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    • 专利摘要:
    The invention relates to an occlusive system implantable in a human or animal body, comprising: a fluidic circuit comprising: an inflatable occlusive cuff (3), a variable volume reservoir (5) filled with a fluid, said reservoir comprising a fixed part and a moving part; - an actuator mechanically coupled to the movable part of the reservoir so as to linearly move said movable part with respect to the fixed part to adjust the volume of the tank, the actuator and the variable volume tank being arranged in a sealed casing (1) containing a gas, - a sensor (21, 22) mechanically connected to the actuator and / or the moving part of the reservoir, measuring a tensile and / or compressive force in the direction of displacement of the mobile part of the reservoir, - a device for measuring the pressure (P) of fluid in the fluid circuit taking into account at least the force measurement of said sensor (21, 22), the surface of the effective pressure (Seff) of the movable portion of the reservoir, and the force exerted on the movable portion of the variable volume reservoir related to the gas pressure in the housing.
    公开号:FR3028749A1
    申请号:FR1461420
    申请日:2014-11-25
    公开日:2016-05-27
    发明作者:Hamid Lamraoui
    申请人:UROMEMS；
    IPC主号:
    专利说明:

    [0001] FIELD OF THE INVENTION The present invention relates to an occlusive system implantable in the human or animal body. BACKGROUND OF THE INVENTION It is known to occlude an anatomical conduit by means of an implantable occlusive system in the body of a patient.
    [0002] The occlusion of the anatomical duct is provided by an inflatable cuff filled with fluid which exerts a more or less strong pressure on the part to be occluded as a function of the volume of the fluid in the inflatable cuff. For example, different artificial urinary sphincters are based on this principle to exert pressure on the urethra. Among the known products, mention may be made of the implant referenced AMS800 marketed by American Medical Systems or the implant referenced ZSI375 marketed by Zephyr. The same principle can be found in other types of applications such as gastric rings that have an inflatable cuff around the stomach. The fluid-filled inflatable cuff may be made in different forms, for example completely or partially surrounding the occlude conduit and may be formed of different biocompatible materials, such as implantable silicone, implantable polyurethane, etc. Injection and aspiration of fluid into the inflatable cuff required for occlusion of the anatomical part can be performed either manually and passively, such as for artificial urinary sphincters AMS800 and ZSI375, or automatically and actively (at from a source of electrical energy for example) for more advanced implants. To allow regulation of the pressure exerted on the conduit to occlude, the inflatable sleeve is in fluid connection with a fluid reservoir coupled to an actuator configured to inject fluid from the reservoir to the sleeve (to increase the pressure exerted on the anatomical conduit ) or from the cuff to the reservoir (to reduce the pressure on the anatomic canal). The assembly of the inflatable sleeve, the reservoir and the fluid connection between them forms a fluidic circuit.
    [0003] In such an occlusive system, it may be necessary to measure the pressure in the inflatable cuff or at another point in the fluid circuit, for example to check the pressure when the actuator is deactivated, or to control the pressure created by said actuator .
    [0004] To this end, there are different types of pressure sensors. Among the possible sensors in an implantable system, pressure sensors based on a flexible membrane in contact with the fluid could be used. These sensors must nevertheless be biocompatible, stable over time, and it is necessary to ensure perfect sealing of the sensor to prevent infiltration of fluid or moisture in the sensor or associated electronics. One solution to this problem could be the use of a pressure sensor comprising a flexible metal membrane sealing the system. However, such a sensor has several disadvantages. On the one hand, the metal membrane 10 of the sensor being thin, the manufacturing processes can be delicate. Indeed, the mechanical stresses due to the thermal effects of the weld on the membrane can have an effect on the stiffness of the membrane, which can induce significant disparities in the mechanical properties of the membrane. Moreover, this type of sensor is generally sealed and filled with a non-compressible fluid in contact with a pressure sensor proper. The assembly process of the different parts of the system (composed of several tens of elements) is therefore delicate and expensive. Finally, when the system is implanted, the fibrosis surrounding the various elements of the implant can induce a change in the stiffness of the membrane and therefore a drift of measurements over time.
    [0005] Another problem to be solved is to be able to apply a defined and precise pressure on the anatomical duct while consuming a minimum of energy. A simple solution would be to use a system based on measured occlusion pressure. Among the means for measuring the occlusion pressure, there may be mentioned systems that directly measure the pressure in the fluid circuit via a suitable sensor 25, or that measure the pressure indirectly, for example, from the current consumed by the actuator. as described in US 8,585,580. However, it has been demonstrated by in vivo tests [1] that the pressure in the fluidic circuit varies strongly and permanently during occlusion. In the case of a system based on pressure regulation, this has the effect of almost continuously soliciting the actuator to stabilize the pressure at a given setpoint, with the consequence of inducing excessive power consumption of the system. Other principles have been proposed. For example, US Pat. No. 8,585,580 proposes a system that transfers a fluid to the inflatable cuff until the measured pressure exceeds a defined threshold. This solution has the disadvantage of being unclear on the applied occlusion pressure. Indeed, during the occlusion phase, the pressure can increase sharply and then decrease because of the relaxation of the tissues and the occlusion device. The fluid supplied to the occlusion device in contact with the anatomical conduit to occlude is therefore generally not sufficient to generate the desired pressure. Moreover, the size of such a sensor is also a problem, insofar as the implantable system must be as small as possible and said system further comprises a fluid transfer device whose volume can be consequently, and a battery which also represents a large part of the volume of the implantable system. The integration of such a sensor in this system can be difficult because of the size of said sensor. Moreover, since this type of sensor has to be in contact with the outside, for the measurement of pressure, and with the inside, for communication with the electronic module, it is necessary to implement a process of reliable and hermetic manufacturing, such as laser welding, which can be binding during the production phase. BRIEF DESCRIPTION OF THE INVENTION An object of the invention is to design an implantable occlusive system that makes it possible to overcome the disadvantages of existing systems. In particular, this system must make it possible to control the pressure in the sleeve reliably while minimizing the energy consumption required to regulate this pressure. According to the invention, there is provided an occlusive system implantable in a human or animal body, comprising: - a fluidic circuit comprising: - an inflatable occlusive cuff containing a variable volume of a fluid, intended to surround at least a part a natural conduit to be occluded; a variable volume reservoir filled with a fluid, said reservoir comprising a fixed part and a movable part; a fluidic connection between the reservoir and the occlusive sleeve; an actuator mechanically coupled to the movable portion of the reservoir so as to linearly move said movable portion relative to the stationary portion to adjust the volume of the reservoir, the actuator and the variable volume reservoir being arranged in a sealed casing containing a gas, - an arranged sensor in the housing, mechanically connected to the actuator and / or the movable part of the tank, arranged so as to measure a traction force and / or comp in the moving direction of the moving part of the tank, said measured force resulting from at least: the force noted Fc, 'exerted on the moving part of the variable volume tank connected to the pressure in the fluidic circuit, and The force noted on the housing exerted on the moving part of the variable-volume tank connected to the pressure in the housing; a device for measuring the fluid pressure in the fluid circuit comprising a processing unit configured to determine said pressure of fluid from a calculation taking into account at least the force measurement of said sensor, the effective pressure surface of the moving part of the reservoir, and the force Fboit, e, exerted on the mobile part of the variable volume reservoir connected at the gas pressure in the housing. According to a preferred embodiment, the system further comprises a device for controlling the fluid pressure in the fluid circuit by the volume of the tank, comprising: a memory in which a relationship between the pressure in the circuit is recorded; fluidic fluid and the volume of said reservoir, - a processing unit configured to: - receive a fluid pressure setpoint in the fluid circuit, - from the relationship stored in the memory between the pressure in the reservoir and the volume of the reservoir determining the volume of the tank for reaching the set pressure, if necessary, controlling the actuator to move the moving part of the tank to the position defining said determined volume, a calibration unit configured to: ) when the patient is in a particular situation, controlling the actuator to move the movable portion of the reservoir in a plurality determined positions, each position defining a determined volume of the reservoir, (b) for each of said positions: - measuring the fluid pressure in the fluid circuit by said device for measuring the fluid pressure in the fluid circuit, - setting the memory by recording said measured fluid pressure in the fluid circuit for the respective volume of the reservoir.
    [0006] According to one embodiment, the sensor is able to measure tensile forces and compressive forces in the direction of movement of the moving part of the reservoir. According to another embodiment, the sensor is able to measure only compressive forces in the direction of movement of the mobile part of the reservoir; In this case, the system further comprises a prestressing device arranged to exert a determined compressive prestress on said sensor. In this case, the processing unit is configured to take into account said preload for the determination of the fluid pressure in the fluid circuit.
    [0007] The prestressing device advantageously comprises at least one compression spring, a tension spring and / or an elastomer stud. According to one embodiment, the movable portion of the variable volume reservoir comprises a drive system coupled to a movable wall and a deformable bellows 5 extending and compressing according to the position of said movable wall. In this case, the processing unit is advantageously configured to take into account the stiffness of said bellows for the determination of the fluid pressure in the fluid circuit. In another embodiment, the movable portion of the variable volume reservoir 10 comprises a drive system coupled to a rolling diaphragm. According to another embodiment, the variable volume reservoir comprises a cylinder forming the fixed part of the reservoir and a piston sliding in said cylinder, forming the mobile part of the reservoir. Advantageously, the actuator is selected from piezoelectric actuators, electromagnetic actuators, electroactive polymers and shape memory alloys. According to one embodiment of the invention, the system further comprises a gas pressure sensor arranged in the housing for measuring the gas pressure in the housing, the processing unit being configured to take into account said 20 gas pressure measured in the determination of the enclosure force. Advantageously, a wall of the variable volume tank is constituted by a wall of the housing, said wall comprising a pierceable puncture port. Advantageously, the system further comprises a device for reducing the stresses in the fluidic circuit when said stresses exceed a predetermined threshold. According to a preferred embodiment, the system further comprises an accelerometer, the processing unit being configured, from the measurement data of the accelerometer, to determine whether the patient is in a given situation. Particularly advantageously, the pressure measuring device is configured to measure the fluid pressure when adjusting the volume of the reservoir and to verify the correspondence between said measured value and an expected value. According to a preferred application of the invention, the system is an artificial urinary sphincter.
    [0008] BRIEF DESCRIPTION OF THE DRAWINGS Other features and advantages of the invention will be apparent from the following detailed description with reference to the accompanying drawings, in which: FIG. 1 is an overview of the implantable occlusive system; FIG. 2 is a sectional view of the inside of the housing of an implantable occlusive system according to a first embodiment of the invention; FIG. 3 is a sectional view of the housing of an implantable occlusive system according to a FIG. 4 is a sectional view of the housing of an implantable occlusive system according to a third embodiment of the invention, FIG. 5 is a sectional view of the embodiment of the invention. FIG. Within the housing of an implantable occlusive system according to a fourth embodiment of the invention, FIG. 6 is a diagram showing the different forces that can be measured by the compressio force sensor. n or traction, in the presence of a prestress, - Figure 7 is a diagram showing the different forces that can be measured by the force sensor compression and traction, in the absence of prestressing, 15 - the figure 8 is a graph showing the variation of the pressure in the fluidic circuit as a function of the volume injected into the occlusive cuff. FIG. 9 is a graph showing the variation of the pressure in the fluid circuit as a function of time for different volumes of fluid injected into the occlusive sleeve during the calibration procedure.
    [0009] DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION General Overview of the Occlusive System With reference to FIG. 1, the occlusive system comprises an inflatable occlusive cuff 3 containing a variable volume of a fluid, intended to surround at least a portion of the fluid. a natural conduit (not shown) to occlude, and a variable volume reservoir (shown in Figures 2 to 5) filled with a fluid. The occlusive sleeve may be made of biocompatible elastomer (see for example US4222377, CA1248303 or US4408597). Said tank comprises a fixed part and a movable part, the displacement of the mobile part varying the volume of the tank. For this purpose, the occlusive system comprises an actuator mechanically coupled to the movable portion of the reservoir so as to linearly move said movable portion relative to the fixed portion to adjust the volume of the reservoir. The actuator may include an electromagnetic motor and a gearbox. The actuator is controlled by a cuff pressure control device which will be described in detail below. For each volume of the reservoir, the movable portion has a known effective pressure area, which may be constant or variable depending on the embodiments.
    [0010] The occlusive system further comprises a fluidic connection 2 (typically a tubing) between the reservoir 5 and the occlusive sleeve 3. Thus, a change in volume of the reservoir 5 causes fluid to be added or withdrawn into the sleeve 3, causing thus increase or decrease the compression exerted on the duct 5 surrounded by the cuff. The assembly formed of the variable volume reservoir, the occlusive sleeve and the fluidic connection is called the fluid circuit in the following description. In addition to the device for controlling the pressure of the occlusive cuff, the implantable system includes one or more electronic modules for performing all the necessary functions. It also includes a rechargeable or non-rechargeable power source for powering the system. In a particular configuration, the power source is outside the human body and transmits the wireless energy to the implantable system. The variable volume reservoir, the actuator as well as the one or more electronic modules and, where appropriate, the energy source, are arranged in a housing 1 intended to be implanted in the body of the patient. The housing 1 contains a gas, for example air. The housing must be sealed to prevent any transfer of fluid or gas to or from the intracorporeal medium. The housing may for example be made of implantable titanium and sealed by laser welding. In particular, a leaktightness check may be carried out with helium (for example, leakage rate less than 10-9 mbar.1 / s of helium) to ensure complete sealing of the casing during the period for which the device is implanted. According to a particular embodiment, the housing may contain a gas pressure sensor, the function of which will be described below. Advantageously, the housing 1 comprises, in a wall delimiting the variable volume reservoir, a puncture port 4 pierceable by a needle and adapted to close tightly after removal of the needle, to inject or to remove fluid from the reservoir. The housing also encloses a sensor in mechanical connection with the actuator and / or the movable wall of the variable volume reservoir capable of measuring a compressive and / or tensile force in the direction of travel of the movable portion of the reservoir. Among the sensors adapted for this purpose, there may be mentioned, for example: a sensor based on one or more strain gauges (such gauges make it possible to measure tensile and compressive forces); One or more sensors of the FSRTM type (market name for the "Force Sensing Resistor") marketed by Interlink Electronics, measuring compression forces); and / or 3028749 8 - one or more pressure sensors coupled to a mechanism for measuring a force. For example, there may be mentioned a hydraulic pressure sensor combined with a fluid filled bag and arranged to measure a pressure on a predetermined surface, thereby making it possible to deduce the force applied to the measurement surface. Variable volume reservoir According to a preferred embodiment, the variable volume reservoir comprises a bellows assembled in the housing, the bellows and the housing being for example made of implantable titanium. The variable volume reservoir then consists of the bellows (acting as moving part), a wall of the housing and a cover acting with said wall of the housing, a fixed part. The reservoir further includes an orifice for transferring the fluid to and from the reservoir. The use of metal bellows to perform the function of variable volume reservoir is known to those skilled in the art (see US4581018 for example). Such a bellows is for example marketed by the companies Servometer and Wtzenmann. The bellows has the advantage of ensuring complete sealing of the implant while allowing movement of the movable wall. Its effective pressure surface can be considered constant over the entire stroke range of the bellows. However, it is necessary to take 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 energy efficiency, direction of the forces, etc.). The way this parameter is taken into account will be described in detail below. However, the present invention is not limited to the use of a bellows to form the variable volume reservoir. Thus, the skilled person can implement 25 to achieve the variable volume reservoir piston or a rolling membrane, which are considered to have no mechanical stiffness. In this case, unlike the case of the bellows, the stiffness will be considered null or negligible in the calculation of the pressure. The movable portion of the reservoir has an effective pressure surface that can be constant or variable depending on the embodiment of the reservoir. In the case of a bellows, the effective pressure area is considered constant and is given by the manufacturer. For a rolling membrane, the effective pressure area varies depending on the position of the rolling diaphragm and is given by the manufacturer for different stroke values. In the case of a sliding piston without friction in a cylinder, the pressure surface effective is equal to the front surface of the piston.
    [0011] Actuator The actuator may be selected from any electromechanical system for converting electrical energy into mechanical motion with the power required to permit displacement at a required force and speed of the movable portion of the variable volume reservoir. For example, among the actuators known to those skilled in the art, piezoelectric actuators, electromagnetic motors with or without brushes (in the case of a brushless motor, it may consist of 2 poles or 4 poles) coupled or not to a reducer, electro-active polymers or alloys shape memory.
    [0012] FIG. 2 illustrates one embodiment of the invention and shows a sectional view of a portion of the interior of the housing 1. The variable volume reservoir 5 comprises a movable portion which, in this embodiment, is a bellows 9. The bellows has a flange 6 coupled to a drive screw 17 via a nut 10 integral with the flange 6 and having a tapping cooperating with the thread of the screw 17. The reservoir is delimited by a part of the wall of the housing 1 and the bellows 9. The wall of the housing 1 further comprises a puncture port 4 which is pierceable by a needle to add or remove fluid from the reservoir.
    [0013] The reservoir 5 further comprises a connection 7 for a tubing providing the fluid connection with the occlusive cuff (not shown). The casing 1 also contains an actuator comprising a motor 13 coupled to a gearbox 8. A connector 9 makes it possible to supply the motor 13 when the control device issues an order to operate the motor in one direction or the other in accordance with FIG. an increase or decrease in the volume of the tank is required. The gearbox is coupled to a gear 18 which is itself coupled to the drive screw 17, so as to transmit torque and rotation of the motor shaft 13 to the drive screw 17. The rotation of the screw 17 then drives the nut 10 in translation, which has the effect of moving the flange 6 in translation in a direction parallel to the axis of the screw 17, the direction of movement of the flange 6 depending on the direction of rotation 13. The interior volume 11 of the housing surrounding the tank 5 is filled with a gas. The variation in volume of the tank 5 therefore has the effect of varying the internal volume 11 and consequently the pressure of the gas in said volume 11.
    [0014] A gas pressure sensor (not shown) may optionally be arranged in the volume 11 to measure the pressure in that volume. The toothed wheel 18 is housed in a block 15 by means of ball bearings 16 which allow its rotation in the block 15. The toothed wheel 18 being secured to the drive screw 17, the block 15 is driven in translation in the housing by the screw 17. The pads 20 extending from the wall of the housing 1 parallel to the axis of rotation of the screw 17 to guide the translation of the block 15. A force sensor is fixed on the wall of the housing opposite the face of the block 15 opposite the tank 5. The reference 19 designates a connector for transmitting measurement data from the sensor to the device for measuring and controlling the pressure. In this embodiment, the force sensor 21 measures only compressive forces.
    [0015] However, in order to make it possible to measure tensile forces, the system comprises a prestressing device 14 which exerts a determined compression force on the force sensor. This prestressing device thus creates an "offset" on the force sensor, which makes it possible to measure both tensile forces and compressive forces.
    [0016] Said prestressing device may comprise one or more adjusting screws cooperating with the guide pads 20 and, interposed (s) between the head of a respective adjusting screw and the block 15, a compression spring, a spring of extension and / or an elastomer stud. FIG. 3 illustrates another embodiment of the invention and shows a sectional view of part of the interior of the housing 1. The elements bearing the same reference numerals as in FIG. 2 fulfill the same function and will not be so not described again. In this embodiment, the force sensor 22 may for example be based on a measurement by strain gauge (s). The sensor 22 is fixed on the block 15 and on the wall 25 of the housing opposite said block, on the opposite side to the tank. The force sensor 22 is able to measure both compressive and tensile forces. The prestressing device of the embodiment of FIG. 2 is not necessary in this case. FIG. 4 illustrates an embodiment of the invention and shows a section of a part of the inside of the casing 1.
    [0017] In this embodiment, the moving part of the reservoir 5 is not a bellows but a rolling diaphragm 27. As in FIG. 2, the force sensor 21 measures only compressive forces and is therefore associated with a prestressing device 14. FIG. 5 illustrates another embodiment of the invention and shows a section of a part of the inside of the casing 1. The elements bearing the same reference signs as in FIG. same function and will not be described again.
    [0018] In this embodiment, the force sensor 22 may for example be based on a measurement by strain gauge (s). It can be integrated between the threaded nut 10 and the flange 6. The threaded nut 10 and the force sensor 22 can also constitute a single and complete assembly integrating the strain gauge (s) and a threaded portion, thus fulfilling the function of force and drive measurement by the drive screw 17. The force sensor 22 is able to measure both compressive and tensile forces. The prestressing device of the embodiment of FIG. 2 is not necessary in this case. Determination of the pressure in the fluid circuit of the occlusive system The pressure in the fluid circuit is determined indirectly. As indicated in the preamble, the integration of a pressure sensor on one of the walls of the variable volume tank or on one of the parts of the fluid circuit would be restrictive and would have several disadvantages. In place of such a sensor, the present invention utilizes the movable portion of the variable volume reservoir 15 to indirectly measure the pressure in the fluid circuit of the occlusive system. The implantable system therefore comprises a device for measuring the fluid pressure in the fluid circuit, which comprises said force sensor and a processing unit (for example a microprocessor) coupled to said sensor. The processing unit 20 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 fluid circuit. The description below is based on a force sensor measuring only compression (no traction). The same principle can be applied for force sensors measuring compressions and pulls. In this case, it eliminates the preload system to create an "offset" on the force to measure both compressive forces and traction. FIG. 6 illustrates the different forces measured by the force sensor, in the context of the embodiment of FIG. 2: the mark 23 designates the force relative to the pressure in the fluidic circuit; the mark 24 designates the prestressing force; the mark 25 designates the force related to the stiffness of the bellows; - The mark 26 designates the force related to the gas pressure in the housing. FIG. 7 illustrates the different forces measured by the force sensor placed at the level of the threaded nut 10 and the movable wall 6, in the context of the embodiment of FIG. 5: the mark 23 designates the force relative to the pressure in the fluidic circuit; the mark 25 designates the force related to the stiffness of the bellows; The mark 26 denotes the force related to the gas pressure in the housing. To deduce the pressure P in the fluid circuit, the parameters taken into account are as follows: Seff: the effective pressure area of the mobile part of the variable volume tank (as indicated above, this surface can be fixed or variable depending the configuration of the system); Fprec: the force generated by the prestressing system; K: the stiffness related to the variable volume tank (for example, a bellows), which may be neglected in certain configurations of the variable volume tank (in the case of a rolling diaphragm system or a piston) ; i: the relative position of the mobile part of the variable volume tank with respect to a reference position, Fpertes: the mechanical losses related to the friction of the different mechanical parts during the transmission of forces on the force sensor 15 Fcapteur: the force measured by the force sensor (s) Pboitier: the pressure of the gas contained in the implantable hermetic housing, said pressure being able to be deduced from the position of the mobile part relative to its reference position and the effective pressure surface of the moving part, to be measured by a gas pressure sensor placed in the housing (optional).
    [0019] From these elements it is possible to deduce several forces applied to the mobile wall of the variable volume tank: Focc1: the force (positive or negative) brought back to the mobile part of the variable volume tank connected to the pressure in the fluidic circuit the occlusive system; Case: the force (positive or negative) brought back to the moving part of the variable volume tank related to the pressure in the implantable hermetic housing; Fparoi: the force related to the position and stiffness of the moving part of the variable volume tank. Subsequently, it is considered that the gas pressure in the housing is deduced from the position of the movable portion relative to its reference position and the effective pressure surface of the movable portion. The balance of forces on the force sensor is expressed as follows: Fcapteur = Foccl + Fprec - Fparois - Fboitier - Fpertes with: Foccl = P - Seff Fparoi = K - i Vinit Fboitier = Pinit 1 Vinit - Se ff - i With Pinit and Vinit, constants corresponding respectively to the initial pressure and the initial volume of gas in the housing when it has been hermetically sealed. The force generated by the prestressing device makes it possible to create an "offset" on the force sensor which makes it possible to measure positive and negative forces.
    [0020] The casing force is derived from the position of the movable wall with respect to its origin and the effective pressure surface of the movable wall. It is considered in this case that the housing is perfectly hermetic. It can also be assumed that a negligible loss of gas from the housing to the outside may be neglected or taken into account in the calculation of the enclosure force. Finally, the casing force can also be directly measured by a pressure sensor and deduced by multiplying by the area Seff. We can thus deduce the pressure P of the fluidic circuit of the occlusive system: Fcaptor - Fprec + Fparec + Fbox + Fpertes P Seff P = + Pinit - Fcaptor - Fprec + K - i + Fpertes Vinit Seff Vinit-Seff - i 1) with Fprec and Fpertes known constants. The Fprec force can be generated by prestressed springs. The displacement of the block 15 being very small, it can be considered that the spring stroke is negligible with respect to their stiffness and that the prestressing force is constant. Fprec is chosen so that it can measure negative and positive pressures throughout the desired measurement range. In the case where the force sensor is capable of measuring compressive and tensile forces, it is possible to remove the prestressing system (in the case of the embodiments described in FIG. 3 and FIG. 5). In this case, the constant Fprec is not considered in the calculations of P. In a preferred embodiment, the housing is sealed so as to maximize the volume of air in the housing (movable wall of the tank in the initial position of so as to have a minimum volume in the variable volume tank). This makes it possible to have a gas pressure in the case always positive regardless of the position of the movable wall. The following paragraphs present two examples of pressure measurement from the method described in the present invention. The device described in the two examples below has the following characteristics: Seff = 1x10-3 m2-K = 5N / mm-Fprec = 20 N-Vinit = 10x10-5 m3 3028749 14-Pinit = 1000 hPa-Fpertes = 0 N Example 1: measurement of the pressure in the fluid circuit from a device according to the embodiment described in Figure 2, comprising a force sensor 5 measuring only compressive forces. For i = 0 (top position of the bellows, corresponding to a minimum tank volume), the processing unit performs the following calculation to measure the pressure in the fluid circuit: P - Fcapteur-20 1x10-3 10 For a relative pressure zero in the fluidic circuit for example, the force sensor only measures the compression force of the prestress (20 N), ie a value calculated by the processing unit: 20 - 20 P = 0 Pa 1 x 10-3 a relative pressure in the fluid circuit of 5 kPa for example, the force on the force sensor is that generated by the pressure in the fluid circuit Foccl (ie 15 N) and that of the prestressing (20 N), or a resultant force of 25 N, ie a value calculated by the processing unit: 25 - 20 P = = 5 kPa 1 X 10-3 For a relative pressure in the fluidic circuit of -5 kPa, for example, the force on the sensor force is that generated by the pressure in the fluidic circuit Foccl (either -5 N) and that of the prestress (ie 20 N), or a resultant force of 15 N, or a value calculated by the processing unit: 15 - 20 P = = 5 kPa 1 X 10-3 For i = 4 mm for example (low position of the bellows, generating a compression of gas in the housing and a restoring force related to the stiffness of the bellows), the processing unit performs the following calculation to measure the pressure in the fluid circuit: F sensor - 5 x 4 + 20 10 - 10-5 1) P 100000 = + x 1 x 10-3 F sensor 10 - 10-5 - 1 - 10-3 x 4 - 10-3 P 100000 10 - 10- 5 1) = + x 1 x 10-3 10 - 10-5 - 1 - 10-3 x 4 - 10-3 F sensor P = + 4166.67 1 x 10-3 25 3028749 15 For a zero relative pressure in the fluidic circuit for example, the forces on the force sensor are Fprec (20 N), Fparoi (-20 N), housing (-4,167 N) is a resultant force of -4,167 N, a value calculated by the unit of treatment: -4,167 P = + 4166,67 = 0 Pa 1 X 10-3 For a relative pressure in the fluidiq circuit for example, the forces on the force sensor are Foc1c (5 N), Fprec (20 N), Fparol (-20 N), enclosure (-4.167 N), a resultant force of 0.833 N, or a value calculated by the processing unit: 0.833 P = + 4166.67 = 5 kP to 1 X 10-3 For a relative pressure in the fluidic circuit of -5 kPa for example, the forces on the force sensor are Foccl (-5 N), Fprec (20 N), wall (-20 N), housing (-4,167 N) is a resultant force of -9,167 N, a value calculated by the treatment unit: 10 -9,167 P = + 4166.67 = -5 kPa 1 x 10-3 Example 2: Measurement of the pressure in the fluid circuit from a device the embodiment described in Figure 5, comprising a force sensor capable of measuring forces compression and pulling forces.
    [0021] For i = 0, the processing unit performs the following calculation to measure the pressure in the fluid circuit: P - F 1x10-3 sensor For a zero relative pressure in the fluid circuit for example, the force sensor measures a zero force a value calculated by the processing unit: 0 P = = 0 Pa 1 x 10-3 For a relative pressure in the fluid circuit of 5 kPa for example, the only force on the force sensor is that generated by the pressure in the fluidic circuit Focc1 (ie 5 N), or a value calculated by the treatment unit: P = = 5 kP to 1 X 10-3 For a relative pressure in the fluidic circuit of -5 kPa, for example the only force on the force sensor is that generated by the pressure in the fluidic circuit Focc1 (ie -5 N), or a value calculated by the processing unit: -5 P = = 5 kPa 1 x 10- For i = 4 mm, the processing unit performs the following calculation to measure the pressure in the circu Fluidic Fensor + 5 x 4 10 - 10-5 P = 1 x 10-3 + 100000 x 10 - 10-5 - 1 - 10-3 x 4 - 10-3 Fensor + 20 P = + 4166.67 1 x 10-3 For a zero relative pressure in the fluid circuit for example, the forces on the force sensor are wall (-20 N) and housing (-4.167 N) is a resultant force of -24.167 N, or a calculated value by the processing unit: -24,167 + 20 P = + 4166,67 = 0 Pa 1 x 10-3 For a relative pressure in the fluid circuit of 5 kPa for example, the forces on the force sensor are Foccl (5). N), wall (-20 N) and enclosure (-4.167 N), either a resultant force of -19.167 N, or a value calculated by the treatment unit: -19.167 + 20 P = + 4166.67 = 5 kPa For a relative pressure in the fluidic circuit of, for example, -5 kPa, the forces on the force sensor are Foc1c (-5 N), F-wall (-20 N) and enclosure (-4.167 N). a resultant force of -29.167 N, or a value calculated by the treatment unit : -29.167 + 20 P = + 4166.67 = -5 kPa 1 x 10-3 In both examples above, it is assumed that the device does not include a pressure sensor measuring the gas pressure in the housing . In a configuration where the device comprises a pressure sensor measuring the gas pressure in the housing, it suffices to replace the term Fboitier = Pinit Vinit 1) - Se ff by the Vinit-Sef sensor 20 with the sensor, the measurement value of the gas pressure sensor. It should be noted that the present invention can also be applied to devices comprising a variable volume tank without mechanical stiffness of the piston or rolling membrane type. In this case, the stiffness K in the calculation of the pressure P is considered to be zero or negligible.
    [0022] Pressure Control of the Occlusive System Since the purpose of the system is to control pressure, closed-loop pressure control appears at first sight to be the most appropriate choice for pressurizing the occlusive system. However, the pressure in the occlusive system is not solely dependent on the pressurization system. External effects related to the movements of the patient's organs or to his breathing for example can generate pressures that will be measured by the pressure measurement system described above.
    [0023] This can have the effect, during the pressure control, of inducing an excessive load of the actuator and therefore a too high power consumption. Indeed, the external pressures may vary during a pressure change of the occlusive system, the servo system will tend to seek to compensate for its variations, which will cause excessive bias of the actuator.
    [0024] To overcome this problem, one of the objects of this invention is to provide a simple pressure control method of the pressurization system. Rather than slaving the system under pressure, the actuator is controlled by servocontrol in position of the moving part of the variable volume tank. Knowing the effective pressure area of the moving part at each position, this therefore corresponds to a volume control of the occlusion system. Tests carried out in vitro and in vivo ([1]) have shown that the relation between the pressure in the fluidic circuit and the volume injected into the occlusive system have a definite and repeatable relationship with time. This is true in particular conditions of the patient, that is to say when it is stationary and in a specific position (extended or standing for example). The device for controlling the fluid pressure in the fluidic circuit comprises in particular a memory in which is recorded a relationship between the pressure in the fluid circuit and the volume of said reservoir, a treatment unit (possibly identical to the treatment unit of the device for measuring the pressure in the fluidic circuit) and a calibration unit, the operation of which is described below. FIG. 8 is a graph illustrating the variation of the pressure in the fluidic circuit as a function of the volume of the reservoir. In order to be able to control the system under pressure, the pressurization system regularly carries out pressure measurements for given injection volumes. This calibration procedure is performed under predetermined conditions. For example, in the case of an artificial urinary sphincter, the calibration can be performed a few minutes after the 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 located in the implant memory. This calibration procedure is performed at a defined period, for example weekly.
    [0025] FIG. 9 is a graph illustrating the variation 28 of the pressure P in the fluid circuit as a function of time t for different volumes of fluid injected into the occlusive sleeve during the calibration procedure. Calibration can be performed additionally when the patient is lying down and substantially immobile. This makes it possible to record pressure values that will be different from those recorded when the patient is standing, because of the water column between the implantable housing and the occlusive sleeve implanted at different heights in the patient. In normal operation, when a pressurization control at a given pressure is sent to the pressurization system, the volume corresponding to the set pressure is sought in the table in memory and is used to pressurize the occlusion system at the same time. desired pressure. As a safety measure, the pressure can be measured during the pressurization phase to ensure proper operation of the device and correspondence with the expected pressure values. To measure the motion of the patient and determine if he is still, and to measure his posture and determine whether he is standing or lying down, an accelerometer can be used. To perform the volume calibration procedure as a function of the pressure in the occlusion system, a clock is used. It could be an example of the RTC type. Safety system In the case where the pressure in the fluidic circuit becomes very high and close to the limits defined in the technical recommendations concerning the pressure resistance of the various elements of the fluidic circuit, the processing unit can send an automatic order decompression of the occlusive cuff. 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 excessive pressure in the fluid circuit, making it possible to protect the risk actuation device. deterioration. The mechanical stresses experienced by the actuating device resulting from too much pressure in the fluidic circuit can become very large, which could cause the deterioration of one or more of the parts of the actuating device. The pressurizing system, tubing, sleeve, pressure sensor and / or connectors may be affected by this degradation. In order to avoid damaging the actuating device, the stress reduction member is designed to, when the mechanical stresses (pressure in the fluidic circuit) exceed a determined stress threshold, absorb a part of said stresses so that to reduce the stresses on the actuating device. The stress reducing member is sized to reduce stresses to a level where they are too small to risk damaging the actuator while being high enough not to fully relax the compression exerted by the actuator. cuff. Depending on the mode of stress reduction envisaged and the structure of the actuating device, the skilled person is able to design a member fulfilling these conditions.
    [0026] According to one embodiment, the stress reduction member comprises an expansion chamber arranged in the hydraulic circuit and triggering mechanically when the pressure in the fluidic circuit exceeds a defined threshold. This has the effect of transferring a portion of the fluid from the hydraulic circuit to the expansion chamber to reduce the pressure in the expansion chamber.
    [0027] Alternatively, the stress reduction member may comprise a piston coupled to a spring system having a sufficiently high stiffness to remain substantially stationary when the pressure in the hydraulic circuit corresponds to the normal operating pressure of the device and movable under the effect of higher pressure. The stress reduction member may have different embodiments; for example and without limitation: - a valve coupled with a spring or a specific material in an expansion chamber; a component of the hydraulic circuit made of a flexible material having the property of being deformed from a certain pressure threshold; A deformable membrane beyond a certain pressure threshold or as a function of the applied pressure; - the variable volume tank designed to be deformable beyond a certain pressure threshold or depending on the applied pressure; the actuating mechanism designed to be deformable beyond a certain pressure threshold or as a function of the applied pressure.
    [0028] REFERENCES US 8,585,580 US 4,581,018 US 4,222,377 CA 1,248,303 US 4,408,597 [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.
    权利要求:
    Claims (17)
    [0001]
    REVENDICATIONS1. Occlusive system implantable in a human or animal body, comprising: - a fluid circuit comprising: - an inflatable occlusive cuff (3) containing a variable volume of a fluid, intended to surround at least a portion of a natural duct to occlude, a reservoir (5) with variable volume filled with a fluid, said reservoir comprising a fixed part and a moving part, a fluidic connection (2) between the reservoir (5) and the occlusive sleeve (3), an actuator mechanically coupled to the movable portion of the reservoir to linearly move said movable portion relative to the stationary portion to adjust the volume of the reservoir, the actuator and the variable volume reservoir being arranged in a gas-tight housing (1) a sensor (21, 22) arranged in the housing (1), mechanically connected to the actuator and / or the moving part of the tank, arranged to measure a tensile and / or compressive force in the direction displacement of the moving part of the tank, said measured force resulting from at least: the force (F0'1) exerted on the moving part of the variable volume tank connected to the pressure in the fluidic circuit, and the force ( Casing) exerted on the moving part of the variable-volume reservoir connected to the gas pressure in the casing; - a device for measuring the pressure (P) of fluid in the fluid circuit comprising a processing unit configured to determine said pressure ( P) of fluid from a calculation taking into account at least the force measurement of said sensor (21, 22), the effective pressure surface (Seff) of the movable part of the reservoir, and the force (housing) exerted on the moving part of the variable volume tank related to the gas pressure in the housing.
    [0002]
    2. System according to claim 1, further comprising a device for controlling the fluid pressure in the fluidic circuit by the volume of the reservoir, comprising: a memory in which is recorded a relationship between the pressure in the fluid circuit and the volume of said reservoir, - a processing unit configured to: - receive a fluid pressure setpoint in the fluid circuit, - from the relation stored in the memory between the pressure in the reservoir and the volume of the reservoir, determine the volume of the tank allowing the target pressure to be reached, - if necessary, controlling the actuator to move the moving part 5 of the tank to the position defining said determined volume, - a calibration unit configured for: (a) when the patient is in a determined situation, control the actuator to move the moving part of the reservoir in a plurality of positi determined, each position defining a determined volume of the reservoir, (b) for each of said positions: - measuring the pressure (P) of fluid in the fluid circuit by said device for measuring the fluid pressure in the fluidic circuit, - updating the memory by recording said measured fluid pressure in the fluid circuit for the respective volume of the reservoir.
    [0003]
    3. System according to one of claims 1 or 2, wherein said sensor is adapted to measure tensile forces and compressive forces in the direction of movement of the movable portion of the reservoir. 20
    [0004]
    4. System according to one of claims 1 or 2, wherein said sensor is able to measure only compression forces in the moving direction of the moving part of the tank, said system further comprising a prestressing device arranged so to exert a compression prestress determined on said sensor.
    [0005]
    5. System according to claim 4, wherein the processing unit is configured to take into account said preload for the determination of the pressure (P) of fluid in the fluid circuit. 30
    [0006]
    6. System according to one of claims 4 or 5, wherein said prestressing device comprises at least one compression spring, a tension spring and / or an elastomer pad. 35
    [0007]
    7. System according to one of claims 1 to 6, wherein the movable portion of the variable volume reservoir comprises a drive system (17) coupled to a movable wall (6) and a deformable bellows extending and compressing depending on the position of said movable wall. 3028749 23
    [0008]
    8. System according to claim 7, wherein the processing unit is configured to take into account the stiffness of said bellows for the determination of the pressure (P) of fluid in the fluid circuit. 5
    [0009]
    9. System according to one of claims 1 to 6, wherein the movable portion of the variable volume reservoir comprises a drive system (17) coupled to a rolling diaphragm. 10
    [0010]
    10. System according to one of claims 1 to 6, wherein the variable volume reservoir comprises a cylinder forming the fixed portion of the reservoir and a piston sliding in said cylinder, forming the movable portion of the reservoir.
    [0011]
    11. System according to one of claims 1 to 10, wherein the actuator is selected from piezoelectric actuators, electromagnetic actuators, electro-active polymers and shape memory alloys.
    [0012]
    12. System according to one of claims 1 to 11, further comprising a gas pressure sensor arranged in the housing (1) for measuring the gas pressure in the housing, the treatment unit being configured to take into account the measured gas pressure in the determination of the force (housing).
    [0013]
    13. System according to one of claims 1 to 12, wherein a wall of the variable volume tank is constituted by a wall of the housing, said wall 25 comprising a port (4) pierceable puncture.
    [0014]
    14. System according to one of claims 1 to 13, further comprising a constraint reduction device in the fluid circuit when said constraints exceed a determined threshold. 30
    [0015]
    15. System according to one of claims 1 to 14, further comprising an accelerometer, the processing unit being configured for, from the measurement data of the accelerometer, determine if the patient is in a specific situation. 35
    [0016]
    16. System according to one of claims 1 to 15, wherein the pressure measuring device is configured to measure the fluid pressure during the adjustment of the volume of the reservoir and to verify the correspondence between said measured value and a expected value. 3028749 24
    [0017]
    17. System according to one of claims 1 to 16, consisting of an artificial urinary sphincter.
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    同族专利:
    公开号 | 公开日
    AU2015352598B2|2019-10-17|
    WO2016083428A1|2016-06-02|
    AU2015352598A1|2017-06-22|
    US11058527B2|2021-07-13|
    FR3028749B1|2020-10-09|
    US20200222161A1|2020-07-16|
    US10350044B2|2019-07-16|
    HK1243912B|2019-09-13|
    EP3223748B1|2018-09-12|
    BR112017010957A2|2018-02-14|
    CN107106282B|2019-03-05|
    PT3223748T|2018-12-19|
    CA2968617A1|2016-06-02|
    US20170325926A1|2017-11-16|
    CN107106282A|2017-08-29|
    JP6696983B2|2020-05-20|
    US20190274802A1|2019-09-12|
    EP3223748A1|2017-10-04|
    ES2701241T3|2019-02-21|
    JP2017535382A|2017-11-30|
    US20200261201A1|2020-08-20|
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    法律状态:
    2015-11-16| PLFP| Fee payment|Year of fee payment: 2 |
    2016-05-27| PLSC| Publication of the preliminary search report|Effective date: 20160527 |
    2016-11-09| PLFP| Fee payment|Year of fee payment: 3 |
    2017-11-10| PLFP| Fee payment|Year of fee payment: 4 |
    2018-11-20| PLFP| Fee payment|Year of fee payment: 5 |
    2019-11-14| PLFP| Fee payment|Year of fee payment: 6 |
    2020-11-10| PLFP| Fee payment|Year of fee payment: 7 |
    2021-10-06| PLFP| Fee payment|Year of fee payment: 8 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1461420A|FR3028749B1|2014-11-25|2014-11-25|IMPLANTABLE OCCLUSIVE SYSTEM|FR1461420A| FR3028749B1|2014-11-25|2014-11-25|IMPLANTABLE OCCLUSIVE SYSTEM|
    PCT/EP2015/077586| WO2016083428A1|2014-11-25|2015-11-25|Implantable occlusion system|
    PT15800824T| PT3223748T|2014-11-25|2015-11-25|Implantable occlusion system|
    ES15800824T| ES2701241T3|2014-11-25|2015-11-25|Implantable Occlusive System|
    EP15800824.3A| EP3223748B1|2014-11-25|2015-11-25|Implantable occlusion system|
    AU2015352598A| AU2015352598B2|2014-11-25|2015-11-25|Implantable occlusion system|
    CA2968617A| CA2968617A1|2014-11-25|2015-11-25|Implantable occlusion system|
    US15/529,413| US10350044B2|2014-11-25|2015-11-25|Implantable occlusion system|
    CN201580070761.7A| CN107106282B|2014-11-25|2015-11-25|Implanted block system|
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    HK18103603.3A| HK1243912B|2014-11-25|2018-03-15|Implantable occlusion system|
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