safety.

Here, the controller microcontroller <NUM>, connected to the power transmitting unit <NUM> over a standard bus, such as an I<NUM>C serial interface bus, sends handshake messages to the power transmitting unit <NUM> for transmission through the transmitter resonator <NUM> to pump in reservoir implant <NUM>. Proper messages must be received back from the pump in reservoir implant <NUM> for the action to continue. The controller microcontroller <NUM> may be programmed to stop operation if the bidirectional communications link132 signal is lost, a preset pump in reservoir implant <NUM> safety parameter is exceeded, or a foreign object is detected. The controller microcontroller <NUM> may turn off power if no patient control <NUM> is received after a preset time interval.

Upon completion of the handshake and safety checks, the power transmitting unit <NUM> generates and transmits evanescent radio frequency transdermal power <NUM> via a transmitting resonator <NUM> to the pump in reservoir implant <NUM>, and may operate in the <NUM> to <NUM> band, a decade below the <NUM> radio frequency of <NUM> tesla MRI machines.

As shown in <FIG>, evanescent power transmission <NUM> may be used to transmit power to the pump in reservoir implant <NUM>, as opposed to a close-coupled magnetic induction power transmission, because it provides more efficient, longer distance, higher power operation at a lower voltage. The transmitter resonator <NUM> may transmit over <NUM> watts of power, across more than <NUM>-inchs of dermis <NUM>, tissue and fat, to the pump in reservoir implant <NUM>.

The transmitter resonator <NUM> includes a wire coil and a matching capacitor network combination which resonates at the desired transmission frequency, such as <NUM>. Wired coils may be located in both the patient external controller case <NUM> and in the transmitter resonator pad <NUM>, which may make it easier for the patient to hold the wire coil on the skin over the implant. The transmitter resonator pad <NUM> may connect to the external controller case <NUM> via a plugin cable <NUM>. Plugging the cable <NUM> into the external controller case <NUM> disconnects the case's wire coil.

As shown in <FIG>, the pump in reservoir implant <NUM> includes an outer flexible reservoir case <NUM>, which may be elliptical in shape and hold isotonic fluid <NUM> as the working fluid for inflatable medical implants <NUM>. As noted, the inflatable medical implants may be penile cylinder implants, urethra cuff implants or anal cuff implants. The amount of isotonic fluid may depend on the implant and desired use. For example, <NUM> milliliters of isotonic fluid may be used with a penile cylinder implant.

The pump in reservoir implant <NUM> further includes a pump package142, which may be in the form of a cylinder, <NUM> millimeters in diameter by <NUM> millimeters long and submerged in the isotonic fluid <NUM>. A flexible tube <NUM> with a connector <NUM> carries the isotonic fluid <NUM> to and from inflatable medical implants <NUM>. A pressure relief tube <NUM> is also included, should the apparatus fail.

The reservoir case <NUM> may have a biologically inert outer wall with an insulating material, such as Nomex, molded into the wall to reduce heat transfer rate from the isotonic fluid to the patient during low duty cycle inflation and deflation. The unfilled reservoir may be folded into a cylindrical shape to ease insertion by the surgeon. The surgeon may insert the reservoir case <NUM> into the patient's abdomen <NUM> and then fill it with isotonic fluid <NUM>. The isotonic fluid <NUM> is the pump's operating fluid, provides a heat sink for the pump package142, and does not change the patient's local electrolytic balance should leakage occur.

As shown in <FIG>, <FIG> and <FIG>, the apparatus may inflate and deflate any combination of penile cylinder implants <NUM>, urethra cuff implants <NUM>, anal cuff implants <NUM>, and other inflatable medical implants. <FIG> illustrates a pump in reservoir implant <NUM> operating a single inflatable medical implant <NUM>. <FIG> shows a pump in reservoir implant <NUM> operating three inflatable medical implants: a penile cylinder implant <NUM>, a urethra cuff implant <NUM>, and an anal cuff implant <NUM>.

The pump in reservoir implant <NUM> may be MR-Conditional or MR-Safe, with components that may not translate, rotate, excessively heat or cause MRI picture distortion when introduced into certain MRI machines. As shown in <FIG>, the pump in reservoir implant <NUM> may also be implemented with components which contain MR-Unsafe ferrous materials.

The MR-Safe or MR-Conditional pump in reservoir implant <NUM> apparatus may inflate and deflate penile cylinder implants <NUM>. In order to inflate and deflate the implants quickly, the pump may pump <NUM> milliliters of fluid at <NUM> pounds per square inch pressure in <NUM> seconds, which includes a safety factor. Pumping equations show that this is equivalent to providing <NUM> watts of pumping power at the penile cylinder implant <NUM>. Since cuffs require less than <NUM>/<NUM>th the amount of fluid transfer than for cylinders, requirements are less stringent for these implants.

MR-Unsafe ferrous brushed direct current and brushless direct current electric motors coupled to ferrous containing positive displacement internal gear pumps, which meet these requirements, may be used. These motors use ferrous materials to greatly increase torque by linking magnetic flux between the motor's stator and rotor such that very little leakage flux is generated. For such motors, removing ferrous materials for MRI safety reduces flux linkages, thereby greatly reducing torque and power output. In such motors, some torque can be bought back by increasing motor diameter and applied voltage. However, minimizing these parameters is desirable.

Furthermore, for positive displacement rotary internal gear pumps, dynamic sealing allows the gears to move while maintaining separation between the pump's inlet and outlet. These dynamic seals are maintained as the gears rotate. However, there must be some clearances for the gears to move. These clearances allow fluid to leak back from the high-pressure outlet to the low-pressure inlet, thereby reducing pump efficiency, especially at low pump output pressures, such as <NUM> pounds per square inch, and will cause fluid leakage back and forth between the reservoir case 141and the inflatable medical implant <NUM> even when the pump is not in operation.

A nonferrous combination of a <NUM>-phase squirrel cage motor and positive displacement internal gear pump may also be used. For example, a <NUM>,<NUM> revolutions per minute motor, reduction gear and low speed pump combination, <NUM> millimeters in diameter, may be used. To maximize motor-pump efficiency and minimize motor diameter without using reduction gears with their efficiency loss, a nonferrous <NUM> millimeter diameter squirrel cage motor <NUM>, operating at <NUM> revolutions per minute, power by a <NUM> volt direct current input <NUM>-phase power inverter <NUM> and driving a <NUM> millimeter diameter nonferrous positive displacement internal gear pump <NUM> may be used.

An electrically operated, nonferrous piezoelectric valve <NUM> may be added at the internal gear pump <NUM> connection with the inflatable medical implant <NUM> to prevent fluid leakage back to the reservoir through the pump, and vice versa. Individually operating a stack of such valves allows a single motor and pump to operate multiple inflatable medical implants, providing a significant cost and size saving. Less than <NUM> watts of transdermal power is needed to power the pump in reservoir implant.

Details of the pump in reservoir implant <NUM> operating a single inflatable medical implant <NUM> are shown in <FIG>. In the figure, a reservoir case <NUM> contains a pump package <NUM> which includes a transdermal power receiver resonator <NUM>; electrical components mounted on circular circuit boards <NUM>; a nonferrous pump assembly, comprising a <NUM>-phase squirrel cage motor <NUM>, an internal gear pump <NUM>, a piezoelectric valve <NUM>; and pump speed and pressure sensors <NUM>, all submerged in an isotonic fluid <NUM>.

<FIG> illustrate a squirrel cage motor, supplied with <NUM>-phase alternating current power, and able to be operated at various speeds. For example, a <NUM> millimeter diameter by <NUM> millimeter long, <NUM>-phase <NUM>-pole squirrel cage motor, supplied with <NUM>-phase <NUM> volts alternating current power, and operating at <NUM>,<NUM> revolutions per minute, may be used. <FIG> shows the motor's <NUM>-pole stator windings <NUM> and the rotor bars <NUM> with their short circuiting endplates. In <FIG>, the stator windings <NUM> and the rotor bars <NUM> are encapsulated in molded plastic to reduce windage losses and to stabilize the rotor under centrifugal force. A <NUM>-phase squirrel cage motor has the advantages of small size, self-starting, high speed operation. Squirrel cage motors do not use brushes or slip rings, wear items which reduce motor life.

As shown in <FIG> and <FIG>, the submerged squirrel cage motor <NUM> drives a submerged nonferrous, positive displacement rotary internal gear pump <NUM>, where one pump orifice is open to the reservoir through the reservoir orifice tube <NUM>. The nonferrous internal gear pump may be <NUM> millimeters in diameter and <NUM> millimeters long and have shaft seals to prevent fluid from entering the squirrel cage motor <NUM>.

The other internal gear pump <NUM> orifice may be assembled to a <NUM> millimeter diameter nonferrous piezoelectric valve <NUM> orifice. The valve is closed when not in use to prevent leakage of fluid through the internal gear pump <NUM>.

An external orifice tube <NUM> connects the piezoelectric valve's 411other orifice to a connector <NUM> placed through the reservoir case 141for attachment of the flexible tube <NUM> during surgery when the surgeon threads the flexible tube <NUM> from the reservoir case <NUM> to the inflatable medical implant <NUM> and connects it to the pump in reservoir implant using connector <NUM>.

<FIG> shows individually controlled piezoelectric stacked valves <NUM> operating three implants: a dual penile cylinder implant <NUM>, a urethra cuff implant <NUM> and an anal cuff implant <NUM>. A computer interlock is provided so only one valve can be open at a time.

Implant electronics driving the pump <NUM>, may be housed on military-grade, multilayer, coated circular circuit boards <NUM> for physical damage and short circuit protection and moisture-proofing. As shown in <FIG>, the circular circuit boards <NUM> may be <NUM> millimeters in diameter and have holes in their centers for placement around the <NUM> millimeter diameter internal gear pump <NUM> and piezoelectric valve <NUM>. The boards and their components are, at least, MR-Conditional and may be MR-Safe.

As shown in <FIG> and <FIG>, the receive resonator <NUM> may receive evanescent power transmissions <NUM> transdermally from the transmitting resonator <NUM>. Additionally, it may be used for the bidirectional communication link <NUM> with the patient external controller <NUM>. The bidirectional communications unit <NUM> codes and decodes these bidirectional signals for the implant microcontroller <NUM>.

The receiver resonator <NUM> includes a resonant circuit made up of an nonferrous wire coil <NUM> inductor, which may be in the shape of a <NUM> millimeter diameter circle, and a MRI filter/matching network <NUM>, which may resonate at <NUM> and filter out the higher frequency transmissions of MRI machines, such as <NUM> from <NUM> tesla MRI machines. The wire coil <NUM> may be etched onto the circular circuit board <NUM>, molded into the reservoir case <NUM>, or housed in a separate case which, in obese patients, may be located under the dermis <NUM>. The receiver resonator's <NUM> output voltage may vary widely from patient to patient with placement of the transmitter resonator <NUM> with respect to coil <NUM>.

The receiver resonator <NUM> feeds alternating current power to a power conditioning unit <NUM>, which converts the varying received alternating current voltage to stable direct current voltages for the electronics, motor and sensors. First, a low power low voltage power supply may generate <NUM> volts direct current to power the electronic components and sensors. The power conditioning unit <NUM> may use Schottky diodes in a full wave bridge rectifier <NUM> configuration to convert the alternating current voltage into direct current. An electromagnetic interference filter <NUM> is applied to remove diode switching transient noise.

Since the electromagnetic interference filtered <NUM> output voltage can vary widely, a low voltage switch mode power supply <NUM> may provide stable <NUM> volts direct current. The low voltage switch mode power supply <NUM> may contain an under voltage-over voltage protection circuit which only energizes the switch mode power supply when appropriate direct current voltage appears at its input to produce its desired output. Switch mode power supplies obviate the need for inefficient linear regulators and are more efficient than voltage feedback loops to the patient external controller <NUM>.

Upon reception of power from the low voltage switch mode power supply <NUM>, an implant microcontroller <NUM> is energized, does a handshake with the patient external controller <NUM> and self-tests for problems in the pump in reservoir implant <NUM>, such as out of range temperature and pressure and electric current leakage. The implant microcontroller <NUM> then sends status data back to the patient external controller <NUM>, which, if all is well, energizes the patient controls <NUM>.

The implant microcontroller <NUM>, such as a MR-Safe MSP430 or C2000 series microcontroller, may contain an encrypted nonvolatile memory, a reduced instruction set computer, a pulse width modulation unit, at least one analog-to-digital converter, at least one data bus, and self-test capability.

Upon reception of inflation or deflation signals and data from the patient external controller <NUM>, the implant microprocessor <NUM> may turn on a gallium nitride transistor, programmable totem pole boost power converter <NUM> to generate stable high voltage direct current <NUM>, such as <NUM> volts direct current. The gallium nitride transistor, programmable totem pole power converter <NUM> uses gallium nitride high electron mobility field effect transistor switches, which achieve lower losses than silicon-based components, to nominally provide <NUM> volts direct current to power the <NUM>-power inverter <NUM> for the <NUM>-phase squirrel cage motor <NUM>. The gallium nitride transistor, totem pole boost power converter <NUM> operates at a lower input voltage, such as <NUM> volts direct current, than its output voltage, thereby allowing for lower evanescent power transmission <NUM> voltage from a lower voltage rechargeable battery power source <NUM>, for example <NUM> volts direct current, in the patient external controller <NUM>, which results in less cost and greater patient safety.

The implant microcontroller <NUM> uses the pulse width modulation voltage control <NUM> path to sense the alternating current input voltage, determines when that voltage crosses zero and then sends pulse width modulation signals to turn on and turn off gallium nitride half-bridge transistors in an inductive boost converter configuration to achieve alternating current to direct current boost conversion to provide the high direct current voltage power <NUM>. The high direct current voltage power <NUM> voltage is fed back to the implant microprocessor <NUM> for closed loop control of the voltage by varying the pulse width modulation.

The high voltage direct current <NUM> output of the gallium nitride transistor, programmable totem pole power converter <NUM> is then inverted to <NUM>-phase alternating current by a <NUM>-phase power inverter <NUM> controlled by the implant microcontroller <NUM>. The frequency and the number of sinusoidal cycles to be generated may be set from the medical provider software application <NUM>. For a <NUM>-pole, <NUM> revolution per minute squirrel cage motor, the implant microcontroller <NUM>'s pulse width modulation unit, operating at <NUM>, may generate three <NUM> pulse width modulation sinusoids set <NUM> degrees apart for low harmonic distortion losses. Soft pulse width modulation gallium nitride transistor startup is used to decrease losses from transistor switching transients. Motor direction, and therefore inflatable medical implant <NUM> inflation or deflation, is achieved by switching two phases of the three <NUM>-phase signals.

The sinusoidal pulse width modulation signals are input to three <NUM>-phase half-bridge gate drivers <NUM>, which, in turn, drive three <NUM>-phase half control bridges <NUM>, to generate <NUM>-phase power to drive the motor. Current and voltage feedback <NUM> from the <NUM>-phase half control bridges <NUM> is used in the implant microcontroller <NUM> to provide stable operation of this nonferrous low stator impedance motor, and detect faults for safe operation.

In operation, the motor, which drives the pump, sees a varying load. At the start of the pumping cycle, the pump sees high pressure at its input and low pressures is at its output and requires reduced motor torque, and therefore power, to operate. At the end of the cycle, the opposite is true. Efficiency of the pump and motor combination is achieved by calculating and applying the optimum <NUM>-phase voltage at the optimum <NUM>-phase frequency continuously over the pumping cycle. This optimization may be achieved by the implant microprocessor <NUM> using the pulse width modulation voltage control <NUM> feedback loop and the current and voltage feedback <NUM> loop to set the high direct current voltage <NUM> and the <NUM>-Phase pulse width modulation signal <NUM> to control the <NUM>-phase squirrel cage motor's <NUM> speed and torque.

Alternatively, the gallium nitride transistor, programmable totem pole boost power converter <NUM> may be replaced by a Schottky diode full wave bridge rectifier and electromagnetic interference filter, and the varying high direct current voltage power <NUM> is fed directly to the <NUM>-phase half control bridges <NUM>, which act as both a voltage regulator and a direct current to alternating current inverter. The implant microprocessor then generates the correct pulse width modulation signals for the varying high direct current voltage power <NUM> when it computes the pulse width modulation signals for the <NUM>-phase squirrel cage motor <NUM>. Additionally it provides over and under voltage protection for the varying high direct current voltage power <NUM>.

The implant microcontroller <NUM> also receives, processes, and formats implant performance and safety data for transmission to the patient external controller <NUM>. In some implementations, additional analog-to-digital and digital-to-analog integrated circuit are necessary to handle all the sensor data.

Pump pressure and motor speed sensors <NUM> are provided along with reservoir pressure and temperature sensors <NUM>. Pressure and speed data is sent to the implant microcontroller <NUM>. The pressure and speed data may be used for automatic cutoff should the pump run over or under speed limits, or on the occurrence of leakage, over inflation or a fluid blockage.

The pressure and speed data may also be used to help the medical provider set the amount of fluid to be transferred that is best suited for the patient. Reservoir pressure and temperature sensors <NUM> may be included on the circular circuit boards <NUM> to send pressure and temperature data to the implant microcontroller <NUM> for high temperature cutoff should the isotonic fluid <NUM> overheat. Additionally, integrated circuit chips used in the power receiving unit <NUM> and implant microcontroller <NUM> may have internal temperatures sensors that turn off the chip in over temperature situations.

Should the apparatus fail with an inflatable medical implant150, such as a penile cylinder implant <NUM>, inflated, a pressure relief tube143 is provided to allow medical providers to manually deflate the inflatable medical implant <NUM> by inserting a small bore hypodermic needle into the pressure relief tube143 and draw out the inflating fluid. One end of the tube is located at the inflatable medical implant <NUM> and the other end just below the dermis <NUM>.

<FIG> shows a diagram of a MR-Unsafe pump in reservoir implant implementation. The implementation of <FIG> includes many of the same components already described in <FIG> and <FIG>. However, in <FIG>, the <NUM>-phase power inverter and nonferrous pump and motor <NUM>, <NUM>, <NUM>, from <FIG> and <FIG> are replaced by an inflate-off-deflate switch <NUM>, direct current motor <NUM> and internal gear pump <NUM>.

Coupling between the direct current motor <NUM> and the internal gear pump <NUM> may be magnetic, allowing the pump to be in submerged in the isotonic fluid <NUM> without the need for seals in the pump, thereby increasing efficiency and reliability. Also, the <NUM>-phase power inverter <NUM> is replaced by connecting the <NUM> gallium nitride transistor, programmable totem pole boost power converter's <NUM> high direct current voltage power <NUM> through an implant microcontroller <NUM> controlled half-bridge reversing direct current power control inflate-off-deflate switch <NUM>, to turn the motor on and off and to reverse its direction.

<FIG> shows the pump package142 illustrating the circular circuit board <NUM>, squirrel cage motor <NUM> and piezoelectric valve <NUM> arrangement. In the pump package <NUM>, an internal gear pump orifice <NUM> directly connects to a piezoelectric valve <NUM> orifice. A reservoir orifice tube <NUM> then connects the other internal gear pump <NUM> orifice to inside the reservoir case <NUM> in contact with the isotonic fluid <NUM>. An external orifice tube <NUM> connects the other piezoelectric valve's <NUM> orifice to a connector <NUM> leading outside of the reservoir case <NUM>. The figure also shows a single circular circuit board <NUM> mounted around a piezoelectric valve <NUM>.

Claim 1:
A pump in reservoir implant (<NUM>) for inflating at least one inflatable medical implant (<NUM>), the pump in reservoir implant comprising:
a reservoir case (<NUM>), which is configured to hold isotonic fluid (<NUM>) as the working fluid for the at least one inflatable medical implant (<NUM>), and
a pump package (<NUM>) contained in the reservoir case (<NUM>), the pump package (<NUM>) including:
at least one nonferrous motor (<NUM>);
a nonferrous fluid pump (<NUM>) connected to the at least one nonferrous motor; and
at least one nonferrous valve (<NUM>) connected to the nonferrous fluid pump (<NUM>), configured to allow fluid to pass from the pump (<NUM>) to the at least one inflatable medical implant (<NUM>), wherein an internal gear pump orifice directly connected to a piezoelectric valve orifice connects the at least one nonferrous valve (<NUM>) and the nonferrous fluid pump (<NUM>);
a reservoir orifice tube (<NUM>) that connects another internal gear pump's orifice to the inside of the reservoir case (<NUM>) in operation in contact with the isotonic fluid; and
an external orifice tube (<NUM>) that connects another piezoelectric valve's orifice to a connector (<NUM>) leading outside the reservoir case (<NUM>).