WO2019145616A1 - Artificial sphincter comprising a magnetic control system - Google Patents

Abstract

The invention relates to an artifical sphincter (1) comprising a valve (3) installed in a channel (2) of the human body and comprising means for mechanically closing said channel, said means being provided with elements that are sensitive to a magnetic field, and a magnetic control means (4) outside the human body, which can deactivate said closing means. Said valve comprises a first stationary magnet (6) attracting a second magnet (7) which is translatably mobile transversely in relation to the axis of the channel, said first and second magnets (6, 7) being arranged facing each other and either side of said channel, said second magnet being provided with a means (8) for compressing said channel, which projects transversely from said second magnet, and being mobile by sliding on the surface of said channel and parallel to the axis of said channel, between two end positions (91, 92) where means (101, 102) for holding said compression means are arranged.

Description

 DESCRIPTION

Title: ARTIFICIAL SPHINCTER WITH MAGNETIC CONTROL The present invention relates to the field of implantable medical devices in a patient.

 In particular, the invention relates to an artificial sphincter and, more specifically, to an artificial sphincter with t

magnetic.

 The artificial sphincter of the invention is intended, for an application, in particular, in the treatment of urinary incontinence.

 Urinary incontinence is defined as accidental or involuntary loss of urine, and the origin of this pathology is often multifactorial.

 Classically, three forms of urinary incontinence are distinguished:

 - Urinary stress incontinence,

 - urinary incontinence urinary urgency, also called urge incontinence or incontinence by overactive bladder,

 - Mixed urinary incontinence that combines the two previous forms of incontinence.

 The first form of incontinence, called urinary stress incontinence, is characterized by an involuntary leakage of urine into the outlet channel of the bladder, the urethra, via the urethral meatus. This leak occurs as a result of physical exertion, in particular a coughing fit, sneezing, laughter or even a heavier load. This is a jet leak, scant, and sudden occurrence at the time of effort, usually standing up and without feeling of need beforehand.

Regarding the second form of urinary incontinence, called "urinary urgency", this consists of an involuntary leak of urine accompanied or immediately preceded by a feeling of urgent and irrepressible need. to urinate, resulting in urination that can not be delayed and retained.

 These leaks are the result of abnormal contractions of the bladder, during the filling thereof. These contractions occur when the bladder is not full; the urethral sphincter remains properly closed, but the pressure in the bladder becomes greater than the pressure exerted by the muscles of the sphincter and perineum.

 As a result, the "lock" of the urethral sphincter is forced and the urine can exit to the urinary port and urine leakage can occur outside any voluntary and conscious urination.

 Urinary incontinence affects a significant proportion of the population. Indeed, the prevalence of urinary incontinence is estimated at about 5% of the general population. Women are the main affected by urinary incontinence (caused by maternity and / or menopause), and the percentage of women over the age of forty years with incontinence disorders is estimated at about 20%.

 However, men are not spared and urinary incontinence affects between 3 and 5% of men over 45 years. Male incontinence is mainly due to surgeries performed on the prostate that are becoming more frequent.

 Also, it is particularly important to find effective ways to prevent, diagnose and treat incontinence, including urinary incontinence, which is a particularly troublesome condition for people who have it.

Numerous medical devices are known in the state of the art, in particular artificial sphincters or artificial prostheses, intended to equip the urethra or the urinary tract in order to reduce or avoid any urinary fluid leakage. In particular, in the treatment of urinary incontinence, the reference device consists of an implantable artificial urinary sphincter composed of three distinct elements and between which a physiological fluid circulates by means of flexible resistant tubings.

 More specifically, this sphincter consists, on the one hand, of a sphincter cuff consisting of a casing enclosing the urethra and allowing the occlusion thereof when filled with liquid. On the other hand, this artificial sphincter has a small mechanical pump, implanted in a purse in men or in a large lip in women. The application of pressure with the fingers of the patient or the patient on the pump will drive the liquid present in the sphincter cuff to a reservoir tank located in the abdominal position.

 However, this artificial artificial sphincter device has a number of disadvantages. On the one hand, the three elements of said device are implanted, during a surgical procedure, in three different locations of the lower abdomen, which constitutes a significant surgical difficulty.

 On the other hand, the circulation of physiological fluid from one element to another of the device through the tubules is likely to cause leakage of said liquid in the body of the patient.

 In addition, the envelope enclosing the urethra is responsible for compression of this biological conduit only on a certain fixed zone of said conduit and for a long time. However, this irremovable compression surface is likely to lead to irritation of the compressed zone, or even necrosis of the urethra.

 Finally, psychological discomfort can also affect the patient equipped with such a device, because of the mechanical manipulation of the pump inserted in the intimate areas.

In order to overcome this last disadvantage in particular, artificial sphincters which can be activated by the patient have been developed. itself, through magnetic control means, in particular magnets, located outside the body of the patient.

 For example, U.S. Patent No. 4,053,952 discloses a control valve actuated by a magnetic fluid whose flow is electrically controlled in a device that can be used as an artificial sphincter.

 In US 5,562,598, concerning an artificial urethral sphincter, a magnet external to the human body is used to obtain the closure or the opening of a urethral sphincter with hydraulic action.

 However, these artificial sphincters are of complex design, requiring a plurality of components, and leaks of liquid or fluid are still possible.

 Also, some artificial sphincters have been developed without fluid circulation, but with a mechanical clamp, positioned on the urethra and controlled by a solenoid, the energy required being produced by an energy sensor controlled by a transmitter magnet outside the body human .

 Such a sphincter is described for example in the patent document FR 2,688,693.

 In US Patent 3,926,175, the artificial sphincter device comprises a mechanical valve, provided with a permanent magnet, which is actuated by an electromagnet positioned outside the body of the patient.

 However, in the last two devices mentioned, the compression zone is irremovable, which is likely to cause irritation of the compressed zone, especially since the external magnetic control commands the mechanical closure of the sphincter only totally, without possibility of adjustment of the degree of closure.

The device described in the patent document WO 99/18885 provides means for postoperative adjustment of the degree of closure of mechanical closure means of a valve positioned on the urethra. Said closure means comprise a first magnet capable of being activated by an external magnet. The means for adjusting the degree of closure comprise a second magnet sensitive to the action of an external electromagnet which is equipped with a doctor.

 However, these devices do not solve the problem of necrosis of the urethra.

 Some known devices of the state of the art seek to combat the risk of necrosis, for example by exerting, on the surface of the channel to be controlled, the lowest pressure possible. Thus, for example, the device described in document WO 0226161 comprises a measurement sensor which continuously evaluates the pressure exerted by the narrowing element of the channel and makes it possible to correct this pressure in the case where it is too important, while minimizing the point of contact between the pressure element and the canal tissues.

 However, this device is of complex design, requiring in particular physical size sensors and control elements operating by supplying external energy.

 It is therefore within the framework of an inventive step that we have imagined to propose an artificial sphincter allowing, without external energy supply, by a simple and effective means, to modify, at random, the compression zone. channel or biological conduit equipped with said sphincter, in particular in the treatment of incontinence disorders.

 For this purpose, the present invention relates to an artificial sphincter with magnetic control comprising, on the one hand, a closure valve intended to be installed on a channel of the human body and comprising means for mechanical closure of said channel, these closure means comprising elements sensitive to a magnetic field, said artificial sphincter comprising, on the other hand, a magnetic control means outside the human body capable of deactivating said closing means.

The sphincter according to the invention is particular in that said closure valve comprises a first fixed magnet attracting a second magnet, movable in translation transversely to the axis of the channel, said first and second magnets being arranged vis-à-vis and on either side of said channel, said second magnet being provided with a means compression of the channel, said compression means projecting transversely from said second magnet and being movable by sliding, on the surface of said channel and parallel to the axis of said channel, between two extreme positions at which are provided means for retaining said means mobile compression.

 In a second embodiment, the closing valve comprises a fixed metal part attracted by a magnet movable in translation transversely to the axis of the channel, said metal part and said second magnet being arranged vis-a-vis and both sides of said channel, said magnet being provided with channel compression means, said compression means protruding transversely from said magnet and being movable by sliding on the surface of said channel and parallel to the axis of said channel, between two extreme positions at which are provided retaining means of said movable compression means.

 In a third embodiment, the closure valve comprises a fixed magnet attracting a metal part movable in translation transversely to the axis of the channel, said fixed magnet and said movable metal part being arranged vis-a-vis and both sides of said channel, said metal part being provided with a channel compression means, said compression means projecting transversely from said metal part and being movable by sliding on the surface of said channel and parallel to the axis said channel, between two extreme positions at which are provided retaining means of said movable compression means.

Advantageously, the means for compressing the channel or organ consists of a cylinder with an axis perpendicular to that of the channel, made of an elastic biocompatible material and filled with a biocompatible gel. According to an advantageous embodiment, said valve comprises a housing composed of two distinct parts joined together around said channel which passes through said housing through a through opening.

 After closing by clipping, these two separable parts of the housing enclose and protect the valve surgically implanted artificial sphincter.

 In particular, said valve can be positioned in the body of a patient such that said mobile compression means is able to move under the effect of a sudden voluntary movement of the patient's pelvis in a given direction.

 Interestingly, said sphincter is sized to be positioned on a patient's urethra for the treatment of urinary incontinence.

 According to one particularity of the invention, the magnetic control means external to the human body consists of a magnet able to neutralize or shunt the effects of the second mobile magnet.

 Depending on the action of the external magnet, urination, for example, in the case where the sphincter is implanted on the urinary canal, is then allowed.

 In a first embodiment, said compression means is movable through slides secured to said second magnet, said cylindrical compression means being traversed longitudinally by an axis cooperating with said slides and each end of which is provided with a retaining stop adapted to retain said axis at the slides.

 This axis and their associated stops are preferably made from rigid materials, dense, non-magnetic and biocompatible.

In another embodiment, even more preferred, said compression means is traversed right through by a dense magnetic axis, the latter being attracted by said movable magnet or said movable metal part, said compression means being movable between means restraint consisting of means for adjusting the compressive force of said compression means on the channel.

 The present invention has many advantages. On the one hand, the artificial sphincter device proposed here is monobloc and, therefore, easily implantable, thanks also to its reduced dimensions, by means of a surgical intervention. On the other hand, no external supply of energy is necessary to allow the operation of said sphincter, the latter being completely autonomous and functioning thanks to a succession of elements sensitive to a magnetic field.

 The patient equipped with the device of the invention controls it himself, and this without feeling the psychological discomfort caused by the manipulation of certain artificial sphincters of the state of the art.

 In addition, and above all, it will be emphasized that the device of the invention allows, in a particularly ingenious manner, to eliminate, or at least to greatly limit, the problems of necrosis likely to appear on the biological conduit equipped with an artificial sphincter device, and this by randomly modifying the compression zone, for example, the urethra, and always without external energy supply but simply through a sudden movement of the pelvis.

 Other characteristics and advantages of the invention will emerge from the following detailed description of non-limiting embodiments of the invention, with reference to the appended figures in which:

 - Figure 1 schematically illustrates an exploded perspective view of a first embodiment of an artificial sphincter device according to the invention for equipping a biological channel, the latter being also shown in said figure;

FIG. 2 schematically represents, in perspective, a detail of the first particular embodiment of the artificial sphincter device of the invention illustrated in Figure 1;

 - Figure 3 shows, schematically, a perspective view of a second particular embodiment of an artificial sphincter device according to the invention for equipping a biological channel, the latter being also shown in said figure;

 FIG. 4 schematically represents a sectional view of the device of FIG. 3.

 Structurally identical and / or functional elements or means, which are illustrated in different figures, are assigned a unique numerical reference.

 As shown in the figures of the accompanying drawings, the present invention relates to an artificial sphincter 1, and more particularly to an artificial sphincter 1 with magnetic control.

 The artificial sphincter 1 of the invention is particularly advantageous because it has a wide variety of applications.

 As will be described in more detail in the description below, said sphincter 1 may be intended, for example, to equip a conduit or biological channel of a patient or a patient to close or constrain, this channel which may consist, in particular, in the urethra through which the urine is evacuated to avoid any inadvertent leakage of liquid, the colon to overcome faecal incontinence, or even the pylorus channel which connects the stomach to the duodenum to control at distance the opening and closing of the latter.

In another application of the invention, equally interesting but not described hereinafter, the artificial sphincter 1 may be intended to print a more or less important stress to an organ of a patient, whether the organ is biological or artificial. . As illustrated more particularly in Figures 1, 3 and 4 attached, the artificial sphincter device 1 of the invention can be affixed to a biological channel 2.

 With regard to the elements constituting said artificial sphincter 1, it essentially comprises at least one valve 3 which comprises means for mechanical closure of this channel 2, it being understood that said valve 3 may also, in a variant embodiment not shown, be equipped with similar means to achieve the contraction of a biological organ or not.

 Said mechanical closing means of the channel 2 are composed of elements sensitive to a magnetic field, and are controlled, more precisely open to release the channel 2, by magnetic control means 4, when these are positioned by the patient opposite of the valve 3 and its elements, outside the human body.

 The boundary between the interior of the human body, where is located the valve 3 of the artificial sphincter 1, and the outside of the body, from which said control means 4 act, is shown schematically, in FIG. skin 5 of the patient.

 Specifically to the invention, the valve 3 of the artificial sphincter 1 comprises a first fixed element 6 sensitive to a magnetic field.

 In a first preferred embodiment, and which is shown in Figures 1, 3 and 4 of the accompanying drawings, this fixed element 6 may consist of a stationary magnet 6 and preferably permanent.

 In a second example, the fixed element 6 corresponds to a part sensitive to a magnetic field, for example a part made of a metallic material.

 This permanent magnet 6 is positioned on one side of said biological channel 2.

On the other side of said biological channel 2, opposite said first element 6 with respect to this channel 2, is located a second element 7 sensitive to a magnetic field which is it, mobile, away from and closer to the first element 6, in translation transversely to the axis of the channel 2, said second element 7 is also preferably covered with a biocompatible plastic film Teflon type (brand deposited for tetrafluoroethylene).

 Said second element 7 may be respectively, depending on whether the first fixed element 6 consists of a metal part or a magnet, a second magnet 7 preferably permanent or a part made of a metallic material and sensitive to a magnetic field.

 In a particularly advantageous embodiment example which is also the example shown in Figures 1, 3 and 4 attached, the first fixed element 6 and the second movable element 7 both consist of a permanent magnet.

 However, it is understood from what has been described above that the first fixed element 6 may also correspond to a fixed metal part and, in this case, the second movable element 7 consists of a movable magnet.

 In another embodiment where the first fixed element 6 consists of a magnet, the second element 7 can then be a metal part sensitive to a magnetic field.

 In the following description is described the preferred embodiment in which the fixed parts 6 and movable 7 are permanent magnets.

 The first and second magnets 6, 7 are positioned on either side of said channel 2, so that the magnetic pole of the first magnet 6 is opposite the magnetic pole and the opposite polarity of the second magnet 7 so that said two magnets 6.7 attract each other (so in North-South or South-North configuration).

 Particularly advantageously, the second mobile magnet 7 is provided with at least one compression means 8 of the biological channel 2.

Said compression means 8, outside the channel 2 on which it acts, protrudes transversely from the second magnet 7. In addition, the compression means 8 is movable, by sliding, on the surface and along said channel 2, parallel to the axis of said channel 2.

 More particularly, said compression means 8 is movable between two extreme positions 91, 92, on the surface of said channel 2. Also, at each of these extreme positions 91, 92, are provided retaining means 101, 102, so that to contain the movement of the compression means 8 between said two extreme positions 91, 92.

 Most preferably, this compression member 8 is constituted by a cylinder whose axis is perpendicular to the axis of the biological channel 2. The cylinder is advantageously made of a non-magnetic and hollow biocompatible soft or rubbery material, said cylinder also being filled a biocompatible deformable gel.

 The compression member 8 may also be made of a plastic membrane and may optionally be covered with a thin biocompatible layer of TéfIon type (registered trademark for tetrafluoroethylene).

 As regards the biocompatible gel of which the compression member 8 in question is filled, this may consist, for example, of collagen or of hyaluronic acid, or else of cellulose derivatives.

 Thus, said cylindrical compression member 8 has optimum flexibility and elasticity so that when the two magnets 6 and 7 attract each other under the effect of their respective magnetic fields, said member 8 filled with gel supports extremely delicate on the duct 2.

 This gentle compression of the duct 2, for example the urinary urethra, is however sufficient to cause a closure of said duct 2 which, therefore, prevents the inadvertent flow of liquid.

Therefore, the patient equipped artificial sphincter 1 of the invention is no longer incontinent, if we consider for example that the conduit 2 consists of the urinary urethra. Still in the example where the patient has disorders of urinary incontinence, and when the latter wishes to urinate, it places, on the outer surface of the skin 5, the magnetic control means 4, the latter preferably consisting of permanent magnet.

 More precisely, the external magnet 4 is positioned opposite the second magnet 7 which, for the sake of memory, is mobile in transverse translation with respect to the axis of the channel 2.

 If the magnetic poles (North / South) of the external magnet 4 are correctly arranged, and of opposite polarity to that of the magnetic pole of the second internal movable magnet 7 opposite which it is positioned, the external magnet 4 attracts said second magnet 7.

 The second magnet 7, to which is attached the compression means 8 of the channel 2, then approaches the external magnet 4 under the effect of the magnetic fields of the two magnets, resulting in decompression of the channel 2, by which can then flow, for example, the urinary fluid in the case of the treatment of urinary incontinence by means of the device 1 of the invention.

 In the opposite case, if the magnetic pole of the external magnet 4 is positioned opposite the same magnetic pole of the second magnet 7, in a north-north or south-south configuration, then they repel each other and no decompression of the channel 2 can to perform.

 The patient equipped with the sphincter 1 then becomes aware of the difficulty he has in urinating, for example, and he can correctly reposition the external magnet 4, turning it over, finally leading to decompression of the channel 2.

 However, in order to avoid this situation, it is conceivable, in a particular embodiment of the invention, to provide means for indicating the correct positioning direction of the external magnet 4.

Thus, the patient equipped with the artificial sphincter 1 of the invention is able to systematically position against his skin 5, the pole of 1 'external magnet 4 which is polarity opposite that of the pole of the second magnet 7 facing the skin 5 to allow the opening of the valve

3.

 This means for indicating the positioning of the external magnet

4, not shown in the accompanying figures, may consist of any pictogram, from the moment it easily allows the patient to know immediately how to position the magnet 4 to disable the closing means of the valve 3.

 In a third hypothesis, considering that the patient has lost the external magnet 4 which allows him to disable the mechanical closing means equipping the valve 3, it will still happen to urinate, or to go to the saddle, forcing voluntarily the expulsion of urine or faeces as appropriate.

 Indeed, in the case of urinary incontinence and a patient whose urethra 2 is equipped with the artificial sphincter 1 of the invention, the patient, voluntarily increasing, and significantly, the pressure of the liquid in the bladder, causes a deformation of the gel filling the biocompatible cylinder 8, which can cause the passage of the liquid under the compression means 8.

 In addition, when said compression means 8 is made from materials which give it, thanks to the biocompatible gel, optimum flexibility and elasticity, it is particularly capable of being deformed under the action of the strong pressure exerted on the surface. bladder through the liquid, allowing urination.

 It is also the same when the artificial sphincter device 1 of the invention is implanted in the colon of a patient suffering from faecal incontinence.

 It has been mentioned above the characteristic according to which said compression means 8, fitted to the second magnet 7, is mobile, preferably randomly, between two extreme positions 91, 92, on the surface of the channel 2.

The mobility of said compression means 8 allows the artificial sphincter 1 to fight particularly clever at the problems of irritation and / or necrosis of the canal 2 which are likely to affect the patients provided with such devices.

 Indeed, thanks to this mobility of the compression means 8, the area of the channel 2 which undergoes compression under the action of this means 8 is modified, randomly and periodically over time.

 Therefore, the biological conduit 2 is not compressed on a non-removable compression surface, which makes it possible to fight, in a particularly effective manner, against the phenomena of irritation, or even necrosis, of the biological conduit 2 in question.

 In an advantageous embodiment of the invention, the compression means 8 can be driven in motion under the effect of a movement of the pelvis carried out by the patient, in a given direction and in one direction or the other, when the external magnet 4 is positioned in the open position of the valve 3, in other words when the opposite south and north poles of the magnets 4 and 7 attract each other.

 The direction of movement that the patient must perform to cause movement of the compression means 8 is determined with respect to the positioning of the valve 3 in the body of said patient.

 As a function of the force and the direction induced, by the movement of the pelvis, by means of compression 8, the latter will move, at random, between the two extreme positions 91, 92 in order to regularly move the compression zone of channel 2.

 In a first particularly advantageous embodiment, which is now described and shown in FIGS. 1 and 2 attached, the cylindrical compression means 8 is slidably movable through slides 11, 12 that are parallel and integral with the second magnet 7.

It should be noted that the support slides 11 and 12 on the upper face of the structure 6 (corresponding to a magnet fixed or to a metal part) makes it possible to limit the compression of the biological channel 2.

 In this example, the cylindrical compression means 8 is traversed longitudinally by an axis 13 cooperating with said slides 11, 12, on which it rests, preferably without friction or with low friction.

 In addition, advantageously, said axis 13 is preferably made of a biocompatible and very dense non-magnetic material chosen from, for example, titanium (having a density of the order of 4.51); Phynox (trade mark) which is a cobalt-chromium-nickel-molybdenum alloy (Co-Cr-Ni-Mo) with a density of about 8.3; austenitic stainless steels with a density of the order of 7.93; Co-Ni-Cr based multiphase alloys sold under the trademark "nivaflex" and which have a density of about 8.5; or else aluminum with a density of 2, 7.

 In all cases, preferably, the density of the biocompatible nonmagnetic material used to manufacture the axis 13 is greater than or equal to 2.5 and, more preferably still, greater than or equal to 2.7.

 Consequently, this axis 13 is able to slide, under the second permanent magnet 7 mobile, with a very low friction on the slides 11, 12 and without contact with the biological channel 2.

 Similarly, the slides 11 and 12 as well as the stops 101 and 102 are made of a non-magnetic material biocompatible selected from titanium, non-magnetic stainless steel, and aluminum covered with a plastic film (for example polytetrafluoroethylene, plus known under the trademark "Teflon").

 Each of the ends of the traversing axle 13 is advantageously provided with a retaining stopper 141, 142 able to maintain said axis 13 at the level of the slides 11, 12.

Each of the retaining stops 141, 142 is advantageously manufactured from a material which is both non-magnetic, biocompatible and has a high density. Thus, preferably, but not exclusively, said retaining stops 141, 142 are manufactured with the same materials as those mentioned for the manufacture of the axis 13.

 Most preferably, said valve 3 comprises a housing 15, preferably made of a biocompatible plastic material, rigid and non-magnetic, for example polytetrafluoroethylene or Teflon (registered trademark), or an elastomeric thermoplastic material, such as thermoplastic referenced ABS-M30i .

 The protective housing 15 is advantageously constituted by two complementary parts 16, 17, or shells, secured together, by interlocking and latching, around said channel 2 which passes through said housing 15 from one end to the other through a through opening 18.

 The first portion 16 of the housing 15 is intended to contain the fixed magnet 6, the latter being secured to the lower inner face 161, while the second portion 17 of said housing 15 encloses the second magnet 7 which is, for its part, a part movable in translation transverse to the axis of the channel 2, and, secondly, provided, preferably through slides 11, 12, the movable compression means 8.

 The movable elements of the valve 3 of the artificial sphincter 1 of the invention, that is to say the second magnet 7, the nonmagnetic smooth slides 11, 12, the compression means 8, the non-magnetic axis 13 and the stops 141, 142 can move freely in the second part 17 of the housing 15.

 In this particular embodiment, and in the event that the biological channel 2 consists of the urethra, the sphincter 1 then being intended to treat urinary incontinence, when the patient wishes to urinate, he places the external magnet 4 in the urethra. above the skin 5, facing the second mobile magnet 7.

If the magnetic poles are correctly arranged, the external magnet 4 attracts the assembly composed of the second magnet 7, slides 11, 12 which are secured to it, the axis non-magnetic 13 resting on these, abutments 141, 142 which is provided with said axis 13 and the cylindrical compression means 8 traversed by the same axis 13.

 If the magnetic poles of the external magnet 12 are not correctly positioned, the second movable magnet 7 remains attracted by the first fixed magnet 6, but no additional contraction is exerted by the external magnet 4 on the moving magnet assembly 7 / slides 11, 12 / non-magnetic axis 13 / stops 141, 142 / cylindrical compression means 8.

 Indeed, preferably, said slides 11, 12 are able to abut against the first fixed magnet 6.

 When the patient performs his pelvic movement to avoid compression of the urethra at a constant location in time, this movement gives the assembly composed of the non-magnetic axis 13, stops 141, 142 and the cylindrical compression means 8, which is free in motion between the two extreme positions 91, 92, a speed V0 and an energy

 1

kinetic equal to ~ m * ¥ 0 ² where m is the mass of said set.

 This kinetic energy of the aforementioned assembly is dissipated by causing a movement of the latter along the slides 11, 12 via the dense non-magnetic axis 13, said movement being effected over a length AL such that

- ni * - VO ² = F _f * AL, where F _f is the friction force, on the one hand, of the dense non-magnetic axis on the slides 11, 12 integral with the movable permanent magnet 7 and possibly, d secondly, compression cylinder 8 on the biological channel 2.

 Also, under the effect of the movement of the artificial sphincter user's pelvis 1 of the invention, the compression zone of the biological channel 2 has changed, and this in a completely random manner according to the direction in which the user has performed its movement and according to the speed VO which has been induced in particular by means of compression 8.

This way of limiting the necroses of biological channels 2 equipped with artificial means of compression is particularly advantageous because it does not require any contribution of external energy, of electric type, but simply a sudden voluntary movement of the basin, for example, after having positioned the external magnet 4.

 This movement can be effected in one direction or the other, whenever the patient decides, and when the valve 3 of the artificial sphincter 1 is open, which corresponds, in the preferred embodiment described above. at a withdrawal of the compression cylinder 8 under the action of the external magnet 4 to allow the urine to pass through the channel 2.

 Referring now to Figures 3 and 4 attached, is described a second embodiment of the invention, equally advantageous as the first example whose mode of operation has been explained in detail above.

 In this second embodiment, said compression means 8, in the form of a hollow cylinder 8, is pressed under the permanent magnet 7 by the permanent vertical force exerted between said magnet 7 and a magnetic axis of high density 19, for example in Samarium Cobalt, preferably of cylindrical or semi-cylindrical shape, which passes right through, the cylinder 8.

 As a remark, as for the first embodiment, the movable magnet 7 can be replaced by a metal part sensitive to a magnetic field to the extent that the fixed part 6 consists of a magnet and / or the axis 19 is a permanent magnet.

 This dense magnetic axis 19, attracted by said magnet 7, is preferably a permanent magnet of cylindrical shape so that the contact surface with the magnet 7 is minimal, in order to limit the friction between said magnet 7 and 1 'axis magnetized 19.

Thus, in this particular embodiment, the assembly consisting of the cylindrical compression means 8 and the magnetic axis 19 is permanently attached to said magnet 7, through a magnetic attraction force perpendicular to the contact surfaces. . However, said assembly can slide with a very low friction, almost negligible, under the permanent magnet 7, the latter being, moreover, preferably, for this purpose, covered with a Teflon-type film (trademark for the tetra- fluoroethylene).

 As for the first embodiment, the attraction of the movable magnet 7, or metal part, by the fixed magnet 6, gently compresses the cylinder 8 filled with a flexible and nonmagnetic gel, on the biological conduit 2, by example the urethra.

 This gentle compression of the urethra 2 presses the latter against a flexible element 20 advantageously equipping said fixed magnet 6 at its face intended to be in contact with the urethra 2, and suppresses the flow of urine in the urethra 2. The person equipped with the device 1 according to the invention no longer suffers from incontinence.

 Advantageously, the final compression force of the assembly 7, 8, 19 on the urethra 2 placed on a soft layer 20, itself deposited on the fixed magnetic structure 6 is adjustable.

 This adjustment can be controlled by the surgeon during the placement of the artificial sphincter 1 of the invention in the body of the patient.

 For this purpose, it simply adjusts the position of adjustment elements 21a, 21b secured to the magnet 7, for example by screwing or unscrewing said adjustment elements 21a, 21b, which modifies the length of these adjustment elements 21a, 21b facing the bottom 161 of housing 16.

 As a remark, the adjustment elements 21a, 21b can advantageously act as retaining means respectively 101, 102 of the mobile compression means 8, when the latter moves by sliding between the two extreme positions 91, 92.

In other words, said adjustment elements 21a, 21b abut on the lower inner face 161 of the biocompatible plastic case 15, which modifies the minimum space that can be achieved between the magnetic structures 6 and 7, thereby adjusting the compressive force of the hollow and flexible cylinder 8 filled with deformable gel on the biological channel, for example the urethra 2.

 The protocol to be applied to move the compression means 8 is similar to that of the first embodiment.

 Indeed, when the patient equipped with the artificial sphincter object of the present invention wishes to urinate, for example, it places, above the skin 5, with respect to the magnet 7, an external magnetic control means 4 , consisting for example of a permanent magnet. If the magnetic poles of this magnet 4 are correctly arranged, they then attract the assembly formed by the magnet 7, the magnetic axis 19, the compression means 8, and the adjustment means 21 serving as stops 101, 102 , which decompresses the urethra 2 and makes it possible to urinate.

 The permanent magnet 6, further from the external magnet 4 and, moreover, rigidly fixed at the lower inner face 161 of the first portion 16 of the housing 15 does not move.

 On the contrary, if the magnetic poles of the magnet 4 are poorly positioned relative to those of the magnet 7, no further contraction of the urethra 2 is exerted because the adjustment elements 21 are in abutment against the inner face lower portion 161 of the first portion 16 of the housing 15 preventing further compression of the urethra 2.

 In addition, in order to avoid compression of the urethra 2 at a constant location over time, which can cause irritation or necrosis of this biological conduit 2, the patient performs a very simple action similar to that described for the first embodiment, namely to place the magnet 4 in the same position as for urination, which releases all the parts 7, 8, 19, 21a, 21b, before making a sudden movement of the pelvis in the one or the other direction.

This movement gives the assembly composed of the magnetic axis 19 and the cylindrical compression means 8, which is free in movement between the two extreme positions 91, 92 at the surface of the magnet 7 preferably covered with Teflon (registered trademark), a speed V0 and a kinetic energy equal to -m * VQ ² , where m is the mass of said set .

 2

 This kinetic energy of the assembly 8, 19 is then dissipated by causing a lateral movement of this assembly which moves by sliding under the magnet 7 preferably coated with Teflon (registered trademark) over a distance AL such that i

-must FO ² = F _f * AL, where F _f is the friction force of the deformable cylinder 8 under the magnet 7.

 It is clear that the deformable cylinder 8 is constantly held in contact with the magnet 7 by the magnetic axis 19 which exerts a vertical force not opposing a lateral sliding.

 The compression zone of the urethra 2 by the compression means 8 has therefore been modified, positioning itself at a distance AL from its starting point. The other subsets of the artificial sphincter 1 of the invention are fixed in biological tissues and do not move.

 This sudden movement of the pelvis can be effected in one direction or the other, for example every time the patient wishes to urinate and then cause the displacement of the assembly 8, 19 under the underside of the magnet 7.

 Lateral displacement of the system 8 and 19 is limited by the adjustment elements 21a, 21b thus constituting retaining means 101, 102 respectively abutting the mobile compression means 8, the latter being movable between the two extreme positions 91, 92.

 Of course, the invention is not limited to the examples illustrated and described above which may have variants and modifications without departing from the scope of the invention.

Claims

1. An artificial sphincter (1) with magnetic control comprising, on the one hand, a closing valve (3) intended to be installed on a channel (2) of the human body and comprising means for mechanical closure of said channel (2), these closure means comprising elements sensitive to a magnetic field, said artificial sphincter (1) comprising, on the other hand, a magnetic control means (4) external to the human body adapted to deactivate said closure means, characterized in that said closing valve (3) comprises a fixed first magnet (6) attracting a second magnet (7) movable in translation transversely to the axis of the channel (2), said first and second magnets (6, 7) being disposed opposite and on either side of said channel (2), said second magnet (7) being provided with a compression means (8) of the channel (2), said compression means (8) protruding transversely from said second magnet (7) and being movable by sliding, to the surface of said channel (2) and parallel to the axis of said channel (2), between two end positions (91, 92) at which are provided retaining means (101, 102) of said movable compression means (8) . 2. An artificial sphincter (1) with magnetic control comprising, on the one hand, a closing valve (3) intended to be installed on a channel (2) of the human body and comprising mechanical closing means of said channel (2), these closure means comprising elements sensitive to a magnetic field, said artificial sphincter (1) comprising, on the other hand, a magnetic control means (4) external to the human body adapted to deactivate said closure means, characterized in that said closure valve (3) comprises a fixed metal part attracted by a magnet (7) movable in translation transversely to the axis of the channel (2), said metal part and said second magnet (7) being arranged opposite and on either side of said channel (2), said magnet (7) being provided with a compression means (8) of the channel (2), said compression means (8) protruding transversely from said magnet (7) and being movable by sliding on the surface of said channel (2) and parallel to the axis of said channel (2) between two extreme positions (91, 92) at which are provided retaining means (101, 102) of said movable compression means (8).  3. Artificial sphincter (1) with magnetic control comprising, on the one hand, a closing valve (3) intended to be installed on a channel (2) of the human body and comprising mechanical closing means of said channel (2), these closure means comprising elements sensitive to a magnetic field, said artificial sphincter (1) comprising, on the other hand, a magnetic control means (4) external to the human body adapted to deactivate said closure means, characterized in that said closing valve (3) comprises a fixed magnet (6) attracting a metal part movable in translation transversely to the axis of the channel (2), said fixed magnet (6) and said movable metal part being arranged opposite and on either side of said channel (2), said metal part being provided with a compression means (8) of the channel (2), said compression means (8) protruding transversely from said metal part and being mobile sliding, on the surface of said channel (2) and parallel to the axis of said channel (2), between two end positions (91, 92) at which are formed retaining means (101, 102) of said compression means mobile (8).  4. Artificial sphincter (1) with magnetic control according to any preceding claim characterized in that said valve (3) comprises a housing (15) consisting of two parts (16, 17) secured together around said channel ( 2) which passes through said housing (15) through a through opening (18). 5. Artificial sphincter (1) with magnetic control according to any preceding claim characterized in that said sphincter (2) is sized to be positioned on the urethra of a patient for the treatment of urinary incontinence.  6. artificial sphincter (1) with magnetic control according to any one of the preceding claims, characterized in that the magnetic control means (4) external to the human body consists of a magnet capable of neutralizing the effects of the moving magnet ( 7) or the movable metal part provided with the compression means (8).  7. artificial sphincter (1) with magnetic control according to any one of the preceding claims, characterized in that the compression means (8) of the channel or member consists of a cylinder axis perpendicular to that of the channel (2) and made of an elastic biocompatible material and filled with a biocompatible gel.  8. Artificial sphincter (1) with magnetic control according to the preceding claim characterized in that said compression means (8) is movable through slides (11, 12) integral with said second magnet (7), said cylindrical compression means (8) being traversed longitudinally by a non-magnetic axis (13) cooperating with said slides (11, 12) and each end of which is provided with a retaining stop (141, 142) adapted to retain said axis (13) at slides (11), (12).  9. Artificial sphincter (1) with magnetic control according to claim 7, characterized in that said compression means (8) is traversed right through by a dense magnetic axis (19), the latter being attracted by said magnet (7). ) mobile or said movable metal part, said compression means (8) being movable between retaining means (101, 102) consisting of adjustment means (21a, 21b) of the compressive force of said compression means (8) on the channel (2).