JP7157093B2 - Temporary contraceptive device for men - Google Patents

Description

The present invention relates generally to male contraceptive systems and devices that operate to close the vas deferens for a controlled, temporary period of time.

A common method of male contraception is to block the vas deferens (the tubes that carry sperm). A vasectomy is a surgical intervention to cut the vas deferens and is most often limited to permanent infertility. More recently, other alternatives have become available by shaping the device for insertion into the vas deferens to provide a sealing effect. One such technique is described in US Pat. No. 6,513,528 for a set of silicone plugs for insertion into the vas deferens. However, even though the technology has shown potential to restore fertility in individuals, it is also associated with side effects such as the formation of antibodies in sperm. Therefore, there is a need for a more gentle technique of controlling male contraception that allows recovery with minimal impact on bodily function. SUMMARY OF THE INVENTION It is an object of the present invention, as outlined below, to provide devices, systems and methods that make male contraception based on obstruction of the vas deferens safer and more convenient.

U.S. Pat. No. 6,513,528

Generally, the present invention relates to a male contraceptive device that temporarily renders male mammalian individuals sterile. The apparatus comprises an implantable restriction device adapted to restrict a region downstream of the ampulla of the vas deferens for a controlled period of time, whereby said device prevents sperm from reaching the urethra. . The apparatus further comprises a control device for controlling operation of the restriction device. Restriction devices may comprise hydraulic or mechanical constriction devices, as well as stimulation devices for temporarily restricting the vas deferens alone or in any combination.

As used herein, restriction of the vas deferens means obstruction of the lumen of the vas deferens in such a manner as to prevent sperm from reaching the urethra by manipulating the vas deferens from the outside. The term "vas deferens" can include one or both vas deferens. Other terms such as "lumen" or "tissue part" or "body organ" are also used when describing the controlled restriction of the vas deferens according to the present invention, although such terms are functionally synonymous. shall be deemed to be The term "ampulla" refers to the enlarged portion of the vas deferens near where it meets the seminal vesicles.

The term "downstream of the ampulla" refers to the position behind the ampulla in the direction of the urethra and seminal vesicles. Thus, "upstream of the ampulla" will refer to the position of the vas deferens in front of the ampulla in the direction towards the testis. That the restriction device is adapted to restrict the vas deferens in such a particular area means that it is preferably designed to be accommodated in this area of the body.

By restricting the portion of the vas deferens downstream of the ampulla, the device of the present invention compartmentalizes the ampulla and shields the sperm, thereby allowing the device to provide immediate contraceptive efficacy. and enable reliable temporary sterilization. Even if the primary use of the device is to prevent sperm transport for a controlled and temporary period of time by activating a restriction device during intercourse, for example, certain embodiments of the present invention prevent such transport. It is also possible to assist sperm transport through the vas deferens to help people with systemic disorders. Advantageously, the present invention makes it possible to limit the time period for which restriction is necessary to a very limited time period. Current treatments require closure of sperm viability at least 5 days before it is safe and therefore risk damaging the vas deferens. In addition, the device prevents those sperm from accumulating in the vas deferens due to long-term restriction that can lead to undesirable complications.

The restriction device is very carefully adapted to a specific location downstream of the ampulla. The amount of space is limited and the requirements are unique to allow placement in the region between the prostate and the vas deferens ampulla. Since the ampulla contains a reservoir for sperm, a restriction is made in the downstream region to prevent sperm from potentially reaching the urethra during intercourse. When relevant, the restriction device according to the invention can also be adapted to achieve restriction of the proximally located seminal vesicle exit duct. Simultaneous restriction of this outlet tube should be viewed as one of the advantages obtained by the present invention.

According to one embodiment of the invention, the restriction device comprises a clamping device for clamping at least a portion of the tissue wall of the vas deferens downstream of the ampulla so as to stop flow in the vas deferens. To that end, the apparatus comprises an adjustable restriction device and an operating device for mechanically or hydraulically operating the adjustable restriction device to change the restriction of the wall portion of the vas deferens. The operating device preferably non-magnetically and/or non-manually operates the restriction device. Preferably, the operating device comprises an electrically powered operating device, such as a motor or boost servo system. The term "boosting servo system" means that the system includes a transmission mechanism that causes a weak force acting on a moving element with a long stroke to exert a strong force on another moving element with a short stroke. According to one alternative, the restriction device comprises a clamping device comprising at least two elongated clamping elements extending along the organ in the direction of flow in the patient's vas deferens on different sides of the organ, and the operating device comprises: The clamping elements are operated to clamp the wall portion between the clamping elements to clamp the wall portion. Alternatively, the operating device may comprise hydraulic means for hydraulically adjusting the limit device and reverse servo operatively connected to the hydraulic means. The term "reverse boost servo" should be understood as a mechanism that transfers a strong force acting on a moving element with a short stroke to a weak force acting on a moving element with a long stroke. Preferably, the reverse boost servo comprises at least two implantable reservoirs containing hydraulic fluid, preferably the first reservoir being a subcutaneously implantable adjustment reservoir. The reverse boost servo further comprises a second implantable servo reservoir, which servo reservoir is preferably in fluid communication with the adjustment reservoir. In one embodiment, the second servo reservoir directly controls the expansion/contraction of the tightening device. In another embodiment, the servo reservoir indirectly controls expansion/contraction of the constricting device, and the reverse force servo further comprises a third reservoir, which third reservoir is in the abdominal or retroperitoneal cavity or It is adapted to be implanted in the pelvic region and is operably connected to a second servo reservoir for moving hydraulic fluid in said third reservoir to operate the constriction device. Suitably the third reservoir is larger in volume than the first reservoir. A third reservoir can be fluidly connected with the tightening device, and a servo reservoir can control the third reservoir with a mechanical interconnection.

Alternatively, the restriction device comprises a non-inflatable mechanical clamping device and the operating device comprises hydraulic means for hydraulically adjusting the mechanical clamping device.

According to another embodiment of the invention, the restriction device comprises a wall of the tissue wall of the vas deferens in a region downstream of the ampulla so as to contract said wall portion so as to affect flow in the vas deferens. It has a stimulation device that stimulates the part. A control device controls the stimulation device to stimulate the wall portion, and the control device preferably controls the implantable energy source to emit energy for use with stimulation. It can be operated from outside the body. The stimulation device is adapted to stimulate different regions of the wall portion, and the control device controls the stimulation device to intermittently and individually stimulate those regions of the wall portion. Such intermittent and discrete stimulation of different regions of the wall portion of the organ allows the tissue of the wall portion to maintain substantially normal blood circulation during operation of the device of the present invention. Various alternatives and useful components for achieving stimulus limitation are described below.

It is also an embodiment of the invention that the restriction device comprises a mechanically or hydraulically operated constriction as described above and a stimulation device as described above. The control device is adapted to control the constriction device and the stimulation device in combination with the restriction of the vas deferens.

The present invention also embodies a method of stimulating the ampulla which includes employing an apparatus as described having a stimulation device restricting the portion of the vas deferens downstream of the ampulla. As a result, it is possible to obtain stimulation of retrograde flow in the ampulla.

Additionally, the present invention comprises a system including any of the devices described in the preceding paragraphs. In a preferred embodiment, the system comprises at least one patient-implantable switch for manually non-invasively controlling the device. In another preferred embodiment, the system comprises a wireless remote control for non-invasively controlling the device. In preferred embodiments, the system comprises a hydraulically operated device for operating the apparatus. In another embodiment, the system includes a motor or pump for operating the device. Other components of the system are described in more detail in the detailed section of this specification.

Stimulation When stimulating nerve or muscle tissue, there is a risk of gradual damage or deterioration of the tissue if the stimulation is not done properly. The device of the present invention is designed to reduce or even eliminate such risks. Thus, according to the invention, the control device controls the stimulation device to intermittently stimulate different regions of the wall portion of the organ, so that at least two of those regions are stimulated at different times; That is, there is a gradual shift of stimulation from one region to another. Further, the control device controls the stimulation device such that currently unstimulated ones of the different regions have time to restore substantially normal blood circulation before the stimulation device re-stimulates the region. do. Further, the control device controls the stimulation device to stimulate each area for successive periods, each period being short enough to maintain adequate blood circulation in that area until the period elapses. This is because the device of the present invention allows the organ wall portion to achieve the desired control of flow while essentially maintaining the original physical properties of the organ over time without the risk of damaging the organ. Provides the advantage of allowing continuous stimulation.

Furthermore, by gradually physically altering the stimulation location on the organ as described above, it is possible to create favorable stimulation change patterns on the organ to achieve the desired flow control.

The control device can control the stimulation device to stimulate one or more areas of the wall portion at a time, for example by sequentially stimulating different areas. Furthermore, the control device can control the stimulation device such that the stimulation of the area along the wall portion is propagated periodically, preferably according to a determined stimulation pattern. In order to achieve the desired response while stimulating the tissue wall, the control device can control the stimulation device such that the intensity of stimulation of the wall portion is varied, preferably periodically.

In a preferred embodiment of the invention, the control device controls the stimulation device such that regions of the wall portion are intermittently stimulated with pulses, preferably forming a pulse train. repetitively stimulating at least a first and a second region of the wall portion with respective first and second pulse trains such that the first and second pulse trains are gradually shifted with respect to each other; can be done. For example, a first region can be stimulated with a first pulse train and a second region is not stimulated with said second pulse train, or vice versa. Alternatively, the first and second pulse trains can be shifted with respect to each other such that the first and second pulse trains at least partially overlap each other.

A pulse train can be constructed in many different ways. The control device thus controls the amplitude of the pulses in the pulse train, the duty cycle of the individual pulses in each pulse train, the width of each pulse in the pulse train, the length of each pulse train, the number of repetitions of the pulses in the pulse train, the number of repetitions of the pulse train, the repetition number of each pulse train, The stimulation device can be controlled such that the number of pulses and/or the OFF period between pulse trains is varied. Multiple pulse trains of different configurations can be used to achieve the desired effect.

If the control device controls the stimulation device to vary the off-periods between pulse trains that stimulate respective regions of the wall portion, a substantially normal state in that region is obtained when the region is not stimulated during the off-periods. It is also possible to control each OFF period between pulse trains to last long enough for blood circulation to be restored.

Electrical Stimulation According to a preferred embodiment of the present invention, the stimulation device is a motorized stimulation device that electrically stimulates tissue wall portions of the patient's body organ, preferably with electrical pulses. This embodiment is particularly suitable for applications in which the wall portion contains muscle fibers that respond to electrical stimulation. In this embodiment, the control device controls the stimulation device to stimulate the wall portion with electrical pulses, preferably in the form of an electrical pulse train, when the wall portion is in a clamped state to contract the wall portion. . It will be appreciated that the configuration of the electrical pulse train may be similar to the pulse trains described above and the control device may be configured to electrically stimulate different regions of the organ wall in a similar manner as described above. can be controlled.

The electrical stimulation device suitably comprises at least one, preferably a plurality of electrical elements, such as electrodes, for engaging and stimulating the wall portion with electrical pulses. Optionally, the electrical elements can be arranged in fixed orientations relative to each other. A control device controls the electrical stimulation device to electrically energize one electrical element at a time, or several groups of electrical elements at a time. Preferably, the control device controls the electrical stimulation device to periodically energize each element with an electrical pulse. Optionally, the control device energizes the electrical elements to sequentially energize one electrical element at a time or energize multiple electrical elements or groups of electrical elements simultaneously. The stimulation device can be controlled so as to Additionally, groups of electrical elements can be sequentially energized randomly or according to a predetermined pattern.

The electrical elements can form any pattern of electrical elements. Preferably, the electrical elements may form an elongated pattern of electrical elements, wherein the elongated pattern of electrical elements extends along the length of the wall of the organ and the elements extend along the wall portion of each of the wall portions. can be applied to the wall of the patient's organ so as to abut the area of . The elongated pattern of electrical elements can include one or more rows of electrical elements that extend longitudinally along the wall of the organ. The electrical elements in each column can form a straight, spiral, or zigzag path of electrical elements, or any form of path. A control device controls the stimulation device such that the electrical elements are sequentially energized along the longitudinally elongated pattern of electrical elements in the opposite direction or the same direction as the flow in the lumen of the patient. be able to.

Optionally, the control device can control the stimulation device to continuously bias the electrical elements in the elongated pattern from a substantially central position of the clamped wall portion toward opposite ends of the electrical elements. . If the lumen of the organ is to remain closed for a relatively long time, the control device adjusts the number of energized electrical elements so that the energized electrical elements form two waves of energized electrical elements. The stimulation device can be controlled such that the waves advance simultaneously from the center of the clamped wall portion toward the ends of the elongated pattern of electrical elements in two opposite directions. These waves of energized electrical elements can be repeated over and over again without damaging the organ and without moving fluids or gases in any direction in the lumen of the organ.

The control device causes the stimulation device to energize the electrical elements such that the currently energized electrical elements form at least one group of energized electrical elements adjacent to each other. control properly. According to a first alternative, the elements of the group of energized electrical elements form one path of energized electrical elements. The path of the energized electrical element can extend at least partially around the patient's organ. In a second alternative, the elements of the group of energized electrical elements preferably extend on each side of the patient's organ substantially transverse to the direction of flow in the lumen of the organ. Two paths of electrical elements can be formed. In a third alternative, the elements of the energized electrical element group are energized extending on different sides of the patient's organs, preferably substantially transverse to the direction of flow in the patient's lumen. More than two paths of electrical elements can be formed.

According to a preferred embodiment of the invention, the electrical elements form a plurality of groups of elements, which groups form a series of groups extending along the patient's organs in the direction of flow in the patient's lumen. do. The electrical elements of each electrical element group can form a path of elements that extends at least partially around an organ of the patient. In a first alternative, the electrical elements of each electrical element group have three or more paths of elements extending on different sides of the patient's organs, preferably substantially transverse to the direction of flow in the patient's lumen. can be formed. The control device can control the stimulation device to energize some of the electrical element groups in the series randomly or according to a predetermined pattern. Alternatively, the control device may have a series of motions, starting from a substantially central position of the clamped wall portion, either in the opposite direction to the flow in the patient's lumen, or in the same direction, or in both said directions. The stimulation device can be controlled to sequentially energize electrical elements of several of the groups. For example, several groups of energized electrical elements may form an advancing wave of energized electrical elements as described above, i.e. the control device may so that the energized electrical elements form two waves of energized electrical elements that advance simultaneously from the center of the wall portion to be clamped in two opposite directions toward the ends of the elongated pattern of electrical elements. A stimulation device can be controlled to energize one group of electrical elements.

A structure may be provided to hold the electrical element in a fixed orientation. The structure may be separate from the clamping device, but is preferably integral with the clamping device, which is a practical design and facilitates implantation of the clamping device and stimulation device. When the electrical elements form an elongated pattern of electrical elements, the structure is such that the elongated pattern of electrical elements extends along the organ in the same direction as the flow in the lumen of the patient, and the elements extend along the wall portion of the organ. It may be applicable to the patient's organ to abut the respective region.

Thermal Stimulation In another embodiment of the invention, the stimulation device thermally stimulates the wall portion of the organ. The control device can thus control the stimulation device such that the wall portion is cooled as it is tightened to cause contraction of the wall portion. For example, the tightening device can tighten the wall portion to at least restrict flow in the lumen, and the control device can cause flow in the lumen to be at least further restricted or further restricted but stopped. The stimulation device can be controlled to cool the clamped wall portion and cause it to contract so that it does not or stops. Alternatively, the control device may control the stimulation device to heat the wall portion as it is tightened and contracted to enlarge the wall portion. If the wall portion includes a blood vessel, the control device may control the stimulation device to cool and constrict the blood vessel or heat and expand the blood vessel. Where applicable, any embodiment of the present invention may perform thermal stimulation and may control thermal stimulation in response to various sensors, such as strain sensors, motion sensors, or pressure sensors.

Sensor-Controlled Clamping Device and/or Stimulation Device As mentioned above, the apparatus may comprise at least one implantable sensor, and the control device controls the clamping device and/or stimulation device according to a signal from the sensor. control in response to Generally, the sensor directly or indirectly senses at least one physical parameter of the patient, or at least one functional parameter of the device, or at least one functional parameter of the medical implant of the patient.

Many types of sensors that sense physical parameters can be used. For example, motion sensors that sense organ movement, i.e., natural contractions, such as contractions of the stomach or intestines; pressure sensors that sense pressure in the organ; strain sensors that sense strain in the organ; a spectrophotometric sensor; a Ph sensor that senses the acidity or alkalinity of the fluid in the lumen of the organ; an oxygen sensor that senses the oxygen content of the fluid in the lumen of the organ , or a sensor that senses the distribution of stimulation to the stimulated organ. Any conceivable sensor that senses any other kind of useful physical parameter can be used.

Many types of sensors sensing functional parameters of the apparatus can also be used to control the constriction device and/or the stimulation device. For example, a sensor that senses an electrical parameter of an implantable electrical component of the device or a sensor that senses operation of an implantable motor of the device.

The sensor may comprise a pressure sensor sensing the pressure of the patient's body related to the pressure in the lumen of the patient's body organ as a physical parameter, the control device sensing a predetermined value of the measured pressure. The tightening device and/or the stimulation device are controlled to alter the tightening of the patient's wall portion in response to the pressure sensor.

Alternatively, or in combination with a pressure sensor, a position sensor can be provided that senses the orientation of the patient with respect to horizontal as a physical parameter. The position sensor may be a biocompatible version of the sensor shown in US Pat. Nos. 4,942,668 and 5,900,909. For example, the control device may change the tightening of the wall portion of the patient in response to the position sensor sensing that the patient is assumed to be substantially horizontal, i.e., the patient is lying down. Additionally, the tightening device and/or the stimulation device can be controlled.

Where applicable, the sensors described above may be used in any embodiment of the invention.

The control device can control the tightening device and/or the stimulation device to change the tightening of the wall portion of the patient in response to time of day. To that end, the control device controls the tightening device and/or the stimulation device to vary the tightening of the wall portion of the patient to increase or decrease the effect on the flow in the lumen during different periods of time. timekeeping mechanism. If any sensor of the type described above for sensing a physical or functional parameter is provided, control the tightening device and/or the stimulation device if the parameter sensed by the sensor does not exceed the timing mechanism. A timing mechanism is used to control or, if the timing mechanism does not exceed the sensor, a sensor is used to control the constriction device and/or the stimulation device. Suitably the control device produces an indication, such as an acoustic signal or information to be displayed, in response to the signal from the sensor.

The control device may comprise an implantable internal control unit that directly controls the constriction device and/or the stimulation device in response to signals from the sensors. The control device may further comprise a wireless remote control adapted to set the control parameters of the internal control unit from outside the patient's body, without mechanically perforating the patient. At least one of the control parameters settable by the wireless remote control is a physical parameter or a functional parameter. Suitably the internal control unit includes a clock mechanism as mentioned above and the wireless remote control device is also adapted to set the clock mechanism.

Alternatively, the control device may comprise an external control unit external to the patient that controls the constriction device and/or the stimulation device in response to signals from the sensors.

The invention will now be described in more detail by way of a non-limiting example with reference to the accompanying drawings.

1 schematically shows a device according to the invention implanted in a human body; 1 schematically shows a device according to the invention implanted in a human body; 1 schematically shows a device according to the invention implanted in a human body; 1 schematically shows a device according to the invention implanted in a human body; 1 schematically shows a device according to the invention implanted in a human body; 1 schematically shows a device according to the invention implanted in a human body; 1A-1F show a system for treating disease including the device of any of FIGS. 1A-1F implanted in a patient; 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1A-1F schematically illustrate various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. FIG. 3 is a schematic block diagram showing the precise amount of biasing mechanism used for operation of the device shown in FIG. 2; Fig. 3 schematically shows an embodiment of a system in which the device operates with hard-wired energy; Figure 3 is a more detailed block diagram of the mechanism controlling the transmission of wireless energy used for operation of the apparatus shown in Figure 2; Figure 20 is a circuit for the mechanism shown in Figure 19 according to a possible implementation; Various methods of hydraulically or pneumatically powering a device implanted in a patient are shown. Various methods of hydraulically or pneumatically powering a device implanted in a patient are shown. Various methods of hydraulically or pneumatically powering a device implanted in a patient are shown. Various methods of hydraulically or pneumatically powering a device implanted in a patient are shown. Various methods of hydraulically or pneumatically powering a device implanted in a patient are shown. Various methods of hydraulically or pneumatically powering a device implanted in a patient are shown. Various methods of hydraulically or pneumatically powering a device implanted in a patient are shown.

FIG. 1A is a schematic diagram of the male contraceptive device shown in FIG. 1B. The device 100 of FIG. 1B shows the restriction of the downstream portion of the vas deferens ampulla of the vas deferens 200A, 200B (both vas deferens). The device is thereby operable to temporarily prevent access to the urethra and achieve time-limited sterilization. Apparatus 100 has a restriction device 120 adapted to mechanically or hydraulically constrict the vas deferens, and a control device 150 for controlling operation of the restriction device to operate by a schematically shown operating device 170. . Control device 150 is placed subcutaneously and includes an external portion and an internal portion. An energy supply unit (energy transmission device) 180 can supply a device with wirelessly transmitted energy to the energy conversion device 151, which supplies energy for energizing the energy consuming part of the apparatus. connected to source 152 . The external remote controller unit 190 can communicate with the control device 150 and the control device's internal control unit 153 . The extracorporeal portion 150A of the control device 150 includes functions necessary for extracorporeal operation, such as an injection port for the supply of hydraulic fluid when the clamping is hydraulically operated, and a start/stop button for operating the restriction device. including. The intracorporeal portion of control device 150B can include multiple functions necessary to control and operate restriction device 120 . In a hydraulically operated restriction device 120, the control device 150 may include a pump 154 operable on a reservoir of hydraulic fluid (not shown) such that transporting the fluid from the reservoir causes the vas deferens to evaporate. When the restriction device is activated to restrict the vas deferens, the restriction device is deactivated to release the vas deferens when transported back to the reservoir. FIG. 1B without the control device in FIG. 1C
shows the device of Restriction device 120 is of the same type as in FIG. 1B, but is now adapted to restrict both the vas deferens and the exit ducts of the seminal vesicles. FIG. 1D shows the apparatus of FIG. 1B or 1C with a modified restriction device 120A operating the stimulation device against both vas deferens. The stimulation device is represented here by a set of electrodes. FIG. 1E shows the apparatus of FIG. 1B or 1C, wherein the restriction device comprises a stimulation device 120A and a constriction device 120B controlled by a control device, the combined action of which restricts both vas deferens. In one embodiment, the constriction device 120B is manually operated by a pump operating on the reservoir to constrict the vas deferens, and the stimulation device operated by the control device is operated by the vas deferens for the effect of blocking sperm transport. to stimulate Another variation of the device of FIG. 1B is shown in FIG. 1F. Restriction device 120 includes two clamping devices, each clamping device adapted to clamp the exit ducts of the vas deferens and the seminal vesicles, respectively, to stop the flow of both sperm and semen. The functioning of the control device and other parts of the invention is further described below in conjunction with FIGS. 1G to 27C.

FIG. 1G shows a system for treating disease in which the device 10 of the present invention is placed on the abdomen of a patient. An implantable energy conversion device 302 is adapted to energize the energy consuming components of the apparatus via a power supply line 303 . An external energy transmission device 304 that non-invasively energizes apparatus 10 transmits energy via at least one wireless energy signal. Implantable energy conversion device 302 converts energy from the wireless energy signal into electrical energy supplied to power supply line 303 .

The wireless energy signal is a wave selected from sonic signals, ultrasonic signals, electromagnetic waves, infrared signals, visible light signals, ultraviolet signals, laser light signals, microwave signals, radio signals, x-ray irradiation signals, and gamma ray irradiation signals. It can contain signals. Alternatively, the wireless energy signal can include an electric or magnetic field, or a combination of electric and magnetic fields.

The wireless energy transmission device 304 can transmit carrier signals for carrying wireless energy signals. Such carrier signals may include digital signals, analog signals, or a combination of digital and analog signals. In that case, the wireless energy signal comprises analog or digital signals, or a combination of analog and digital signals.

Generally, the energy conversion device 302 converts a first form of wireless energy transmitted by the energy transmission device 304 into a second form of energy, typically different from the first form of energy. established for Implantable device 10 is operable in response to a second form of energy. When the energy conversion device 302 converts the first form of energy transmitted by the energy transmission device 304 to the second form of energy, the energy conversion device 302 can directly power the device with the second form of energy. The system can further include an implantable accumulator, wherein the second morphological energy is at least partially used to charge the accumulator.

Alternatively, the wireless energy transmitted by the energy transmission device 304 can be used to directly power the device as the wireless energy is being transmitted by the energy transmission device 304 . If the system includes an actuation device for operating the apparatus, as described in detail below, the wireless energy transmitted by the energy transmission device 304 can be used to directly power the actuation device. , can produce kinetic energy for the operation of the device.

The first form of wireless energy can include sound waves, and the energy conversion device 302 can include piezoelectric elements for converting sound waves into electrical energy. The second form of energy may comprise electrical energy in the form of direct current or pulsating direct current or a combination of direct and pulsating direct current or alternating current or a combination of direct and alternating current. Typically, the device comprises electrical components that are energized with electrical energy. Other implantable electrical components of the system may be at least one voltage level guard or at least one constant current guard connected to the electrical components of the device.

Optionally, one of the first form of energy and the second form of energy comprises magnetic energy, kinetic energy, acoustic energy, chemical energy, radiant energy, electromagnetic energy, optical energy, atomic energy, or thermal energy be able to. Preferably, one of the first form of energy and the second form of energy is non-magnetic, non-kinetic, non-chemical, non-acoustic, non-nuclear or non-thermal.

The energy transmission device can be controlled from outside the patient's body to emit electromagnetic wireless energy, and the emitted electromagnetic wireless energy is used to operate the device. Alternatively, the energy transmission device is controlled from outside the patient's body to emit non-magnetic wireless energy, and the emitted non-magnetic wireless energy is used to operate the apparatus.

The external energy transmission device 1004 also includes a wireless remote control having an external signal transmitter that transmits wireless control signals for non-invasively controlling the device. The control signal is received by an implantable signal receiver, which may be integrated with or separate from the implantable energy conversion device 1002 .

The wireless control signals may include frequency, amplitude, or phase modulated signals, or combinations thereof. Alternatively, the wireless control signal comprises analog or digital signals, or a combination of analog and digital signals. Alternatively, the wireless control signal comprises an electric or magnetic field, or a combination of electric and magnetic fields.

A wireless remote control device may transmit a carrier signal that carries wireless control signals. Such carrier signals may include digital signals, analog signals, or a combination of digital and analog signals. If the control signal comprises an analog or digital signal, or a combination of analog and digital signals, the wireless remote control preferably transmits a digital control signal or an electromagnetic carrier wave signal carrying the analog control signal.

FIG. 2 shows the system of FIG. 1G in more schematic block diagram form, showing the apparatus 10, an energy conversion device 302 that powers the apparatus 10 via a power supply line 303, and an external energy source. A transmission device 304 is shown. A patient's skin 305, shown schematically by a vertical line, separates the patient's body to the right of the line from the patient's body to the left of the line.

FIG. 3 shows an embodiment of the invention identical to the embodiment of FIG. 1 shows an embodiment. When the switch is operated by polar energy, the wireless remote control of the external energy transmission device 304 transmits a wireless signal carrying the polar energy and the implantable energy transformation device 302 transmits a wireless signal to operate the electrical switch 306. Converts polar energy into polar current. Electrical switch 306 reverses the function performed by apparatus 10 when the polarity of the current is changed by implantable energy conversion device 302 .

FIG. 4 is the same as the embodiment of FIG. 1 shows an embodiment of Such an actuation device may be in the form of a motor 307, such as an electric servomotor. Motor 307 is powered by energy from implantable energy conversion device 302 when the remote control of external energy transmission device 304 transmits a wireless signal to the receiver of implantable energy conversion device 302 .

FIG. 5 shows an embodiment identical to that of FIG. 2 except that it comprises an actuation device in the form of an assembly 308 including a motor/pump unit 309 and a fluid reservoir 310 and implanted in the patient. . In this case, the device 10 operates hydraulically, i.e., hydraulic fluid is pumped from the fluid reservoir 310 through the conduit 311 to the device 10 by the motor/pump unit 309 to operate the device. is pumped from the device 10 back into the fluid reservoir 310 by the motor/pump unit 309 to return to the starting position. Implantable energy conversion device 302 converts wireless energy into current, eg, polarized current, for powering motor/pump unit 309 via power supply line 312 .

Instead of a hydraulically operated device 10, it is also envisaged that the actuation device comprises a pneumatic actuation device. In that case, the hydraulic fluid may be pressurized air used for regulation, and an air chamber is used instead of a fluid reservoir.

In all of these embodiments, the energy conversion device 302 can include a chargeable accumulator such as a battery or capacitor that is charged with wireless energy to power any energy consuming portion of the system.

Alternatively, instead of the wireless remote control described above, manual control of the implantable portion is contacted by the patient's hand, often indirectly, e.g., by a push button located under the skin. can be used.

FIG. 6 shows an external energy transmission device 304 having a wireless remote control, in this case hydraulically operated apparatus 10, and an implantable energy conversion device 302, all implanted in the patient, a hydraulic energy transfer device. An embodiment of the invention further comprising a fluid reservoir 313 , a motor/pump unit 309 and a reversing device in the form of a hydraulic valve shifting device 314 is shown. Of course, hydraulic operation can also be carried out simply by changing the direction of pumping, so that the hydraulic valves can be dispensed with. A remote control may be a device separate from or included in the external energy transmission device. The motor of motor/pump unit 309 is an electric motor. In response to a control signal from the wireless remote control of the external energy transmission device 304, the implantable energy conversion device 302 powers the motor/pump unit 309 with energy from the energy carried by the control signal; Motor/pump unit 309 thereby distributes hydraulic fluid between hydraulic fluid reservoir 313 and device 10 . The remote control of the external energy transfer device 304 controls the direction in which fluid is pumped from the hydraulic fluid reservoir 313 to the device 10 by the motor/pump unit 309 to operate the device and returns the device to the starting position. To shift the direction of flow of the hydraulic fluid between the other opposite direction in which the fluid is pumped by the motor/pump unit 309 back into the hydraulic fluid reservoir 313 from the apparatus 10 . Controls pressure valve shift device 314 .

FIG. 7 shows an external energy transmission device 304 having a wireless remote control, the apparatus 10, an implantable energy conversion device 302, and an implantable internal control unit 315 controlled by the wireless remote control of the external energy transmission device 304. , an embodiment of the invention comprising an implantable accumulator 316 and an implantable capacitor 317. FIG. Internal control unit 315 accumulates electrical energy received from implantable energy conversion device 302 in accumulator 316 which supplies energy to apparatus 10 . In response to a control signal from the wireless remote control of the external energy transmission device 304, the internal control unit 315 releases electrical energy from the accumulator 316 and transmits the released energy via power lines 318 and 319, or or directly transfer electrical energy from the implantable energy conversion device 302 via power line 320 , current stabilizing capacitor 317 , power line 321 , and power line 319 for operation of apparatus 10 .

The internal control unit is preferably programmable from outside the patient's body. In preferred embodiments, the internal control unit adjusts the device 10 according to a preprogrammed time schedule or input from any sensor sensing any possible physical parameter of the patient or any functional parameter of the system. is programmed to

According to an alternative, the capacitor 317 of the embodiment of FIG. 7 can be omitted. According to another alternative, the accumulator 316 in this embodiment can be omitted.

FIG. 8 shows the embodiment of FIG. 2 except that a battery 322 for energizing the operation of the device 10 and an electrical switch 323 for switching the operation of the device 10 are also implanted in the patient. 2 shows the same embodiment. The electrical switch 323 can be controlled by a remote control to switch from an off mode, in which the battery 322 is not in use, to an on mode, in which the battery 322 powers the device 10 for operation, and is implantable. It can also be operated by energy supplied by energy conversion device 302 .

FIG. 9 shows an embodiment identical to that of FIG. 8 except that an internal control unit 315 controlled by the wireless remote control of the external energy transmission device 304 is also implanted in the patient. In that case, the electrical switch 323 causes the energy supplied by the implantable energy conversion device 302 to operate the device 10 from an off mode in which the wireless remote control prevents control of the internal control unit 315 and the battery is not in use. The internal control unit 315 operates to switch to a standby mode in which the remote control device can control the internal control unit 315 to discharge electrical energy from the battery 322 for the purpose.

FIG. 10 shows an embodiment identical to that of FIG. 9 except that an accumulator 316 is used in place of the battery 322 and the interconnection of the implantable components is different. Accumulator 316 then stores energy from implantable energy conversion device 302 . In response to a control signal from the wireless remote control of the external energy transmission device 304, the internal control unit 315 causes the accumulator 316 to energize for operation of the apparatus 10 from an OFF mode in which the accumulator 316 is not in use. Control the electrical switch 323 to switch to the ON mode. Accumulators may be combined with capacitors, or capacitors may be used in place of accumulators.

FIG. 11 shows an embodiment identical to that of FIG. 10 except that a battery 322 is also implanted in the patient and the interconnection of the implanted components is different. In response to a control signal from the wireless remote control of the external energy transfer device 304, the internal control unit 315 causes the battery 322 to electrically energize the device 10 from an off mode in which the battery 322 is not in use. The accumulator 316 is controlled to deliver energy to operate the electrical switch 1023 so as to switch to the on mode to control the accumulator 316 .

Alternatively, the electrical switch 323 can be turned off to prevent the battery 322 from being electrically energized by the wireless remote control when the wireless remote control is not in use.
From that mode, it can be operated by the energy supplied by the accumulator 316 to switch to a standby mode in which the wireless remote control can control the battery 322 to provide electrical power for operation of the device 10 .

It should be understood that switch 323 and all other switches in this application should be interpreted as being of the broadest embodiment. This means that a transistor, MCU, MCPU, ASIC, FPGA or DAC or any other electronic component or circuit can switch power on and off. Preferably, the switch is controlled externally or by an implanted internal control unit.

FIG. 12 shows the embodiment of FIG. 8, except that motor 307, a mechanical reversing device in the form of gear box 324, and an internal control unit 315 controlling gear box 324 are also implanted in the patient. 2 shows the same embodiment. The internal control unit 315 controls the gear box 324 to reverse the functions performed by the (mechanically operated) device 10 . Even simpler is to switch the direction of the motor electronically. The gearbox, interpreted to be the broadest embodiment, may represent a servomechanism that saves force for the actuation device in favor of longer actuation strokes.

FIG. 13 shows an embodiment of the invention identical to the embodiment of FIG. 19 except that the interconnection of the implantable components is different. In that case, internal control unit 315 is therefore powered by battery 322 when accumulator 316, suitably a capacitor, actuates electrical switch 323 to switch to the on mode. When the electrical switch 323 is in the on mode, the internal control unit 315 can control the battery 322 to supply or not supply energy for the operation of the energy device 10 .

FIG. 14 schematically illustrates possible combinations of implantable components of the device to achieve various communication options. Basically, there is an apparatus 10, an internal control unit 315, a motor or pump unit 309, and an external energy transmission device 304 including an external wireless remote control. As already explained above, the wireless remote control device transmits control signals received by the internal control unit 315, which controls the various implantable components of the device.

Preferably, a feedback device comprising a sensor or measuring device 325 can be implanted in the patient to sense physical parameters of the patient. The physical parameter is at least one selected from the group consisting of pressure, volume, diameter, elongation, elongation, dilation, movement, curvature, elasticity, muscle contraction, nerve impulse, body temperature, blood pressure, blood flow, heart rate, and respiration. It's good. A sensor can sense any of the above physical parameters. For example, the sensor can be a pressure sensor or a motility sensor. Alternatively, sensor 325 can be configured to sense function parameters. Functional parameters can be related to each other to transfer energy to charge the implantable energy source, electrical, any electrical parameter, pressure, volume, diameter, elongation, elongation, dilation, movement, bending, stretching It can further include at least one selected from the group of parameters consisting of properties, temperature, and flow.

Feedback can be sent to the internal control unit or preferably out through the internal control unit to the external control unit. Feedback can be delivered outside the body via an energy transfer system or a separate communication system with a receiver and transmitter.

The internal control unit 315 or the external wireless remote control of the external energy transmission device 304 can control the apparatus 10 in response to signals from the sensor 325 . A transceiver can be combined with the sensor 325 to transmit information of the sensed physical parameter to the external wireless remote control device. The wireless remote control device can comprise a signal transmitter or transceiver, and the internal control unit 315 can comprise a signal receiver or transceiver. Alternatively, the wireless remote control device can comprise a signal receiver or transceiver and the internal control unit 315 can comprise a signal transmitter or transceiver. The transceivers, transmitters, and receivers described above can be used to transmit information or data about the device 10 from inside the patient's body to outside the body.

If the motor/pump unit 309 and the battery 322 that powers the motor/pump unit 309 are implanted, information regarding the charge of the battery 322 can be fed back. To be more precise, when charging the battery or accumulator with energy, send feedback information about said charging process and modify the energy supply accordingly.

Figure 15 shows an alternative embodiment in which device 10 is adjusted from outside the patient's body. System 300 includes battery 322 , which is connected to device 10 via subcutaneous electrical switch 326 . Adjustment of the device 10 is thus performed non-invasively by manually pressing a subcutaneous switch, thereby switching the operation of the device 10 on and off. It will be appreciated that the illustrated embodiment is a simplification and that additional components can be added to the system, such as an internal control unit or any other part disclosed in this application. Two subcutaneous switches can also be used. In a preferred embodiment, one implantable switch sends information to the internal control unit to perform some predetermined action, and the action is reversed when the patient presses the switch again.

Figure 16 shows an alternative embodiment in which the system 300 comprises a hydraulic fluid reservoir 313 hydraulically connected to the device. Non-invasive adjustments are made by manually pushing on a hydraulic reservoir connected to the device.

The system can include an external data communicator and an implantable internal data communicator communicating with the external data communicator. An internal communicator provides data about the device or patient to the external data communicator and/or the external data communicator provides data to the internal data communicator.

FIG. 17 schematically illustrates the mechanics of the system, which mechanism is used to provide a precise amount of energization to the implantable internal energy receiver 302 connected to the implantable energy consuming components of the device 10 . Alternatively, information can be sent from inside the patient to outside the body to provide feedback information regarding at least one functional parameter of the system or a physical parameter of the patient. Such energy receivers 302 can include energy sources and/or energy conversion devices. Briefly, wireless energy is transmitted from an external energy source 304a located outside the patient and received by an internal energy receiver 302 located inside the patient. The internal energy receiver is adapted to directly or indirectly supply received energy to the energy consuming components of device 10 via switch 326 . An energy balance is determined between the energy received by the internal energy receiver 302 and the energy used for the device 10, and then the transmission of wireless energy is controlled based on the determined energy balance. be done. Accordingly, the energy balance accurately presents the exact amount of energy required to properly operate the device 10 without excessive temperature rise.

In FIG. 17 the patient's skin is indicated by vertical lines 305 . Here, the energy receiver comprises an energy conversion device 302 positioned within the patient's body, preferably just below the patient's skin 305 . In general, the implantable energy conversion device 302 may be placed in the abdomen, ribcage, fascia (eg of the abdominal wall), subcutaneously, or in any other suitable location. The implantable energy conversion device 302 is adapted to receive wireless energy E transmitted from an external energy source 304a that penetrates the patient's skin 305 in the vicinity of the implantable energy conversion device 302. Provided on the externally located external energy transmission device 304 .

As is well known in the art, wireless energy E is generally a device that includes a primary coil located on the external energy source 304a and an adjacent secondary coil located on the implantable energy conversion device 302. etc., can be delivered by any suitable transcutaneous energy transfer (TET) device. When current is supplied through the primary coil, energy in the form of a voltage is induced in the secondary coil, for example by storing the incoming energy in an implantable energy source such as a rechargeable battery or capacitor before utilizing it. to power the implantable energy consuming components of the device. However, the present invention is generally not limited to any particular energy transfer technique, TET device or energy source, and any type of wireless energy can be used.

The amount of energy received from the implantable energy receiver can be compared to the energy used by the implantable components of the device. It is then understood that the term "used energy" also includes energy stored by implantable components of the device. The control device includes an external control unit 304b, which controls the external energy source 304a to adjust the amount of energy transferred based on the determined energy balance. In order to deliver the correct amount of energy, the energy balance and required amount of energy are determined by a decision device including an implantable internal control unit 315 connected between switch 326 and apparatus 10 . Accordingly, the internal control unit 315 can be configured to receive various measurements obtained by suitable sensors or the like (not shown) that measure characteristics of the device 10 and are used for proper operation of the device 10 . to some extent reflects the required amount of energy required for Additionally, the patient's current condition can also be detected by a suitable measuring device or sensor to provide a parameter reflecting the patient's condition. Such features and/or parameters may thus relate to the current state of the device 10, such as power consumption, operating mode and temperature, and the state of the patient as reflected in parameters such as body temperature, blood pressure, heart rate, and respiration. Other types of patient physical parameters and device functional parameters are described separately.

Additionally, an energy source in the form of an accumulator 316 can optionally be connected to the implantable energy conversion device 302 via the control unit 315 to store received energy for later use by the apparatus 10 . Alternatively, or additionally, characteristics of such accumulators that also reflect the required amount of energy can be measured. A rechargeable battery can be used instead of an accumulator, and the measured characteristic can relate to the current state of the battery, such as energy consumption voltage, temperature, or any other electrical parameter. Optimally charging the battery by receiving the correct amount of energy from the implantable energy conversion device 302, i.e., not too little and not too much, to provide sufficient voltage and current to the device 10 and to avoid overheating. It is clearly understood what should be done. The accumulator may be a capacitor with corresponding characteristics.

For example, a characteristic of the battery can be measured periodically to determine the current state of the battery, which can then be stored as state information in suitable storage means of the internal control unit 315 . Therefore, whenever a new measurement is made, the stored information of battery status can be updated accordingly. In this manner, the state of the battery can be "calibrated" by delivering the correct amount of energy to maintain the battery in optimum condition.

Accordingly, the internal control unit 315 of the determining device, based on measurements made by the sensors or measuring devices of the apparatus 10 referred to above, or the patient, or the implanted energy source, if used, or any combination thereof, It is adapted to determine the energy balance and/or the current amount of energy required (energy per unit time or stored energy). The internal control unit 315 is further connected to an internal signal transmitter 327 which transmits a control signal reflecting the determined amount of energy required to an external signal receiver connected to the external control unit 304b. 304c. The amount of energy transmitted from the external energy source 304a can then be adjusted in response to the received control signal.

Alternatively, the determination device can include the external control unit 304b. In this alternative, the sensor readings can be transmitted directly to the external control unit 304b, and the energy balance and/or current energy requirement can be determined by the external control unit 304b, thus allowing the internal control unit The above-described functions of 315 can be integrated into the external control unit 304b. In that case, the internal control unit 315 can be omitted and the sensor measurements are fed directly to the internal signal transmitter 327, which transmits those measurements to the external signal receiver 304c and the external signal receiver 304c. Send to control unit 304b. The energy balance and current energy requirement can then be determined by the external control unit 304b based on those sensor readings.

Therefore, current solutions according to the mechanism of FIG. 17 employ feedback of information indicative of energy demand, which is the percentage of energy used, e.g. It is more effective than previous solutions because it is based on actual energy usage relative to the amount of energy compared, the energy difference, or the percentage of energy received. The device can use the received energy for consumption or for energy storage, such as in an implantable energy source. Therefore, where relevant and necessary, we will also use the different parameters described above as a tool for determining the actual energy balance. However, such parameters may be inherently required, especially for operations performed within the body to operate the device.

The intracorporeal signal transmitter 327 and the extracorporeal signal receiver 304c can be implemented as separate units using suitable signal transmission means, such as radio, IR (infrared) signals, or ultrasonic signals. Alternatively, intracorporeal signal transmitter 327 and external signal receiver 304c may be combined with implantable energy conversion device 302 and external energy source, respectively, to convey control signals in opposite directions to energy transmission using essentially the same transmission techniques. 304a. The control signal can be modulated with respect to frequency, phase, or amplitude.

Therefore, the feedback information can be conveyed by a separate communication system including receivers and transmitters, or it can be incorporated into the energy system. In accordance with the present invention, such an integrated information feedback and energy system has a first body coil and a first electronic circuit connected to the first coil for receiving wireless energy. An external energy transmitter for transmitting wireless energy comprising an internal energy receiver and having a second external coil and a second electronic circuit connected to the second coil. A second extracorporeal coil of the energy transmitter is connected to the first coil of the energy receiver.
transmits wireless energy received by the coil of the The system further comprises a power switch for switching on and off connection of the first body coil to the first electronic circuit, wherein the power switch turns on and off connection of the first body coil to the first electronic circuit. When switching, feedback information regarding the charge of the first coil is received by the external energy transmitter in the form of a change in the impedance of the load of the second external coil. In implementing such a system in the mechanism of FIG. 17, the switch 326 is either controlled separately from the internal control unit 315 or incorporated into the internal control unit 315 . It should be understood that switch 326 should be interpreted as the broadest embodiment. This means that a transistor, MCU, MCPU, ASIC, FPGA or DAC or any other electronic component or circuit can switch power on and off.

In conclusion, the energy supply mechanism shown in FIG. 17 can basically operate as follows. The energy balance is first determined by the internal control unit 315 of the determination device. A control signal reflecting the required amount of energy is also generated by the internal control unit 315 and transmitted from the internal signal transmitter 327 to the external signal receiver 304c. Alternatively, the energy balance can alternatively be determined by the external control unit 304b, depending on the implementation, as mentioned above. In that case, the control signals may carry measurements from various sensors. The amount of energy emitted from the external energy source 304a can then be adjusted by the external control unit 304b based on the determined energy balance, eg, in response to received control signals. This process can be repeated intermittently at specific intervals during ongoing energy transfer, or it can be performed somewhat continuously during energy transfer.

The amount of energy transmitted can generally be adjusted by adjusting various transmission parameters of the external energy source 304a, such as voltage, current, amplitude, wave frequency, and pulse characteristics.

This system is used to find the optimal position of the extracorporeal coil with respect to the internal coil and to obtain information about the coupling coefficient between the coils of the TET system so as to further calibrate the system to optimize energy transfer. can also Simply compare the amount of energy transmitted in this case with the amount of energy received. For example, if the extracorporeal coil moves, the coupling coefficient may change, and accurate movement may also allow the extracorporeal coil to find the optimal position for energy transfer. Preferably, the extracorporeal coil is adapted to calibrate the amount of energy transferred so as to implement the feedback information of the decision device before the coupling coefficient is maximized.

This coupling coefficient information can also be used as feedback during energy transfer. In such cases, the energy system of the present invention comprises an implantable internal energy receiver for receiving wireless energy having a first internal coil and a first electronic circuit connected to the first coil; an extracorporeal energy transmitter for transmitting wireless energy having two extracorporeal coils and a second electronic circuit connected to the second coil. A second extracorporeal coil of the energy transmitter transmits wireless energy received by the first coil of the energy receiver. The system further comprises a feedback device communicating the amount of energy received at the first coil as feedback information, the second electronic circuit including a decision device, the decision device receiving the feedback information, The amount of energy transmitted by the second coil is compared with feedback information regarding the amount of energy received by the first coil to obtain a coupling coefficient between the one coil and the second coil. The energy transmitter can adjust the transmitted energy in response to the obtained coupling coefficient.

Referring to FIG. 18, although wireless transmission of energy to operate the device to enable non-invasive manipulation has been described above, it will be appreciated that the device can also operate with wired energy. One such example is shown in Figure 18, where an external switch 326 is interconnected between an actuation device, such as an electric motor 307, which operates the apparatus 10, and an external energy source 304a. External control unit 304b controls the operation of external switch 326 so that device 10 operates properly.

FIG. 19 shows different embodiments of how received energy can be supplied to and used by device 10 . Similar to the example of Figure 17, an internal energy receiver 302 receives wireless energy E from an external energy source 304a controlled by a transmission control unit 304b. The internal energy receiver 302 may comprise a constant voltage circuit that supplies energy to the device 10 at a constant voltage, indicated by the dashed box "CONSTANT VOLTAGE V" in the figure. The intrabody energy receiver 302 may further include a constant current circuit for energizing the device 10 with a constant current, indicated by the dashed box "CONSTANT CURRENT C" in the figure.

Apparatus 10 comprises an energy consuming portion 10a, which may be a motor, pump, restriction device, or any other medical equipment requiring energy for electrical operation. Apparatus 10 may further comprise an energy storage device 10b that stores energy supplied from internal energy receiver 302 . Thus, the energy supplied may be consumed directly by the energy consuming portion 10a, stored in the energy storage device 10b, or the energy supplied may be partly consumed and partly stored. good. Apparatus 10 may further comprise an energy stabilization unit 10c for stabilizing the energy supplied from internal energy receiver 302 . Therefore, energy can be supplied up and down, which requires stabilization before consumption or storage.

The energy delivered from the internal energy receiver 302 may further be stored and/or stabilized by a separate energy stabilization unit 328 located outside the device 10 before being consumed and/or stored by the device 10. . Alternatively, the energy stabilization unit 328 can be incorporated into the internal energy receiver 302 . In any case, the energy stabilization unit 328 may comprise a constant voltage circuit and/or a constant current circuit.

17 and 19 show some possible but non-limiting implementation options as to how the various functional components and elements shown may be arranged and connected together; Please note. However, one of ordinary skill in the art will readily appreciate that many variations and modifications may be made within the scope of the invention.

FIG. 20 schematically shows an energy balance measurement circuit, which is one of the design proposals of a system for controlling the transmission of wireless energy or an energy balance control system. The circuit has an output signal that is centered at 2.5V and is proportional to the energy imbalance. The derivative of such a signal indicates whether the value is going up or down and the rate at which that change occurs. If the amount of received energy is less than the energy used by the implantable components of the device, more energy will be delivered, thus charging the energy source. The output signal from the circuit is typically supplied to an A/D converter and converted to digital format. The digital information can then be transmitted to an external energy transmission device where the level of transmitted energy can be adjusted. Another possibility is to have a complete analog system using comparators, which compare the level of energy balance to certain maximum and minimum thresholds, causing an out-of-balance maximum/minimum threshold. If the minimum window is exceeded, the information is sent to the external energy transfer device.

Schematic 20 shows a circuit implementation of a system that uses inductive energy transfer to transfer energy from outside the patient's body to the implantable energy component of the device of the present invention. Inductive energy transfer systems typically use an extracorporeal transmit coil and an internal receive coil. The receive coil L1 is included in schematic FIG. 3 and the transmit part of the system is not included.

The general concept of energy balance and implementation of the method of transmitting information to the external energy transmitter can of course be implemented in many different ways. The schematic diagram 20 and the methods described above for evaluating and transmitting information should only be interpreted as examples of how the control system may be implemented.

Circuit Details In FIG. 20, the symbols Y1, Y2, Y3, etc. symbolize the test points in the circuit. The components in the figure and their respective values are the values that work in this particular implementation, which of course is just one of the myriad of possible design solutions.

The energy that powers the circuit is received by the energy receiving coil L1. Energy to the implantable component is transmitted at a frequency of 25 kHz in this particular case. The energy balance output signal is at test point Y1.

Those skilled in the art will recognize that the various embodiments of the systems described above can also be combined in many different ways. For example, the electrical switch 306 of FIG. 3 could be incorporated into any of the embodiments of FIGS. 6-12, the hydraulic valve shift device 314 of FIG. 6 could be incorporated into the embodiment of FIG. • Box 324 may also be incorporated into the embodiment of FIG. It should be recognized that a switch can also simply refer to any electronic circuit or component.

The embodiments described with respect to Figures 17, 19 and 20 identify methods and systems for controlling the transmission of wireless energy to implantable energy consuming components of electrically operable devices. Such methods and systems are defined generally below.

Accordingly, a method is provided for controlling transmission of wireless energy supplied to an implantable energy consuming component of a device as described above. Wireless energy E is transmitted from an external energy source located outside the patient's body and received by an internal energy receiver located inside the patient's body, which transmits the received energy to the implantable energy consumption component of the device. connected to that energy consuming component to supply directly or indirectly to the An energy balance is determined between the energy received by the internal energy receiver and the energy used for the device. Transmission of wireless energy E from the external energy source is then controlled based on the determined energy balance.

Wireless energy can be inductively transmitted from a primary coil of an external energy source to a secondary coil of an internal energy receiver. A change in energy balance can be determined and the transmission of wireless energy can be controlled based on the change in energy balance. A difference between the energy received by the internal energy receiver and the energy used for the medical device can also be detected and the transmission of wireless energy controlled based on the detected energy difference.

When controlling energy transmission, if the detected energy balance change indicates that the energy balance is increasing, the amount of wireless energy transmitted can be reduced, and vice versa. is. The decrease/increase in energy transfer may also match the detected amount of change.

If the detected energy difference indicates that the received energy is greater than the used energy, the amount of transmitted wireless energy can be further reduced, or vice versa. The decrease/increase in energy transfer may then match the magnitude of the detected energy difference.

As mentioned above, the energy used for the medical device can be consumed to operate the medical device and/or stored in at least one energy storage device of the medical device.

When electrical and/or physical parameters of the medical device and/or physical parameters of the patient are determined, transmit energy for consumption and storage according to a transmission rate per unit time determined based on said parameters. can do. The total amount of energy transmitted can also be determined based on said parameters.

detecting a difference between a total amount of energy received by an internal energy receiver and a total amount of energy expended and/or stored, wherein the detected difference is associated with at least one measured electricity for said energy balance; When related to the time integral of the physical parameter, the integral can be determined with respect to the monitored voltage and/or current in relation to the energy balance.

When the derivative of the measured electrical parameter with respect to the amount of energy consumed and/or stored is determined over a period of time, the derivative can be determined with respect to the monitored voltage and/or current related to the energy balance. can.

applying an electrical pulse having a rising edge and a trailing edge from the first electrical circuit to the external energy source to transmit wireless energy, the length of a first time interval between successive rising and trailing edges of the electrical pulse; and/or the transmission of wireless energy from an external energy source can be controlled by varying the length of the second time interval between successive falling and rising edges of the electrical pulse to transmit wireless energy. , the transmitted energy resulting from the electrical pulse has a modified power, the change in power depending on the length of the first and/or second time intervals.

In that case, the frequency of the electrical pulses may be substantially constant when changing the first and/or second time intervals. When applying an electrical pulse, the electrical pulse may remain unchanged except for changing the first and/or second time intervals. The amplitude of the electrical pulse may be substantially constant when changing the first and/or second time intervals. Furthermore, the electrical pulse can be varied simply by varying the length of the first time interval between successive rising and falling edges.

Two or more electrical pulse trains can be supplied in series, applying a pulse train having a first electrical pulse at the beginning of the pulse train and a second electrical pulse at the end of the pulse train. When having two or more pulse trains can be supplied in succession, and between the falling edge of the second electrical pulse of the first pulse train and the rising edge of the first electrical pulse of the second pulse train The length of the second time interval is changed.

When applying an electrical pulse, the electrical pulse can have a substantially constant current and a substantially constant voltage. The electrical pulse can also have virtually constant current and virtually constant voltage. Additionally, the electrical pulses can also have a constant frequency in nature. The electrical pulses in the pulse train can likewise have a constant frequency in nature.

The circuit formed by the first electrical circuit and the external energy source may have a first characteristic period or a first time constant, such frequency time period when effectively changing the energy transmitted. It may be within or less than the first characteristic period or time constant.

A system comprising a device as described above is therefore also provided for controlling the transmission of wireless energy supplied to the implantable energy consuming components of the device. In the broadest sense, the system comprises a control device for controlling the transmission of wireless energy from the energy transmission device and an implantable internal energy receiver for receiving the transmitted wireless energy; An internal energy receiver is connected to the implantable energy consuming components of the device to directly or indirectly supply received energy to those components. The system further comprises a determining device adapted to determine an energy balance between energy received by the internal energy receiver and energy used by the implantable energy consuming component of the device; A control device controls transmission of wireless energy from the external energy transmission device based on the energy balance determined by the determination device.

Additionally, the system may comprise any of the following.

A primary coil in an external energy source adapted to inductively transmit wireless energy to a secondary coil of an internal energy receiver.

The decision device is adapted to detect a change in energy balance and the external control device controls transmission of wireless energy based on the detected change in energy balance.

The determining device is adapted to detect a difference between the energy received by the internal energy receiver and the energy used for the implantable energy consuming component of the apparatus, the control device detecting Control the transmission of wireless energy based on the energy difference.

If the detected change in energy balance indicates that the energy balance is increasing, the control device controls the external energy transmission device to decrease the amount of wireless energy transmitted, or vice versa. is also possible, and the decrease/increase in energy transfer matches the detected rate of change.

the control device controls the external energy transmission device to decrease the amount of wireless energy transmitted if the detected energy difference indicates that the energy received is greater than the energy used; or Vice versa is also possible and the decrease/increase in energy transfer corresponds to the magnitude of the detected energy difference.

Energy used for the device is consumed to operate the device and/or stored in at least one energy storage device of the device.

If the electrical and/or physical parameters of the apparatus and/or the physical parameters of the patient are determined, the energy transmission device consumes and consumes according to the transmission rate per unit time determined based on said parameters by the determination device. Transmits stored energy. The determining device also determines a total amount of energy to be transmitted based on said parameters.

A difference is detected between the total amount of energy received by the body energy receiver and the total amount of energy expended and/or stored, and the detected difference is associated with at least one measured electrical energy balance. When related to the time integral of the physical parameter, the determining device determines the integral over the monitored voltage and/or current with respect to the energy balance.

When the derivative of the measured electrical parameter with respect to the amount of energy consumed and/or stored is determined over a period of time, the determining device determines the derivative with respect to the monitored voltage and/or current related to the energy balance. to decide.

The energy transmission device comprises a coil positioned outside the human body, and an electrical circuit is provided to power the extracorporeal coil with electrical pulses to transmit wireless energy. The electrical pulse has a rising edge and a trailing edge, and the electrical circuit includes a first time interval and/or sequence between successive rising and trailing edges of the electrical pulse to alter the power of the transmitted wireless energy. adapted to vary the second time interval between falling and rising edges. As a result, the energy receiver receiving the transmitted wireless energy has an altered power.

The electrical circuit is adapted to deliver electrical pulses that remain unchanged except for changing the first and/or second time intervals.

The electrical circuit has a time constant and is adapted to change the first and second time intervals only within the first time constant, so that the first and/or second time intervals are When the length is changed, the power transmitted over the coil is changed.

The electrical circuit is adapted to deliver electrical pulses that are varied only by varying the length of first time intervals between successive rising and falling edges of the electrical pulse.

The electrical circuit is adapted to sequentially supply two or more electrical pulse trains, said trains having a first electrical pulse at the beginning of the pulse train and a second electrical pulse at the end of the pulse train. have a pulse.

The length of the second time interval between the trailing edge of the second electrical pulse of the first pulse train and the leading edge of the first electrical pulse of the second pulse train is varied by the first electronic circuit. be done.

The electrical circuit is adapted to provide electrical pulses as pulses having substantially constant height and/or amplitude and/or intensity and/or voltage and/or current and/or frequency.

The electrical circuit has a time constant and is adapted to change the first and second time intervals only within the first time constant, so that the first and/or second time intervals are The power transmitted over the first coil is changed when the length is changed.

The electrical circuit has a length of the first and/or second time intervals that includes or is relatively close to the first time constant as compared to the magnitude of the first time constant. adapted to deliver electrical pulses that vary only at

21-24 show in more detailed block diagrams four different ways of hydraulically or pneumatically powering an implantable device according to the present invention.

FIG. 21 shows the system described above. The system comprises an implantable device 10 and further comprises a separate regulation reservoir 1013 , a one-way pump 1009 and an alternating valve 1014 .

FIG. 22 shows device 10 and fluid reservoir 1013 . By moving the wall of the adjustment reservoir or changing its size in any other different way, the adjustment of the device without valves by mere passages without fluid at any time can be done.

FIG. 23 shows device 10, two-way pump 1009, and conditioning reservoir 1013. FIG.

FIG. 24 shows a block diagram of a reverse boost servo system having a first closed system controlling a second closed system. The servo system comprises adjustment reservoir 1013 and servo reservoir 1050 . Servo reservoir 1050 mechanically controls implantable device 10 via mechanical interconnect 1054 . The device has an expandable/accessible cavity. The cavity is preferably expanded or contracted by supplying hydraulic fluid from a larger adjustable reservoir 1052 in fluid connection with device 10 . Alternatively, the cavity contains a compressible gas, which can be compressed and expanded under the control of servo reservoir 1050 .

Servo reservoir 1050 can also be part of the device itself.

In one embodiment, the conditioning reservoir is placed subcutaneously under the patient's skin and is activated by pressing on its outer surface with a finger. This system is shown in Figures 25a-25c. In FIG. 30 a flexible subcutaneous regulation reservoir 1013 is shown connected by conduit 1011 to bulge-shaped servo reservoir 1050 . Such a bellows-shaped servo reservoir 1050 is included in the flexible device 10 . In the state shown in FIG. 25a, servo reservoir 1050 contains the least amount of fluid, with most fluid in regulation reservoir 1013. FIG. Due to the mechanical interconnection between servo reservoir 1050 and device 10, the profile of device 10 shrinks, ie, it occupies less than its maximum volume. This maximum volume is indicated by a dashed line in the figure.

In FIG. 25b, a user, such as a patient implanted with the device, pushes on the adjustment reservoir 1013, so that the fluid contained therein flows through the conduit 1011, causing the servo reservoir 1050 to extend longitudinally thanks to the bellows shape. Indicates the state of being transported to This expansion then causes device 10 to occupy its maximum volume, thereby expanding to constrict the vas deferens downstream (not shown) of the ampulla where device 10 contacts.

The adjustment reservoir 1013 preferably comprises means 1013a for maintaining its shape after compression. Thus, this means, shown schematically in the figures, maintains the device 10 in an extended position even when the user releases the adjustment reservoir. In this way, the regulation reservoir essentially acts as an on/off switch for the system.

Alternative embodiments of hydraulic or pneumatic operation will now be described with reference to Figures 26 and 27a-27c. The block diagram shown in Figure 26 comprises a first closed system controlling a second closed system. The first system comprises adjustment reservoir 1013 and servo reservoir 1050 . Servo reservoir 1050 mechanically controls a larger adjustable reservoir 1052 via mechanical interconnect 1054 . The implantable device 10 having an expandable/accessible cavity is then controlled by the larger adjustable reservoir 1052 by supplying hydraulic fluid from the larger adjustable reservoir 1052 fluidly connected to the device 10. be done.

An example of this embodiment will now be described with reference to Figures 27a-27c. As in the previous embodiment, the conditioning reservoir is placed subcutaneously under the patient's skin and is activated by pressing on its outer surface with a finger. Tuning reservoir 1013 is fluidly connected by conduit 1011 to bellows-type servo reservoir 1050 . In the first closed system 1013, 1011, 1050 shown in FIG.

Servo reservoir 1050 is mechanically connected to a larger adjustable reservoir 1052 , which is also bellows-shaped but larger in diameter than servo reservoir 1050 . A larger adjustable reservoir 1052 is in fluid communication with device 10 . This is because when the user pushes on the adjustment reservoir 1013 , thereby moving fluid from the adjustment reservoir 1013 to the servo reservoir 1050 , expansion of the servo reservoir 1050 causes a larger volume of fluid to flow into the larger adjustable reservoir 1052 . to the device 10. In other words, in such an inverted servomechanism, a smaller volume of the tuning reservoir is compressed with a larger force, thereby moving a larger overall area with a smaller force per unit area.

As in the previous embodiment described above with reference to Figures 25a-25c, the conditioning reservoir 1013 preferably comprises means 1013a for maintaining its shape after compression. This means, shown schematically in the figure, thus maintains the device 10 in an extended position even when the user releases the adjustment reservoir. In this way, the regulation reservoir essentially acts as an on/off switch for the system.

120 restriction device; 150 control device; 170 operation device; 180 energy supply unit; 190 extracorporeal remote controller unit.

Claims (18)

A control device configured for subcutaneous implantation, said control device configured to control a constriction device for temporary restriction of the vas deferens, thereby temporarily preventing sperm from reaching the urethra. and provide time-limited infertility, said control device:
a. a wireless energy receiver capable of receiving wireless energy;
b. an energy supply unit capable of supplying energy to said tightening device;
c. A control device comprising a remote control receiver capable of receiving control signals from a remote control located outside the patient's body. 2. The control device of claim 1, wherein the energy supply unit is configured to convert received wireless energy from a first form to a second form of energy. 3. The control device of claim 2 , wherein the second form of energy is electrical energy. 4. Control device according to claim 3, wherein the energy supply unit is arranged to supply the electrical energy to an actuating device of the tightening device in order to actuate the tightening device. 5. Control device according to claim 4, wherein the actuation device is a mechanical actuation device for mechanical actuation of the tightening device. 5. Control device according to claim 4, wherein the actuation device is a hydraulic actuation device for hydraulically actuating the clamping device. 4. The control device of claim 3, wherein the electrical energy is used at least partially to charge an accumulator. 8. A control device according to any one of the preceding claims , configured to be programmable from outside the patient's body. 9. A control device according to any preceding claim, further comprising a sensor for sensing a physical parameter of the patient or a functional parameter of the control device or the tightening device. A control device according to any one of claims 1 to 9,
comprising a constriction device that temporarily restricts the vas deferens, thereby temporarily preventing sperm from reaching the urethra and providing time-limited sterility;
The system, wherein the tightening device comprises an actuation device for actuating the tightening device. 11. The system of claim 10, wherein the energy supply unit is configured to convert received wireless energy from a first form to a second form of energy. 12. The system of claim 11, wherein said second form of energy is electrical energy. 13. System according to claim 12, wherein the energy supply unit is arranged to supply the electrical energy to the actuation device. 14. The system of Claim 13, wherein the actuation device is a mechanical actuation device for mechanically actuating the tightening device. 14. The system of claim 13, wherein the actuation device is a hydraulic actuation device for hydraulically actuating the tightening device. 16. The system of claim 15, wherein the actuation device comprises a pump for pumping hydraulic fluid. The actuation device comprises a reservoir holding hydraulic fluid, transport of hydraulic fluid from the reservoir activates the clamping device to restrict the vas deferens, and transport of hydraulic fluid back to the reservoir. 17. The system according to claim 15 or 16, wherein the clamping device is stopped so as to open the vas deferens. 18. The system of any one of claims 15-17, wherein the actuation device comprises an injection port for supply of hydraulic fluid.

Images