Embryo regulation system
The system uses fallopian tube restriction devices to control egg retention and release, addressing the need for effective fertility control without existing birth control methods, ensuring pregnancy prevention and normal blood circulation.
Patent Information
- Application Number
- JP2025231476
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2007-10-19
- Filing Date
- 2025-12-04
- Publication Date
- 2026-02-24
AI Technical Summary
Many women do not want to become pregnant but do not want to use existing birth control methods.
A system and method for fertility control that involves placing restriction devices on the fallopian tubes to retain eggs and control their release, using hydraulic, mechanical, or combined mechanisms to adjust the fallopian tube constriction and stimulate the tube walls to prevent pregnancy.
Effectively prevents pregnancy by retaining eggs in the fallopian tubes for a predetermined period and releasing them at a convenient time, avoiding the need for invasive methods and maintaining normal blood circulation.
Smart Images

Figure 2026031700000001_ABST
Abstract
Description
[Technical Field]
[0001] The present invention relates generally to medical devices and treatments, and more particularly to embryo regulation systems and methods for female patients. [Background technology]
[0002] Many women do not want to become pregnant but do not want to use the existing birth control methods available. Summary of the Invention [Problem to be solved by the invention]
[0003] It is an object of the present invention to provide a system and method for fertility control for female patients. [Means for solving the problem]
[0004] The system of the present invention allows eggs from the ovaries to be retained in the fallopian tubes to prevent pregnancy. Restriction devices are placed on the two fallopian tubes to restrict and release the tubes, thereby achieving egg retention as described above.
[0005] According to a first aspect of the present invention, there is provided a system for treating a female patient to prevent pregnancy, the system including a restriction device configured to post-operatively restrict and release the patient's fallopian tubes.
[0006] According to a second aspect of the present invention, there is provided a method of preventing pregnancy in a female patient, the method comprising the steps of restricting the patient's fallopian tube to form a restriction and causing at least one egg released from an ovary to accumulate in the fallopian tube for a predetermined period of time, and releasing the restriction to allow the at least one egg in the fallopian tube to pass to the uterus.
[0007] All embodiments and features described below can, where possible, be used in both the device and any of the methods described below, i.e., configured for use in the device and for use in any of the methods described below.
[0008] A system for treating a female patient to prevent pregnancy, the system comprising a restriction device configured to post-operatively restrict and release the patient's fallopian tubes.
[0009] The restriction device is preferably configured to form a restriction in the fallopian tube to accumulate at least one egg released from the ovary within the fallopian tube.
[0010] The restriction device can be configured to release the fallopian tubes only when pregnancy is desired and when pregnancy is not possible.
[0011] The restriction device may be configured to be adjusted from outside the patient's body, preferably non-invasively, to restrict and release the fallopian tube passageway.
[0012] The restriction device may be configured to be manually adjusted, electrically or magnetically adjusted, or hydraulically adjusted, which may include at least one subcutaneously placed reservoir controlled by the patient.
[0013] The restriction device can of course preferably be configured to be reversibly adjusted.
[0014] The system is configured to form a restriction to store at least one egg released from the ovary in the fallopian tube for a predetermined period of time and to release the restriction at a time convenient for the patient to avoid pregnancy, the predetermined period of time being set to avoid pregnancy and may be between 1 and 30 days or greater than 30 days.
[0015] Flow Restriction The system of the present invention is suitable for controlling the flow of eggs into the uterus of a female patient. Basically, the restriction device can be implemented in eight different principle ways: Hydraulic restriction Mechanical restriction Any hydraulic or mechanical restriction device in combination with a stimulation device for restriction Using a stimulation device alone for restriction Changing the restriction area. Any of the above, in any combination, can be used to change the restriction area of the fallopian tube from one area to another over time and then change it back later. In such a system, several different areas can be involved in changing the restriction / area. This allows the fallopian tube to regain the restriction area and maintain the restriction for a longer period of time. Using a movement device. When moving a restriction region between various regions, particularly when moving the restriction upstream toward the ovaries, it may be advantageous to use a movement device to prevent any eggs from being squeezed in the new upstream restriction region and accidentally being released and carried further downstream when the restriction is released and moved further upstream. The movement device can be configured to create a movement portion of the fallopian tube wall to create a movement portion for any eggs placed in the new restriction region. This can be achieved by either the restriction device described above, or a mechanical, hydraulic, or stimulation device alone, or any combination thereof, or it can also be a separate device that can also be a mechanical, hydraulic, or stimulation device. In one embodiment, the movement device generates vibrations. A peristaltic wave motion of the fallopian tube wall toward the ovaries. Another principle is to prevent eggs from reaching the uterus by generating a peristaltic wave motion of the fallopian tube wall. Such peristaltic wave motion in an upstream direction towards the ovary can stop the flow of eggs towards the uterus and preferably always completely restrict a section of the fallopian tube so that sperm cannot pass through, and Peristaltic wave motion of the fallopian tube wall towards the uterus. Another principle is to propel the egg to the uterus by allowing downstream peristaltic waves to move the egg towards the uterus when there is no risk of conception.
[0016] This area is briefly described below.
[0017] Hydraulic Restriction If the operating device hydraulically operates the constriction device of the restriction unit or combined restriction / stimulation unit (d), the operating device comprises hydraulic means for adjusting the restriction device.
[0018] In one embodiment of the invention, the hydraulic means includes a reservoir and an inflatable / contractable cavity in the constriction device, in which case the operating device distributes hydraulic fluid from the reservoir to expand the cavity and distributes hydraulic fluid from the cavity to the reservoir to contract the cavity. The cavity may be formed by a balloon of the constriction device abutting a tissue wall of the patient's organ, so that the patient's wall constricts upon cavity expansion and is released upon cavity contraction.
[0019] Alternatively, the cavity can be formed by a relatively large constriction member of the constriction device, such as a bellows member that displaces a large balloon against the wall, so that the patient's wall constricts upon contraction of the bellows member and releases upon expansion of the bellows member. Thus, the addition of a relatively small amount of hydraulic fluid to the bellows member significantly increases the constriction of the wall. Such a bellows member could also be replaced by a suitably configured piston / cylinder mechanism.
[0020] When the hydraulic means comprises a cavity in the constriction device, the apparatus of the present invention can be configured according to the options listed below.
[0021] 1) The reservoir comprises first and second walls, and the operating device displaces the first and second walls relative to each other to change the volume of the reservoir, thus dispersing fluid from the reservoir to the cavity or from the cavity to the reservoir.
[0022] 1a) The first and second walls of the reservoir are displaceable relative to one another by at least one of a magnetic device, a hydraulic device, and an electrical control device.
[0023] 2) The device includes a fluid conduit between the reservoir and the cavity, where the reservoir forms part of the conduit. The conduit, reservoir, and device are free of check valves. The reservoir forms a fluid chamber with a variable volume, and reducing the volume of the chamber distributes fluid from the chamber to the cavity, and increasing the volume of the chamber draws fluid from the cavity. The device further includes a motor driving the reservoir, which has a movable wall that changes the volume of the chamber.
[0024] In a special embodiment of the invention, the operating device comprises a reversing servo operatively connected to the hydraulic means. The term "reversing servo" should be understood as a mechanism that converts a strong force acting on a moving member with a short stroke into a weak force acting on another moving member with a long stroke, i.e., the reverse function of a normal servo mechanism. Thus, a small change in the amount of fluid in a smaller reservoir is converted by the reversing servo into a large change in the amount of fluid in a larger reservoir. The reversing servo is particularly suitable for its manual operation.
[0025] The manual reservoir is preferably subcutaneously positionable for manual operation.
[0026] Mechanical Restriction: The operating device may be non-expandable if the restriction device or restriction / stimulation unit (d) is mechanically operated. Furthermore, the operating device may include a servo system, which may include a gearbox. The term "servo system" encompasses the conventional definition of a servo mechanism, i.e., an automatic device that controls a very large force with a very small force, but may also encompass, alternatively or in addition, the definition of a mechanism that converts a weak force acting on a moving member having a long stroke into a strong force acting on another moving member having a short stroke. Preferably, the operating device operates the constriction device non-magnetically and / or non-manually. A motor may be operably coupled to the operating device. The operating device may be operable to perform at least one reversible function, and the motor may be capable of reversing this function.
[0027] Combination of Mechanical or Hydraulic Restriction Device and Stimulation Device The present invention provides an advantageous combination of a restriction device and a stimulation device, resulting in a two-stage effect on egg flow within the lumen of the fallopian tube. Thus, the constriction device can gently constrict the tissue barrier of the fallopian tube wall by applying a relatively weak force to the wall, and the stimulation device can stimulate the constricted wall to achieve the final desired effect on flow within the lumen. The phrase "mildly constricting a portion of a tissue wall" should be understood to mean restricting the wall without substantially impeding blood circulation within the tissue wall.
[0028] According to the first flow restriction option, the control device controls the constriction device to constrict the wall, thus restricting or stopping flow in the lumen, and controls the stimulation device to stimulate the constricted wall to contract, thus further restricting or more safely stopping flow in the lumen. More precisely, the control device controls the stimulation device in the first mode to stimulate the constricted wall to further restrict or stop flow in the lumen; a) in a second mode, the stimulation device can be controlled to stop stimulation of the wall and increase flow within the lumen, or b) in a second mode, the stimulation device and constriction device can be controlled to stop stimulation of the wall and release the wall to restore flow within the lumen.
[0029] Thus, both the method of controlling flow within a lumen and the device configured to control flow within a lumen may be implemented according to various embodiments and features in any combination as described herein.
[0030] d) Only stimulation devices that can both 1) restrict stimulation and 2) induce peristaltic waves, a) stop upstream flow without completely restricting the fallopian tubes, and b) allow downstream peristaltic waves to move the egg to the uterus.
[0031] Preferably, the stimulation device is configured to stimulate different regions of the wall when the restriction device restricts the wall, and the control device controls the stimulation device to stimulate each region of the wall intermittently and individually. By intermittently and individually stimulating different regions of the wall of the fallopian tube in this manner, the tissue of the wall can maintain substantially normal blood circulation during operation of the device of the present invention.
[0032] Various areas of stimulation can be used to safely close the lumen as well as to create peristaltic waves within the fallopian tubes.
[0033] Movement of the egg within the fallopian tube lumen In one embodiment, the restriction device is configured to constrict a wall to restrict or alter flow within the lumen, and the control device controls the stimulation device to gradually stimulate the constricted wall in an upstream or downstream direction within the lumen, gradually contracting the wall to move the egg downstream within the lumen or to prevent the egg from being delivered further into the uterus.
[0034] Control Device Configuration The restriction device is preferably controlled manually from outside the body. The restriction device can be powered. The control device can be powered. The control device preferably controls the restriction device or stimulation device or restriction / stimulation unit from outside the patient's body. The control device is preferably operable by the patient. For example, the control device may comprise a manual switch for turning the constriction / stimulation unit on and off, where the switch is configured to be subcutaneously implanted in the patient and operated manually or magnetically from outside the patient's body. Alternatively, the control device may conveniently comprise a handheld wireless remote control operable by the patient to turn the constriction / stimulation unit on and off. The wireless remote control may also be configured to be attached to the patient's body like a wristwatch. Such a wristwatch-type remote control may emit control signals that cause the patient's body to follow the implanted signal-responsive means of the device.
[0035] In a preferred embodiment of the present invention, the constriction device is adjustable to allow adjustment of the constriction of the wall as needed, in which case the control device controls the constriction device to adjust the constriction of the wall. The control device can control the constriction device and the stimulation device independently of each other and simultaneously. Optionally, the control device can control the stimulation device to stimulate the wall or not stimulate the wall, while the control device controls the constriction device to change the constriction of the wall.
[0036] The constriction device can be calibrated first by using the control device to control the stimulation device to stimulate the wall while controlling the constriction device to adjust the constriction of the wall until the desired restriction of flow within the lumen is achieved.
[0037] Regarding stimulation alone or in combination with a restriction device, the control device can control the stimulation device to stimulate one or more regions of the wall at a time, for example by sequentially stimulating each different region. Furthermore, the control device can control the stimulation device to propagate stimulation of each region cyclically along the wall, preferably according to a predetermined stimulation pattern. To produce a desired response of the tissue wall during stimulation of the tissue wall, the control device can control the stimulation device to vary, preferably cyclically, the intensity of stimulation of the wall.
[0038] In a preferred embodiment of the invention, the control device controls the stimulation device to intermittently stimulate each region of the wall with pulses, preferably forming a pulse train. At least a first region and a second region of each region of the wall can be repeatedly stimulated with a first pulse train and a second pulse train, respectively, such that the first and second pulse trains are offset in time. For example, the first region can be stimulated with the first pulse train while the second region is not stimulated with the second pulse train, or the second region can be stimulated with the second pulse train while the first region is not stimulated with the first pulse train. Alternatively, the first and second pulse trains can be offset from each other such that they at least partially overlap.
[0039] Pulse trains can be configured in a number of different ways. Thus, the control device can control the stimulation device to vary the amplitude of the pulses in a pulse train, the duty cycle of the individual pulses in each pulse train, the width of each pulse in a pulse train, the length of each pulse train, the repetition frequency of the pulse train, the number of pulses in each pulse train, and / or the off-time period between pulse trains. Several pulse trains of various configurations can be used to achieve a desired effect.
[0040] When the control device controls the stimulation device to vary the off-time periods between pulse trains that stimulate each region of the wall, each off-time period between pulse trains can be adjusted to last for a period of time sufficient to restore approximately normal blood circulation in the region when the region is not stimulated during the off-time period.
[0041] The electrical stimulation device preferably comprises at least one, and preferably a plurality of, electrical members, such as electrodes, that engage the wall portion and stimulate the wall portion with electrical pulses. Optionally, the electrical members may be oriented relative to one another. The control device controls the electrical stimulation device to energize the electrical members one at a time or groups of electrical members at a time. Preferably, the control device controls the electrical stimulation device to energize each member with electrical pulses in a cyclical manner. Optionally, the control device may control the stimulation device to energize the electrical members one at a time or such that several electrical members or groups of electrical members are energized simultaneously. Furthermore, groups of electrical members may be energized randomly or sequentially according to a predetermined pattern.
[0042] The electrical members can form any pattern of electrical members. Preferably, the electrical members form an elongated pattern of electrical members, in which case the electrical members can be attached to the wall of the patient's organ such that the elongated pattern of electrical members extends longitudinally along the wall of the patient's organ and the members abut respective regions of the wall. The elongated pattern of electrical members can include one or more rows of electrical members extending longitudinally along the wall of the organ. Each row of electrical members can form a linear, spiral, or zigzag path of electrical members, or a path of any shape. The control device can control the stimulation device to sequentially energize the electrical members longitudinally along the elongated pattern of electrical members, either counter-directionally or co-directionally with the flow of electrical energy through the patient's lumen.
[0043] According to a preferred embodiment of the present invention, the electrical members form a plurality of member groups, each group forming a series of groups extending along the patient's organ in the direction of flow within the patient's lumen. The electrical members of each electrical member group can form a member path extending at least partially around the patient's organ. In a first alternative embodiment, the electrical members of each electrical member group can form more than two member paths extending on different sides of the patient's organ, preferably generally transverse to the direction of flow within the patient's lumen. The control device can control the stimulation device to energize each electrical member group of the series of electrical member groups randomly or according to a predetermined pattern. Alternatively, the control device can control the stimulation device to energize each electrical member group of the series of electrical member groups in the direction opposite to or in the direction of flow within the patient's lumen, or sequentially in both directions from a location approximately in the center of the constricted wall. For example, the group of energized electrical members can form a forward wave of energized electrical members as described above, i.e., the control device can control the stimulation device to energize the group of electrical members so that the energized electrical members form two waves of energized electrical members that simultaneously advance in two opposite directions from the center of the constricted wall portion toward both ends of the elongated pattern of electrical members.
[0044] The control device can control the stimulation device to vary the wall stimulation in response to sensed physical parameters of the patient or functional parameters of the system. For example, in response to sensed increased pressure in the fallopian tubes, the control device can control the stimulation device to increase the intensity of wall stimulation, thus causing flow in the fallopian tubes to remain halted. Optional sensors can be provided that sense a patient's physical parameter, such as pressure within the patient's body relative to pressure in the fallopian tubes, in which case the control device controls the stimulation device in response to signals from the sensors. Such sensors can sense, for example, pressure within the patient's abdomen, pressure against an implanted constriction device, or pressure against the tissue walls of a body organ.
[0045] For example, hormone level sensors can be applied, where the flow of eggs is controlled using the present invention.
[0046] Sensor-Controlled Restriction and / or Stimulation Devices As described above, the system may include at least one implantable sensor, in which case the control device controls the constriction device and / or stimulation device in response to signals from the sensor. Generally, the sensor directly or indirectly senses at least one physical parameter of the patient, or at least one functional parameter of the system, or at least one functional parameter of a medical implant within the patient.
[0047] The system is further preferably configured to transmit feedback information from inside the body to outside the body to provide feedback regarding any functional parameter of the device or physical parameter of the patient.
[0048] The functional parameters of the device can be correlated with the delivery of energy to recharge the internal energy source as described elsewhere.
[0049] The functional parameter of the device may be energy balance, the balance between energy received and energy used including energy stored by the device, which may include the balance between the rate of energy acceptance and the rate of energy use including the rate of storage.
[0050] Many different types of sensors that sense physical parameters can be used.
[0051] The control device may include an implantable internal control unit that directly controls the constriction device and / or the stimulation device in response to signals from the sensor. The control device may further include a wireless remote control configured to set control parameters of the internal control unit from outside the patient without mechanically penetrating the patient. At least one of the control parameters settable by the wireless remote control is a physical parameter or a functional parameter. Preferably, the internal control unit includes the clock mechanism described above, in which case the wireless remote control is also configured to set the clock mechanism.
[0052] Alternatively, the control device may comprise an external control unit outside the patient's body that controls the constriction device and / or stimulation device in response to signals from the sensors.
[0053] Adjustable Constriction Device In some other embodiments of the present invention, the constriction device is adjustable. In these embodiments, an operating device is provided for operating the adjustable constriction device to vary the constriction of a patient's tissue wall, and the constriction device and stimulation device form a constriction / stimulation unit. The constriction device and stimulation device of the constriction / stimulation unit are preferably integrated into a single member suitable for implantation. The constriction device of the unit has a contact surface sized to contact the tissue wall of the patient's organ over a certain length, and the stimulation device of the unit has a plurality of stimulation members disposed on and distributed along the contact surface. When the control device controls the stimulation device to stimulate the wall, the stimulation members stimulate various regions of the wall along its length. Preferably, the stimulation members comprise electrical members that stimulate the wall with electrical pulses, as described above. However, for most applications of the present invention, other types of stimulation, such as thermal stimulation, are suitable for use.
[0054] The manipulation device operates the adjustable constriction device of the constriction / stimulation unit according to the configuration of the constriction device, as described in the following examples of embodiments. 1) The constriction device includes at least two elongated clamping members having contact surfaces and extending along the wall on different sides of the organ, and an operating device for operating the clamping members to clamp the wall between the clamping members to constrict the wall of the organ.
[0055] 2) The constriction device includes an elongated clamping member having a contact surface and extending along one side of the wall of the organ, and an operating device operates the clamping member to clamp the wall between the clamping member and the patient's bone or tissue, thereby constricting the wall.
[0056] 3) The constriction device has at least two engagement members having contact surfaces and positioned on different sides of the organ, and the operating device rotates the engagement members so that the engagement members engage with the wall of the organ and constrict the wall.
[0057] 4) The constriction device comprises at least two articulated clamping members having contact surfaces and positioned on different sides of the organ, and an operating member moves the clamping members toward each other to clamp the wall of the organ between the clamping members and constrict the wall.
[0058] 5) The constriction device comprises at least two separate clamping members having contact surfaces, at least one of the clamping members being capable of rotating and thus pivoting within a plane in which the loop of the constriction member extends, and the operating device pivots the rotated clamping member to vary the size of the constriction opening.
[0059] 6) The constriction device includes at least one elongated constriction member having a contact surface, forming means for forming the constriction member into an at least substantially closed loop around the organ, the loop forming a constriction opening, and a manipulation device for manipulating the constriction member within the loop to vary the size of the constriction opening.
[0060] 6a) The elongate constriction member comprises a belt having a contact surface, and the manipulation device operates the belt to vary the longitudinal extension of the belt within the loop to vary the size of the constriction opening. The forming means can form the constriction member or belt into a loop having at least one predetermined size.
[0061] 6b) The elongate constriction member is operable to vary the size of the constriction opening and thus vary or not vary the peripheral limiting surface of the constriction device.
[0062] 6c) The elongate constriction member is resilient and has a variable thickness when viewed in cross section, operable to fold back on itself over the longitudinal extension of the constriction member.
[0063] 6d) The elongate constriction member comprises two generally or partially semicircular frame members having contact surfaces and hinged to one another so that the semicircular members can swing relative to one another from a fully open state in which they form a generally or partially circle to a fully folded state in which they form a generally semicircle.
[0064] 7) The constriction device is configured to curve and constrict the wall of the organ.
[0065] In the above embodiments (1) to (7), it is important that the constriction device is configured to constrict the tissue wall of the patient's organ along the length. To this end, the constriction device may include two or more of the aforementioned constriction elements attached in a row along the length of the wall, the row extending in the direction of flow within the fallopian tube of the organ. Preferably, such constriction elements are non-expandable and mechanically operable or adjustable.
[0066] In the above embodiments (1) to (7), the operating device can mechanically or hydraulically adjust the constriction device of the constriction / stimulation unit. Additionally, the operating device may include an electric operating device that operates the constriction device. In many applications of the present invention, the operating device preferably operates the constriction device so that the inflow region of the fallopian tube is sized to create a constriction that allows the stimulation device to contact the wall, thereby stopping flow through the fallopian tube.
[0067] Mechanical Operation The operating device may be non-expandable if it mechanically operates the constriction device of the constriction / stimulation unit. Furthermore, the operating device may include a servo system, which may include a gearbox. The term "servo system" encompasses the conventional definition of a servomechanism, i.e., an automatic device that controls a very large force with a very small force, but may alternatively or additionally encompass the definition of a mechanism that converts a weak force acting on a moving member having a long stroke into a strong force acting on another moving member having a short stroke. Preferably, the operating device operates the constriction device non-magnetically and / or non-manually. A motor may be operably coupled to the operating device. The operating device may be operable to perform at least one reversible function, and the motor may be capable of reversing this function.
[0068] Hydraulic Operation When the operating device hydraulically operates the constriction device of the constriction / stimulation unit, the operating device comprises hydraulic means for adjusting the constriction device.
[0069] In one embodiment of the invention, the hydraulic means comprises a reservoir and an inflatable / contractable cavity in the constriction device, in which case the operating device distributes hydraulic fluid from the reservoir to expand the cavity and distributes hydraulic fluid from the cavity to the reservoir to contract the cavity. The cavity may be formed by a balloon of the constriction device abutting a tissue wall of the patient's organ, so that the patient's wall constricts upon cavity expansion and is released upon cavity contraction.
[0070] Alternatively, the cavity can be formed by a relatively large constriction member of the constriction device, such as a bellows member that displaces a large balloon against the wall, so that the patient's wall constricts upon contraction of the bellows member and releases upon expansion of the bellows member. Thus, the addition of a relatively small amount of hydraulic fluid to the bellows member significantly increases the constriction of the wall. Such a bellows member could also be replaced by a suitably configured piston / cylinder mechanism.
[0071] When the hydraulic means comprises a cavity in the constriction device, the system of the invention can be configured according to the options listed below.
[0072] 1) The reservoir comprises first and second walls, and the operating device displaces the first and second walls relative to each other to change the volume of the reservoir, thus dispersing fluid from the reservoir to the cavity or from the cavity to the reservoir.
[0073] 1a) The first and second walls of the reservoir are displaceable relative to one another by at least one of a magnetic device, a hydraulic device, and an electrical control device.
[0074] 2) The operating device includes a pump that pumps fluid between the reservoir and the cavity.
[0075] 2a) The pump comprises a first actuating member that actuates the pump to move fluid from the reservoir to the cavity, and a second actuating member that actuates the pump to move fluid from the cavity to the reservoir.
[0076] 2a1) The first and second actuation members are manually operable.
[0077] 2a2) At least one of the actuating members operates when subjected to a predetermined external pressure.
[0078] 2a3) At least one of the first and second actuating members is operable by magnetic means, hydraulic means, or electrical control means.
[0079] 2b) The system includes a fluid conduit between the pump and the cavity, where the reservoir forms part of the conduit. The conduit and the pump are free of check valves. The reservoir forms a fluid chamber having a variable volume, where reducing the volume of the chamber distributes fluid from the chamber to the cavity and increasing the volume of the chamber draws fluid from the cavity. The system further includes a motor driving the pump, where the pump includes a movable wall of the reservoir that changes the volume of the chamber.
[0080] In all of the above embodiments 1-2b, in which the hydraulic means comprises an inflatable cavity in the constriction device, the cavity may be replaced with a cylinder / piston mechanism for adjusting the constriction device, in which case the operating device distributes hydraulic fluid between the reservoir and the cylinder / piston mechanism to adjust the constriction device.
[0081] In a special embodiment of the invention, the operating device comprises a reversing servo operatively connected to the hydraulic means. The term "reversing servo" should be understood as a mechanism that converts a strong force acting on a moving member with a short stroke into a weak force acting on another moving member with a long stroke, i.e., the reverse function of a normal servo mechanism. Thus, a small change in the amount of fluid in a smaller reservoir is converted by the reversing servo into a large change in the amount of fluid in a larger reservoir. The reversing servo is particularly suitable for its manual operation.
[0082] Preferably, the reversing servo comprises an expandable servo reservoir containing a servo fluid, and a fluid supply reservoir hydraulically coupled to the servo reservoir to form a sealed conduit system for the servo fluid, the expandable servo reservoir having first and second walls displaceable relative to one another in response to a change in volume of the expandable servo reservoir.
[0083] According to a first alternative embodiment, the first and second walls of the servo reservoir are operably coupled to hydraulic means, and an inverting servo operates the hydraulic means to distribute fluid between the fluid supply reservoir and the inflatable servo reservoir to vary the volume of the servo reservoir and thereby adjust the constriction device.
[0084] According to a second alternative embodiment, an implantable main reservoir containing a predetermined volume of hydraulic fluid is provided, and a reversing servo is operable to distribute hydraulic fluid between the main reservoir and the hydraulic means to adjust the constriction device. Specifically, the main reservoir includes first and second walls operatively connected to the first and second walls of the inflatable servo reservoir, such that a change in the volume of the inflatable servo reservoir changes the volume of the main reservoir. Thus, when the reversing servo distributes servo fluid between the fluid supply reservoir and the inflatable servo reservoir to change the volume of the main reservoir, hydraulic fluid is distributed from the main reservoir to the hydraulic means or from the hydraulic means to the main reservoir. Advantageously, the servo reservoir and the main reservoir are sized such that a change in the volume of the servo reservoir by a relatively small amount of servo fluid changes the volume of the main reservoir by a relatively large amount of hydraulic fluid.
[0085] In either of the alternative embodiments described above, the fluid supply reservoir may have first and second walls that are displaceable relative to one another to change the volume of the fluid supply reservoir and distribute the servo fluid between the fluid supply reservoir and the inflatable servo reservoir. The first and second walls of the fluid supply reservoir may be displaceable relative to one another by manual operation, a magnetic device, a hydraulic device, or an electrical control device to change the volume of the fluid supply reservoir and distribute the servo fluid between the fluid supply reservoir and the inflatable servo reservoir.
[0086] In all of the above embodiments 1-2b in which the hydraulic means comprises an inflatable cavity in the constriction device, or in embodiments in which the hydraulic means comprises a hydraulically operable mechanical configuration, the operating device may include the above-mentioned reversing servo. In another embodiment of the invention, the hydraulic means comprises first and second inflatable / contractable reservoirs hydraulically interconnected. The first reservoir is operably connected to a constriction device, which therefore changes the constriction of the patient's wall when the first reservoir is inflated or deflated. Changing the volume of the second reservoir distributes hydraulic fluid between the two reservoirs, thus expanding or contracting the first reservoir. In this embodiment, no check valve is required in the fluid communication conduit between the two reservoirs, which is advantageous for long-term operation of the hydraulic means.
[0087] Alternatively, the hydraulic means may include hydraulically interconnected piston / cylinder mechanisms rather than the first and second reservoirs described above. The first piston / cylinder mechanism is operably connected to the deflation device, which therefore varies the constriction of the patient's wall upon operation of the first piston / cylinder mechanism. By operating the second piston / cylinder mechanism, hydraulic fluid is distributed between the two piston / cylinder mechanisms, which therefore adjust the deflation device.
[0088] If the constriction device does not include an inflatable / contractable cavity, the constriction device may include at least two elongated clamping members having the above-described contact surfaces and extending along the wall on different sides of the organ. The hydraulic means may include the above-described reversing servo to hydraulically move the elongated clamping members toward the wall to constrict the wall. For example, the constriction device may include a hydraulic chamber within which the clamping members slide back and forth, and the hydraulic means may also include a pump and an implantable reservoir containing hydraulic fluid. The pump distributes hydraulic fluid from the reservoir to the chamber to move the clamping members into contact with the wall and distributes hydraulic fluid from the reservoir to the chamber to move the clamping members away from the wall.
[0089] Regardless of which type or combination of types of restriction device is preferred, the restriction device may be configured with multiple restriction regions to change the restriction region over time, thereby preventing damage to the fallopian tubes and ensuring that the fallopian tubes remain closed, preventing an egg from traveling to the uterus and therefore preventing pregnancy.
[0090] In one embodiment, the system includes a hydraulic restriction device having two or more restriction areas individually connected to two or more reservoirs containing hydraulic fluid, the reservoirs configured to be adjusted to individually move fluid from the reservoirs to each of the associated restriction areas. Alternatively, it is possible to use only one reservoir if a valve regulates which restriction the hydraulic fluid acts on.
[0091] Each hydraulic restriction zone is configured to be restricted for a predetermined period of time, preferably with some overlap, and configured to restrict the zone closest to the ovary first, followed by a change of zone toward the uterus. In this way, restriction is maintained at all times, but does not allow eggs to pass as the restriction zone is changed, not only because the restrictions overlap, but also because the restriction begins closest to the ovary where the egg is released.
[0092] The hydraulic restriction area may be configured to be adjusted by manually manipulating it.
[0093] The system may also be configured such that, when the restriction area is altered, a peristaltic wave-like restriction wave is generated in the direction towards the ovary to prevent the egg from being delivered to the uterus. This peristaltic wave may be generated by any of the various types of restriction devices described above or a combination thereof.
[0094] The restriction device can also be configured to deliver at least one egg to the uterus upon release of the ovary, using a peristaltic wave-like restriction wave in a direction opposite to that towards the uterus.
[0095] A system for preventing pregnancy may be configured to restrict a first portion or region of a patient's fallopian tube to establish a restriction, allowing at least one egg released from an ovary to accumulate in the fallopian tube for a predetermined period of time, and to restrict a second portion of the fallopian tube and then release the restriction on the first portion and later release the restriction on the second portion, thereby allowing the egg to pass to the uterus; or to further restrict a third portion of the fallopian tube and release the restriction on the second portion and then release the restriction on the third portion, thereby allowing the egg to pass to the uterus; or to restrict a fourth portion of the fallopian tube and release the restriction on the third portion. Finally, the system may be further configured to release the restriction on the fourth portion, thereby allowing the egg to pass to the uterus.
[0096] The number of restriction regions is not limited except by practical size considerations, and preferably the restriction period is divided between the restriction regions. The restriction regions are moved in stages from the ovaries further towards the uterus, thus avoiding interference with accumulated eggs involved in the restriction regions when overlapping in time between successive restriction regions in use, or the restriction regions are moved both upstream and downstream, and then a moving device is preferably used to move the eggs in the oviducts to avoid squeezing the eggs in the restriction regions.
[0097] Preferably, a hydraulic restriction device that only partially restricts the fallopian tube is used in combination with a stimulation device to complete the occlusion of the fallopian tube, where the stimulation device can move the restricted area. The hydraulic device can, for example, have a movement function that causes the required movement.
[0098] Any combination is possible.
[0099] In short, it is preferable to use more than two restriction areas and change the restriction areas while at least one restriction area is closed when the device is in restricted mode.
[0100] When the device is configured to restrict a first portion of the fallopian tube closest to the ovary, it causes a second restriction to be restricted without interfering with the stored eggs.
[0101] A system configured to sequentially restrict each restriction area, starting with the restriction area closest to the ovary, i.e., a portion of the fallopian tube, and then restricting new areas progressively closer to the uterus, and further configured to overlap the time at which multiple restriction areas are restricted, will perform the restriction without interfering with stored eggs.
[0102] A method for preventing pregnancy in a female mammal or a female human patient includes: post-operatively restricting the patient's fallopian tube to create a restriction and allowing at least one egg released from the ovary to accumulate in the fallopian tube for a predetermined period of time; The step of removing the restriction and allowing the eggs in the fallopian tubes to travel to the uterus, and controlling the restriction and release procedures from outside the patient's body.
[0103] In this and other methods, the predetermined period is designed to avoid pregnancy and may be between 2 and 30 days or may be longer than 30 days.
[0104] A method for placing and controlling two implanted restriction devices that prevent pregnancy in a human or mammalian patient is provided. Inserting a needle or tube-like surgical tool into the abdominal part of the patient's body; filling the abdomen with gas using a needle or tube-like surgical tool, thereby inflating the abdominal cavity; placing at least two laparoscopic trocars within the patient; inserting a camera into the abdomen through one of the trocars; inserting at least one cutting instrument through the trocar and cutting at least a portion of the area of two fallopian tubes of the patient; placing two implanted restriction devices into each of the two fallopian tubes; adjusting the restrictive device after surgery to a time favorable for not becoming pregnant; controlling the adjustment from outside the patient's body; and restricting the two fallopian tubes after surgery to prevent pregnancy.
[0105] Both of the above methods restrict the fallopian tubes. restricting a first portion of a region of the patient's fallopian tube to form a restriction and allowing at least one egg released from the ovary to accumulate in the fallopian tube for a predetermined period of time; restricting a second portion of the fallopian tube; Releasing the restriction on the first portion; and allowing shorter tubal restriction cycles in each restriction region.
[0106] This method is removing the restriction on the second portion; and transmitting the eggs to the uterus.
[0107] This method is restricting a third portion of the fallopian tube; removing the restriction on the second portion; and allowing shorter tubal restriction cycles in each restriction region.
[0108] This method is removing the restriction on the third portion; and transmitting the eggs to the uterus.
[0109] This method is restricting a fourth portion of the fallopian tube; removing the restriction on the third portion; and allowing shorter tubal restriction cycles in each restriction region.
[0110] This method is removing the restriction on the fourth portion; and transmitting the eggs to the uterus.
[0111] In both of these methods, the restricted first part of the fallopian tube is usually located closer to the ovary, thereby The second limit can be limited without interfering with the stored eggs.
[0112] Typically, these methods More than two restricted areas are established, When it is desired to restrict, the restricted area is changed, while At least one restricted area remains closed.
[0113] In a preferred embodiment, each restriction region is contiguous with the restriction region of the portion of the fallopian tube closest to the ovary; The new area is restricted so that it approaches the uterus step by step. The restrictions of the multiple restriction areas are overlapped in time, thereby The restriction is achieved without interfering with the egg reserves.
[0114] One method may involve simply restricting the fallopian tubes at all times, while altering the restriction area post-operatively, regardless of the order, to allow the tubes to heal or avoid damage from the restriction.
[0115] Other methods of preventing pregnancy in female patients include: preventing eggs in the fallopian tubes of a human or mammalian patient from being delivered to the uterus; storing at least one egg released from an ovary in a fallopian tube for a predetermined period of time; generating a peristaltic restrictive wave movement of a portion of the fallopian tube wall to prevent the egg from being delivered to the uterus while keeping the fallopian tube constantly restricted; Preventing sperm from reaching the eggs while the eggs are being accumulated; and releasing the regulated eggs from outside the human body after surgery and allowing at least one egg in the fallopian tube to travel to the uterus.
[0116] A method for deploying the above-described device and controlling the implanted device to prevent pregnancy in a human or mammalian patient comprises: Inserting a needle or tube-like surgical tool into the abdominal part of the patient's body; filling the abdomen with gas using a needle or tube-like surgical tool, thereby inflating the abdominal cavity; placing at least two laparoscopic trocars within the patient; inserting a camera into the abdomen through one of the trocars; inserting at least one cutting instrument through the trocar and cutting at least a portion of the area of two fallopian tubes of the patient; placing each of the two portions of the implanted device into each of the two fallopian tubes; Finishing the surgery and withdrawing the surgical tools after final suturing postoperatively; adjusting the device post-operatively at a time appropriate to avoid pregnancy; controlling the adjustment from outside the patient's body; Preventing the flow of eggs in the two fallopian tubes from reaching the uterus for a predetermined period of time by the above steps, thereby avoiding pregnancy; The above steps are performed to accumulate the eggs released from the ovaries in the fallopian tubes, and the steps of causing a peristaltic wave motion in a part of the fallopian tube wall to prevent the eggs from being sent to the uterus and to keep the fallopian tubes always restricted. preventing sperm from reaching the eggs while the eggs are being stored; and releasing the eggs from the fallopian tubes when the risk of conception is low, allowing the eggs to travel normally to the uterus.
[0117] Restriction Embodiments The restriction device may comprise a mechanical restriction device, or a hydraulic restriction device, or a stimulation device, or a combination of a stimulation device and a mechanical or hydraulic restriction device, or any other combination.
[0118] The method includes providing a reservoir and transferring gas or fluid to or from the restriction device, the reservoir comprising: i. The patient can reach ii. It may include a hydraulic restriction device that is placed subcutaneously so that fluid can be manually moved to and from the restriction device.
[0119] Movement Device The movement device is configured to move the eggs from the changed, newly restricted area before the new area is restricted, and is useful when the restriction needs to be maintained for a long period of time, and therefore the restricted area also needs to be moved in the direction towards the ovary, in which case the eggs may be squeezed by one restricted area and slip if later released.
[0120] The movement device may be the same device as the restriction device, configured to operate differently in restricting movement of the egg or in moving the egg, or may be a different device than the restriction device, configured to operate differently in restricting movement of the egg or in moving the egg.
[0121] The migration device can create a vibration or wave-like motion in the wall of the fallopian tube, thereby migrating the egg.
[0122] Thus, another method of preventing pregnancy in a female human patient or a female mammalian patient, comprising: restricting a first portion of a region of the patient's fallopian tube to form a restriction and allowing at least one egg released from the ovary to accumulate in the fallopian tube for a predetermined period of time; transferring the stored eggs from the restricted area within the fallopian tube toward the ovary with the transfer device; restricting a second portion of the fallopian tube closer to the ovary without interfering with the stored eggs; removing the restriction on the first portion; repeating the first portion of the constraints; removing the restriction on the second portion; and restoring the fallopian tube between the restriction intervals.
[0123] After these steps, moving the stored eggs through the fallopian tube from the first restricted region toward the ovary with the movement device; repeating the step of restricting a second portion of the fallopian tube closer to the ovary without interfering with the stored eggs; further repeating the step of removing the restriction on the first portion; Preferably, the complete procedure is repeated, with the step of allowing the fallopian tube to recover between the restriction intervals.
[0124] Preferably, the restriction region is configured to vary between three or more regions while keeping the fallopian tubes closed at all times.
[0125] The moving device may comprise a vibration device that vibrates at least a portion of the wall of the fallopian tube to move the accumulated eggs, and the moving is repeated.
[0126] The movement device may comprise a mechanical device, or a hydraulic device, or a stimulation device, or a hybrid device.
[0127] Control Device Configuration The control device preferably controls the constriction and / or stimulation unit from outside the patient's body. The control device is preferably operable by the patient. For example, the control device may comprise a manual switch for turning the constriction / stimulation unit on and off, where the switch is configured to be subcutaneously implanted in the patient and operated manually or magnetically from outside the patient's body. Alternatively, the control device may conveniently comprise a handheld wireless remote control operable by the patient to turn the constriction / stimulation unit on and off. The wireless remote control may also be configured to be attached to the patient's body like a wristwatch. Such a wristwatch-style remote control may emit control signals that cause the patient's body to comply with the system's implanted signal-responsive means.
[0128] When the control device wirelessly controls the constriction / stimulation unit from outside the patient's body, the wireless control function is preferably performed non-magnetically, i.e., the control device non-magnetically controls the constriction device of the constriction / stimulation unit. The patient uses the remote control to control the constriction / stimulation unit to adjust stimulation intensity and / or adjust wall constriction. The wireless remote control may include at least one external signal transmitter or transceiver and at least one internal signal receiver or transceiver implantable in the patient.
[0129] The wireless remote control preferably transmits at least one wireless control signal to control the constriction / stimulation unit. The control signal may include a frequency-modulated signal, an amplitude-modulated signal, a phase-modulated signal, or a combination thereof, and may be an analog signal, a digital signal, or a combination of analog and digital signals. The remote control may transmit an electromagnetic carrier signal carrying the digital or analog control signal. Furthermore, the carrier signal may be a digital signal, an analog signal, or a combination of digital and analog signals.
[0130] Any of the above control signals may include wave signals, such as sound wave signals, ultrasound signals, electromagnetic wave signals, infrared light signals, visible light signals, ultraviolet light signals, laser light signals, microwave signals, radio frequency signals, x-ray radiation signals, or gamma radiation signals. Alternatively, the control signals may include electric fields, or magnetic fields, or a combination of electric and magnetic fields.
[0131] As mentioned above, the control signal can cause the patient's body to comply with the system's implanted signal-responsive means.
[0132] The control device may be implantable in a patient and may include a programmable internal control unit, such as a microprocessor, that controls the constriction / stimulation unit. The control device may further include an external control unit located outside the patient's body, in which case the internal control unit is programmable by the external control unit. For example, the internal control unit may be programmable to control the constriction / stimulation unit over time, preferably according to an activity schedule program. The system of the present invention may include an external data communicator and an implantable internal data communicator that communicates with the external data communicator, in which case the internal data communicator feeds back data regarding the constriction / stimulation unit to the external data communicator, or the external data communicator sends data to the internal data communicator.
[0133] Energy Source The present invention also provides a solution for providing energy for use in connection with operation of the constriction / stimulation unit. Thus, broadly speaking, the present invention provides a system for controlling the flow of eggs through a fallopian tube formed by a tissue wall of a patient's organ, comprising an implantable constriction device for gently constricting a portion of the tissue wall to affect flow within the fallopian tube, a stimulation device for intermittently and individually stimulating various regions of the wall as the constriction device constricts the wall, causing the wall to contract and further affect flow within the fallopian tube, forming a constriction / stimulation unit operable with the constriction device, an energy source, and a control device operable from outside the patient's body to operate the energy source to release energy for use in connection with operation of the constriction / stimulation unit. In a simple form of the invention, the energy source, such as a battery or accumulator, is implantable within the patient's body.
[0134] Wireless Energy Transmission In a preferred, more advanced form of the invention, the energy source is located outside the patient's body, and the control device controls the external energy source to emit wireless energy. In this advanced form of the invention, the system includes an energy transmission device that transmits the emitted wireless energy from outside the patient's body into the patient's body. In particular, the wireless energy may include electromagnetic energy, an electric field, an electromagnetic field, or a magnetic field, or a combination thereof, or an electromagnetic wave. The energy transmission device can transmit wireless energy that is directly used in connection with the operation of the constriction / stimulation unit when the wireless energy is transmitted. For example, if an electric motor or pump operates the constriction device, the wireless energy in the form of a magnetic field or electromagnetic field can be used to directly drive the motor or pump.
[0135] Thus, the motor or pump operates directly while the wireless energy is being transmitted. This can be achieved in two ways: a) by using a conversion device implanted in the patient to convert the wireless energy into a different form of energy, preferably electrical energy, and then using the converted energy to drive the motor or pump; or b) by using the wirelessly transmitted energy to directly drive the motor or pump. Preferably, the wireless energy in the form of an electromagnetic or magnetic field is used to directly affect specific components of the motor or pump, generating kinetic energy to drive the motor or pump. Such components may include coils integrated with the motor or pump, or materials that are affected by magnetic fields, or permanent magnets. In this case, the magnetic or electromagnetic field affects the coils to generate current that drives the motor or pump, or the material or permanent magnet to generate kinetic energy that drives the motor or pump.
[0136] The energy-transmission device preferably transmits energy by at least one wireless signal, preferably a wave signal. The wave signal may include an electromagnetic wave signal, including any of an infrared signal, a visible light signal, an ultraviolet signal, a laser signal, a microwave signal, a radio signal, an X-ray radiation signal, and a gamma radiation signal. Alternatively, the wave signal may include an audio signal or an ultrasonic signal. The wireless signal may be a digital signal, an analog signal, or a combination of a digital signal and an analog signal.
[0137] Wireless Energy Conversion According to certain embodiments of the present invention, an implantable energy-transforming device is provided that converts a first form of wireless energy transmitted by an energy-transmission device into a second form of energy, typically different from the first form of energy. The constriction / stimulation unit is operable in response to the second form of energy. For example, the first form of wireless energy may include sound waves, while the second form of energy may include electrical energy. In this case, the energy-transforming device may include a piezoelectric element that converts sound waves into electrical energy. Optionally, one of the first form of energy and the second form of energy may include magnetic energy, kinetic energy, sound energy, chemical energy, radiant energy, electromagnetic energy, light energy, nuclear energy, or thermal energy. Preferably, one of the first form of energy and the second form of energy is non-magnetic, non-kinetic, non-chemical, non-sound energy, non-nuclear energy, or non-thermal energy.
[0138] The energy-transforming device can function differently or similarly to the energy-transmission device. In a particular embodiment, the energy-transforming device comprises at least one element, such as at least one semiconductor, having a positive region and a negative region when exposed to the first form of energy transmitted by the energy-transmission device, where the element can form an energy field between the positive and negative regions, and the energy field generates the second form of energy. More specifically, the element can comprise an electrical junction element, which can induce an electric field between the positive and negative regions when exposed to the first form of energy transmitted by the energy-transmission device, whereby the second form of energy comprises electrical energy.
[0139] The energy-transforming device can directly or indirectly convert the energy of the first form into the energy of the second form. An implantable motor or pump can be provided to operate the constriction device of the constriction / stimulation unit, where the motor or pump is driven by the energy of the second form. The constriction device can be operable to perform at least one reversible function, and the motor can be capable of reversing its function. For example, the control device can shift the polarity of the energy of the second form to reverse the motor.
[0140] The energy-transforming device can directly drive a motor or pump with the energy converted when the second form of energy is converted from the first form of energy. Preferably, the energy-transforming device directly operates the constriction / stimulation unit with the second form of energy in a non-magnetic, non-thermal, or non-mechanical manner.
[0141] Typically, the constriction / stimulation unit comprises an electrical component energized by electrical energy. Other implantable electrical components of the system may be at least one voltage level guard or at least one constant current guard. Thus, the energy-transforming device can transform the first form of energy into direct current, or pulsating direct current, or a combination of direct current and pulsating direct current.
[0142] Alternatively, the energy-transforming device may transform the energy in the first form into alternating current or a combination of direct and alternating current.
[0143] The system of the present invention may be implantable in a patient and may include an internal energy source that provides energy to operate the constriction / stimulation unit. The system may further include an implantable switch operable to switch from an "off" mode, in which the internal energy source is not used, to an "on" mode, in which the internal energy source provides energy to operate the constriction / stimulation unit and / or energize implanted electronic components of the system. The switch may be operable with a first form of energy transmitted by the energy-transmission device or a second form of energy supplied from the energy-transmission device. The above-described switch configuration reduces power consumption of the system between operations.
[0144] The internal energy source can store the second form of energy provided by the energy-transforming device. In this case, the internal energy source preferably comprises an accumulator, such as at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery. If the internal energy source is a rechargeable battery, it can be charged only at the patient's convenience, for example, while the patient is sleeping. Alternatively, the internal energy source can provide energy to operate the constriction / stimulation unit, but is not used to store the second form of energy. In this alternative embodiment, the internal energy source can be a battery, with or without the switch described above.
[0145] Preferably, the system of the present invention comprises an implantable stabilizer for stabilizing the energy in the second form. When the energy in the second form is electrical energy, the stabilizer preferably comprises at least one capacitor.
[0146] The energy-transforming device may be configured to be implanted subcutaneously in the abdominal, thoracic or head region of the patient, or alternatively, the energy-transforming device may be configured to be implanted in an orifice of the patient, beneath the mucosa or intramuscularly outside the mucosa of the orifice.
[0147] It should be noted that while the constriction / stimulation unit in the above-described embodiments is configured as a single member, which is more practical for implantation, in alternative embodiments the constriction device and stimulation device can be configured as separate members. Any of the above-described constriction and stimulation units can be replaced with two or more separate constriction / stimulation members that are controlled independently of each other.
[0148] When the system is used to control the flow of eggs into a woman's uterus, the system comprises an implantable constriction device that constricts each of the woman's uterine canals to restrict their passage, and a control device that controls the constriction device to restrict the uterine canals, thereby preventing eggs that appear in the uterine canal passage from entering the uterine cavity, and to open the uterine canals, thereby allowing eggs present in the uterine canal passage to enter the uterine cavity. The constriction device can gently constrict at least a portion of the tissue wall of the uterine canal to restrict its passage, and can be provided with an implantable stimulation device that stimulates the tissue wall, wherein the control device controls the stimulation device to stimulate the tissue wall, and the constriction device constricts the tissue wall, causing it to contract and further restrict the passage of the uterine canal.
[0149] Alternatively, the egg flow control system includes an implantable constriction device that gently constricts at least a portion of the tissue wall of each of the female's uterine canals to restrict their passage; a stimulation device that stimulates the tissue wall of the uterine canal; and a control device that controls the stimulation device so that as the constriction device constricts the tissue wall, it stimulates the tissue wall, causing the tissue wall to contract and further restrict the passage of the uterine canal, preventing eggs present in the uterine canal from entering the uterine cavity.
[0150] Alternatively, the egg flow control system comprises an implantable stimulation device that stimulates a portion of the tissue wall of each of the female's uterine canals, and a control device that controls the stimulation device to stimulate the tissue wall of the uterine canal to cause the tissue wall to contract, thus restricting the passage of the uterine canal to prevent eggs present in the uterine canal from entering the uterine cavity, and to stop stimulation of the tissue wall of the uterine canal to allow eggs present in the passage of the uterine canal to enter the uterine cavity.
[0151] The present invention provides a method for controlling the flow of eggs in a fallopian tube formed by the tissue walls of a patient's organs using the system described above, comprising: providing a wireless remote control configured to control the constriction device and / or the stimulation device from outside the patient's body; and operating the wireless remote control by the patient when the patient desires to affect the flow of eggs in the fallopian tubes.
[0152] The present invention provides a method for controlling the flow of eggs within a fallopian tube formed by a tissue wall of an organ of a patient, comprising: Also provided is a method that includes: a) gently constricting at least a portion of the tissue wall to affect flow within the fallopian tube; and b) stimulating the constricted wall to cause the wall to contract and further affect flow within the fallopian tube. [Brief explanation of the drawings]
[0153] [Figure 1A] FIG. 1 illustrates a system according to the present invention mounted on the fallopian tubes of a female patient, with the restriction device in a non-restrictive operating state. [Figure 1B] 1B is a view similar to FIG. 1A, but showing the restriction device in a restricting operating state. [Figure 2A] FIG. 1 illustrates a system according to the present invention having a remote control mounted on the fallopian tube of a female patient, with the restriction device in a non-restrictive operating state. [Figure 2B] 2B is a view similar to FIG. 2A, but with the restriction device in a restricting operating state. [Figure 3A]FIG. 1C is a schematic diagram of a hydraulic operating means having a subcutaneously placed reservoir suitable for operating the restriction device of the embodiment of FIGS. 1A and 1B. [Figure 3B] 3B illustrates the embodiment of FIG. 3A in which the constriction device constricts the tissue wall of the patient's fallopian tube. [Figure 4A] FIG. 12 is a schematic diagram of a mechanical operating means suitable for operating the constriction device of the embodiment of FIGS. [Figure 4B] 4B illustrates the embodiment of FIG. 4A with a constriction device for constricting a tissue wall of a patient's organ. [Figure 4C] FIG. 4C shows a variation of the embodiment of FIG. 4B. [Figure 5A] 3A-3C are cross-sectional views of the embodiment of FIG. 2 illustrating different operating states of the system attached to the tissue wall of a patient's organ. [Figure 5B] 3A-3C are cross-sectional views of the embodiment of FIG. 2 illustrating different operating states of the system attached to the tissue wall of a patient's organ. [Figure 5C] 3A-3C are cross-sectional views of the embodiment of FIG. 2 illustrating different operating states of the system attached to the tissue wall of a patient's organ. [Figure 6A] 3A-3C are cross-sectional views of a variation of the embodiment of FIG. 2 illustrating different states of operation of the system attached to the tissue wall of a patient's organ. [Figure 6B] 3A-3C are cross-sectional views of a variation of the embodiment of FIG. 2 illustrating different states of operation of the system attached to the tissue wall of a patient's organ. [Figure 6C] 3A-3C are cross-sectional views of a variation of the embodiment of FIG. 2 illustrating different states of operation of the system attached to the tissue wall of a patient's organ. [Figure 7A] 1A-1D show schematic diagrams of different operating states of a general embodiment of a system according to the invention; [Figure 7B] 1A-1D show schematic diagrams of different operating states of a general embodiment of a system according to the invention; [Figure 7C]1A-1D show schematic diagrams of different operating states of a general embodiment of a system according to the invention; [Figure 7D] 1A-1D show schematic diagrams of different operating states of a general embodiment of a system according to the invention; [Figure 7E] 1A-1D show schematic diagrams of different operating states of a general embodiment of a system according to the invention; [Figure 7F] 10A-10C illustrate different operating states of variants of the general embodiment. [Figure 7G] 10A-10C illustrate different operating states of variants of the general embodiment. [Figure 7H] 10A-10C illustrate different operating states of variants of the general embodiment. [Figure 7I] 10A and 10B illustrate other modes of operation of variants of the general embodiment. [Figure 7K] 10A and 10B illustrate other modes of operation of variants of the general embodiment. [Figure 7L] 10A and 10B illustrate other modes of operation of variants of the general embodiment. [Figure 8A] FIG. 2 is a pulse / time diagram illustrating electrical stimulation pulses generated by the system of the present invention to stimulate the tissue wall of a patient's organ. [Figure 8B] FIG. 8B is a pulse / time diagram illustrating a variation of the electrical stimulation shown in FIG. 8A in which pulses of mixed frequencies and / or amplitudes are used. [Figure 8C] 1A-1C are two pulse / time diagrams respectively illustrating electrical stimulation of two different regions of a tissue wall with pulses forming a pulse train. [Figure 8D] 1A-1C are two pulse / time diagrams respectively illustrating electrical stimulation of two different regions of a tissue wall with pulses forming a pulse train. [Figure 9A] FIG. 1 is a longitudinal cross-sectional view of one embodiment of a system of the present invention that includes a thermal stimulation device, where the system constricts the tissue wall of a patient's fallopian tube. [Figure 9B] FIG. 9B is a view of the same embodiment as FIG. 9A with the thermal stimulation device activated. [Figure 10A] 1 is a schematic diagram of a hydraulically operable, inflatable constriction device used in accordance with the present invention; [Figure 10B] FIG. 10B is a view of the same embodiment as shown in FIG. 10A with the constriction device inflated. [Figure 11A] 10B is a block diagram illustrating four different principles of hydraulic operation of the constriction device shown in FIG. 10A. [Figure 11B] 10B is a block diagram illustrating four different principles of hydraulic operation of the constriction device shown in FIG. 10A. [Figure 11C] 10B is a block diagram illustrating four different principles of hydraulic operation of the constriction device shown in FIG. 10A. [Figure 11D] 10B is a block diagram illustrating four different principles of hydraulic operation of the constriction device shown in FIG. 10A. [Figure 12] A cross-sectional view of a reservoir with a variable volume controlled by a remote control motor. [Figure 13A] 11D is a perspective view of a reversing servo according to a specific embodiment of the hydraulic operating principle shown in FIG. 11C. [Figure 13B] 11D is a perspective view of a reversing servo according to a specific embodiment of the hydraulic operating principle shown in FIG. 11C. [Figure 14] 1 is a schematic diagram of another hydraulically operable constriction device for use in accordance with the present invention; [Figure 15A] FIG. 35 shows the constriction device of FIG. 34 in a constricted state. [Figure 15B] FIG. 15 shows the constriction device of FIG. 14 in a released state. [Figure 16] 1 is a schematic block diagram illustrating a general embodiment of the system of the present invention in which energy is transmitted to energy-consuming components of the system implanted in a patient. [Figure 17] 37A-37C are schematic block diagrams illustrating 12 embodiments in which wireless energy is transmitted from outside the patient's body to energy-consuming components of a system implanted in the patient, each embodiment based on the general embodiment shown in FIG. [Figure 18] 37A-37C are schematic block diagrams illustrating 12 embodiments in which wireless energy is transmitted from outside the patient's body to energy-consuming components of a system implanted in the patient, each embodiment based on the general embodiment shown in FIG. [Figure 19] 37A-37C are schematic block diagrams illustrating 12 embodiments in which wireless energy is transmitted from outside the patient's body to energy-consuming components of a system implanted in the patient, each embodiment based on the general embodiment shown in FIG. [Figure 20] 37A-37C are schematic block diagrams illustrating 12 embodiments in which wireless energy is transmitted from outside the patient's body to energy-consuming components of a system implanted in the patient, each embodiment based on the general embodiment shown in FIG. [Figure 21] 37A-37C are schematic block diagrams illustrating 12 embodiments in which wireless energy is transmitted from outside the patient's body to energy-consuming components of a system implanted in the patient, each embodiment based on the general embodiment shown in FIG. [Figure 22] 37A-37C are schematic block diagrams illustrating 12 embodiments in which wireless energy is transmitted from outside the patient's body to energy-consuming components of a system implanted in the patient, each embodiment based on the general embodiment shown in FIG. [Figure 23] 37A-37C are schematic block diagrams illustrating 12 embodiments in which wireless energy is transmitted from outside the patient's body to energy-consuming components of a system implanted in the patient, each embodiment based on the general embodiment shown in FIG. [Figure 24] 37A-37C are schematic block diagrams illustrating 12 embodiments in which wireless energy is transmitted from outside the patient's body to energy-consuming components of a system implanted in the patient, each embodiment based on the general embodiment shown in FIG. [Figure 25]37A-37C are schematic block diagrams illustrating 12 embodiments in which wireless energy is transmitted from outside the patient's body to energy-consuming components of a system implanted in the patient, each embodiment based on the general embodiment shown in FIG. [Figure 26] 37A-37C are schematic block diagrams illustrating 12 embodiments in which wireless energy is transmitted from outside the patient's body to energy-consuming components of a system implanted in the patient, each embodiment based on the general embodiment shown in FIG. [Figure 27] 37A-37C are schematic block diagrams illustrating 12 embodiments in which wireless energy is transmitted from outside the patient's body to energy-consuming components of a system implanted in the patient, each embodiment based on the general embodiment shown in FIG. [Figure 28] 37A-37C are schematic block diagrams illustrating 12 embodiments in which wireless energy is transmitted from outside the patient's body to energy-consuming components of a system implanted in the patient, each embodiment based on the general embodiment shown in FIG. [Figure 29] FIG. 2 is a block diagram illustrating the control components of one embodiment of the present invention. [Figure 30] FIG. 1 is a schematic diagram of an exemplary circuit of one embodiment of the present invention in which wireless energy is converted into electrical current. DETAILED DESCRIPTION OF THE INVENTION
[0154] In the drawings, like reference numerals designate identical or corresponding parts throughout the several views.
[0155] 1A and 1B illustrate a first embodiment of a system for treating a female patient to prevent pregnancy, mounted over the patient's fallopian tubes 31a, 31b. Clamping members 5, 6 of the restriction or constriction device 2 constrict the fallopian tubes 31a, 31b. (For clarity, the housing is not shown, and the clamping members 5, 6 are exaggerated.) In this embodiment, the control device includes a subcutaneously implanted push button that can be manually switched "on" and "off" by the patient. This control device is described in more detail below with reference to FIGS. 3A and 3B. Such a manually operable push button may also be provided in combination with a remote control as an emergency button, allowing the patient to disable operation of the system in the event of an emergency or malfunction. Such a remote control is described below with reference to FIGS. 2A and 2B. This system can also be fully manually controlled, for example, by manually manipulating a hydraulic reservoir controlling a hydraulic restriction device, such as that shown in any of Figures 3A-3D, 15A and 15B, 10A and 10B, or 11A-11D. Note that the restriction device can be adjusted using only the reservoir, which manually displaces fluid, as in Figures 3C and 3D. This reservoir can be controlled so that the change in reservoir volume stabilizes after manual manipulation of the reservoir occurs. While a looking device is shown in this particular example, numerous different methods can be used. A small amount of fluid in the reservoir can displace the restriction device described in some of the above embodiments over a larger range.
[0156] 2A and 2B show another embodiment mounted on the fallopian tubes 31a, 31b of a female patient. Clamping members 5, 6 of constriction device 2 constrict the fallopian tubes 31a, 31b. (For clarity, the housing is not shown, and the clamping members 5, 6 are exaggerated.) In this embodiment, the control device includes an external control unit in the form of a handheld wireless remote control 32 and an implanted internal control unit 33, which may include a microprocessor, that controls the constriction device and the stimulation device. Remote control 32 is operable by the patient to control internal control unit 33 to turn the restriction device on and off.
[0157] An internal control unit 33 controls an implanted operating device 34 to move the clamping members 5, 6. An implanted energy source 35, such as a rechargeable battery, drives the operating device 34. The internal control unit 33 can be implanted subcutaneously or abdominally and can also function as an energy receiver, i.e., converts wireless energy into electrical energy and charges the implanted energy source 35 (a rechargeable battery) with electrical energy.
[0158] The implanted sensor 36 senses a patient's physical parameter, such as temperature, and the internal control unit 33 controls the constriction device 2 and / or the stimulation device 3 in response to signals from the sensor 36. In this embodiment, the sensor 36 is a hormone level sensor, and the internal control unit 33 controls the constriction device and / or the stimulation device to change the constriction of the patient's fallopian tubes 31 in response to the sensor 36 sensing a predetermined value. For example, the control unit 33 can control the constriction device and / or the stimulation device to increase the constriction of the patient's fallopian tubes 31 in response to the sensor sensing an increase or decrease in hormone levels. Alternatively or in combination, the remote control 32, as well as the internal control unit 33, controls the constriction device and / or the stimulation device in response to signals from the sensor 36.
[0159] The remote control 32 may include means for generating an indication, such as an audio signal or displayed information, in response to a signal from the sensor 36. When the patient notices such an indication of tubal release based on said sensor input, the patient may use the remote control to control a constriction or stimulation device to pump an egg through the patient's fallopian tube.
[0160] 3A and 3B illustrate hydraulically actuated means suitable for operating the constriction device embodiment described above with reference to FIGS. 1A and 1B. Specifically, FIGS. 3A and 3B illustrate the system of FIGS. 1A and 1B equipped with such hydraulically actuated means for constriction device 2. Housing 1 thus defines two hydraulic chambers 22a and 22b within which two clamping members 5 and 6 are slidable back and forth against the tubular tissue wall 8 of a patient's fallopian tube. The hydraulically actuated means includes an inflatable reservoir 23, such as an elastic balloon, containing hydraulic fluid; conduits 24a and 24b between reservoir 23 and hydraulic chambers 22a and 22b; and a two-way pump 25 for pumping hydraulic fluid from conduits 24a and 24b. Reservoir 23 is positioned subcutaneously between the skin, shown in solid lines, and the fascia / muscle layer, typically shown in dashed lines. The control device 4 controls the pump 25 to direct hydraulic fluid from the reservoir 23 to the chambers 22a, 22b to move the clamping members 5, 6 into contact with the wall 8, thereby constricting the tubular wall 8, as can be seen in Figure 3B, and to direct hydraulic fluid from the chambers 22a, 22b to the reservoir 23 to move the clamping members 5, 6 away from the wall 8, thereby releasing the tubular wall 8, as can be seen in Figure 3A.
[0161] Alternatively, the embodiment of Figures 3A and 3B can be operated manually by applying suitable manually operable hydraulic means to distribute hydraulic fluid between the expandable reservoir 23 and the hydraulic chambers 22a, 22b. In this case, the pump 25 is omitted. Again, the control device 4 is merely a manual operation of the reservoir. An example is shown in Figures 3C and 3D. In this particular embodiment, a small looking of the reservoir wall (4b) is provided, but this is only one of many ways to realize this embodiment.
[0162] 4A and 4B schematically illustrate a mechanically operable embodiment of the present invention, comprising an open-ended tubular housing 26 mounted on a tubular tissue wall 8 of a patient's organ, a constriction device 27 disposed within the housing 26, and a control device 4 for controlling the constriction device 27. The stimulation device (not shown) described above is also provided within the housing 26. The constriction device 27 is movable radially within the tubular housing 26 toward and away from the tubular wall 8 between a retracted position, seen in FIG. 4A, and a clamped position, seen in FIG. 4B, in which the clamping member 28 gently constricts the tubular wall 8. The mechanical operating means for mechanically operating the clamping member 28 includes an electric motor 29 mounted on the housing 26 and a telescoping device 30 driven by the motor 29 and operably coupled to the clamping member 28. The control device 4 controls the electric motor 29 to expand the telescopic device 30 to move the clamping member 28 into contact with the wall 8, thereby constricting the tubular wall 8, as seen in FIG. 4B, and to retract the telescopic device 30 to move the clamping member 28 away from the wall 8, thereby releasing the wall 8, as seen in FIG. 4A.
[0163] Alternatively, as shown in FIG. 4C , the motor 29 can be omitted and the telescopic device 30 can be modified to be manually operable. Accordingly, a spring 30a can be provided to keep the telescopic device 30 expanded so as to press the clamping member 28 against the wall 8. The mechanical operation means can include a lever mechanism 29a implanted subcutaneously and operably connected to the telescopic device 30. The patient presses the lever mechanism 29a through the patient's skin 29b, as shown in phantom, to pull the telescopic device 30 against the action of the spring 30a to its retracted position. When the patient releases the lever mechanism 29a, the spring 30a expands the telescopic device 30, thereby pressing the clamping member 28 against the wall 8.
[0164] 5A-5C illustrate the principle of function of the system of FIG. 1 when the system is attached to a portion 8 of the tubular tissue wall of a patient's fallopian tube. Accordingly, FIG. 5A illustrates the system in an unclamped state, where the clamping members 5, 6 are in their retracted positions and the wall portion 8 extends through the open end of the housing 1 without being constricted by the clamping members 5, 6. FIG. 5B illustrates the system in a clamped state, where the clamping members 5, 6 have been moved from their retracted positions to their clamped positions, where the clamping members 5, 6 gently constrict the wall portion 8, resulting in a constriction that substantially unrestricts blood circulation within the constricted wall portion 8 and restricts flow within the fallopian tube. FIG. 5C illustrates the system in an optional stimulated state, where the clamping members 5, 6 constrict the wall portion 8 and the electrical member 7 of the stimulation device 3 electrically stimulates different regions of the wall portion 8, thereby causing the wall portion 8 to contract (thicken) and close the fallopian tube.
[0165] When the system is in any stimulation state, it is important to stimulate each different region of the wall 8 so that it substantially maintains its natural physical properties over time to prevent damage to the region. Therefore, the control device 4 controls the stimulation device 3 to intermittently stimulate each region of the wall 8 for successive periods, where each period is short enough to maintain sufficient blood circulation in each region over time. Furthermore, the control device 4 controls the stimulation of each region of the wall 8 so that each currently unstimulated region regains approximately normal blood circulation before being stimulated again. To maintain the effect of the stimulation over time, i.e., to keep the fallopian tubes closed by contracting the wall 8, the control device 4 controls the stimulation device 3 to stimulate one or more regions at a time and to transfer stimulation from one region to another over time. The control device 4 can control the stimulation device 3 to propagate stimulation of each region cyclically along the tubular wall 8, for example, according to a predetermined stimulation pattern. The control device may control the stimulation device to vary, preferably cyclically, the intensity of stimulation of the wall portion 8 in order to obtain a desired response of the tissue wall upon stimulation of the tissue wall.
[0166] It will be appreciated that the fully restricted state shown in Figure 5C can be achieved by purely mechanical means without electrical stimulation.
[0167] 6A-6C illustrate another embodiment of the present invention including a tubular housing 9 and three elongated clamping members 10a, 10b, and 10c that move radially within the tubular housing 9 toward and away from the central axis of the housing 9 between a retracted position, as seen in FIG. 6A, and a clamped position, as seen in FIG. 6B. The three clamping members 10a-10c are symmetrically arranged about the central axis of the housing 9. The stimulation device of this embodiment includes electrical members 11a, 11b, and 11c that form a series of groups extending along the longitudinally elongated clamping members 10a-10c, with the electrical members 11a-11c of each group forming a path of three electrical members 11a, 11b, and 11c that extends circumferentially around the central axis of the housing 9. Each group of three electrical members 11a-11c is located on one of the three clamping members 10a-10c. Thus, three electrical member paths 11a-11c extend around the patient's organ. Of course, the number of electrical members 11a-11c in each electrical member path may be greater than three, with several parallel rows of electrical members 11a-11c forming each electrical member path.
[0168] Figures 7A, 7B, and 7C schematically illustrate different operating states of a system of general configuration according to the present invention when the system is attached to the wall of a fallopian tube, designated BO. The system includes a constriction device and a stimulation device, designated CSD, and a control device, designated CD, for controlling the constriction device and stimulation device CSD. Figure 7A illustrates the system in an inactive state, in which the constriction device does not constrict the organ BO and the stimulation device does not stimulate the organ BO. Figure 7B illustrates the system in a constriction state, in which the control device CD controls the constriction device to gently constrict the wall of the organ BO, resulting in a constriction in which blood circulation within the constricted wall is substantially unrestricted and flow within the wall of the fallopian tube is restricted. Figure 7C illustrates the system in a stimulation state, in which the control device CD controls the stimulation device to stimulate different regions of the constricted wall, thus causing substantially the entire wall of the organ BO to contract (thicken) and close the fallopian tube.
[0169] Figures 7D and 7E show how stimulation of the constricted wall can be varied cyclically between a first stimulation mode in which the left region of the wall (see Figure 7D) is stimulated while the right region of the wall is not stimulated, and a second stimulation mode in which the right region of the wall (see Figure 7E) is stimulated while the left region of the wall is not stimulated, to maintain sufficient blood circulation within the constricted wall over time.
[0170] It should be noted that the stimulation modes shown in Figures 7D and 7E constitute only principle examples of how to stimulate the constricted wall of an organ BO. Thus, more than two different regions of the constricted wall can be stimulated simultaneously, either repeatedly or sequentially. Furthermore, each group of different regions of the constricted wall can be stimulated sequentially.
[0171] 7F, 7G, and 7H illustrate different operational states of a variation of the general embodiment shown in FIGS. 7A-7E, in which the constriction and stimulation device CSD includes several separate constriction / stimulation members, here three members CSDE1, CSDE2, and CSDE3. FIG. 7F illustrates a first operational state in which member CSDE1 is activated to constrict and stimulate the organ B0, thus blocking the fallopian tube of the organ B0, while the other two members CSDE2 and CSDE3 are inactive. FIG. 7G illustrates a second operational state in which member CSDE2 is activated, thus blocking the fallopian tube of the organ B0, while the other two members CSDE1 and CSDE3 are inactive. FIG. 7H illustrates a third operational state in which member CSDE3 is activated, thus blocking the fallopian tube of the organ B0, while the other two members CSDE1 and CSDE2 are inactive. By alternating between the first, second and third operating states randomly or according to a predetermined sequence, different portions of the organ can be temporarily constricted and stimulated while the fallopian tubes of the organ remain closed, minimizing the risk of damage to the organ. Members CSDE1-CSDE3 can also be actuated sequentially along the fallopian tubes of the organ to move fluids and / or other bodily substances within the fallopian tubes.
[0172] 7I, 7K, and 7L show other operating modes of the variant of the general embodiment. Fig. 7I shows a state in which the member CSDE7 in a first operating state is activated to constrict and stimulate the organ B0, thus blocking the fallopian tube of the organ B0, while the other two members CSDE2 and CSDE3 are activated to constrict but not stimulate the organ B0, thus not completely blocking the fallopian tube of the organ B0, and the members CSDE2 and CSDE3 are engaged with the organ B0. Fig. 7K shows a state in which the member CSDE2 in a second operating state is activated to constrict and stimulate the organ B0, thus blocking the fallopian tube of the organ B0, while the other two members CSDE7 and CSDE3 are activated to constrict but not stimulate the organ B0, thus not completely blocking the fallopian tube of the organ B0, and the members CSDE1 and CSDE3 are engaged with the organ B0. 7L shows the next state in which the member CSDE3 in the third operating state is activated to constrict and stimulate the organ B, thus closing the fallopian tube of the organ B, while the other two members CSDE1 and CSDE2 are activated to constrict but not stimulate the organ B, thus not completely closing the fallopian tube of the organ B, and the members CSDE1 and CSDE2 engage the organ B. By switching between the first, second, and third operating states randomly or according to a predetermined sequence, different portions of the organ can be temporarily stimulated while the fallopian tube of the organ remains closed, thereby reducing the risk of organ damage. The stimulation of the members CSDE1-CSDE3 can also be activated sequentially along the fallopian tube of the organ B to move fluids and / or other bodily substances within the fallopian tube.
[0173] This embodiment, which combines a mechanical or hydraulic partial restriction system with a stimulation system that changes the stimulation position, is preferably used when it is desired to occlude the fallopian tube for a longer period of time. The system is preferably energy-efficient, as only the stimulation needs to be repositioned, allowing the fallopian tube to recover until the stimulation returns to the same position. If the restriction regions are positioned closer together and the mechanical or hydraulic restriction is continuous, peristaltic waves can be generated in any direction within the fallopian tube. If the restriction is continuously moved from the restriction closest to the ovary, eggs will no longer be squeezed within the restriction region. If the restriction is moved in the reverse direction toward the uterus, a displacement device can be used to move the eggs away from the new restriction region. Such a displacement device can be a hydraulic or mechanical partial restriction device that displaces within the fallopian tube wall before the stimulation device closes the region.
[0174] Figure 8B is a pulse / time diagram illustrating a variation of the electrical stimulation shown in Figure 8A. Thus, the pulse combination of Figure 8A is mixed with a pulse train combination having a relatively long first pulse train PTL of high-frequency / low-amplitude pulses that appears simultaneously with the positive pulse PL of the pulse combination of Figure 8A, and a relatively short second pulse PTS of high-frequency / low-amplitude pulses that appears simultaneously with the negative pulse PS of the pulse combination shown in Figure 8A. As a result, the high-frequency / low-amplitude pulse trains PTL and PTS are superimposed on the positive pulse PL and negative pulse PS of Figure 8A, as shown in Figure 8B. The pulse configuration of Figure 8B and variations thereof may be advantageously used in connection with stimulation of certain organs in humans to achieve desired stimulation effects.
[0175] The electrical pulses are preferably formed into a pulse train as shown in the pulse / time diagrams P / t in Figures 8C and 8D. The pulse / time diagram P / t in Figure 9A represents individual regions of the wall of a patient's tubular organ stimulated by pulse train 18A. Pulse train 18A includes three initial negative pulses, each short in duration and high in amplitude (voltage), with one long-duration, short-amplitude positive pulse followed by a negative pulse. After a delay to allow each region of the organ to regain approximately normal blood circulation, pulse train 18A is repeated.
[0176] The pulse / time diagram P / t in Figure 8D represents another individual region of the wall stimulated by pulse train 18B, which has the same configuration as pulse train 18A. Pulse trains 18A and 18B are staggered relative to each other and therefore overlap so that the constricted wall is always stimulated to contract as needed.
[0177] 9A and 9B show another embodiment of the present invention for controlling blood flow through a blood vessel 19, comprising a constriction device having two clamping members 20a and 20b, a stimulation device in the form of two thermal stimulation members 21a and 21b integrated with the clamping members 20a and 20b, respectively, and a control device 4 for controlling the clamping members 20a and 20b and the stimulation members 21a and 21b. The clamping members 20a and 20b can move toward and away from each other in the same manner as described above in connection with the embodiment according to FIGS. 5A-5C. The thermal stimulation members 21a and 21b may include Peltier elements and are located on the clamping members 20a and 20b, such that the thermal stimulation member 21a faces the thermal stimulation member 21b. FIG. 11A shows the state in which the clamping members 20a and 20b constrict the blood vessel 19, thereby restricting blood flow. 11B controls the thermal stimulation members 21a, 21b to cool the walls of the blood vessel 19, thus causing the walls to contract and close the blood vessel 19. When releasing the blood vessel 19, the control device 4 controls the thermal stimulation members 21a, 21b to heat the walls of the blood vessel 19, thus causing the walls to expand.
[0178] Figures 10A and 10B show a hydraulically operable elongated constriction device in the form of a band 72 having an inflatable / constrictable cavity 73 in fluid communication with an adjustable reservoir 74 containing hydraulic fluid. Figure 10A shows the band in a non-constricted state, while Figure 10B shows the band in a constricted state with cavity 73 inflated by hydraulic fluid supplied from reservoir 74.
[0179] Figures 31A, 31B, 31C, and 31D are block diagrams of hydraulic constriction devices that operate differently. Figure 31A shows the band 72 of Figure 10A, in which the cavity 73 is in fluid communication with a reservoir 75. Figure 31B shows the embodiment of Figure 10A, in which the cavity 73 of the band 72 is in fluid communication with a reservoir 74 via an actuation device in the form of a two-way pump 76. Figure 11C shows an actuation device in the form of an inverted servo system with a closed first system controlling a second system. The inverted servo system includes an adjustable fluid supply reservoir 77 and an adjustable servo reservoir 78. The servo reservoir 78 controls a larger adjustable reservoir 79 that varies the volume of the cavity 73 of the band 72 relative to the band 72 attached around a portion of the tubular tissue wall of a patient's organ, thereby varying the constriction of the wall. Figure 11D shows an embodiment identical to that of Figure 11C, except that the larger reservoir 79 has been omitted. Instead, the servo reservoir 78 is in fluid communication with the cavity in the band 72.
[0180] In all the above embodiments according to Figures 12A to 10B, the stimulation device can be arranged so that multiple electrical members 7 (shown in Figures 12A to 15, 18, 20 to 23, 26 to 11B) located on the constriction device form a constriction / stimulation unit included in the stimulation device.
[0181] FIG. 12 is a cross-sectional view of a fluid delivery device including a bellows reservoir 80 forming a chamber 81 whose size can be varied by an operating device including a remotely controlled electric motor 82. The reservoir 80 and motor 82 are disposed within a housing 83. Moving a large wall 84 changes the size of the chamber 81. The wall 84 is secured to a nut 85 threaded onto a rotatable spindle 86. The spindle 86 is rotated by the motor 82. A battery 89 disposed within the housing 83 drives the motor 82. A signal receiver 90 that controls the motor 82 is also disposed within the housing 83. Alternatively, the battery 89 and signal receiver 90 can be mounted in separate locations. The motor 82 can also be powered by energy converted from a transmitted signal.
[0182] Where applicable, the fluid supply device of Figure 12 can be used to supply hydraulic fluid to operate the constriction devices described herein. For example, reservoir 74 in the embodiment according to Figure 10A can be replaced by the fluid supply device of Figure 12.
[0183] 13A and 13B show a reversing servo that includes a rectangular housing 91 and an intermediate wall 92 that is movable within housing 91. A relatively large, generally cylindrical bellows reservoir 93 is disposed within housing 91 and is joined to movable intermediate wall 92. Another cylindrical bellows reservoir 94, which is much smaller than reservoir 93, is disposed within housing 91 on the opposite side of intermediate wall 92 and is also joined to wall 92. Small bellows reservoir 94 has a fluid supply tube 95, and large bellows reservoir 93 has a fluid supply tube 96.
[0184] Referring to Figure 13A, when a small amount of hydraulic fluid is directed into small bellows reservoir 94 through supply tube 95, small bellows reservoir 94 expands movable intermediate wall 92, pushing it toward large bellows reservoir 93. As a result, as shown in Figure 13B, large bellows reservoir 93 is contracted by intermediate wall 92, thereby forcing a large amount of hydraulic fluid out of large bellows reservoir 93 through supply tube 96.
[0185] For example, the reversing servo of Figures 13A and 13B could be used in the embodiment of Figure 11C, where small bellows reservoir 94 corresponds to small servo reservoir 78 and large bellows reservoir 93 corresponds to large reservoir 79. Furthermore, the reversing servo of Figures 13A and 13B could be used in the embodiment of Figures 10A and 10B, where small bellows reservoir 94 is coupled to adjustable reservoir 74 and large bellows reservoir 93 is coupled to cavity 73 of band 72.
[0186] Figure 14 schematically illustrates a hydraulically operable constriction device 97 of the system of the present invention, similar to the embodiment shown in Figure 10A, except that the hydraulic system is configured differently. That is, constriction device 97 includes a relatively small, expandable cavity 98 in fluid communication with a reservoir 99 containing hydraulic fluid, and a relatively large cavity 100 displaceable by the small cavity 98. The small cavity 98 is configured to displace the large cavity 100 to constrict a tubular wall of a patient when expanded, and to displace the large cavity 100 to release the wall when contracted. Thus, adding a relatively small amount of hydraulic fluid from reservoir 99 to the small cavity 98 significantly increases the constriction of the wall.
[0187] Large cavity 100 is formed by a constricting member in the form of a large balloon 101 that can be connected to an inlet (not shown) that calibrates the volume of large cavity 100. The volume of balloon 101 is calibrated by adding or withdrawing fluid into the inlet using a syringe. Small cavity 98 is formed by a small bellows 102 attached to an annular frame 103 of constriction device 97 and attached to balloon 101 at the opposite end.
[0188] 15A and 15B schematically illustrate the operation of constriction device 97 when annular frame 103 is attached around a tubular wall of a patient's organ. Referring to FIG. 15A, when small cavity 98 is deflated, bellows 102 draws balloon 101 inside annular frame 103, thus constricting device 97. Referring to FIG. 15B, when small cavity 98 is expanded, bellows 102 pulls balloon 101 out of annular frame 103, thus constricting device 97 releases the wall.
[0189] As described above, the constriction device and stimulation device cooperate to actively move an egg within the fallopian tube of a patient's organ. This can be achieved using the constriction / stimulation unit shown in FIG. 2. Thus, according to a first cooperation option, the clamping members 5, 6 of the constriction device constrict the wall 8 without completely closing the fallopian tube, thereby restricting flow within the fallopian tube, and the control device 4 controls the electrical member 7 to gradually stimulate the constricted wall in a downstream or upstream direction of the fallopian tube, gradually contracting the wall 8 and moving the egg within the fallopian tube.
[0190] According to a second cooperation option, the constriction device constricts the wall, thus restricting flow within the fallopian tube, and the control device 4 controls several electrical members 7 at one end of the elongated clamping members 5, 6 to stimulate the constricted wall 8 to close the fallopian tube at either the upstream or downstream end of the wall 8. With the fallopian tube thus closed, the control device 4 controls the constriction device to increase the constriction of the wall, thereby moving eggs within the fallopian tube upstream or downstream of the wall 8.
[0191] In another embodiment of the invention implementing the second cooperation option, the constriction device constricts the wall, thus restricting flow through the fallopian tube, and the control device 4 controls the stimulation device to stimulate the constricted wall, while the constriction device varies the constriction of different regions of the wall, thus gradually narrowing the wall in the downstream or upstream direction of the fallopian tube. Figures 16A-16E show different stages of operation of such another embodiment, comprising a constriction device 104 including two elongated constriction members 105, 106 having convex surfaces 107, 108 on either side of the wall 8 over a length thereof, and a number of electrical members 7 (such as electrodes) located on the convex surfaces 107, 108. The control device 4 controls the electrical member 7 during operation of the constriction device 104, and as can be seen in Figures 16A to 16D, controls the elongated constriction members 105, 106 to move relative to the tubular wall portion 8, thereby controlling the constriction members 105, 106 to gradually constrict the wall portion 8.
[0192] 16A, the wall is not constricted by the constriction members 105, 106, and the electrical member 7 is not energized. From this initial position, as can be seen in FIG. 16B, the control device 4 controls the constriction members 105, 106 to swing the left ends of the constriction members 105, 106 toward the wall (indicated by the arrows) to constrict the tubular wall 8, while energizing the electrical member 7, so that the electrical member 7 in contact with the wall 8 contracts the wall 8. FIG. 16C shows the fallopian tube in a state where the tubular wall 8 is completely closed by the thickened wall 8. Next, as shown in FIG. 16C, the control device 4 controls the constriction members 105, 106 so that the right ends of the constriction members 105, 106 move toward each other (indicated by the arrows), while, as can be seen in FIG. 16D, the convex surfaces 107, 108 of the constriction members 105, 106 roll toward each other, sandwiching the constricted wall portion 8 therebetween. As a result, the body material in the organ's fallopian tube is pushed to the right (indicated by the white arrows). Once the constriction members 105, 106 roll toward each other to the position shown in FIG. 16E, the control device 4 controls the right ends of the constriction members 105, 106 to move away from each other (indicated by the arrows in FIG. 16E) to the initial position shown in FIG. 16A. The operational steps described by FIGS. 16A-16E can be repeated cyclically several times until a desired amount of body material is peristaltically moved through the organ's fallopian tube.
[0193] Alternatively, only one of the constriction members 105, 106 may have a convex surface, while the other constriction member has a planar surface that abuts the wall. It is also possible to use a single constriction member that includes a convex surface that presses the tubular portion 8 of the organ against the patient's bone.
[0194] Figure 16 shows a schematic diagram of a general embodiment of a system of the present invention in which energy is transmitted to an energy-consuming component of the system implanted in a patient. The system of Figure 16 includes an implanted constriction / stimulation unit 110 operable to gently constrict a portion of a tubular tissue wall of a patient's organ and stimulate different regions of the constricted portion to cause the wall to contract. The constriction device of the constriction / stimulation unit 110 is capable of performing a reversible function, i.e., it can constrict and release the wall, and thus the constriction / stimulation unit 110 functions as an artificial sphincter.
[0195] The energy source 111 is configured to supply energy to the energy-consuming components of the constriction / stimulation unit 110 via a power supply line 112. A wireless remote control or a subcutaneously implanted switch operable by the patient to turn on and off the supply of energy from the energy source can be provided. The energy source can be an implantable permanent or rechargeable battery, or can be included in an external energy-transmission device operable directly by the patient or controlled by a patient-operable remote control to transmit wireless energy to the energy-consuming components of the constriction / stimulation unit. Alternatively, the energy source can comprise a combination of an implantable rechargeable battery, an external energy-transmission device, and an implantable energy-conversion device that converts the wireless energy transmitted by the external energy-transmission device into electrical energy that charges the implantable rechargeable battery.
[0196] FIG. 17 shows a specialized embodiment of the general embodiment of FIG. 16 , with some portions implanted in the patient and other portions positioned outside the patient's body. Thus, in FIG. 17 , all portions positioned to the right of the patient's skin 109 are implanted, and all portions positioned to the left of the skin 109 are positioned outside the patient's body. The system's implanted energy-transforming device 111A is configured to supply energy to the energy-consuming components of the constriction / stimulation unit 110 via a power supply line 112. The system's external energy-transmitting device 111 includes a wireless remote control that transmits a wireless signal that is received by a single receiver integrated into the implanted energy-transforming device 111A. The implanted energy-transforming device 111A converts energy from the signal into electrical energy, which is then supplied to the constriction / stimulation unit 110 via the power supply line 112.
[0197] The system of Fig. 17 may also include an implanted rechargeable battery that powers the implanted energy-consuming components of the system, in which case the implanted energy-transforming device 111A also charges the battery with electrical energy when it converts energy from the signal into electrical energy.
[0198] A reversing device in the form of an electrical switch 114, such as a microprocessor, is implanted in the patient to reverse the constriction device of the constriction / stimulation unit 110. A wireless remote control of the external energy-transforming device 113 sends a wireless signal to send energy, and the implanted energy-transforming device 111A converts the wireless energy into an electric current that operates the switch 114. When the polarity of the electric current is changed by the energy-transforming device 111A, the switch 114 reverses the function performed by the constriction device of the constriction / stimulation unit 110.
[0199] 18 shows an embodiment of the invention comprising an energy-transforming device 111A, a constriction / stimulation unit 110 and an implanted operating device in the form of a motor 115 for operating the constriction device of the constriction / stimulation unit 110. The motor 115 is driven by energy from the energy-transforming device 111A when the remote control of the energy-transforming device 113 sends a wireless signal to a receiver of the energy-transforming device 111A.
[0200] 19 shows an embodiment of the invention comprising an energy-transforming device 111A, a constriction / stimulation unit 110, and an implanted assembly 116 comprising a motor / pump unit 117 and a fluid reservoir 118. In this case, the constriction device of the constriction / stimulation unit 110 is hydraulically operated, i.e., the motor / pump unit 117 pumps hydraulic fluid from the reservoir 118 to the constriction / stimulation unit 110 to constrict the wall, and the motor / pump unit 117 pumps hydraulic fluid back from the constriction / stimulation unit 110 to the reservoir 118 to release the wall. The implanted energy-transforming device 111A converts wireless energy into electrical current to drive the motor / pump unit 117.
[0201] 20 illustrates an embodiment of the invention comprising an external energy-transmission device 113, which controls a control unit 122 to reverse the motor 115 as needed, a constriction / stimulation unit 110 in which the constriction device is hydraulically operated, an implanted energy-transforming device 111A, an implanted hydraulic fluid reservoir 119, an implanted motor / pump unit 120, an implanted reversing device in the form of a hydraulic valve-shifting device 121, and a separate external wireless remote control 111B. The motor of the motor / pump unit 120 is an electric motor. In response to a control signal from the wireless remote control of the external energy-transmission device 113, the implanted energy-transforming device 111A drives the motor / pump unit 120 with energy from the energy sent by the control signal, causing the motor / pump unit 120 to distribute hydraulic fluid between the reservoir 119 and the constriction device of the constriction / stimulation unit 110. The remote control 111B changes the direction of hydraulic fluid flow between one direction in which the motor / pump unit 120 pumps fluid from the reservoir 119 to the constriction device of the constriction / stimulation unit 110, causing the wall to constrict, and the other opposite direction in which the motor / pump unit 120 pumps fluid back from the constriction device of the constriction / stimulation unit 110 to the reservoir 119, causing the wall to open.
[0202] 21 shows an embodiment of the present invention including an energy-transforming device 111A and a constriction / stimulation unit 110. A control unit 122, an accumulator 123, and a capacitor 124 are also implanted in the patient. A separate external wireless remote control 111B controls the control unit 122. The control unit 122 controls the energy-transforming device 111A to store electrical energy in the accumulator 123, which supplies the energy to the constriction / stimulation unit 110. In response to a control signal from the wireless remote control 111B, the control unit 122 either releases electrical energy from the accumulator 123 and transmits the released energy via a power line, or transmits the electrical energy from the energy-transforming device 111A directly through a capacitor 124 that stabilizes the current, to operate the constriction / stimulation unit 110.
[0203] According to one alternative embodiment, the capacitor 124 of the embodiment of Figure 21 may be omitted. According to another alternative embodiment, the accumulator 123 of this embodiment may be omitted.
[0204] 22 shows an embodiment of the invention comprising an energy-transforming device 111A and a constriction / stimulation unit 110. A battery 125 that provides energy to operate the constriction / stimulation unit 110 and an electrical switch 126 that switches the operation of the constriction / stimulation unit 110 are also implanted in the patient. The switch 126 is operated by the energy provided by the energy-transforming device 111A to switch from an off mode, in which the battery 125 is not used, to an on mode, in which the battery 125 provides energy to operate the constriction / stimulation unit 110.
[0205] Figure 23 shows an embodiment of the invention which is identical to the embodiment of Figure 43, except that a control unit 122 is also implanted in the patient. A separate external wireless remote control 111B controls the control unit 122. In this case, a switch 126 is operated by energy provided by the energy-transforming device 111A to switch from an off mode, in which the wireless remote control 111B is prevented from controlling the control unit 122 and the battery 125 is not used, to a standby mode, in which the wireless remote control 111B is enabled to control the control unit 122 to discharge electrical energy from the battery 125 to operate the constriction / stimulation unit 110.
[0206] Figure 24 shows an embodiment of the invention that is identical to the embodiment of Figure 44, except that the battery 125 is replaced by an accumulator 123 and the implanted components are interconnected differently. In this case, the accumulator 123 stores energy from the energy-transforming device 111A. In response to a control signal from the wireless remote control 111B, the implanted control unit 122 controls a switch 126 to switch the accumulator 123 from an off mode, in which it is not used, to an on mode, in which it provides energy to operate the constriction / stimulation unit 110.
[0207] Figure 25 shows an embodiment of the invention that is identical to the embodiment of Figure 45, except that a battery 125 is also implanted in the patient and the implanted components are interconnected differently. The implanted control unit 122, in response to a control signal from the wireless remote control 111B, provides energy to operate a switch 126 and controls an accumulator 123, which may be a capacitor, to switch from an off mode, in which the battery 125 is not in use, to an on mode, in which the battery 125 provides electrical energy to operate the constriction / stimulation unit 110.
[0208] Alternatively, the switch 126 can be operated by energy supplied from the accumulator 123 to switch from an off mode, in which the wireless remote control 111B is prevented from controlling the battery 125 to supply electrical energy and the battery 125 is not in use, to a standby mode, in which the wireless remote control 111B is enabled to control the battery 125 to supply electrical energy to operate the constriction / stimulation unit 110.
[0209] Figure 26 shows an embodiment of the invention that is identical to the embodiment of Figure 43, except that a motor 115, a mechanical reversing device in the form of a gearbox 127, and a control unit 122 that controls the gearbox 127 are also implanted in the patient. A separate external wireless remote control 111B controls the implanted control unit 122 to control the gearbox 127 to reverse the functions performed by the constriction device (which is mechanically operated) of the constriction / stimulation unit 110.
[0210] Figure 27 shows an embodiment of the present invention that is identical to the embodiment of Figure 46, except that the implanted components are interconnected differently. Thus, in this case, battery 125 powers control unit 122 when accumulator 123, preferably a capacitor, is switched to an on mode by actuating switch 126. When switch 126 is in its on mode, control unit 122 is able to control battery 125 to either provide or not provide energy to operate constriction / stimulation unit 110.
[0211] Figure 28 shows an embodiment of the invention which is identical to that of Figure 39, except that a gearbox 127 which couples the motor 115 to the constriction / stimulation unit 110, and a control unit 122 which controls the energy transforming device 111A to drive the motor 115, are also implanted in the patient. A separate external wireless remote control 111B is provided which controls the control unit 122 to reverse the motor 115 as required.
[0212] Optionally, the accumulator 123 shown in Figure 21 can be provided in the embodiment of Figure 49, in which case the implanted control unit 122 controls the energy-transforming device 111A to store the converted energy in the accumulator 123. The control unit 122 controls the accumulator 123 to provide energy to operate the constriction / stimulation unit 110 in response to a control signal from the wireless remote control 111B.
[0213] Those skilled in the art will recognize that the various embodiments described above in accordance with Figures 17-28 can be combined in many different ways. For example, the energy-operated switch 114 could be incorporated into any of the embodiments of Figures 18, 21-28, the hydraulic shifting device 121 could be incorporated into the embodiment of Figure 21, and the gearbox 127 could be incorporated into the embodiment of Figure 39. The switch 114 could be any type of switch that includes electronic components configured to perform the switching, such as a microprocessor or a field-programmable gate array (FPGA). Alternatively, the energy-operated switch 114 could be replaced by a subcutaneously implanted push button that can be manually turned "on" and "off" by the patient.
[0214] Alternatively, the energy-transforming device 111A in the embodiments shown in Figures 38 to 49 can be replaced by a permanent or rechargeable battery.
[0215] Figure 29 shows the basic components of the remote control of the system of the present invention, which controls the constriction / stimulation unit 110. In this case, the stimulation device of the constriction / stimulation unit stimulates the wall with electrical pulses. The remote control is based on wireless transmission of electromagnetic signals through the patient's skin 132, often at high frequencies on the order of 100 kHz to 1 GHz. In Figure 29, all components located to the left of the skin 132 are external to the patient's body, while all components located to the right of the skin 132 are implanted.
[0216] The external signal transmitting device 133 is located near the signal receiving device 134, which is implanted near the skin 132. Alternatively, the signal receiving device 134 can be placed inside the patient's abdomen, for example. The signal receiving device 134 includes a coil approximately 1 mm to 100 mm in diameter, preferably 25 mm, wound with very thin wire and tuned to a specific high frequency by a capacitor. A small coil is selected when the signal receiving device 134 is implanted under the patient's skin, and a larger coil is selected when the signal receiving device 134 is implanted in the patient's abdomen. The signal transmitting device 133 includes a coil approximately the same size as the coil of the signal receiving device 134, but wound with thicker wire to handle the larger current required. The coil of the signal transmitting device 133 is tuned to the same specific high frequency as the coil of the signal receiving device 134.
[0217] The signal transmitting device 133 is configured to transmit digital information to the implanted control unit 135 via a power amplifier and a signal receiving device 134. A digital signal code is used to prevent accidental random high-frequency fields from triggering control commands. A conventional keypad located on the signal transmitting device 133 is used to instruct the signal transmitting device 133 to transmit digital signals for control of the constriction / stimulation unit. The signal transmitting device 133 initiates the command by generating a high-frequency signal. After a while, when the signal energizes the implanted portion of the control system, the command is transmitted and the constriction device of the constriction / stimulation unit 110 operates in a predefined step. The command is transmitted as a digital packet in the form shown below. Start pattern, 8-bit command, 8-bit count, 8-bit checksum, 8-bit
[0218] The commands are sent continuously over a fairly long period of time (e.g., about 30 seconds or more). If a new constriction or release step is required, the count byte is incremented by 1, allowing the implanted control unit 135 to decode and understand that another step has been requested by the signaling device 133. If any part of the digital packet is in error, its contents are simply ignored.
[0219] An implanted energizer unit 137 draws energy from the high frequency electromagnetic signal received by the signal receiving device 134 via line 136. The energizer unit 137 stores the energy in an energy source such as a large capacitor and drives the control unit 135, which drives the constriction / stimulation unit 110 via line 138.
[0220] The control unit 135 comprises a demodulator and a microprocessor. The demodulator demodulates the digital signal transmitted from the signal transmitting device 133. The microprocessor receives and decodes the digital packets and transmits control signals over signal line 139 to control the constriction device of the constriction / stimulation unit 110 to constrict or release the wall of the patient's organ according to the received command code.
[0221] Figure 30 shows a circuit of an embodiment of the invention in which wireless energy is converted into electrical current. The external components of the circuit include a microprocessor 140, a signal generator 141, and a power amplifier 142 connected thereto. The microprocessor 140 is configured to switch the signal generator 141 on and off and to modulate the signal generated by the signal generator 141 via digital commands. The power amplifier 142 amplifies the signal and transmits it to an external signal-transmitting antenna coil 143. The antenna coil 143 is connected in parallel with a capacitor 144 to form a resonant circuit tuned to the frequency generated by the signal generator 141.
[0222] The implanted components of the circuit include a signal-receiving antenna coil 145 and a capacitor 146, which together form a resonant circuit tuned to the same frequency as the transmitting antenna coil 143. The signal-receiving antenna coil 145 induces a current from the received high-frequency electromagnetic waves, and a rectifying diode 147 rectifies the induced current, which charges a storage capacitor 148. The storage capacitor 148 drives a motor 149, which drives the constriction device of the constriction / stimulation unit 110. A coil 150, connected between the antenna coil 145 and the diode 147, prevents the capacitor 148 and the diode 147 from loading the circuit of the signal-receiving antenna 145 at higher frequencies. Thus, the coil 150 charges the capacitor 148 and enables digital information to be transmitted using amplitude modulation.
[0223] The parallel connection of capacitor 151 and resistor 152 and diode 153 form a detector used to detect the amplitude-modulated digital information. Resistor 154 is connected in series with resistor 155, which is connected in series with capacitor 156, which is connected in series with resistor 154 via ground. A filter circuit is formed by capacitor 157, with one terminal connected between resistors 154 and 155 and the other terminal connected between diode 153 and the circuit formed by capacitor 151 and resistor 152. The filter circuit is used to filter out undesired low and high frequencies. The detected and filtered signal is sent to an embedded microprocessor 158, which decodes the digital information and controls motor 149 via an H-bridge 159 comprising transistors 160, 161, 162, and 163. Motor 149 can be driven in two opposite directions by H-bridge 159.
[0224] The microprocessor 158 also monitors the amount of stored energy in the storage capacitor 148. The microprocessor 158 checks whether there is enough energy stored in the storage capacitor 148 before sending a signal to operate the motor 149. If there is not enough energy stored to perform the requested operation, the microprocessor 158 waits for a received signal to charge the storage capacitor 148 before operating the motor 149.
[0225] Alternatively, the energy stored in the storage capacitor 148 may be used solely to drive the switch, and the energy to drive the motor 149 may be obtained from another implanted energy source having a relatively high capacity, such as a battery. In this case, the switch is configured to connect the battery to the motor 149 in an on mode when powered by the storage capacitor 148, and to keep the battery disconnected from the motor 149 in a standby mode when not powered.
[0226] While the present invention has been described in connection with what are presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims. [Explanation of symbols]
[0227] 2 constriction device; 5, 6 clamping member; 8 tubular wall; 22 hydraulic chamber; 23 reservoir; 24a, 24b conduit; 25 two-way pump; 26 tubular housing; 27 constriction device; 28 clamping member; 31 fallopian tube; 32 wireless remote control; 33 internal control unit; 34 manipulation device; 35 energy source; 36 sensor.
Claims
1. 1. A device for controlling the flow of a bodily fluid within a lumen of a patient, comprising: an implantable constriction device for constricting the lumen to affect the flow within the lumen, the constriction device including a plurality of clamping elements arranged in a common plane intersecting the lumen and configured to be radially movable toward and away from a central axis of the lumen to modify the constriction of the lumen; an operating device configured to operate the movement of the clamping element; an implantable motor configured to operate the manipulation device; a gearbox configured to transfer a force generated by the motor to a force that operates the operating device; the manipulation device is configured to manipulate movement of the clamping elements such that a clamping force acting on the lumen is distributed between the clamping elements. Device.
2. 10. The apparatus of claim 1, An apparatus wherein a clamping force acting on the lumen is substantially evenly distributed between the clamping elements.
3. 10. The apparatus of claim 1, The apparatus, wherein the clamping element is attached to a support configured to at least partially surround the lumen.
4. 10. The apparatus of claim 1, The apparatus, wherein the plurality of clamping elements comprises a first clamping element and a second clamping element configured to be positioned 180 degrees apart along a circumference.
5. 10. The apparatus of claim 1, The apparatus, wherein the plurality of clamping elements comprises first, second and third clamping elements configured to be circumferentially spaced 120° apart.
6. 10. The apparatus of claim 1, The operating device is configured to be coupled to each of the clamping elements to transmit a clamping force urging the clamping elements toward the central axis.
7. 10. The apparatus of claim 1, The manipulation device is configured to distribute a clamping force between the clamping elements so as to restrict the flow of bodily fluids in the lumen while not substantially restricting blood circulation in a wall of the constricted portion of the lumen.
8. 10. The apparatus of claim 1, The apparatus further comprising an internal energy source implanted in the patient and configured to power the manipulation device.
9. 9. The apparatus of claim 8, The device, wherein the internal energy source comprises a battery.
10. 9. The apparatus of claim 8, The apparatus, wherein the internal energy source comprises a capacitor.
11. 9. The apparatus of claim 8, The apparatus further comprising a control device configured to control operation of the manipulation device.
12. 12. The apparatus of claim 11, The device further comprising a sensor configured to sense a functional parameter of the device.
13. 12. The apparatus of claim 11, The apparatus, wherein the control device comprises an implantable pressure sensor configured to sense pressure within the patient's body.
14. 14. The apparatus of claim 13, The control device is adapted to control the contraction device in response to a signal from the pressure sensor.
15. 14. The apparatus of claim 13, The apparatus, wherein the pressure sensor is configured to directly or indirectly sense pressure acting on the constriction device.
16. 12. The apparatus of claim 11, The control device further comprises a switch.