AU2015203000B2 - Device and method for embryo control - Google Patents

Device and method for embryo control Download PDF

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AU2015203000B2
AU2015203000B2 AU2015203000A AU2015203000A AU2015203000B2 AU 2015203000 B2 AU2015203000 B2 AU 2015203000B2 AU 2015203000 A AU2015203000 A AU 2015203000A AU 2015203000 A AU2015203000 A AU 2015203000A AU 2015203000 B2 AU2015203000 B2 AU 2015203000B2
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Australia
Prior art keywords
restriction
oviduct
patient
energy
egg
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AU2015203000A1 (en
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Peter Forsell
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Implantica Patent Ltd
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Implantica Patent Ltd
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Priority claimed from AU2008311434A external-priority patent/AU2008311434B2/en
Priority to AU2015203000A priority Critical patent/AU2015203000B2/en
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Publication of AU2015203000A1 publication Critical patent/AU2015203000A1/en
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Publication of AU2015203000B2 publication Critical patent/AU2015203000B2/en
Priority to AU2017200415A priority patent/AU2017200415B2/en
Assigned to IMPLANTICA PATENT LTD. reassignment IMPLANTICA PATENT LTD. Request for Assignment Assignors: MILUX HOLDING SA
Priority to AU2019204811A priority patent/AU2019204811B2/en
Priority to AU2021204626A priority patent/AU2021204626B2/en
Priority to AU2023285917A priority patent/AU2023285917A1/en
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Abstract

A system for treating a female patient to promote pregnancy comprising a restriction device (2) adapted to postoperatively restrict and release an oviduct (31a, 31b) of the patient. Fig. 2B Zla5 5 33 34 ---- 5 (Ile Fig. 2B

Description

DEVICE AND METHOD FOR EMBRYO CONTROL FIELD OF THE INVENTION
[0001] The present invention relates generally to medical devices and treatment and, more particularly, to a device and a method for embryo control of a female patient.
BACKGROUND OF THE INVENTION
[0002] Many women have difficulties getting pregnant. Older age when trying to get pregnant with lower fertility rate is one main reason.
[0003] Artificial insemination is one way to promote pregnancy and this way has increased dramatically the last few years. However, this method is not always easy and safe and is furthermore very expensive, particularly when repeated, which often is the case.
[0004] Although uterus is prepared to receive an embryo for approximately three days it seems that the right timing is of outmost importance when fertility goes down.
BRIEF SUMMARY OF THE INVENTION
[0005] It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative.
[0006] Accordingly, the invention provides a pregnancy control system for promoting pregnancy of a female mammal or human patient, comprising: an implantable restriction device adapted to be implanted outside an oviduct of the patient and to be postoperatively adjusted to restrict the lumen of the oviduct of the patient to accumulate at least one egg released from the ovary in the oviduct and to cease restricting the oviduct lumen to admit the egg in the oviduct to be transported to the uterus, wherein the restriction device is adapted to be noninvasively adjusted from outside the patient's body to restrict and cease restricting the oviduct lumen, and wherein the restriction device is adapted to be reversibly adjusted by hydraulic power means comprising at least one hydraulic reservoir hydraulically connected to the restriction device to provide distribution of hydraulic fluid between the hydraulic reservoir and restriction device.
[0007] Unless the context clearly requires otherwise, throughout the description and the claims, the words “comprise”, “comprising ”, and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to”.
[0008] Advantageously, at least in a preferred form the present invention provides a device and a method for embryo control of a female patient.
[0009] The inventive device allows the egg from the ovary to be retained in the oviduct for a couple of days to be able to achieve the right timing for egg release and thereby increasing the likelihood to get pregnant with up to 10 times. A respective restriction pregnancy device is placed on the two oviducts to restrict and release the oviduct, thereby effecting the above mentioned retaining of the egg.
[0010] To reduce any possible risk of the egg being to the wall of the oviduct the restriction device may be combined with a movement device. Such a device may comprise a vibrating device or a stimulating device. The stimulation device may create a peristaltic like wave in the oviduct. For example, a vibrating device may be provided, which causes vibrations in a hydraulic fluid or mechanically causes vibrations in the wall of the oviduct. Another embodiment is an electrical stimulation device causing contractions or stimulation waves in the upstream direction of the oviduct. The device may also be replaced by a device not permitting the flow of the egg down to the uterus but without any full restriction. This may be created by using a device causing a peristaltic like wave in the oviduct in the direction of the ovary, thus without fully closing the oviduct instead preventing further transport of the egg down to the uterus by the wave, but still allowing the sperm to reach the egg. Any possible device without restriction at all or in any combinations of partly restriction or vibration or stimulation may be used. This will then allow the egg to be accumulated in the oviduct and allowing conception to take place over a longer period of time.
[0011] In accordance with a preferred aspect of the invention, there is provided a method of promoting pregnancy of a female patient, comprising the steps of restricting an oviduct of the patient to provide a restriction to accumulate at least one egg released from the ovary in the oviduct for a predetermined period of time, and releasing the restriction to admit the at least on egg in the oviduct to allow a transport of the at least one egg to the uterus.
[0012] The restriction device is adapted to provide a restriction of the oviduct to accumulate at least one egg released from the ovary in the oviduct and to provide a release of the oviduct after accumulating the egg normally up to three days when pregnancy is wanted to achieve right timing for pregnancy.
[0013] The restriction device may be adapted to be adjusted from outside the patients body to restrict and release the oviduct passageway, preferable adjusted from outside the patients body noninvasively.
[0014] It may also be adjusted by manual manipulation or adapted to be adjusted by electrical or magnetic power or adapted to be adjusted by hydraulic power. The hydraulic power may comprising at least one subcutaneously placed reservoir controlled by the patient.
[0015] The restriction device may of course preferable be adapted to be adjusted reversible.
[0016] The system is adapted to provide a restriction to accumulate at least one egg released from the ovary in the oviduct for a predetermined period of time, and releasing the restriction when convenient for the patient to increase the likelihood to get pregnant. The predetermined period of time is adapted to be between 0 and 2 days repeated very month until pregnancy is achieved or preferable a predetermined period between 8 and 12 hours.
[0017] All embodiments and features described below may if possible be used for both, be adapted to be used with the apparatus, and being used with any of the methods described below. -—^
Flow: restriction.
The device of the present invention Is well stated for the controlling the how of eggs into the uterus of a female patient; Basically the device could be performed, in. ei ght di fferent principle ways: »Hydraulic restrictions* - Mechanical restrictions,, - Combination of .any hydraulic or mechanical restriction device with a stimulation device for restricting, and - Stimulation device stone, - Vary the restriction area. Any of these in any combination could be used to over time vary the restriction area of the oviduct from one portion to another one and later hack again.
Several different areas could he Involved in such a system to vary the restriction poriion/area. This would allow the oviduct to recover the restricted area still beeping the restriction over a longer period. - Using a moving device. When the restriction area being mo ved between different areas, specially when the restriction is moved upstream towards the-ovary, it may be convenient to use a moving device, to a void any egg being squeezed in a new upstream restriction area and by mistake being released tor further downstream transportation when the restriction being released and moved further upstream. The moving device may be adapted to create a movement of the oviduct wall to create a movement of any egg placed in the new upcoming restricted area. This could be caused by any of the above mentioned restriction devices, mechanical, hydraulic or stimulation device alone or in any combination* but may also be a separate device which also may he a mechanical, a hydraulic or a stimulation device. In one embodiment the moving device cause vibrations, - Peristaltic like wave movement, of the oviduct wall towards the ovary. Another principle is to stop the egg reaching the uterus by creating peristaltic wave like movements of the oviduct
Such peristaltic wave like movements upstream direction towards the ovary may stop Sow of any egg towards the uterus without fully restricting the o viduct to allow any spoon to pass and also ~ Peristaltic like wave movement of the oviduct wall towards the uterus by being able to cause movement of the egg down to 'uterus with a down stream peristaltic wave.
These areas will he outlined below,
Hydraulic restriction
Where the operation, device hydraulically operates the constriction device of the restriction or combined resirietioa/stinmladon unit (d), it includes hydraulic means for adjusting the device.
In an embodiment of the invention, the hydraulic means comprises a reservoir and m expandahie/contraetlbte cavity in the constriction device, wherein the operation 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 defined by a balloon of the constriction device that abuts the tissue wall portion of the .patient’s organ, so that the patient’s wall portion is constricted upon expansion of the cavity and released upon contraction of the cavity.
Alternatively, the cavity may be defined by a. bellows that displaces a relatively large contraction element of the constriction device, for example a large balloon, that abuts the wall portion, so that the patient’s wall portion is constricted upon-contraction of the bellows and released -upon. expansion of the bellows. Thus, a relatively small addition of hydraulic fluid to the bellows causes a relatively large increase in the constriction of the wall portion. Such a bellows may also fee replaced fey a suitably designed pistonteylinder mechanism.
Where the hydraulic means comprises a cavity in the constriction device, the apparatus of the invention can fee designed in accordance with the options listed below, 1} The reservoir comprises first and second wall portions, and the operation device displaces the first and second wall portions relative to each other to change the volume of the reservoir, such that fluid is distributed horn the-reservoir to the cavity, or from the cavity to the reservoir. la) The first and second wall portions of the .réservoir arc 'displaceable· relative to each other by at least one of a magnetic device, a hydraulic device or an electric· control device. 2) The apparatus comprises a fluid conduit between the reservoir and the cavity, wherein the reservoir forms part of the conduit. The conduit and resemdr and apparatus are devoid of any non-return valve. The reservoir forms a fluid -chamber with a .variable volume, and distributes fluid from the chamber to the cavity by a reduction hi the volume of the chamber and 'withdraws fluid from the cavity by an expansion of the volume of the chamber. The apparatus further comprises a motor for driving the reservoir, comprising a movable wall of the reservoir for changing the volume of the chamber. in a special embodiment of the invention, the operation device comprises a reverse servo operatively connected to the .hydraulic means. The term “reverse servo” is to be understood as a mechanism that transfers a strong force acting on a moving element having a short stroke 'into a weak force acting on another moving element having a long stroke; l.e, the reverse function of a normal servo mechanism. Thus, minor changes in the amount, of fluid in a smaller reservoir could he transferred by the reverse servo into major changes in die amount of fluid in a larger reservoir. The reverse servo is particularly suited for manual operation thereof.
Preferably a manually operated reservoir could be placed subcutaneously for manual manipulation thereo £
Mechanical restnctlon
Where the operation device meehaftically operates the device or the restnction/stlmulatlon unit (d% it may he non-lailatahle. Furthermore, the operation device may comprise a servo device, which may include a gearbox. 'The term “servo device” encompasses the normal definition of a servo mechanism, i.e., an automatic device dint controls large amounts of power by means of very small amounts of power, but may alternatively or additionally encompass the definition of a mechanism that transfers a weak force acting on a moving element having a long stroke into a strong force acting on another moving element having a short stroke. Preferably, the operation device operates the constriction device in a nonmagnetic and/or non-manual mauser. A motor may be operatively connected to the operation device. The operation device may be operable to perform at least one reversible function and the motor may be capable of reversing the function.
The present· invention, provides an advantageous, combination of restriction and stimulation devices, which results in a two-stage influence on the flow of eggs in the lumen of the oviduct Thus, the constriction device may gently constrict the tissue wall of the oviduct wall by applying a relatively weak force against the wall portion, and the stimulation device may stimulate the constricted wall portion, to achieve the desired final, influence on the flow in the l umen. The phrase “gently constricting a portion of the tissue wall” is to be understood as restricting the wail portion without substantially' hampering the blood circulation in the tissue wall
In accordance with a first flow restriction option, the control device controls the. constriction device to constrict the wall portion, such that Sow In the lumen is· restricted or stopped, .and controls the stimulation device to stimulate the constricted wall portion to cause contraction thereof, such that Sow in the lumen is further restricted or more safely stopped. More precisely, a control device may control the stimulation device in a first mode to-stimulate the constricted wall portion to further restrict or stop the flow in the lame» and to: a) control the stimulation device in a second mode to cease the simulation of the wall portion to increase the flow in the lumen; or b) control the stimulation and constriction devices in the second mode to cease the stimulation of the wall portion and release the wall portion to restore the flow in the lumen.
Thus both a method for controlling the flo w in the lumen and an apparatus adapted to control the flow 1» the luoien may he implemented according to different embodiments and features in any combination.described, in this document d) Stimulation device alone, which could both 1) restrict by stimulation and 2) also creating peristaltic wave like movements to if a) upstream stop flow without fully restricting the oviduct and also b) being able to cause movement of the egg do wn to uterus with a down stream peristaltic wave:
Preferably, the stimulation device is adapted to stimulate different areas of the wall portion as the device restricts the wall portion, and the control device controls the stimulation device to intermi ttently and Individually stimulate die areas of the wall portion. This intermittent and individual stimulation of different areas of the wall portion of the oviduct allows tissue of the •wall portion to maintain substantially normal blood circulation during the operation of the apparatus of the invention.
The stimulation of different areas may be used both for closing the lumen in a safe way but also be used for creating a peristaltic wave in the oviduct
Movement of the cun in the oviduct lumen
In one embodiment the device is adapted to constrict the wall portion to restrict or vary the flow' in the lumen, and the control device controls the stimulation, device to progressively stimulate the constricted wall portion, in the downstream or upstream direction of the lumen. to cause progressive contraction of the wall portion to move the egg downstreams 'in the lumen or prevent further transport down of the egg to the uterus.
The device is preferable controlled horn outside the body in a manual way. The device may also he powered. A control device may be supplied. The control device suitably controls the device or the stimulation device or restnction/stimulation unit from outside the patient's body. Preferably, the control device is operable by the patient. For example, the control device may compose a manually operable switch for switching on and off die •eonsMction/sdmulation. unit, wherein the switch is adapted for subcutaneous implantation in the patient to be manually or magnetically operated from outside the patient’s body. Alternatively, the control device may comprise a hand-held wireless remote control, which is conveniently operable by the patient to switch on and off the coBstriciion/silmulation unit. The wireless remote control may also be designed for application on the patient's· body like a wristwatek Such a wristwatch type of remote control may emit a control signal that follows the patient's body to implanted signal responsive means of the apparatus. in a preferred embodiment of the invention, the constriction device is adjustable to enable adjustment of the constriction of the wall portion as desired, wherein the control device controls the constriction device to adjust the constriction of the wall portion. The control device may control the constriction and stimulation' devices independently of each other, and simultaneously. Optionally, the control device may control the stimulation device to stimulate, or to not stimulate the wall portion while the control device controls the constriction device to change the constriction of the wall portion.
Initially, the constriction, device may be calibrated by using the control device to control the stimulation device to stimulate the wall portion, while controlling the constriction device to adjust the constriction of the wall portion until the desired restriction, of the flow in the lumen Is obtained.
Regarding Stimulation alone or in combination,with a dtn ice
The control device may control the stimulation device to stimulate one or more of the areas of the wall portion at a time, for example by sequentially stimulating the different areas. Furthermore, the control device may control the stimulation device to cyclically propagate the stimulation of the areas along the wall portion, preferably -in accordance with a determined stimulation pattern. To achieve the desired reaction of the tissue wall during the stimulation the intensity öf the stimulation of the wait portion,. in a preferred embodiment of the invention, the control device controls the stimulation device to intermittently stimulate the areas of the wall portion with pulses that preferably form pulse trains. At least a first area and a second area of the areas of the wall portion may be repeatedly stimulated with a first pulse train, and a second pulse train, respectively, such that the first and second pulse trains over time-are shifted relative to each other. For example, the first area may he stimulated w'ith the first pulse train, while the second area is ml stimulated with said second pulse train, tod vice versa. Alternatively, the first and second pulse trains may he shifted relative to each other, such that the first and second pulse trains at least partially overlap each other.
The pulse trains can he configured in many different ways. Thus, the control device may control the stimulation device to vary file amplitudes of the pulses of file pulse trains, the duty cycle of the individual pulses of each pulse train, the width of each pulse of the pulse trains, the length of each pulse train, the repetition frequency of the pulses of the pulse trains, the repetition frequency of the pulse trains, the number of pulses of each pulse train, and/or the off time periods between the pulse trains. Several pulse trains of different configurations may be employed to achieve the desired -effect
In ease the control device controls the stimulation device to vary the off time periods between pulse trains that stimulate the respective area of the wall portion, it is also possible to control each off time period between pulse trains to last long enough to restore substantially normal blood '.circulation in the: area when, the latter is not stimulated during the off time periods.
An electric stimulation device suitably comprises at least one, preferably a plurality of electrical elements, such, as electrodes, for engaging and stimulating the wall portion, with electric pulses. Optionally, the electrical, elements may be placed in a fixed orientation relative to one another. The control device controls the electric stimulation, device to electrically energize the electrical elements, one at a time, or groups of electrical elements at a time. Preferably, the control device controls the electric stimulation: device to cyclically energize each element, with electric pulses. Optionally, the control device may control the stimulation device to energize the electrical elements, such that the electrical elements are energized one at a time In sequence, or such that a «umber or groups of the electrical elements are energized at the same time,. Also, groups of electrical elements maybe sequentially energized, either randomly or in accordance with a predetermined pattern.
The electrical elements may fonts any pattern of electrical elements* Preferably, the electrical elements form an elongate pattern of .electrical elements, wherein the electrical elements are applicable on the patient’s wall of the organ, such that the elongate pattern of electrical elements extends lengthwise along the wall, of the organ, tod the elements abut the respective areas of the wall portion* The elongate pattern of electrical elements may include one or more rows of electrical elements extending lengthwise along the wall of the organ. Each row of electrical elements may form a straight, helical or zig-zag path of electrical elements* or any form of path,. The control device may control the stimulation device to successively energize the electrical elements longitudinally along the elongate pattern of electrical elements In a direction opposite to, or in the same direction as that of, the flow in the patient’s lumen.
In accordance with a preferred embodiment of the invention, the electrical elements form a plurality of groups of elements, wherein the groups form a .series of groups extending along the patient’s organ in.the Sow direction in the patient’slunten, The electrical elements of each group of electrical elements may form a path of elements extending at least in part around the patient’s organ* In a first alternative, the eleetrical elements of each group of electrical elements may Irirm more than two paths of elements extending on different si des of the patient’s organ, preferahly substantially transverse to the flow direction in the patient’s lumen. The control device may control .'the· stimulation device to energize the groups of electrical elements in the series of groups in random, or in accordance with a predetermined pattern. Alternatively, the control device may control the stimulation device to successively energize the groups of electrical elements in the series of groups in a direction opposite to, or in. the same direction as that of, the flow in the patient’s lumen, or in both said directions starting from a position substantially at the center of the constricted wall portion. For example, groups of energized electrical elements may form advancing waves of energized electrical elements, as described above; that is, the control device may control the stimulation device to energize the groups of electrical elements, such that energized electrical elements form two waves of energized electrical elements that simultaneously advance from the center of the constricted wall portion in two opposite directions towards both ends of the elongate pattern -of electrical elements.
Sensor
The control device may control the stimulation .device to change the stimulation of the wall portion In response to a sensed physical parameter of the patient or hmctional parameter of the device. For example, the control device may control the stimulation device to increase the intensity of the stimulation of the wall portion in response to a sensed pressure increase in. the oviduct» such that the flo w in the oviduct remains stopped. Any sensor for sensing a physical parameter of the patient, such as a pressure in the patient’s body that relates to the pressure in the oviduct may be provided», wherein the control device controls the stimulation device in response to signals from the sensor. Such a sensor may for example sense the pressure in the patient's abdomen, the pressure against the implanted constriction device or the pressure on the tissue wall, of the bodi ly organ.
For example, a hormone level sensor may be applied where the present invention is used for controlling flow of the egg,
Sensor Controlled Restriction and/or Stimulation Device
As mentioned above, the device may comprise at least one implantable sensor, wherein the control device controls the constriction device and/or the stimulation devicein 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 device, or at least one functional parameter of a. medical impl ant in. the patient.
The system is further preferable adapted to send feedback information from inside the body to the outside thereof to give feed hack related to any functional parameter of the device or physical parameter of the patient.
The functional parameter of the device may be correlated to the transfer of energy for charging the. internal energy source mentioned In other places.
The functional parameter of the device may he the energy balance, the balance between the energy received and the energy used including accumulated by the device and the energy balance could also include the balance between an energy reception rate and an energy using including accumulating rate.
Many different kinds of sensor for sensing physical parameters may be used.
The control device may comprise an implantable internal control unit that directly controls the constriction device and/or stimulation device In response to signals from the sensor. The control device may further comprise a wireless remote control adapted to set control parameters' of the internal control unit horn outside the patient without mechanically penetrating the patient. At least one of the control parameters, which is settable by the wireless remote control, is the physical or functional parameter. Suitably,, foe internal control trait includes the above mentioned dock mechanism, wherein die wireless remote control also is adapted to set the clock mechanism.
Alternatively, the control device may comprise an external control unit outside the patient’s body for controlling the constriction device and/or stimulation device in response to signals from the sensor;
In several alternative embodiments of the Invention, the constriction device is adjustable. In .these embodiments, there Is an operation device for operating the adjustable constriction device-to'change the constriction of the patient’s tissue wall portion, and the constriction and stimulation devices form a constrietion/stimulation unit Preferably, the constriction and stimulation devices of the consiriction/stinraiatioe unit are integrated in a single piece sui table for implantation. The constriction device of the unit comprises contact surfaces dimensioned to contact a length of a tissue wail portion of a patient’s organ, trad the stimulation device of the unit comprises a plurality of stimulation elements provided on and distributed along die contact surfaces. When the control device controls the stimulation device to stimulate the wall portion, the stimulation elements stimulate different areas of the wall portion, along the length of the wall portion. Hie stimulation elements preferably comprise electric elements, as described above, for stimulating the wall portion with electric pulses. However, in most applications of fee present invention, other kinds of stimulations, such as thermal stimulation, could be suitable to employ,
The operation device operates the -adjustable constriction device of the consirictk>&%imulatioa unit in a manner that depends on the design, of the constriction device, as will be explained by the following examples of embodiments, 1) The constriction device comprises at least two elongated clamping elements having the contact surfaces and extending along the wall portion on different sides of the organ, and the operation device operates the clamping elements to clamp the wall portion between the damping; dements to constrict the wall portion of the organ, 2) The constriction device comprises one elongate clamping element: having the contact surfaces and extending along the wall portion on one side of the organ, and the operation device operates the clamping demerit to damp the wall portion between- the clamping element and the bone or tissue of the patient to constrict the wall portion. 3} The constriction device comprises at least two engagement elements having the contact surfaces and positioned on different sides of the organ* and the operation device rotates the engagement elements* such that the engagement elements engage and constrict the wall portion of the organ. 4) The constriction device comprises at least two -artiaiiated clamping elements having the contact surfaces and positioned on di fferent sides of the organ* and· the operation device moves the damping elements towards each other to clamp the-wall portion of the organ between the clamping, elements, to constrict the wall portion, 5) The constriction device comprises at least two separate clamping elements having the contact surfaces, at least one of the clamping elements being pivoted, such, that it .may turn in a plane in which the loop of the constri ction member extends, and the operation device toms the pivoted, clamping element to change the size of the constriction opening, 6) The constriction device comprises at least one elongated constriction member having the contact surfaces, and forming mentis for forming the constriction member into at least a substantially closed: loop around the organ, wherein the loop defines a constriction opening. The operation device operates the constriction member in the loop to change the size of the constriction opening, da) The elongated constriction member comprises a belt having the contact surfaces, and the operation device operates the belt to change the longitudinal extension of the belt in the loop to change the size of the constriction opening. The forming means may form the constriction member or belt into a loop having at least one predetermined size, 6b) The elongated constriction member is operable to change the si ze of the constriction opening, such that the outer circumferential confinement surface of the constriction device Is changed, or, alternatively, is ««changed. be) The elongated constriction., member is elastic and varies In thickness as seen in a cross-section 'there through, and is operable to turn around the longitudinal extension of the constriction member. §d) The elongated constriction member comprises two substantially or partly semi-circular feme elements having the contact surfaces and hinged together, such that the semi-circular elements are swiagable relative to each other from a fully open state in which thpy-substantially or partly form a circle to a folly folded state In which they substantially form a semi «circle. 7) The completion device is adapted to bend the wall portion of the organ to constrict the latter,.
In'the above noted embodiments (1) to (7), it is important that the constriction device is designed to constrict said length of the tissue wall portion of the patient’s organ. For this purpose, the constriction device may include two-or more of the described constriction elements/meoibers to be applied in a row along said length of the wall portion, wherein said row extends in the direction of Sow in the oviduct of the organ. Preferably, such constric tion eiemenis/memhers are nou-hiilatable and mechanically operable or adjustable.
In the above noted embodiments (1) to .(7), the operation device may either mechanically or hydraulically adjust the constriction device of the constriclion/siiuiulation unit. Also», die operation device may comprise an electrically powered operation device for operating the constriction device. For many applications of the present invention, the operation device suitably operates the constriction device, such that the through-flow area of the oviduct assumes a size in the constricted state that enables the stimulation device to contract the wall portion such that the flow in the oviduct. Is stopped.
Where the operation device mechanically operates the constriction device of the constriction/stimulation unit, it may be non-mfiatable. Porihermore, the operation device may comprise « servo device, winch may include a gearbox. The term “servo device” encompasses the normal definition of a· servo mechanism, i,e., an automatic device that controls large amounts of power by means of very small amounts of power, but may alternatively or additionally encompass the definition of a mechanism that transfers a weak force acting on a moving element having a long stroke into a strong force acting on another moving element having a short stroke. Preferably, the operation device operates the constriction device in a non-magnetie and/or non-manual manner. A motor may be operatively connected to the operation device. The operation device may fee operable to perform at least one reversible .function and the motor may be capable of reversing the funct ion,
Where the operation device hydraulically operates the constriction device of the constriction/stimulation unit, it includes hydraulic means for adj usting the constriction device.
In an embodiment of the invention, the hydraulic means comprises a reservoir and an expandabie/contraetible cavity in the constriction device, wherein the operation 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 defined by a balloon of the constriction device that abuts the tissue wall portion of the patient’s organ, so that the patient’s wall portion is constricted upon expansion of the cavity and released upon contraction of the cavity.
Alternatively, the cavity may be defined by a bellows that displaces a relati vely large contraction element of the constriction device, for example a large balloon that abuts the wall portion, so that the patient's wall portion is constricted upon contraction of the bellows and released upon expansion of the bellows. Thus, a relatively small addition of hydraulic fluid to foe bellows causes a relatively large increase in the constriction of the wall portion. Such a bellows may also be replaced by a suitably designed piston/cyhnder mechanism.
Where the hydraulic means comprises a cavity in the constriction device, the device of the invention can be designed in accordance with the options listed below. 1) The reservoir comprises first and second wall portions, and foe operation device displaces the first and second wall portions relative to each other to change the volume of the reservoir, such that fluid is distributed .from the reservoir to the cavity, of from the cavity to foe reservoir. la) Hie -first and second wall portions of the reservoir are displaceable relative to each other by at least one of a magnetic device, a hydraulic device or m electric control device, 2) The operation device comprises a pump for pumping fluid between the .reservoir and the cavity. 2a) The pump comprises a first activation member for activating foe pump to pump fluid from the reservoir to the cavity and a second activation member for .activating·the pump to pump fluid from foe cavity to the reservoir. 2a 1) The first and second activation members are operable by manual manipulation thereof, 2a2) At least one of the activation members operates when subjected to an external predetermined pressure. 2a3) At least one of the first and second activating members is operable by magnetic mesas, hydraulic means, or electric control means. 2b) The device comprises a fluid conduit between the pump ami the cavity, wherein the reservoir forms part- of the conduit The conduit and pump are devoid of any nonreturn valve. The reservoir forms a fluid chamber with a variable volume, and the pump distributes fluid from the chamber to die cavity by a reduction in the volume of the chamber and withdraws fluid from the cavity by an.expansion of the volume of ibe chamber, The device further comprises a motor for dri ving the pump, wherein the pump comprises a movable wall of the reservoir for changing the volume of the chamber.
In ail of the above noted embodiments I to 2b where the hydraulic means comprises an expandable cavity in the constriction device, the cavity can be exchanged by a cylinder/piston mechanismfor adjusting the constriction device. In this case, the operation device distributes hydraulic fluid between the reservoir and the cylinder/piston mechanism to adjust the constriction device.
In a special embodiment of the invention, the operation device, comprises a reverse servo, operatively connected to the hydraulic means. The term "Reverse servo” is to be understood as a mechanism that transfers a strong force acting on a moving element having a short stroke into a weak force acting on another moving element having a long stroke; ie», the reverse function of a normal servo, mechanism. Thus, minor changes in the amount of fl uid in a smaller reservoir could he transferred by the reverse· servo Into major changes in the amount of fluid in a larger reservoir.' The 'reverse servo is particularly suited fen manual operation thereof
Preferably, the reverse servo comprises· an expandable servo reservoir containing servo fluid and a fluid supply reservoir hydraulically connected to'the servo reservoir to form a closed conduit device for the servo fluid. The expandable: servo reservoir has first and second wall portions, which are displaceable relative to each other in response to a change in the volume of the expandable .servo reservoir.
In accordance with a first alternative, the first and second wall portions of the servo reservoir are operatively connected to the hydraulic means. The reverse servo distributes fluid between the fluid supply reservoir and the expandable servo reservoir to change the volume of the servo- reservoir, whereby the hydraulic means is operated to adjust the constriction device,.
In accordance with a second alternative, there Is provided an implantable main reservoir containing a predetermined amount of hydraulic fluid, wherein the reverse servo is operable to distribute hydraulic fluid between the main reservoir and the hydraulic means to adjust the wall portions operatively connected to the first and second wall portions of the expandable servo reservoir, such that the volume of the main reservoir is changed when the volume of the expandable servo reservoir is changed. Thus, when the reverse servo distributes servo fluid between the fluid supply reservoir and the expandable 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 and main reservoirs are dimensioned, such that when the volume of the servo reservoir is changed by a relatively small amount of servo fluid,'the volume of the main reservoir is changed by a relatively large amount 'of hydraulic fluid, in both of the above-described alternatives, the fluid supply reservoir may have first and second wall portions, which are displaceable relative to each other to change the volume of the fluid supply reservoir to distribute servo fluid between the fluid supply reservoir and the expandable servo reservoir. The first and second wall portions of fee fluid supply reservoir may be displaceable relative to each other by manual manipulation, a magnetic device, a hydraulic device, or an electric con trol device to change the volume of the fluid supply reservoir to distribute servo fluid between fee fluid supply reservoir and the expandable servo reservoir.
In all of fee above noted embodiments 1 to 2b where fee hydraulic means comprises an expandable cavity In. the constriction device, or in embodiments where the hydraulic means comprises a hydraulically operable mechanical construction:, the operation device .may include the reverse servo described above. In a further embodiment of the invention, the hydraulic means include first arid second hydraulically hitereomiected expandable/eonü'aetible reservoirs. The first reservoir is operatively connected to the constriction device, such that the constriction device changes the constriction of the patienfis wall 'portion upon expansion or con traction of the first reservoir. By changing fee volume of the second reservoir hydraulic fluid is. distributed between fee two reservoirs, so that the fust reservoir is either expanded or contracted. This embodiment requires no non-return valve in. the fluid communication conduits between fee two reservoirs, winch Is beneficial to long-term operation of the hydraulic means.
Alternatively, fee hydraulic means may include first and second hydraulically interconnected pisfon/eyilnder mechanisms instead of fee first and second .reservoirs described abo ve,. The first piston/eylinder mechanism is operatively connected to fee constriction device, such, that the constriction device changes the constriction of the patient’s wall portion «poft operation of the first plston/cylinder .mechanism, By operating the second pision/eylmdet mechanism hydraulic fluid is distributed between the two piston/cylinder mechanisms, so that the first piston/eyfinder mechanism. adjusts the constriction device.
Where the constriction device does not include an eapandablc/contractible cavity, the constriction device may comprise at.least two elongated clamping elements having the above-mentioned cont act surfaces and extending along the wall portion on different sides of the organ. The hydraulic means, which may include the reverse servo described, above, hydraulically moves the elongated damping elements towards the wall portion to constrict the wall portion. For example, the constriction device may have hydraulic chambers in which the clamping elements 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 chambers to move the clamping elements against the wall portion, and distributes hydraulic fluid from, the chambers to the reservoir to move the clamping elements away from firewall portion.
More than one restriction area
The restriction device independent of which type or combination' Of types preferable comprises a more than one restriction area being: adapted to change the restriction area over time. This will prevent any damage to the oviduct still keeping the oviduct closed avoiding any egg to pas down to the uterus thus avoiding pregnancy.
In one embodiment the system comprising a hydraulic restriction device with two or more restriction areas connected individually to two or more reservoirs with hydraulic fluid» said reservoirs adapted to he regulated to move fluid from said reservoirs individually to each of the connected restriction areas. It Is possible to use only one reservoir if valves instead control to which restriction the hydraulic fluid is acting on.
The hydraulic restriction areas is adapted to be restricted for a predetermined time period preferahle with some overlap in time and adapted to first restrict the restriction area closest to the ovary theft changing restriction area towards the uterus. This way the restriction may all the time be kept but without risking to have any egg to pas when changing restriction area 'both because of the overlap in restriction and also because restriction is started first closest to the ovary where the egg is released.
The hydraulic restriction areas may fee adapted to be regulated fey manual manipulation thereof.
The system may also fee adapted to have the changes of the restriction, area cause a peristaltic wave like restriction wave in the direction towards the ovary to prevent the egg being transported down to the uterus. This peristaltic wave may be caused fey any of the different types of restriction devices or combinations described earlier. This wave could prevent tire egg feeing transported down to the uterus also without fully restricting the oviduct. This would then allow the sperm to reach the egg daring the accumulation period of a few days, thus increasing likelihood of pregnancy even further.
The restriction device may also be adapted to effect a transport of the at least one egg to the nteras upon release of the oviduct. This may be with a peristaltic wave like restriction wave In the opposite direction towards the uterus. A system of increasing likelihood of pregnancy may be adapted to restrict a first part or area of an oviduct of the patient to provide a restriction to accumulate at least one egg released from the ovary In the oviduct for a predetermined period of time, and adapted to restrict a second part of the oviduct and thereafter release .the restriction of the first part and also later release the restriction of the second part, thereby allow transport of the egg down to the uterus or the system may further be adapted to also restrict, a third part of the oviduct and release the restriction of the second part also it may further he adapted to release the restriction of the third part thereby allow transport of the egg down to the uterus or the system may he adapted to restriet a fourth part of the o viduct and release the restriction of the third part. Finally it may be further adapted to release the .restriction of tire fourth -part, thereby allow transport of the egg down to the uterus,
The number of restriction areas has no limit except practical size issues and the ..restriction time period is preferable divided between the restriction areas. Either the restriction area is moved from the ovary and. further down towards the uterus step fey step thus avoiding any interference with any accumulated egg being involved in any restriction area if a certain overlap in time is fulfilled between the consecutive restriction areas in use or the restriction areas are moved both up- and down-stream then preferable using a movement device to move the egg in the oviduct to avoid any egg feeing squeezed in any .restriction area when, restriction are moved towards the ovary or having die peristaltic like wave moving towards the ovary keeping the egg accumulated in the oviduct without .fully restricting the same.
Preferable a hydraulic restriction device only partly restricting the oviduct is used maybe in combination with a stimulation, device to cause the peristaltic wave in the oviduct With the stimulation device it is then possible to move the restriction area, The hydraulic device may for example have the movement function to cause die movements necessary.
Any combination is possible of mechanical, hydraulic or stimulation device or separate use of the same
In summary preferable more than two restricting areas is used and varying the restricting area while at least one restricting area is closed when the device being in restriction mode.
If the device is adapted to restrict the first part of the oviduct closest to the ovary it will allow the second restriction being restricted without interfering with any accumulated egg.
There are no limit tow many areas could be restricted except practical and size issues.
Moving in restriction from the ovary and down towards the uterus is then the preferred way of doing it for example three restrictions could share a time period of three days with one day-each to not risking to In any way damage the oviduct, A system adapted to restrict the restriction areas iu'consecutive order starting with the restriction area, pari, of the oviduct, doses! to the ovary and thereafter restrict any new area one step closer to the uterus and 'farther adapted to overlap in rims the restriction of more than, one restriction area will allow to restrict without Interfering with any accumulated egg.
PERISTALTIC LIKE WAVE OVIDUCT WALL MOVEMENTS
The restriction device may be adapted to only partly restrict the oviduct and to create peristalti c· wave like movem ents of a part of the ovidoct(s) wall to prevent the transport o f an egg in an oviduct to the uterus of the human or mammal patient, and therefore accumulate at least one egg released from the ovary in the oviduct for a, predetermined period of time, and wherein the sperm is able to reach the egg during the time the egg is accumulated because the oviduct is only partly restricted, and the restriction device further adapted to release the egg, controlled from outside the body, to allow the at least on egg In the oviduct a transport to the uterus.
The device is then preferable adapted to comprise at least one restricted area adapted to at least partly restrict and change the restriction area: over time most likely adapted to eompri.se two or more restricted areas adapted to at least partly restrict different portions of the oviduct and change the restriction area o ver time.
The change of the restriction area may fee adapted to cause a peristaltic wave like wave in the direction towards the ovary to prevent the egg feeing transported: down to the uterus.
The restriction device may comprise a hydraulic device or a mechanical device or a stimulation device adapted to cause said peristaltic wave like restriction wave.
The device is adapted to allow a transport of the at least one egg to the uterus upon release of the oviduct and may even cause a another peristaltic wave like restriction wave in the opposite direction towards the uterus.
The device is adapted to fee adjusted which could fee done by manual manipulation or electrical or magnetic power.
The restriction areas is only partly restricted to allow the sperm to reach the egg and die device adapted to prevent the egg to temporary reach the uterus with the peristaltic wave, to accumulate the egg temporary in the oviduct to allow increased likelihood for pregnancy to pro long the time .period'die egg feeing reachable fey the sperm.
When the restriction areas is completely restricted to prevent the egg. to temporary teach the uterus, the timing of the release of the egg is crucial after having accumulated the egg temporary in the oviduct, the whole procedure to allow increased likelihood for pregnancy when released.
The restriction device is adapted to and intended to repeatedly every month repeat the post» operational and non-ln vasive regidatlon of the device actively reversible to prevent transport, of an egg from the ovary to the uterus in the oviduct of the patien t and reverse the function fey allowing die normal transport of the egg from the ovary to the uterus until pregnancy has heen achieved.
Hie device may comprise a mechanical device or a hydraulic device or a stimulation device adapted to cause said peristaltic like wave towards the ovary.
Restriction embodiments
The restriction device may comprises a mechanical restriction device or a hydraulic restriction device or a stimulation device or a stimulation device in combination with a mechanica! or hydraulic restriction device or any other combination.
The method may include a hydraulic restriction device comprising a réservoir» lor moving gas or fluid to or from said restriction device and wherein said reservoir is placed subeutaneously for i, being reached by the patients hand for ii moving fluid manually to or from said restriction device
Preferable two or more reservoirs could be used for restricting different areas, .starting-with the area closest to the ovary.
Method -movement device
The movement device is adapted to move the egg out of a varied upcoming new restricted area before a new area is restricted useful if the restriction need to he moved also in the direction towards the-ovary in which case the egg could slip through if being squeezed- by one restriction area and later released.
The movement device may be the same device as the restriction device, adapted to. work differently when restricting or causing mo vements of the egg or it may he a different devi ce as the restriction device adapted to work differently when restricting or cansing movements of the egg.
The movement device .may cause vibration or wave like movements in the oviduct: wall thereby causing movements of the egg,
FURTH ER -METHODS A method of promoti ng pregnancy of a female mammal or human patient, may comprise the following steps: restricting an oviduct of the patient postoperatively to provide a restriction to accumulate at least one egg released from the ovary' in the oviduct for a predetermined period of ti me, and releasing the restriction to admit any egg in the oviduct a transport to the uterus controlling the restricting ami releasing procedures from outside the patients body.
In this and other methods the predetermined period of time is adapted to avoid pregnancy and may be between Ö and 2 days or preferable 8-12 hours. A method for placing and- controlling two 'implanted restriction devices promoting pregnancy in a human or mamma! patient, the method comprising the steps of: . «inserting: a needle like tube into the abdomen of the patients body, ~ «sing the tube like needle like to fill the abdomen with gas thereby expanding the abdominal cavity, - placing at least two laparoscopic trocars in the patient's body, - inserting a camera through one of the trocars into the abdomen, - inserting at least one dissecting tool through a trocar and dissecting an area of at least one portion of the two oviducts of the patient, ~ placing two implanted restriction devices, on each of the two oviducts - adjusting the restriction devices after the operation at a time convenient: to get pregnat thus, - controlling the adjustment from outside the patients body mid - poshoperati vely restricting and releasing the two' oviducts to increase the likelihood of getting pregnant
Both methods above could when restricti ng the oviduct 'comprising the following steps: - restricting a first pari or area of an oviduct of the patient to pro vide a restriction to accumulate at least one egg released from the ovary in the oviduct for a predetermined period of time, and - 'restricting a second part of the o viduct - releasing the restriction of the first part - allowing the oviduct shorter restriction periods .at each restriction area.
May also comprise: the steps of: - releasing the restriction of the second part - allowing transport of the egg down to the uterus
May also comprise the steps of: ~ restricting a third part: of the oviduct - releasing the restriction of the second part - allowing the oviduct shorter restriction periods at each restriction area.
May also comprise the steps of: ~ releasing the restriction of the third pari - allowing transport piths egg down, to the uterus May also comprise the steps of; -restricting a fourth part, of the oviduct - releasing the restriction of the third pari - allowing the oviduct shorter restriction periods at each restriction area.
May also comprise the steps of: * releasing the restriction of the fourth part ~ allowing transport of the egg down to the uterus
In both these methods normally if the restricted fi rst part of the oviduct, being closer to die ovary'' this is, - allowing the second restriction being restricted without interfering with, any accumulated egg.
Normally these methods, - having more than two restricting: areas and - varying-the restricting area while - keeping at least one restricting area closed when restriction being wished in a preferred embodiment; the restriction areas being restricted in consecutive order starting with die restriction area, part of the oviduct, closest to the ovary thereafter - restricting any new area one step closer to the uterus ~ overlapping in time the restriction of more than one restriction area thereby, ~ restricting without interfering with any -accumulated egg A method may of course only include- independent of order varying the restriction, area postoperatively to allow the oviduct to recover or avoid any damage front the restriction while - keeping the oviduct restricted.
Another method of promoting pregnancy of a female patient, comprising the following steps: preventing the transport of an egg in an oviduct to the uterus of the human or mammal patient, accumulating at least one egg released from the ovary in the oviduct for a predetermined period of time, by »easing a. peristaltic like restriction wave movement of a pari of the oviduct(s) wall preventing the egg being transported down to the uterus while only partly restricting the oviduct,-and ~ allowing the spermie to reach the egg during the time the egg is accumulated, and »releasing the egg post-operatively controlled from the outside the human body to admit the at least on egg in the- oviduct to allow a transport of tire at least one egg to tire uterus. A method for placing the device above and controlling the implanted device promoting pregnancy'in a human or mammal patient, the'method comprising the steps of: »insetting a tube like needle into tire abdomen of ibe patients body, - using the tube like needle like to ill the abdomen with gas thereby expanding the abdominal cavity, «placing at least two laparoscopic trocars in the patient’s body, - inserting a camera through one of the trocars into the abdomen, - inserting at least one dissecting tool through a trocar'and dissecting an area of at least one portion of the two oviducts of the patient : - placing two parts of the Implanted device, one each on the two o viducts - finishing the operation and withdrawing the moments after eventual suturi ng and thereafter posioperativelyr - adjusting the device after the operation at a time relevant to get pregnat, - controlling the adjustment Horn outside the patients body and thereby ~ easing a peristaltic like wave awvement of a part of the oviducts) wall towards the ovary preventing the egg being .transported down to the uterus without fully restricting tbs oviduct,, thereby - preventing flow of any egg to reach the uterus in the'two oviducts for a predetermined period of time and thereby ~ accumulating any -egg-released from the ovary in the ovidnet(s) by ~ allowing the spermie to reach tire egg during the time the egg is accumulated - releasing any egg in die oviduct from outside the body to allow the egg to In a normal way fee transported do wn to the clems.
Movement device method
Another method o f pre ven ting pregn ancy of a female human or mammal patient may he provided, comprising the following steps: - restricting a .first part, of an oviduct of the patient to provide a restriction to accumulate at least one egg released from the ovary in the oviduct tor a predetermined period of time, and - moving the accumulated, egg by said movement device away lathe oviduct towards the ovary from the restriction area, »allowing a second part of the oviduct closer to the ovary being restricted without interfering with any accumulated egg ~ releasing the restriction of the first part - repeating the restriction of the-first, part - releasing the restriction of the second part - allowing the oviduct to recover between restriction intervals.
Preferably followed by; - repeating moving any accumulated egg by said movement device away in the oviduct towards the ovary from the restricted first area, repeating - allowing a second part of the oviduct closer to the ovary being restricted without interfering with any accumulated egg, further repeating ~ releasing the restriction of the first part ~ repeating the complete procedure allowing the o viduct to recover between' restriction intervals.
Preferable also the restriction areas is adapted to be varied between three or more areas always keeping the oviduct closed.
Said movement device may comprise a vibrating device, for causing a vibration of at least a part of the wall of said oviduct causing movement-of any accumulated egg, said movement being repeated.
Said movement device may comprise a mechanical device or a hydraulic device or a stimulation device or a combined device.
Design of control device
The control device suitably controls die constriction- and /or stimulation unit.from outside the . . - *r .... patient’s body. Preferably, the control device Is operable by the patient. For example, the control device may comprise a manually operable switch for switching on and off the consbiction/stimolation unit, wherein the switch is adapted for subcutaneous implantation in the patient to be manually or magnetically operated from outside the patient*s body. Alternatively, the control device may comprise a hand-held wireless remote control, which is conveniently operable by the patient to switch: on and off the eonstrietlon/sfimulMion unit.
The wireless remote control may also be designed for application on the patient s body like a wristwateh. Such a. wristwatch type of remote control, may emit a control signal that follows the patient’s body to implanted signal responsive means of tlie device,
Where the control device wirelessly controls the coastrietion/stimnlation unit tom outside the patient's body, the wireless control function is preferably performed in a non-magnetic manner, Le,, the control device controls the constriction device of the eonstrletlon/stlmulation unit in a non-magrserie manner. The patient may use the remote control to control the eonstrictioiVstimulafion unit to adjust the stimulation intensity and/or adjust the constriction of the wall portion. The wireless remote control may comprise at least one external signal transmitter or transceiver and ai least one internal signal receiver or transceiver Implantable in the patient.
The wireless remote control preferably transmits at least one wireless control signal for controlling the eomiriction/stimulation «nit. The control signal may comprise a frequency, amplitude, phase modulated signal or a combination thereof, and may he an analogue or a digital signal, or a combination of an analogue and digital signal. The remote control may transmit art electromagnetic earner wave signal for carrying the digital or analogue control signal. Also the carrier signal may comprise digital, analogue or a combination of digital and analogue signals.
Any of the abo ve control signals may comprise wave signals, for example a sound wave signal, an ultrasound wave signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, an. ultra violet light signal, a laser light signal, a microwave signal, a radio wave signal, an x-ray radiation signal or a gamma radiation signal. Alternatively, the control signal may compri se an electric or magnetic field, or a combined el ectric and magnetic held.
As mentioned above, the control signal may follow the patient’» body to implanted signal responsive means of the device,
The control device may include a programmable internal control unit, such .as. a miaoprocessof, implantable in the patient for controlling the eonsfricitosVsiimuIation unit.
The control device may further include an external control unit intended to he outside the patient’s body, wherein the internal control unit is programmable by the external control unit For example, the internal control unit maybe programmable for controlling the constoction/stimnlation unit over time, suitably in accordance with an activity schedule program.. The device of the invention may comprise an external data communicator and an implantable internal data communicator communicating with the external data communicator, wherein the internal communicator feeds data related to the eonstrietion/stitnuiation unit back to the external data communicator or the external data communicator feeds data to the internal data communicator,
Source of Enemy
The present invention also presents a solution for supplying energy for use in connection with the operation of the constriction/stimulation unit. Thus, in a broad sense, the present mvention provides an device for controlling a llow of egg in a oviduct formed by a tissue wall of a patient's organ, wherein the device comprises an implantable constriction device for gently constricting a portion of the tissue wall to influence the flow in the oviduct, a stimulation device for intermittently and indi vidually stimulating different areas of the wall portion, as the constriction device constricts the wall portion, to cause contraction of the wall portion to further influence the flow in the oviduct, wherein the constriction and stimulation devices form an operable:.comtriction/stim.«lation unit, a source of energy, aid a control device operable from outside the patient’s body to control the source of energy to release energy for use in connection with the operation of the eonsferiction/srimulation unit In a simple form of the invention, the source of energy, such as a battery or accumulator, is implantable in the patient’s body*
In a more sophisticated form of the invention, which is preferable, the source of energy is external to the patient’s body and the control device controls, the external source of energy to release wireless energy, in this sophisticated form of the Invention, the device comprises an energy-transmission device that transmits the released wireless energy from outside the patient’s body to inside the patient’s body. Among many things the wireless energy may comprise electromagnetic energy, an electric field, an electromagnetic field or a magnetic field, or a combination thereof, or electromagnetic waves. The energy-transmission device may transmit wireless energy for direct use in connection with the operation of the consfilction/stimuiation unit, as the wireless energy is being transmitted., for example, where an electri c motor or pump operates the constriction device, wireless energy In fire form of a magnetic or an electromagnetic field may be used tor direct power of the motor or pump.
Thus, the motor or pump is running directly during transmission of foe wireless energy. This may be achieved in two different' ways: a) using a transforming device implanted in the patient to transform the wireless energy into energy of a different form, preferably electric energy, and powering fire motor or pump' with· the transformed energy, or b) using the wirelessly transmitted energy to directly power the motor or pump. Preferably wireless energy In: the form of an electromagnetic or magnetic field is used to directly influence specific components of the motor or pump to create kinetic energy for driving the motor or pump.
Such components may include coils integrated In the motor or pump, or materials Influenced by magnetic fields, or permanent magnets, wherein the magnetic or electromagnetic field influences the colls to generate a current for driving ibe motor or pump, or Influences the materia! or permanent magnets to create kinetic energy tor driving file motor or pump.
Preferably, the energy-transmission device transmits energy by at least one wireless signal,, suitably a wave signal. The wave signal may comprise an electromagnetic wave signal including one of an infrared light signal, a visible light signal , an. ultra violet light signal, a laser signal, a microwave signal, a radio wave signal, an x-ray radiation signal, and a gamma radiation signal Alternatively, the wave signal may comprise a sound or ultrasound wave-signal. The wireless signal may he a digital or analogue signal, or a combination of a digital and analogue signal.
Transforming Wireless Enemy
In. accordance with-a particular embodiment of the invention, an implantable energy-transfomhng device is provided for transforming· wireless energy of a first form transmitted by the energy-transmission device into energy of a second loon, which typically is different from the energy of the first form. The cousin ction/stimu lation unit is operable in response to the .energy of the second, form. For example, the wireless energy of the first form may comprise sound waves, whereas the energy of the second form may comprise electric energy. In this case, the energy-transforming device may include-a piezo-electric element for transforming, the sound waves into electric energy. Optionally, one of the energy of the first form .and the energy of the second form may comprise magnetic energy, kinetic energy, sound energy, chemical energy, radiant energy, electromagnetic energy', photo energy, nuclear energy or thermal energy. Preferably, one of the energy of the first form and the energy of the second form is nem-magnetic, non-kinette, non-chemical, non-sonic, non-nuclear or nonthermal
The energy-transforming device may inaction differently from or similar to the energy-transmission device. In a special 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 energy of the first form transmitted by the energy-transmission device, wherein the element is capable of creating an energy field ."between the positive and negative regions, and the energy field produces the -energy of fee second form. More specifically, the element-may comprise an electrical junction: element, which is capable of inducing an electric field between the positive and negative regions when exposed to fee energy of the: first form transmitted by the energy-transmission device, whereby fee energy of the second form comprises electric energy.
The energy-transforming device may transform the- energy of fee first form directly or indirectly into the energy of the second form. An implantable motor or pump for operating ' the constriction device of the eonstnefion/sfimulation unit may he provided, whereas the motor or pomp is powered by the energy of the second form. The constriction device may he operable to perform at least one reversible function and the motor may be capable of reversing the function. For example, the control device may shift polarity of the energy of the second form to reverse the motor.
The energy-transforming device may directly power the motor or pump with the transformed energy, as the energy of the second form is being, transformed from the-energy of the first form. Preferably, the energy-txansfonning device directly operates the eonstriciioo/stirnulation unit with the energy of the second form in a non-magnetic, non-thermal or non-mechanical manner.
Normally, the constriction/stimulation trait comprises electric components that are energized with electrical energy. Other implantable electric componen ts of die device may be at least one voltage level guard or at least one constant current guard. Therefore, the energy» transforming device may transform the energy of the first form into a. direct current or pulsating direct, current, or a combination of a direct current and pulsating direct current Alternatively, the energy-transforming device may transform the energy of the first form into an alternating current or a combination of a direct and alternating current,
The device of the invention may comprise an internal source of energy implantable in the patient for supplying energy for die operation of the constriction/stimulation unit. The device may further comprise an implantable switch operable to switch from an “off5 mode, in which t he internal source of energy is not in use, to an “or”' mode, in which the internal source of energy supplies energy for the operation of the constriofion/stimulafion unit, and/or for energizing implanted electronic components of the device. The switch may be operable by the energy of the first form, transmitted by the energy-transmission device or by the energy of the second form supplied by the energy-iransforaung device. The described switch arrangement reduces power consumption of the device between operations.
The internal source of energy may store the energy of the second form supplied by the energy-transforming device, hi this case, the internal source of energy suitably 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. Where the internal source of energy is a rechargeable battery·' it may be charged only at times convenient for the patient, for example when the patient is sleeping. Alternatively, the internal source of energy may supply energy for foe operation of the constrfctiofostimulaifon unit hut not be used for storing the energy of the second form, in this alternati ve, the internal source o f energy may he a battery and the switch described above may or may not be provided.
Suitably, the device of the i n vention compri ses an implantable stabilizer for st abilizing the energy of the second form, Where the energy of the second .form is electric energy the stabilizer suitably comprises at least one capacitor,
The energy- transforming device may be designed tor implantation 'subcutaneously in the abdomen, thorax or cephalic region of the patient. Alternatively, it may be designed for implantation in an orifice of the patient’s body and under the mucosa or intramuscularly outside the mucosa of the orifice.
Although the constdoion/sttmulaiion unit in the embodiments described above is designed as a single piece, which is most practical for implantation», it should be noted that as an alternative the constriction device and stimulation device could be designed as separate pieces. Any one of the constriction and stimulation units described above may alternatively be replaced by two or more separate constriction/'stiniulation elements, which are controlled independently of one another.
Where the a device is used tor controlling the flow of eggs into, the uterus of a female, the device comprises an implantable constriction device for constricting each one of the female’s uterine tubes to restrict the: passageway thereof, and a control device for controlling said constriction device to constrict the uterine tube such that an egg appearing in the passageway of the uterine tube is prevented, front entering the uterine cavity, and to release the uterine tube such that an egg existing in the passageway of the uterine tube is allowed to enter the uterine cavity.. The constriction device may gently constrict at least one portion of the tissue wall, of the uterine tube to restrict the passageway thereof, and an implantable stimulation device maybe provided for stimulating the tissue wall portion, wherein the control device controls said stimulation device to stimulate the tissue wall portion, as said constriction device constricts the tissue wall portion, to cause contraction of the tissue wall portion, to further restrict the passageway of the uterine tube.
Alternatively, the egg flow control device comprises m implantable constriction device for gently constricting at least one portion of the tissue wall of each one of the female’s uterine tubes to restrict the passageway thereof,, a stimulation devies for stimulating the tissue wail portion of the uterine tube, and a control device for controlling said stimulation device to stimulate the tissue wall portion, as said constriction device .constricts the tissue wall portion, to cause contraction of the tissue wall portion to further restrict the passageway of the uterine tube to prevent an egg existing in the-uterine tube -from entering the uterine cavity.
Alternatively, the egg How control device comprises an implantable stimulation device for stimulating a portion of the tissue wait of each one. of the female’s uterine tubes, and a control device for controlling said stimulation device to stimulate the tissue-wall portion of the uterine tube to cause contraction of the tissue wall portion, such that the passageway of fee uterin e tube is restricted to prevent an egg appearing in the uterine tube from entering the uterine cavity, and to cease stimulating the tissue wall portion of the uterine tube to allow an egg existing in the passageway of the uterine tube to enter the uterine cavity.
The present invention also provides a method for using an device as described above to control a flow of egg in a oviduct formed by a tissue wall of a patient's organ, the method comprising; providing a wireless remote control adapted to control fee constriction device and/or stimulation device from outside the patient's body, and operating the wireless remote control by the patient, when the patient wants to influence the flow of egg in the-oviduct.
Thé present invention also provides a method for controlling a flow of egg in a oviduct formed by a tissue wall of a patient’s organ, the method comprising: a) gently constricting at least one portion-of the tissue wail to influence the flow In the oviduct, and h) stimulating fee constricted wall portion to cause contraction: of the wall portion to further influence the flow in the oviduct,
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. IA illustrates a device according to fee invention applied on. the oviducts of a female patient, wherein devices are in a non-restricting operating state.
Fig. IB is a view similar to that of Fig- I A, but wherein devices are in a restricting operating state,
Pig, 2 A illustrates a device according to fee invention with remote control applied on. the oviducts of a female patient, wherein devices are in a non-restricting operating state. fïg, 2B is a view similar to that of Fig, 2A, but wherein devices are in a restricting operating state, fig, 3 A is a schematic view of a hydraulic operation means with a subcutaneously placed reservoir suited for operating the device of the embodiments of Fig. I A, .1B,
Fig. 3 B shows the embodiment of Fig, 3 A with the constriction device constricting a tissue wall of a patient's oviduct.
Fig, 4 A is a schematic view of mechanical operation means suited for operating the constriction device of the embodiments of Figs, 2-11.
Fig. 4B shows the embodiment of Fig. 4A with the constriction device constricting a tissue wall of a patient's organ.
Fig. 4C shows a modification of the embodiment of Fig, 4B.
Figs, 5 A, 5B and 5C are cross-sections of the embodiment of Fig. 2. showing different states of operations with the device appli ed on a tissue wall of a patient* $ organ.
Figs. 6A> 6B and 6C are cross-sections of a modification of the embodiment of Fig, 2 showing different states of operations with the device applied on a tissue wail of a patienfs organ.
Figs. 7AS 7B, 7C, ?D and ?E schematically illustrate different states of operation of a general embodiment of an device according to the present invention.
Figs, ?Ff?Cs and 7H illustrate different states of operation of a modification of the general embodiment
Figs, 71, 7K and 7L illustrate an -alternative, mod? of operation of the modification of the general embodiment.
Fig, 8A is a palse/time diagram showing electric stimulation pulses generated by the device of the invention for stimulating a tissue wall of a patient's organ.
Fig, SB is pulse/time diagram showing a modification of the electric stimulation sho wn in Fig, 8 A, in which pulses of mixed tfeqaencies and/or amplitudes am employed.
Figs, 8C and SD show two pulse/time diagrams* respectively* representing electric stimulation of two different areas of the tissue wail with pulses forming pulse trains, .
Fig. 9 A is a longitudinal cross-section of an embodiment of the device of the invention including a thermal stimulation device, wherein the device is constricting a tissue wall of a patient’s oviduct.
Fig. 9B is the same embodiment of Fig, 9A with the thermal stimulation device activated.
Fig. 10A is a schematic view of a hydraulically operable Inflaiahle constriction device- for use in accordance with the invention.
Fig, 10B is the same embodiment shown in Fig. 1OA with the constriction device inflated.
Figs. 11 A, 1 IB, 11C and 1 I D are block diagrams illustrating four different principles for hydraulic operation of the constriction device shown in Fig. IÖA.
Fig. 12 is a cross-sectional view of a reservoir having a variable volume controlled by a remote control motor.
Figs, 13 A and 13B are perspective views of a reverse servo in accordance with a particular embodiment of the hydraulic operation principle shown in Fig. 1 Id
Fig. 14 is a schematic view of another hydraulically operable constriction, device for use In accordance with the invention.
Fig, ISA illustrates the constriction device of Fig, 34 m a constricted state.
Fig, 1 SB illustrates the constriction device of Fig, 14 in a released stale.
Fig, lb is a schematic block diagram ilinstrating a general embodiment of the device of the invention, in which energy is transferred to energy consuming-'components, of the device implanted in the patient.
Figs. 1 ? to 2.8.are schematic block diagrams ilinstrating twelve embodiments» respectively, based on the general embodiment, shown. In Fig, 37, wherein wireless energy Is transmitted from outside a patient’s body to energy consuming components of the device Implanted in the patient.
Fig, 29 is a block diagram Illustrating control components of an embodiment of the invention.
Fig. 30 Is a schematic view of exemplary circuitry of an embodiment of the invention, In which .wireless energy is transformed into a current. MMIJDMaiEmglffi
Referring to the drawing figures, like reference numerals designate identical or corresponding 'elements throughout the several figures.
Figs, 1A and 1E illustrates a first embodiment of device for treating a female patient to promote pregnancy applied on the oviducts 31 a, 31b of a female patient Clamping elements 5,6 of a .restriction or constriction device 2 constrict the oviducts 31a, 31b. (For the sake of clarity, the housing is not shown and the clamping elements 5,6 are exaggerated.) In this embodiment, a control device includes a subcutaneously implanted push button that Is manually switched by the patient between “on” and "off 3 This control device will be described in more detail below wi th reference to Figs. 3 A AND 3B. Such a manually operable push button may also be. provided in combination with a remote control as an emergency button to allow the patient to stop the operation of the device in case of emergency or malfunction. Such a remote control will be described below with reference to Figs, 2A and 2B, This device could also he fully manually-controlled by manual manipulation of for example a hydraulic reservoir controlling a hydraulic device such as described in Fig. 3A-3D or ISA and 15B or 1ÖA and 10B or any of 11A -.11D. Please observe that only & reservoir moving fluid manually as in Fig. 3Cand 3D may he used to adjust the device. This reservoir may be controlled In such a way that the change of the reservoir vol ume will be stable after the manual'manipulation of the reservoir wall has taken place, lathis particular case is showed a looking device but many di fferent ways may be used, Small amount of fluid in the reservoir mdy also ease a larger mo vement of the devi ce as described in some of the embodiments above.
Figs, 2A and 2B illustrates an alternative embodiment applied on the oviducts 31 a, 31 b of a female patient Thé. clamping elements 5,6 of the constriction device 2 constrict the oviducts 31a, 3 lb, (For the sake of clarify, the housing is not shown, and the clamping elements 5,6 are exaggerated,) In this embodiment, a.eontrol device includes an. external control unit in the form of a hand-held wireless remote control 32, and an implanted internal control unit 33, which may include a microprocessor, for controlling the constriction and stimulation devices. The remote control 32 is operable, by the patient to control the internal control unit 33 to swi tch on and off the device.
The internal control unit 33 controls an implanted operation device 34 to move the clamping elements 5,6, An implanted source of energy 35, such as a rechargeable battery» powers the operation device 34. The internal control unit 3 3 , which may he implanted subcutaneously or in the abdomen, may also work as on energy receiver, i.e., for transfomimg wireless energy into electric energy and charging the implanted source of energy 35 (rechargeable battery) with the electric energy.
An implanted sensor 36 senses a physical parameterof the patient, such, as the temperature, wherein 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, wherein the internal control unit 33 controls the constriction device and/or stimulation device to change the constriction of the patient’s oviduct 31 in response to the sensor 36 sensing a predetermined value of measured value. For example, the control unit 33 may control the constriction device and/or stimulation device to increase the constriction of the patient’s oviduct 31 in. respouse to the sensor sensing an increased or decreased hormone level Alternatively or in combination, the remote control 32 controls the constriction device and/or a stimulation device in response to signals, from the sensor 36, in the same manner as the internal control unit 33.
The remote control 32 may be equipped with means for producing an indication, such as a sound signal or displayed information, in response to signals from the sensor 36. When the patient’ s attention is taken by such an indication indicating a release of the oviduct based on said sensor input.. The patient may use the remote control to control the constriction device or stimulation device to pump eggs through the oviducts of the patient.
Figs. 3 A and 36 show hydraulic operation means suited for operating the .constriction device of the embodiments described above with reference to Figs, 1A and IE, Specifically, Figs. 3 A. and 3B show the device of Figs. 1A and IB provided with such means for hydraulic operation of the constriction device 2, Thus, the housing 1 forms two hydraulic chambers 22a and 22b, in which the two clamping elements 5S 6 are slidable back and forth relative to the tubular tissue wall portion 8 of a patient’s o viduct. The hydraulic operation .means Include an expandable reservoir 23, such as an elastic balloon», containing.hydraulic luid, conduits 24a and 24b between the reservoir 23 and the hydraulic chambers 22a, 22b, and a two-way pump 25 for pumping the hydraulic fluid in the conduits 24a, 24b. The reservoir 23 is subcutaneously placed between the skin, shown with a solid line In the figure, and the .normally fascial/muscular layer, 'shown with a dashed line. The control device 4 controls the pump 25 to pump hydraulic fluid from the reservoir 23 to the chambers 22a, 22b to move the clamping elements 5,6 against the wall portion 8, whereby the tubular wall portion 8 is constricted, see Fig, 3B, and to pump hydraulic fluid .front the chambers 22a, 22b to the reservoir 23 to move the clamping elements 5,6 away from the wall portion 8, whereby the tubular wal! 8 is released, see Fig, 3 A,
Alternatively, the embodiment of Figs* 3 A and 3B may be manually operated by applying suitable manually operable hydraulic means tor distributing the hydraulic fluid between the expandable reservoir 23 and the hydraulic chambers 22a, 22b, In this case the pump 25 is omitted. Also in this case is the control device 4 only manual manipulation of the reservoir. An. example is showed in Fig, 3Cand 3D, In this particular embodiment is supplied a small looking of the reservoir wall (4b), but this is only one of many ways of solving this embodiment.
Figs. 4A and 4B schematically show a mechanically operable embodiment of the invention, comprising an open ended tubular housing 26 applied on the tubular tissue wall portion 8 of a patient’s organ, a constriction device 27 arranged in the housing 26 and a control device 4 for controlling the constriction- device 27, A stimulation device (not shown).as described above is also provided in the housing 26, The constriction device 2? includes a clamping element 28, which is radially movable in the tubular boosing 26 towards and away from die tubular wall portion 8 between a retracted position, see Fig. 4A, and a clamping position, see Fig, 4B, in which the clamping element 28 gently constricts the tubular wall portion 8, Mechanical operation means for mechanically operating the clamping element :28 includes an electric motor 29 attached to die housing 26 and a telescopic device 30, which is driven by the Motor 29 and operatively connected to the clamping element 28. The control device 4 controls the electric motor 29 to expand the telescopic device 30 to move the elamping element 2S against the wall portion 8, whereby the tubular wall portion 8 is constricted, see Fig. 4B, and .controls the motor 29 to retract the telescopic device 30 to move the clamping element 28 away from, the wall portion 8, whereby the wall portion 8 is released, see Fig. 4A.
Alternatively* the motor 29 may be omitted and the telescopic device 30 be modified for manual operation, as shown in Fig, 40, Thus, a spring 30a may be provided acting to keep the telescopic device 30 expanded to force the clamping element 28 against the wall portion 8. The mechanical operation means may include a subcutaneously implanted lever Mechanism 29a that is operatively connected to the telescopic device 30, The patient may push the lever mechanism 29a through the patient 5s skin 29b to pul! the telescopic device 30 against the action of the spring SOa to the retracted position of the telescopic device 30, as indicated in phantom lines. When the patient releases the lever mechanism 29a, the spring 30a expands the telescopic device 30» whereby damping element 28 is forced against the wall portion 8,
Figs. SA ~ $C Illustrate in principle the function of the device of Pig. 1 when the device is applied on a portion 8 of a tubular tissue wall of a patient5s oviduct Thus, Fig. 5 A shows the device in a nonmlamping state, in which the clamping elements 5,6 are in their retracted positions and die wail portion 8 extends through the open ends of the housing 1 without being constricted by the clamping elements 5, ti Fig. SB shows the device ίο a damping state, in which the clamping clemente 5,6 have been moved from their retracted positions to their clamping positions, m which the clamping elements 5, 6 gently constrict the wall portion 8 to a constricted state, in which the blood circulation in the constricted wail portion 8 is substantially 'unrestricted and the flow in the oviduct of the wall portion 8 is restricted. Fig. SC shows the device in an optional stimulation state, in which the clamping elements 5, 6 constrict the wall portion 8 and the electrical elements 7 of die stimulation device 3 electrically stimulate different areas of the wall portion 8, so that the wall portion B contracts (thickens) and closes the oviduct
When the device is in its optional stimulation state, it is important to stimulate the different areas: of the wall portion 8 in a .manner so that they essentially maintains their natural physical properties over time to prevent die areas from being injured. Consequently, the control device 4 controls the-stitnui&iio» device 3 to intermittently stimulate each area of die wall portion 8 during .successive time periods, wherein each time period is short enough to maintain over time satisfactory blood circulation in die area. Furthermore, the control device 4 .controls the stimulation of the areas of the wall portion 8, so that each: area that currently is not stimulated restores substantially normal Mood circulation before it is stimulated again. To maintain over time the effect of stimulation, he., to keep the oviduct closed by maintaining die wall portion •8 contracted, the control device 4 controls die stimulation, device 3 to stimulate one or more of the areas at a time and to 'Shirt the stimulation from one area to another over time. The control device 4 may control the stimulation device 3 to cyclically propagate the stimulation. of the areas along the tubular wall portion 8, lor example, in accordance with a determined stimulation pattern. To achieve die desired reaction of the tissue wall during the stimulation thereof the control device may control the stimulation device to, preferably cyclically, vary the intensity of the stimulation of the wall portion 8, it will he appreciated that the fully restricted state shown in Pig. SC cart be obtained by purely mechanical means not Involving electrical stimulation.
Figs, 6A - 6C show another embodiment of die invention which includes a tubular housing 9 and three elongate clamping elements 1 Oa, l Ob, 10c, which are radially movable in the tubular housing 9 towards and away from a central axis thereof between retracted positions», see Fig. 6A, and clamping positions, see Fig. 6B, The three damping elements 10a~löc are symmetrically disposed around the central axis of the housing 9. The stimulation device of this embodiment includes electrical elements 11a, 11 h, 11c that form a series of groups of elements extending longitudinally along the elongate clamping elements iOa-10e, wherein the electrical elements 11a~ lie of each group of electrical elements form a path of three electrical elements 11 a, I lb and 11c extending ckcumfereniially around die central axis of the housing 9. The three electrical elements I la- 11 e of each group are positioned on the three clamping elements lOa-IOc, respectively. Thus, the path of three electrical elements Ha-ilc extends around the patient’s organ. Of course, the number of electrical elements 11 a«l le of each path of electrical elements can be greater than three, and several parallel rows electrical elements 1 la-1 le can form, each path of electrical elements.
Figs, 7 A, 7B and ?C schematically Illustrate different states of operation of a generally designed device according to the present invention, when the device is applied on a wall portion of an oviduct designated BO, The device includes a constriction device and a stimulation device, which ate designated CSD, and a control device designated CD for controlling the constriction and stimulation devices CSD. Fig, 7A-shows the device in an inactivation st ate, in which the constriction device does not constrict the organ BO and the stimulation device does not stimulate the organ BO, Fig, ?B shows the device in a constriction state, in which the control device CD controls the constriction device to gently constrict the wall portion of the organ BO to a constricted state, in which the blood circulation in the constricted wall portion is substantially unrestricted and the flow in the oviduct of the wall portion, is restricted. Fig, 7C shows the device in a stimulation state, in which the control device CD controls the stimulation device to stimulate different areas of the constricted wall portion, so that almost the entire wall portion of the organ. BO contracts {tliiefcens) and closes the oviduct.·
Figs. 7D and 7E show ho w the stimulation of the constricted wall portion can fee cyclically varied between a first stimulation mode, in which the left area of the wall portion, (see Fig, 70) is stimulated, while the right area of the wall portion is not stimulated, and a second stimulation mode, in which the. right area of the wall portion (see Fig, 7E) is stimulated, while the left area of the wall portion is not. stimulated, in order to maintain over time satisfactory blood circulation in the constricted wall portion.
It should be noted that the stimulation modes shown m Figs. 7D and 7.E only constitute a principle example of how the constricted wall portion of the organ BÖ may fee .stimulated Thus, more than two different areas of the constricted wall portion may be simultaneously stimulated in cycles or successively stimulated. Also, groups of different areas of the constricted wall portion may he successi vely stimulated.
Figs. 7F, 7G and 7.H ill ustrate different states of operation of a modification of the genera! embodiment shown In Figs. 7A-7E, wherem the constriction and stimulation devices CS3D include several separate constriction/stimulaiion elements, here three elements CSDEI, CSDE2 and CSDE3. Fig, 7F shows how the element CSDE1 In a first state of operation is activated to both constrict and stimulate the organ BO, so that the oviduct of the organ BO is closed, whereas the other two dements CSDE2 and CSDE3 are inactivated. Fig, 70 shows how tire element CSDE2 In a second following state of operation is activated, so that the oviduct of the organ BO is closed, whereas the other two elements CSDEI and CSDE3 are inactivated. Fig. 7H shows how the element CSPB3 in a following third state of operation is activated, so that the oviduct of the organ BO is closed, whereas the. other two elements CSDEI and CSDE2 are inactivated. By shifting between the first, second and third states of operation, either randomly or in accordance with a predetermined sequence, different portions of the organ can by temporarily constricted and stimulated while maintaining the oviduct of the organ closed, whereby the risk of injuring the organ is minimized. It is also possible to activate the elements CSDEI -CSDEI successi vely along the oviduct of the organ to move .fluids and/or oilier bodily matter in the oviduct.
Figs. 71, ?K aid ?L illustrate au alternative mode of operation of the modification of the general .embodiment Th us, Fig, ?! shows how the element CSDE? in a first state of operation is activated to both constrict and. stimulate the organ BO, so that the oviduct of the organ BO is closed, whereas the other two elements CSDE2 aid CSDE3 are activated to constrict but not stimulate the organ BO, so that the oviduct of the organ BO is not completely closed where the elements CSDB2 aid CSDE3 engage the organ BO. Fig. ?K. shows how the element CSDE2 in a second following' state of operation is activated to both constrict and stimulate the organ SO,· so that the oviduct of the organ BO is dosed, whereas the other two elements CSDE? and CSDE3 are-activated to constrict but not stimulate the organ BO, so that the oviduct of the organ BO is not completely closed where the elements CSDE I and CSDB3 engage the organ BO. Fig. 7L shows how the element CSDE3 in a following third state of operation is activated to both constrict and stimulate the organ BO, so that the oviduct of the organ BÖ is dosed, whereas the other two dements CSBE1 and CSDE2 are activated to constrict hut not stimulate the organ. BO, so that the oviduct of the organ BO is not completely dosed where the elements CSDEI and CSDE2 engage the organ.BO. By shifting between the first, second and third states of operation, either randomly or in accordance with a predetermined sequence, different portions of the organ can by temporarily stimulated while .maintaining, the oviduct of the organ closed, whereby the risk of injuring the organ is reduced, It is also possibl e to activate the stimulation o f the dements CSBBI-CS DE3 successi vely along the oviduct of the organ BO to move fluids and/or other bodily matter in the oviduct.
This embodiment, with a combination of a mechanical or hydraulic part ly restricting system and a stimulation system varying the stimulation position, is preferable used when one wants to close the oviduct in a safe way. The system is energy efficient because preferable only stimulation need to he changed in position and the oviduct allows to recover until the stimulation comes back to the same position again. If the restriction areas are placed closer to each other and maybe the mechanical or hydraulic restriction is continuous, a peristaltic like wave could be created in any direction hi the oviduct If the restriction Is moved in consecutive order starting with the restriction closest to fee ovary, no egg may be.squeezed in the restriction area. If restriction are moved in fee o ther direction towards- fee uterus a movement device could be used to move any egg away from any new upcoming restriction area. Such a movement device could be the hydraulic or mechanical partly restricting device causing movements in. the oviduct wall before fee stimulation device close the area.
Fig, -8B is a pulse/time diagram showing a modification of the electric stimulation shown in Fig. 8A, Thus, the pulse combination of Fig, 8A Is mixed wife a pulse train combination having a first relatively long pulse train PTE of high Irequencyriow amplitude, pulses, appearing simultaneously wife the positive pulse PL of the pulse combination of Fig, 8A, and a second relati vely short' pulse train PTS of high ifequency/low amplitude appearing simultaneously with the negative pulse PS of the pulse combination shown in Fig, 8Ά. As a result, the high frequency/low amplitudes pulse trains PTL and PTS are superimposed on fee positive and negative pulses PL and PS of Fig, 8A„. as illustrated in Fig, SB. The pulse configuration of Fig. SB, and. variations thereof, is beneficial to use in connection, with fee stimulation of particular human organs, in order to .achieve the desired stimulation effect
Preferably, the electric pulses form pulse trains, as illustrated in the Pnl.se/fene diagrams P/i of Pigs. BC and 8D. The Pulse/time diagram. P/t of Fig, 9A represents an individual area of the wall portion of the patient’s tubular organ, which, is stimulated with-a pulse train ISA,. The puise train ISA includes three initial negative pulses, each of which is of short duration mé high amplitude (voltage), and one positive pulse of long duration and low amplitude following the negative pulses. After a delay to enable the area of the organ to.restore substantially normal blood circulation* the pulse train 18 A is repeated.
The Fulse/ume diagram P/t of Fig. 8D represents another indi vidual area of the wall portion, which is stimulated with a pulse train 1EB having the same configuration as the pulse train ISA. Hie pulse trains 18 A and I SB are shifted relative to each other, so that they partially overlap one another to ensure that the constricted wall portion always is stimulated to contract as desired.
Figs. 9 A and 9B show another embodiment of the in vention that· controls Mood flow in a blood vessel 19, comprising a constriction device with two clamping elements 20a and 20b, a stimulation device in the form of two therm al stimul ation elements 21a and 21b integrated in the clamping elements 20a, 20b, respectively, and a control device 4 for controlling the damping elements 20a, 20b and stimulation elements 21 a, 21b. The damping elements 20a and 20b are movable towards and away from each other in the same manner as described abo ve in connection wi th the embodiment according to f igs. SA-SC, The thermal stimulation elements 21 a and 21 b, which may include Pettier elements, are positioned on the clamping elements 20a, 20b, so that the thermal elements 2la arc facing the thermal elements 21b. Fig. 11A shows how the clamping elements 20a, 20h constrict the blood vessel 19, so that the blood flow is restricted. Fig. 1 IB shows how the control.device 4 controls the thermal stimulati on elements 21a, 21b to am! the wall of the blood vessel 19, so that the wall contracts and closes the blood vessel 19. To release the blood vessel 19, the control device 4 controls the thermal stimulation elements 21a, 21 h to heat the wall of the blood vessel 19» so that the wall expands.
Figs. 1ÖA and 10B show a hydraulically operable elongated constriction device in the form of a band 72 having an expandable/contractible cavity 73 , which is in Huid communication with an adjustable reservoir 74 containing hydraulic fluid. Fig. 10A illustrates when the band is in a non-constriction state, whereas Fig. 1ÖB illustrates when the hand is in a constriction state, in which the cavity 73 is expanded by hydraulic fluid supplied by the reservoir 74.
Figs. 31 A, 31B, 31 € and 31D are block diagrams of four differently operated hydraulic constriction devices. Fig. 31A shows the band 72 of Fig. IQ A, the cavity 73 ofwbiehis in fluid communication with a réservoir 75. Fig, 3 IB shows the embodiment of Fig, 10A, In which the cavity 73 of the hand 72 is in fluid communication with the reservoir 74 via an operation device in the form of a two-way pomp 76,. Fig, 1IC shows an operation device in the form of a reverse servo device with a first closer! device controlling a second device. The reverse servo device comprises an adjustable fluid supply reservoir 77 and an adjustable servo reservoir 78, The servo reservoir '78 controls a larger adjustable reservoir 79 which in connection with the hand 72 applied around a portion of tubular tissue wall of a patient ' s organ varies the volume of the cavity 73 of the hand 72, which in turn varies the constriction of the wall portion. Fig, 1 ID shows an embodiment identical to the 'embodiment of Fig, 11C, except that the larger reservoir 79 is omitted. Instead, the servo reservoir 78 is in fluid communication with the cavity of the band 72,
In all of the above embodiments according to Figs, 12A through 1ÖB, stimulation devices maybe provided to form eonstrietiou^imuiation units, in which the stimulation devices include a multiplicity of electrical elements 7 (indicated in Figs, 12A - 15, I S, 2(1 - 23,26 -1:1. B) positioned on the constriction devices.
Fig, 12 is a cross-sectional view of a fhiid supply device including a bellows reservoir 80 defining a chamber 81, the sixe of which is variable by an operation device comprising a remote controlled electric motor 82, The reservoir 80 and the motor 82 are placed in a housing 83, Moving a large wail 84 varies the chamber 81. The wall 84 is secured to a nut 85, which, is threaded on a rotatable spindle 86. The spindle 86 is rotated by the motor 82, A battery 89 placed in the housing S3 powers the motor 82, A signal receiver 90 for control ling the motor 82 is also placed in the housing 83. Alternatively,, the battery 89 and the .signal receiver 90 may be mounted in a separate place. The motor 82 may also he powered- with energy transferred from Itansmitied signals.
Where applicable, the fl uid supply device of Fig, 12 may be used for supplying hydraulic fluid for the operation of the constric tion devices described in thi s speei fication, For example, the fluid supply device of Fig. 12 may be substituted for the réservoir 74 in the embodiment according To Fig, 10A,
Figs, 13A 'and I 3B show a reverse servo Including a rectangular housing Sri and an intermediate wall 92, which is movable in the bousing 91'. A relatively large, substantially cylindrical bellows reservoir 93 is arranged in fee bousing 91 and is joined to the movable intermediate wall. 92. Another cylindrical bellows reservoir 94, which is substantially smaller than reservoir 93, is arranged in the housing 91 at the other side of the intermediate wall 92 and is also joined to the wail 92, The small bellows reservoir 94 has a fluid supply pipe 95 and the large bellows reservoir 93 has a fluid supply pipe 96:.
Referring to Fig, 13 A, when a small amount of hydraulic fluid is conducted through the supply pipe 95 Into the small bellows reservoir 94, the small bellows reservoir 94 expands and pashes the movable intermediate wall 92 towards the large hollows reservoir 93, As a result, the large bellows reservoir 93 is contracted by the intermediate wall 92, whereby a large amount of hydraulic fluid is forced out o f the large bellows reservoir 93 thro ugh the supply pipe 96, as shown in Fig, 13B.
For example, the reverse servo of Figs, 13A and 13B may be used in the embodiment of Fig, 11C, wherein fee small bello ws reservoir 94 corresponds to the small servo reservoir 78 and the large bellows reservoir 93 corresponds to the large reservoir 79, Also, the reverse servo of Figs, 13 A and 13 B may be used in the embodiment of Fig, XÖA and 10B, wherein the small bellows reservoir 94 is connected to the adjustable reservoir 74, and the large bellows reservoir 93 is connected to the cavity 73 of the band 72,.
Fig, 14 schematically shows a hydraulically operable constriction device 97 of the device of the invention, which is simitar to the embodiment shown in Fig, 10 A, except that the hydraulic device is designed ditterently. Thus, the constriction device 97 includes a relatively small inflatable cavity 98, which is in fluid communication with a reservoir 99 containing hydraulic fluid, and a relatively large cavity 100, which is displaceable fey small cavity 98,
Small cavity 98 is adapted to displace large cavity 100 to constrict the patient*s tubular wall . portion when small cavity 98 is Inflated and to displace large cavity 1.00 to release the wall portion when small cavity 98 is deflated. Thus, a relatively small addition of hydraulic fluid from reservoir 99 to small cavity 98 causes a relati vely large increase in the constriction of the wail portion,
Largs' cavity 100 is defined by a contraction element in the form, of a Mg balloon 101, which may be connected to an inj ection port (not shown) for calibration of the volume of large cavity 100, Adding .fluid to or withdrawing fluid from the infection port with the aid of a syringe calibrates the volume of balloon 101. Small cavity 98 is defined by a small bellows 102 attached to an annular frame 103 of constriction device 97 and at the opposite end Is attached to balloon 101,
Figs, 15 A. and 1 SB schematically illustrate the operation of constriction device 97, when •annular frame 103 is applied around the tubular wall portion of the pafienfs organ. Referring to Fig, 15A, when small cavity 98 is deflated bellows .102 pulls balloon 101 inwardly into annular· frame 103, so that constriction device 97 constricts: the wall portion, .Referring·to Fig, 15B, when small cavity 98 is inflated bellows 102 pulls balloon 101 out of annular frame 103, so that constriction device 97 releases the wall portion,
As mentioned above, the constriction device and stimulation device can co-operate to actively move the egg in the oviduct of a patient’s organ. This can be achieved using the eonsirictiou/stimulation unit shown in Fig, 2. Thus, in accordance with a first cooperation option, the clamping elements 5,6 of the constriction de vice constricts the wall portion 8 without completely closing the oviduct, whereby the flow in the oviduct is restricted, and the control device 4 controls the electrical elements 7 to progressively stimulate the constricted wall portion in the downstream or upstream direction of the oviduct, to cause progressi ve contraction of the wall portion 8 to move the egg in the oviduct
In accordance with a second cooperation option, the constriction device constricts the wall portion so that the flow in the oviduct is restricted, and the control device 4 controls a few electrical elements 7 at one end of the elongate clamping elements S, 6 to stimulate the constricted wail portion 8 to dose the oviduct either at an upstream end or a-downstream end of the wall portion 8, With the oviduct dosed in this manner, the control device 4 controls the constriction device to increase the constriction of the wall portion, whereby the egg to the oviduct is mo ved, downstream, or upstream of the wall portion 8.
In another embodiment of the Invention for performing the second cooperation option, the constriction device constricts the wall portion so that the flow in the oviduct is restricted, and the control device.4 controls the stimulation device to stimulate the constricted wall portion while the constriction .device· varies the constriction of the different areas of the wall portion, such that the wall portion is progressively constricted in the downstream or upstream direction of the oviduct. Figs, 16A - 16B show different .operation stages of such an alternative embodiment, which comprises a. constriction device 104 including two idongutc constriction elements .105,106 having con vex surfaces .107,1.08 that abut a length of the wall portion 8 on mutual, sides thereof, and a multiplicity of electrical elements 7 (such as electrodes) that are positioned on the convex, surfaces 1.07, 1Ü8, The control device 4 controls the electrical elements 7 during operation of the constriction device 104 and controls the elongate constriction elements 105, J 06 to move relative ip the tubular wall portion 8 so that the ' constriction dements 105,106 progressively constrict the wall portion. 8, as appears from Figs, 16A to 16D,
Thus, in an initial position of the constriction elements 105,. 106 show-aits Fig, 16A, the wall portion, is not constricted by the constriction -elements 105,106 and the electrical elements 7 are not energized. Starting from this initial position, the control device 4 controls the constriction demente 105, 106 to swing the left ends of the constriction elements 1ÖS» 106 toward the wall portion (indicated by arrows) to constrict the tubular wall portion 8, see Fig. I6B, while energizing the electrical elements 7, so that the electrical elements 7 that contact the wall portion 8 contract the latter. Fig. 16 O sho ws how the o viduct of the tubular wall portion 8 is completely closed by the thickened wall portion 8. Then, as shown in Fig. 16C, the control device 4 controls the constriction elements 105, 106 to move so that their right ends are moving towards each other (indicated: by arrows), while the convex surfaces 107, 108 of the constriction dements. 1(15,106· are rolling on each other with the contracted wall portion 8 between them, see Fig. 16D. As a result, the bodily matter in the oviduct of the organ is forced to the right (indicated by a white arrow). When the constriction elements 105, 106 have roiled on each other to the position shown in Fig, 16E» the control device 4 controls the right ends of the constriction elements 105,106 to move away from each other (indicated by arrows in Fig. 16E) to the initial position shown in Fig, 16 A. The operation stages described according to Figs. 16A to 16E can be cyclically repeated a number of times until the desired amount of bodily matter has been moved in the oviduct of the organ in a peristaltic marmer.
Alternatively, only one of the constriction elements I Ö5,106 can be provided with a convex surface, whereas the other constriction element has a plane surface that abuts the wall portion, It is also possible to use a single constriction element with a convex surface that presses the tabular portion 8 of the organ against a hone of the patient, .Fig. 16 schematically shows a general embodiment of the device of the invention. In which energy is transferred to energy consuming components of the device implanted in the patient. The device of Fig, 16 comprises an implanted constrietion/stimnlation unit 110, which is operable to gently constrict a portion of a tubular' tissue wall of a patient's organ and to stimulate different areas of the constricted portion to cause contraction- of the wall portion.
The constriction device of the eonstrietrorhsiminlation unit 110 is capable of performing a reversible function, i,e.s to constrict anti release the wall portion, so that the constrietion/stimnlation unit 110 works as an artificial sphincter, A source of energy 111 is adapted to supply energy consuming components of the constriction/stiniuiation unit 110 with energy via a power supply line 112, A wireless remote control or a subcutaneously implanted switch operable by the patient to switch on or off the supply of energy from the source of energy may be provided. The source of energy may be an implantable permanent or rechargeable battery, or be included in an external energy-transmission device, which may be operable directly by the patient or be controlled by a remote control operable by the patient to transmit wireless energy to the energy consoming components of the consiricttonMmalatkra unit Alternatively, the source of energy may comprise a combination of an implantable rechargeable battery, an external energy-transmission device and an implantable energy-iransfonnmg device for transforming wireless energy transmitted by the external energy-transmission device into electric energy for the charge of the implantable rechargeable battery;
Fig, 1? shows a special embodiment of the general embodiment of Fig, 16 having some parts implanted in a patient and other paris located outside the patient's body, Thus, in Fig, 17 all parts placed to t he right of the patient's skin 109 are implanted and all parts placed to the left of the skitt 109 are located outside the patient's body. An implanted energy-tfanstbrnung. device 311A of the device is adapted to supply energy consuming components of the constriction/stimulaiion unit 110 with energy via the power supply line 112, An external energy-transmission device 111 of the device includes a wireless remote control transmit ting a wireless signal, which is received by a signal receiver incorporated in the implanted energytransforming device 1.11 A, The implanted energy-transforming device 111A transforms energy tom the signal Into electric- energy, which is supplied via the power supply line 112 to die conslrlctlon/stimuiation unit 1 ID.
The device of Fig. 17 may also include an implanted rechargeable battery for energising energy consuming implanted components of the device. In this ease, the implanted energytransforming device 111A also charges the battery with electric energy, as the energytransforming device transforms energy from the signal Into the electric energy. A reversing device in the form of an electric switch 114, such as a microprocessor, is implanted in the patient for reversing the constriction device of the constrietion/stimulation «nit 110, The wireless remote control of the external energy-transmission device 113: transmits a wireless signal that carries energy and the implanted energy-trans&mting device 111A transforms the wireless energy into a current lor operating the switch 114, When the polarity of the current is shifted by die energy-transiorming-device 111A the smutch 114 reverses the function performed by tire constriction device of the constriction/stimulation unit HO,
Fig, 1 S' shows an embodiment of the invention Including tire energy-transforming device 11 !A, the constriction/stimulation unit 1 ID and an implanted operation device in the form of a motor ! 15 for operating the constriction device of the comtriöüon/stimulatidn «nit 110.. The motor 115 is powered with energy from the energy-transforming device 111 A, as the remote control of the external energy-transmission device! 13 transmits a wireless signal to the receiver o f the energy4ransiomimg de vice ί 11 A.
Fig. 19 shows an embodiment of the invention including the energy-transforming device 111 A, the eirnstTietion/stimuIation unit 110 and art implanted assembly ! 16 including a motor/piunp unit 117 and a fluid reservoir 118, In this case the 'constriction 'device of the coustrieifoa/stimutalion unit 110 is hydraulically operated, i,s,5 hydraulic fluid is pumped by themotor/pump unit 117 -from the restarvoir 118 to the constti^iou/stinwdation unit 110 to constrict the wall portion, and hydraulic fluid is pumped by the motor/pump unit 117 back from the eonstrietioii/stimulation unit 11Ö to the reservoir 118 to release the wall portion. The implanted energy-transforming device 1 HA transforms wifeless energy into acutTcnt, for powering the motor/pump unit 117,
Fig, 20 shows an embodiment of the invention comprising the external energy-transmission device 113.that controls the control unit 122 to reverse the motor 115 when needed, the constrichon/stimulation and 11. 0, the constriction device of which is hydraulically operated, and the implanted energy-transfonning device 111 A, and further comprising an implanted hydraulic fluid reservoir 119, an implanted motor/pump unit 120, an implanted reversing device in the form of a hydraulic valve shilling device 121 and a separate -external wireless remote control 11 IB. 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 powers the motor/pump unit 120 with energy from the energy carried by the control signal, whereby the motor/pump unit 120 distributes hydraulic fluid between the reservoir 119 and the constriction device of the eonstrietiofostmirdation unit 110. Tho remote control 1.1 IB controls the shifting device 1.21 to shill the hydraulic fluid flow direction between one direction in which the fluid is pumped by foe motor/pump unit 120 from the reservoir 119 to the constriction device of the ernrstriction/stimulation unit 110 to constrict foe wall portion, and another opposite direction in which the Huid is pumped by the motor/pump unit 120 hack from the -constriction, device of the eonstriction/stimulation unit 110 to the- reservoir 119 to release foe wall portion.
Fig. 21 shows an embodiment of the invention including the euergy-tTansfomring device 111 A and the eonstriction/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 η IB controls the control unit 122. The control unit 122 controls the energyAransfemnlng device 111A to store electric energy in the accumulator 123, which supplies energy to tire coHSiHction/stimuiation unit 11Ö, In response to a control signal from the wireless remote control 11 IS, the control unit 122 either releases electric energy from the accumulator 123 and transfers the released energy via power lines, or directly transfers el ectrie energy from the eBeFgydransforaiing device 111A via the capacitor 124, which stabilises the electric current, for the operation, of the eonshiction/stimulation unit 110.
In accordance with one alternative, the capacitor 124 In the embodiment of Fig. 21. may he omitted. In. accordance with another alternative,; the accumulator 123 in this embodiment may be omitted,
Fig. 22 shows an .embodiment of the invention mciuding the energy-transforming device I II A, the eonstrlctiojristimulation unit 110. A battery 125 for supplying energy for the operation of the-oonstdctiop/stimulaiion unit 1 TO and an electric switch 126 for switching the operation of the eonstrietion/stimulatlon unit 110 are also implanted in the patient, The s witch 126 is operated by the· energy supplied by the energydmnstomriiig device 111A to switch from air off mode, In which the battery' 125 Is not in use, to an on mode, in which the battery 125 supplies energy for the operation, of the constricfiOn/stimulation unit. 110,
Fig. 23 shows an embodiment of the invention identical to that of Fig, 43, except that a control unit 122 also Is implanted in the patient A separate external wireless remote control II IB controls die control unit 122, In this case, the switch 126 is operated by the energy supplied by the energy-transfomring device 111A to switch from an off mode, In which the wireless remote control 11 IB is prevented from controlling the control unit 122 and the battery 125 is not In use, to a standby mode, in which the remote control 11 I B is permitted to control the control unit 122 to release electric energy from the battery 125 for the operation of the eonsfrietfon/stlmnlatlon unit 1 TO,
Fig. 24 shows an embodiment of the in vention identical to that of Fig. 44, except that the aeoimolator 123 is substituted for the battery 125 and the implanted components are interconnected differently. In this, case, the accumulator 123 stores energy from the energytransforming device 111 A, In response to a control signal from the wireless remote control 11 I B, the implanted control unit 122 controls the switch 126 to switch from an off mode, in which the accumulator 123 is not in use, to an on mode, in which the accumulator 123 supplies energy lor the operation of the constrietion%ti:m«!ation unit 110.
Fig. 25 shows an embodiment of the .invention, identical to that of Fig, 45, except that the battery 125 also is implanted in the patient, and' the implanted components are interconnected, differently. In response to a control signal from the wireless remote control 11 I B, the implanted control unit 122 controls the accumulator 123, which may he a capacitor, to deliver energy fer operating the switch 126 to switch from an off mode, In which the battery 125 is not in use, to an on mode, in which the battery 125 supplies electric energy for the operation of the constriclion/stimulation unit! 10.
Alternatively, the switch 126 may he operated by energy supplied by the accumulator 123 to switch from an off mode, in which the wireless remote control 11 IB is prevented from controlling die battery 125 to supply electric energy and the battery 125 is not i n use, to a standby mode. In which the wireless remote control. Ill® is permitted to control the battery 125 to supply electric energy for the operation of the constiictioiiVsiimula.li.oo unit 110.
Fig, 26 shows an embodiment of the invention identical to that of Fig. 43, except that a motor 115, a mechanical reversing device in the .form, of a gearbox 12? and a control unit 122 for controlling the gearbox 127 also are implanted m the patient:, A separate external wireless remote control 111B controls the implanted control unit 122 to control the gearbox 12? to reverse the function performed by the constriction, device (mechanically operated) of the consteictioiVstimulation unit 110.
Fig. 27 shows an embodiment of the invention identical to that of fig, 46, except that the Implanted components are interconnected differently. Thus, in this case, the battery 125 powers the control unit 122 when the accumulator 123, suitably a capacitor,, activates the switch 126 to switch, to mi on. mode. When the switch 126 is in Its on mode the control unit 122 is permitted to control the battery 125 to supply, or not supply, energy fer the operation, of the consfriction/sthnnlatlon unit 11Ö.
Fig, 28 shows an embodiment of the invention Identical to that of Fig. 39» except that a gearbox 127 that connects the motor 115 to the constriction/stiinnlation unit 110, and a control unit 122 that controls the energy-iransiorming device 111. A to power the motor 115 also are Implanted in the patient. There Is a separate external wireless remote control 111B that controls the control unit ,122 to reverse the motor 115 when needed.
Optionally, the accumulator 123 shown in Fig. 21 may be provided in the embodiment of Fig. 49, wherein the implanted control unit 122 controls the energydranstbrmmg device 111A to store the transformed energy in the accumulator 123 . In response to a control signal from the wireless remote control 11 IB, the control trait 122 controls the accumulator 123 to supply energy for the operation of the consirictk>o/stii« ulatioo. trait 110.
Those skilled in the art will realise that the above various embodiments according to Figs. 1728 could be combined in many different ways. For example, the energy operated switch 114 could be incorporated in any of the embodiments of Figs, 18,21-2E» the hydraulic shifting device 121 could he incorporated in the embodiment of Fig. 21, and die gearbox 127 could be incorporated in the embodiment of Fig. 39, The switch 114 maybe of a type that includes electronic components, for example a microprocessor, or a FGPA (Field Programmable Gate Array) designed tor switching. Alternatively, however, the energy operated switch 114 may be replaced by a subcutaneously implanted push button that is manually switched by the patient between “on” and ”off 7
Alternatively, a permanent or rechargeable battery may be substituted for the energytransforming devices 111A of the embodiments shown in Figs. 38-49.
Fig, 29 shows basic parts of a remote control of the device of the invention for rxmirolling the constriction/stimulation unit 110. In this case, the 'Stimulation device of the consipcticm/stimulation trait stimulate?'the wall pprtlon with electric pulses. The remote control is based on wireless transmission of electromagnetic wave signals, often of high frequencies in the order of 100 kHz ~ 1 GHz, through, the skin 13:2 of the patient, in Fig. 29, all parts placed to the left of the skin 132 are located outside the patient 's body and all pads placed to the right of the skin 132 are implanted.
An external signal-traosmmion device 133 is to be positioned close to a signal-receiving device 134 implanted close to the skin 132. As an alternative, the signal-receiving device 134 may be placed for example inside the abdomen of the patient The signal-receiving device ..1.34 comprises a coil, approximately I-10Ö mm, preferably .25 rara in diameter, wound with a very thin wire and tuned with a capacitor to a specific high frequency, A small coil is chosen if it is; to be implanted under the skin of the patient and a large coil is chosen if it is to he implanted in the abdomen of the patient, The signal transmission device 133 comprises a coil having about the same size as the coil erf the signal-receiving device 134 but wound with a thick wire that can. handle the larger currents that is necessary'. The coil of the signal transmission device 133 is timed to the same-specific high .frequency as the coil of the signal-mcei ving device 134.
The sigruil-transirrission device .133 is adapted to send digital information via the power amplifier and signal-receiving device 134 to an implanted control unit 135. To avoid that accidental random high frequency fields trigger control commands, digital signal codes are used. A conventional keypad placed on. the signal transmission device 133 is used to order the signal transmission device 133 to send digital signals for the control of the ec>nstrictiorystimulation unit. The signal transmission device 133 starts a command hy generating a high frequency signal. After a short time, when the signal has energized tire implanted part s of the control devi ce, commands are sent to operate the constriction device of the constriction/stim.uIation unit 110 in predefined steps. The commands are sent as digital packets in. the form illustrated below.
Start pattern, 8 bits Command, 8 hits
Count, 8 bits
Checksum, 8 hits
The commands are sent continuously during a rather long time period (e.g,, about 30 seconds or more). When anew constriction nr release step is desired, the Count byte is increased by one to allow the implanted control unit 135 to decode arid understand that another step is demanded by the signal transmission device 133, If any pari of the digital packet is erroneous, its content is simply ignored.
Through a line 136, an implanted energizer unit 137 draws energy from the high frequency electromagnetic wave signals received hy the signal-receiving device 134. The energizer unit 137 stores the energy in a source of energy, such as a large capacitor, powers the control unit 135 and powers the constocticsn/stimulation mïlt 110 via a line 138.
Tlie aintroi unit 135 comprises a demodulator and a microprocessor. The demodulator demodulates digital -signals sent from the signal transmission device 133. The microprocessor receives the digital packet, decodes it and sends a control signal via a signal line 139 to control the constriction device of the constriction/stinmlation unit .110 to either constrict or release the wall portion of the patient’s organ depending on the received command code.
Fig, 30 shows acircuitry ©fan embodiment of the invention, in- which wireless energy is transformed into a current. External components of the circuitry include a microprocessor 140, a signal generator 141 and a power ampli fier 142 connected thereto. The microprocessor 140 is adapted to switch the signal generator 141 on/otYand to modulate signals generated by the signal generator 141 with digital commands. The power amplifier .142 amplifies the signals and sends them to an externa! signal-tiansmitting antenna coil 143 . The antenna coil .143 is connected in parallel with a capacitor 144 to form a resonant circuit tuned ip the frequency generated by the signal generator 141,
Implanted components of the circuitry include a signal receiving antenna coil 145 and a capacitor 146 forming together a resonant circuit that is toned 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 14? rectifies the induced current, which charges a storage capacitor '148. The storage capacitor '148 powers a motor 149 for driving the constriction device of the constrictiotostinmlation 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 makes it possible to charge the capacitor 148 and to transmit digital information using amplitude modulation. A capacitor 151 and a resistor 152 connected in parallel and a diode I S3 form a detector used to detect amplitude modulated digital information, A filter circuit is formed by a resistor 154 connected, in series with a resistor 155 connected in series with a capacitor 156 connected in series with the resistor 154 via ground, and a capacitor 157, one terminal of which is connected between, the .resistors 154,155 and the other terminal of which is connected between the diode 153 and the circuit formed by the-capacitor 151 and resistor 152. Hie; filter circuit is used to filter out undesired low and high frequencies. The detected and filtered signals are fed to an implanted microprocessor 158 that decodes the digital information and controls the motor 149 via an H~hridge 159 comprising transistors 1 §0,161,-162 and 163, The motor 149 can be driven in two opposite directions by the H-hrklge 159.
The microprocessor 158 also monitors the amount of stoned energy in the storage capacitor 148. Before sending signals to activate the motor 149, the microprocessor 158 checks whether the energy stored in the storage capacitor 148 Is enough., if t he stored energy is not enough to perform the requested operation, the .microprocessor 158 waits for the received signals to charge the storage capacitor 148- before, activating the motor 149.
Alternatively, the energy stored in the storage capacitor 148 may only be used for powering a switch, and the energy for powering the motor 149 may be obtained .from another implanted energy source of relatively high capacity, for example a battery. In this case the switch is adapted to connect, the battery to the motor 149 in an on mode when the switch is powered by the storage capacitor 148 and to keep the-battery disconnected from the motor 149 in a standby mode when the switch is not powered.
While'the invention has beeft described In connection wife what is presently considered to be the most practical and preferred mbodhnent, it Is to be understood that fee invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims*
This application is a divisional application of Australian patent application number 2008311434, whose specification as originally filed is hereby incorporated by reference in its entirety.

Claims (17)

1. A pregnancy control system for promoting pregnancy of a female mammal or human patient, comprising: an implantable restriction device adapted to be implanted outside an oviduct of the patient and to be postoperatively adjusted to restrict the lumen of the oviduct of the patient to accumulate at least one egg released from the ovary in the oviduct and to cease restricting the oviduct lumen to admit the egg in the oviduct to be transported to the uterus, wherein the restriction device is adapted to be noninvasively adjusted from outside the patient's body to restrict and cease restricting the oviduct lumen, wherein the restriction device is adapted to be reversibly adjusted by hydraulic power means comprising at least one hydraulic reservoir hydraulically connected to the restriction device to provide distribution of hydraulic fluid between the hydraulic reservoir and restriction device.
2. A system according to claim 1, wherein the restriction device is adapted to restrict the oviduct lumen to accumulate at least one egg in the oviduct for a predetermined period of time, and to cease restricting the oviduct lumen when convenient for the patient to become pregnant, and the predetermined period of time is selected to increase the likelihood of the patient becoming pregnant, the predetermined period of time being between 0 and 2 days.
3. A system according to claim 1 or 2, wherein the restriction device comprises at least two restriction areas adapted to restrict the oviduct lumen at different places on the oviduct, the restriction device being adapted to change the restriction of the oviduct lumen over time from one restriction area to another restriction area.
4. A system according to claim 3, further comprising a hydraulic restriction device comprising at least two restriction areas adapted to restrict the oviduct lumen at different places on the oviduct, a hydraulic reservoir hydraulically connected to the hydraulic restriction device to provide distribution of hydraulic fluid between the hydraulic reservoir and hydraulic restriction device, and at least one valve operable to direct the hydraulic fluid individually to or from the restriction areas of the restriction device to restrict or release the restriction areas individually.
5. A system according to claim 3, further comprising two or more hydraulic reservoirs connected one each to the different areas of the restriction device, wherein the hydraulic restriction device is hydraulically connected to the reservoirs, the reservoirs being adapted to move hydraulic fluid to or from the respective restriction areas of the restriction device individually to restrict or release the oviduct lumen at different places on the oviduct.
6. A system according to claim 4 or 5, wherein each of the hydraulic restriction areas of the restriction device is adapted to restrict the oviduct lumen for a predetermined time period with some overlap in time, and the restriction areas of the restriction device are adapted to restrict the oviduct lumen such that the restriction of the oviduct lumen is changed from the restriction area situated closest to the ovary to the next restriction area in the direction towards the uterus.
7. A system according to any one of claims 4 to 6, wherein each of the hydraulic restriction areas is adapted to be regulated by manual manipulation of the reservoirs.
8. A system according to any one of claims 1 to 7, further comprising a stimulation device with two or more restriction areas combined with a hydraulic or mechanical restriction device, wherein the hydraulic or mechanical restriction device is adapted to restrict only in part the oviduct lumen, and the stimulation device is adapted to stimulate the oviduct wall to cause contraction thereof to completely restrict the oviduct lumen.
9. A system according to any one of claims 3 to 5 and 8, wherein the restriction device is adapted to change between the restriction areas such that the oviduct lumen is restricted in the form of a peristaltic wave restriction moving in the direction towards the ovary to prevent the egg in the oviduct lumen from being transported down to the uterus.
10. A system according to any one of claims 1 to 9, wherein the restriction device is adapted to effect transportation of the egg to the uterus upon release of the oviduct lumen, wherein the restriction device is adapted to restrict the oviduct lumen in the form of a peristaltic wave restriction moving in the direction towards the uterus.
11. A system according to any one of claims 1 to 10, wherein the restriction device comprises more than two restriction areas adapted to restrict the oviduct lumen at different places on the oviduct, and the restriction areas are adapted to vary the restriction of the oviduct lumen between the restricting areas while at least one of the restriction areas restricts the oviduct lumen.
12. A system according to any one of claims 1 to 10, wherein the restriction areas are adapted to restrict the oviduct lumen in consecutive order starting with the restriction area situated closest to the ovary and thereafter restricting the oviduct lumen by another restriction area one step closer to the uterus, wherein the restriction of the oviduct lumen by two consecutive restriction areas are overlapped in time.
13. A system according to claim 1, wherein the restriction device is adapted to only in part restrict the oviduct and to create peristaltic wave like movements of a part of the wall of the oviduct wall to prevent an egg released from the ovary from being transported in the oviduct to the uterus of the patient to accumulate the egg in the oviduct for a predetermined period of time, whereby any sperm in the oviduct is able to reach the egg during the time the egg is accumulated because the oviduct is only restricted in part, the restriction device being controlled from outside the patient's body to release the egg to allow the egg in the oviduct to be transported to the uterus.
14. A system according to any one of claims 1 to 13, further comprising a control device operable from outside the patient's body to control the restriction device, wherein the control device comprises an internal control unit adapted to be implanted in the patient's body, the internal control unit controlling the restriction device.
15. A system according to any one of claims 1 to 14, further comprising an implantable internal energy source for powering the restriction device, the energy source being chargeable by wireless energy, and a transmitter for transmitting wireless energy for charging the internal energy source, wherein the internal energy source is controlled from outside the patient's body by - a wireless remote control, or - a switch implantable in the human body and adapted to be regulated from outside the body.
16. A system according to claim 15, further comprising a feedback device adapted to send feedback information from inside the patient's body to the outside thereof to give feed back related to a functional parameter of the system or a physical parameter of the patient, wherein the functional parameter of the system is correlated to the transfer of energy for charging the internal energy source.
17. A system according to any one of claims 1 to 14, further comprising a wireless energy transmitter for wireless transfer of energy to power the restriction device during energy transfer.
AU2015203000A 2007-10-11 2015-06-05 Device and method for embryo control Ceased AU2015203000B2 (en)

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AU2019204811A AU2019204811B2 (en) 2007-10-11 2019-07-04 Device and Method for Embryo Control
AU2021204626A AU2021204626B2 (en) 2007-10-11 2021-07-01 Device and Method for Embryo Control
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AU2017200415A1 (en) 2017-03-16
AU2019204811B2 (en) 2021-04-01
AU2021204626A1 (en) 2021-07-29
AU2017200415B2 (en) 2019-04-04
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AU2015203000A1 (en) 2015-06-25
AU2019204811A1 (en) 2019-07-25

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