EP4138726A1

EP4138726A1 - Method for adjusting a fill level of a liquid balloon of a medical device, and medical device comprising a liquid balloon for forming artificial sphincters

Info

Publication number: EP4138726A1
Application number: EP21719551.0A
Authority: EP
Inventors: Martin Hohlrieder; Roland Huber
Original assignee: AMI Agency for Medical Innovations GmbH
Current assignee: AMI Agency for Medical Innovations GmbH
Priority date: 2020-04-23
Filing date: 2021-04-13
Publication date: 2023-03-01
Also published as: WO2021213834A8; AU2021261453A1; US20230141054A1; WO2021213834A1; AT523786A1; CA3176396A1

Abstract

The invention relates to a device comprising: a liquid balloon (1); a pump unit (5) connected to the liquid balloon (1) via a hose (3) to pump liquid into the liquid balloon (1) and to pump liquid out of the liquid balloon (1), which pump unit has a receiving chamber (10) that can be filled with liquid, the volume of which chamber can be changed by moving an adjustment part (11) of the pump unit (5) by means of an electric motor (6) fed by a battery (7); an electronic control unit (8) for controlling the electric motor (6); and at least one pressure sensor (20) for detecting the pressure of the liquid in the receiving chamber (10), characterised in that the device also has a position sensor for detecting the position of the adjustment part (11). In a method for adjusting the fill level of the liquid balloon (1), the volume of a receiving chamber (10) of the pump unit (5) filled with liquid is changed by moving an adjustment part (11) of the pump unit (5) by means of an electric motor (6) fed by a battery (7), wherein an adjustment process of the adjustment part (11) is performed by a control unit (8) controlling the electric motor (6). The adjustment process comprises controlling the path of the adjustment part (11) to approach a target position of the adjustment part (11) and, after this path control, checking whether the pressure of the liquid in the receiving chamber (10) lies within an admissible filling pressure range around the second filling pressure. If necessary, the position of the adjustment part (11) is adjusted once more.

Description

A METHOD OF ADJUSTING A FILLING STATE OF A LIQUID BALLOON OF A MEDICAL EQUIPMENT, AND A MEDICAL EQUIPMENT INCLUDING A LIQUID BALLOON FOR THE EDUCATION OF

ARTIFICIAL FINAL MUSCLES

The invention relates to a method for setting a first filling state of a liquid balloon with a first filling pressure and a differently filled second filling state of the liquid balloon with a second filling pressure Liquid-filled receiving space of a pump unit, which is connected to the liquid balloon via a hose, is changed by moving an actuator of the pump unit by means of an electric motor fed by a battery and for setting the second filling state of the liquid balloon starting from the first filling state of the liquid balloon by an electric motor controlling control unit a setting process of the

Actuating part is carried out, the pressure of the liquid is detected in the receiving space. The invention also relates to a device comprising a

Liquid balloon, a pump unit connected to the liquid balloon via a hose for pumping liquid into the liquid balloon and for pumping liquid out of the liquid balloon, which has a receiving space that can be filled with liquid, the volume of which is obtained by moving an actuator of the pump unit by means of an electric motor powered by a battery is changeable, an electronic control unit for controlling the electric motor and at least one pressure sensor for detecting the pressure of the liquid in the receiving space.

In the medical field, liquid balloons that can be filled with a liquid and that can be closed to form a ring are used to develop artificial sphincters (= artificial sphincters), e.g. for the urethra. In order to close the artificial sphincter, liquid is pumped into the inner chamber of the liquid balloon, which is closed in a ring around a body channel to be blocked, in order to expand the inner wall of the liquid balloon against the hollow organ to be blocked. In order to open the body channel, the fluid is emptied from the chamber of the fluid balloon.

A manually operated pump for pumping the liquid from the chamber of the liquid balloon is usually implanted in the scrotum of an artificial urethral sphincter for male patients. The liquid can be pumped by applying pressure to a flexible part of the pump. The urethra is then automatically closed by pumping fluid back into the inner chamber of the fluid balloon through a resilient element of the pump.

Medical devices for constricting or shutting off a body canal are also used elsewhere in the human body, for example to form an artificial sphincter for an, possibly artificial, anus, as gastric bands to constrict the gastrointestinal tract or as bands to close a passage for Bile. Such medical facilities are also known as cuffs, cuffs or artificial sphincters. For example, US Pat. No. 5,478,305 A reveals a medical device which is referred to in this document as a cuff and can be used for the treatment of urinary or fecal incontinence. The cuff is made of silicone. By filling the cuff with fluid, the pressure in the cavity of the cuff increases and closes the body channel. Examples of gastric bands emerge from EP 1389 453 B1.

A method and a device of the type mentioned above emerge from WO 2017/205883 A1. A pump unit driven by an electric motor, a battery for power supply and an electronic control unit are arranged in a housing that can be implanted in the human body. The pressure of the liquid in the receiving space of the pump unit is recorded by a pressure sensor. In order to fill a liquid balloon placed in a ring around a body channel and thereby shut off the body channel, liquid is pumped into the chamber of the liquid balloon by means of the pump unit. The control unit sets the pressure to a specific setpoint.

The object of the invention is to provide a method or a device of the type mentioned at the outset which enables the battery to consume as little energy as possible. According to the invention, this is achieved by a method having the features of claim 1 or by a device having the features of claim 8.

In the method according to the invention, the adjusting process, which is carried out by the control unit, comprises a path control of the adjusting part of the pump unit in order to move to a target position of the adjusting part. Here is a respective position (= Actual position) of the control part recorded by means of a displacement transducer. Such a path control in order to move to a target position of the actuator can be carried out in a very efficient and energy-saving manner. In particular, the regulation can be carried out as a discontinuous regulation. In order to achieve a second filling state starting from a first filling state of the liquid balloon, it is particularly preferred to carry out a two-point control, ie the control unit only controls the electric motor via the switching states "on" and "off". The controlled variable here is the position of the actuating part, which is recorded by means of the displacement transducer.

Subsequent to this position regulation, there is a check as to whether the pressure of the liquid in the receiving space is within a permissible filling pressure range. The filling pressure range extends around the second filling pressure to which the pressure of the liquid is to be brought in the second filling state of the liquid balloon. If the pressure in the receiving space of the pump unit is not within this permissible filling pressure range, the position of the control part is readjusted. This process (checking the pressure in the receiving space and, if necessary, adjusting the position of the actuating part) can be carried out repeatedly.

In order to determine the target position of the actuating part if, starting from a first filling state of the liquid balloon with a first filling pressure, a differently filled second filling state of the liquid balloon with a second filling pressure is to be achieved, a characteristic curve stored in the control unit is favorably used, which shows the dependency between the position of the actuating part and the pressure of the liquid in the receiving space of the pump unit. This characteristic curve, which is preferably applied as a straight line from which the gradient is stored in the control unit, is expediently recorded in a preceding learning cycle. In such a learning cycle, two or more positions of the control part can be approached and the pressure of the liquid in the receiving space can be determined in each case. From these recorded value pairs, a straight line can be determined against which the smallest deviations from these value pairs exist (for example, the sum of the amounts of the deviations or the sum of the squares of the deviations can be minimized).

An advantageous development provides that if the position of the control part is readjusted in the course of an adjusting process, the slope of the straight line is changed proportionally to the size of the readjustment of the position of the control part. The characteristic curve is therefore adapted for subsequent control processes.

Should the position of the control part need to be readjusted after the position control of the control part has been carried out, since the pressure in the receiving space is outside the permissible filling pressure range, an advantageous embodiment of the invention provides that the target position of the control part is modified and from the Control unit a further path control of the actuator to approach the modified target position is carried out.

In an advantageous device according to the invention it is provided that the pumping device comprises a bellows within which the receiving space for the liquid is located, wherein an end piece of the bellows is rigidly connected to the actuating part. The actuating part can in particular have an external thread which interacts with an internal thread of an adjusting ring that can be rotated by the electric motor. The adjusting ring can in this case have a toothing, in particular on its outer circumference, which interacts with a worm wheel driven by the electric motor. A robust and precise adjustment of the control part can thereby be achieved, the position of the control part being fixed in the state in which the electric motor is not supplied with energy.

A device according to the invention can advantageously form an artificial sphincter, in particular urethral sphincter, the liquid balloon being designed in the form of a flexible band that can be closed to form a ring with a longitudinal inner chamber that can be filled with the liquid.

As a result of the low energy consumption made possible by the invention, a long service life can be achieved until it is necessary to replace the battery. If the battery is designed to be rechargeable, a less frequent need for charging the battery can be achieved.

Further advantages and details of the invention are explained below with reference to the accompanying drawing. In this show:

1 shows a device according to the invention in the implanted state;

2 and 3 a side view and view of the motorized actuating unit; FIG. 4 shows a section along the line AA from FIG. 3 in a first position of the actuating part; FIG.

FIG. 5 shows a section corresponding to FIG. 4 in a second position of the actuating part; FIG.

Fig. 6 is an exploded view;

7 shows an oblique view of the plate of the displacement transducer, which is electrically connected to the electronic control unit and has the spiral-shaped conductor track;

8 shows an oblique view of the bellows of the pump unit; 9 shows an oblique view of the liquid balloon closed to form a ring;

10 shows an axial view of the liquid balloon closed to form a ring in the unfilled state of the inner chamber;

11 shows a section along the line BB of FIG. 10; FIG. 12 shows an illustration corresponding to FIG. 10 in the filled state of the inner chamber; FIG.

Fig. 13 is a side view of the manual operating unit; 14 is a plan view of the manual operating unit; FIG. 15 shows a section along the line CC of FIG. 13 in the inactivated state of the manual operating unit; FIG.

16 shows a section analogous to FIG. 15 in the actuated state of the manual actuation unit;

FIG. 17 shows a section along the line DD from FIG. 14 in the closed state of the shut-off valve; FIG.

18 shows a section corresponding to FIG. 17 in the open

Condition of the shut-off valve;

19 is an exploded view of the manual

Actuation unit;

FIG. 20 is a diagram showing the learning cycle and the determination of the characteristic curve; FIG. 21 shows a diagram for explaining the setting of a second filling state based on a first filling state of the liquid balloon.

An embodiment of a device according to the invention is shown in the figures.

A liquid balloon 1 is designed in the form of a flexible band with a longitudinally extending inner chamber la. The liquid balloon can be closed to form a ring by means of closure parts 1b, 1c arranged at the two end regions, whereby it can be placed in a ring around a body channel, here the urethra 2, see FIG. 1.

When the liquid balloon 1 is closed to form a ring and the chamber la is emptied, the liquid balloon 1 closed to form a ring has a passage opening ld, see FIG. 10. By pumping liquid into the chamber la, the size of the passage opening ld can be reduced , see Fig. 11.

A pump unit 5, which is connected to the liquid balloon 1 via a hose 3 and which is arranged in a motorized actuation unit 50 that can be implanted in the body, is used to pump liquid into the liquid balloon 1 and pump out liquid from the liquid balloon 1. This motorized actuation unit 50 has a housing 4 in which, apart from the pump unit 5, an electric motor 6 for driving the pump unit 5, a battery 7 for supplying energy to the electric motor 6 and an electronic control unit 8 are arranged, which controls the electric motor 6 and thus also the Pump unit 5 is controlled and also fed by battery 7. In the exemplary embodiment, the housing 4 comprises a half-shell-shaped upper housing part 4a and a half-shell-shaped lower housing part 4b, which are connected to one another in a gas-tight manner. The interior of the housing 4 is thus insulated in a gas-tight manner from the surroundings of the housing 4.

The pump unit 5 has a bellows 9, in particular a bellows. The bellows 9 encloses a receiving space 10 in which a liquid, for example water, is located. Furthermore, the pump unit 5 has an actuating part 11 which is rigidly connected to an end piece 9a of the bellows, in the exemplary embodiment by means of screws 12. The actuating part 11 has a bottom 11a connected to the end piece 9a of the bellows 9 and a base 11a surrounding the bellows 9 on the outside Sleeve section with an external thread 11b. With the external thread 11b there is an internal thread 13a of an adjusting ring

13 engaged. The adjusting ring 13 is rotatably mounted in a bearing housing 14. For the rotatable mounting of the adjusting ring 13 in the bearing housing 14, a ball bearing 15 can in particular be provided as shown. The adjusting ring 13 also has a toothing 13b surrounding it on the outside. A worm wheel 16 driven by the electric motor 6 is in engagement with the teeth 13b of the adjusting ring. The worm wheel 16 can be arranged directly on the motor shaft 6 a of the electric motor 6.

In the exemplary embodiment, the electric motor 6 is on the bearing housing

14 and the motor shaft 6a is rotatably supported at the end by a bearing ring 17 relative to the bearing housing 14.

On the end membrane 9b of the bellows 9 delimiting the interior of the bellows 9 in the axial direction of the bellows 9, strain gauges are applied, for example sputtered on, as indicated in FIG. By means of these strain gauges, a pressure sensor 20 is used to detect the pressure that acts between the receiving space 10 of the bellows 9 and the space surrounding the bellows 9 (= interior of the housing 4). Such pressure sensors designed by means of strain gauges are known per se.

The pressure sensor 20 is electrically connected to the control unit 8.

A plate 18, which has a spiral-shaped conductor track 18a, is rigidly connected to the actuating part 11. In the exemplary embodiment, the plate 18 is arranged between the actuating part 11 and the end piece 9 a of the bellows 9. The plate 18 serves as a distance sensor from the section 19 of the wall of the housing 4 that is opposite the plate.

The conductor track 18a of the plate 18 is electrically connected to the control unit 8. In the exemplary embodiment, a flexible conductor track carrier 24 running from the plate 18 in the shape of a screw surface to the control unit 8 is provided for this purpose.

When the electric motor 6 is actuated by the control unit 8, it adjusts the adjusting part 11 in the axial direction of the adjusting part 11 via the worm gear formed between the electric motor and the adjusting ring 13 and the screw gearing formed between the adjusting ring 13 and the adjusting part 11 Helical gear and the bellows 9. This changes the volume of the receiving space 10.

A remote control 21 is preferably provided for operating the device. A wireless data transmission takes place between the remote control 21 and the control unit 8. The remote control 21 has operating elements 22. These can be used to switch between an open and closed state of the device. In the open state there is a first filling state of the liquid balloon 1 with a first filling pressure and in the closed state there is a differently filled second filling state of the liquid balloon with a second filling pressure which is higher than the first filling state.

In the remote control 21 there is also an air pressure sensor 23 for detecting the atmospheric pressure pU, the meaning of which is explained in more detail below.

To detect the air pressure pG in the hermetically sealed housing 4, a housing air pressure sensor 48 is arranged in the housing 4, the meaning of which is explained in more detail below.

In addition to the motorized actuation unit 50, there is preferably also a manual actuation unit 51 with which the device can be switched manually between the open and closed state, in particular in the event that the motorized actuation unit 50 should fail. The manual operating unit 51 is explained in more detail below. A learning cycle for determining a characteristic curve which reproduces the dependency between the position of the actuating part and the pressure of the liquid in the receiving space of the pumping device is explained below with reference to FIG. 20. Such a learning cycle is carried out in particular when the device is started up for the first time and can, if necessary, be repeated at later points in time. To carry out the learning cycle, the device is filled with liquid. The learning cycle is preferably carried out in the implanted state of the device. In principle, it would also be conceivable and possible to carry out the learning cycle with the device located outside the body. For this purpose, the liquid balloon could be placed around an element, in particular a tubular element, which corresponds to the urethra in its dimensions and possibly in its elasticity.

Several different positions of the control element are approached to record the characteristic. With the detection of the actual positions of the actuating part 11 by means of the displacement transducer 18, 19, the control unit 8 carries out a displacement control for moving to the desired target positions sl, s2, s3 and s4, based on an initial position in which the lowest filling pressure is present in the liquid balloon. Starting from this starting position, the position regulation is carried out by the control unit 8 as a discontinuous regulation, preferably as a two-point regulation, which uses only "motor on" and "motor off" as control values. When a respective target position sl, s2, s3 and s4 is reached, a certain relaxation time is awaited. Within this, the fluid pressure in the system is equalized, so that the pressure in the receiving space of the pump unit drops. The pressure pl, p2, p3, p4 is then applied the respective approached position sl, s2, s3 and s4 are recorded and the position and pressure values are saved.

The characteristic is set as a straight line. An optimized straight line is thus determined from the stored value pairs, in which the sum of the amounts of the deviations of the pressure values p1, p2, p3, p4 or the sum of the squares of the deviations of the pressure values p1, p2, p3, p4 from the straight line are smallest . The slope k of this straight line is saved.

In principle, it would also be conceivable and possible to record the characteristic curve by approaching only two positions of the actuating part and determining the associated pressure values, the straight line running through these two pairs of values. However, it is preferred to record the characteristic curve by approaching more than two positions of the actuating part.

After the characteristic curve has been recorded, it is also possible to change the amount of liquid in the device in order to adapt the working range of the pump unit 5 (that is to say the range over which the actuating part 11 is moved). The slope of the straight line of the characteristic can be assumed to be unchanged here. A renewed recording of the characteristic is also conceivable and possible.

The setting of a second filling state of the liquid balloon 1 based on a first filling state is explained below with reference to FIG. 21. Fig.

21 shows the course of the pressure p of the liquid in the receiving space 10 of the pump unit 5 as a function of the time t. In the first filling state of the liquid balloon 1, the control part is in an initial position sA. The pressure p of the liquid in the receiving space 10 of the pump unit 5 has an initial value pA. In the static state, the pressure pA of the liquid in the receiving space corresponds to the filling pressure in the liquid balloon.

To now the second filling state of the

To set liquid balloons 1, the end position sE to which the control element 11 is to be brought is determined on the basis of the slope of the characteristic curve. The end position sE is calculated as follows: sE = sA + k * (pE - pA). pE corresponds to the desired second filling pressure.

In particular, it can be provided that the liquid balloon 1 should only assume two different states, which correspond to an open state and a closed state of the device, the filling pressure pE in the liquid balloon being greater than the filling pressure pA in the open state in the closed state of the device -State.

The control unit 8 now controls the position of the actuating part 11 with the desired end position sE as the target position. This position control is advantageously carried out as a discontinuous control, preferably as a two-point control with the control values "motor on" and "motor off". In this position control, the actual position of the control element 11 is continuously recorded by means of the position transducer 18, 19 and the control value "motor on" is first sent to the electric motor 6. The end position sE of the control element 11 minus a specified latency distance is set as the switch-off position When the actuator 11 reaches this switch-off position, the electric motor 6 is switched off. This enables the position control to be ended. However, after the electric motor 6 has been switched off, a check can also be carried out to determine whether the desired target position sE has been reached within a specified tolerance range, and if not , the latency distance can be adapted for subsequent path controls and / or a further path control can be carried out to reach the target position within the tolerance range.

After the path control has been completed, a specified latency time tL is awaited in which the

Can equalize fluid pressure in the facility. During the latency period tL, the pressure of the liquid in the receiving space will therefore drop, see FIG. 21. After this latency period has elapsed, the pressure is recorded by means of the pressure sensor 20. The solid line in FIG. 21 shows the situation in which the pressure p in the receiving space after the latency time tL lies within a permissible filling pressure range Dr around the desired filling pressure pE. It is then not necessary to readjust the position of the actuator.

The desired filling pressure pE is preferably in the middle of the filling pressure range Dr. For example, the filling pressure range Dr can be in the range from +/- 1% to +/- 5% around the value of the filling pressure pE. The situations in which the pressure p in the receiving space is above or below the permissible filling pressure range Δr around the desired pressure pE after the latency period has elapsed are drawn in with dotted or dashed lines in FIG. In these situations, the position of the control part 11 is readjusted, so that after the position of the control part 11 has been readjusted, the pressure p in the receiving space lies within the permissible filling pressure range.

This readjustment of the position of the control part is preferably carried out by means of a further position control of the control part, which in turn is advantageously carried out as a discontinuous control, preferably as a two-point control. However, it would also be conceivable and possible for the position of the control part to be readjusted in predetermined steps, that is to say that the control part 11 is moved by a predetermined step in the appropriate direction until it is determined that the pressure p in the receiving space within the filling - Pressure range Dr is.

If the position of the actuating part is readjusted, the slope k of the characteristic curve is preferably adapted. The new slope kb can be determined from the previous slope ka using the following relationship:

The constant α is between 0.1 and 0.9, preferably between 0.5 and 0.9. Osmosis effects, which could possibly change the volume of the liquid in the device, can also be compensated for.

In order to determine the pressure of the liquid in the receiving space 10 of the pump unit 5, the air pressure in the housing 4 and a change in the atmospheric pressure are taken into account. The pressure sensor 20 detects the differential pressure between the two sides of the end membrane 9b of the bellows 9. Da on the liquid balloon 1 and thus also on the im

If the liquid contained in the liquid balloon acts at atmospheric pressure pU, the pressure acting on the liquid side on the end membrane 9b is the sum of the liquid pressure p and the atmospheric pressure pU. The air pressure pG present within the housing 4 is present on the opposite side of the end membrane 9b. Since the housing 4 is hermetically sealed, it changes only as a function of the volume that the bellows 9 occupies in its respective position, that is to say in the respective position of the actuating part 11. The pressure value pS output by the pressure sensor 20 thus results in: pS = p + pU - pG.

In order to determine the pressure of the liquid in the receiving space 10 of the pump units 5, the atmospheric pressure pU, which is output by the air pressure sensor 23, and the air pressure pG inside the housing (and outside the housing) are subtracted from the pressure value pS output by the pressure sensor 20 Bellows), which is output from the housing air pressure sensor 48.

Preferably, after each setting process carried out by the control unit 8, the one in the receiving space 10 of the Pump unit 5 stored pressure p of the liquid. Before a new adjustment process, a check is made as to whether the current pressure p of the liquid in the receiving space 10 of the pump unit 5 is still within a tolerance range around the stored value of the pressure p. If this is not the case, this can essentially be due to the following reasons:

The liquid balloon 1 could have been opened by means of the manual actuation unit 51. When the liquid is then again pumped into the liquid balloon 1 by means of the manual actuation unit 51, the pressure p of the liquid in the receiving space 10 can be checked again. If it cannot be achieved in this way that the pressure p is in the specified range, it is assumed that there is a leak and it is therefore necessary to check the device.

The manual actuation unit 51 has a flexible pump body 30 which is connected to the liquid balloon 1 via a connecting line 31. Furthermore, the manual actuation unit 51 has a manually openable shut-off valve 32 which is arranged between two sections 31a, 31b of the connecting line 31. In an open position of the shut-off valve 32, the two sections 31a, 31b of the connecting line are connected to one another in a fluid-conducting manner. In a closed position of the shut-off valve 32, the fluid-conducting connection between the two sections 31a, 31b is interrupted.

The first section 31a of the connecting line 31, which is formed by a hose, connects the shut-off valve 32 to the inner chamber la of the liquid balloon 1. The The second section 31b of the connecting line 31, which is made significantly shorter than the first section 31a, connects the shut-off valve 32 to a pump chamber 33 arranged in the pump body 30.

The volume of the pump chamber 33 arranged in the pump body 30 can be reduced by a manually exertable actuating force of the user acting on the pump body 30. For this purpose, in particular two opposite side walls 34, 35 of the pump body 30 can be pressed together until they are brought into contact. At least one of the side walls 34, 35, preferably both side walls 34, 35, have a plurality of elevations 36 on its side lying in the interior of the pump chamber 33. In the completely compressed state of the side walls 34, 35, they rest against one another via the elevations 36. The elevations can in particular be ribs which are spaced apart from one another and preferably run in parallel.

The second section 31b of the connecting line 31, which runs through a connecting wall 37 of the pump body, which connects the opposite side walls 34, 35, opens at one point into the pump chamber 33, which in the completely compressed state of the opposite side walls 34, 35 in the area of a recess which is located between or next to the elevations 36 of the at least one side wall 34, 35. In a sectional view orthogonal to the longitudinal direction of the pump body 30, the connecting line 31 opens into the pump chamber 33 in the area between two elevations 36 of the same side wall 34, 35 , 35 liquid flow out of the pumping chamber 33 (when the Shut-off valve 32).

It would also be conceivable and possible for the elevations 36 to end at a distance from the connecting wall 37.

The shut-off valve 32 has a closure member 39 which is mounted displaceably in a valve housing 38. Starting from a closed position in which the closure member 39 is sealed off from a valve seat 41 by means of a seat seal 40, the closure member 39 can be displaced against the force of a return spring 42 into an open position. For this purpose, an actuating button 43 connected to the closure member 39 or formed in one piece with it is pressed in.

The return spring 42 is supported on a closure part 45 which is screwed into the valve housing 38. The closure part is cup-shaped and sealed off from the environment by a port 46. Port 46 is used to introduce liquid into the device by piercing it with a cannula. In this case, openings 47 are made in the cup-shaped closure part 45.

The shut-off valve 32 and the pump body 30 are advantageously formed integrally with one another. This integral unit also comprises the second section 31b of the connecting line 31.

There is preferably an envelope 44 which envelops the shut-off valve 32 and is formed in one piece with the pump body 30.

In order to manually empty the liquid balloon 1, the The shut-off valve 32 is opened by pressing the actuating button 43, whereby liquid can flow out of the chamber 1 a of the liquid balloon into the pump chamber 33 of the pump body 30.

In order to fill liquid into the chamber la of the liquid balloon 1, the shut-off valve 32 is opened by pressing the actuating button 43 and the side walls 34, 35 of the pump body 30 are pressed together until they abut against one another. After releasing the actuating button 43, a backflow of liquid from the chamber 1 a of the liquid balloon 1 is blocked.

It would also be conceivable and possible to design the shut-off valve 32 to be self-opening when the pump body 30 is compressed, for example by appropriately dimensioning the return spring 42.

When designed as an artificial urethral sphincter, the manual actuation unit 51 is preferably implanted in the scrotum.

The manual actuation unit 51 together with the connecting line 31 could in principle also be omitted.

Legend

To the reference numbers

1 liquid balloon 21 remote control la chamber 22 control element lb closure part 23 air pressure sensor lc closure part 24 conductor track carrier ld passage opening 30 pump body

2 urethra 31 connecting line

3 hose 31a first section

4 housing 31b second section

4a upper housing part 32 shut-off valve 4b lower housing part 33 pumping chamber

5 pumping unit 34 side wall

6 electric motor 35 side panel

6a motor shaft 36 elevation

7 Battery 37 Connection wall

8 Control unit 38 valve housing

9 bellows 39 closure link

9a end piece 40 seat seal

9b end membrane 41 valve seat

10 receiving space 42 return spring

11 Control part 43 Control button

11a bottom 44 envelope

11b external thread 45 closure part

12 screw 46 port

13 Adjusting ring 47 opening

13a internal thread 48 housing air pressure sensor

13b toothing 50 motorized

14 Bearing housing actuation unit

15 ball bearings 51 manual

16 worm gear actuation unit

17 bearing ring

18 tiles

18a conductor track

19 section

20 pressure sensor

Claims

1. A method for setting a first filling state of a liquid balloon (1) with a first filling pressure and a differently filled second filling state of the liquid balloon (1) with a second filling pressure, whereby for pumping in liquid into the liquid balloon (1) and for pumping out liquid the liquid balloon (1) the volume of a liquid-filled receiving space (10) of a pump unit (5), which is connected to the liquid balloon (1) via a hose (3), by moving an actuating part (11) of the pump unit (5) by means of an electric motor (6) fed by a battery (7) is changed and, in order to set the second filling state of the liquid balloon (1) starting from the first filling state of the liquid balloon (1), a control unit (8) controlling the electric motor (6) controls an actuating process of the actuator (11) is carried out, the pressure of the liquid in the receiving space (10) is detected, characterized in that the actuating process comprises a position control of the control part (11) for moving to a target position of the control part (11), a respective position of the control part (11) being detected by means of a position sensor, and a check after this position control , whether the pressure of the liquid in the receiving space (10) is within a permissible filling pressure range around the second filling pressure, wherein, in the event that the pressure of the liquid in the The receiving space (10) is outside the permissible filling pressure range around the second filling pressure, the position of the control part (11) is readjusted.

2. The method according to claim 1, characterized in that a characteristic curve stored in the control unit (8), preferably recorded in a learning cycle, is used to determine the target position of the actuating part (11) which shows the dependence between the position of the actuating part ( 11) and the pressure of the liquid in the receiving space (10).

3. The method according to claim 2, characterized in that the characteristic curve is applied as a straight line from which the control unit (8) stores the gradient (k).

4. The method according to claim 3, characterized in that if the position of the control part (11) is readjusted in the course of an adjusting process, the slope (k) of the straight line is changed proportionally to the size of the readjustment of the position of the control part (11) will.

5. Method according to one of claims 1 to 4, characterized in that to readjust the position of the control part (11), in the event that the pressure in the receiving space (10) is outside the filling pressure range around the second filling pressure, the target position of the Control part (11) is modified and the control unit (8) carries out a further position regulation of the control part (11) for moving to the modified setpoint position.

6. The method according to any one of claims 1 to 5, characterized in that the path control for setting the second filling state, starting from the first filling state, is carried out as a discontinuous regulation, preferably as a two-point regulation.

7. The method according to any one of claims 1 to 6, characterized in that the pressure of the liquid in the receiving space (10) is stored in the control unit (8) after completion of an adjusting process and is stored with the currently existing pressure in the receiving space ( 10) is compared.

8. Device comprising a liquid balloon (1), a pump unit (5) connected to the liquid balloon (1) via a hose (3) for pumping liquid into the liquid balloon (1) and for pumping liquid out of the liquid balloon (1), which has a receiving space (10) that can be filled with liquid, the volume of which can be changed by moving an actuating part (11) of the pump unit (5) by means of an electric motor (6) fed by a battery (7), an electronic control unit (8) for controlling the Electric motor (6) and at least one pressure sensor (20) for detecting the pressure of the liquid in the receiving space (10), characterized in that the device also has a displacement sensor for detecting the position of the actuating part (11).

9. Device according to claim 8, characterized in that the pump unit (5) has a bellows (9) within which the receiving space (10) for the liquid lies, wherein an end piece (9a) of the bellows (9) with the actuating part (11) is rigidly connected.

10. Device according to claim 9, characterized in that the pressure sensor (20) has at least one strain gauge applied to an end membrane (9b) delimiting the interior of the bellows (9) in the axial direction of the bellows.

11. Device according to claim 10, characterized in that the device has an air pressure sensor (23) for detecting the atmospheric pressure and a housing air pressure sensor (48) for detecting the air pressure in a gas-tight insulated interior of a housing (4) in which the pump unit ( 5) is arranged, wherein to determine the pressure of the liquid in the receiving space (10) of the pump unit (5), the atmospheric pressure detected by the air pressure sensor (23) is subtracted from the measured value output by the pressure sensor (20) and the atmospheric pressure detected by the Housing air pressure sensor (48) recorded air pressure in the housing (4) is added.

12. Device according to one of claims 9 to 11, characterized in that the adjusting part (11) has an external thread (11b) which cooperates with an internal thread (13a) of an adjusting ring (13) rotatable by the electric motor (6).

13. Device according to one of claims 9 to 12, characterized in that the displacement transducer has a plate (18) rigidly connected to the actuating part (11) with a spiral-shaped conductor track (18a) which is opposite a static, electrically conductive counterplate.

14. Device according to one of claims 9 to 13, characterized in that the device forms an artificial sphincter, the liquid balloon (1) in the form of a flexible band closable to form a ring with a longitudinal inner chamber (la), which is formed with the liquid can be filled.

15. Device according to one of claims 9 to 14, characterized in that the control unit (8) is set up to carry out an adjusting process of the adjusting part (11) by means of the electric motor (6) in order, starting from a first filling state of the liquid balloon (1) with a first filling pressure to set a second filling state of the liquid balloon (1) with a second filling pressure, the actuating process being a path control of the actuating part (11) for moving to a target position of the actuating part (11), after this path control a check as to whether the pressure of the Liquid in the receiving space (10) lies within a permissible filling pressure range around the second filling pressure, and, in the event that the pressure of the liquid in the receiving space (10) is outside the permissible filling pressure range around the second filling pressure, an adjustment of the position of the actuating part (11).