AU2019204811B2 - Device and Method for Embryo Control - Google Patents

Device and Method for Embryo Control Download PDF

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AU2019204811B2
AU2019204811B2 AU2019204811A AU2019204811A AU2019204811B2 AU 2019204811 B2 AU2019204811 B2 AU 2019204811B2 AU 2019204811 A AU2019204811 A AU 2019204811A AU 2019204811 A AU2019204811 A AU 2019204811A AU 2019204811 B2 AU2019204811 B2 AU 2019204811B2
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oviduct
energy
patient
constriction
egg
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AU2019204811A1 (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
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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 affect pregnancy comprising a restriction device (2) adapted to postoperatively restrict and release an oviduct (31a, 31b) of the patient.

Description

DEVICE AND METHOD FOR EMBRYO CONTROL FIELD OF THE INVENTION
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
Many women have difficulties getting pregnant. Older age when trying to get pregnant with lower fertility rate is one main reason.
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.
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
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.
Accordingly, the invention provides a pregnancy control system for affecting 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; an implantable stimulation device adapted to stimulate a wall of the oviduct to cause contraction thereof; wherein at least one of the implantable restriction device and the implantable stimulation device is operable 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.
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".
The discussion of the background to the invention in this text is intended to facilitate an understanding of the present invention only. It should be appreciated that the discussion is not an acknowledgement or admission that any of the material referred to was published, known or part of the common general knowledge of the person skilled in the art in any jurisdiction as at the priority date of the invention.
In an aspect of the invention there is provided a pregnancy control system for affecting pregnancy of a female mammal or human patient comprising;
an implantable stimulation device adapted to stimulate a wall of an oviduct of
the patient to cause contraction thereof;
wherein the implantable stimulation device is operable 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.
In a preferred aspect the invention provides a pregnancy control system for affecting 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.
Advantageously, at least in a preferred form the present invention provides a device and a method for embryo control of a female patient.
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.
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.
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.
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.
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.
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.
The restriction device may of course preferable be adapted to be adjusted reversible.
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 every month until pregnancy is achieved or preferable a predetermined period between 8 and 12 hours.
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 suited for th controlling the flow of eggs into the uterus of a female patient. Basically the device could be perfonned in eight different principle ways:
Hydrauli restrictions
Mechanical restrictions,
Combination of any hydraulic or mechanical restriction device with a stimulation device for restricting, and
- Stimudation devicealone,
Vary the restriction area Any of these inany combination could be used to over time vary therestriction areaof the oviduct from one ortonto another one and later back again Several different areas could be involved in such a system to vary therestrictionportion/area This would allow the oviduct to recover the restricted area still keeping the restriction over a longer period,
Using a moving device.When the restriction area being moved between different areas, speciallywhentherestrictionismovedupstreamtowardstheovary,itmayhbeconvenient to use amoving deviceto avoid any eggbeingsqueezedinanewupstreamrestrictionareaand by mistake being released for further downstream transportation when the restriction being released andmovedfurther 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 byany ofthe above mentioned restriction devices, mechanical, hydraulic or stimulation devicealoneor in any combination,but may also be a separate device which also may be a mechanical, a hydraulic or a stimulation device.In one embodiment the loving device cause vibrations.
- Peristaltic like wave movement of the oviduct wall towards the ovaryAnother principle is tostop the egg reaching the uterus by creating peristaltic wave like movements of the oviduct Wall,
Such peristahic wave like movements upstream direction towards the ovary may stop flow of any egg towards the uterus without fully restricting the oviduct to allow any sper to passand also
- Peristaltic like wave movement of the oviductwall towards the uteus by being able to cause movementof theegg down to uterus with a downstreamperistaltic wave
Theseareas will be outlined below
Hydraulic restriction Where the operationdevice hydraulically operates the constriction device ofthe restriction or combined restriction/timulationunit (d) it includes hydraulic means fKr adjusting the device,
inan embodiment of the invention, the hydraulic means comprises a reservoir and an expandable/contractiblecavity inthe constriction device, wherein the operationdevice 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 cavitymaybe 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 releasedupon contraction of the cavity
Alternatively, the cavity may be defined by a bellows that displaces a relatively large contractionelement of the constriction device, for example a large balloon thatabuts the wall portionso that the patient's wall portion isconstricted upon contraction ofthe 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 ofthe wall portion. Such a bellows may also be replaced by a suitably designed piston/cylinder mechanism,
Wherethehydraulicmeanscomprise cavity in theconstriction device, the apparatus of the invention can be designed in accordance with the options listed below,
1) The reservoir comprises firstand 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 from the reservoir to the cavity or from the cavity to the reservoir.
Ia) The first and second wall portions of the reservoirare displaceable relative to each other by at least one of a magnetic devicea hydraulic device or an electric control device
2) The apparatuscomprisesafluid conduit between the reservoir and the cavitywherein the reservoir oirms part of the conduit; The conduit and reservoir and apparatus are devoid ofany non-return valve. The reservoir fons a fluid chamber with a variable volume, and distributes fluid from the chamber to the cavity bya reduction in the volume of the chamber and withdraws uidf om the cavityby 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 forchangingthevolumeofthechamber
In a special embodiment ofthe invention, the operation devicecomprises a reverse servo operatively connected to the hydraulicmeans The tern "reverseservo" is to beunderstood as a mechanism that transfers a strong force acting on a moving ement having ashort stroke into a weak force acting on anothermoving element having along stroke; x. the reverse function of a normal servo mechanism Thus, minor changes in the amount of fluid in a smaller reservoir could be transferred by the reverse servointo maior changes in the amount of fluid in a larger reservoirThe reverseservo is particularly suited for manualoperation thereof
Preferably amually operated reservoir could be placed subctaneously for manual manipulation thereof Mechanicalrestri ction
Where the operation device mechanically operates the device or therestriction/stimulation unit (d)itmay be non-inflatabie Furthermorethe operation device may comprisea servo vice which mayinclude a gearbox. The term "servodevice"encompasses thenormal definition of a servo mechanismA. e an automatic device that controls large amounts of power by means of very small amounts of powerbut may alternatively or additionally encompass the definition of a mechanism that transfers a weak force actingon a moving element having alongstroke into a strong force acting on another moving element having a short stroke Preferablythe operation device operates the constriction device in a non manetic and/ornon-manual manner A. motor mayb e operatively connected to the operation device.The operationdevice may be operable to perform at least one reversible function and the motor may be capable of reversing thefunction.
Combinationof mechanical or hydraulic device and a stimulation device The present invention provides an advantageous combination of restrictionandstimulation devices,which results in a two-stage influence on the flow of eggs in the lumen of the oviduct.Thusthe constriction device may gentlyconstrictthetissuewallofthe oviductwall byapplying a relatively weak force against the wall portion, and the stimulation deviceemay stimulate the constricted wall portion to achieve the desired final influence on the flow in the lumen.The phrase gentlyconstrictinga portion of the tissue wall"is to be understood as restricting the wall 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 flow in the lumen is restricted or stopped, and controls the situation deviceto stimulate the constricted wall portion to cause contraction thereof, such that flow in thelumen is fiirther restricted or moresafely stopped. More precisely, a control device may control the stimulationdevice in a first mode to stimulate the constrictedwailportion tofurtherrestrict or stop the flow in the lumen and to,
a) control the stimulation device in asecond mode tocease thestimulation of the wall portion to increase the flow in the lunen; or
b) control thestimulation and constriction devices in thesecond mode to cease the stimulation ofth wallportion and release the wall portion to restore the flow in the lumen.
Thus both a method for controlling the flow in the lumen and an apparatus adapted to control theflowin the lumenmay beimplemented 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 peristatic wave like movements ts if a) upstream Stop without fully restricting the oviduct and also b) being able to ausemoveentof the egg down to uteus witha down stream peristalt icwave:
Preferably,the stimulationdeviceis adapted tostimulate different areas of the wall portion as the device restricts the wall portion, and the control device controlsthe stnulation deviceto intermittently and individuallystimulate the areas of the wall portion.This intennittent and individual stimulationof different areas of the wall portionoftheoviductallowstissueofthe wall portion to maintain substantially normal blood circulation during the operation of the apparatus ofthe invention,
The stimulation of different areas may be used bothforosingthe lumen in a safe way but also be used for creating a peristaltic wave in the oviduct
Moveentof theggginthovidutlumen In one embodiment the devices adapted to constrict the wall portion to restrict or vary the flow in the lumen, and the control device controls thestiulation 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 eggdowstreamsin the lumen or prevent further transport downof the egg to theuterus
Design of control device The device is preferablecontrolled from outside the body in a manual way, The device may also bepowered. A control devicemay be supplied. The control devicesuitably controls the device or the stimulationdevice orrestriction/stimulationunit from outside the patient' 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 theconsiction/stimulation unit, wherein the switch is adapted for subcutaneousimplantation inthe patient to be manually or magnetically operated from outside the patient's body. Alternatively, the control device may comprise a hand-heidwireless remote control, which is conveniently operable by the patient toswitch on and off the onstition/stimlationunitThewireless remote control may also be designed forapplication on the patient's body like a wristwatch 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 ofthe constrictionofthe wall portion as desired, wherein the control device controlstheconstrction 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 stimulatethe wallportionwhile 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 tostitnulate the wall portion, while controlling the constriction deviceto adjust the constriction of the waiportion until the desired restriction of the flow in the lumen is obtained.
Regarding Stimulation alone or in combination withadevice
The control device may control the stimulation device to stimulate one or more of the areas of thewall portion at a time,; forexampleby sequentially estimating the different areas. Furthermore, the control device may control the stimulation device to cyclically propagate the stimulation of the areasalong the wall portion, preferably in accordance with a determined stimulationpattern To achieve the desired reaction of the tissue wal during the stimulation thereof;the control device may control the stimulation device to, preferably cyclically,vary the intensity of the simulation of thewall portion
In a preferred embodiment ofthe 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 firstareamay be stimulated with the firstpulse train, while the second area isotstimulated with said second pulse train, and vice versa, Alternatively, the first and second pulse trains may be shiftedrelativeto eachother,such tha.thefirstand secondpulse trains at leastpartially overlap each other,
The pulse trains can be configured in many different ways. Thus, the control device may control thestimulation device to vary the amplitudes of thepulses of the pulse trains, the duty cycle of the individual pulses of each pulse train, the width ofeachpulse of the pulsetrains 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, andlor the off thne periods between the pulse trains Several pulse trains of different configurations may be employed to achieve the desired effect.
in case the control device controls the stimulation device to vary the offtime periods between pulse trainsthat stimulate the respectivearea of the wall portion, it is also possible to control each off tine period between pulse trains to last long enough to restoresubstantially normal blood circulation in the area when the latter is not stimulated during the offtime 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 portionwith electric pulses Optionally the electrical elements may be placed in a fixed orientation relative to one anotherThe control device controls the electric stimulationdevicetoelectrically energizethe electrical elementsone at a time, or groups of electrical elements at time, Preferably, the control device controls the electric stimulation device to cyclically energize each element with electric pulsesOptionally, the control device may control thestimulation deviceto energize the electrical elements, such that the electrical elementary energized one at a time in sequenceor such that anumber or groups of theelectricalelements are energized at the same time. Alo, groups of electrical elements may besequentially energizedeither randomly or inaccordance with a predetermined patten.
Theelectrical elementsmay formanypattern ofelectrical elements. Preferably, the electrical elements form an elongate patten 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, and the elements abut the respective areas ofthe wail portionTheelongatepattern of electrical elements may include oneor more rows of electrical elements extending lengthwise along the wall of the organEach row of electrical elements mayform a straight helical orzig-zagpathof electrical elements,or any fonnof path. The control devicemay controlthestimulation device to successively energize the electrical elements longitudinally along the elongate pattem 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 ofthe invention, the electrical elements forn a plurality of groups ofelements, wherein the groups form a series of groups extending along the patient's organ in the flow direction in the patient's lumen. Theelectrical elements of each group of electrical elements may fbma path of elements extending at least in part around the patient's organic a firstaternativethe electrical elements of each group of electrical elements may fbrm inore than two paths ofelements extending on different sides of the patient's organ,preferably 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 offgroups in random, or in accrdance 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 patientslumen, or in both said directions starting from aposition substantiallyatthe centerofthe constricted wall portion Forexample, groups of energized electrical elements may fom advancing waves of energized electricalelements as described above; that is, the control device may control the stimulation device to energize the groups of electrical elementssuch that energized electrical elements form two waves of energized electrical elementsthat simultaneously advance from the center of the constricted wall portionin two oppositedirections towards both ends of the elongate patten of electrical elements.
Sensor
The control device may control the stimulation deviceto change the stimulation of the wall portion in response to a sensed physical parameter of the patient or functional parameter of the device, For example, the control device may control the stimulation device to increase the intensity ofthe stimulation of the wall portion in response to a sensed pressure increase in the oviduct, such that the flow in theoviduct remainsstopped 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 maybe provided, wherein the control device controls the stimulation device n 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 orthe pressure on the tissue wall of the bodily 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 abovethe device may comprise at least one implantable sensor, wherein the control device controls the constriction deviceand/or thestimulation device in response to signals from the sensor. Generallythe 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 implant inthepatient.
The systems further preferable adapted to send feedback information from inside the body to the outside thereof to give feed backelatedto any functional parameterof the device or physical parameter of the patient.
The functional parameter of the device may be correlated to the transfer of energy fr charging the integral energy sourcementionedin other places
The functional parameter of the device may be theenergy balancethe balance between the energy received and the energy used including accumulated by the device and the energy balance could also include the balancebetween an energy reception rate and anenergy 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 tosignals from the sensor The control device may father comprise a wirelessremote control adapted to setcontrol parameters ofithe internal control unit fom outside the patient without mechanically penetrating the patient.Atleast one of the control parametershich issettable by the wireless remote controls the physical or functional parameter. Suitably, the internal control unit includes the above entionedclock mechanismwherein the wireless remote control also is adapted to set the clockmechanism.
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.
AdsaleonictionDevice in several alternative embodiments of the inventionthe constriction device is adjustable, In these embodiments, there is an operation device for operating the ad justable constriction device to change the constriction ofthepatientstissue wall portionand the constiction and stimulation devices form a constriction/stimulationunit. Preferably,the constriction and stimulation devices of the constriction/stimulationunit are integrated in a single piece suitable for implantation.The constriction device of theunit comprises contact surfaces dimensioned to contact a length of a tissue wall portion of a patient's organ, and thestinulation device of the unit comprises a plurality of stimulation elements provided on and distributed along the contact surfaces When the control device controsthe stimulation device to stimulate the wall portionthe stimulation elements stimulate different areas ofthe wall portion along the length of the wall portion, The stimulation elements preferably comprise electric elements, as described above, for stimulating the wall portion with electric pulses However, in most applications of the present invention, other kinds ofstimulations, such as thermal stimulation, coudbe suitable to employ.
The operation device operates the adjustable constriction device of the constriction/stimuationunit in a manner that depends on the design. of the constriction device., as will he explained by the following examples of embodiments ) The constriction device comprises at least two elongatedclamping elements having the contact surfaces and extending along the wall portiondifferent sides of the organ, and the operation device operates the clamping elements to clamp the wall portion between the clamping elements to constrict the wall portion of the organ
2) The constriction device comprises one elongate clamping element having the contact surfaces and extendingalongthe wall portion on oneside of the organ, and the operation device operates the clamping element to clamp the wall portion between the clamping element and the bone or tissue of the patient to constrict the wall portion.
3) The construction 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 engagementelentnts engage and constrict the wall portion ofthe organ
4) The constriction device comprises at least twoarticulated clamping elements having the contact surfaces and positioned on different sides of the organ, and theoperation device moves the clamping elements towards each other to clamp the wall portionof the organ between the clamping elements, to constrict the wall portion,
)Theconstriction device comprises at least twoseparate clampingelements having the contact surfaces, at least one of the clamping elements being pivoted, suchthat it may tu in a plane in which the loop of the constriction member extends, and the operation device turns the pivoted clamping element to change the size of the constriction opening,
6)The constriction device comprisesat least oneelongated constriction member having the contact surfaces, and forming means for frming the constriction member into at least a substantially closed loop around the organ., wherein the loop defines aconstriction opening The operation device operatesth constrictionmemberin the loop to change thesize of the constriction opening.
6a) 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 ofthe constriction opening The fonning means may form the constriction member or belt into a loop having atleast one predetermined size.
6b) The elongated constriction member is operable to change the size of the constrictionopening, such that the outercircumferential confinement surface of the constriction device is changed, ory altematively,isunchanged
6tc)The elongated constriction member is elastic and varies in thickness as seen in a cross-section there through, and is operable to tum around the longitudinal extension of the constriction member.
6d) The elongated constriction membercomprises two substantially or partly semi-ircularfame elements having the contactsrfaces and hinged together, such that the semincircular elements are swingable relative to each other ftom a f(Ily open state in which they substantially or partly forn a circle to a fullyflded stateinwhich they substantially form a semicirclc
7)The constriction device is adapted to bend the wall portion of the organ to constrit 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/members to be applied in a row along said length of the wall portion, wherein said row extends in the direction of flow in the oviduct of the organ Preferably, such constriction elements/members are non-inflatable and mechanically operable or adjustable.
In theabove noted embodiments(1) to (7), the operationdevicemay either mechanically or hydraulically adjust the constriction device oftheconstriction/stimulationunit, Also, the operation device may comprise an electrically powered operation device for operating the constrictiondeviceFor manyapplications ofthe present invention, the operation device suitably operates the constriction device, suchthat 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,
Mechanical operation Where the operation device mechanically operates the constriction device of th constriction/simulationunit it may be noninflatable.Furthernorethe operation device may coamrise a servo device, which may include a gearbox.The term "servodevice"encompasses the normal definition of a servo mechanism, ie., an automatic device that controls large amounts of power by means of very small amounts of power, but mayalternatively or additionally encompass the definitionof amechanismthat transfers a weak. force acting on a moving element having longstroke into astrong force acting onanother moving element having a shodstroke Preferably, the operation device operates the constriction device in a non-magneticand/or non-manual manner 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,
Hvdraudic Oeration Where the operation device hydraulically operates the constriction device of the constriction/stimation unit, itincludes hydraulic means for adjusting the constriction device.
In an embodiment of the invention, the hydraulic means comprises a reservoir andan expandable/contractiblecavity in the constriction device, wherein the operation device distributes hydraulicfluid ftom the reservoir to expand the cavity and distributes hydraulic fluid from thew city to the reservoir to contract the cavity. The cavity may be defined by a balloonof 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 contractionof the cavity,
Alternatively, the cavity may be defined by a belows that displaces a relatively large contraction element ofthe constriction device,for example a largeballoon that abuts the wall portion, so that the patient's wall portion is constricted uponcontraction of the bellows and released upon expansion ofthe bellows. Thus, a relatively small addition of hydraulic fluid to the bellowscauses relatively large increase in the constriction of the wall portion. Such a bellows may alsohbe replaced by asuitably designed piston/cylinder mechanism
Where the hydraulic neans comprises a cavityin the constriction device, thedevice of the invention can be designed in accordancewiththe options listed below.
1) The reservoir comprises first and second wall portions, and the operation device displaces the firsthand second wall portionsrelativeto each other to changethe volumeof thereservoir such that fluid s distributed from the reservoir to the cavity, or from the cavity to the reservoir,
I a) The first and second wall portions of the reservoirare displaceable relative to each other by at least one of a magnetic device hydraulic device or an 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 the pump to pumpfluid from the reservoir to the cavity and a second activation member for activating the pump to pump fluid from the cavity to the reservoir,
2al) The first and second activation members are operable by manual manipulation thereof
2a2) At least one of the activationmembers operas when subjected toan etemal predetermined pressure,
2a) At least one of the first and second activating members is operable by magnetic means, hydrauc means,or electriccontrol means
2b) The device comprises a fluid conduit between the pump and the cavity, wherein the reservoir fons part of the conduit The conduit and pump are devoid of any non retum valve, The reservoirforms a fluid chamber with a variable volumeand the pump distributes fluid fom the chamber to the cavity by a reduction in the volume of thechamber and withdraws fluid from the cavity byanexpansionof the volumeof the chamber The device further comprisesa motor for driving the pumpwherein the pump comprises a movable wall of the reservoir forchanging the volume of the hamber
In all 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 mechanism for adjusting the constriction device.In this case the operation device distributes hydraulic fluid between the reservoir and thecylinder/pistonmechanismto adjust the constriction device.
in a special embodiment of the invention, theoperation device comprises a reverse servo operatively connected to the hydraulicmeans The term "reverseservo" 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 onanothermoving element having a long stroke;e., the reverse function of a normal servo mechanism. Thusminor changes in theamount of fluid in a smaller reservoir could be transferred by the reverseservo into major changes in the amount of fluid in a largerreservoir. The reverse servo is particularly suited for manual operation thereof
Preferably, the reverse servo comprises an expandable servo reservoircontaining servo fluid and a fluid supply reservoirhydraulicallyconnected to the servo reservoir to form a closed conduitdevice for the servo fluid. The expandableservo reservoir has first and second wall portions, which are displaceablerelative to each other in response to a change in the volume of the expandableservo reservoir
In accordance with a first alternativethe first and second wall portions of theservo reservoir are operatively connected to the hydraulic meansThe reverse servo distributes fluid between the fluid supply reservoir and the expandableservoreservoir to change the volume of the servo reservoir, whereby the hydraulic meansis operated to adjust the constriction device,
Inaccordance with a second aernativethere is provided an implantable mainreservoir containinga predetermined amount of hydraulic fluid, wherein the reverse servo is operable to distribute hydraulic flaid between the main reservoir and thehydraulic means to adjust the constriction device.More specifically, the main reservoir is provided with first and second 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 fom the main reservoir to the hydraulic means, or from the hydraulic neans to themain reservoir, Advntageously the servo and main reservoirs are dimensioned, such that when the volume of theservo reservoir is changed by a relativelysmall amount ofservo fluid the volume of the main reservoir is changed by a relatively large amount of hydraulicfluid.
In both of the above-dcscribed alternatives, the fluid supplyreservoir may have first and second wall portions, which are displaceable relative to each other to change the volunie 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 the fluid supply reservoir may be displaceable relative to eachother by manual anipulation, amagnetic device, a hydraulic device, or an electriccontrol device to change the volume ofthe fluid supply reservoir to distribute servo fluid between the fluid supply reservoir and the expandable servo reservoir.
In all ofthe above noted embodiments I to 2b where the hydraulicmneans comprises an expandable cavity in the constriction device,or in embodiments where the hydraulicmeans comprises a hydraulically operable mechanical constructionthe operation devicemay include the reverse servo describedabove.In a further embodiment of the invention, the hydraulic means include first and second hydraulically interconnected expandable/contractible reservoirs The first reservoirs operatively connected to the constriction device, such that the constriction device changes the constriction of the patient's wall portion upon expansion or contraction of the first reservoir. By changing the volume of the second reservoir hydraulic fluid is distributed between the two reservoirs, so that the first reservoir is either expanded or contracted. This embodiment requires no non-retum valve in thefluid communication conduits between the two reservoirs, which is beneficial to ong-ermoperation of the hydraulic means.
Alternatively, the hydraulic meansmay includefirstandsecond hydraulicallyinterconnected piston/cylinder mechanisms instead of the first and second reservoirs described above. The first piston/cylinder mechanism is operatively connected to the constriction device, such that the constriction device changes the constriction of the patient's wall portion upon operation of the first piston/cylinder mehanismBy operating the second pisto/cylinder mechanism hydraulic fluid is distributed between the two piston/cylinder mechanisms, so that the first piston/cylinder mechanism adjuststhe constriction device
Where the constrictiondevice does not include an expandable/contractiblecavity, the constriction device may comprise atleast two elongated clamping elements having the above mentioned contact surfaces and extending along the wall portion on different sides ofthe organ. The hydraulic means,whichmay include the reverseservodescribedabove, hydraulically moves the elongated clampingelements towards the wall portion to constrict the wall portion. For example the constriction devicemay have hydraulic chambers in which the camping elements slide back and forth, and the hydraulic means may also include a punp 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, anddistributeshydraulicfluid from the chambersto the reservoir to move the clamping elements away from the wall 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 theoviduct still keeping the oviduct closed avoiding any egg to pas down to the uterus thus avoiding pregnancy.
In one embodiment the system comprising a hydraulicrestriction device with two or more restriction areas connected individually to two or more reservoirs withhydraulic fluid, said reservoirsadapted to be 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 hydraulicrestriction areas is adapted to be restrictedfor a predetermined time period preferable with some overlap in. time and adapted tofirst restrict the restriction area closest to the ovary then changing restriction area towards the uterus. This way the restriction may all the tne bekept 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 firstclosest to the ovary where the egg is released.
The hydraulic restriction areas may beadapted to be regulated by manual manipulation thereof,
The system may also be adapted to have the changes of therestriction 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 by any of the different types of restriction devices or combinations described earlier.This wave could prevent the egg being transported down to the uterus also withoutRally restricting the oviduct. This would then allow the sperm to reach the egg during the accumulation period of a few days, thus increasing likelihood of pregnancy even furher.
The restriction device may also be adapted to effect a transport oftheat least one egg to the uterus upon release of the oviduct.Thismay 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 oneegg released from the ovary in the oviduct for a predetemined periodof time, and adapted to restrict a second part ofthe oviduct and thereater release the restriction of the first part and also later release the restriction of the second part, therebyallow transport of the egg down to theuterus or thesystemmayftheher beadaptedtoalsorestrict a third part of theoviduct and release the restriction of the second part also it may further be adapted to release the restriction ofthe third part thereby allow transport ofthe egg down to the uterus or the system may be adapted to restrictafourth part of the oviduct
and release the restritionof the third part Finally it may be further adapted to releasethe restriction of the fourth part, thereby allow transport of the egg down to the uterus,
Thenumber of restrictionareas 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 bystep 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 devicetomove the eggin the oviduct to avoid any egg being squeezed in anyrestriction area when. restriction are moved towards the ovary or having the peristaltic like wave moving towards the ovary keeping the egg ac imulated 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 oviductWith the stimulation device it is then possible to move the restriction areaThe hydraulic device may for example have the movement function to cause the movements necessary
Any combination is possible of mechanicalhydraiic or stimulation device or separate use of the same.
In summary preferable more than two restricting areas is used and varyingtherestrictinarea 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 areno limit how many areas could be restricted except practical andsize issues
Moving in restriction from theovary and down towards the uterus is then the preferred way of doing it, for example three restrictions could sharea time period ofthree days with one day each to not asking to in any way damage the oviduct,
A system adapted to restrict the restriction areas in consecutive order starting with the restrictionarea, part of the oviduct, closestto theovary and thereafterrestrictany new area one step closer to the uterus and further adapted to overlap intime the restriction of more than onerestriction area will allow to restrict without interfering with any accumulated egg
PERISTA:TIC LIKE WAVE OVIDUCT WALL MOVEMENTS
The restriction devicemay he adapted to only partly restrict the oviduct and to create peristaltic wave like movements of a part of the oviduct(s) wallto prevent the transport of an egg in an oviduct to the uterus of the human ormammal patient, and thereforeaccumlate at least one egg released from the ovary in the oviductt forapredetermined period of time, and wherein thespermis able toreach the egg during the tiie 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 uters.
The devices then preferable adapted to comprise at least one restricted area adapted to at least partly restrict and change the restriction areaovertime most likely adapted to comprise two or more restricted areas adapted to at least partly restrict different portions of the oviduct and change the restriction area ver time.
The change of the restriction area may be adapted to cause a peristaltic wave like wave in the direction towards the ovary to prevent the egg being transported down to theutems
The restriction device may comprise a hydraulic device or a mechanical device or a stimulation device adapted to cause said peristalticwave like restriction wave.
The device is adapted to allow a transport of theatleast one egg to the uterus upon release of the oviduct and may even cause a another peristaltic wave like restriction wave in theopposite direction towards the utes.
The device is adapted to beadjusted which could be done bymanualmanipulation or electricalor magnetic power
The restriction areas is only partly restricted to allow the sperm to reach the egg and the device adapted to prevent the egg to temporary reach the uterus with the peristaic waveto accumulate the egg temporary in the oviduct to allow increased likelihood for pregnancy to prolong the time period the egg being reachable by the sperm.
When the restriction areas is coimpletelyrestricted to preventthe egg to temporary reach the uterus, the timing of the release of the egg is crucial after havingaccumulatedtheegg temporary in the oviduct the whole procedure to allowincreased likelihood for pregnancy when released,
The restriction device is adapted to and intended to repeatedly every month repeat the post operational and non-invasive regulation of the deviceactively reversible to preventtransport of an egg from the ovary to theuterus in the oviduct ofthe patient and reverse the function by allowing the normal transport of the egg from the ovary to the uterus until pregnancy has been achieved.
The 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 restrictiondevice ora hydraulic restriction device or a stimulation device or a stimulation device in combination with a mechanical or hydraulic restrictiondvcc or any other combination
The method may include a hydraulic restriction device comprising a reservoir, fbr moving gas or fluid to or fom said restriction device andwherein said reservoir is placedsubcutaneously for
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 ofvaried upcomingnew restricted area before a new area is restricted useful if the restrictionneed tobe movedalso 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 movements of the egg or it may be a different device as the restriction device adapted to work differently when restricting or causing movements of the egg.
The movementdevicemay cause vibration or wave like movements in the oviduct wall thereby causing movements of the egg,
FURTHER METHODS
A method of promoting pregnancy of a female mammal or human patient/may comprise the following steps:
restrictingan oviduct of the patientpostoperatively to provide a restriction to accumulate at least one egg released from the ovary in theoviduct for a predetennined period of time, and
releasing the restriction to admit any egg in the oviduct a transport to the uterus controlling the restrictingand releasing procedures from outside the patients body.
In this and othermethods the predeterinedperiod of time is adapted to avoid pregnancy and may be between 0 and 2 days or preferable 8-12 hours.
A method for placing and controlling two implanted restriction devices promoting pregnancy in a human or mammal patientthe method comprising the steps of:
inserting a needle like tube into the abdomen of the patients body,
~ using the tube like needle like to fill the abdomenwithgas thereby expanding the abdominal cavity,
- placingat least two laparoscopic trocars in thepatient's body,
inserting a camera through one ofthe 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 iplantedrestrictiondevices, on each of the two oviducts
- adjustingtherestriction devices after the operation at atime convenient to get pregnat thus,
controlling the adjustment from outside the patients body and
post-operatively restricting and releasing the twooviducts to increase the likelihood of getting pregnant,
Both methods above could whenrestricting the oviductcomprising the foblowingsteps
- restricting a first part or area of an oviduct ofthe patient to provide resinctionto accumulate at least one eggreleased from the ovary in theo viduct for a predetermined period of time, and
- restricting asecond part of the oviduct
releasing the restriction of the first part
- allowing the oviduct shorterrestriction periods at each restrictionarea.
May also comprise the steps of:
releasing the restriction of thesecond 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 ofthe second part
allowing the oviduct shorter restriction periods at eachrestriction area,
May also comprise the steps of
- releasing the restriction of the third part
allowing transport of the egg down to the uterus
May also comprise the steps of
restricting a fourth part of the oviduct
releasing therestriction of the third part
allowingthe viduct 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 thesemethods normally ifthe restricted first part of the oviduct being closer to the ovarythisis,
allowing the second restriction being restricted without interfering with anyacunulated eggs Nonnally these methods,
having more than two restrictingareas and
varying the restricting area while
keeping at least one restricting area closed when restriction beingwished
In a preferred embodiment;
the restrictionareas being restricted in consecutive order startingwiththe restriction area,part of theoviduct, osest 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, restrictingwithout interfering with any accumulated egg
A method may of course onlyinclude independent of order varying therestrictionarea postoperatively to allow the oviduct to recover or avoid any damage from the restriction while
- keeping the oviduct restricted.
Another method ofpromotingpregnancy of female patient, comprising the folowingsteps
preventing the transport of an egginanoviduct to the uterus of the human or mammal patient,
accumulating at leastone egg released fom the ovary in the oviduct tfr a predeternined period of time, by
- casinga peristaltic like restriction wave movement of a part of the oviduct(s) wall preventing the egg being transported down to the uteus while only partlyrestricting the oviduct, and
- allowing thespennie 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 the at least one egg to the uterus.
Amethod for placing the device above and controlling the implanted device promoting pregnancyinahuman or mammal patient, the method comprising the steps of;
-inserting a tube like needle into the abdomen of the patients body,
- using the tube like needle like to fil the abdomen with gas thereby expanding the abdominal cavity,
placing atleast two laparoscopic trocars in the patient's body,
inserting a camera through one ofthe trocars into the abdomen,
inseringatleast one dissecting tool through a trocar and dissecting anarea of at least one portion of the two oviducts ofthe patient,
placing two parts of the implanted device, one each on the two oviducts
- finishing the operation and withdrawingthe instruments after eventual suturing and thereafter postoperatively:
- adjusting the device after the operation at a time relevant to get pregnat
- controlling the adjustment from outsidethe patients body and thereby
- casing aperistaltic ike wave movement of a part of the oviduct(s) wall towards the ovary preventing the egg being transported down to the uterus without fully restricting the 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 releasedfrom the ovary in the oviduct(s) by
- allowing the spermie to reach the egg during the time the egg is accumulated
releasingany egg in the oviduct from outsidethe bodyto allow the egg to inanonnalway be transported down to the uterus.
Movement devicemethod
Another method of preventing pregnancy of a female human or mammal patient may be provided, comprising the followingsteps:
- restricting a first part of an oviduct of the patient to provide a restriction to accumulate at least one egg released from the ovaryin the oviduct fora predetermined period of time, and
- moving the accumulated egg by said movement device away in the oviduct towards the ovary from the restriction area,
- allowing a second part of the oviduct closer to the ovary bang restricted without interfering with any accumulated egg
~ releasing the restriction of the first part
repeating the restriction of thefirst part
releasing the restrictionof thesecond part
allowing the oviduct to recover between restriction intervals.
Preferably followed by;
- repeating moving any accumulated egg bysaid movement deceawayin theoviduct towards the ovary from the restricted first area, repeating
- allowing a second part ofthe oviduct closer to the ovary being restricted withoutinterfering with any accumulated egg further repeating
~ releasing the restriction ofthe firstpart
repeating the complete pmcedure allowing the oviduct to recover between restriction intervals.
Preferable also the restrictionareas 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 ofthe wall ofsaid 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 stimulationdeviceoracombineddevice
gofeontxd-evice -- The control device suitably controls the constriction and /or stimulation unit fromoutside the patient's body. Preferablythe control device is operable by the patient Forexample the control device may comprise manuallyoperable switch for switching on and off the constrctionstmuationunit, wherein theswitch is adapted for subcutaneous implantation in the patient to be manually or magnetically operated from outside the patient's body. Alternatively, the contMl devicemay comprise a hand-held wireless remote control, which is conveniently operable by the patient to switch on and off the onstction/stimulatonunit, The wireless remote control may also be designed for application on the patient's body like a wristwatch. Such a wristwatch type ofremote control may emit a control signal thati fllows the patient's body toimplanted signal responsive means of the device;
Where the control devicewirelesslycontrols the constriction/stimuilation unit fom outside the patient body, the wireless control function is preferably performed in a non-magnetic manner, i.e, the control device controls the constriction device of theconstriction/stimulation unitin a non-magnetic manner The patient may use the remote control tocontrol the constriction/stimulationunit to adjust the stimulation intensity and/or adjust the constriction of the wall portion. The wireless remote controlmay comprise at least one external signal transmitter or transceiver and at least one internal signal receiver ortransceiver implantabein the patient.
The wirelessremote control preferably transmits at least one wireless control signal for controlling the onstriction/stimulation unitThe control signal may comprise a frequency amplitude, phase odulatedsignal combination thereof, and may be ananaloguemor a digital signaler a combination of an analogue and digital signal. The remote control may transmit an electromagnetic carrier wave signal tbr carrying the digital or analogue control signal Also the carrier signal may comprise digital, analogue or a combination of digitaland analogue signals
Any of the above control signals may comprise wave signalsfor example a sound wave signal,an ultrasound wave signal, an electromagnetic wavesignal,aninfraredlightsignala visible light signal an ultra violet light signal, a laser light signal, a microwave signal a radio wavesignal,an x-ray radiationsignal or a gamma radiation signal Altemativelythe control signal maycompriseanelectriormagneticfieldor a combined electric and magnetic field
As mentioned above, the controlsignalmay follow the patient's body to implanted signal responsive means of the device,
The control device may include a programmable internal control unit, such as a microprocessor, implantablein the patient fbr controlling the constrictionlstimulation unit, The control devicemay furtherincludean extemal control unit intended to be outside the patient'sbody, wherein the interalcontrolunit is programmable by the external control unit, For example, the intemal control unit may be progranmable forcontrolling the constriction/stimuationunit over timesuitably in accordancewithanactivity schedule program The device of the invention may comprise an extemal data communicator and an implantable integral data communicator communicating with the external data communicator, wherein the intenalcomunicator feeds data related to the onstriction/stimulationunitback to the external data communicator or the extemal data conununicator feeds data to the intemal data communicator.
SourceofFnergZy
The present invention also presents a solution for supplying energyfor use in connection with the operation of the constrctionstimulationunit, Thusin a broad sense, the presentinvention provides an device for controlling a flowof egg in a oviduct formed by a tissue wall of a patient organ, wherein the device comprises an implantable constriction device for gently constriction a portion of the tissue wall to influence the flow in theoviduct, a stimulatioit device forintermittentlyad individually stimulating different areas of the wall portion, as the constriction device constricts thewall portion, to cause contraction of the wall portion to further influence the flow in the oviduct, wherein th constrictionandstimulation devices forn an operable constrictionstimulation unit a source ofenergyand 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 constriction/stimulation unit. In a simple form of the invention, the source of energysuchasabatteryoraccumulator,isimplantableinthe patient's body.
Transmission of Wireless Energy In amore sophisticated form of the inventionwhichis preferable, the source of energy is extemal to the patient's bodyand the control device controls the external source ofenergy to release wireless energy, In thissphisticatedfrmof the invention, the device comprises an energy-transmissiondevice 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 lectromagneticenergy, an electriefield, an electromagneticfield or a magnetic field, or a combination thereof, orelectromagnetic waves. The energy-transmission device nmaytransmit wirelessenergy ft direct use in connectionwiththeoperation of the constriction/stimulationunit, as thewireless energy is being transmitted., For example, where an electric motor or pump operates the constriction device, wireless energy in the forn of a magnetic or an electromagnetic field may be used for direct power of the motor or pump.
Thus, the motor or pump isrunning directly during transmission of thewirelessenergy. This maybe 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 the motor or pump with the transformed energy, or b) using the wirelessly transmitted energy to directly power the motoror pump Preferablywirelessenergy in the form of anelectroagneticor magnetic field is used to directly influence specific components of the motor or pump tocreate kinetic energy for drivingthemotororpump Such components may include coils integrated in the motor pump, ormaterials influenced by magneticeldsor pennanent magnets, wherein the agneticorelectromagneticfield influences the coilsto generate a current fordriving the motor orpump, or influences the materialor permanentmagnets t create kinetic energyfrdriving the motor or pump.
Preferably the energy-transmission device transmits energy by at least one wireless signal, suitably a wave signal The wavesignal may comprise an electromagneticwavesignal including one ofan infrared light signal, a visible light signal an ultraviolet light signal laser signal,a microwave signal, a radio wave signal, an x-ray radiation signal, and a gamma radiation signalAlItermatively the wave signal may comprise a sound or ultrasound wave signal The wireless signal may be a digital or analogue signal, or a combination of a digital and analoguesignaL
Elmg~JtmildnYielessiergy In accordance with a particular embodiment of the invention, an impiantable energy transforming device is provided for transforning wireless energyof a first form transmitted by the energy-transnssiondevice into energy of asecond fonn which typically is different fom the energy ofthe fistform The onstrictiostimulationunit is operable in response to the energy of the second fbrm. For example, the wireless energy of the first n may comprise sound waveswhereas the energy of the second form may compriseeectri energy In this case, the energytransforming device may include a piezo-electric element for transforming the sound waves into electric energy. Optionallyoneoftheenergyofthefirst form and the energy of the second form may comprise magnetic energy,kinetic energy, sound energy, chemical energy, radiant energy, dectromagnetic energy, photoenergy,nuclear energyor thermal energy Preferably, one of the energyofthe first form and the energyof the second form is non-magnetic, non-kinetic, non-chemical, non-sonic, non-nuclear or non thermal,
The energy-transforming device may function differently from or similar to the energy transmission device, in aspecial embodiment, the energy-tansfonningdevicecomprises at least one element, such as at least one semiconductor, having a positive region and a negative regionwhenexposedtotheeergy of thefirst form tra.nnitted 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 ofthe second form. More specificallythe element may comprise an electrical junction elementwhich is capable of inducing an electric field between the positive and negative regions when exposed to the energy of the first form transmitted by the energy-transmission devicewhereby the energy of the second fonn comprises electric energy.
The energy-transfonning device may transform the energy of the first fomi directly or indirectly into the energy of the second forn An implantable motor or pump for operating the constriction device of the constriction/stulation unitmay be provided, wherein the motor or pump ispowered by the energy of the second form The constriction device may be opebe toperform at leastone reversible function and the motor may becapable of reversing the function.For example, the control device may shift polariyof the energy ofthe second formto reverse the motor,
The energy-transforming device may directly power the motor or pump with the transfored energy, as the energyof the second form is being transformed from the energy of the first fnn Preferably,the energy-transforming device directly operates the constriction/stimulation unit with the energy of the second form in anon-magnetic, non thermal ornon-mechanical manner.
Normially, the constrctionstimiation unitcomprises electriccomponents that are energized withelectricalenergy.Otherimplantable electric componentsof the device maybe at least one voltagelvelguard or at least one constant current guard iTheretore, theenergy transforming device may transform the energy of the first form into a direct current or pulsating direct currentor a combination of a direct current and pulsatingdirectcurrent. Alternatively, the energy-transformingdeviemay transform the energy of the first form into analternating current or a combination of a direct and alternatingcurrent
The device ofthe invention may compose an internal source of energy implantable in the patientfor supplying energy for the operation of the constriction/stimulation unit. The device may further comprise an implantable switch operable to switch from an "off'modein which theintemal source of energy is not in use, to an"on" modein which the internalsource of energysupplies energy for theoperation of the constrictio/stimuilationunit, and/orfor 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-transforning device, The described switcharrangement reduces power consmption of the device between operations
The internal source of energy maystore the energy of the second form supplied by the energytransforming device Inthis casetheintenal source of energy suitably comprises an accumulatorsuch as at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitorandat least one rechargeable batteryWhere theinternal source of energy is a rechargeable battery it may be charged only at times convenient for the patient, for example when the patient issleeping. Alternatively, the internalsource of energy maysupply energy for the operation of the constriction/stimulation unit but not be used for storing the energy of the second fom. In this alternative, the internal source ofenergy may be a battery and theswitch described above may or may not be provided,
Suitably the device ofthe invention copies an implantable stabilizer for stabilizing the energy of the second form Where the energy of the second tan is electric energy the stabilizer suitably comprises at least one capacitor
The energy-transforming device may be designed for implantation. subcutaneously in the abdomen, thoaxor cephalicregion of the patient Alternativelyit may be designed for implantation in an orifice of the patient's body andunder the mucosa or intramuscularly outsidethe mucosaof the orifice,
Although the constriction/stimulationunit in the embodiments described above is designed as a single piecewhich is most practical forimplantationitshould be noted that as an alternative the constriction deviceand stimulation device could be designed as separate pieces. Any one of the onstriction and stimulation units described above may alternatively be replaced by two or more separateconsictionstimulation elements, which are controlled independently of one another.
Where the adevice is used for controlling the flow of eggs into the uterus of a female, the devicecomprises an implantable constriction device for constricting each one of the female's uterine tubes torestrict 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 from entering the uterine cavity, and to release theuterine tube such that an egg existing in the passageway of the uterine tube is allowed to enter the uteine cavity.The constriction device may gently constrictat least one portion of the tissue wall of the uterinetube to restrict the passageway thereof, and an implantable stimulation device may be provided for stimulating the tissue wallportion,wherein the control device controls said stimulation deice tostimulate the tissue wall portionias said constriction device constricts the tissue wall portion, to cause contraction ofthe tissue wall portion to further restrict the passageway of the uterine tube,
Alternatively,the egg flow control device comprises an implantableonstriction device for gently constricting atleast one portion of the tissue wall of each one ofthe female's uterine tubes to restrict the passageway thereof, a stimulation device for stimulating the tissue wall portion of the uterine tube, and a control. device forcontrolling said stimulation device to stimulate the tissue wall portion,as said constriction deviceconstricts theissue wallpcrtin to cause contraction of the tissue wall portion to further restrict the passageway of theuterine tube to prevent an egg existing in theuterine tube from entering the uterine cavity,
Alternatively, the egg flow control device comprises an implantable stimulation device for stimulating a portion of the tissue wallof each one of the female's uterine tubes, and a control device for controlling said stimulation deviceto stimulate the tissue wall portion oftheuterine tube to cause contraction of the tissue wa portion, such that the passageway of the uterine tube is restricted to prevent an egg appearing in the uterine tubefrom entering theuterine cavity, and to cease stimulating thetissuewall portion of the uterine tube to allow an egg existing in the passageway of the uterine tube to enter the uterine cavity,
The present inventionalso 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 the constriction device and/or stimulation device fom 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 viduct.
The present invention also provides method for controlling a flow of egg in a oviduct formed bya tissuewallofapatient's organ themethod comprising:
a)gentylconstrictingateast one portion of the tissue wall to influence the flow in the oviduct, and
b)stimulatingthconstrictedwall portionto cause contraction of the wall portionto further influence the flow in the oviduct,
BRIEF DESCRIPTION OF THE DRAWINGS Fig.IA illustratesadeviceaccordingtotheinventionappliedontheoviductsofafemale patient, wherein devicesare in a non-restricting operating state.
FigB is a view similar to that of Fig.I A, but wherein devices are in a restricting operating state,
Fig 2A illustrates a device according to the invention with remote control applied on the oviducts of afemale patient, wherein devices are in a non-restricting operating state.
Fig 2B is a view similar to that of Fig 2Abut wherein devices are in a restricting operating state.
Fig 3A is a shematicview of a hydraulic operation means with a subcutaneously placed reservoirsuited for operatingthe device of the embodiments ofFig IA, IB.
Fig B shows the embodiment of Fig. 3A with the constriction device constricting a tissue wall of a patientIs oviduct.
Fig.4A is a schematicview of mechanical operation means suited for operatingthe constrictiondevice of the embodiments of Figs. 2-11,
Fig 4B shows the embodiment of Fig. 4A withthe constriction device constricting a tissue wall of a patient's organ.
Fig 4C shows a modification of the embodiment of Fig, 4B
Figs, A, 5B and 5C are cross-sections of the embodiment of Fig.2 showing different states of operations with the device appiedon a tissue wall ofa patient's organ.
Figs.6A,6B and 6C are rosseetions of a modificationof the embodiment of.Fig. 2 showing differentstates of operations wihthedevice applied on a tissue wal of a patient's organ,
Figs7A, 7B 7C, 7Dand 73schematically illustrate different states of operation ofageneral embodiment of an device according to the present invention.
FigsF, 70 and 7H illustrate different states of operation of a modification of the general embodiment.
Figs 71, 7K and Lilustrate an. alternative mode of operation of the modification of the general embodiment,
Fig. 8A is apuseinediagramshowingelectric stimulation pulsesgeneratedby the device of the invention forstimulating a tissue wall of a patient's organ.
Fig, 8Bis pulse/time diagramshowing amodification of the electric stimulationshownin Fig 8A in which pulses ofmixedfrequencies and/or amplitudes are employed.
Figs, SCand 8D show two pulse/time diagramsrespetively, representing electric stimulation of two different areas of the tissue wall with pulses forming pulse trains,
Fig. 9A is a longitudinalcross-sectionof an embodiment of the device of the invention including thermal stimulation device, wherein the devices constricting a tissue wall of a patient's oviduct
Fig 9B is the same embodiment of Fig. 9A with the thermalstimulation device activated,
Fig, 0A is a schematic view of a hydraulically operable inflatable constriction device for use in accordance with the invention.
Fig 10B is the same embodiment shown in Fig. IA ith the constriction device inflated.
Figs 11A, I IB,1 C and IDare block diagrams illustrating four different principles for hydraulic operation of the constriction deviceshown in FigA.,
Fig. 12 is a cross-sectional view of a reservoir having a variable volume controlled by a remote control motor
Figs 3A and 13B areperspective views of a reverse servo inaccordance with a particular embodiment of thehydrauli operationprinciple shown in Fig. IIC.
Fig 14 is aschematic view of another hydraulically operable constriction device for use in accordance with theinvention
Fig 15A illustrates the constriction device ofFig.34 in a constricted state
Fig. 15B illustrates the constriction device of Fig 14 in a releasedstate
Fig.16 is a schematic blockdiagramillustrating a general embodiment ofthe device of the invention, inwhich energy transferred toenergyconsumingcomponents of thdevice implanted in thepatient
Figs 17 to 28 are schematic block diagrams illustrating twelve embodiments, respectively, based on the general embodiment shown in Fig,37 wherein wireless energy is transmitted fromoutsideapatiensbodytoenergy consuming components of the device impanted 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 oftheinvention, in which wreless energy is transfonned into a.current
DETAILED DESCRIPTION OF THE INVENTION
Referring to the drawing figures, like reference numerals designate identical or corresponding elements throughout theseveral figures.
Figs IA and 1B illustrates a first embodiment of device fo.rtreating a female patient to promote pregnancy applied on the oviducts 31a,31b of a female patient.Clamping elements , 6 of arestriction or constriction device 2 constrict the oviducts 31a 31b, (For the sake of claritythe housing is not shown and the clamping elements 5 6are exaggerated.) In this embodiment, a control device includes asubcutaneouslyimplantedpush button that is manually switched by the patient between"on" and "off'.This control device will be described in more detail below with reference to Figs 3A AND 3B Such a manually operable push button may also be provided in combination witha remote control as an emergency button to allow the patient to stop the operation of the devicein case of emergency or malfunction. Such a remote control will be described belowwithreference to Figs2A and 2B,.This device could also be fully manually controlledbymanual manipulation of for example a hydraulic reservoir controlling a hydraulic device such as described inFig3A-3D or ISA and 1SB or IOA and 10B or any of IIA 4ID, Pleaseobserve that onlya reservoir moving fluid manually as in Fig.3Cand 3D may be used toadjust the device This reservoir may be controedin such a way that the change of thereservoivolume will be stable after the manual manipulation of the reservoir wall has taken place. In this particular case is showed a lookingdevice but manydifferentways may be used, Small amount of fluid in the reservoir may also case larger movement ofthe device as described in some of the embodiments above,
Figs. 2A and 2B illustrates an alternative embodiment applied on the oviducts31a,31bofa female patient The clamping elements 5, 6 of the constriction device 2 constrict theovidcts 31a,3lb.(For the sake of claritythe housing is not shown and the clamping elements3,6 are exaggerated. in this embodiment, a control device includes an external control unit in the form of a hand-held wireless remote control 32, and an implanted intemal control unit 33, whichmay include microprocessor, frcontrolling the constriction andstimulation devices The remote control 32 is operable by the patient to control the internal control unit 33 to switchonand off the device
The intemal 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 33, whichmay be implanted subcutaneously or in the abdomen, may also work as en energy receiver,e fortransfoming wrdess energy into electric energyand charging the implanted source of energy 3 (rechargeable battery) with theelectricenergy
An implanted sensor 36senses a physical parameter of the patient, such as the temperature, whereinthe internal control unit 33 controls the constriction device 2 and/or thestinulation device 3 in response to signals from the sensor 36. In this embodiment the sensor 36 is a hormone level sensor wherein the intemal control unit 33 controls the constriction device and/orstimulaion device to change the constriction of the patient's oviduct 31 in response to the sensor 36 sensing predeterminedvalueof 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 response to the sensorsensing an increased or decreased horone level Alternativelyor 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 controlunit33
The remote control 32 may be equipped with means forproducing an indication,such asa sound signal or displayed infonnation 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 saidsensor input..Thepatient may use the remote control tocontroltheconstrictiondevice or stimulation device topumpeggsthrough the oviducts of the patient,
Figs, 3A and 3Bshowhydraulic operationmeans suited for operating the constriction device of the embodiments described above with reference to Figs IA and 1B. SpecificallyFigs.A and 3B show the device of Figs, IAand1B provided with such meansfbr hydraulic operation of theconstriction device 2, Thus, the housing Itinns two hydraulic chambers 22a and 22b, in which the two clamping elements 5 6are slidable back and forth relative to the tbular tissue wall portion 8 of a patient's oviduct. The hydraulic operationmeans include an. expandablereservoir23 such as an elastic balloon, containing hydraulic fluid, conduits 24a and 24b betweenthe reservoir23andthe hydraulic chambers 22a, 22band atwo-waypump for pumpingthe hydraulic fluid in the conduits 24a,24b. The reservoir 23 is subcutaneously placed between the skin., shownwith asolid line in the figure, and the normalyfascial/muscularlayershown with a dashed line. The control device 4 controls the pump 25 to pump hydraulifluid from the reservoir 23to 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 Fig3B, and to pump hydraulic fluid from the chambers 22a,22b to the reservoir23 to move the clamping elements 6 away from the wall portion 8.whereby the tubular waN 8 is released, see Fig 3A
Alternatively the embodiment of Figs.3A and3B$may be manually operated by applying suitable manually operable hydrailic means for distributing the hydraulic fluid between the expandable reservoir 23and the hydraulic chambers22a22b. hI this case the pump 25 is omitted. Also in this case is the control device 4only manual manipulation of the reservoir. An example is showed in Fig. 3Cand 3D .n 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 4Bschematically 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 27arrangedin 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 27includes aclamping element 28, which is radially movable in the tubular housing 26 towards and away from the 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 tubularwall portion 8 Mechanical operation means for mechanically operating the clampingelement 28 includes aneletni motor 29 attached to the 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 theclamping eleent28against the wall portion 8, whereby the tubular wall portion 8 is constricted, see Fig. 4B and controls the motor 29 to retract thetelescopic device 30 to move the clamping element 2 away fom the wall portion 8, whereby the walporttion 8 isreleasedsee Fig. 4
Alternatively, the motor 29 may be omitted and the telescopic device 30 he modified for manualoperation, as shown in Fig 4CThus, 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 levermechanism 29a that is operatively connected to the telescopic device 30The patient may push the lever mechanism 29a through the patient's skin 29b to pull the telescopic device 30 against the action of the spring 30a to the retracted position ofthe telescopic device 30, as indicated in phantom lines. When the patient releases the lever mechanism 29a, the spring30a expands the telescopic device 30, whereby clamping element 28 is forced against the wall portion 8,
Fig.SA-SC illustratein principlethe function of the deviceofFig when the device is applied on a portion'8'of a tubular tissue wall of a patient'sovidact, Thus, Fig. SAshows the device in anon-clampingstate, in which the clamping elements 5, 6 are in their retracted positions and the wall portion 8 extends through the open ends of the housing I without being constricted by the clamping elements 5, 6 Fig 5B shows the device in a clamping state, in which the clamping elements 5, 6 have been moved from their retracted positions to their clampingpositions, in which the clamping elements 5, 6gently constrict the wall portion to a constricted statein which the blood circulationin the constricted wall portion 8 is substantially unrestrictedand the flow in the oviduct of the wall portion 8 is restricted Fig, C shows the device in an optionalstimulation state, in which the clamping elements, 6 constrict thewalportion8 and theelectrical ements7 of the stinulationdevice3 electricallystimulate different areas of the wall portion 8, so that the wall portion 8 contracts (thickens)and closes the oviduct.
When the deviceis in its optional stimulation state, it is important to stimulate the different areas ofthewall portion S ina manner sothat they essentially maintains their naturalphysical properties over time to prevent the areas from beinginjured, Consequently, the control device 4 controls the stimulation device 3 to intermittently stimulate each area ofthewall portion 8 during successive time periods,wherein each time period isshort enough to maintain over time satisfactory blood circulation in the area Furthermore, the control device 4 controls the stimulationof the areas of the wall portion 8, so that each area that currently is not stimulated restores substantiallynormal blood circulation before it is stimulated again. To maintain over time the effect of stimulationi e to keep the oviduct closed bymaintaining the wal portion 8 contracted, the control device 4 controls the stimulation device3to stimulate one or more of the areas at a timeand to shiftthe stimulation from one areato another over time The control device 4 may control the stimulation device 3 to yclically propagate the stimulation of the areas along thetubular wall portion 8,for example, in accordance with a determine stimulation pattern. To achieve the desired reaction of the tissue wall during thestimulation there the control device may control thestimulation device to, preferably cyclically, vary the intensity of the stimulation ofthe wall portion 8
It will be appreciated that thefully restricted state showniFig.C can be obtained by purely mechanical means not involving electrical stimulation.
Figs, 6A - 6C show another embodiment of the invention which includes a tubular housing 9 and three elongate clamping elements I0a,IObI c which are radiallymovable in the tubular housing 9 towards and away from a central axis thereof between retracted positionssee Fig. 6A., and dampingpositionsseeFig 6B. The three clamping elements 10a10c are symmetrically disposed around the central axis of the housing 9. The stimulation device of this embodiment includeselecrical elements Ila, I I b, lie that fbrm a series ofgroups of elements extendinglongitudinallyalongthe elongate clamping elements 1a-10c, wherein the electrical elements a - 11eofeach group of electrical elements fon a path of three electricalelements Ila, 11 and IIc extending circumferentially around the centralaxis of the housing 9, The three electrical elements I La- I Icof each group are positioned on the three clamping elements -1a-I0o respectively yThus, the path of three electrical elements I Ia-I c extends around the patient' organOfcoursethe number of electrical elements IaI Icof each path of electrical elements can be greater than three, and several parallel rows electrical elements IIa-11. ccan fonr each path of electrical elements
Figs. 7A, 7B and 7C schematically illustrate differentstates of operation of a generally designed device according to the present invention, when the device is applied on awall portion of an oviduct designated BO The device includes a constriction device and a stimulation devicewhich are designated CSD, and a control device designated CD for controlling the constriction and stimulation device CSD Fig.7A shows the device in an inactivationstate, in which the constriction device does not constrict the organ BO and the stimulation devicedoesnot stimulate the organ $0 Fig 7B shows the device in a constriction state in whichthe control deviceCD)controls the constriction device to gently constrict the wall portion of the organ BO to a constricted statein which the blood circulationin the constricted wall portion issubstantialy unrestricted and the flow in the oviduct of the wall portion.is restricted. Fig 7C shows the devicein astimulation state, in which the control device CD controls thestinulation device to stimulate different areas of the constricted wall portion, so that almost the entire wall portion of the organ BO contracts (thickens) and closes the oviduct.
Figs.7D and 7E show how the stimulation of the constricted wall portion can be cyclically varied between afist stimulation mode, in which the left area of the wall portion (see Fig, 7D) is stimulated, while the right area ofthe wall portion is not stimulated, and second stimulation mode, in which the right area of the wall portion (see Fig 7E) is stimulatedwhile the left area of the wall portion is not stimulated, in order to maintain overtime satisfactory blood circulation in the constricted wal portion
Itshould be noted that the stimulation modes shown in Figs. 7D and 7E only constitute a principle example of how the constricted wall portion of the organ BO may be stimulated, Thus, more than two differentareas of theconstricted walportion mayhbesimultaneously stimulated in cycles orsuccessively stimulated.Alsogroupsofdifferentareasofthe constricted wal portion inay be successively stimulated.
Figs, 7F,7G and 71-1 illustrate differentstates of operation of a modification of thegeneral embodimentshown in Figs, 7A-7E, whereinth constriction and stimulation devices CSD include several separate constriction/stimulationelements, here threeelements CSDEl, CSDE2 and CSDE3 Fig. 7F showshow the element CSDE in a firststate of operation is activated to both constrict and stimulate the organ BCso that theoviductof theorgan BO is closed, whereas the other two elements CSDE2 and CSDE3 areinactivated Fig. 70 shows how the element CSDE2 in a second following state of operation is activated, so that the oviduct of the organ B isclosedwhereas the other two elements CSDEI and CSDE3 are inactivated Fig.7H shows how the element CSDE in a following third state of operation is activatedso that the oviduct of the organ BO is closedwhereas the other two elements CSDE Iand 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 riskof injuring the organ is minimized, It is also possible to activate the elements CSDE1,SDE3 successivelyalong the oviduct of the organ to move fluids andor other bodilym atter in the oviduct,
Figs. 77K andi 7L illustrate analtemative mode of operation of the modification of the general embodiment.Thus Fig71 shows how the element CSDE7 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 and CSDE3 are activated to constrict but not stimulate the organ BO so that theoviduct othe organ BO is notcompletelyclosed where the elements CSDE2 and CSDE3 engage the organ BO, Fig, 7K shows how the element CSDB2 in a second followingstate of operation is activated to both constrict and stimulate the organ BO so that the oviduct of the organ BO is closedwhereas theother two elementsCSDE7 and CSDE3 are activated to constrict but notstimulate the organ BO sothat the oviduct of the organBO is not completely closed where the elements CSDE and CSDF3 engage the organ BO. Fig. 71shows how the element CSDE3 in a following third state of operation isactivated to both constrict and stimulatethe organBO, so that theoviduct ofthe organ B is dosedwhereas the other two elements CSDF Iand CSDE2 are activated to constrictbutnot sting te theorgan BOso that the oviduct of the organ BO is not completely closed where the elements CSDE1 and CSDE2 engage the organ BO. Byshifting between the first, second and third states of operation, either randomly or in accordance with a predetermined sequence, different portions of the organ can bytemporarilystimulatedwhile maintaining the oviduct of the organ closed, wherebythe risk of injuring the organ is reduced, ft is also possible to acvate thestimulation of theelementsCSDI-CSDE3 successively alongtheoviductoftheorganBOto ove uidsand/or other bodily-matter in theoviduct
This embodiment, with a combination of a mechanical or hydraulic partly restricting system and a stimulationsystem varying the stirmulation positions preferable used when one wants to close the oviduct in a safe way.The system is energy efficient because preferable only stimulation need to be changed in position and the oviduct allows torecover until the stimulationcomesbackto the same position again if the restriction areas areplaced closer to each other and maybethe mechanical or hydraulic restriction is continuous,a peristalticlike wave could be createdin any direction in the oviduct. Iftherestriction is moved in consecutive orderstartingwith the restriction closest to the ovary, no egg may be squeezed in the restriction area If restriction are moved in the other direction towards the 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 the stimulation device close the area,
Fig. 8 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 with pulse train combination having afirst relatively long pulse train.Pl ofhigh frequency/lw amplitude puses appearing simultaneously with the positive pulse.PL of the pulse combination of Fig. 8A and a second relatively short pulse train PTS of high frequecylow amplitude appearing simultaneously with thenegative pulse PS of the pulse combination shown in Fig; 8A. As a result,the high frequency/low amplitudes pulse trains PTL and PTS are superimposed on the positiveand negative pulses PL and PS of Fig 8-as illustrated in Fig8B The pulse configuration of Fig 8B and variations thereof is beneficial to use in connection with the stimulation of particular human organs in order toachievethe desired stimulation effect
Preferablythe electric pulses form pulse trains, as illustrated in the Pulsetime diagrams Pit of Figs. 8C and 8D. The Pulse/time diagramPt of Fig. 9Arepresents an individual area ofthe wall portion of the patient's tubularorgan, which is stimulated with a pulse train ISA The pulsetrain 1Aincludes three initial negative pulses, each of which is of short duration and high amplitude (voltage) and one positive pulse oflong duration and lowamplitude following the negativepulsesAfter a delay to enable thearea of the organ torestore substantially normal blood circulation,the pulse train 18A is repeated;
The Pulse/time diagram P/t of FigSD represents another individual area of the wall portion, which is stimulated wih a pulse train 18M having the same configuration as the pulse train 18A, Thepulse trains 18A and I83 are shifted relative to each other,so that theypartialy overlap one another to ensure that the constricted wall portion always is stimulated to contract as desired.
Figs. 9A and 9Bshow another embodiment of the invention that controls blood flow in a blood vessel 19, comprising aconstriction devicewith. two coping elements 20a and 20, a stimulation device in thefbrrn oftwo thermal stimulation elements 21a and 21b integrated in the clamping elements 20a, 20b, respectively, and a control device 4 for controlling the clamping elements 20a 20b and stimulationelements 21a 21b, The clamping elements20a and 20b are movable towards andawayfromeachother in the same manner as described above in connection with the embodiment according to Figs SA-5C. The thermal stimulation elements21aand 21b, whichmayincludePeterelementsarepositionedon the clamping elements 20a, 20b,so that the thermal elements 21a are facing the thermal elements 21b, Fig, IIA showshow the camping elements2Ga2bconstrict theblood vessel 19,so thatthe blood flow is restricted. FigII B shows how the control device 4 controls the thennal stirmuationelements2a,2bto cool the wall of the blood vessel 19, so that the wall contracts and closes the blood vessel 19, To release the blood vessel 19, tie control device 4 controls the thetal stimulation elements 21a,21b to heat the wai of the blood vessel 19, so that thewallexpands.
Figs, IA and 10B show ahydraulically operable elongated constriction device in the form of a band 72 havingan expandable/contractible cavity 73,which is in fuid communication with an adjustable reservoir 74 containing hydraulic fluid, fig 10A illustrates when the band is in anononstriction state, whereas Fig. illustrates when the band is in a constriction state, in which the cavity 73 is expanded byhydraulic fluid supplied by the reservoir 74,
Figs.31A,31B, 31C and 31Dare block diagrams of four differently operated hydraulic constriction devices Fig.31A shows the band 72 of Fig, 10A, the cavity 73 of which is in fluid communication with a reservoir 75. Fig. 31B shows theembodiment of Fig 10A, in which the cavity 73 of the band 72 is in fluid communication with the reservoir 74 via an operation devie in the form of a two-way pump 76 Fig. 11C showman operation device in the form of a reverse servo device with a first osed device controlling second device, The reverseservo device comprises an adjustable fluid supply reservoir 77 and an ajustable servo reservoir 78, The servo reservoir 78 controls a.larger adjustable reservoir 79 which in connection with the band 72 applied around a portion of tubular tissue wall of a patient's organ varies the volume of the cavity 73 of the band 72, which in turn varies theconstriction of the wall portion. Fig. I1D shows an embodiment identical to the embodiment of Fig 1.1C, except that the larger reservoir79isomittedInstead, the servo reservoir 78is influid conmmncationwith the cavity of the band 72,
In all of the above embodiments according to Figs.12Athrough 10B,stiulation devices may be provided to form constriction/stimulationunits, in which the stimulation devices include amultiplicityof electrical elements (indicated in Figs, 12A- 1 18, 20 23, 26 ,11)positioned on the constriction devices.
Fig 12 is a cross-,ectional view of a fluid supply device including a bellows reservoir 80 defining a chamber 81, the size of which is variable by an operation device comprising a remote controlled electric motor 82 The reservoir 80and the motor 82 are placed in a housing 83, Movinga large wall 84 varies the chamber 81 The wall 84 is secured to a nut 8 which is threaded on arotatable spindle 6 Thespindle 86 is rotated by the motor 82 A battery 89 placed in the housing 83 powers the motor 82, A signal receiver 90 for controlling 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 be powered withenergy transferred from transmitted signals
Whereapplicable, the uidsupply device of Fig. 12 may be used for supplying hydraulic fluid for the operation of theconstriction devices described in this specification, Forexample the fluid supplydevice of Fig12 may be substituted for the reservoir 74in the embodiment according to Fig, 1A,
Figs. 13A and 13B show a reverse servo including a rectangular housing 91 and an intermediate wall 92 which is movable in the housing 91 A relatively large substantially cylindrcal belows reservoir 93 is arranged in the housing 91 and is joined to the movable intermediate wall 92. Another cylindrical bellows reservoir 94, which issubstantiallysmaller than reservoir 93,is arranged in the housing91 at the other side of the intermediate wall 92 and is also joined to the wall 92 The small bellowsreservoir94 has a fluidsupply pipe 95 and the large bellows reservoir 93 has a fiuidsupply pipe 96.
Referring to Fig13Awhen 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 pushes the movable intermediate wall 92 towardsthe large bellows reservoir 93 Asa result, the large bellows reservoir 93 is contracted by the intermediate wall 92,whereby a large amount of hydraulicflud is forced out ofthe large bellows reservoir 93 through the supply pipe 96, as shown in Fig. 13B
For example, the reverseservo ofFigs13A and 13 may be usedintheembodiment of Fig IC, whereinthemall bellows reservoi94corresponds to the small servo reservoir 78 and the large bellows resrvoir93 corresponds to the large reservoir 79, Also,the reverse servo of Figs 13A and 13Bmay he used in the embodiment ofFig A and10B3 wherein the small bellows reservo94 is connected to the adjustable reservoir74, andthe largebellows reservoir 93 is connected to the cavity 73 of theband 72,
ig, 14 schematically shows a hydraulically operable constriction device97 of the device of the invention, whichis similar to the embodimentshown inFig IA, except that the hydraulic device is designed differently. Thus theconstctiondevice 97 includesarelativdy small inflatable cavity 98, whichis in fluid communicationvith a reservoir 99 containing hydraulic fluid, and a relatively large cavity 100, which is displaceableby small cavity 98 Small caviy 98 is adapted to displace large cavity 100 to constrict the patient's tublarwall portion when small cavity98 is inflated and to displace large cavity 100 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 relatively large increase in the constriction of the wall portion.
Large cavity 100 isdefined by a contraction element in the form of a big balloon 101, which may be connected to aninjection port (not shown) for calibration of thevolume of large cavity 100, Adding fluid to or withdrawing fluid from the injection port with the aid of a syringecalibrates the volume of balloon 101 Smallcavity 98is defined by a small bellows 102 attached to anannular frame 103 of constriction device 97 and at the opposite end is attached to balloon 101,
Figs, 15A. and I5B schematically illustrate the operation of constriction device 97, when annular frame 103 is applied around the tubular wall portion of thepatients organReferring to Fig.1A, when small cavity 98 is deflated bellows 102 pulls balloon 101 inwardly into annular rame103, so that constriction device 97 constricts the wall portion Referring to Fig,
B, when smallavity 98 i's inflated bellows 102 pulls balloon 101 out of annuar fame 103 so that constriction device 97 releases the wall portion.
As mentioned abovethe constricion device and stimulation device canco-operate to actively movetheegg in the oviductof a patient's organ. This can be achievedusing the constriction/stiulationunitshown in Fig 2 Thus, in accordance with afist ooperation option, the clamping elements 5, 6 ofthe constriction device constricts the wall portion 8 without completelyclosingthe viduct,whereby the flow in theoviduct isrestricted, 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 progressive contraction of the wall portion8to move the egg in the oviduct.
in accordance with a second cooperation option ,th constriction device constricts the wall portions thatthe flow in the oviduct isrestricted, and the control device 4 controls a few electrical elements 7 at one end of the elongate clamping elements 5,6 tostimulate the constricted wall portion 8 to close the oviduct either atan upstream end or a downstream end of the wall portion 8, With the oviduct closed in this manner, the control device 4 controls the constriction device toincrease the constriction of the wall portion, Whereby the egg in the oviduct is moved downstream or upstreamof the wall portion 8;
In another embodiment of the invention for performing the second cooperation optionthe constriction device constricts the wall portion so that the flow in the oviduct is restrictedand the control device 4 controls the stimulation deiceto stimulate the constricted wall portion whiletheconstriction device varies the constriction of the different areas of the wall portion, suchthatthewalportionisprogressivelyconstrictedinthedownstream or upstream direction of the oviduct Figs 16A -6Eshow different operation stages of such an alternative embodiment, which comprises a constriction device 104 including two elongate constition elements 105, 106 having convex surfaces 107, 108 that abut a length of the wall portion 8 on mutual sides thereofand a multiplicity of electrical elements 7 (such as eletrodes) that are positioned on the convex surfaces 107.108,The control device 4 controls theelectrical elements 7 during operation oftheconstrictiondevice 104 and controls the elongate constriction elements 105 106 to move relative to the tubular wall portion 8 so that the constrictionleents 105, 106 progressively constrict the wall portion 8, as appears from Rigs.6A to 16D,
Thus, in an initial position of the construction elements 105, 106 shown in Fig 16A, the wall portionis not conrcbstricdbyt ntriction elements 105, 106 and the electrical elements arenot energizedStarting fom this initial position, the control device 4 controls the constriction elements 105 106 to swing the left ends of the constriction elements 105, 106 toward the wall portion (indicated by arrows) to constrict the tubular wall portion 8, see Fig. 16B, while energizingthe electrical elements 7, so that the electrical elements 7 that contact the walportion S contractthe latter; Fig 16 C shows how the oviduct ofthe tubular wall portion 8 is completely closed by the thickened wall portion 8. Then, as shown in Fig. 16C, the control device 4 controsthe constriction eternents 105 106 to move so that their right ends are moving towards each other (indicated by arrows),while theconvex surfaces 107, 108 of the constriction elements 105, 106 are rolling on each other with the ontractedwall portion 8 between them,see Fig, 16D As a resultthe 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 rolled on each other to the position shown in Fig, 6E, the control device 4cotrols the right ends oftheconstrictionelements 105, 106 to move away from each other(indicated by arrows in Fig, I6E) to the initial position shown in Fig, 16A. The operationstages descrihbcd according to Figs6A to 16E can be cyclically repeated a number of times until the desired amount of bodily matter has been moved in theo viduct of theorganin a peristaltic manner
Alternativeyonlyoneoftheostrictionelerents105,106canbeprovided with convex surface, whereas the other constrictioncelement has plane surface that abuts the wallportion It is also possible to use a singleconstrictionelement with a convex surface that presses the tubular portion 8 of the organ against a bone of the patient
Fig 16 schematically shows a genera embodiment of thedevice ofthe invention, in which energy istransferredto energy consuming components of the device implanted in the patient The device of Fig16 comprises an implanted constrictionistnulationunit 110,which is operable to gently constrict a portion of a tubular tissue wall of a patients organand to stimulate different areas of the constricted portion to cause contraction of the wall portion. The coniiodvicoftheonstriction/stimulation unit 110 is capable of performing a reversible function ie. to constrict and release the wall portion, sothat the constriction/stimulation unit 11 works as an artificial sphincter,
A source of energy I1 is adapted to supply energy consumingco1p)Ieits of the constritionstimlationunit I10 withenergy via a powersupply 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 energymaybean implantable permanent or rechargeable battery,or beincluded 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 consuming components of the constriction/stiulation unit Alternatively,the source of energymay comprise a combination ofanimpiantable rechargeable battery, an extemal energy transmission device and an implantable energytransformingdevice for transforming wireless energy transmitted by the external energy-transmission device into electric energy for the chargeof the implantable rechargeable battery
Fig 17 shows special embodiment ofthe general embodiment of Fig 16 having some parts implanted in a patient and other parts lcatedoutside the patient's body Thus,in Fig 17 all parts placed to the right of the patient's skin 109 are implanted and all parts placed to the left of the skin 109 are locatedoutside the patient'sbody.Animpantedenergytransforming device IllA of the device is adapted tosupplyenergy consuming components of the constriction/stimulation unit I10 with energy via the power supply line 112 An extemal energytrannmissiondevice i i of the device includes a wirelessremote control transmitting a wireless signal, which is received by asignalreceiver incorporated in thetimplanted energy transformingdevice 1iLA The implanted energy-transormingdevice liA transforms energyfrm the signal into electric energywhich is supplied via thepower supplyline 112 to theconstriction/stimulation unit110.
The device of Fig. 17may also include an implanted rechargeable battery forenergizing energy consuming implanted components of the device.In this casethe implanted energy transfomingdevice I A alsocharges the battery with electric energy as theenergy transforming device transforms energyfrom the signalinto the electric energy.
A reversing device in the form of anlectric switch 14, such asamicroprocessor,is implanted in the patient for reversing the constriction device of theconstriction/stimulation unit I10The wireless remote control of the external energy-transmission device 113 transmits a wireless signal that carries energy and the implantedenergytransfonningdevice i11A transforms the wireless energy into a current for operating the switch 114 When the polarity of the current is shifted by the energy-ransforming-device 1 A the switch 1.14 reverses the function performed by the constriction device of the constrictionistimulation unit 110.
Fig.1 shows an mdientofthe invention includingthe energy-transforming device I ILA, theconstriction/stimulationunit 110 and an implanted operation device in the form of a motor 115 for operating theconstriction deviceof the onstriction/stiulationunit 1.10 The motor15ispoweredwithenergy from the energy-transforming device 11 Aas the remote controloftheextemnalenergytransmission devicel13 transmits a wireless signal to the receiver of theenergy-transfbring device 1 A,
Fig19 shows anembodiment of the invention including the energy-transforming device 1IA, the constriction/stimuationunit 110 and animplanted assembly 116 including a motor/pump unit 117 and a fluid reservoir I Ih this case the constriction device of the constrictionstimuationunit 110 is hydraulically operated, Le. hydraulic fluid is pumped by the motor/pump unit 117 from the reservoir 118 to theconstrictionstimlationunit 1 0 to constrictthewallportion, andhydraulic fluidispumpedby the motor/pumpunit117back fromth constrictionstimulationunit110tothereservoir 118 toreleasethewal portion.The implanted energy-transfomgdeviceIlA transfornmswireless energyinto acurrent, for powering the motorlpump unit 117,
Fig. 20 shows an embodiment of the invention comprising the external energytransmission device 1 that controls the control unit 122to reverse the motor 115 whenneeded, the constrictionstimulationunit I10, the constriction device of which is hydraulically operated, and the implanted energy-transforming device I A, and further comprising an implanted hydraulicfluid reservoir 119; an implanted motor/pump unit 120, an implanted reversing device in the form of a hydraulic valve shifting device 121 and a separate exteal wireless remote control I111 The motor of the otorpumpunit 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-transfonning device 11IA powers the motor/pump unit 120 with energy from the energy carried by the control signal, whereby the motor/pump unit 120 distributes hydrauic fluid between the reservoir 119 and the constriction device of the constriction/imulationunit 110.The remote control 111B controls the shiingdevice 121 to shift the hydraulic fluid flowdirectionbetweenonedirection in which the fluid is pumpedby the motor/pump unit 120 from the reservoir 119 to the constriction device of the constriction/stimulation unit 110 to constrictthe allportion, and another opposite direction in which the fluid is pumped by the motor/tmpunit 120 back from theconstriction device of the constrition/stimulation unit 110 to the reservoir 119 to release the walportion.
Fig,21 shows an embodimentofthe inventionincludingthe energytransrming device 11IA and the onstriction/stimulationunit I 10. A control unit 122, an accumulator 123 and a capacitor 124 are also implanted in the patient. A separate external wireless remote control
1.1B controls the control unit 122 The control unit 122 controls the energy-transforming device 1I1A to storeelectric energy in the accumulator 123whichsupplies energy to the constriction/stimulationunit 110 In response to a control signal from the wireless remote control IllB, the control unit 122 either releases electric energy from the accumulator 123 and transfers the released energy viapowerlinesordirectly transfers eetric energyfromthe cnergy-transforming device IlA via the capacitor 124, which stabilises the electric current for the operation of the constrictionlstinulation unit 110,
in accordance with onealternative, the capacitor 124 in the embodiment of Fig 21 may be omitted. in accordance with another alternative, the accumulator 123 in this embodiment may be omitted.
Fig.22 showsan embodiment of the invention including the energy-transfonning device I I IA, the constriction/stimulation unit 10 A battery 125 for supplying energy rthe operation of the constriction/stmulaonunit 110 and an electric switch 126 forswitching the operation of the constriction/stimulation unit 110 are also implanted in the patient, The switch 126 is operated by the energy supplied by the energytransforming device 111A to switch from an off modein which the battery 125 is not in use, to an on mode, in which the battery 125 supplies energy for the operation. of theconstriction/stimulationunit I10,
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 extemal wireless remotecontml I llB controls the control unit 122 In this case the switch 126 is operated by the energy supplied by the enegytransfrmingdevice 1A to switch from an offmode, in which the wireless remote control 111Bis prevented from controlling th controlunit 122 andthe battery 125 isnot inuse, to a standby mode, in which the remote control 111Bis permitted to control the control unit 122 to release electric energy from the battery 125 for the operation of the constriction/stimulation unit 10
Fig 24 shows an embodiment of'the invention identical to that of Fig. 44, except that the accumlator123 is substituted for the battery 125 and the implanted components are interconnected differentlyIn this case, the accumulator 123 stores energy frm the energy transforming device IlAIn response to a control signal from the wireless remote control I I I B, the implanted control unit 122 controls the switch 126 to switch roman off mode, in which the accumulator 123 is not in use,to anonmode, in which. the accumulator 123 supplies energy for the operation of theconstriction/stimuationunit 110.
Fig25shows an embodiment ofthe invention identicalto thatofFig 45,exceptthatthe battery 125 also is implanted in the patient, and the implanted components are interconnected differently. In response to a controlsignal othe wireless remote control I I I B the implanted control unit 122 controls the accumulator 123, which may be a capacitor, to deliver energy' for operatingthe switch 126 toswitch ftrom an off mode, inwhich the battery 125 is not in use, to an onmode, inwhich the battery 125 supplieselectric energy forteoperation of the constriction/stimulationunit 110,
Alternatively, the switch126 may be operated by energysupplied by the accumulator 123 to switch froman offmode, in which the wirelessremotecontrol I1B is prevented from controllingthe battery 25 to supplyelectric energyand the battery125 is not inuse, toa standby modein which the wireless remote control. 11 IB is permitted to controlthebattery 125 to supply electric energy for the operation of theconstrictio/stimulation unit 110,
Fig.26 shows an embodiment of the invention identical to that of Fig.43, exceptthatamotor 115amechanical reersingdevicein thefbrmof a gearbox127 and a control unit 122 for controlling the gearbox 127 also are implanted in the patient.A separate external wireless remote control I11B controls the implanted control unit 122 to control the gearbox 127 to reverse the function performed by the constriction device (mechanically operated) of the constriction/stimulation unit 110.
Fig 27 shows an embodiment of the invention identical to that of Fig. 46, except that the implantedcomponents are interconnected differently. Thus, in this case, the battery 125 powers the control unit 122 when theaccumulator 123, suitably a capacitor, activates the switch 126 to switch.to an on. mode.When the switch 126 is in its on mode the control unit 122 is permitted to control the battery 125 to supply, ornot supply, energy for the operation of the constriction/stimulation unit 110
Fig 28 shows an embodiment of the invention identical to that of Fig. 39,exceptthat a gearbox 127 that connects the motor 115 to the onstriction/stimulationunit 110,and a control unit 122 that controls the energy-transfoning device iA to power the motorI 15 also are implanted nthe patient. There is a separate external wirelessremote control1111B that controls the control unit 122 to reversethe motor 115 whenneeded.
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 energy-transforning device 111A to store the transformed energy in the accumulator 123. Response to a control signal front the wireless remote control 111B, the control unit 122 controls theaccumulator 123 tosupply energy for the operation ofthe constriction/stinulationu ift I10
Those skilled in the art will realize that the above various embodiments according to Figs 17 28 could be combined in many different ways.For example, the energy operated switch 114 could be incorporated in any of the embodiments of FigsI8, 21-28, the hydraulic shiing device 121 could be incorporated in the embodiment of Fig 21,and the gearbox 127 could be incorporated in the embodiment of Fig. 39.The switch 1 14 may be of a type that includes electronic components, fr example a microprocessoror a FGPA (Field Programmable Gate Aray) designed forswitching. Altematively however, the energy operatedswitch 114 may be replaced by a subcutaneously implanted push button that is manuallyswitchedby the patient between "on" and "ott
Alternatively, a permanent or rechargeable battery may be substituted for the energy transforming devices 1Aof the embodiments shown in Figs 3849,
Fig.29 shows basic parts ofa remote control ofthedevice of the invention for controlling the onstriction/stinulationni 110, in this case, the stimulation device of the constriction/stimulation unit stimulates the wall portion with electric pulses.The remote control is based on wireless transmission of electromagnetic wave signalsoften of high frequencies in the order of 100 kz- 1 GHz, through the skin 132 of the patient-In Fig 29, all parts placed to the left of the skin132 are located outside the patient's body and all parts placed to therightof the skin 132 areimplanted
An external signal-transmission device 133 is to be positioned close to a signal-receiving device 134 implanted close to theskin 132. As analternativethe signa-receiving device 134 maybeplaced fexampleinsidetheabdomenofthe patienThe signal-receiving device 134 comprises acoil, approximately 1-100 mmepreferably25numnin diameter; wound with avery thinwireand tunedwith a capacitortoa specifichighfrequency. A small coil is chosen ifit is to be implanted under the skin of the patient and a large coil is chosen. if it is tobe implanted intheabdomenofthepatient Thesignal transmission device 133 comprises a coil having about the same size as the coil of the signal-receving device134 but wound with a thick wire that can handle the larger currents that is necessary The coil of the signal transmission device 133istunedtothesamespecifichighfrequencyas thcolofthesignal-receiving device 134.
Thesignal-transmissiondevice 133 is adapted to send digital information via the power amplifier and signal-receiving device 134 toan implanted control unit 135 To avoid that accidental random high frequency fields trigger control commandsdigitalsignalcodesare usedA conventional keypad placed on the signal transmission device 133 is used to order the signal transmission device 133 to senddigital signals for the control of the constriction/stimulationunitThe signaltransmission device 133 starts a comand by generating a high frequency signal After a short time, whenthe signal hasenergized the implantedparts of the control device, commands are sentto operate the constriction device of theconstriction/stimuation unit 110 in redefined steps. The commands are sent as digital packets in the firm illustrated below.
Start pattern,8 bits Command, 8bits
Count 8 bits
Checksum, 8 bits
The commandsare sent continuously during rather long time period (e.g. about 30 seconds or more). When a newconstriction or release steps desired, the Count byte is increased by one to allow the implanted control unit 135 to decode and understand that another step is demanded by the signal transmission device 133 if any part of the digital packet is erroneous, its contents simply ignored.
Through a line 136, animplanted energizer unit 137 draws energy from the high fequency electromagnetic wave signals received by the signalbreceiving device 134 The energizer unit 137 stores the energy in a source of energy, such as a large capacitorpowersthecontrolunit 135 and powers the constrictiostiulationunit 110 via a line 138.
Thecontrol unit 135 comprises a demodulator and a microprocessor;The demodulator demoduates digital signals sent fromthe signal transmission device 1.33 The microprocessor receives the digital packet, decodes it and sends a control signal viaa signal line 139 to control the constriction device ofthe constrictionistimUation unit 110 to either constrict or release the wall portion of the patient's organ depending on the received command code,
Fig 30 shows a circuitryof an embodiment ofthe inventionin which wireless energy is transformed into a current External components of the circuitry include a microprocessor 140 a signal generator 141 and a power amplifier 142 connected thereto. The microprocessor 140 is adapted to switch the signal generator 141 on/off and to modulate signals generated by the signal generator 141 with digital commands The power amplifier 142 amplifies the signals and sendsthem to an external signatransmittingantennacoil 143. The antenna coil
143 is connected in parallel with a capacior 144 to form a resonantcircuit tuned to the frequency generated by the signal generator 141,
Implanted components of the circuitry include a signal receiving antenna coil 145and a capacitor 146 forming together a resonant circuit that is tuned to the same frequency as the transmitting antenna coil 143 The signal receiving antenna coil 145 iduces a current from the received high frequency electromagnetic waves and a rectifyingdiode147rectifiesthe induced current, whichchargesa storage capacitor 148. The storage capacitor 148 powers a motor 149 for driving the constriction deviceof theconstrictionstilationunit 110,A coil 150 connected between the antenna coil 145 and the diode 147 prevents the capacitor 148 and the diode 147 fromloading the circuit of the signalreceiving 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 153 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 capacitor156 connected in series with the resistor 154 via groundand a capacitor 157, one terminal of which is connected between.the resistors 154,155 and theother terminal of which is connected between the diode 153iand the circuit formed by the capacitor 151 and resistor 152 The fiter circuit is used to filter out undesired low and high frequencies. The detected and fitered signals are fed toan implanted microprocessor 158 that decodes the digital information and controls the motor 149 via an H-bridge 159 comprisingtransistors.160,161 162 and 163 The motor 149 can be driven intwo opposite directions by the:I-bridge 159.
The microprocessor 158 also monitors the amount of stored 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 enoughIf the stored energy is not enough to perform the requested operation, the microprocessor 158 waits for the received signals to charge the storage apacitor148 before activating the motor 149.
Alternatively, the energy stored in the storage capacitor 148 may only be used for powering a switch, andthe 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 connet 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 been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the 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 2017200415 which is a divisional application of Australian patent application number 201520300, which is a divisional application of Australian patent application number 2008311434, each specification of which as originally filed are hereby incorporated by reference in their entirety.

Claims (20)

1. A pregnancy control system for affecting pregnancy of a female mammal or human patient comprising; an implantable stimulation device adapted to stimulate a wall of an oviduct of the patient to cause contraction thereof; wherein the implantable stimulation device is operable 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.
2. The system according to claim 1, wherein the implantable stimulation device is adapted to stimulate the oviduct wall to completely restrict the oviduct lumen.
3. The system according to claim 1 or 2, wherein the implantable stimulation device comprises two or more restriction areas adapted to cause constriction of the oviduct wall at different positions on the oviduct.
4. The system according to claim 3, wherein the implantable stimulation device is adapted to restrict the oviduct lumen in the form of a peristaltic wave restriction, moving towards the ovary to prevent the egg in the oviduct lumen from being transported to the uterus.
5. The system according to claim 3 or 4, wherein the implantable stimulation device is adapted to restrict the oviduct lumen in the form of a peristaltic wave restriction moving towards the uterus to effect transportation of the egg to the uterus.
6. The system according to any one of the preceding claims, further comprising a control device operable from outside the patient's body to control the implantable stimulation device.
7. The system according to claim 6, wherein the control device further comprises an internal control unit adapted to be implanted in the patient's body, wherein the control of the implantable stimulation device is made by said internal control unit.
8. The system according to any one of the preceding claims, further comprising an implantable internal energy source for powering the implantable stimulation device.
9. The system according to claim 8, wherein the implantable internal energy source is chargeable by wirelessly transmitted energy.
10. The system according to claim 8 or 9, wherein the implantable internal energy source is controllable from outside the patient's body.
11. The system according to any one of the preceding claims, comprising a sensor sensing at least one physical parameter of the patient.
12. The system according to claim 11, wherein said sensor is configured to sense a hormone level or a temperature.
13. The system according to any one of the preceding claims, comprising a sensor sensing at least one functional parameter of the system.
14. The system according to claim 13, wherein said sensor is configured to sense an electrical parameter or a pressure related to the system.
15. The system according to any one of claims 11 to 14, when dependent on claim 7, wherein the internal control unit controls the implantable stimulation device to restrict said oviduct based on information from said sensor.
16. The system according to any one of claims 11 to 14, further comprising a feedback device adapted to send feedback information from inside the patient's body to the outside thereof to give feedback related to the at least one functional parameter of the system or the at least one physical parameter of the patient.
17. The system according to claim 16, wherein the at least one functional parameter of the system is correlated to the transfer of energy for charging the internal energy source.
18. The system according to claim 16 or 17, wherein the at least one functional parameter of the system is an energy balance being the balance between energy received by the system and energy used by the system including energy accumulated by the system.
19. The system according to claim 18, wherein the energy balance is the balance between an energy reception rate of the system and an energy usage rate of the system including an energy accumulating rate of the system.
20. The system according to any one of the preceding claims, wherein the implantable stimulation device stimulates different areas of the oviduct to vary the area of the oviduct that is completely restricted.
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AU2015203000A AU2015203000B2 (en) 2007-10-11 2015-06-05 Device and method for embryo control
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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3750194A (en) * 1971-03-16 1973-08-07 Fairchild Industries Apparatus and method for reversibly closing a natural or implanted body passage
US3817237A (en) * 1972-08-24 1974-06-18 Medtronic Inc Regulatory apparatus
EP0263360A2 (en) * 1986-10-06 1988-04-13 Waldemar Dr.Med. Bleier Clip to close an oviduct, a vas deferens, or a blood vessel
US6482145B1 (en) * 2000-02-14 2002-11-19 Obtech Medical Ag Hydraulic anal incontinence treatment
WO2006114004A2 (en) * 2005-04-25 2006-11-02 Hafeez, Naila A remote controlled tubular implant device and implanting apparatus

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3750194A (en) * 1971-03-16 1973-08-07 Fairchild Industries Apparatus and method for reversibly closing a natural or implanted body passage
US3817237A (en) * 1972-08-24 1974-06-18 Medtronic Inc Regulatory apparatus
EP0263360A2 (en) * 1986-10-06 1988-04-13 Waldemar Dr.Med. Bleier Clip to close an oviduct, a vas deferens, or a blood vessel
US6482145B1 (en) * 2000-02-14 2002-11-19 Obtech Medical Ag Hydraulic anal incontinence treatment
WO2006114004A2 (en) * 2005-04-25 2006-11-02 Hafeez, Naila A remote controlled tubular implant device and implanting apparatus

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AU2017200415A1 (en) 2017-03-16
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