EP4138726A1 - Procédé de réglage d'un niveau de remplissage d'un ballonnet de liquide d'un dispositif médical, et dispositif médical comprenant un ballonnet de liquide pour former des sphincters artificiels - Google Patents

Procédé de réglage d'un niveau de remplissage d'un ballonnet de liquide d'un dispositif médical, et dispositif médical comprenant un ballonnet de liquide pour former des sphincters artificiels

Info

Publication number
EP4138726A1
EP4138726A1 EP21719551.0A EP21719551A EP4138726A1 EP 4138726 A1 EP4138726 A1 EP 4138726A1 EP 21719551 A EP21719551 A EP 21719551A EP 4138726 A1 EP4138726 A1 EP 4138726A1
Authority
EP
European Patent Office
Prior art keywords
liquid
pressure
balloon
receiving space
filling
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21719551.0A
Other languages
German (de)
English (en)
Inventor
Martin Hohlrieder
Roland Huber
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
AMI Agency for Medical Innovations GmbH
Original Assignee
AMI Agency for Medical Innovations GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by AMI Agency for Medical Innovations GmbH filed Critical AMI Agency for Medical Innovations GmbH
Publication of EP4138726A1 publication Critical patent/EP4138726A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/003—Implantable devices or invasive measures inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F2005/0016—Implantable devices or invasive measures comprising measuring means
    • A61F2005/002—Implantable devices or invasive measures comprising measuring means for sensing mechanical parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0065—Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0001—Means for transferring electromagnetic energy to implants
    • A61F2250/0002—Means for transferring electromagnetic energy to implants for data transfer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0013—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting fluid pressure
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/25—Artificial sphincters and devices for controlling urinary incontinence

Definitions

  • 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
  • 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.
  • artificial sphincters e.g. for the urethra.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the regulation can be carried out as a discontinuous regulation.
  • 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.
  • 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.
  • 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 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.
  • 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 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.
  • FIG. 1 shows a device according to the invention in the implanted state
  • FIG. 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. 5 shows a section corresponding to FIG. 4 in a second position of the actuating part
  • Fig. 6 is an exploded view
  • FIG. 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;
  • FIG. 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. 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.
  • 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
  • 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.
  • 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.
  • the liquid balloon 1 closed to form a ring has a passage opening ld, see FIG. 10.
  • the size of the passage opening ld can be reduced , see Fig. 11.
  • 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.
  • 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.
  • 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
  • the adjusting ring 13 is rotatably mounted in a 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.
  • the electric motor 6 is on the bearing housing
  • strain gauges are applied, for example sputtered on, as indicated in FIG.
  • 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.
  • 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.
  • 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.
  • the electric motor 6 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.
  • 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.
  • a housing air pressure sensor 48 is arranged in the housing 4, the meaning of which is explained in more detail below.
  • 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.
  • 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.
  • the control unit 8 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.
  • 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.
  • 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.
  • the control part 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.
  • the pressure pA of the liquid in the receiving space corresponds to the filling pressure in the liquid balloon.
  • 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 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".
  • 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.
  • 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.
  • the desired filling pressure pE is preferably in the middle of the filling pressure range Dr.
  • 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 ⁇ r 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.
  • the position of the control part 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.
  • 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 ⁇ 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.
  • 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
  • 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 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.
  • the one in the receiving space 10 of the Pump unit 5 stored pressure p of the liquid.
  • 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.
  • 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 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.
  • 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.
  • 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).
  • 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.
  • an envelope 44 which envelops the shut-off valve 32 and is formed in one piece with the pump body 30.
  • 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.
  • 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.
  • shut-off valve 32 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Transplantation (AREA)
  • Child & Adolescent Psychology (AREA)
  • Obesity (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • External Artificial Organs (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un dispositif comprenant : un ballonnet de liquide (1); une unité de pompe (5) reliée au ballonnet de liquide (1) par l'intermédiaire d'un tuyau flexible (3) pour pomper le liquide dans le ballonnet de liquide (1) et pour pomper le liquide hors du ballonnet de liquide (1), ladite unité de pompe comportant une chambre de réception (10) qui peut être remplie avec un liquide, le volume de ladite chambre pouvant être modifié par déplacement d'une partie de réglage (11) de l'unité de pompe (5) au moyen d'un moteur électrique (6) alimenté par une batterie (7); une unité de commande électronique (8) pour commander le moteur électrique (6); et au moins un capteur de pression (20) pour détecter la pression du liquide dans la chambre de réception (10), caractérisé en ce que le dispositif comporte en outre un capteur de position pour détecter la position de la pièce de réglage (11). L'invention concerne en outre un procédé de réglage du niveau de remplissage du ballonnet de liquide (1), dans lequel le volume d'une chambre de réception (10) de l'unité de pompe (5) remplie de liquide est modifié par déplacement d'une partie de réglage (11) de l'unité de pompe (5) au moyen d'un moteur électrique (6) alimenté par une batterie (7), un processus de réglage de la partie de réglage (11) étant effectué par une unité de commande (8) commandant le moteur électrique (6). Le procédé de réglage comprend la commande du trajet de la partie de réglage (11) pour s'approcher d'une position cible de la partie de réglage (11) et, après cette commande de trajet, la vérification du fait que la pression du liquide dans la chambre de réception (10) est ou non située dans une plage de pression de remplissage admissible autour de la deuxième pression de remplissage. Si nécessaire, la position de la partie de réglage (11) est ajustée une fois de plus.
EP21719551.0A 2020-04-23 2021-04-13 Procédé de réglage d'un niveau de remplissage d'un ballonnet de liquide d'un dispositif médical, et dispositif médical comprenant un ballonnet de liquide pour former des sphincters artificiels Pending EP4138726A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ATA96/2020A AT523786A1 (de) 2020-04-23 2020-04-23 Verfahren zum Einstellen eines Befüllungszustandes eines Flüssigkeitsballons
PCT/EP2021/059479 WO2021213834A1 (fr) 2020-04-23 2021-04-13 Procédé de réglage d'un niveau de remplissage d'un ballonnet de liquide d'un dispositif médical, et dispositif médical comprenant un ballonnet de liquide pour former des sphincters artificiels

Publications (1)

Publication Number Publication Date
EP4138726A1 true EP4138726A1 (fr) 2023-03-01

Family

ID=75562713

Family Applications (1)

Application Number Title Priority Date Filing Date
EP21719551.0A Pending EP4138726A1 (fr) 2020-04-23 2021-04-13 Procédé de réglage d'un niveau de remplissage d'un ballonnet de liquide d'un dispositif médical, et dispositif médical comprenant un ballonnet de liquide pour former des sphincters artificiels

Country Status (6)

Country Link
US (1) US20230141054A1 (fr)
EP (1) EP4138726A1 (fr)
AT (1) AT523786A1 (fr)
AU (1) AU2021261453A1 (fr)
CA (1) CA3176396A1 (fr)
WO (1) WO2021213834A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3111539B1 (fr) * 2020-06-19 2022-10-14 Uromems Dispositif medical et methode de detection d’un changement de position

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014140283A1 (fr) * 2013-03-15 2014-09-18 Milux Holding S.A. Dispositif de restriction
US20160123835A1 (en) * 2013-05-21 2016-05-05 Uromems Method and device for detecting a slow leak in an implantable hydraulic occlusion system

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4581018A (en) * 1983-02-08 1986-04-08 Novacor Medical Corporation Implantable infusion device
GB9202247D0 (en) 1992-02-03 1992-03-18 British Tech Group Prosthetic sphincter device
EP0982048A1 (fr) * 1998-03-12 2000-03-01 Leonhardt, Steffen, Dr.-Ing. Implant de drainage à commande de fluide cephalo-rachidien
EP1389453B1 (fr) 2002-08-16 2007-03-07 AMI Agency for Medical Innovations GmbH Anneau pour produire une constriction artificielle du tract gastro-intestinal
US7390294B2 (en) * 2004-05-28 2008-06-24 Ethicon Endo-Surgery, Inc. Piezo electrically driven bellows infuser for hydraulically controlling an adjustable gastric band
US7775966B2 (en) * 2005-02-24 2010-08-17 Ethicon Endo-Surgery, Inc. Non-invasive pressure measurement in a fluid adjustable restrictive device
FR3028749B1 (fr) * 2014-11-25 2020-10-09 Uromems Systeme occlusif implantable
AT518714B1 (de) * 2016-06-03 2018-09-15 Ami Agency Medical Innovations Gmbh Medizinische Einrichtung zum Verengen oder Absperren eines Körperkanals

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014140283A1 (fr) * 2013-03-15 2014-09-18 Milux Holding S.A. Dispositif de restriction
US20160123835A1 (en) * 2013-05-21 2016-05-05 Uromems Method and device for detecting a slow leak in an implantable hydraulic occlusion system

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2021213834A1 *

Also Published As

Publication number Publication date
AT523786A1 (de) 2021-11-15
CA3176396A1 (fr) 2021-10-28
WO2021213834A8 (fr) 2022-03-24
US20230141054A1 (en) 2023-05-11
WO2021213834A1 (fr) 2021-10-28
AU2021261453A1 (en) 2022-12-01

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