Implantable medical devices

Abstract

The present invention relates to a medical device comprising a hermetically sealed casing (1) suitable for implantation inside the body of a human or animal patient, an inflatable element (2), a fluid circuit comprising a fluid reservoir (5) with a variable fluid volume and arranged within the casing with tubing between the fluid reservoir and the inflatable element, an actuator arranged within the casing for selectively varying the volume of fluid in the fluid reservoir, a control unit (100) configured to control the actuator, and at least one sensor suitable for measuring an absolute pressure of fluid in the fluid circuit, a force on the fluid reservoir, a gas pressure within the casing, atmospheric pressure or a value related to the altitude of the patient, wherein the control unit (100) is configured to detect, based on measurements from the sensor while the actuator is not activated, a difference between the value related to the altitude of the patient and a reference value, and to determine, as a function of said difference, a command to be issued to the actuator in order to control the pressure of the fluid in the fluid circuit.

Description

[Technical Field]

[0001] The present invention relates to implantable medical devices that include fluid circuits for selectively closing anatomical conduits. [Background technology]

[0002] Medical devices exist that can be implanted into the body of a human or animal patient to compensate for organ dysfunction.

[0003] These medical devices include, among other things, artificial urinary sphincters that include an inflatable occlusion cuff suitable for placement around a natural conduit, such as the urethra or bladder neck, a fluid reservoir in fluid communication with the cuff, and an actuator suitable for moving fluid between the cuff and the reservoir in accordance with compression applied to the natural conduit by the cuff.

[0004] Such medical devices are designed to operate within a range of fluid pressures, for example, as imposed by regulations.

[0005] However, there may be circumstances in which the pressure falls outside this range.

[0006] Therefore, even in such circumstances, it is desirable to prevent impairment of the patient and to avoid risks to the patient that could lead to such impairment. Summary of the Invention

[0007] It is therefore an object of the present invention to prevent actuator malfunctions that could be dangerous to a patient wearing such medical equipment when the patient is at high altitude for a period of time.

[0008] Another object of the present invention is to prevent malfunction of the actuator when a patient wearing the medical device is below the surface of the ocean, for example, when practicing diving.

[0009] For this purpose, the invention proposes a medical device, comprising: a sealed casing containing a gas and suitable for implantation within a human or animal patient; an inflatable element outside the casing, suitable for implantation within the patient's body; a fluid circuit including a fluid reservoir with a variable fluid volume and arranged within the casing together with a tube ensuring a fluid connection between the fluid reservoir and the inflatable element; an actuator disposed within the casing and mechanically coupled to the fluid reservoir for selectively varying a volume of fluid within the fluid reservoir; a control unit configured to control the actuator to move the fluid between the fluid reservoir and the inflatable element; at least one sensor suitable for measuring a value related to the absolute pressure of the fluid in the fluid circuit, the force on the fluid reservoir, the gas pressure in the casing, the atmospheric pressure or the altitude of the patient; Including, The control unit detecting a difference between a value related to the patient's altitude and a reference value based on measurements from the sensor while the actuator is not activated; determining a command to be issued to the actuator as a function of the difference to control the pressure of the fluid in the fluid circuit; The device is further configured to:

[0010] According to an advantageous but optional feature of the present invention, the control unit is configured to control the actuator to reduce a volume of fluid in the inflatable element when the patient's altitude is greater than a first reference value; the control unit is further configured to maintain the reduced volume of fluid in the inflatable element as long as the patient's altitude value is greater than the first reference value or the patient's altitude value is between the first reference value and a second reference value less than the first reference value; the control unit is configured to determine a control for the actuator to increase a volume of fluid in the inflatable element when the value related to the patient's altitude is less than the second reference value; the control unit is configured to control the actuator to reduce a volume of fluid in the inflatable element when the patient is underwater and a value related to the patient's altitude is less than a third reference value; the control unit is further configured to maintain the reduced volume of fluid in the inflatable element as long as the patient is underwater and the patient's altitude value is less than the third reference value or the patient's altitude value is between the third reference value and a fourth reference value greater than the third reference value; the control unit is configured to determine a control for the actuator to increase a volume of fluid in the inflatable element when the patient is underwater and a value related to the patient's altitude is greater than the fourth reference value; the control unit is configured to trigger control of the actuator after a time period has elapsed during which the patient's altitude value is greater than the first reference value or the patient is underwater and the patient's altitude value is less than a third reference value; the fluid reservoir includes a stationary portion and a movable portion, the actuator being mechanically coupled to the movable portion for linearly moving the movable portion relative to the stationary portion to vary the volume of the fluid reservoir; The at least one sensor comprises a sensor disposed within the casing, mechanically connected to the actuator and / or to a movable part of the fluid reservoir, and arranged to measure a tensile force and / or a compressive force in a direction of movement of the movable part of the fluid reservoir, the force measured comprising at least the force exerted by the moving part of the fluid reservoir in relation to the pressure in the fluid circuit; and a force applied to the movable portion of the fluid reservoir in relation to the pressure of the gas within the casing; Due to the control unit is configured to measure a pressure of fluid in the fluid circuit based on the measured force; the at least one sensor includes a gas pressure sensor within the casing; the at least one sensor includes an altimeter disposed within the casing and configured to measure a value related to an altitude of the patient; the device further comprises a control device external to the patient's body and suitable for being carried by the patient, the control device including an atmospheric pressure sensor and adapted to transmit a pressure measured by the atmospheric pressure sensor to the control unit in order to determine a value related to the patient's altitude; the control unit is configured to detect an altitude difference based on measurement data of the force sensor, the pressure sensor, or the altimeter; the control unit is configured to detect the altitude difference based on measurement data from a first sensor among the force sensor, the pressure sensor, and the altimeter, and to confirm the detected altitude difference based on measurement data from another sensor among the force sensor, the pressure sensor, and the altimeter; the control unit is configured to detect the altitude difference non-continuously; the control unit is configured to detect the altitude difference at regular intervals of 1 to 300 minutes, preferably 5 to 60 minutes, more preferably 5 to 15 minutes; the inflatable element is a closure cuff adapted to be placed around the anatomical conduit to selectively close the anatomical conduit; The device is configured to be implanted in a human or animal body for closure by the cuff, and the anatomical conduit is selected from at least the group consisting of the urethra, the gastric tract, the colon, and the rectum. [Brief explanation of the drawings]

[0011] Other features and advantages of the present invention will become apparent from the following detailed description when taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 shows an overview of an implantable medical device within a patient's body and a remote control device outside the patient's body. [Figure 2] FIG. 2 is a schematic cross-sectional view of the inside of a casing according to one embodiment. [Figure 3] FIG. 3 is a graph showing a rough outline of the reference values ​​to be taken into account for controlling the medical device when the patient stands up at a high level. [Figure 4] FIG. 4 is a graph that shows, in outline, the reference values ​​that are taken into account for controlling a medical device when a patient is in water. DETAILED DESCRIPTION OF THE INVENTION

[0012] As used herein, "patient" means a human or animal.

[0013] The present invention relates, inter alia, to active implantable medical devices that address urinary incontinence by means of artificial sphincters capable of closing anatomical conduits, inter alia, the urethra (in men) or the bladder neck (in women). More generally, however, the present invention relates to medical devices that include fluid circuits that are sensitive to pressure fluctuations caused by changes in altitude, inter alia. These other devices may include penile implants and restrictive gastric bands, inter alia.

[0014] By way of non-limiting example, an implantable medical device within a human or animal body is shown in FIGS.

[0015] Implantable devices are a sealed casing 1 containing a gas; an inflatable element 3 outside the casing, suitable for implantation inside the patient's body; a fluid circuit comprising a fluid reservoir 5 with a variable fluid volume, arranged together with the tube 2 within the casing and ensuring a fluid connection between said reservoir 5 and said inflatable element 3; an actuator 8 disposed within the casing 1 and mechanically coupled to a portion of the fluid reservoir 5 for selectively varying the volume of fluid within the fluid reservoir 5; a control unit 100 configured to control an actuator to move fluid between the reservoir and the inflatable element; Includes:

[0016] The fluid circuit is adapted to be filled with fluid. A change in the volume of the reservoir 5 causes a change in pressure within the fluid circuit. More specifically, a decrease in the volume of the reservoir 5 causes fluid to move from the reservoir 5 to the inflatable element 3, causing an increase in pressure within the fluid circuit. Conversely, an increase in the volume of the reservoir 5 causes fluid to move from the inflatable element 3 to the reservoir 5, causing a decrease in pressure within the fluid circuit.

[0017] The casing, tube and cuff are suitable for implantation in the body of a patient P, the outlines of which are shown diagrammatically in FIG. 1 on either side of this assembly.

[0018] It is particularly advantageous that a remote control device 9 external to the patient's body can be used by the patient or a third party to communicate wirelessly with the medical device.

[0019] Inflatable element The inflatable element 3 can be made of a biocompatible material such as implantable silicone, implantable polyurethane, etc. The inflatable element 3 can be made of a biocompatible elastomer, for example biocompatible silicone.

[0020] The inflatable element 3 may be an inflatable occlusion cuff, especially if the implanted system is an artificial urinary sphincter. The fluid-filled inflatable occlusion cuff 3 may be adapted to completely or partially surround the conduit to be closed.

[0021] Alternatively, the inflatable element 3 may be an inflatable penile implant, in which case the implantable system is, inter alia, an erectile prosthesis.

[0022] Fluid Connections The fluid connection 2 may consist of a tube arranged between the reservoir 5 and the inflatable element 3. A first end of the tube opens into the reservoir 5 and a second end of the tube opens into the inflatable element 3.

[0023] The fluid connection 2 can be made of a biocompatible material such as implantable silicone, implantable polyurethane, etc. The fluid connection 2 can be made of a biocompatible elastomer, for example biocompatible silicone.

[0024] Variable Volume Reservoir The reservoir 5 is composed of a portion that is stationary relative to the casing and a portion that is movable relative to the stationary portion, and this movable portion is moved by an actuator.

[0025] The reservoir 5 further includes an orifice for transferring fluid from the exterior of the reservoir 5 to the cuff 3 via the fluid connection 2 .

[0026] According to an advantageous but non-limiting embodiment, the fixed part of the reservoir comprises a part of the inner wall of the casing 1, and the movable part comprises a movable wall 6, which is preferably rigid, and a deformable bellows 7 extending between the movable wall 6 and the fixed part of the reservoir.

[0027] Actuator The actuator 8 is adapted to control the linear movement of the movable wall 6 , and the bellows 7 is adapted to expand and contract in response to the linear movement of the movable wall 6 controlled by the actuator 8 .

[0028] The actuator 8 can be selected from any electromechanical system capable of converting electrical energy into mechanical movement, the mechanical movement output of which is necessary to enable the force and movement at the required speed of the movable wall 6 of the variable volume reservoir 5. The actuator 8 can in particular be a piezoelectric actuator, an electromagnetic actuator including an electromagnetic motor with or without brushes coupled with a reduction gear, an electroactive polymer or a shape memory alloy.

[0029] The movable wall 6 can be translated along the longitudinal axis by the action of a drive screw 17 integral with the movable wall 6. The movable wall 6 is connected to the drive screw 17 via a nut 10 integral with the movable wall 6 and has an internal thread that cooperates with the thread of the screw 17. The drive screw 17 can extend substantially along the longitudinal axis. The position of the drive screw 17 can substantially correspond to the center of the movable wall 6.

[0030] The actuator 8 is suitable for driving the rotation of the drive screw 17, for example by rotating a pinion. Rotation of the drive screw 17 about its longitudinal axis drives the movable wall 6 to move along the longitudinal axis, which in turn causes the bellows 7 to expand and contract along the longitudinal axis.

[0031] The actuator 8 may include a motor 13 connected to a reduction gear. A connector 12 allows power to be supplied to the motor 13 according to the sequence of operation of the motor.

[0032] The reduction gear is connected to a toothed wheel 18 which is itself connected to the drive screw 17 and transmits the torque and rotation of the shaft of the motor 13 to the drive screw 17. The drive system therefore comprises a nut connected to the drive screw and rotatable on a double-acting thruster ball bearing about the axis of the screw under the effect of the driving action of the actuator 8, said nut being connected to the screw in such a way that rotation of said nut uniquely drives the screw to translate in the direction of movement of the moving part.

[0033] The rotation of the screw 17 drives the nut to move in parallel, which has the effect of moving the movable wall 6 in a direction parallel to the axis of the screw, i.e., in the direction of the longitudinal axis. The direction of movement of the movable wall 6 depends on the direction of rotation of the motor 13.

[0034] The toothed wheel 18 is housed within the block 15 by ball bearings 16 which allow it to rotate within the block 15 .

[0035] Control Unit The implantable system can include a control unit 100 configured to receive a pressure set point in the fluid circuit and to determine a reservoir volume 5 corresponding to the received pressure set point.

[0036] The control unit is also suitable for controlling the actuator 8 so as to move the movable wall 6 of the reservoir 5 to a position corresponding to the determined volume. More specifically, in the example shown in Figure 2, the control unit is suitable for issuing a command to the motor of the electromagnetic actuator 8 to move in one direction or the other depending on whether it is necessary to increase or decrease the volume of the reservoir 5.

[0037] casing The variable volume reservoir 5 and actuator 8 are incorporated into a hermetically sealed biocompatible casing 1 intended for implantation within a patient's body. A control unit 100 (not shown in FIG. 2) may also be incorporated into the casing 1. The casing encloses an energy source (not shown), for example, a primary or secondary battery suitable for powering the control unit, the actuator, and other components of the device requiring power.

[0038] The casing 1, and in particular the internal volume 11 of the casing 1 surrounding the reservoir 5, contains a gas, for example an inert gas.

[0039] The casing 1 can be made of titanium, which is a gas-tight and biocompatible material and can therefore be used to protect the elements placed in the casing 1, in particular electronic components such as the control unit, potential sensors, etc., from the external environment.

[0040] The casing 1 is sealed to prevent fluid or gas transfer to or from the body environment.

[0041] set The set may include the implantable device described above and a remote control suitable for use by the individual or persons in whom the system is implanted.

[0042] The implantable system and the remote control device comprise communication means suitable for communication therebetween, the remote control device being particularly suitable for controlling the movement of the movable part of the reservoir by the actuator 8 based on commands transmitted by the communication means of the remote control device to the communication means of the implantable device.

[0043] The communication means of the implantable device can be integrated into the casing 1.

[0044] sensor The casing 1 encloses one or more sensors 101, 102 and / or 103 suitable for measuring values ​​related to the altitude at which the patient in whom the medical device is implanted is located.

[0045] In certain embodiments, the casing may include a sensor 101 mechanically connected to the actuator 8 and / or the movable wall 6 of the variable volume reservoir 5. The sensor is suitable for measuring compressive and / or tensile forces in the direction of movement of the movable part of the reservoir 5 and may include a strain gauge based sensor or a pressure sensor coupled to a mechanism for measuring forces. When the actuator is inactive (volume of fluid in the reservoir is constant), variations in the force measured by the sensor are translated into variations in the fluid pressure in the hydraulic circuit.

[0046] In a particular embodiment, an absolute pressure sensor 102 can be located within the casing 1 and outside the reservoir, taking into account the gas pressure within the casing of the device and atmospheric pressure.

[0047] In certain embodiments, the atmospheric pressure sensor 90 can be located inside the remote control device 9 outside the patient's body.

[0048] In another embodiment, an altimeter 103 is included in the casing 1 .

[0049] In all cases, the measurements from these sensors (force, absolute and atmospheric pressure sensors, altimeter) can be correlated with the patient's altitude. For example, when the actuator is not activated, the patient's altitude value can be determined by measuring the pressure difference between the gas pressure in the casing, which is subject to atmospheric pressure fluctuations, and the fluid pressure in the reservoir.

[0050] The measurement data from each sensor is transmitted to a control unit, which processes them and compares them with reference values ​​to determine whether the volume of fluid in the inflatable element needs to be reduced. For ease of reading, the connections between the sensors and the control unit are not shown. These connections may be wired or wireless.

[0051] The above embodiments can be combined to utilize measurement data from different sensors, for example to determine the patient's altitude as reliably as possible.

[0052] Thus, for example, the control unit can determine an altitude value based on measurement data from a pressure sensor 102 and / or a force sensor 101 integrated in the casing 1 and can confirm the determined altitude based on measurement data from an atmospheric pressure sensor 90 in the remote control device 9 arranged outside the patient's body.

[0053] Alternatively, the altitude value can be determined based on atmospheric pressure measurements by a sensor 90 on the remote control device 9 outside the patient, and the determined altitude can then be confirmed based on measurement data from a pressure sensor 102 and / or force sensor 101 integrated into the casing.

[0054] When the control unit determines a difference between the altitude value and a reference value, it can activate the medical device to adjust the pressure in the fluid circuit, so that if the altitude value is such that high pressure in the fluid circuit poses a risk to the operation of the medical device, the control unit can activate the actuator to open the inflatable element, transfer fluid from the inflatable element to the reservoir, and deactivate the actuator until the altitude value returns to a value considered acceptable for the operation of the device.

[0055] To avoid inappropriate deactivation of the medical device (e.g., when the patient is not actually at the detected altitude or when the patient remains at the altitude for a short period of time), the control unit may be configured to confirm the altitude determined by the first sensor via measurement data from the second sensor, as described above. Alternatively or additionally, the control unit may wait a predetermined period of time, e.g., several minutes, during which the determined altitude is maintained before issuing a command to reduce the volume of fluid in the inflatable element.

[0056] The measurements performed by the sensor and the processes performed by the control unit are preferably not performed continuously but at regular intervals to avoid excessive power consumption, for example, 1 to 300 minutes, preferably 5 to 60 minutes, more preferably 5 to 15 minutes.

[0057] If the patient ascends When a patient increases altitude, such as when hiking or on an airplane, the air pressure decreases.

[0058] Above an altitude of 3,000 meters, the fluid pressure in the fluid circuit becomes too high for the actuator to move the moving part of the variable volume reservoir and open the inflatable element.

[0059] To avoid such a situation, when the control unit detects that the patient is at an altitude higher than a first reference value (denoted as A1 in the graph of Figure 3), the control unit controls the actuator to open the inflatable element by increasing the volume of the reservoir.

[0060] FIG. 3 is a graph that shows, in a simplified manner, the reference values ​​that are taken into account for controlling the medical equipment when the patient's altitude A varies over time t.

[0061] When the patient exceeds altitude A1, the control unit activates the actuator at time t1, either coincident with passing altitude A1 or a short period of time (e.g., several minutes) later, to increase the volume of the reservoir to open (i.e., at least partially deflate) the inflatable element.

[0062] While the patient remains at an altitude above A1, the actuator is deactivated to keep the inflatable element open.

[0063] The second reference value A2 advantageously defines an altitude above which the control unit can optionally re-actuate the actuator to transfer fluid into the inflatable element.

[0064] The value A2 is advantageously selected to be less than A1 to avoid a situation where the control unit activates and stops the actuator multiple times in a relatively short period of time if the patient remains at an altitude that fluctuates around A1 for a certain period of time.

[0065] When the patient descends to altitude A2, the control unit activates the actuator at time t2, either coincident with the passage of altitude A2 or a short period of time (e.g., several minutes) later, to reduce the volume of the reservoir to at least partially inflate the inflatable element.

[0066] In other embodiments, it is possible for the control unit to stop operation of the actuator until the patient visits a physician who is solely authorized to reactivate the actuator for normal operation of the medical device.

[0067] If the patient is in water If the patient is below sea level or another water surface, they will be subjected to pressures that increase on the order of 1 bar for every 10 metres of depth. For consistency with the previous discussion, depth will be considered as a negative altitude below sea level or the considered water surface. Thus, altitude is always referenced, and the lower the altitude, the greater the depth of immersion.

[0068] In this situation, overpressurization of the fluid circuit can damage the medical device.

[0069] FIG. 4 is a graph that shows, in a simplified manner, the reference values ​​that are taken into account for controlling the medical equipment when the altitude A of the patient in water changes over time t.

[0070] When the patient descends below altitude A3, the control unit activates the actuator at time t3, either coincident with passing altitude A3 or a short period of time (e.g., several minutes) later, to increase the volume of the reservoir to open (i.e., at least partially deflate) the inflatable element.

[0071] While the patient remains at an altitude below A3, the actuator is deactivated to keep the inflatable element open.

[0072] The second reference value A4 advantageously defines an altitude above which the control unit can optionally re-actuate the actuator to transfer fluid into the inflatable element.

[0073] The value A4 is advantageously selected to be greater than A3 to avoid a situation where the control unit activates and stops the actuator multiple times in a relatively short period of time if the patient remains at an altitude fluctuating around A3 for a certain period of time.

[0074] If the patient ascends back to altitude A4, the control unit will activate the actuator at time t4, either coincident with the passage of altitude A4 or a short period of time (e.g., several minutes) later, to reduce the volume of the reservoir to at least partially inflate the inflatable element.

[0075] In other embodiments, it is possible for the control unit to stop operation of the actuator until the patient visits a physician who is solely authorized to reactivate the actuator for normal operation of the medical device.

Claims

1. A medical device, a sealed casing containing a gas and suitable for implantation within a human or animal patient; an inflatable element outside the casing, suitable for implantation within the patient's body; a fluid circuit including a fluid reservoir with a variable fluid volume and arranged within the casing together with a tube ensuring a fluid connection between the fluid reservoir and the inflatable element; an actuator disposed within the casing and mechanically coupled to the fluid reservoir for selectively varying a volume of fluid within the fluid reservoir; a control unit configured to control the actuator to move the fluid between the fluid reservoir and the inflatable element; at least one sensor suitable for measuring a value related to the absolute pressure of the fluid in the fluid circuit, the force on the fluid reservoir, the gas pressure in the casing, the atmospheric pressure or the altitude of the patient; Including, The control unit detecting a difference between a value related to the patient's altitude and a reference value based on measurements from the sensor while the actuator is not activated; determining a command to be issued to the actuator as a function of the difference to control the pressure of the fluid in the fluid circuit; The medical device is further configured to:

2. 2. The device of claim 1, wherein the control unit is configured to control the actuator to reduce a volume of fluid in the inflatable element when the patient's altitude value is greater than a first reference value.

3. 3. The device of claim 2, wherein the control unit is further configured to maintain the reduced volume of fluid in the inflatable element as long as the patient's altitude value is greater than the first reference value or the patient's altitude value is between the first reference value and a second reference value that is less than the first reference value.

4. 4. The device of claim 3, wherein the control unit is configured to determine a command to the actuator to increase a volume of fluid in the inflatable element if the patient's altitude value is less than the second reference value.

5. 5. The device of claim 4, wherein the control unit is configured to control the actuator to reduce a volume of fluid in the inflatable element when the patient is underwater and a value related to the patient's altitude is less than a third reference value.

6. 6. The device of claim 5, wherein the control unit is further configured to maintain the reduced volume of fluid in the inflatable element as long as the patient is underwater and the patient's altitude value is less than the third reference value or the patient's altitude value is between the third reference value and a fourth reference value greater than the third reference value.

7. 7. The device of claim 6, wherein the control unit is configured to determine a command to the actuator to increase a volume of fluid in the inflatable element when the patient is underwater and a value related to the patient's altitude is greater than the fourth reference value.

8. 8. The apparatus of claim 2, wherein the control unit is configured to control the actuator after a predetermined period of time has elapsed since the patient's altitude value is greater than the first reference value or the patient is underwater and the patient's altitude value is less than a third reference value.

9. 9. The device of claim 1, wherein the fluid reservoir comprises a stationary portion and a movable portion, and the actuator is mechanically coupled to the movable portion for linearly moving the movable portion relative to the stationary portion to vary the volume of the fluid reservoir.

10. The at least one sensor comprises a force sensor arranged within the casing, mechanically connected to the actuator and / or to a movable part of the fluid reservoir, and arranged to measure a tensile force and / or a compressive force in a direction of movement of the movable part of the fluid reservoir, the force measured comprising at least a force exerted by a movable portion of the fluid reservoir in relation to the pressure in the fluid circuit; and a force applied to the movable portion of the fluid reservoir in relation to the pressure of the gas within the casing; Due to The apparatus of claim 9 , wherein the control unit is configured to measure a pressure of fluid in the fluid circuit based on the measured force.

11. The device of claim 10 , wherein the at least one sensor includes a gas pressure sensor within the casing.

12. The device of claim 11 , wherein the at least one sensor comprises an altimeter disposed within the casing and configured to measure a value related to the patient's altitude.

13. 13. The apparatus of claim 12, further comprising a control device external to the patient's body and suitable for carrying by the patient, the control device including an atmospheric pressure sensor and adapted to communicate pressure measured by the atmospheric pressure sensor to the control unit to determine a value related to the patient's altitude.

14. The device of claim 13 , wherein the control unit is configured to detect an altitude difference based on measurement data of the force sensor, the atmospheric pressure sensor, or the altimeter.

15. 15. The apparatus of claim 14, wherein the control unit is configured to detect the altitude difference based on measurement data from a first sensor among the force sensor, the atmospheric pressure sensor, and the altimeter, and to confirm the detected altitude difference based on measurement data from another sensor among the force sensor, the pressure sensor, and the altimeter.

16. 16. The apparatus of claim 15, wherein the control unit is configured to detect the altitude difference non-continuously.

17. 17. The apparatus of claim 16, wherein the control unit is configured to detect the altitude difference at regular intervals of 1 to 300 minutes.

18. 18. The device of any one of claims 1 to 17, wherein the inflatable element is a closure cuff suitable for placement around an anatomical conduit to selectively close the anatomical conduit.

19. 20. The device of claim 18, wherein the device is configured to be implanted in a human or animal body for closure by the closure cuff, and the anatomical conduit is selected from at least the group consisting of the urethra, the gastric tract, the colon, and the rectum.

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