EP4138727A1 - Dispositif médical comprenant un ballonnet liquide pour former des sphincters artificiels - Google Patents

Dispositif médical comprenant un ballonnet liquide pour former des sphincters artificiels

Info

Publication number
EP4138727A1
EP4138727A1 EP21719552.8A EP21719552A EP4138727A1 EP 4138727 A1 EP4138727 A1 EP 4138727A1 EP 21719552 A EP21719552 A EP 21719552A EP 4138727 A1 EP4138727 A1 EP 4138727A1
Authority
EP
European Patent Office
Prior art keywords
liquid
balloon
pressure
pump
unit
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.)
Withdrawn
Application number
EP21719552.8A
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 EP4138727A1 publication Critical patent/EP4138727A1/fr
Withdrawn legal-status Critical Current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
    • A61F5/41—Devices for promoting penis erection
    • 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
    • A61F2250/0013—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 device comprising a liquid balloon, a pump unit connected to the liquid balloon via a first connecting line for pumping liquid into the liquid balloon and for pumping out liquid from the liquid balloon, an electric motor for driving the pump unit, a battery for supplying energy to the electric motor and an electronic control unit for controlling the electric motor.
  • 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.
  • 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 one Ganges for bile.
  • Such medical facilities are also known as cuffs, cuffs or artificial sphincters.
  • a manually operated pump with a flexible pump body is used to pump liquid.
  • a manual actuating device is implanted in the scrotum.
  • liquid is pumped out of the liquid balloon into a reservoir in order to clear the body channel.
  • an automatic closing of the body canal e.g. the uretra, with a time delay and / or throttled, through the automatic backflow of fluid into the inner chamber of the fluid balloon, which is triggered, for example, by the pressure exerted by the elastically stretched reservoir.
  • US 2014/0364686 A1 discloses several exemplary embodiments of medical devices in the form of urethral sphincters, which are referred to as a cuff
  • a liquid balloon Comprising a liquid balloon, the cuff having an inner chamber and an outer chamber.
  • An intermediate wall which separates the two chambers of the cuff from one another, has a throttle valve which enables fluid to be exchanged between the chambers.
  • the throttle valve enables the body duct to be automatically closed by a gradual overflow of fluid from the outer chamber into the inner chamber.
  • the liquid balloon also referred to as a cuff in this document, is made of silicone.
  • a flexible pump body is used to pump out liquid into an elastically expandable storage container. The return of liquid to the cuff takes place automatically due to the relative overpressure in the expanded storage container compared to the pressure in the cuff via overflow channels or throttle valves.
  • the object of the invention is to provide an advantageous device of the type mentioned at the beginning, which has a high level of functional reliability. This is achieved according to the invention by a device with the features of claim 1.
  • a device comprises, in addition to the motor-driven pump unit, a manual actuation unit for removing liquid from the liquid balloon and for pumping liquid back into the liquid balloon, which has a flexible pump body which is connected to the liquid balloon via a second connecting line.
  • the provision of the manual actuation unit in addition to the motor-driven pump unit ensures increased operational reliability. So it can or hear in practice, particularly V that the user has forgotten the remote control to operate the motorized actuator unit.
  • the manual actuation unit can also be used in the event that the motor-operated actuation unit does not function, for example in the event that the battery is not replaced in time.
  • the manual actuation unit preferably has a manually openable shut-off valve which is arranged between two sections of the second connecting line, the two sections of the second connecting line being connected to one another in an open position of the shut-off valve and the liquid-conducting connection between the two sections of the second connecting line in one Closed position of the shut-off valve is interrupted.
  • Manual draining of liquid from the liquid balloon can advantageously take place in such a way that the shut-off valve is opened manually. Liquid can then flow out of the liquid balloon into the flexible pump body.
  • the volume of an inside The pump chamber arranged on the pump body is enlarged, preferably without the material of the pump body being stretched, ie the pump body is merely unfolded (not elastically stretched, for example) when liquid flows in.
  • the manually openable shut-off valve is opened and, when the shut-off valve is open, the pump body is compressed. Operation by the user can thus be done with both hands.
  • the motor-operated pump unit advantageously has a receiving space that can be filled with liquid, the volume of which can be changed by moving an actuating part of the pump unit by means of the electric motor. Furthermore, a pressure sensor for detecting the pressure of the liquid in the receiving space is expediently available. It is preferred that the detected pressure of the liquid in the receiving space of the motor-driven pump unit is stored in the control unit after each actuating process of the actuating part carried out by means of the electronic control unit has been completed and is compared with the current pressure in the receiving space before a further actuating process is carried out. If the control unit detects a pressure change that is above a predetermined threshold value, this means a malfunction.
  • liquid could have been drained manually from the liquid balloon without having been pumped back into the liquid balloon. It can therefore be used, for example, on a remote control of the Device a request is issued to the user to manually pump liquid into the liquid balloon. If the pressure drop cannot be eliminated in this way, it is concluded that there is a leak. The user can then be informed on the remote control that an immediate visit to the doctor is required.
  • 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 liquid.
  • FIG. 1 shows a device according to the invention in the implanted state
  • 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
  • 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
  • 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 Chamber la is emptied, points to a ring closed liquid balloon 1 has a passage opening 1d, see FIG. 11.
  • the size of the passage opening 1d can be reduced, see FIGS. 10 and 12.
  • a pump unit 5 For pumping liquid into the liquid balloon 1 and pumping out liquid from the liquid balloon 1, a pump unit 5 is used, which is connected to the liquid balloon 1 via a first connecting line 3 (which is designed as a hose) and which is in a motorized actuation unit that can be implanted in the body 50 is arranged.
  • 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 saline solution, 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, to the end membrane 9b of the bellows 9, as indicated in FIG. 8.
  • 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 plate opposite section 19 of the wall of the housing 4.
  • An inductive displacement transducer for detecting the position of the actuating part 11 is thus formed by the plate 18 in connection with the section 19 of the wall of the housing 4.
  • 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 helical gear and the bellows 9 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. 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.
  • 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.
  • 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 in the liquid balloon in the closed state of the device being greater than the filling pressure in the open state .
  • the electric motor 6 is actuated accordingly by the control unit 8.
  • the control unit 8 can carry out a corresponding pressure regulation for this purpose by setting the pressure in the receiving space 10 of the bellows 9 to the desired value based on the value output by the pressure sensor 20 (the system being allowed to relax sufficiently before the setting is completed in order to equalize the pressure cause).
  • the displacement transducer 18, 19 could then also be omitted.
  • control unit 8 in order to set a desired filling state of the liquid balloon 1, regulates the position of the actuating part 11 with a desired end position as the target position.
  • This position regulation is advantageously as discontinuous regulation, preferably as Two-point control carried out 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 desired end position of the control element 11 minus a specified latency distance is set as the switch-off position If the actual position of the actuating part 11 reaches this switch-off position, the electric motor 6 is switched off. This enables the position control to be terminated.
  • the latency distance can be adapted for subsequent position controls and / or readjustment of the position of the actuating part 11, so that after the readjustment of the position of the actuating part 11, the pressure p in the receiving space is within the permissible filling pressure range.
  • a learning cycle is preferably carried out when the device is first started up or repeatedly to determine a characteristic curve which reflects the dependency between the position of the actuating part and the pressure of the liquid in the receiving space of the pumping device.
  • This characteristic curve is preferably applied as a straight line, the value of the gradient k of the characteristic curve being stored by the control unit 8. If more than two points are approached in the learning cycle, i.e. when recording the characteristic, the straight line can be optimized (for example to the smallest sum of the error squares).
  • 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 manual actuation unit 51 has a flexible pump body 30 which is connected to the liquid balloon 1 via a second 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 second 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 connecting line 3 and the second connecting line 31 could be connected separately to the liquid balloon 1 and open into the chamber 1 a of the liquid balloon 1 at separate locations. In the exemplary embodiment, however, a common line section starts from the liquid balloon 1 and splits into the first connecting line 3 and the second connecting line 31.
  • 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 second 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 Depression is located between or next to the elevations 36 of the at least one side wall 34, 35.
  • the second connecting line 31 opens into the pump chamber 33 in the area between two elevations 36 of the same side wall 34, 35 34, 35 liquid flow out of the pump chamber 33 (with the shut-off valve 32 open).
  • the shut-off valve 32 has a closure member 39 which is mounted displaceably in a valve housing 38. Starting from a closed position, the closure member 39 is in which the closure member 39 is sealed against a valve seat 41 by means of a seat seal 40, can be displaced into an open position against the force of a return spring 42. 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 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 bodies 30 are pressed together except for mutual contact. 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 pressure p of the liquid present in the receiving space 10 of the pump unit 5 is stored.
  • 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:
  • Liquid could have been drained from the liquid balloon 1, which was filled with liquid during the last motorized actuating process, 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 that there is a leak and it is therefore necessary to check the device.

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)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Child & Adolescent Psychology (AREA)
  • Obesity (AREA)
  • Reproductive Health (AREA)
  • Prostheses (AREA)
  • External Artificial Organs (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (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'une première conduite de raccordement (3) pour pomper le liquide dans le ballonnet de liquide (1) et pour pomper le liquide hors du ballonnet de liquide (1), un moteur électrique (6) pour entraîner l'unité de pompe (5), une batterie (7) pour fournir de l'énergie au moteur électrique (6) et une unité de commande électronique (8) pour commander le moteur électrique (6). Le dispositif comprend en outre une unité d'actionnement manuel (51) pour retirer le liquide du ballonnet de liquide (1) et pour pomper le liquide de retour dans le ballonnet de liquide (1), l'unité d'actionnement manuel (51) comportant un corps de pompe flexible (30) qui est relié au ballonnet de liquide (1) par l'intermédiaire d'une deuxième conduite de raccordement (31).
EP21719552.8A 2020-04-23 2021-04-13 Dispositif médical comprenant un ballonnet liquide pour former des sphincters artificiels Withdrawn EP4138727A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ATA97/2020A AT523787A1 (de) 2020-04-23 2020-04-23 Einrichtung umfassend einen Flüssigkeitsballon
PCT/EP2021/059480 WO2021213835A1 (fr) 2020-04-23 2021-04-13 Dispositif médical comprenant un ballonnet liquide pour former des sphincters artificiels

Publications (1)

Publication Number Publication Date
EP4138727A1 true EP4138727A1 (fr) 2023-03-01

Family

ID=75562714

Family Applications (1)

Application Number Title Priority Date Filing Date
EP21719552.8A Withdrawn EP4138727A1 (fr) 2020-04-23 2021-04-13 Dispositif médical comprenant un ballonnet liquide pour former des sphincters artificiels

Country Status (6)

Country Link
US (1) US20230145684A1 (fr)
EP (1) EP4138727A1 (fr)
AT (1) AT523787A1 (fr)
AU (1) AU2021260728A1 (fr)
CA (1) CA3175806A1 (fr)
WO (1) WO2021213835A1 (fr)

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FR3111539B1 (fr) * 2020-06-19 2022-10-14 Uromems Dispositif medical et methode de detection d’un changement de position

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CA3175806A1 (fr) 2021-10-28
WO2021213835A1 (fr) 2021-10-28
AT523787A1 (de) 2021-11-15
AU2021260728A1 (en) 2022-12-01

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