IMPLANTABLE OCCLUSION SYSTEM

Abstract

An occlusion system implantable in a human or animal body, including a fluidic circuit which includes an inflatable occlusive sleeve, a reservoir with variable volume filled with a fluid. The reservoir includes a fixed portion and a movable portion, an actuator mechanically coupled with the movable portion of the reservoir to linearly displace the movable portion relative to the fixed portion for adjusting the volume of the reservoir. The actuator and the reservoir are laid out in a sealed casing containing a gas. A sensor mechanically bound to the actuator and/or to the movable portion, measures a traction and/or compressive force of the movable portion of the reservoir. Also included is a device for measuring the fluid pressure in the fluidic circuit.

Claims

1. An occlusion system implantable in a human or animal body, comprising: a casing made of a biocompatible material; an inflatable occlusive sleeve outside the casing, the inflatable occlusive sleeve being configured to surround an anatomical duct; a reservoir filled with a fluid arranged within the casing, the reservoir comprising a fixed portion and a movable portion defining together a fluid volume of the reservoir; a tubing fluidically coupling the reservoir to the inflatable occlusive sleeve; an actuator mechanically coupled with the movable portion of the reservoir so as to displace said movable portion relative to the fixed portion for adjusting the fluid volume of the reservoir and cause fluid to move between the reservoir and the occlusive sleeve through the tubing; and a control unit configured to command the actuator based on a pressure to be applied by the occlusive cuff onto the anatomical duct.

2. The occlusion system of claim 1, wherein the movable portion of the reservoir comprises a movable wall and bellows extending from the movable wall, the wall being coupled to a drive system configured to linearly move the wall, thereby compressing or expanding the bellows.

3. The occlusion system of claim 2, wherein the drive system comprises a screw secured to the movable wall and a nut coupled with the screw, the nut being movable in rotation around an axis of the screw under the effect of a driving action by the actuator, the nut being coupled with the screw so that a rotation of the nut drives the screw only in translation.

4. The occlusion system of claim 1, further comprising an accelerometer, the control unit being configured for, from measurement data of the accelerometer, determining whether the body is in a determined situation.

5. The occlusion system of claim 1, wherein the actuator is selected from piezoelectric actuators, electromagnetic actuators, electro—active polymers and shape memory alloys.

6. The occlusion system of claim 1, wherein the actuator is electrically connected to a power source within the casing.

7. The system occlusive according to claim 1, wherein the casing is hermetically sealed and comprises a gas pressure sensor for measuring a gas pressure in the casing.

8. The occlusive system of claim 1, further comprising at least one force sensor in a mechanical connection with at least one of the actuator and the movable wall of the reservoir to measure a compressive and/or traction force in a direction of displacement of the movable wall.

9. The occlusive system of claim 8, wherein the at least one force sensor comprises one or several strain gauges.

10. The occlusive system of claim 1, further comprising an external device adapted to be held by the patient, configured to communicate wirelessly with the control unit.

Description

SHORT DESCRIPTION OF THE DRAWINGS

[0064] Other features and advantages of the invention will become apparent from the detailed description which follows, with reference to the appended drawings wherein:

[0065] FIG. 1 is an overall view of the implantable occlusion system,

[0066] FIG. 2 is a sectional view of the inside of the casing of an implantable occlusion system according to a first embodiment of the invention,

[0067] FIG. 3 is a sectional view of the casing of an implantable occlusion system according to a second embodiment of the invention,

[0068] FIG. 4 is a sectional view of the casing of an implantable occlusion system according to a third embodiment of the invention,

[0069] FIG. 5 is a sectional view of the inside of the casing of an implantable occlusion system according to a fourth embodiment of the invention,

[0070] FIG. 6 is a diagram showing the different forces which may be measured by the compressive or traction force sensor, in the presence of a pre—stress,

[0071] FIG. 7 is a diagram showing the various forces which may be measured by the compressive and traction force sensor in the absence of any pre—stress,

[0072] FIG. 8 is a graph showing the variation of the pressure in the fluidic circuit depending on the volume injected into the occlusive sleeve,

[0073] FIG. 9 is a graph showing the variation of the pressure in the fluidic circuit versus time for different volumes of fluid injected into the occlusive sleeve during the calibration procedure.

[0074] FIG. 10 is a sectional view of the casing of an implantable occlusive system according to a fifth embodiment of the invention.

[0075] FIG. 11 is a sectional view of the force sensor and of the actuator of the system of FIG. 10, with an illustration of the measured forces.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0076] General Presentation of the Implantable Occlusion System

[0077] With reference to FIG. 1, the occlusion system comprises an inflatable occlusive sleeve 3 containing a variable volume of a fluid, intended to surround at least one portion of a natural conduit (not shown) to be occluded, and a reservoir 5 with a variable volume (illustrated in FIGS. 2 to 5) filled with a fluid.

[0078] The occlusive sleeve may be made of a biocompatible elastomer (cf. for example documents U.S. Pat. No. 4,222,377, CA 1,248,303 or U.S. Pat. No. 4,408,597).

[0079] Said reservoir comprises a fixed portion and a movable portion, the displacement of the movable portion varying the volume of the reservoir.

[0080] For this purpose, the occlusion system comprises an actuator mechanically coupled with the movable portion of the reservoir so as to linearly displace said movable portion relatively to the fixed portion in order to adjust the volume of the reservoir. The actuator may notably comprise an electromagnetic motor and a reducer. The actuator is controlled by a device for controlling the pressure of the sleeve which will be described in detail later on.

[0081] For each volume of the reservoir, the movable portion has a known effective pressure surface area, which may be constant or variable according to the embodiments.

[0082] The occlusion system further comprises a fluidic connection 2 (typically tubing) between the reservoir 5 and the occlusive sleeve 3.

[0083] Thus, a variation in volume of the reservoir 5 causes addition or withdrawal of fluid in the sleeve 3, thereby increasing or decreasing the compression exerted on the conduit surrounded by the sleeve.

[0084] The assembly formed with the reservoir of variable volume, of the occlusive sleeve and of the fluidic connection is called a fluidic circuit in the following of the description. In addition to the device for controlling the pressure of the occlusive sleeve, the implantable system includes one or several electronic modules giving the possibility of producing all the required functions. It further includes a rechargeable power source or not, allowing the system to be powered. In a particular configuration, the power source is outside the human body and transmits the energy in a wireless way to the implantable system. The reservoir with variable volume, the actuator as well as said electronic module(s) and, if necessary, the power source, are laid out in a casing 1 intended to be implanted into the body of the patient. The casing 1 contains a gas, for example air, said casing has to be sealed so as to avoid any transfer of fluid or gas from or to the intracorporeal medium. The casing is in a biocompatible material, and may for example be made in implantable titanium and sealed by laser welding. A check of the seal may notably be achieved with helium (for example, a leak rate of less than 10.sup.−9 mbar.L/s of helium) for ensuring the total seal of the casing during the period for which the device is implanted.

[0085] According to a particular embodiment, the casing may contain a gas pressure sensor, the function of which will be described below.

[0086] Advantageously, the casing 1 comprises, in a wall delimiting the reservoir with a variable volume, a puncture port 4 which may be perforated with a needle and able to sealably close after withdrawing the needle, allowing injection or withdrawal of the fluid of the reservoir.

[0087] The casing also contains a sensor in a mechanical connection with the actuator and/or the movable wall of the reservoir with a variable volume which may measure a compressive and/or traction force in the direction of displacement of the movable portion of the reservoir.

[0088] Among the sensors suitable for this use, mention may for example be made of: [0089] a sensor based on one or several strain gauges (such gauges allow measurement of traction and compressive forces); [0090] one or several sensors of the FSR™ type (acronym “Force Sensing Resistor”) marketed by Interlink Electronics, measuring compressive forces); and/or [0091] one or several pressure sensors coupled with a mechanism allowing measurement of a force. For example, mention may be made of a hydraulic pressure sensor combined with a pocket full of fluid and laid out so as to measure a pressure on a predetermined surface, thereby allowing inference of the force applied to the measurement surface.

[0092] The system may further comprise a device allowing measurement of the atmospheric pressure in the surroundings of the patient. A barometric sensor capable of measuring the current atmospheric pressure exerted on the body of the patient, may for example be laid out in an external device borne by the patient. This measurement may be transmitted by a wireless link to the control device laid out in the implantable casing.

[0093] Reservoir with a Variable Volume

[0094] According to a preferred embodiment, the reservoir with a variable volume comprises bellows assembled in the casing, the bellows and the casing for example being made in implantable titanium. The reservoir with variable volume then consists of the bellows (acting as a movable portion), of a wall of the casing and of a hood acting with said wall of the casing, as a fixed portion. The reservoir further comprises an orifice allowing transfer of the fluid from and to the outside of the reservoir.

[0095] The use of metal bellows for producing the function of a reservoir with variable volume is known to the person skilled in the art (cf. document U.S. Pat. No. 4,581,018 for example). Such bellows are for example marketed by Servometer and Witzenmann.

[0096] The bellows have the advantage of ensuring total seal of the implant while allowing movement of the movable wall. Its effective pressure surface area may be considered as constant over the whole range of travel of the bellows.

[0097] Nevertheless, it should be taken into account in the design of the device, the mechanical stiffness of the bellows which may have an influence on the behavior of the device (impact on the power yield, direction of the forces, etc.). How this parameter is taken into account will be described in detail below.

[0098] However, the present invention is not limited to the use of bellows for forming the reservoir with variable volume. Thus, the person skilled in the art may apply for producing the reservoir with a variable volume, a piston or a rolling membrane, which are considered as not having any mechanical stiffness. In this case, unlike the case of bellows, the stiffness will be considered as zero or negligible in the calculation of the pressure.

[0099] The movable portion of the reservoir has an effective pressure surface area which may be constant or variable according to the embodiment of the reservoir.

[0100] In the case of bellows, the effective pressure surface area is considered as constant and is given by the manufacturer. For a rolling membrane, the effective pressure surface area varies according to the position of the rolling membrane and is given by the manufacturer for different travel values,

[0101] In the case of a piston sliding without any friction in a cylinder, the effective pressure surface area is equal to the front surface area of the piston.

[0102] Actuator

[0103] The actuator may be selected from any electromechanical system allowing transformation of electric energy into a mechanical movement with the required power for allowing the displacement at a force and at a required speed of the movable portion of the reservoir with variable volume. For example mention may be made from among the actuators known to the person skilled in the art, of piezo—electric actuators, of electromagnetic motors with or without brushes (in the case of a brushless motor, the latter may consist of 2 poles or of 4 poles) either coupled or not with a reducer, electro—active polymers or else shape memory alloys.

[0104] FIG. 2 illustrates an embodiment of the invention and represents a sectional view of a portion of the inside of the casing 1.

[0105] The reservoir with variable volume 5 comprises a movable portion which, in this embodiment is bellows 9.

[0106] The bellows have a flange 6 coupled with a driving screw 17 via a spotted wheel 10 secured to the flange 6 and having tapping cooperation with the threading of the screw 17.

[0107] The reservoir is delimited by a portion of the wall of the casing 1 and of the bellows 9.

[0108] The wall of the casing 1 moreover comprises a puncture port 4 which may be perforated by a needle in order to add or withdraw fluid from the reservoir.

[0109] The reservoir 5 further comprises a connection 7 for tubing ensuring the fluidic connection with the occlusive sleeve (not shown).

[0110] The casing 1 further contains an actuator comprising a motor 13 coupled with a reducer 8. A connector 12 allows the motor 13 to be powered when the control device transmits an order for operating the motor in one direction or in the other depending on whether an increase or a decrease in the volume of the reservoir is required.

[0111] The reducer is coupled with a toothed wheel 18 which is itself coupled with the driving screw 17, so as to transmit the torque and the rotation of the axis of the motor 13 to the driving screw 17. Rotation of the screw 17 then drives the spotted wheel 10 into translation, which has the effect of displacing the flange 6 in translation in a direction parallel to the axis of the screw 17, the displacement direction of the flange 6 depending on the direction of rotation of the motor 13.

[0112] The inner space 11 of the casing surrounding the reservoir 5 is filled with a gas.

[0113] The volume variation of the reservoir 5 therefore has the effect of varying the inner volume 11 and therefore the pressure of the gas in said volume 11.

[0114] A gas pressure sensor (not shown) may optionally be laid out in the volume 11 for measuring the pressure in this volume.

[0115] The toothed wheel 18 is housed in a block 15 via ball bearings 16 which allow its rotation in the block 15. As the toothed wheel 18 is secured to the driving screw 17, the block 15 is driven into translation in the casing by the screw 17. Pads 20 extend from the wall of the casing 1 parallel to the axis of rotation of the screw 17 allowing guidance of the translation of the block 15.

[0116] A force sensor is attached on the wall of the casing facing the face of the block 15 opposite to the reservoir 5. The mark 19 refers to a connector allowing transmission of the measurement data of the sensor to the device for measuring and controlling the pressure.

[0117] In this embodiment, the force sensor 21 only measures compressive forces.

[0118] In order to nevertheless allow measurement of the traction forces, the system comprises a pre—stress device 14 which exerts a determined compressive force on the force sensor. This pre—stress device thus generates an “offset” on the force sensor, which allows measurement of both the traction forces and the compressive forces.

[0119] Said pre—stress device may comprise one or several adjustment screws cooperating with the guiding pads 20 and, interposed between the head of a respective adjustment screw and the block 15, a compressive spring, an extension spring and/or an elastomeric pad.

[0120] As this is seen, the integration of the force sensor to the pressurization system of the sleeve is particularly compact and is therefore not a penalty for the bulkiness of the implantable system.

[0121] FIG. 3 illustrates another embodiment of the invention and represents a sectional view of a portion of the inside of the casing 1.

[0122] The elements bearing the same reference signs as in FIG. 2 fulfill the same function and will therefore not be described again.

[0123] In this embodiment, the force sensor 22 may for example be based on a measurement with strain gauge(s). The sensor 22 is attached on the block 15 and on the wall of the casing facing said block, on the opposite side to the reservoir. The force sensor 22 is able to measure both compressive and traction forces. The pre—stress device of the embodiment of FIG. 2 is not necessary in this case.

[0124] FIG. 4 illustrates an embodiment of the invention and represents a sectional view of a portion of the inside of the casing 1.

[0125] In this embodiment, the movable portion of the reservoir 5 is not bellows but a rolling membrane 27. As in FIG. 2, the force sensor 21 only measures compressive forces and is therefore associated with a pre—stress device 14.

[0126] FIG. 5 illustrates another embodiment of the invention and represents a sectional view of a portion of the inside of the casing 1.

[0127] The elements bearing the same reference signs as in FIG. 2 fulfill the same function and will therefore not be described again.

[0128] In this embodiment, the force sensor 22 may for example be based on a measurement with strain gauge(s). It may be integrated between the tapped spotted wheel 10 and the flange 6. The tapped spotted wheel 10 and the force sensor 22 may also form a single and complete assembly integrating the strain gauge(s) and a tapped portion, thereby fulfilling the force measurement and of drive by the driving screw 17. The force sensor 22 is able to measure both compressive and traction forces. The pre—stress device of the embodiment of FIG. 2 is not necessary in this case.

[0129] FIG. 10 illustrates another embodiment of the invention and illustrates a sectional view of a portion of the inside of the casing 1.

[0130] The elements bearing the same reference signs as on FIG. 2 fulfill the same function and will therefore not be described again.

[0131] In this embodiment, the screw 17 is secured to the movable flange 6 of the bellows 9 and does not rotate. The linear movement of the flange 6 of bellows 9 is performed by means of the rotation of the nut 10 which linearly drives the screw 17. The nut 10 is secured to the wheel 18 which is driven by the reducer gear 8. The nut 10 is laid out so that only one rotation around the axis of the screw 17 is allowed. For this, a dual-effect bead abutment is laid out on the force sensor 22, by means of beads 16 which allow the nut 10 to turn and support the experienced forces along the axis of the screw 17. The forces exerted on the nut 10 are identical with the exerted ones in the other configurations.

[0132] FIG. 11 illustrates the main forces experienced and measured by the force sensor 22 with the purpose of inferring therefrom the pressure in the fluidic circuit. For measuring force in the two directions along the axis of the screw 17, the force sensor 22 is integrated into the bead abutment 16 so as to be able to measure forces in both directions. The supports 29 give the possibility of maintaining the force sensor 21. In this embodiment, the forces 23, 25 and 26 are measured by the force sensor at the bead abutment 16 integrated into the driving nut 10. The force sensor may be in this case a sensor comprising strain gauges placed so as to measure forces in both directions along the axis of the screw 17 secured to the flange 6 of the bellows 9.

[0133] The embodiment illustrated in FIGS. 10 and 11 has the advantage of allowing a gain in space and gives the possibility of obtaining a larger travel of the bellows for the same dimensions of the implant, as compared with other embodiments. The mechanical integration is moreover simpler.

[0134] Determination of the Pressure in the Fluidic Circuit of the Occlusion System

[0135] The pressure in the fluidic circuit is determined indirectly. As this was indicated in the preamble, the integration of a pressure sensor on one of the walls of the reservoir of variable volume or on one of the portions of the fluidic circuit would be a restriction and would have several drawbacks.

[0136] Instead of such a sensor, the present invention uses the movable portion of the reservoir with variable volume for indirectly measuring the pressure in the fluidic circuit of the occlusive system.

[0137] The implantable system therefore comprises a device for measuring the fluid pressure in the fluidic circuit, which comprises said force sensor and a processing unit (for example a microprocessor) coupled with said sensor. The processing unit takes into account the force measurements acquired by said sensor, as well as other mechanical, physical and dimensional parameters of the system, for determining the fluid pressure in the fluidic circuit.

[0138] In order to measure a relative pressure in the fluidic circuit, a sensor (for example a barometric sensor) allowing measurement of the current atmospheric pressure may be laid out in an external device borne by the patient in order to take into consideration the changes of atmospheric pressure related to the altitude and/or weather conditions.

[0139] Another embodiment may be based on the measurement of the current atmospheric pressure directly from the fluidic circuit when one is sure under determined conditions of having a pressure in the fluidic circuit equal to a known relative pressure (for example, zero relative pressure for a particular position of the movable portion of the reservoir).

[0140] The measurement of the atmospheric pressure is then taken into account in both embodiments described below for inferring therefrom a relative pressure from a measurement of absolute pressure as described below.

[0141] The description below is based on a force sensor only measuring the compression (not traction). The same principle may be applied for force sensors measuring compressions and tractions. In this case, one does without the pre—stress system allowing generation of an “offset” on the force for measuring both compressive and traction forces.

[0142] FIG. 6 illustrates the different forces measured by the force sensor, within the scope of the embodiment of FIG. 2: [0143] the mark 23 refers to the force relatively to the pressure in the fluidic circuit; [0144] the mark 24 refers to the pre—stress force; [0145] the mark 25 refers to the force related to the stiffness of the bellows; [0146] the mark 26 refers to the force related to the gas pressure in the casing.

[0147] FIG. 7 illustrates the different forces measured by the force sensor placed at the tapped spotted wheel 10 and at the movable wall 6, within the scope of the embodiment of FIG. 5: [0148] the mark 23 refers to the force relative to the pressure in the fluidic circuit; [0149] the mark 25 refers to the force related to the stiffness of the bellows; [0150] the mark 26 refers to the force related to the gas pressure in the casing.

[0151] In order to infer the pressure P1 in the fluidic circuit, the considered parameters are the following:

[0152] S.sub.eff: the effective pressure surface area of the movable portion of the reservoir with a variable volume (as indicated above, this surface area may be fixed or variable depending on the configuration of the system);

[0153] F.sub.prest: the force generated by the pre—stress system;

[0154] K: the stiffness related to the reservoir with variable volume (case of bellows for example), the latter may be neglected in certain configurations of the reservoir of variable volume (the case of a system with a rolling membrane or a piston);

[0155] i: the relative position of the movable portion of the reservoir with a variable volume relatively to a reference position,

[0156] F.sub.losses: the mechanical losses related to friction of the different mechanical parts during transmission of the forces on the force sensor.

[0157] F.sub.sensor: the force measured by the force sensor(s).

[0158] P.sub.casing: the pressure of the gas contained in the implantable hermetic casing, said pressure may either be inferred from the position of the movable portion relatively to its reference position and from the effective pressure surface area of the movable portion, or be measured by a gas pressure sensor placed in the casing (optional).

[0159] From these elements, several forces applied on the movable wall of the reservoir with a variable volume may be inferred therefrom:

[0160] F.sub.occl: the (positive or negative) force reduced on the movable portion of the reservoir of variable volume related to the pressure in the fluidic circuit of the occlusion system;

[0161] F.sub.casing: the (positive or negative) force reduced on the movable portion of the reservoir of variable volume related to the pressure in the implantable hermetic casing;

[0162] F.sub.wall: the force related to the position and to the stiffness of the movable portion of the reservoir of variable volume.

[0163] Subsequently it is considered that the gas pressure in the casing is inferred from the position of the movable portion relatively to its reference position and from the effective pressure surface area of the movable portion.

[0164] The balance of the forces on the force sensor is expressed in the following way:

F.sub.sensor=F.sub.occl+F.sub.prest−F.sub.wall−F.sub.casing−F.sub.losses

[0165] with:

[00001]$F_{\mathrm{occl}}=P.Math.S_{\mathrm{eff}}$$F_{wall}=K.Math.i$$F_{\mathrm{ca}\sin g}=P_{\mathrm{init}}.Math.\left(\frac{V_{\mathrm{init}}}{V_{\mathrm{init}}-S_{\mathrm{eff}}.Math.i}-1\right).Math.S_{\mathrm{eff}}$

[0166] with P.sub.init and V.sub.init being constants corresponding to the initial pressure and the initial gas volume respectively in the casing when the latter has been hermetically sealed.

[0167] P.sub.init may for example be equal to atmospheric pressure when the casing is hermetically sealed.

[0168] The force generated by the pre—stress device allows generation of an “offset” on the force sensor which allows measurement of positive and negative forces.

[0169] The F.sub.casing force is inferred from the position of the movable wall relatively to its origin and from the effective pressure surface area of the movable wall. In this case it is considered that the casing is perfectly hermetic. It is also possible to assume a negligible loss of gas of the casing outwards which may either be neglected or taken into account in the calculation of the force F.sub.casing. Finally, the force F.sub.casing may also be directly measured by a pressure sensor and inferred by multiplying by the surface S.sub.eff.

[0170] The pressure P1 of the fluidic circuit of the occlusion system may therefore be inferred therefrom:

[00002]$P1=\frac{F_{sensor}-F_{prest}+F_{\mathrm{wall}}+F_{\mathrm{ca}\sin g}+F_{losses}}{S_{\mathrm{eff}}}$$P1=\frac{F_{sensor}-F_{prest}+K.Math.i+F_{losses}}{s_{\mathrm{eff}}}+P_{\mathrm{init}}.Math.\left(\frac{V_{\mathrm{init}}}{V_{\mathrm{init}}-S_{\mathrm{eff}}.Math.i}-1\right)$

[0171] with F.sub.prest and F.sub.losses being known constants.

[0172] The force F.sub.prest may be generated by pre—stressed springs. As the displacement of the block 15 is very small, it may considered that the travel of the springs may be neglected relatively to their stiffness and that the pre—stress force is constant.

[0173] F.sub.prest is selected so as to be able to measure negative and positive pressures over the whole desired measurement range.

[0174] In the case when the force sensor is capable of measuring compressive and traction forces, it is possible to remove the pre—stress system (case of the embodiments described in FIG. 3 and FIG. 5). In this case, the constant F.sub.prest is not considered in the calculations of P1.

[0175] In order to infer the relative pressure P2 in the fluidic circuit, the current atmospheric pressure exerted on the body of the patient should be taken into account. The measurement of the pressure Patm may be achieved as described in the previous paragraphs.

[0176] In this case, P2 is calculated in the following way:

P2=P1+(Pinit−Patm)

In a preferred embodiment, the casing is sealed so as to maximize the air volume in the casing (movable portion of the reservoir in an initial position so as to have a minimum volume in the reservoir of variable volume). This gives the possibility of having a pressure of the gas in the casing always positive regardless of the position of the movable wall.

[0177] The paragraphs below show two examples of measurement of the pressure from the method described in the present invention.

[0178] The device described in both examples below has the following characteristics: [0179] S.sub.eff=1×10.sup.−3 m.sup.2 [0180] K=5 N/mm [0181] F.sub.prest=20 N [0182] V.sub.init=1° 10×10.sup.−5 m.sup.3 [0183] P.sub.init=1,000 hPa [0184] P.sub.atm=900 hPa [0185] F.sub.losses=0 N

[0186] We have considered in these examples that the atmospheric pressure during the sealing of the casing (Pinit) is different from the atmospheric pressure (Patm) exerted on the body of the patient during the measurement of the pressure in the fluidic circuit.

[0187] Example 1: measurement of the pressure in the fluidic circuit from a device according to the embodiment described in FIG. 2, comprising a force sensor only measuring compressive forces.

[0188] For i=0 (upper position of the bellows, corresponding to a minimum volume of the reservoir), the processing unit performs the following calculation for measuring the pressure P1 in the fluidic circuit:

[00003]$P1=\frac{F_{sensor}-20}{1\times 10^{-3}}$

[0189] For a relative zero pressure in the fluidic circuit for example, the force sensor measures the compressive force of the pre—stress (20 N), as well as the force related to the atmospheric pressure difference (900 hPa) exerted on the body of the patient and therefore on the flexible occlusive sleeve and the gas pressure in the casing (1,000 hPa) i.e. a value P1 calculated by the processing unit:

[00004]$F\mathrm{sensor}=20N+\mathrm{Seff}\times \left(\mathrm{Patm}-\mathrm{Pinit}\right)$$F\mathrm{sensor}=20N+1.10^{-3}\times \left(90000-100000\right)=10N$$P1=\frac{10-20}{1\times 10^{-3}}=-10k\mathrm{Pa}$

[0190] The relative pressure P2 in the fluidic circuit may be inferred therefrom:

P2=P1+(Pinit−Patm)

P2=−10000+(100000−90000)=0Pa

[0191] For a relative pressure in the fluidic circuit of 5 kPa for example, the force on the force sensor is the one generated by the pressure in the fluidic circuit F.sub.occl (i.e. 5 N), that of the pre—stress (i.e. 20 N), and that related to the atmospheric pressure (−10 N) or a resulting force of 15 N, or a value calculated by the processing unit:

[00005]$P1=\frac{15-20}{1\times 10^{-3}}=-5k\mathrm{Pa}$

[0192] The relative pressure P2 in the fluidic circuit may be inferred therefrom:

P2=P1+(Pinit−Patm)

P2=−5000+(100000−90000)=5 kPa

[0193] For a relative pressure in the fluidic circuit of −5 kPa for example, the force on the force sensor is the one generated by the pressure in the fluidic circuit F.sub.occl (i.e. −5 N), that of the pre—stress (i.e. 20 N), and that related to the atmospheric pressure (i.e.−10 N) i.e. a resulting force of 5 N, i.e. a value calculated by the processing unit:

[00006]$P1=\frac{5-20}{1\times 10^{-3}}=-15k\mathrm{Pa}$

[0194] The relative pressure P2 in the fluidic circuit may be inferred therefrom:

P2=P1+(Pinit−Patm)

P2=−15000+(100000−90000)=−5 kPa

[0195] For i=4 mm for example (low position of the bellows, generating a gas compression in the casing and a return force related to the stiffness of the bellows), the processing unit performs the following calculation for measuring the pressure in the fluidic circuit:

[00007]$P1=\frac{F\mathrm{sensor}-5\times 4+20}{1\times 10^{-3}}+100000\times \left(\frac{10.Math.{10}^{-5}}{10.Math.{10}^{-5}-1.Math.{10}^{-3}\times 4.Math.{10}^{-3}}-1\right)$$P1=\frac{F\mathrm{sensor}}{1\times 10^{-3}}+100000\times \left(\frac{10.Math.{10}^{-5}}{10.Math.{10}^{-5}-1.Math.{10}^{-3}\times 4.Math.{10}^{-3}}-1\right)$$P1=\frac{F\mathrm{sensor}}{1\times 10^{-3}}+4166,67$

[0196] For zero relative pressure in the fluidic circuit for example, the forces on the force sensor are F.sub.prest (20 N), F.sub.wall (−20 N), F.sub.casing (−4.167 N) and the force related to the atmospheric pressure (i.e.−10 N) i.e. a resulting force of −14.167 N, i.e. a value calculated by the processing unit:

[00008]$P1=\frac{-14,167}{1\times 10^{-3}}+4166,67=-10k\mathrm{Pa}$

[0197] The relative pressure P2 in the fluidic circuit may be inferred therefrom:

P2=P1+(Pinit−Patm)

P2=−10000+(100000−90000)=0Pa

[0198] For a relative pressure in the fluidic circuit of 5 kPa for example, the forces on the force sensor are F.sub.occl (5 N), F.sub.prest (20 N), F.sub.wall (−20 N), F.sub.casing (−4.167 N) and the force related to the atmospheric pressure (i.e.−10 N) i.e. a resulting force of −9.167 N i.e. a value calculated by the processing unit:

[00009]$P1=\frac{-9,167}{1\times 10^{-3}}+4166,67=-5k\mathrm{Pa}$

[0199] The relative pressure P2 in the fluidic circuit may be inferred therefrom:

P2=P1+(Pinit−Patm)

P2=−5000+(100000−90000)=5 kPa

[0200] For a relative pressure in the fluidic circuit of −5 kPa for example, the forces on the force sensor are F.sub.occl (−5 N), F.sub.prest (20 N), F.sub.wall(−20 N), F.sub.casing (−4.167 N) and the force related to the atmospheric pressure (i.e.−10 N) i.e. a resulting force of—19.167 N, i.e. a value calculated by the processing unit:

[00010]$P1=\frac{-19,167}{1\times 10^{-3}}+4166,67=-15k\mathrm{Pa}$

[0201] The relative pressure P2 in the fluidic circuit may be inferred therefrom:

P2=P1+(Pinit−Patm)

P2=−15000+(100000−90000)=−5 kPa

[0202] Example 2: measurement of the pressure in the fluidic circuit from a device based on the embodiment described in FIG. 5, comprising a force sensor capable of measuring compressive forces and traction forces.

[0203] For i=0, the processing unit performs the following calculation for measuring the pressure in the fluidic circuit:

[00011]$P1=\frac{F\mathrm{sensor}}{1\times 10^{-3}}$

[0204] For a zero relative pressure in the fluidic circuit for example, the force sensor only measures a force related to the atmospheric pressure difference (900 hPa) exerted on the body of the patient, and therefore on the flexible occlusive sleeve, and the gas pressure in the casing (1,000 hPa) corresponding to a force of −10 N, i.e. a value calculated by the processing unit:

[00012]$P1=\frac{-10}{1\times 10^{-3}}=-10k\mathrm{Pa}$

[0205] The relative pressure P2 in the fluidic circuit may be inferred therefrom:

P2=P1+(Pinit−Patm)

P2=−10000+(100000−90000)=0Pa

[0206] For a relative pressure in the fluidic circuit of 5 kPa for example, the only force on the force sensor is the one generated by the pressure in the fluidic circuit F.sub.occl(i.e. 5 N), and the force related to the atmospheric pressure (i.e.−10 N) i.e. a value calculated by the processing unit:

[00013]$P1=\frac{-5}{1\times 10^{-3}}=-5k\mathrm{Pa}$

[0207] The relative pressure P2 in the fluidic circuit may be inferred therefrom:

P2=P1+(Pinit−Patm)

P2=—5000+(100000−90000)=5 kPa

[0208] For a relative pressure in the fluidic circuit of −5 kPa for example, the only force on the force sensor is the one generated by the pressure in the fluidic circuit F.sub.occl(i.e. —5 N), and the force related to the atmospheric pressure (i.e.−10 N) i.e. a value calculated by the processing unit:

[00014]$P1=\frac{-15}{1\times 10^{-3}}=-15k\mathrm{Pa}$

[0209] The relative pressure P2 in the fluidic circuit may be inferred therefrom:

P2=P1+(Pinit−Patm)

P2=−15000+(100000−90000)=−5 kPa

[0210] For i=4 mm, the processing unit performs the following calculation for measuring the pressure in the fluidic circuit:

[00015]$P1=\frac{F\mathrm{sensor}+5\times 4}{1\times 10^{-3}}+100000\times \left(\frac{10.Math.{10}^{-5}}{10.Math.{10}^{-5}-1.Math.{10}^{-3}\times 4.Math.{10}^{-3}}-1\right)$$P1=\frac{F\mathrm{sensor}+20}{1\times 10^{-3}}+4166,67$

[0211] For zero relative pressure in the fluidic circuit for example, the forces on the force sensor are F.sub.wall(−20 N) and F.sub.casing (−4.167 N) and the force related to the atmospheric pressure (i.e.−10 N) i.e. a resulting force of −34.167 N, i.e. a value calculated by the processing unit:

[00016]$P1=\frac{-34,167+20}{1\times 10^{-3}}+4166,67=-10k\mathrm{Pa}$

[0212] The relative pressure P2 in the fluidic circuit may be inferred therefrom:

P2=P1+(Pinit−Patm)

P2=−10000+(100000−90000)=0Pa

[0213] For a relative pressure in the fluidic circuit of 5 kPa for example, the forces on the force sensor are F.sub.occl (5 N), F.sub.wall (−20 N) and F.sub.casing (−4.167 N), and the force related to the atmospheric pressure (i.e.−10 N) i.e. a resulting force of −29.167 N, i.e. a value calculated by the processing unit:

[00017]$P1=\frac{-29,167+20}{1\times 10^{-3}}+4166,67=-5k\mathrm{Pa}$

[0214] The relative pressure P2 in the fluidic circuit may be inferred therefrom:

P2=P1+(Pinit−Patm)

P2=−5000+(100000−90000)=5 kPa

[0215] For a relative pressure in the fluidic circuit of −5 kPa for example, the forces on the force sensor are F.sub.occl (−5 N), F.sub.wall (−20 N) and F.sub.casing (−4.167 N), and the force related to the atmospheric pressure (i.e.−10 N) i.e. a resulting force of −39.167 N, i.e. a value calculated by the processing unit:

[00018]$P1=\frac{-39,167+20}{1\times 10^{-3}}+4166,67=-15k\mathrm{Pa}$

[0216] The relative pressure P2 in the fluidic circuit may be inferred therefrom:

P2=P1+(Pinit−Patm)

P2=−15000+(100000−90000)=−5 kPa

[0217] In both examples above, it is assumed that the device does not comprise any pressure sensor measuring the pressure of gas in the casing.

[0218] In a configuration where the device comprises a pressure sensor measuring the gas pressure in the casing, it is sufficient to replace the term

[00019]$F_{\mathrm{ca}\sin g}=P_{\mathrm{init}}.Math.\left(\frac{V_{\mathrm{init}}}{V_{\mathrm{init}}-S_{\mathrm{eff}}.Math.i}-1\right).Math.S_{\mathrm{eff}}\mathrm{with}P\mathrm{sensor}$

[0219] with Psensor being the measurement value of the gas pressure sensor.

[0220] It should be noted that the present invention may also be applied to devices including a reservoir with variable volume without any mechanical stiffness of the piston or rolling membrane type. In this case, the stiffness K in the calculation of the pressure P is considered as zero or negligible.

[0221] Pressure Control of the Occlusive System

[0222] As the preferred goal of the system is to control the pressure, a closed loop regulation of the pressure first seems to be the wisest choice for the pressurization of the occlusion system. However, the pressure in the occlusion system is not only dependent on the pressurization system. Outer effects related to the movements of the organs of the patient or to his/her breathing for example may generate pressures which will be measured by the pressure measurement system described earlier.

[0223] This may have the effect, during the pressure server control, of inducing excessive stressing of the actuator and therefore a too large electric consumption. Indeed, the outer pressures may vary during a change in the pressure of the occlusion system, the server control system will tend to try and compensate for these variations, which will generate excessive stressing of the actuator.

[0224] In order to find a remedy to this problem, one of the objects of this invention is to propose a simple method for controlling pressure of the pressurization system. Rather than subordinate the system as regards pressure, the actuator is controlled by position server control of the movable portion of the reservoir with variable volume. Knowing the effective pressure surface area of the movable portion at each position, this therefore corresponds to a volume server control of the occlusion system.

[0225] Tests conducted in vitro and in vivo ([1]) have shown that the relationship between the pressure in the fluidic circuit and the volume injected into the occlusion system have a defined and repeatable relationship over time. This is true under particular conditions of the patient, i.e. when the latter is motionless and in a determined position (stretched out or standing for example).

[0226] The device for controlling the fluid pressure in the fluidic circuit notably comprises a memory in which is recorded a relationship between the pressure in the fluidic circuit and the volume injected from or to the reservoir, a processing unit (optionally identical with the processing unit of the device for measuring the pressure in the fluidic circuit) and a calibration unit, the operation of which is described hereafter.

[0227] FIG. 8 is a graph illustrating the variation of the pressure in the fluidic circuit versus the volume injected into the fluidic circuit from the reservoir. It should be noted that the pressure relationship depending on the injected or removed volume may have hysteresis, i.e. the pressure curve during a rise in pressure may be different from the pressure curve during a drop in pressure. In order to be able to control the system as regards pressure, the pressurization system regularly conducts pressure measurements for given injection volumes. This calibration procedure is carried out under predetermined conditions. For example in the case of an artificial urinary sphincter, the calibration may be achieved a few minutes after urination and when the patient is standing and substantially motionless. For this purpose, the pressurization system gradually increases the pressure for predetermined injection volumes and records the measured values in a table localized in the memory of the implant. This calibration procedure may be carried out at a defined time period, for example every week, or else upon an examination by a physician, by means of a programmer in wireless communication with the implant. In every case, the current atmospheric pressure should be able to be recovered for carrying out an accurate pressure measurement in the fluidic circuit regardless of the altitude or of the weather conditions of the location where the patient is found during the calibration.

[0228] FIG. 9 is a graph illustrating the variation 28 of the pressure P2 in the fluidic circuit versus time t for different fluid volumes injected into the occlusive sleeve during the calibration procedure.

[0229] The calibration may be carried out additionally when the patient is in a stretched—out position and substantially motionless. This gives the possibility of recording pressure values which will be different from those recorded when the patient is standing, because of the water column between the implantable casing and the occlusive sleeve implanted at different heights in the patient.

[0230] The calibration may take into account the hysteresis which may exist in the fluidic circuit. In this case, the memory of the implant includes a table containing the values of the volume to be injected in order to attain a given pressure as well the values of the volume to be withdrawn in order to attain a given pressure.

[0231] During normal operation, when a command for pressurization at a given pressure is sent to the pressurization system, the volume corresponding to the set pressure value is looked up in the table in memory and is used for pressurizing the occlusion system to the desired pressure.

[0232] As a safety step, the pressure may be measured during the pressurization phase in order to ensure proper operation of the device and a match with the expected pressure values.

[0233] In order to measure the movement of the patient and determine whether he/she is motionless, and for measuring his/her posture and determine whether he/she is standing or stretched out, an accelerometer may be used.

[0234] In order to achieve the procedure for calibrating the volume versus the pressure in the occlusion system, a clock is used. For example it may be of the RTC type.

[0235] Safety System

[0236] In the case when the pressure in the fluidic circuit becomes very high and close to the limits defined in the technical recommendations relating to the pressure strength of the different elements of the fluidic circuit, the processing unit may automatically send an order for decompressing the occlusive sleeve.

[0237] According to a particularly advantageous embodiment of the invention, the device for actuating the sleeve comprises a member for reducing the mechanical stresses caused by too large pressure in the fluidic circuit, giving the possibility of protecting the actuation device from risks of deterioration.

[0238] The mechanical stresses experienced by the actuation device resulting from too large pressure in the fluidic circuit may become very significant, which may cause deterioration of one or more of the portions of the actuation device. The pressurization system, the tubing, the sleeve, the pressure sensor and/or the connectors may be concerned by this degradation.

[0239] In order to avoid deterioration of the actuation device, the stress—reducing member is designed for, when the mechanical stresses (pressure in the fluidic circuit) exceed a determined stress threshold, absorbing a portion of said stresses so as to reduce the stresses experienced by the actuation device.

[0240] The stress—reducing member is dimensioned so as to reduce the stresses down to a level at which they are too low for a risk of damaging the actuation device while being sufficiently high so as to not totally release the compression exerted by the sleeve.

[0241] Depending on the contemplated method for reducing stresses and on the structure of the actuation device, the person skilled in the art is able to design a member fulfilling these conditions.

[0242] According to an embodiment, the stress—reducing member comprises an expansion chamber laid out in the hydraulic circuit and being mechanically triggered when the pressure in the fluidic circuit exceeds a defined threshold. This has the effect of transferring a portion of the fluid of the hydraulic circuit towards the expansion chamber in order to reduce the pressure in the latter.

[0243] Alternatively, the stress—reducing member may comprise a piston coupled with a spring system having a sufficiently high stiffness for remaining substantially fixed when the pressure in the hydraulic circuit corresponds to the normal operating pressure of the device and movable under the effect of a higher pressure.

[0244] The stress—reducing member may have different embodiments; for example and in a non—limiting way: [0245] a valve coupled with a spring or a specific material in an expansion chamber; [0246] a component of the hydraulic circuit made in a flexible material having the property of deforming from a certain pressure threshold; [0247] a deformable membrane beyond a certain pressure threshold or depending on the applied pressure; [0248] the reservoir with variable volume designed so as to be deformable beyond a certain pressure threshold or depending on the applied pressure; [0249] the actuation mechanism designed so as to be deformable beyond a certain pressure threshold or depending on the applied pressure.

REFERENCES

[0250] EP 1 584 303 [0251] U.S. Pat. No. 8,585,580 [0252] U.S. Pat. No. 4,581,018 [0253] U.S. Pat. No. 4,222,377 [0254] CA 1,248,303 [0255] U.S. Pat. No. 4,408,597

[0256] [1] Lamraoui, H; Bonvilain, A; Robain, G; Combrisson, H; Basrour, S; Moreau—Gaudry, A; Cinquin, P; Mozer, P “Development of a Novel Artificial Urinary Sphincter: A Versatile Automated Device”, IEEE-ASME Transactions on Mechatronics, 15, 916-924, 2010.