Implantable medical device

Abstract

The present invention relates to an implantable medical device (10) comprising: a variable volume fluid reservoir that is deformable under the action of a change in atmospheric pressure; an expandable element (3) in fluid connection with the reservoir (5); an actuator (8) adapted to selectively vary the volume of the reservoir (5); and a data processing and control unit (200) configured to command a selective change in the volume of the storage (5) via the actuator (8) and to control the storage (5) if the atmospheric pressure estimate exceeds at least one atmospheric pressure threshold and / or the altitude estimate exceeds at least one altitude threshold. At least one of the following steps is performed: a) commanding a volume of fluid to be withdrawn from the expandable element (3) to the reservoir (5) at least once by the actuator (8) by means of the unit (200); b) or by means of a unit (200) commanding at least one injection of a volume of fluid from the reservoir (5) to the expandable element (3) by means of the actuator (8).

Description

Technical Field

[0001] The present invention relates to an implantable medical device comprising a variable volume fluid reservoir which is deformable under the influence of changes in atmospheric pressure. Background Art

[0002] Some medical devices are in the form of systems that can be implanted in a human or animal subject. In particular, such devices may correspond to artificial urinary sphincters for combating urinary incontinence, gastric bands or rings suitable for constraining the stomach for the purpose of combating obesity, inflatable penile implants for erectile prostheses, etc.

[0003] In a manner known per se, the implantable system may function hydraulically and may in particular comprise a variable volume fluid reservoir and an expandable element containing the variable volume fluid. The expandable element is fluidically connected to the variable volume fluid reservoir so as to be able to transfer fluid from the reservoir to the expandable element and vice versa.

[0004] In the case of an occlusive implantable system, such as an artificial urinary sphincter, the inflatable element is an inflatable occlusive cuff capable of selectively occluding an anatomical passage (such as the urethra in men, or the bladder neck in women). Fluid can be transferred from a reservoir to the cuff to increase the pressure applied to the passage, and conversely from the cuff to the reservoir to reduce the pressure applied to the passage. Thus, depending on the volume of fluid in the cuff, a greater or lesser pressure can be applied to the anatomical passage to be occluded.

[0005] The elements of the implantable fluid system can be sensitive to changes in atmospheric pressure (due to changes in, for example, altitude) and deform. For example, the reservoir of the implantable fluid system can include a part that can be elastically deformed, which is deformed according to atmospheric pressure changes. This deformation can cause fluid to be injected into the cuff or fluid to be withdrawn uncontrollably from the cuff and therefore the increase or decrease of the pressure in the cuff.

[0006] However, such pressure variations in the inflatable element are to be avoided. In the case of an artificial urinary sphincter, overpressures are likely to degrade the tissues arranged around the cuff, for example by causing lesions in these tissues. It is therefore necessary to compensate for these overpressures in order to limit the corresponding risk of tissue degradation. Summary of the invention

[0007] It is an object of the present invention to compensate for the effects of atmospheric pressure changes on implanted medical devices.

[0008] Thus, according to a first aspect, the invention relates to an implantable medical device comprising: a variable volume fluid reservoir, the reservoir being deformable under the influence of changes in atmospheric pressure; an expandable element, which is fluidically connected to the reservoir; an actuator, which is adapted to selectively vary the volume of the fluid reservoir; and a data processing and control unit, which is configured to control the selective variation of the volume of the fluid reservoir by means of the actuator, the unit being configured to carry out at least one of the following steps if an estimate of the atmospheric pressure crosses at least one atmospheric pressure threshold and / or if an estimate of the altitude crosses at least one altitude threshold:

[0009] a) controlling, by means of a data processing and control unit, at least one withdrawal of a volume of fluid from the expandable element to the reservoir by means of an actuator;

[0010] b) Controlling by means of a data processing and control unit at least one injection of a volume of fluid from the reservoir into the expandable element by means of an actuator.

[0011] According to the advantageous and non-limiting features, taken alone or in any combination:

[0012] - The data processing and control unit is configured to:

[0013] - if the estimated value of the atmospheric pressure crosses at least one atmospheric pressure threshold value so that the atmospheric pressure is less than at least one atmospheric pressure threshold value, or if the estimated value of the altitude crosses at least one altitude threshold value so that the estimated value of the altitude is greater than at least one altitude threshold value, performing step a); and / or

[0014] - if the estimated value of the atmospheric pressure crosses at least one atmospheric pressure threshold value so that the atmospheric pressure is greater than at least one atmospheric pressure threshold value or if the estimated value of the altitude crosses at least one altitude threshold value so that the estimated value of the altitude is less than at least one altitude threshold value, performing step b);

[0015] - the data processing and control unit is configured to implement, before step a) or b), a step a01) or b01) of calculating the volume of said fluid to be withdrawn or injected;

[0016] - the data processing and control unit is configured to implement a step a0) of estimating the atmospheric pressure based on at least one value of the fluid pressure in the reservoir;

[0017] - the data processing and control unit is configured to calculate the volume of fluid to be evacuated or to be injected according to an atmospheric pressure range in which the estimated value of the atmospheric pressure is newly included, the lower limit or the upper limit of the atmospheric pressure range being the atmospheric pressure threshold, and / or according to an altitude range in which the estimated value of the altitude is newly included, the lower limit or the upper limit of the altitude range being the altitude threshold;

[0018] - the data processing and control unit is configured to calculate the volume of fluid to be evacuated or to be injected according to an atmospheric pressure range in which an estimated value of the atmospheric pressure is newly included, the estimated value of the atmospheric pressure being included in one of the plurality of atmospheric pressure ranges, and / or according to an altitude range in which an estimated value of the altitude is newly included, the estimated value of the altitude being newly included in one of the plurality of altitude ranges;

[0019] - the data processing and control unit is configured to calculate the volume of fluid to be evacuated or to be injected according to an atmospheric pressure range in which an estimated value of the atmospheric pressure is newly included, an estimated value of the atmospheric pressure is newly included in one of at least two atmospheric pressure ranges, preferably at least three atmospheric pressure ranges, more preferably at least four atmospheric pressure ranges, and / or according to an altitude range in which an estimated value of the altitude is newly included, an estimated value of the altitude is newly included in one of at least two altitude ranges, preferably at least three altitude ranges, more preferably at least three altitude ranges, more preferably at least four altitude ranges;

[0020] - the data processing and control unit is configured to calculate the volume of fluid to be evacuated or to be injected according to the atmospheric pressure range in which the estimated value of the atmospheric pressure is newly included and / or according to the altitude range in which the estimated value of the altitude is newly included, each atmospheric pressure range and / or each altitude range being associated with a corresponding fluid volume value, and when determining the fluid volume value associated with the atmospheric pressure range in which the estimated value of the atmospheric pressure is newly included and / or with the altitude range in which the estimated value of the altitude is newly included, the volume of fluid to be evacuated or to be injected corresponds to the determined fluid volume value;

[0021] - the data processing and control unit is configured to calculate at least one lower limit and / or at least one upper limit of at least one atmospheric pressure range and / or at least one altitude range based on at least one reference atmospheric pressure value and / or at least one reference altitude value and based on at least one atmospheric pressure difference threshold and / or as a function of at least one altitude difference threshold;

[0022] - the data processing and control unit is configured to calculate at least one fluid volume value associated with each atmospheric pressure range and / or with each altitude range, the at least one fluid volume value corresponding to a sub-portion of the maximum volume to be evacuated or to be injected during the atmospheric pressure change and / or the maximum altitude change;

[0023] - The data processing and control unit is configured to implement the following steps:

[0024] x) detecting whether the estimated value of the atmospheric pressure crosses at least one atmospheric pressure threshold or whether the estimated value of the altitude crosses at least one altitude threshold, the at least one atmospheric pressure threshold being a lower limit or an upper limit of an atmospheric pressure range, and the at least one altitude threshold being a lower limit or an upper limit of an altitude range;

[0025] - the data processing and control unit is configured to exchange data with an external control element comprising a barometer and / or an altimeter and / or a GPS, the data processing and control unit being configured to estimate the atmospheric pressure based on atmospheric pressure measurement data from the barometer and / or to estimate the altitude based on altitude measurement data from the altimeter and / or from the GPS;

[0026] - the data processing and control unit is configured to record the atmospheric pressure measurements obtained by the barometer as an estimate of the atmospheric pressure if the measured atmospheric pressure is comprised between 1054 mbar and 694 mbar and / or to record the altitude measurements obtained by the altimeter as an estimate of the altitude if the measured altitude is comprised between 0 m and 3000 m above sea level;

[0027] - the data processing and control unit is configured to calculate the volume of fluid to be evacuated based on an estimate of the volume of the second fluid injected into the inflatable element due to deformation of the reservoir caused by a decrease in atmospheric pressure and / or an increase in altitude;

[0028] - the data processing and control unit is configured to calculate the volume of fluid to be injected based on an estimate of the volume of the second fluid withdrawn from the inflatable element due to deformation of the reservoir caused by an increase in atmospheric pressure and / or a decrease in altitude;

[0029] - the data processing and control unit is configured to exchange data with an external control element comprising a barometer and / or an altimeter and / or a GPS, and is configured to record the atmospheric pressure measurements obtained by the barometer and / or the altitude measurements obtained by the altimeter, and / or the altitude measurements obtained by the GPS, if the command is implemented by the patient implanted with the device via the external control element;

[0030] - the data processing and control unit is configured to update, as a result of the recording of the atmospheric pressure measurements obtained by the barometer and / or the altitude measurements from the altimeter and / or the altitude measurements from the GPS, the lower and upper limits of one or more atmospheric pressure ranges so that the atmospheric pressure ranges are centered around the atmospheric pressure measurements and / or to update the lower and upper limits of one or more altitude ranges so that the altitude ranges are centered around the altitude measurements;

[0031] - the data processing and control unit is configured to increase, preferably double, the extent of the atmospheric pressure range centered on the atmospheric pressure measurement and / or the extent of the altitude range centered on the altitude measurement;

[0032] - the data processing and control unit is configured to calculate, as a result of the recording of atmospheric pressure measurements obtained by a barometer and / or altitude measurements obtained by an altimeter and / or altitude measurements obtained by a GPS, the volume of fluid to be withdrawn from the inflatable element by means of the actuator into the reservoir or the volume of fluid to be injected from the reservoir into the inflatable element by means of the actuator, by applying the atmospheric pressure or altitude measurements to the function;

[0033] - a data processing and control unit configured to exchange data with an external control element comprising a barometer and / or an altimeter for recording atmospheric pressure measurements obtained by the barometer and / or altitude measurements obtained by the altimeter at a predetermined frequency;

[0034] - the data processing and control unit is configured to control the increase or decrease of the volume of the reservoir by means of the actuator so as to allow the withdrawal of this volume of fluid from the inflatable element or the injection of this volume of fluid into the reservoir;

[0035] - the data processing and control unit is configured to periodically implement step a) and / or periodically implement step b);

[0036] -The device is configured to be implanted in a human or animal body to selectively occlude an anatomical passage in the human or animal body, the anatomical passage being selected from at least one of the following passages: the urethra, the gastric passage, the colon or the rectum or comprising an expandable element of an elongated shape configured to function as a penile implant.

[0037] According to a second aspect, the present invention relates to a component comprising an implantable medical device as described above and an external control element suitable for exchanging data with the implantable medical device and configured to be used by an individual in which the medical device is implanted, wherein the implantable medical device and the external control element include communication means suitable for communicating with each other.

[0038] According to a third aspect, the invention relates to a method for compensating for atmospheric pressure changes to which an implantable medical device is exposed, the medical device comprising a variable volume fluid reservoir capable of deforming under the influence of atmospheric pressure changes, an expandable element connected to the reservoir fluid, an actuator adapted to selectively vary the volume of the fluid reservoir, and a data processing and control unit configured to control the selective variation of the volume of the fluid reservoir by the actuator, the method comprising: if an estimate of the atmospheric pressure crosses at least one atmospheric pressure threshold or if an estimate of the altitude crosses at least one altitude threshold, performing by the data processing and control unit at least one of the following steps:

[0039] a) sending at least one command from the control unit to the actuator to change the volume of the reservoir for withdrawing a volume of fluid from the expandable element to the reservoir;

[0040] b) sending at least one instruction by the control unit to the actuator to change the volume of the reservoir for injecting a volume of fluid from the reservoir to the expandable element.

[0041] According to a fourth aspect, the invention relates to a computer program product comprising code instructions for performing the previously proposed compensation method when said program is executed by a computer.

[0042] According to a fifth aspect, the invention relates to a storage means readable by a computing device, on which storage means a computer program product comprises code instructions for executing the previously proposed compensation method. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Other features and advantages of the present invention will appear after reading the following description of the preferred embodiment. This description will be given with reference to the accompanying drawings, in which:

[0044] - Figure 1 An overall view showing a medical device implantable within an individual and control elements external to the individual;

[0045] - Figure 2 is a schematic cross-sectional view of the interior of a housing according to one embodiment;

[0046] - Figure 3 A subdivision of the atmospheric pressure range is shown;

[0047] - Figure 4 shows a subdivision of the atmospheric pressure range according to another embodiment;

[0048] - Figure 5 Steps in a method for compensating for changes in atmospheric pressure to which an implantable medical device is exposed are shown. DETAILED DESCRIPTION

[0049] equipment

[0050] According to a first aspect, a medical device is proposed that can be implanted in an individual. In this text, "individual" means a human or an animal. The device is an implantable active medical device capable of blocking a natural passage, such as the urethra (in men), the bladder neck (in women), the gastric passage, the colon or even the rectum. In one case of application to the urethra or the bladder neck, the device allows in particular to combat urinary incontinence with the aid of an artificial sphincter capable of blocking the urethra or the bladder neck. However, the proposed device is more generally a device comprising a fluid circuit that is sensitive to pressure changes, in particular generated by changes in altitude. Among the other forms that the device can take, one can cite in particular a penile implant and a gastric constriction band.

[0051] exist Figure 1 and Figure 2 Detailed Description of the Invention Medical devices that may be implanted in a human or animal body are shown by way of non-limiting example.

[0052] The implantable device 10 comprises:

[0053] - a sealed housing 1 containing a gas,

[0054] - an expandable element 3 suitable for implantation in an individual outside the housing,

[0055] a fluid circuit comprising a fluid reservoir 5 with a variable fluid volume arranged inside the housing and a fluid connection 2 between the reservoir 5 and said expandable element 3,

[0056] an actuator 8 arranged in the housing 1 and mechanically coupled to a portion of the fluid reservoir 5 to selectively vary the volume of fluid in said reservoir,

[0057] - a data processing and control unit 200 configured to control the selective variation of the volume of the fluid reservoir 5 by means of the actuator 8 and thus configured to control the actuator in order to transfer fluid between the reservoir 5 and the inflatable element 3. The unit 200 is also configured to implement a method for compensating for atmospheric pressure variations to which the implantable medical device is exposed.

[0058] Fluid circuit

[0059] The fluid circuit is suitable for being filled with a fluid, in particular a liquid. A change in the volume of the reservoir 5 causes a change in the pressure in the fluid circuit. More particularly, a decrease in the volume of the reservoir 5 causes a transfer of fluid from the reservoir 5 to the expandable element 3 and causes an increase in the pressure in the fluid circuit. Conversely, an increase in the volume of the reservoir 5 causes a transfer of fluid from the expandable element 3 to the reservoir 5 and causes a decrease in the pressure in the fluid circuit.

[0060] The reservoir 5 is preferably a variable volume fluid reservoir adapted to deform under the influence of atmospheric pressure changes. The reservoir 5 may thus comprise an elastically deformable portion that deforms in response to atmospheric pressure changes. This deformation may cause a change in the volume of the reservoir 5 and thus a transfer of fluid between the reservoir 5 and the expandable element 3.

[0061] The reservoir 5 also comprises an opening allowing fluid outside the reservoir 5 to be transferred therefrom to the expandable element 3 via the fluid connection 2 .

[0062] The fluid connection 2 may be constituted by a tube 2 arranged between the reservoir 5 and the expandable element 3. A first end of the tube 2 opens into the reservoir 5 and a second end of the tube 2 opens into the expandable element 3.

[0063] The inflatable element 3 may be an inflatable occlusive cuff, in particular when the device 10 is an artificial urinary sphincter. The inflatable occlusive cuff 3 filled with a fluid may be adapted to fully or partially surround the passage to be occluded.

[0064] As a variant, the inflatable element 3 may be an inflatable penile implant and therefore have an elongated shape, in particular when the device 10 is an erection prosthesis.

[0065] case

[0066] The housing 1, the fluid connection 2 and the expandable element 3 are adapted to be implanted in the body of an individual 1 and have a contour in the Figure 1 Schematically shown on either side of this assembly.

[0067] The housing 1 , in particular the inner volume 11 of the housing 1 surrounding the reservoir 5 , contains a gas, for example an inert gas.

[0068] sensor

[0069] Advantageously, the housing 1 encloses a reservoir sensor 102 adapted to measure a representative value of the pressure of the fluid in the reservoir 5. The reservoir sensor 102 may be, for example, a force sensor or a pressure sensor.

[0070] External control elements

[0071] In a particularly advantageous manner, an external control element 9 , such as a remote control, which is outside the patient's body can be used by the patient or a third party to communicate wirelessly with the medical device 10 .

[0072] In some embodiments, a barometer 90 (i.e., an atmospheric pressure sensor) is included in the device 10, for example in the housing 1. According to another embodiment, the barometer 10 is arranged on the outer wall of the housing 1 and is configured to communicate with the device 10. According to yet another embodiment, the barometer 90 may be arranged in an external control element 9 outside the body of the individual in which the device 10 is implanted. The barometer 90 is suitable for measuring a representative value of the atmospheric pressure experienced by the implanted medical device 10. In the case where the barometer 90 is arranged in the external control element 9, the measurement of the representative value of the atmospheric pressure can thus be performed via the external control element 9, for example when the patient himself activates the command of the external control element 9. Also in some embodiments, an altimeter 92 (i.e., an altitude sensor) may be arranged in an external control element 9 outside the body of the individual in which the device 10 is implanted. The altimeter 92 is suitable for measuring a representative value of the altitude at which the implanted medical device is located. The measurement of the representative altitude value can also be performed when the user controls the device 10 via the external control element 9.

[0073] The barometer 90 and the altimeter 92 or GPS (“Global Positioning System”) may also be configured to carry out measurements of atmospheric pressure or altitude, respectively, at a predetermined frequency.

[0074] Actuator

[0075] The actuator 8 is adapted to control the variation of the volume of the reservoir 5. In a certain embodiment, the actuator 8 is adapted to control the linear movement of the movable wall 6, and the bellows 7 is adapted to extend or compress according to said linear movement of the movable wall 6 commanded by the actuator 8.

[0076] The actuator 8 may be chosen from any electromechanical system allowing the conversion of electrical energy into mechanical movement, the power required to allow the movement with the force and speed required of the movable wall 6 of the variable volume reservoir 5. The actuator 8 may in particular be a piezoelectric actuator, an electromagnetic actuator which may comprise an electromagnetic motor coupled or not coupled to a reduction gear with or without brushes, an electroactive polymer or a shape memory alloy.

[0077] Data processing and control unit

[0078] The device 10 comprises a data processing and control unit 200 configured to control the actuator 8 so as to move the movable wall 6 of the reservoir 5 to a position corresponding to the determined volume. Figure 2 In the example illustrated in , the control unit 200 is configured to transmit operating instructions to the motor of the actuator 8 in one direction or in the other direction, depending on whether the volume of the reservoir 5 needs to be increased or decreased.

[0079] As previously explained, atmospheric pressure or altitude changes can cause deformations of the reservoir 5 of the device 10. These deformations can cause fluid to be injected into the expandable element 3 or fluid to be withdrawn from the expandable element 3 in an uncontrolled manner and thus cause an increase or decrease in the fluid pressure in the expandable element 3. However, if the fluid pressure in the expandable element 3 is too high, this can cause degradation of the tissue of the anatomical passage surrounded by the expandable element 3. Conversely, if the fluid pressure in the expandable element 3 is too high, the anatomical passage surrounded by the expandable element 3 cannot be adequately blocked, which in the example case where the passage is the urethra can lead to an incontinence episode.

[0080] For example, in Figure 2 In the embodiment illustrated in FIG. 1 , a bellows 7 forms part of the wall of the variable volume reservoir. The bellows is formed by a plurality of coils that are elastically deformable. The bellows 7 may be in the form of an accordion bellows, the coils of which correspond to the folds of an accordion. Statically, i.e. when no stress is applied by the actuator 8 to change the volume of the reservoir, atmospheric pressure changes may cause deformation of the coils, thereby changing the volume of the reservoir.

[0081] It is therefore necessary to be able to compensate for this injection or this withdrawal by withdrawing fluid from the expandable element 3 or by injecting fluid into the expandable element 3 , respectively.

[0082] The unit 200 is configured to control the injection or withdrawal of the fluid volume to be compensated. For this purpose, the unit 200 is configured to determine whether the atmospheric pressure is less than or greater than at least one atmospheric pressure threshold and / or to determine whether the altitude is less than or greater than at least one altitude threshold. This determination allows the injection or withdrawal to be triggered or not by the unit 200.

[0083] It will be appreciated that the unit is configured to react to changes in atmospheric pressure and / or altitude. Atmospheric pressure means the atmospheric pressure to which the device 10 is exposed. Altitude means the altitude at which the device 10 is located. These quantities are linked together because atmospheric pressure varies linearly with altitude. During an increase in altitude, atmospheric pressure decreases, and conversely, during a decrease in altitude, atmospheric pressure increases.

[0084] For the sake of clarity, the continuation of this description will be divided into two parts. The first part relates to the configuration of the unit 200 for compensating for atmospheric pressure values. The second part relates to the configuration of the unit 200 for compensating for altitude values. Obviously, atmospheric pressure and altitude are inversely related (when one increases, the other decreases), and the embodiment related to altitude is the same as this embodiment, but in reverse.

[0085] Atmospheric Pressure Example

[0086] The unit 200 is advantageously configured to estimate a value of atmospheric pressure.

[0087] The atmospheric pressure value may be measured by the barometer 90 and then communicated to the unit 200. According to a certain embodiment, the unit 200 is configured to record the atmospheric pressure value measured by the barometer 90 due to the command of the individual via the external control element 9. According to a certain embodiment, the unit 200 is configured to record the atmospheric pressure value measured by the barometer 90 at a predetermined frequency.

[0088] An estimate of the value of the atmospheric pressure is thus obtained. This estimate corresponds to the atmospheric pressure to which the device is exposed at the instant tn.

[0089] According to another embodiment, the unit 200 is configured to implement step a0): estimating the atmospheric pressure based on at least one value of the fluid pressure in the reservoir 5. The fluid pressure value in the reservoir can be measured by the reservoir sensor 102. The manner in which the atmospheric pressure is estimated based on the fluid pressure value in the reservoir 5 will not be described in detail in this description.

[0090] The unit 200 is also configured to store a reference atmospheric pressure value P_atm t0 The reference value may typically be acquired by a barometer. The reference value is recorded by the unit 200 at the instant t0 corresponding to the activation of the device 10. The reference value is therefore fixed at the activation of the device 10 and is not intended to be modified (although it is reconfigurable if necessary).

[0091] The unit 200 is configured to calculate at least one lower limit and / or at least one upper limit of at least one atmospheric pressure range based on at least one reference atmospheric pressure value and based on at least one atmospheric pressure difference threshold. In practice, the unit 200 is configured to determine atmospheric pressure ranges. In brief, each range is associated with a volume of fluid to be injected or to be withdrawn, and, depending on the estimate to be made of the atmospheric pressure, the unit 200 is configured to determine in which pressure range this estimate is newly included and, therefore, to determine the volume of fluid to be injected from the reservoir 5 into the expandable element 3 or to be withdrawn from the expandable element 3. In this way, the unit 200 is configured to compensate within the device for deformations of the reservoir 5 caused by changes in atmospheric pressure.

[0092] The unit 200 is configured to determine at least one range, preferably several ranges. In fact, preferably, the unit 200 is configured to determine at least three ranges, more preferably at least four ranges.

[0093] As explained, each atmospheric pressure range is determined based on at least one reference atmospheric pressure value and based on at least one atmospheric pressure difference threshold. The reference atmospheric pressure value ideally corresponds to the maximum atmospheric pressure value, for example, corresponding to an atmospheric pressure at an altitude of 0 meters relative to sea level or approximately 1054 mbar. In addition, the atmospheric pressure difference threshold corresponds to the extent of the predetermined range. Typically, this difference threshold is configured at the time of activation of the device 10 and is not specified to be modified (although it can be reconfigured if necessary).

[0094] Therefore, refer to Figure 3 , if the first difference threshold is fixed at 90 mbar, the first range P1 will extend from 1054 mbar over 90 mbar to 964 mbar. The upper limit of P1 is 1054 mbar and the lower limit of P1 is 964 mbar. If, for all ranges determined by unit 200, the difference threshold is the same, then the upper limit of the second range P2 is 964 mbar and the lower limit of P2 is 874 mbar. Similarly, the third range P3 has 874 mbar as its upper limit and 784 mbar as its lower limit. The fourth range P4 has 784 mbar as its upper limit and 694 mbar as its lower limit. According to another embodiment, the atmospheric pressure threshold (i.e., the extent of the range) is not the same from one range to another.

[0095] In the example given above, note that the upper limit of P1 is equal to 1054 mbar, and the lower limit of P4 is equal to 694 mbar. This corresponds to an altitude range extending from 0 meters above sea level (1054 mbar) to 3000 meters (694 mbar).

[0096] In practice, the device 10 is preferably configured to be used at certain atmospheric pressures and / or altitudes. Thus, for an atmospheric pressure or altitude comprised between 1054 mbar and 694 mbar or between 0 and 3000 meters above sea level, respectively, the unit 200 can be configured to compensate for deformations of the reservoir 5 caused by variations in atmospheric pressure and / or altitude. However, for different atmospheric pressures or altitudes (e.g., an altitude comprised between 0 and 4000 meters above sea level), the unit 200 can be configured to compensate for deformations of the reservoir 5 caused by variations in atmospheric pressure and / or altitude.

[0097] Unit 200 is configured to associate a value of fluid volume with each range. This value of fluid volume corresponds to the volume of fluid to be injected into or withdrawn from the expandable element 3 if the estimated value of atmospheric pressure is newly contained within a certain range. The fluid volume associated with each range is ideally configured upon activation of the device 10 and is not specified to be modified (although it can be reconfigured if necessary). Advantageously, unit 200 is configured to calculate the value of fluid volume associated with each range based on the maximum fluid volume corresponding to the volume of fluid to be withdrawn or injected during the maximum atmospheric pressure change. Therefore, each value of the fluid volume associated with a range corresponds to a sub-portion of the maximum fluid volume.

[0098] The maximum volume of fluid is typically an estimate of the volume that can be injected from the reservoir 5 into the expandable element 3 at a maximum decrease in atmospheric pressure (e.g. a decrease in atmospheric pressure of 360 mbar corresponds to an increase in altitude of 3000 meters). The maximum volume of fluid thus corresponds to an estimate of the volume that can be withdrawn from the expandable element 3 to the reservoir 5 at a maximum increase in atmospheric pressure (e.g. an increase in atmospheric pressure of 360 mbar corresponds to a decrease in altitude of 3000 meters). The value of the volume of fluid associated with a range may be equal to another range, or different.

[0099] According to a particular embodiment, the unit 200 is configured to update the range. In other words, the range is dynamic. More precisely, the unit 200 is configured to update the range when an atmospheric pressure value is measured by the barometer 90 (e.g. due to a command of an individual via the external control element 9). "Update" means that the lower and upper limits of the range are modified. The limits are modified depending on the atmospheric pressure value measured by the barometer 90. Preferably, the range is modified so that the range (preferably the first range P1) is re-centered on the atmospheric pressure value measured by the barometer 90. For example, if the atmospheric pressure value measured by the barometer 90 is 940 mbar (according to Figure 3The example of the range P2 includes the value contained in the range P2), then the range P1 will be modified so that its lower limit corresponds to 895mbar and its upper limit corresponds to 985mbar, and the value of 940mbar is for the center of this new range P1. In this example, it can be understood that the example of the range extending beyond 90mbar has been repeated. Range P2 will have an upper limit of 895mbar and a lower limit of 815mbar (895mbar-90mbar). Similarly, range P3 will have an upper limit of 815mbar and a lower limit of 725mbar (815mbar-90mbar). Range P4 will have an upper limit of 725mbar and a lower limit of preferably 694mbar, because as previously explained, the unit 200 is preferably configured to be used at an atmospheric pressure greater than or equal to 694mbar. The advantages obtained by the embodiment with a dynamic range will be described in detail later in conjunction with the other elements described.

[0100] According to a particular embodiment, the unit 200 is configured to modify the extent of the range re-centered on the atmospheric pressure value measured by the barometer 90. Preferably, this extent is increased and still preferably, doubled relative to the initial extent. In this way, starting from the center of the newly calculated range, a change of more than 90 mbar in one direction or the other will induce a single range change (for example, based on the center of the range P2, a change of more than 90 mbar will induce only a change from the range P2 to the range P3 or from the range P2 to the range P1). This allows to avoid withdrawing fluid from the inflatable 3 or injecting fluid into the inflatable 3 too abruptly. In other words, this allows a more gradual and more precise compensation of atmospheric pressure changes. If we repeat the example of the previous paragraph, the unit 200 is configured as follows Figure 4 The range P1 is re-centered on 940 mbar and the extent of the range P1 is increased to 180 mbar (90 mbar times 2). Thus, the range P1 will have 1030 mbar (940 mbar+90 mbar) as an upper limit and 850 mbar (940 mbar-90 mbar) as a lower limit. On the other hand, the extents of the other ranges will remain unchanged. Thus, the range P2 will have 850 mbar as its upper limit and 760 mbar (850 mbar-90 mbar) as its lower limit.

[0101] The unit 200 is preferably configured to implement the following steps: x) detecting whether the estimate of the atmospheric pressure crosses at least one atmospheric pressure threshold, and this threshold is preferably the lower limit or the upper limit of the atmospheric pressure range. In other words, the unit 200 is preferably configured to implement the step of detecting a change in the range in which the estimate of the atmospheric pressure is newly included. Therefore, "new" means that the estimate of the atmospheric pressure was previously included in another range, and crossing the atmospheric pressure threshold brings it into the new range. It is recalled that the estimate of the atmospheric pressure estimate is estimated at the time tn. The change in range indicates that the estimate of the atmospheric pressure value has crossed the atmospheric pressure threshold (corresponding to the limit of the range). This also means that at the time tn, the individual in which the device 10 is implanted is exposed to a lower or higher atmospheric pressure than at the previous moment (possibly related to a change in altitude).

[0102] In order to detect the change of the range in which the estimation of the atmospheric pressure is newly included, the unit 200 is advantageously configured to determine whether the difference between the estimation of the atmospheric pressure and the reference atmospheric pressure value is greater than the atmospheric pressure difference threshold value. For this purpose, the unit 200 is configured to determine the difference between the estimation of the atmospheric pressure and the reference atmospheric pressure value. In other words, the unit 200 can evaluate the difference between the estimation and the reference value, which has been recorded before the estimation. It is understood here that the unit 200 is configured to detect an increase or decrease in atmospheric pressure exceeding a certain atmospheric pressure increase or decrease threshold value. For example, assuming that the atmospheric pressure estimation value is 900mbar and the reference atmospheric pressure is 1054mbar. The difference between the atmospheric pressure estimation value and the reference atmospheric pressure value is 154mbar. Obtaining the reference value before the estimation, it is understood that the device 10 is subjected to a decrease in atmospheric pressure of 154mbar (which can correspond to an increase in altitude).

[0103] This difference is then compared with an atmospheric pressure difference threshold or with a set of atmospheric pressure difference thresholds. As previously explained, the atmospheric pressure difference threshold corresponds to the extent of a range. Take a range with equal extent as an example, and therefore the atmospheric pressure difference threshold is equal from one range to another, and is equal to 90mbar. In the example given above, the atmospheric pressure difference is equal to 154mbar, which is greater than 90mbar but less than 180mbar (or 2x90mbar). The pressure difference is therefore greater than the difference threshold but does not reach a set of two difference thresholds. The unit is configured to infer that the range of atmospheric pressure estimation (i.e., 900mbar) is range P2. Based on this, unit 200 is configured to determine whether the range is the same or different from the range including the atmospheric pressure estimation at the moment tn-1 earlier than the moment tn. If at the moment tn-1, the atmospheric pressure estimation is included in the range P1, then unit 200 is configured to detect the change of the range and warn that the new atmospheric pressure estimation (at the moment tn) is less than the atmospheric pressure threshold, i.e., the lower limit of the range P1. Unit 200 is configured to determine whether the barometric pressure estimate is less than or greater than a barometric pressure threshold value if a change in the range in which the barometric pressure estimate is included is detected.

[0104] If it is determined that the estimate of the atmospheric pressure has crossed the atmospheric pressure threshold (in such a way that the estimate of the atmospheric pressure at the time tn is included in a range different from the estimate of the atmospheric pressure at the time tn-1), the unit 200 is configured to control the withdrawal or injection of the fluid. In fact, the range variation phenomenon indicates that the reservoir 55 will probably be deformed to inject or withdraw fluid in the inflatable element, which is not desired. These undesired injections or withdrawals can affect the integrity of the tissue surrounded by the inflatable element (in the case of an overpressure caused by the injection of the fluid), or conversely urine leakage (in the case of an underpressure caused by the withdrawal of the fluid).

[0105] Therefore, the unit 200 is preferably configured to implement a step a01) or b01) of calculating the volume of fluid to be evacuated or to be injected. Advantageously, the unit 200 is configured to select the fluid volume associated with the range in which the atmospheric pressure estimate is newly included, considering that preferably, as explained above, a fluid volume is associated with each range.

[0106] The unit 200 is configured to implement a step a of commanding, by means of the actuator 8, at least one withdrawal of a volume of fluid from the expandable element 3 to the reservoir 5, if the estimate of the atmospheric pressure crosses at least one atmospheric pressure threshold so that the atmospheric pressure is less than at least one atmospheric pressure threshold. To implement this, the unit is configured to control an increase in the volume of the reservoir 5, which allows the withdrawal of fluid in the expandable element 3. In this particular case, the unit 200 compensates for the decrease in atmospheric pressure (possibly associated with an increase in altitude) "by causing" the injection of fluid from the reservoir 5 into the expandable element 3. This particular case corresponds to the example presented above corresponding to the range change from P1 to P2. The volume of fluid to be withdrawn can be withdrawn once or several times.

[0107] Furthermore, the unit 200 is configured to implement a step b) of commanding at least one injection of a volume of fluid from the reservoir 5 into the expandable element 3, if the estimate of the atmospheric pressure crosses at least one atmospheric pressure threshold value so that the atmospheric pressure is greater than at least one atmospheric pressure threshold value). To implement this, the unit is configured to command a reduction in the volume of the reservoir 5, which allows the fluid to be injected into the expandable element 3. In this particular case, the unit 200 compensates for the increase in atmospheric pressure (perhaps associated with a decrease in altitude) “by” causing a withdrawal of the fluid in the expandable element 3.

[0108] Furthermore, the embodiment with dynamic range described in detail above allows to avoid the situation to be described. The unit 200 estimates an atmospheric pressure value included in the range P2, near the upper limit of the range P2, so that this limit is crossed, which leads to the command of fluid withdrawal. Then, due to the command by the individual via the external control element 9, the barometer 90 measures an atmospheric pressure value, which updates the estimated atmospheric pressure value (and corrects it, since the value measured by the barometer is assumed to be more reliable than the estimate by the unit 200). This measured value is included in the range P1, near the lower limit of P1 (and therefore near the upper limit of P2), which leads to the command of fluid injection. If the patient remains at the same altitude, the alternating passage from one range to another risks repeated injections and withdrawals of fluid, which causes useless energy consumption of the device 1 and possible discomfort to the patient. The embodiment with dynamic range allows to avoid this phenomenon, which occurs when the patient remains at an atmospheric pressure / altitude close to the extreme values ​​of the range, by adjusting the limits of the range.

[0109] Advantageously, the unit 200 is configured to command the injection or withdrawal of a volume of fluid when the value of atmospheric pressure is measured by the barometer 90 (in particular due to a command of an individual via the external control element 9). In other words, instead of the injection or withdrawal of fluid being automatically controlled by the unit 200 as a function of the estimation of the atmospheric pressure, the injection or withdrawal of fluid can be controlled by the user via the external control element 9. More precisely, the unit 200 is configured to calculate the volume of fluid to be injected or to be withdrawn due to a command of the individual via the external control element 9 (and therefore due to the measurement of the value of atmospheric pressure by the barometer 90). Preferably, this volume is calculated based on a function and on the value of the atmospheric pressure measured by the barometer 90. Preferably, the function is an affine function, i.e. a function of the type y=a*x+b, x corresponding to the value of atmospheric pressure measured by the barometer 90, y corresponding to the volume of fluid to be withdrawn or injected, a and b being real constants. It will thus be appreciated that the unit 200 is configured to calculate the volume of fluid to be withdrawn or injected by applying this volume to the value of atmospheric pressure measured by the barometer 90. It is duly noted that if the value of atmospheric pressure measured by the barometer 90 is the same as the estimate of the current atmospheric pressure ("current" meaning the last estimate of the current atmospheric pressure determined by the unit 200), the volume of fluid to be withdrawn or injected will be zero. Furthermore, it will be appreciated that the unit 200 is configured to determine whether the measured atmospheric pressure value is greater than or less than the estimate of the current atmospheric measurement, so that the unit 200 is configured to determine whether a certain volume of fluid is to be injected or withdrawn. This embodiment is combined with an embodiment involving a dynamic range to ensure consistent compensation for atmospheric pressure variations. According to this embodiment, the unit 200 therefore allows for a more regular compensation of possible atmospheric pressure variations, ensuring better comfort and greater safety for the patient. Furthermore, according to this embodiment, the compensation can be directly controlled by patient commands.

[0110] Thus, the device 10 is adapted to compensate for atmospheric pressure variations. The device 10 is thus advantageously adapted to compensate for deformations of the reservoir 5 caused by atmospheric pressure variations. An individual implanted with the device 10 can expose himself to atmospheric pressure variations (e.g. increasing or decreasing altitude) without the risk of degrading the tissue surrounding his anatomical passage. Preferably, the unit 200 is thus configured to perform at least steps a) and b) periodically, e.g. once an hour, more preferably once every half an hour, more preferably once every 10 minutes.

[0111] Altitude Example

[0112] The unit 200 is advantageously configured to estimate and altitude value. The altitude value may be measured by the altimeter 92 of the external control element 9 and then communicated to the unit 200. According to a certain embodiment, the unit 200 is configured to record the altitude value measured by the altimeter 92 due to the command of the individual via the external control element 9. According to a certain embodiment, the unit 200 is configured to record the altitude value measured by the altimeter 92 at a predetermined frequency.

[0113] The unit 200 is also configured to store a reference altitude value A_atm t0 The reference value may typically be acquired by an altimeter. The reference value is recorded by the unit 200 at the instant t0 corresponding to the activation of the device 10. The reference value is therefore fixed at the activation of the device 10 and is not intended to be modified (although it may be reconfigured if necessary).

[0114] The continuation of the embodiments regarding altitude is similar to the embodiments regarding atmospheric pressure, with some differences. First, it can be understood that the estimation of atmospheric pressure, atmospheric pressure threshold, atmospheric pressure range, etc. correspond to the estimation of altitude, altitude threshold, altitude range, etc. in the embodiments regarding altitude, respectively.

[0115] Furthermore, as previously mentioned, a decrease in altitude involves an increase in atmospheric pressure, and conversely, an increase in altitude involves a decrease in atmospheric pressure. It will therefore be appreciated that a decrease in altitude will be compensated for by injecting fluid into the expandable element, while an increase in altitude will be compensated for by withdrawing fluid from the expandable element.

[0116] Thus, by accounting for these differences, embodiments relating to altitude can be simply based on embodiments relating to atmospheric pressure.

[0117] Components

[0118] According to a second aspect, a component is proposed, which comprises an implantable medical device 10 as described above and an external control element 9 suitable for use by an individual (e.g., an individual in whom the system is implanted). The implantable medical device 10 and the external control element 9 comprise communication means suitable for communicating with each other. The communication means of the implantable device 10 may be integrated into the housing 1.

[0119] method

[0120] refer to Figure 5 According to a third aspect, a method for compensating for changes in atmospheric pressure to which an implantable medical device 10 is exposed is proposed, comprising: if an estimate of the atmospheric pressure crosses at least one atmospheric pressure threshold, or if an estimate of the altitude crosses at least one altitude threshold, performing by a data processing and control unit at least one of the following steps:

[0121] a) sending at least one command from the control unit to the actuator to change the volume of the reservoir so as to withdraw a volume of fluid from the expandable element to the reservoir;

[0122] b) sending at least one instruction by the control unit to the actuator to change the volume of the reservoir in order to inject a volume of fluid from the reservoir into the expandable element.

[0123] Program product and storage device

[0124] According to a fourth aspect, a computer program product is proposed, comprising code instructions for performing a method for compensating for atmospheric pressure variations to which an implantable medical device 10 is exposed, when said program is executed by a computer.

[0125] According to a sixth aspect, a storage device readable by a computing device is proposed, wherein a computer program product comprises code instructions for executing a method for “compensating” for atmospheric pressure variations to which an implantable medical device 10 is exposed.

[0126] The invention is not limited to the embodiments described and shown in the attached figures. Modifications are still possible, in particular from the point of view of the composition of the various technical features or by replacement by technical equivalents, without departing from the general teaching.

Claims

1. An implantable medical device (10), comprising: a variable volume fluid reservoir, the reservoir (5) being deformable under the influence of changes in atmospheric pressure; an inflatable element (3) in fluid connection with the reservoir (5); an actuator (8) adapted to selectively vary the volume of the fluid reservoir (5); and a data processing and control unit (200) configured to control the selective variation of the volume of the fluid reservoir (5) via the actuator (8), the unit (200) being configured to implement at least one of the following steps if the estimated value of the atmospheric pressure crosses at least one atmospheric pressure threshold and / or if the estimated value of the altitude crosses at least one altitude threshold: a) controlling, by means of the data processing and control unit (200), at least one withdrawal of a volume of fluid from the expandable element (3) to the reservoir (5) by means of the actuator (8); b) controlling, by means of the data processing and control unit (200), at least one injection of a volume of fluid from the reservoir (5) into the expandable element (3) by means of the actuator (8).

2. The device according to claim 1, wherein: The data processing and control unit (200) is configured to: - if the estimated value of the atmospheric pressure crosses the at least one atmospheric pressure threshold value so that the atmospheric pressure is less than the at least one atmospheric pressure threshold value, or if the estimated value of the altitude crosses the at least one altitude threshold value so that the estimated value of the altitude is greater than the at least one altitude threshold value, implementing step a); and / or - if the estimated value of the atmospheric pressure crosses the at least one atmospheric pressure threshold value such that the atmospheric pressure is greater than the at least one atmospheric pressure threshold value or if the estimated value of the altitude crosses the at least one altitude threshold value such that the estimated value of the altitude is less than the at least one altitude threshold value, implementing step b).

3. The device according to any one of claims 1 and 2, wherein: The data processing and control unit (200) is configured to implement, before step a) or b), a step a01) or b01) of calculating the volume of the fluid to be withdrawn or injected.

4. The device according to claim 1, wherein: The data processing and control unit (200) is configured to implement a step a0) of estimating the atmospheric pressure based on at least one value of the fluid pressure in the reservoir (5).

5. The device according to claim 1, wherein: The data processing and control unit (200) is configured to calculate the volume of the fluid to be withdrawn or to be injected according to an atmospheric pressure range, in which the atmospheric pressure estimate is newly included and the lower or upper limit of the atmospheric pressure range is the atmospheric pressure threshold, and / or according to an altitude range, in which the altitude estimate is newly included and the lower or upper limit of the altitude range is the altitude threshold.

6. The device according to claim 1, wherein: The data processing and control unit (200) is configured to calculate the volume of the fluid to be withdrawn or to be injected according to an atmospheric pressure range, in which the atmospheric pressure estimate is newly included, and / or according to an altitude range, in which the atmospheric pressure estimate is newly included, and the atmospheric pressure estimate is newly included in one of the plurality of atmospheric pressure ranges, and in which the altitude estimate is newly included, and the altitude estimate is newly included in one of the plurality of altitude ranges.

7. The device according to claim 6, wherein: The data processing and control unit (200) is configured to calculate the volume of the fluid to be withdrawn or to be injected according to an atmospheric pressure range and / or according to an altitude range, in which the atmospheric pressure estimate is newly included, the atmospheric pressure estimate is newly included in one of at least two atmospheric pressure ranges, preferably at least three atmospheric pressure ranges, more preferably at least four atmospheric pressure ranges, and in which the altitude estimate is newly included, the altitude estimate is newly included in one of at least two altitude ranges, preferably at least three altitude ranges, more preferably at least four altitude ranges.

8. The device according to one of claims 6 and 7, wherein: The data processing and control unit (200) is configured to calculate the volume of the fluid to be withdrawn or to be injected according to the atmospheric pressure range in which the atmospheric pressure estimate is newly included and / or according to the altitude range in which the altitude estimate is newly included, each atmospheric pressure range and / or each altitude range being associated with a corresponding fluid volume value, and when determining the fluid volume value associated with the atmospheric pressure range in which the atmospheric pressure estimate is newly included and / or with the altitude range in which the altitude estimate is newly included, the volume of the fluid to be withdrawn or to be injected corresponds to the determined fluid volume value.

9. The device according to one of claims 5 to 8, wherein: The data processing and control unit (200) is configured to calculate at least one lower limit and / or at least one upper limit of the at least one atmospheric pressure range and / or the at least one altitude range based on the at least one reference atmospheric pressure value and / or the at least one reference altitude value and based on at least one atmospheric pressure difference threshold and / or according to at least one altitude difference threshold.

10. The device according to one of claims 5 to 9, wherein: The data processing and control unit (200) is configured to calculate at least one fluid volume value associated with each atmospheric pressure range and / or with each altitude range, the at least one fluid volume value corresponding to a sub-portion of the maximum volume to be evacuated or to be injected during the atmospheric pressure change and / or the maximum altitude change.

11. The device according to one of claims 5 to 10, wherein: The data processing and control unit (200) is configured to implement the following steps: x) detecting whether the estimated value of the atmospheric pressure crosses at least one atmospheric pressure threshold or whether the estimated value of the altitude crosses at least one altitude threshold, wherein the at least one atmospheric pressure threshold is a lower limit or an upper limit of an atmospheric pressure range, and the at least one altitude threshold is a lower limit or an upper limit of an altitude range.

12. The device according to one of claims 1 to 11, wherein The data processing and control unit (200) is configured to exchange data with an external control element (9) including a barometer (90) and / or an altimeter (92) and / or a GPS, and the data processing and control unit (200) is configured to estimate the atmospheric pressure based on atmospheric pressure measurement data of the barometer (90) and / or to estimate the altitude based on altitude measurement data of the altimeter (92) and / or the GPS.

13. The device according to claim 12, wherein: The data processing and control unit (200) is configured to record the atmospheric pressure measurement obtained by the barometer (90) as an estimate of the atmospheric pressure if the measured atmospheric pressure is comprised between 1054 mbar and 694 mbar and / or to record the altitude measurement obtained by the altimeter (92) as an estimate of the altitude if the measured altitude is comprised between 0 meters and 3000 meters above sea level.

14. The device according to one of claims 1 to 13, wherein: The data processing and control unit (200) is configured to calculate the volume of fluid to be evacuated based on an estimate of the volume of second fluid injected into the inflatable element (3) due to deformation of the reservoir caused by a decrease in the atmospheric pressure and / or an increase in the altitude.

15. The device according to one of claims 1 to 14, wherein: The data processing and control unit (200) is configured to calculate the volume of fluid to be injected based on an estimate of the second fluid volume withdrawn from the inflatable element (3) due to deformation of the reservoir 5 caused by the increase in atmospheric pressure and / or the decrease in altitude.

16. The device according to one of claims 1 to 15, wherein: The data processing and control unit (200) is configured to exchange data with an external control element (9) comprising a barometer (90) and / or an altimeter (92) and / or a GPS, and is configured to record the atmospheric pressure measurement obtained by the barometer (90) and / or the altitude measurement obtained by the altimeter (92), and / or the altitude measurement obtained by the GPS, if a command is implemented by a patient implanted with the device via the external control element (9).

17. The device according to one of claims 5 to 11 in combination with claim 16, or according to one of claims 12 to 15 in combination with claims 5 and 16, wherein The data processing and control unit (200) is configured to update one or more lower limits and upper limits of the atmospheric pressure range due to the recording of the atmospheric pressure measurement value obtained by the barometer (90) and / or the altitude measurement value obtained by the altimeter (92) and / or the altitude measurement value obtained by the GPS so that the atmospheric pressure range is centered on the atmospheric pressure measurement value, and / or update one or more lower limits and upper limits of the altitude range so that the altitude range is centered on the altitude measurement value.

18. The apparatus according to claim 17, wherein: The data processing and control unit (200) is configured to increase, preferably double, the extent of the atmospheric pressure range centered around the atmospheric pressure measurement and / or the extent of the altitude range centered around the altitude measurement.

19. The device according to one of claims 17 and 18, wherein The data processing and control unit (200) is configured to calculate, as a result of the recording of atmospheric pressure measurements obtained by the barometer (90) and / or altitude measurements obtained by the altimeter (92) and / or altitude measurements obtained by the GPS, the volume of fluid to be withdrawn from the inflatable element (3) into the reservoir (5) by means of the actuator (8) or the volume of fluid to be injected from the reservoir (5) into the inflatable element (3) by means of the actuator (8), by applying the atmospheric pressure measurements or the altitude measurements to a function.

20. The device according to one of claims 1 to 19, wherein The data processing and control unit (200) is configured to exchange data with an external control element (9) comprising a barometer (90) and / or an altimeter (92) to record atmospheric pressure measurements obtained by the barometer (90) and / or altitude measurements obtained by the altimeter (92) at a predetermined frequency.

21. The device according to one of claims 1 to 20, wherein The data processing and control unit (200) is configured to command an increase or decrease in the volume of the reservoir (5) by means of the actuator (8) so as to allow the fluid volume to be withdrawn from the inflatable element (3) into the reservoir (5) or to be injected into the reservoir (5).

22. The device according to one of claims 1 to 21, wherein The data processing and control unit (200) is configured to periodically implement step a) and / or periodically implement step b).

23. An implantable medical device according to one of claims 1 to 22, configured to be implanted in a human or animal body to selectively block an anatomical passage in the human or animal body, the anatomical passage being selected from at least one of the following passages: the urethra, the gastric passage, the colon or the rectum or comprising an expandable element of an elongated shape configured to function as a penile implant.

24. An assembly comprising an implantable medical device according to one of claims 1 to 23 and an external control element (9) adapted to exchange data with the implantable medical device and configured to be used by an individual in whom the medical device is implanted, wherein The implantable medical device and the external control element (9) comprise communication means adapted to communicate with each other.

25. A method for compensating for atmospheric pressure changes to which an implantable medical device (10) is exposed, the medical device (10) comprising a variable volume fluid reservoir (5) capable of deforming under the influence of atmospheric pressure changes, an expandable element (3) in fluid connection with the reservoir (5), an actuator (8) adapted to selectively change the volume of the fluid reservoir (5), and a data processing and control unit (200) configured to control the selective change of the volume of the fluid reservoir (5) by the actuator (8), the method comprising: If the estimated value of the atmospheric pressure crosses at least one atmospheric pressure threshold or if the estimated value of the altitude crosses at least one altitude threshold, at least one of the following steps is performed by the data processing and control unit (200): a) sending at least one command from the control unit to the actuator (8) to change the volume of the reservoir (5) for withdrawing a volume of fluid from the expandable element (3) to the reservoir (5); b) sending at least one instruction by the control unit to the actuator (8) to change the volume of the reservoir (5) for injecting a volume of fluid from the reservoir (5) into the expandable element (3).

26. A computer program product comprising code instructions for executing a method for compensating for atmospheric pressure variations to which an implantable medical device (10) is exposed, the medical device (10) comprising a variable volume fluid reservoir (5) capable of deforming under the influence of atmospheric pressure variations, an expandable element (3) in fluid connection with the reservoir (5), an actuator (8) adapted to selectively vary the volume of the fluid reservoir (5), and a data processing and control unit (200) configured to control the selective variation of the volume of the fluid reservoir (5) by means of the actuator (8), the method comprising: If the estimated value of the atmospheric pressure crosses at least one atmospheric pressure threshold or if the estimated value of the altitude crosses at least one altitude threshold, at least one of the following steps is performed by the data processing and control unit (200): a) sending at least one command from the control unit to the actuator (8) to change the volume of the reservoir (5) for withdrawing a volume of fluid from the expandable element (3) to the reservoir (5); b) sending at least one instruction by the control unit to the actuator (8) to change the volume of the reservoir (5) for injecting a volume of fluid from the reservoir (5) into the expandable element (3), When the program is executed by a computer.

27. A storage device capable of being read by computing equipment, wherein: A computer program product understands code instructions for executing a method for compensating for atmospheric pressure changes to which an implantable medical device (10) is exposed, the medical device (10) comprising a variable volume fluid reservoir (5) capable of deforming under the influence of atmospheric pressure changes, an expandable element (3) fluidically connected to the reservoir (5), an actuator (8) suitable for selectively changing the volume of the fluid reservoir (5) and a data processing and control unit (200) configured to control the selective change of the volume of the fluid reservoir (5) by the actuator (8), the method comprising: if an estimated value of the atmospheric pressure crosses at least one atmospheric pressure threshold or if an estimated value of the altitude crosses at least one altitude threshold, at least one of the following steps is performed by the data processing and control unit (200): a) sending at least one command from the control unit to the actuator (8) to change the volume of the reservoir (5) for withdrawing a volume of fluid from the expandable element (3) to the reservoir (5); b) sending at least one instruction by the control unit to the actuator (8) to change the volume of the reservoir (5) for injecting a volume of fluid from the reservoir (5) into the expandable element (3).

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