JP2020078582A - Apparatus for temporary male contraception - Google Patents

Abstract

To provide a male contraception apparatus for temporary sterility of a male mammalian individual.SOLUTION: The apparatus comprises an implantable restriction device adapted to restrict the vas deferens in the region downstream of the ampulla during a controlled period in order to prevent sperms from reaching the urethra. Further, the apparatus comprises a control device for controlling the operation of the restriction device.SELECTED DRAWING: Figure 18

Description

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

  A common male contraceptive technique is to occlude the vas deferens (the tube that carries sperm). Vasectomy is a surgical intervention to cut the vas deferens and is most often limited to permanent infertility. Recently, other alternative methods have been available by inserting the device into the vas deferens and forming the device to obtain 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 this technique has the potential to restore an individual's fertility, it is also associated with side effects such as sperm antibody formation. Therefore, there is a need for more gentle techniques to control male contraception that allow recovery with minimal impact on physical function. It is an object of the present invention, as outlined below, to provide devices, systems, and methods that make male contraception based on vas deferens more safe and convenient.

US Patent No. 6513528

  In general, the present invention relates to male contraceptive devices that temporarily sterilize male mammalian individuals. The device comprises an implantable restriction device adapted to restrict the ampullary downstream region of the vas deferens for a controlled period of time, whereby the device prevents sperm from reaching the urethra. .. The apparatus further comprises a control device that controls the operation of the restriction device. The restriction device may comprise a hydraulic or mechanical clamping device, as well as a stimulation device, alone or in any combination, for temporarily restricting the vas deferens.

  As used herein, restriction of the vas deferens means that the lumen of the vas deferens is obstructed by manipulation of the vas deferens from the outside to prevent sperm from reaching the urethra. The term "vas deferens" can include one or both vas deferens. Other terms such as "lumen" or "tissue portion" or "body organ" are also used when describing controlled vas deferens limitation according to the present invention, but such terms are functionally synonymous. Shall be considered. The term "bulge" refers to the enlarged portion of the vas deferens near the location where it impacts the seminal vesicle.

  The term "downstream of the ampulla" refers to the location posterior to the ampulla in the direction of the urethra and seminal vesicles. Therefore, "upstream of the ampulla" refers to the position of the vas deferens in front of the ampulla in the direction toward the testicle. That the restriction device is adapted to restrict the vas deferens in these particular areas means that it is preferably designed to be housed in this area of the body.

By limiting the portion of the vas deferens downstream of the ampulla, the device of the present invention partitions into the ampulla and shields sperm, thereby allowing the device to immediately provide a contraceptive effect. It enables reliable and temporary infertility. Even though the primary use of the device is to prevent the transport of sperm for a controlled, temporary period of time by activating a restriction device during intercourse, for example, in certain embodiments of the invention, such transport is It is also possible to support the transport of sperm through the vas deferens to help people with systemic disorders. Advantageously, the present invention is able to limit the time period during which the restriction is needed to a very limited time period. Current treatments must close at least 5 days before becoming safe, ie sperm lifetime, thus risking damage to the vas deferens. In addition, the device prevents their sperm from accumulating in the vas deferens due to long-term limitations that can cause undesirable complications.

  The restriction device is very carefully adapted to a specific location downstream of the ampulla. The size of the space is limited and the requirements are unique to allow placement in the region between the prostate and vas deferens. Since the ampulla comprises a sperm reservoir, restrictions are made in the downstream region to prevent the possibility of sperm reaching the urethra during intercourse. When relevant, the restriction device according to the invention can also be adapted to achieve a restriction of the outlet tubing of the proximate seminal vesicle. Simultaneous restriction of this outlet tube should be seen as one of the effects 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 to arrest 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 operates the limiting device non-magnetically and/or non-manually. Preferably, the motion device comprises a motorized motion device, such as a motor or boost servo system. The term "boost servo system" means that the system includes a transmission mechanism that applies a weak force acting on a moving element having a long stroke to a strong force on another moving element having a short stroke. According to one alternative, the restriction device comprises a clamping device comprising at least two elongate clamping elements extending along the organ in the direction of flow in the vas deferens of the patient on different sides of the organ, the working device comprising: Operating the clamping elements to clamp the wall portions between the clamping elements to tighten the wall portions. Alternatively, the operating device may comprise a limiting device operably connected to the hydraulic means and hydraulic means for hydraulically adjusting the reverse servo. The term "reverse boost servo" should be understood as a mechanism for transmitting a strong force acting on a moving element having a short stroke to a weak force acting on a moving element having a long stroke. Preferably, the reverse boost servo comprises at least two implantable reservoirs containing hydraulic fluid, preferably the first reservoir is a subcutaneously implantable conditioning reservoir. The reverse boost servo further comprises a second implantable servo reservoir, which servo reservoir is preferably in fluid connection with the conditioning 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 the expansion/contraction of the tightening device, and the reverse boost servo further comprises a third reservoir, the third reservoir comprising the abdominal or retroperitoneal cavity or Adapted for implantation in the pelvic region and operably connected to a second servo reservoir for moving hydraulic fluid in the third reservoir for operating the tightening device. Suitably, the third reservoir is larger in volume than the first reservoir. The third reservoir can be in fluid connection with the tightening device and the servo reservoir can control the third reservoir with a mechanical interconnect.

  Alternatively, the restriction device comprises a non-expandable 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 the region downstream of the ampulla so as to contract the wall portion so as to influence the flow in the vas deferens. A stimulation device for stimulating the part is provided. A control device controls the stimulation device to stimulate the wall portion, and the control device preferably controls the implantable energy source to release energy for use with the 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 the regions of the wall portion. Such intermittent and individual stimulation of different regions of the wall portion of the organ allows the tissue of the wall portion to maintain a virtually normal blood circulation during operation of the device of the present invention. Various alternatives and useful components for achieving stimulation limitation are described below.

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

  The present invention also implements a method of stimulating the ampulla, which method comprises the step of incorporating an apparatus as described, having a stimulation device, which limits the portion of the vas deferens downstream of the ampulla. As a result, it is possible to obtain stimulation of regurgitation of the ampulla.

  Further, the invention comprises a system including any of the devices described in the preceding paragraph. In a preferred embodiment, the system comprises at least one switch implantable in the patient for manually non-invasively controlling the device. In another preferred embodiment, the system comprises a wireless remote control device that non-invasively controls the device. In a preferred embodiment, the system comprises a hydraulically operated device for operating the apparatus. In another embodiment, the system comprises a motor or pump for operating the device. The other components of the system are described in more detail in the detailed portion of this specification.

  Stimulation When stimulating nerve or muscle tissue, if not properly stimulated, there is a risk of gradual tissue damage or deterioration. The device of the present invention is designed to mitigate and even eliminate such risks. Therefore, according to the invention, the control device controls the stimulation device to intermittently stimulate different regions of the wall portion of the organ, such that at least two of those regions are stimulated at different times, That is, the stimulus gradually shifts from one area to another. In addition, the control device controls the stimulation device such that the currently unstimulated region of the different regions has time to restore substantially normal blood circulation before the stimulation device restimulates the region. To do. Further, the control device controls the stimulation device to stimulate each region for successive periods, each period being short enough to maintain sufficient blood circulation in the region until the period expires. This means that the device of the present invention enables the device of the invention to achieve the desired flow control while essentially maintaining the original physical properties of the organ for a period of time without the risk of damaging the organ. It offers the advantage of allowing continuous stimulation.

  Moreover, by gradually changing the stimulation position of the organ as described above, it is possible to create an advantageous stimulation change pattern on the organ to achieve the desired flow control.

  The control device can control the stimulation device to stimulate one or more regions of the wall portion at a time, eg, by sequentially stimulating different regions. Furthermore, the control device can control the stimulation device such that the stimulation of the region along the wall portion propagates periodically, preferably according to a defined stimulation pattern. In order to achieve its desired response while stimulating the tissue wall, the control device can control the stimulation device, preferably periodically, such that the intensity of the stimulation of the wall portion is changed.

In a preferred embodiment of the invention, the control device controls the stimulation device such that the regions of the wall portion are intermittently stimulated, preferably with pulses forming a pulse train. Repetitively stimulating at least a first region and a second region of the region of the wall portion with a first pulse train and a second pulse train, respectively, such that the first and second pulse trains gradually shift with respect to each other. You can For example, the first region can be stimulated with a first pulse train and the second region is not stimulated with the second pulse train, and 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.

  The pulse train can be constructed in many different ways. Therefore, the control device can determine 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 pulse repetitions in the pulse train, the number of pulse train repetitions, each pulse train. The stimulation device can be controlled such that the number of pulses of the pulse and/or the off period between pulse trains is changed. A desired effect can be realized by using a plurality of pulse trains having different configurations.

  If the control device controls the stimulating device to change the off period between the pulse trains that stimulate each region of the wall portion, it is effectively normal in that region when the region is not stimulated during the off period. It is also possible to control each off period between pulse trains to last long enough for blood circulation to recover.

  Electrical Stimulation According to a preferred embodiment of the present invention, the stimulation device is a motorized stimulation device that electrically stimulates the wall portion of the tissue of a body organ of a patient, preferably with electrical pulses. This embodiment is particularly suitable for applications where the wall portion comprises 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 clamped to contract the wall portion. . Of course, the configuration of the electrical pulse train may be similar to the pulse train described above, and the control device causes the stimulation device to electrically stimulate different regions of the wall of the organ in the same manner as described above. Can be controlled.

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

  The electrical element can form any pattern of electrical elements. Preferably, the electrical elements are capable of forming an elongated pattern of electrical elements, the electrical elements having an elongated pattern of electrical elements extending along the length of the wall of the organ, the elements being each of a wall portion. Can be applied to the wall of the patient's organ so as to abut the area. The elongated pattern of electrical elements can include one or more rows of electrical elements extending lengthwise along the wall of the organ. The electrical elements in each row can form straight, spiral, or zigzag path electrical elements, or any form of path. The control device controls the stimulation device such that the electrical elements are sequentially energized along a longitudinally elongated pattern of electrical elements in a direction opposite or the same as the flow in the patient's lumen. be able to.

Optionally, the control device can control the stimulation device to continuously bias the electrical elements from a location substantially at the center of the clamped wall portion toward both ends of the elongated pattern of electrical elements. . If the lumen of the organ is to remain closed for a relatively long period of time, the control device controls the electrical element so that the biased electrical element forms two waves of the biased electrical element. The stimulation device can be controlled so that it is biased, and those waves simultaneously advance from the center of the clamped wall portion in two opposite directions towards both ends of the elongated pattern of electrical elements. These waves of energized electrical elements can be repeated many times without damaging the organ and without moving fluid or gas in any direction of the organ's lumen.

  The control device activates the stimulating device to energize the electrical elements so that the currently energized electrical elements form at least one group of energized electrical elements adjacent to one another. Control properly. According to a first alternative, the elements of the energized group of electrical elements form one path of the energized element. The path of the biased electrical element may extend at least partially around the patient's organ. In a second alternative, the elements of the biased electrical element group are preferably biased, extending on either side of the patient's organ, substantially transverse to the direction of flow in the organ's lumen. It is possible to form two paths of the electric element which are connected to each other. In a third alternative, the elements of the biased group of electrical elements are biased, preferably extending across different sides of the patient's organ, 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 present invention, the electrical elements form a plurality of groups of elements, the groups forming a series of groups extending along the patient's organ in the direction of flow in the patient's lumen. To do. The electrical elements of each group of electrical elements may form a path of elements that extends at least partially around a patient's organ. In a first alternative, the electrical elements of each group of electrical elements preferably have three or more paths of elements extending across different sides of the patient's organ, substantially transverse to the direction of flow in the patient's lumen. Can be formed. The control device may control the stimulation device to bias some electrical elements of the series in a random or according to a predetermined pattern. Alternatively, the control device begins in a position substantially central to the clamped wall portion and runs in a series of opposite directions, or in the same direction, with respect to flow in the patient's lumen, or both. The stimulation device can be controlled to sequentially energize the electrical elements of some of the groups. For example, some groups of energized electrical elements can form a forward wave of energized electrical elements as described above, i.e., the control device is energized. The electrical element to form two waves of energized electrical elements that simultaneously advance from the center of the wall portion to be clamped in two opposite directions towards both ends of the elongated pattern of electrical elements. The stimulation device can be controlled to energize the electrical elements of the group.

  A structure can be provided that holds the electrical element in a fixed direction. The structure may be separate from the tightening device, but is preferably integral with the tightening device, which is a practical design and facilitates implantation of the tightening and stimulating devices. If the electrical element forms 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 patient's lumen, and the element is in the wall portion of the organ. It may be applicable to the patient's organ to abut the respective area.

Thermal Stimulation In another embodiment of the invention, the stimulation device thermally stimulates the wall portion of the organ. Thus, the control device can control the stimulation device such that the wall portion is cooled when the wall portion is clamped to cause the wall portion to contract. For example, the clamping device can clamp the wall portion to at least restrict flow in the lumen, and the control device causes the flow in the lumen to be at least further restricted, or even restricted, but stopped. The stimulation device can be controlled to cool the clamped wall portion and cause its contraction, either not or to stop. Alternatively, the control device may control the stimulation device to heat the wall portion as it is tightened and contracted to expand the wall portion. If the wall portion comprises a blood vessel, the control device can control the stimulation device to cool the blood vessel to contract or heat the blood vessel to expand. Where applicable, any embodiment of the present invention can perform thermal stimulation and control thermal stimulation in response to various sensors, such as strain sensors, motion sensors, or pressure sensors.

  Sensor Controlled Tightening Device and/or Stimulation Device As mentioned above, the device may comprise at least one implantable sensor, the control device signaling the fastening device and/or the stimulation device from the sensor. Control in response to. In general, 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, a motion sensor that senses the movement of an organ, that is, a natural contraction such as contraction of the stomach or intestines, a pressure sensor that senses the pressure in the organ, a strain sensor that senses the strain of the organ, or a lumen of the organ. Flow sensor, spectrophotometric sensor, Ph sensor for detecting acidity or alkalinity of fluid in the lumen of an organ, oxygen sensor for sensing oxygen content of fluid in the lumen of an organ , Or a sensor that senses the distribution of the stimulus to the organ to be stimulated. Any anticipated sensor that senses any other kind of useful physical parameter can be used.

  Many types of sensors that sense functional parameters of the device can also be used to control the tightening 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 the operation of an implantable motor of the device.

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

  Alternatively, or in combination with a pressure sensor, a position sensor may be provided that senses the patient's orientation with respect to the horizontal as a physical parameter. The position sensor may be a biocompatible sensor of the sensors 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. In addition, the tightening device and/or the stimulation device can be controlled.

  The sensors described above can be used in any embodiment of the invention where applicable.

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 the time of day. To that end, the control device controls the tightening device and/or the stimulation device to change the tightening of the wall portion of the patient to increase or decrease the effect on flow in the lumen during different periods. Can be included. If any sensor of the type described above for sensing a physical or functional parameter is provided, it controls the tightening device and/or the stimulation device if the parameter sensed by the sensor does not transcend the timing mechanism. Or a sensor that controls the tightening device and/or the stimulation device when the timing mechanism does not transcend the sensor. Suitably, the control device responds to the signal from the sensor to produce an indication, such as an acoustic signal or displayed information.

  The control device may comprise an implantable intracorporeal control unit that directly controls the tightening device and/or the stimulation device in response to signals from the sensor. 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 puncturing the patient. At least one of the control parameters that can be set by the wireless remote controller is a physical or functional parameter. Suitably, the internal control unit comprises the timing mechanism mentioned above and the wireless remote control device is also adapted to set the timing mechanism.

  Alternatively, the control device may include an extracorporeal control unit external to the patient that controls the tightening device and/or the stimulation device in response to signals from the sensor.

  The invention will now be described in more detail by way of 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. 1 illustrates a system for treating a disease that includes the device of any of FIGS. 1A-1F implanted in a patient. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 1 schematically illustrates various embodiments of a system for wirelessly powering the device shown in FIGS. 1A-1F. 3 is a schematic block diagram showing a precise amount of biasing mechanism used for operation of the apparatus shown in FIG. 2. FIG. 1 schematically illustrates an embodiment of a system in which a device is operated by wire-connected energy. 3 is a more detailed block diagram of a mechanism for controlling the transmission of wireless energy used for the operation of the apparatus shown in FIG. 20 is a circuit for the mechanism shown in FIG. 19 according to a possible implementation. 9 illustrates various methods of hydraulically or pneumatically powering a device implanted in a patient. 9 illustrates various methods of hydraulically or pneumatically powering a device implanted in a patient. 3 illustrates various methods of hydraulically or pneumatically powering a device implanted in a patient. 3 illustrates various methods of hydraulically or pneumatically powering a device implanted in a patient. 9 illustrates various methods of hydraulically or pneumatically powering a device implanted in a patient. 9 illustrates various methods of hydraulically or pneumatically powering a device implanted in a patient. 9 illustrates various methods of hydraulically or pneumatically powering a device implanted in a patient.

1A is a schematic diagram of the male contraceptive device shown in FIG. 1B. The device 100 of FIG. 1B illustrates the restriction of the vas deferens portion of the vas deferens of the vas deferens 200A, 200B (both vas deferens). Thereby, the device is operable to temporarily prevent access to the urethra and achieve timed infertility. The apparatus 100 comprises a limiting device 120 adapted to mechanically or hydraulically tighten the vas deferens, and a control device 150 controlling the operation of the limiting device to operate by means of an operating device 170 shown schematically. .. The control device 150 is placed subcutaneously and includes an extracorporeal portion and an intracorporeal portion. An energy supply unit (energy transfer device) 180 can supply a device having energy to be transmitted wirelessly to the energy conversion device 151, the energy conversion device 151 providing energy for energizing the energy consuming part of the apparatus. Connected to the source 152. The extracorporeal remote control unit 190 can communicate with the control device 150, the control device's internal control unit 153. The extracorporeal portion 150A of the control device 150 includes functions required for extracorporeal operation, such as an injection port for the supply of hydraulic fluid when the tightening is hydraulic, and a start/stop button for operating the restriction device. Including and The body portion of control device 150B may include multiple functions necessary to control and operate restriction device 120. In the hydraulically actuated restriction device 120, the control device 150 can include a pump 154 operable on a reservoir of hydraulic fluid (not shown), such that upon delivery of fluid from the reservoir, the vas deferens. When the limiting device is activated to limit and transport back to the reservoir, the limiting device stops to release the vas deferens. FIG. 1C, FIG. 1B without control device
Shows the device. The restriction device 120 is of the same type as in FIG. 1B, but here it is adapted to restrict both the vas deferens and the seminal vesicle exit tract. FIG. 1D shows the apparatus of FIG. 1B or FIG. 1C, in which a modified restriction device 120A operates the stimulation device on both vas deferens. The stimulation device is here represented by a set of electrodes. FIG. 1E shows the apparatus of FIG. 1B or FIG. 1C, where the restriction device comprises a stimulation device 120A and a clamping device 120B controlled by a control device, the combination of which action limits both vas deferens. In one embodiment, the tightening device 120B is manually operated by a pump operating on the reservoir to tighten the vas deferens, and the stimulator device operated by the control device is operated by the vas deferens to have the effect of blocking sperm transport. Stimulate. FIG. 1F shows another variation of the device of FIG. 1B. The restriction device 120 includes two tightening devices, each tightening device adapted to tighten the vas deferens and seminal vesicle outlet tract, respectively, to stop the flow of both sperm and semen. The functioning of the control device and other parts of the present invention will be further described below in conjunction with FIGS. 1G to 27C.

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

  The wireless energy signal is a wave selected from a sound wave signal, an ultrasonic wave signal, an electromagnetic wave signal, an infrared ray signal, a visible light signal, an ultraviolet ray signal, a laser beam signal, a microwave signal, a radio wave signal, an x-ray irradiation signal, and a gamma ray irradiation signal. Signals can be included. 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 a carrier signal for carrying a wireless energy signal. Such carrier signals can include digital signals, analog signals, or a combination of digital and analog signals. In that case, the wireless energy signal comprises an analog or digital signal, or a combination of analog and digital signals.

  In general, the energy conversion device 302 converts the first form of wireless energy transmitted by the energy transfer device 304 into a second form of energy that is typically different from the first form of energy. It is provided for. The implantable device 10 is operable in response to the second form of energy. The energy conversion device 302 may directly power the device with the second form energy when converting the first form energy transmitted by the energy transfer device 304 into the second form energy. The system may further include an implantable accumulator, the second form energy being at least partially used to fill the accumulator.

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

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

  The extracorporeal energy transmission device 1004 also includes a wireless remote control, which has an extracorporeal signal transmitter that transmits a wireless control signal for non-invasively controlling the device. The control signal is received by the implantable signal receiver, which may be incorporated into the implantable energy conversion device 1002 or may be separate therefrom.

  The radio control signal can include a frequency, amplitude, or phase modulated signal, or a combination thereof. Alternatively, the wireless control signal comprises an analog or digital signal, 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.

  The wireless remote control device can transmit a carrier signal that carries a wireless control signal. Such carrier signals can 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 device preferably transmits an electromagnetic carrier signal carrying the digital control signal or the analog control signal.

  FIG. 2 shows the system of FIG. 1G in the form of a more schematic block diagram, which shows the device 10, an energy conversion device 302 for powering the device 10 via a power supply line 303, and extracorporeal energy. 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 exterior to the left of the line.

  3 of the present invention identical to the embodiment of FIG. 2 except that an inversion device, for example in the form of an electrical switch 306 operable by polar energy, is also implanted in the patient to invert the device 10. An embodiment is shown. When the switch operates with polar energy, the wireless remote control of the extracorporeal energy transfer device 304 transmits a radio signal carrying polar energy and the implantable energy conversion device 302 wirelessly operates the electrical switch 306. Converts polar energy to polar current. When the polarity of the current is changed by the implantable energy conversion device 302, the electrical switch 306 reverses the function performed by the device 10.

  4 is identical to the embodiment of FIG. 2 except that a patient-implanted actuation device 307 for operating the apparatus 10 is provided between the implantable energy conversion device 302 and the apparatus 10 in FIG. 2 shows an embodiment. Such actuating device may be in the form of a motor 307, such as an electric servomotor. The motor 307 is powered by energy from the implantable energy conversion device 302 when the remote controller of the extracorporeal energy transfer device 304 transmits a wireless signal to the receiver of the implantable energy conversion device 302.

  FIG. 5 shows an embodiment identical to that of FIG. 2 except in the form of an assembly 308 that includes a motor/pump unit 309 and a fluid reservoir 310, which is implanted in the patient and includes an actuation device. .. In this case, the device 10 operates hydraulically, that is, 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 to the fluid reservoir 310 by the motor/pump unit 309 to return the device to the starting position. Implantable energy conversion device 302 converts wireless energy into electrical current, eg, polar current, for powering motor/pump unit 309 via power supply line 312.

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

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

  Alternatively, instead of the wireless remote control device described above, manual control of the implantable part, which is contacted by the patient's hand, often indirectly, for example by a push button located under the skin, may be used. Can be used.

  FIG. 6 shows an external energy transfer device 304 having a wireless remote control device, a hydraulically actuated device 10 in this case, and an implantable energy conversion device 302, all of which are implanted in a patient. 5 illustrates 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 shift device 314. Of course, the hydraulic operation can also be carried out simply by changing the direction of pumping, thus omitting the hydraulic valve. The remote control may be a device separate from and included in the extracorporeal energy transmission device. The motor of motor/pump unit 309 is an electric motor. In response to the control signal from the wireless remote control of the extracorporeal energy transfer device 304, the implantable energy conversion device 302 powers the motor/pump unit 309 with energy from the energy carried by the control signal, The motor/pump unit 309 thereby distributes hydraulic fluid between the hydraulic fluid reservoir 313 and the device 10. The remote control of the extracorporeal energy transfer device 304 includes one direction in which fluid is pumped by the motor/pump unit 309 from the hydraulic fluid reservoir 313 to the device 10 for operating the device and returning the device to the starting position. In order to shift the flow direction of the hydraulic fluid relative to the opposite direction in which the fluid is pumped from the device 10 back to the hydraulic fluid reservoir 313 by the motor/pump unit 309. Control the pressure valve shift device 314.

In FIG. 7, an extracorporeal energy transfer device 304 having a wireless remote control device, an apparatus 10, an implantable energy conversion device 302, and an implantable intracorporeal control unit 315 controlled by the wireless remote control device of the extracorporeal energy transfer device 304. 2 illustrates an embodiment of the present invention including an implantable accumulator 316 and an implantable capacitor 317. The internal control unit 315 stores electrical energy received from the implantable energy conversion device 302 in an accumulator 316 that supplies energy to the device 10. In response to a control signal from the wireless remote control of the extracorporeal energy transfer 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 Alternatively, electrical energy is transferred directly from the implantable energy conversion device 302 via a power line 320, a current stabilizing capacitor 317, a power line 321, and a power line 319 for operation of the apparatus 10.

  The internal control unit is preferably programmable from outside the patient's body. In a preferred embodiment, the internal control unit adjusts the device 10 according to a pre-programmed time schedule or input from any sensor that senses 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 of this embodiment may be omitted.

  FIG. 8 illustrates the embodiment of FIG. 2 except that a battery 322 for energizing the operation of device 10 and an electrical switch 323 for switching operation of device 10 are also implanted in the patient. The same embodiment is shown. The electrical switch 323 can be controlled by a remote control device to switch from an off mode in which the battery 322 is not in use to an on mode in which the battery 322 is energized for operation of the device 10 and is implantable. It can also be operated by the energy provided by the 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 extracorporeal energy transmission device 304 is also implanted in the patient. In that case, the electrical switch 323 operates the device 10 from an off mode in which the energy provided by the implantable energy conversion device 302 prevents the wireless remote controller from controlling the internal control unit 315 and the battery is not in use. The remote control operates to switch to a standby mode in which the internal control unit 315 can be controlled to release electrical energy from the battery 322 for.

  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 implantable component interconnections are different. In that case, accumulator 316 stores energy from implantable energy conversion device 302. In response to a control signal from the wireless remote control of the extracorporeal energy transfer device 304, the internal control unit 315 activates the accumulator 316 for operation of the device 10 from the off mode when the accumulator 316 is not in use. The electric switch 323 is controlled so as to switch to the ON mode to be turned on. The accumulator may be combined with a capacitor, and a capacitor may be used instead of the accumulator.

  FIG. 11 shows an embodiment identical to the embodiment of FIG. 10 except that the battery 322 is also implanted in the patient and the implantable component interconnections are different. In response to a control signal from the wireless remote control of the extracorporeal energy transfer device 304, the internal control unit 315 causes the battery 322 to be electrically energized for operation of 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.

Alternatively, the electrical switch 323 is prevented from controlling the battery 322 to be electrically energized by the wireless remote controller and the wireless remote controller is not in use, off.
From the mode, the wireless remote control can be operated by the energy provided by the accumulator 316 to switch to a standby mode in which the battery 322 can be controlled to energize for operation of the device 10.

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

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

  FIG. 13 shows an embodiment of the invention that is identical to the embodiment of FIG. 19 except that the interconnections of the implantable components are different. Thus, in that case, the internal control unit 315 is powered by the battery 322 when the accumulator 316, suitably a capacitor, switches the electrical switch 323 into 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 transfer device 304 that includes an external radio remote control. As already described above, the wireless remote control device transmits control signals received by the internal control unit 315, which controls various implantable components of the device.

  Preferably, a feedback device comprising a sensor or measurement device 325 can be implanted in the patient to sense the patient's physical parameters. The physical parameter is at least one selected from the group consisting of pressure, volume, diameter, elongation, extension, expansion, movement, curvature, elasticity, muscle contraction, nerve impulse, temperature, blood pressure, blood flow, heartbeat, and respiration. One is good The sensor can sense any of the above physical parameters. For example, the sensor may be a pressure sensor or a motion sensor. Alternatively, the sensor 325 can be configured to sense the function parameter. The function parameters can be related to each other to transfer energy to fill the implantable energy source, electrical, any electrical parameter, pressure, volume, diameter, elongation, extension, expansion, movement, bending, stretching. It may further include at least one selected from the group of parameters consisting of sex, temperature, and flow.

  Feedback can be sent to the internal control unit, or preferably externally via 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 having a receiver and a transmitter.

  The internal control unit 315, or the external radio remote control of the external energy transmission device 304, can control the device 10 in response to a signal from the sensor 325. A transceiver can be combined with the sensor 325 to send the sensed physical parameter information to the extracorporeal wireless remote control. The wireless remote controller may comprise a signal transmitter or transceiver and the in-body control unit 315 may comprise a signal receiver or transceiver. Alternatively, the wireless remote control device may comprise a signal receiver or transceiver and the in-body control unit 315 may comprise a signal transmitter or transceiver. The transceivers, transmitters, and receivers described above can be used to send information or data about device 10 from inside the body of a patient 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 filling of the battery 322 can be fed back. To be more precise, when filling the battery or accumulator with energy, send feedback information about the filling process and change the energy supply accordingly.

  FIG. 15 illustrates an alternative embodiment in which device 10 is adjusted from outside the patient's body. The system 300 includes a battery 322, which is connected to the device 10 via a subcutaneous electric switch 326. Therefore, the adjustment of the device 10 is performed non-invasively by manually pressing a subcutaneous switch, which switches the operation of the device 10 on and off. It will be appreciated that the illustrated embodiment is a simplification and that additional components may 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 in-body control unit to perform a certain predetermined action and the action is reversed when the patient presses the switch again.

  FIG. 16 illustrates 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 a hydraulic reservoir connected to the device.

  The system can include an extracorporeal data communicator and an implantable intracorporeal data communicator in communication with the extracorporeal data communicator. The internal communicator supplies data to the external data communicator regarding the device or patient, and/or the external data communicator supplies data to the internal data communicator.

  FIG. 17 schematically illustrates the mechanism of the system, which is designed to provide an accurate amount of activation to an implantable intrabody energy receiver 302 connected to an implantable energy consuming component of device 10. Alternatively, information can be transmitted from within 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 may include energy sources and/or energy conversion devices. Briefly, wireless energy is transmitted from an extracorporeal 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 provide energy received to the energy consuming components of device 10 via switch 326. The energy balance is determined between the energy received by the internal energy receiver 302 and the energy used for the device 10, and the wireless energy transfer is then controlled based on the determined energy balance. To be done. Thus, the energy balance properly presents exactly the exact amount of energy required, sufficient to operate the device 10 without excessive temperature rise.

  In FIG. 17, the patient's skin is indicated by the vertical line 305. Here, the energy receiver comprises an energy conversion device 302 located within the patient's body, preferably just below the patient's skin 305. Generally, the implantable energy conversion device 302 can be placed in the abdomen, thorax, fascia (eg, in the abdominal wall), subcutaneously, or in any other suitable location. Implantable energy conversion device 302 is adapted to receive wireless energy E transmitted from an extracorporeal energy source 304 a, which extracorporeal energy source 304 a is in the skin 305 of the patient in the vicinity of the implantable energy conversion device 302. It is provided on the external energy transmission device 304 located outside.

  As is well known in the art, wireless energy E is generally a device that includes a primary coil located on an extracorporeal energy source 304a and an adjacent secondary coil located on an implantable energy conversion device 302. , Etc. and can be delivered by any suitable transdermal energy transfer (TET) device. When a current is supplied through the primary coil, energy in the form of a voltage is induced in the secondary coil, which is used after accumulating the incoming energy in an implantable energy source such as a battery or a capacitor that can store the energy. Power to the implantable energy consuming components of the device. However, the invention is generally not limited to any particular energy transfer technique, TET device, or energy source, and any type of wireless energy may be used.

  The amount of energy received from the implantable energy receiver can be compared to the energy used by the implantable component of the device. It is then understood that the term "energy used" also includes energy stored by the implantable components of the device. The control device includes an extracorporeal control unit 304b, which controls the extracorporeal 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 energy demand are determined by a decision device including an implantable intrabody control unit 315 connected between the switch 326 and the device 10. Accordingly, the internal control unit 315 can be configured to receive various measurements, such as obtained by a suitable sensor or the like (not shown) that measures the characteristics of the device 10, for proper operation of the device 10. The required amount of energy required for is reflected to some extent. Further, the current condition of the patient can be detected by a suitable measuring device or sensor to provide parameters that reflect the patient's condition. Thus, such features and/or parameters may be related to the current state of the device 10 such as power consumption, mode of operation and temperature, and the patient's state reflected in parameters such as body temperature, blood pressure, heart rate, and respiration. Other types of physical parameters of the patient and functional parameters of the device are described separately.

  Furthermore, 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 for storing the received energy for the device 10 to use later. Alternatively, or additionally, a characteristic of such accumulators that also reflects the amount of energy required can be measured. A rechargeable battery can be used in place of the accumulator and the measured characteristic can relate to the current state of the battery, such as energy consumption voltage, any electrical parameters such as temperature, and the like. The battery is optimally filled by supplying sufficient voltage and current to the device 10 and receiving an exact amount of energy from the implantable energy conversion device 302, i.e. not too little or too much, in order to avoid overheating. It is clearly understood that this should be done. The accumulator may be a capacitor with corresponding features.

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

  Therefore, the internal control unit 315 of the determination device is based on the measurements made by the sensor or measurement device of the apparatus 10 mentioned above, or the patient, or the implantable energy source, if used, or any combination thereof. It is adapted to determine the energy balance and/or the current energy demand (energy per unit time or stored energy). The in-vivo control unit 315 is further connected to an in-vivo signal transmitter 327, and the in-vivo signal transmitter 327 is connected to the extra-corporeal control unit 304b with a control signal reflecting the determined required energy amount. It is configured to transmit to 304c. The amount of energy transmitted from the extracorporeal energy source 304a may then be adjusted in response to the received control signal.

  Alternatively, the decision device may include an extracorporeal control unit 304b. In this alternative, the sensor readings can be transmitted directly to the extracorporeal control unit 304b and the energy balance and/or the current demanded energy amount can be determined by the extracorporeal control unit 304b and thus the internal control unit. The above-described functionality of 315 can be integrated into the extracorporeal control unit 304b. In that case, the internal control unit 315 can be omitted, and the measured values of the sensor are directly supplied to the internal signal transmitter 327, and the internal signal transmitter 327 outputs these measured values to the external signal receiver 304c and the external signal. It transmits to the control unit 304b. The energy balance and the current energy requirement can then be determined by the extracorporeal control unit 304b based on the measurements of those sensors.

  Therefore, the current solution by the mechanism of FIG. 17 uses the feedback of information indicating the energy demand, which is, for example, the proportion of energy used by the implantable energy consuming component of the device compared to the received energy. It is more effective than the previous solution because it is based on the actual use of energy, based on the amount of energy compared, the energy difference or the rate of energy reception. 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, the different parameters described above will be used as tools for further determining the actual energy balance. However, these parameters may be required in essence, especially for the movements performed within the body to operate the device.

  The in-vivo signal transmitter 327 and the in-vitro signal receiver 304c can be implemented as separate units using appropriate signal transmission means such as radio signals, IR (infrared) signals, or ultrasonic signals. Alternatively, the intracorporeal signal transmitter 327 and the extracorporeal signal receiver 304c are provided with an implantable energy conversion device 302 and an extracorporeal energy source, respectively, to carry control signals in opposite directions to the energy transmission using essentially the same transmission technique. Can be incorporated into 304a. The control signal may be frequency, phase, or amplitude modulated.

Therefore, the feedback information may be conveyed by a separate communication system including a receiver and a transmitter and may be incorporated into the energy system. In accordance with the present invention, such an integrated information feedback and energy system has an implantable body for receiving wireless energy having a first body coil and a first electronic circuit connected to the first coil. An internal energy receiver is provided and an external energy transmitter for transmitting wireless energy is provided that has a second extracorporeal coil and a second electronic circuit connected to the second coil. The second extracorporeal coil of the energy transmitter is the first external coil of the energy receiver.
Transmit wireless energy received by the coil of the. The system further comprises a power switch for turning on and off the connection of the first body coil to the first electronic circuit, the power switch turning on and off the connection of the first body coil to the first electronic circuit. Upon switching, feedback information regarding the charge of the first coil in the form of changes in the impedance of the load of the second extracorporeal coil is received by the extracorporeal energy transmitter. In implementing such a system in the arrangement 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 appreciated that switch 326 should be construed in the broadest embodiment. This means that a transistor, MCU, MCPU, ASIC, FPGA or DA converter 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 energy amount is also generated by the internal control unit 315, and the control signal is transmitted from the internal signal transmitter 327 to the external signal receiver 304c. Alternatively, as mentioned above, the energy balance may be determined by the extracorporeal control unit 304b depending on the implementation. In that case, the control signal may carry measurement results from various sensors. The amount of energy emitted from the extracorporeal energy source 304a may then be adjusted by the extracorporeal control unit 304b based on the determined energy balance, eg, in response to the received control signal. This process can be repeated intermittently at specific intervals during ongoing energy transfer, or can be performed to some extent during energy transfer.

  The amount of energy transferred can generally be adjusted by adjusting various transfer parameters of the extracorporeal 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. You 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 when the movement is accurate, the extracorporeal coil may also find the optimal position for energy transfer. Preferably, the extracorporeal coil is adapted to calibrate the amount of energy transferred to achieve 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 a case, the energy system of the present invention comprises an implantable intracorporeal energy receiver for receiving wireless energy, the implantable intracorporeal energy receiver having a first intrabody coil and a first electronic circuit connected to the first coil. An extracorporeal energy transmitter having two extracorporeal coils and a second electronic circuit connected to the second coil for transmitting wireless energy. The second extracorporeal coil of the energy transmitter transmits the wireless energy received by the first coil of the energy receiver. The system further comprises a feedback device for communicating the amount of energy received at the first coil as feedback information, the second electronic circuit including a determining device, the determining device receiving the feedback information, To obtain the coupling coefficient between the one coil and the second coil, the amount of energy transferred by the second coil is compared with feedback information regarding the amount of energy received by the first coil. The energy transmitter can adjust the transmitted energy in response to the obtained coupling coefficient.

  Referring to FIG. 18, although wireless transfer of energy to operate the device to enable non-invasive manipulation is described above, it will be appreciated that the device can also be operated with wire-energy. One such example is shown in FIG. 18, where an extracorporeal switch 326 is interconnected between an extracorporeal energy source 304a and an actuating device, such as an electric motor 307, that operates the apparatus 10. The extracorporeal control unit 304b controls the operation of the extracorporeal switch 326 so that the device 10 performs the appropriate operation.

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

  The apparatus 10 comprises an energy consuming portion 10a, which may be a motor, pump, limiting device, or any other medical device that requires energy for electrical operation. The apparatus 10 may further include an energy storage device 10b that stores the energy provided by the internal energy receiver 302. Thus, the energy delivered may be consumed directly by the energy consuming portion 10a, may be stored in the energy storage device 10b, or the energy delivered may be partially consumed and partially stored. Good. The device 10 may further include an energy stabilization unit 10c that stabilizes the energy provided by the internal energy receiver 302. Therefore, the energy can be supplied in increments or decrements, so that it is necessary to stabilize the energy before it is consumed or stored.

  The energy provided by the internal energy receiver 302 may further be stored and/or stabilized by a separate energy stabilizing 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 stabilizing unit 328 may include a constant voltage circuit and/or a constant current circuit.

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

FIG. 20 schematically shows an energy balance measuring circuit which is one of the design proposals of the system for controlling the transmission of wireless energy or the energy balance control system. The circuit has an output signal that is centered on 2.5V and is proportional to the energy imbalance. The derivative of such a signal indicates whether the value goes up or down and the rate at which such a change occurs. If the amount of energy received is less than the energy used by the implantable components of the device, more energy will be transferred and thus the energy source will be charged. The output signal from the circuit is typically provided to an A/D converter and converted to digital format. The digital information can then be transmitted to an extracorporeal energy transmission device, where the level of energy transmitted therein can be adjusted. Another possibility is to have a fully analog system that uses a comparator, which compares the level of energy balance to certain maximum and minimum thresholds and is out of balance max/max. If the minimum window is exceeded, send the information to the extracorporeal energy transfer device.

  Schematic Figure 20 shows a circuit implementation of a system for transferring energy from outside the patient's body to the implantable energy component of the device of the invention using inductive energy transfer. Inductive energy transfer systems typically use extracorporeal transmission coils and internal reception coils. The receiving coil L1 is included in the schematic diagram 3 and does not include the transmitting part of the system.

  The general concept of energy balance and the implementation of the method of transmitting information to an extracorporeal energy transmitter can, of course, be implemented in a number of different ways. The schematic diagram 20 and the method described above for evaluating and transmitting information should only be construed as an example of how a control system may be implemented.

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

  Energy for powering 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 system described above can also be combined in many different ways. For example, the electrical switch 306 of FIG. 3 may be incorporated into any of the embodiments of FIGS. 6-12, the hydraulic valve shift device 314 of FIG. 6 may be incorporated into the embodiment of FIG. Box 324 can also be incorporated into the embodiment of FIG. It should be appreciated that a switch may simply mean any electronic circuit or component.

  The embodiments described in connection with FIGS. 17, 19 and 20 identify methods and systems for controlling the transfer of wireless energy to an implantable energy consuming component of an electrically operable device. Such methods and systems are defined generally below.

  Accordingly, there is provided a method of controlling the transmission of wireless energy delivered to the implantable energy consuming components of the apparatus described above. The wireless energy E is transmitted from an extracorporeal energy source located outside the patient's body and received by an internal energy receiver located inside the patient's body, the internal energy receiver receiving the received energy from the implantable energy consuming component of the device. Is connected to its energy consuming component to supply it directly or indirectly. An energy balance is determined between the energy received by the internal energy receiver and the energy used for the device. The transmission of wireless energy E from the extracorporeal energy source is then controlled based on the determined energy balance.

  Wireless energy can be inductively transmitted from the primary coil of the extracorporeal energy source to the secondary coil of the internal energy receiver. Changes in energy balance can be determined and wireless energy transmission can be controlled based on the changes in energy balance. It is also possible to detect the difference between the energy received by the internal energy receiver and the energy used for the medical device and control the transmission of wireless energy based on the detected energy difference.

When controlling energy transfer, if the detected change in energy balance indicates that the energy balance is increasing, the amount of wireless energy transferred can be reduced and vice versa. Is. The decrease/increase in energy transfer may further correspond to the detected amount of change.

  If the difference in the detected energies indicates that the received energy is higher than the used energy, then the amount of wireless energy transmitted can be further reduced, or vice versa. The decrease/increase in energy transfer may then be consistent with 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 the electrical and/or physical parameters of the medical device and/or the physical parameters of the patient are determined, the energy is transferred for consumption and storage according to the transmission rate per unit time determined based on said parameters. can do. It is also possible to determine the total amount of energy transmitted based on said parameters.

  A difference is detected between the total amount of energy received by the internal energy receiver and the total amount of energy consumed and/or stored, and the detected difference is at least one measured electricity relating to said energy balance. When concerned with the time integral of the dynamic parameter, the integral can be determined with respect to the monitored voltage and/or current relating 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, it is possible to determine the derivative with respect to the monitored voltage and/or current relating to the energy balance. it can.

  Applying an electrical pulse having rising and falling edges from the first electrical circuit to the extracorporeal energy source to transmit wireless energy, the length of the first time interval between successive rising and falling edges of the electrical pulse, By changing the length of the second time interval between successive falling and rising edges of the electrical pulse and transmitting the wireless energy, the transmission of the wireless energy from the extracorporeal energy source can be controlled. , The transmitted energy resulting from the electrical pulse has an altered power, the variation of the power being dependent on the length of the first and/or second time interval.

  In that case, the frequency of the electrical pulse 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 a change in 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 modified simply by modifying the length of the first time interval between successive rising and falling edges.

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

When applying an electrical pulse, the electrical pulse can have a virtual constant current and a virtual constant voltage. The electrical pulse can also have a virtual constant current and a virtual constant voltage. Furthermore, the electrical pulse can also have a virtually constant frequency. The electrical pulses in the pulse train can also have a virtually constant frequency.

  The circuit formed by the first electrical circuit and the extracorporeal energy source may have a first characteristic time period or a first time constant, and such frequency time periods may change when the energy transferred is substantially changed. It may be within or below the first characteristic period or time constant.

  Therefore, a system comprising a device as described above is also provided for controlling the transmission of wireless energy supplied to the implantable energy consuming component of the device. In the broadest sense, the system comprises a control device for controlling the transmission of wireless energy from the energy transfer device and an implantable internal energy receiver for receiving the transmitted wireless energy, The internal energy receivers are connected to the energy consuming components of the device to supply the received energy directly or indirectly to the implantable energy consuming 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 in the implantable energy consuming component of the device, The control device controls the transmission of wireless energy from the extracorporeal energy transmission device based on the energy balance determined by the determination device.

  Further, the system can include any of the following:

  A primary coil in an extracorporeal energy source that is adapted to direct radio energy to a secondary coil of an internal energy receiver.

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

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

  When the detected change in the energy balance indicates that the energy balance is increasing, the control device controls the extracorporeal energy transfer device to reduce the amount of transmitted wireless energy, or vice versa. It is also possible, that the decrease/increase in energy transfer corresponds to the detected rate of change.

  If the detected energy difference indicates that the received energy is greater than the energy used, the control device controls the extracorporeal energy transfer device to reduce the amount of wireless energy transmitted, or The reverse is also possible, the decrease/increase in energy transfer corresponding 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 device and/or the physical parameters of the patient are determined, the energy transfer device consumes and according to the transmission rate per unit time determined by the determination device based on said parameters. Transfers the energy stored. The determining device also determines the total amount of energy transmitted based on said parameters.

  A difference is detected between the total amount of energy received by the internal energy receiver and the total amount of energy consumed and/or stored, and the detected difference is at least one measured electrical value relating to the energy balance. When concerned with the time integral of the dynamic parameter, the determination device determines the integral with respect to the monitored voltage and/or current for 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 determination device is adapted to provide a derivative with respect to the monitored voltage and/or current relating to the energy balance. To decide.

  The energy transfer device comprises a coil located 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 falling edge, and the electrical circuit is configured to change the power of the transmitted wireless energy by a first time interval and/or a continuous time between consecutive rising edges and falling edges of the electrical pulse. Is adapted to change the second time interval between the falling and the rising. As a result, the energy receiver that receives the transmitted wireless energy has a modified 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 range of the first time constant, so that of the first and/or second time interval. When the length is changed, the power transmitted on the coil is changed.

  The electrical circuit is adapted to deliver an electrical pulse that is modified by simply changing the length of the first time interval between successive rising and falling edges of the electrical pulse.

  The electrical circuit is adapted to provide a sequence of two or more electrical pulse trains, the 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. Have a pulse.

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

  The electrical circuit is adapted to supply the electrical pulse as a pulse having a virtually 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 range of the first time constant, so that of the first and/or second time interval. When the length is changed, the power transmitted on the first coil is changed.

  The electrical circuit includes a length of the first and/or second time interval in a range that includes or is relatively close to the first time constant as compared to the magnitude of the first time constant. It is adapted to deliver electric pulses that only change at.

  21-24 show, in more detail block diagrams, four different methods of hydraulically or pneumatically powering an implantable device in accordance with the present invention.

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

  FIG. 22 shows the device 10 and the fluid reservoir 1013. Adjusting the device without a valve by simply moving the wall of the reservoir, or by simply changing its size in any other different way, by simply moving the wall of the reservoir by a simple passage without fluid You can

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

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

  The servo reservoir 1050 can also be part of the device itself.

  In one embodiment, the conditioning reservoir is located subcutaneously under the patient's skin and operates by pushing its outer surface with a finger. This system is shown in Figures 25a to 25c. In FIG. 30a, a flexible subcutaneous conditioning reservoir 1013 is shown connected by conduit 1011 to a bulge-shaped servo reservoir 1050. Such a bellows type servo reservoir 1050 is included in the flexible device 10. In the situation shown in Figure 25a, the servo reservoir 1050 contains a minimum amount of fluid and most of the fluid is in the conditioning reservoir 1013. The mechanical interconnection between the servo reservoir 1050 and the device 10 causes the profile of the device 10 to shrink, i.e. occupy less than the maximum volume. This maximum volume is indicated by a broken line in the figure.

  In FIG. 25b, a user, such as a patient with the device implanted, pushes the conditioning reservoir 1013 so that the fluid contained therein flows through the conduit 1011 and, due to the bellows shape, the servo reservoir 1050 extends longitudinally. The state of being carried to. This expansion then causes the device 10 to occupy the maximum volume, thereby expanding to clamp the vas deferens downstream (not shown) of the ampulla with which the device 10 contacts.

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

An alternative embodiment of hydraulic or pneumatic operation will now be described with reference to Figures 26 and 27a-27c. The block diagram shown in FIG. 26 comprises a first closed system controlling a second closed system. The first system comprises a conditioning reservoir 1013 and a servo reservoir 1050. Servo reservoir 1050 mechanically controls a larger adjustable reservoir 1052 via mechanical interconnect 1054. The implantable device 10 having the expandable/contactable cavity is then controlled by the larger adjustable reservoir 1052 by supplying hydraulic fluid from a larger adjustable reservoir 1052 fluidly connected to the device 10. To 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 operates by pushing its outer surface with a finger. Conditioning reservoir 1013 is in fluid connection with bellows type servo reservoir 1050 by conduit 1011. In the first closed system 1013, 1011, 1050 shown in FIG. 31a, the servo reservoir 1050 contains the least fluid and most of the fluid is in the conditioning reservoir 1013.

  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. The larger adjustable reservoir 1052 is in fluid connection with the device 10. This is because as the user pushes on the adjustment reservoir 1013, which causes fluid to move from the adjustment reservoir 1013 to the servo reservoir 1050, the expansion of the servo reservoir 1050 allows a larger volume of fluid to be adjusted to a larger adjustable reservoir 1052. To move to device 10. In other words, in such an inverted servomechanism, a smaller volume of the conditioning reservoir is squeezed with a greater force, thereby moving a larger overall area with less force per unit area.

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

120 Restriction device; 150 Control device; 170 Operating device; 180 Energy supply unit; 190 Extracorporeal remote control unit.

Claims (17)

A male contraceptive device for temporarily rendering a male mammal individual sterile,
It has a structure that restricts the vas deferens and seminal vesicle outlet tract in the region downstream of the ampulla for a controlled period of time, and when implanted, is housed in the region between the prostate and the ampulla of the vas deferens. , With an implantable restriction device, which is capable of preventing sperm from reaching the urethra,
A control device for controlling the operation of the limiting device,
Contraceptive device.   2. The contraceptive device of claim 1, wherein 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 to stop flow in the vas deferens.   The contraceptive device of claim 2, wherein the tightening device is adjustable and comprises an actuation device for actuating the adjustable tightening device to alter the restriction of the wall portion of the vas deferens.   The contraceptive device of claim 3, wherein the operating device is manually operated.   The contraceptive device according to claim 3, wherein the movement device mechanically, hydraulically or non-magnetically and/or non-manually operates the restriction device.   The contraceptive device according to claim 3, wherein the operating device comprises an electrically powered operating device.   7. The contraceptive device of claim 6, wherein the motion device comprises a motor or servo system.   The actuating device mechanically actuates the clamping device, and the restriction device comprises 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. The contraceptive device of claim 3, wherein the movement device operates the clamping elements to clamp the wall portions between the clamping elements to clamp the wall portions.   2. The restriction device comprises a stimulator device for stimulating a wall portion of the tissue wall of the vas deferens in a region downstream of the ampulla, and contracting the wall portion to affect flow in the vas deferens. Contraceptive device according to.   The contraceptive device according to claim 9, wherein the control device controls the intensity of stimulation from the stimulation device to a wall portion in response to sensed functional parameters or physical parameters of the patient.   In the vas deferens, the control device controls the stimulation device as follows, that is, the tightened wall portion is subjected to stimulation such that contraction occurs in the stimulation device. The contraceptive device according to claim 9, wherein the flow is stopped or completely stopped.   The control device stimulates the clamped wall portion to stop the flow in the vas deferens in the first mode, and stops the stimulation of the wall portion in the second mode to stop the flow in the vas deferens. The contraceptive device of claim 9, wherein the contraceptive device is controlled to allow.   The contraceptive device according to claim 9, wherein the control device controls the stimulation device to intermittently and individually stimulate different regions of the wall portion, wherein at least two regions are stimulated at different times. The control device controls the stimulation device to stimulate one or more regions of the wall portion at a time,
The control device controls the stimulation device to periodically propagate stimulation of a region along a wall portion in a direction that is the same as or opposite to a flow in a patient's vas deferens, or
The contraceptive device according to claim 9, wherein the control device controls the stimulation device so as to periodically propagate the stimulation of the region according to the determined stimulation pattern. The stimulation device electrically stimulates an area of a wall portion of a patient with an electrical pulse,
The stimulation device includes at least one electrical element that engages the wall portion and stimulates the wall portion with an electrical pulse;
The contraceptive device according to claim 9, wherein the stimulation device includes a plurality of electrical elements.   A system comprising the contraceptive device according to claim 1. With an implantable internal energy source for driving implantable energy consuming components of the device,
17. The system of claim 16, comprising an external energy source for mobile energy in a wireless mode, the internal energy source being rechargeable by energy transferred in the wireless mode.

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