EP4472697A1 - Blutbehandlungsvorrichtung mit schwingvorrichtung - Google Patents
Blutbehandlungsvorrichtung mit schwingvorrichtungInfo
- Publication number
- EP4472697A1 EP4472697A1 EP23702774.3A EP23702774A EP4472697A1 EP 4472697 A1 EP4472697 A1 EP 4472697A1 EP 23702774 A EP23702774 A EP 23702774A EP 4472697 A1 EP4472697 A1 EP 4472697A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- blood
- treatment device
- blood treatment
- pump
- venous
- 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
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1601—Control or regulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3626—Gas bubble detectors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3627—Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
- A61M1/363—Degassing by using vibrations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/0021—Special media to be introduced, removed or treated removed from and reintroduced into the body, e.g. after treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0413—Blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/10—General characteristics of the apparatus with powered movement mechanisms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/18—General characteristics of the apparatus with alarm
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3334—Measuring or controlling the flow rate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3344—Measuring or controlling pressure at the body treatment site
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/75—General characteristics of the apparatus with filters
Definitions
- the present invention relates to a blood treatment device according to claim 1 or according to the preamble or generic term of this claim.
- Various types of blood treatment devices are known from practice. They include, for example, devices for hemodialysis, hemofiltration and hemodiafiltration.
- the blood flows through a blood treatment unit in an extracorporeal blood circuit.
- the blood treatment unit is a dialyzer or filter which, to put it simply, is separated into a blood chamber and a dialysis fluid chamber by a semi-permeable membrane.
- the blood flows through the blood chamber while a dialysis fluid flows through the dialysis fluid chamber.
- Air or microbubbles in extracorporeal circuits downstream of a venous air separating chamber can lead to gas embolism in the patient's body. Embolism can block vessels and cause ischemia.
- the venous air separation chamber is located in the venous blood tubing system. It reduces the flow rate within the extracorporeal Circulation partially so that gas bubbles rise against gravity according to the Archimedean principle and can be deposited through an opening in an upper region of the venous air separation chamber.
- the venous system downstream of the venous air separation chamber is checked for the presence of air, e.g. B. in the form of microbubbles, monitored in the extracorporeal flowing blood.
- a further blood treatment device with an air bubble detector is achieved by the blood treatment device having the features of claim 1.
- a blood treatment device is thus proposed, the blood treatment device having a blood pump and an air bubble detector for an extracorporeal blood circuit and a pump for conveying dialysis liquid and/or dialysate on its hydraulic side or being connected to such a device.
- the extracorporeal blood circuit which is not part of the blood treatment device, but with this for the purpose of treating blood of a specific Patient connected or upgraded prior to the start of their blood treatment session may be provided in whole or in part on a blood cassette.
- the blood pump is intended for pumping blood through the extracorporeal blood circuit or through the blood cassette during a blood treatment session when connected to the extracorporeal blood circuit and to a blood filter or dialyzer, the dialyzer itself having a semi-permeable membrane.
- the air bubble detector serves to detect air bubbles within the extracorporeal blood circuit. It can be arranged, for example, between a venous air separation chamber and the venous patient access.
- the blood treatment device also has an oscillating device, by means of which the extracorporeal blood circuit or at least a section thereof, or the content or part of the content of the blood circuit or section, can be made to oscillate, swing, move or vibrate.
- the blood treatment device also has a control or regulating device or is connected to such a device.
- the control or regulation device is configured to initiate, carry out, control and/or regulate a method—in particular automatically—in cooperation with the blood treatment device or its facilities or devices, in particular as disclosed herein. So it is in particular for driving the blood pump, the pump for Dialysis fluid and / or dialysate and configured to control the oscillating device.
- Interaction can be or include driving, controlling or regulating. Interaction may be or require a signal connection.
- the blood treatment device according to the invention can be a correspondingly suitable and/or configured facility or device such as a B. have a pressure measuring device for pressure measurement or the like or be connected to such facilities or devices.
- a pressure measuring device for pressure measurement or the like or be connected to such facilities or devices.
- the use of the expression “can be” or “can have” etc. is to be understood synonymously with “is preferably” or “has preferably” etc. and is intended to explain an embodiment according to the invention.
- numerical words are mentioned herein, the person skilled in the art understands them as indicating a numerical lower limit. Provided that this does not lead to a discernible contradiction for the person skilled in the art, the person skilled in the art always reads “at least one” or “at least one” when specifying “a” or “an”.
- the oscillating device of the blood treatment device according to the invention is arranged in or on the extracorporeal blood circuit, or with an effect on it, with the aim of causing the extracorporeal blood circuit, at least a section thereof or its contents, to oscillate, which usually depends on the corresponding programmed control or regulating device is initiated.
- the vibrating device is not (or not only) the venous tube clamp, at least not unless the control or regulating device is programmed accordingly to cause the venous tube clamp to generate a vibration by opening and closing sufficiently quickly, e.g. B. as described herein.
- the vibrating device is or includes a venous tube clamp.
- control or regulating device is programmed to control the venous hose clamp in such a way that it is automatically opened and closed again several times within a minute or second, or actuated in some other way.
- This action of the venous tube clamp preferably occurs at a rate of at least once per second.
- the oscillating device is a venous hose clamp
- vibrations of the hose system can be triggered by means of the pressures or negative pressures generated when the hose clamp is opened and closed.
- the oscillating device is or comprises a holding device for releasably holding at least one section of the extracorporeal blood circuit, in particular on a housing surface of the blood treatment device.
- the holding device can be a clamp for holding a flexible tubing section, the drip chamber, or another section of the disposable.
- the oscillating device is configured and driven accordingly to oscillate at a frequency of 1 Hz, 5 Hz or more.
- a swing in some embodiments, is a left-right movement or an up-down movement. The oscillation preferably does not occur about a longitudinal or transverse axis and/or does not represent a rotational movement.
- the control or regulating device is configured to modulate the frequency of the vibrations generated by the oscillation device. This can be done, for example, by means of a frequency sweep, amplitude modulation and/or resonance excitation or include such methods and can advantageously contribute to the air within the extracorporeal blood circuit be removed as effectively as possible.
- the resonance behavior of the air and/or the liquid is used.
- the direction of the vibration is not limited here and can be both radial and linear, for example in the direction of the venous air separation chamber, or in any spatial direction, with certain directions (e.g. buoyancy direction) preferably being used.
- control or regulating device is programmed or configured to carry out the steps of one of the two alternative embodiments of the following method during an extracorporeal blood treatment session after detecting air bubbles or air pockets in the extracorporeal blood circuit, or after an air bubble alarm.
- the method comprises stopping the blood pump or reducing the pumping capacity provided immediately before the air bubbles are detected, and generating a negative transmembrane pressure across the semi-permeable membrane of the blood filter. This negative transmembrane pressure can be achieved on the hydraulic side by appropriately controlling the pump for delivering dialysis liquid and/or dialysate while the blood pump is stopped or its delivery capacity is reduced.
- the transmembrane pressure can be measured in a variety of ways and its existence can be determined directly or indirectly.
- Air bubbles or air inclusions in the extracorporeal blood circuit can be detected using the air bubble detector.
- the air bubble detector can be suitable or configured to trigger an air bubble alarm (alternatively: gas alarm) as a result of the detection of gas, air or air bubbles, which in turn causes the method to be initiated or carried out.
- Air bubbles or air inclusions can be detected, for example, by an air bubble alarm, by the fulfillment of conditions that trigger an air bubble alarm or are sufficient to trigger an air bubble alarm.
- the method includes that the conveying direction of the blood pump is reversed, that is to say it conveys backwards.
- a negative transmembrane pressure is generated across the semi-permeable membrane in some embodiments with the venous hose clamp fully or partially closed.
- the method comprises, as a further step, opening the venous hose clamp when a negative transmembrane pressure has already been generated or is present, while maintaining a negative transmembrane pressure. Due to the negative transmembrane pressure, a (transmembrane) plasma water transfer takes place via the semi-permeable membrane and the blood in the dialyzer is hemoconcentrated.
- the volume of liquid that is pumped into the hydraulic system or that is shifted from the extracorporeal blood circuit to the hydraulic side via the semi-permeable membrane due to the pressure difference is replaced by blood that flows in the opposite (also: retrograde) direction to its usual flow direction within the blood circuit via the venous part of the hose system from the latter and from the patient's vascular system is caused to flow by the hemoconcentration and negative pressure.
- the air bubbles or air inclusions (e.g. gas and micro-bubbles) in the line are transported back retrograde into the venous air separation chamber and separated there, mostly to the environment.
- the venous hose clamp is opened when a pressure sensor of the blood treatment device has determined that a negative minimum transmembrane pressure has been reached.
- a negative transmembrane pressure is generated by the pump on the hydraulic side of the blood treatment device, while an optional substituate pump of the blood treatment device is stopped or not pumping.
- the creation or maintenance of the negative transmembrane pressure by means of the control or regulating device is terminated as soon as a negative transmembrane pressure of about -300 mmHg to -500 mmHg is reached or if a volume of at least 20 ml to 60 ml of blood was conveyed past the air bubble detector in the direction of the venous air separation chamber by means of the generated transmembrane pressure.
- the conveying by means of the pump on the hydraulic side of the blood treatment device for generating a negative transmembrane pressure is terminated after the air bubble detector no longer detects air bubbles or air pockets and/or there is no air bubble alarm and/or at least 20 ml to 60 ml of blood has been conveyed retrograde .
- the control or regulation device is programmed to initiate some or all of the method steps disclosed herein in any combination, at least with a temporal overlap.
- the pump for conveying dialysis liquid and/or dialysate is an optionally provided ultrafiltration pump, by means of which z. B.
- the blood treatment device is connected to an extracorporeal blood circuit and a blood filter or dialyzer with a semi-permeable membrane.
- the extracorporeal blood circuit is a blood tubing set and/or a blood cassette or has a blood tubing set and/or a blood cassette.
- the blood treatment device is designed as a hemodialysis device, hemofiltration device, hemodiafiltration device or as a device for carrying out a separation method.
- the method initiated by the control or regulation device includes determining whether the generated negative transmembrane pressure or its amount is within predetermined limits, exceeds or falls below a limit value, exceeds a minimum value and/or does not exceed a maximum value. This can be done using at least one criterion (limit, range, maximum, etc.), which z. B. can be stored in a storage device, such as the blood treatment device.
- the process initiated by the control or regulating device includes only emitting or outputting an acoustic and/or visual or other signal-based air bubble alarm if, during or after the process, there is still or a new state that was already present before the start of the procedure would have resulted in an air bubble alarm for the responsible person and/or the blood treatment device. Provision can thus be made for the user to be informed optically and/or acoustically about the presence of an air bubble alarm and/or to only interrupt the blood treatment automatically if, after detecting air bubbles, the removal of the detected air by means of the Method, which is carried out by the blood treatment device according to the invention, was not successful.
- the additional pump is a displacement pump, in particular a membrane pump, eccentric membrane pump, hose pump, roller pump or piston pump. If a signal or communication connection between two components is discussed here, this can be understood to mean a connection that exists during use.
- the method disclosed herein which is caused by the control or regulation device, can comprise causing a vibration, movement, oscillation or the like as a further optional step. This step will preferably occur simultaneously or in an overlapping manner with other process steps as described herein. Causing a vibration, movement, oscillation or the like can be a method step in all embodiments of the disclosed method.
- the blood treatment device does not have a drive device that is arranged and/or controlled in order to cause the dialyzer or blood filter to rotate, shake or vibrate.
- the controller may preferably not be configured to cause such rotation (e.g., about a longitudinal axis or about a transverse axis), shaking motion, or vibration.
- Another advantage of the present invention can be that the patient does not lose blood by discarding whole blood, e.g. B. in the aforementioned saline bag suffers. This also advantageously contributes to patient well-being and patient safety.
- a fully automated and hygienically ongoing method for treating air bubble alarms in the venous line can be used induced separation of the microbubbles are carried out. This can advantageously help to reduce personnel costs and increase patient safety.
- Air that is inside the disposable and is to be removed can be detached more easily from the inner wall of the disposable due to the vibration in which the blood circuit is set. If the contents of the disposable are additionally placed under negative pressure, the volume of the air bubbles increases, which further facilitates their removal.
- FIG. 1 shows a schematically simplified fluid line structure of a blood treatment device according to the invention in a first embodiment
- Fig. 2 shows a schematically simplified part of the blood treatment device of Fig.
- FIG. 1 shows, in a schematically simplified manner, a fluid line structure of a blood treatment device 100 according to the invention in a first embodiment.
- the blood treatment device 100 is connected to an extracorporeal blood circuit 300, which can be used for treatment by means of double-needle access (see e.g. FIG. 5), or using e.g. B. an additional Y connector (reference Y) such.
- B. shown in Fig. 1 can be connected to the vascular system of the patient, not shown, by means of a single-needle access.
- the blood circuit 300 can optionally be present in portions thereof in or on a blood cassette. Pumps, actuators and/or valves in the area of the blood circuit 300 can be connected to the blood treatment device 100 according to the invention or to one of these, e.g. B. included control or regulating device 150 connected.
- the blood circuit 300 has an arterial hose clamp or patient hose clamp 302 as a first hose clamp and an arterial connection needle of an arterial section or an arterial patient line, an arterial line section, a blood sampling line or the first line 301 (or is connected to it).
- the blood circuit 300 further comprises (or is connected to) a venous hose clamp or patient hose clamp 306 as a second hose clamp and a venous connection needle of a venous section, a venous patient line, a venous line section, a blood return line or second line 305 .
- a blood pump 101 is provided in or on the first line 301, a substituate pump 111 for pumping substituate is arranged on a substituate line 105, which can be fluidically connected to a dialysis fluid supply line 104 for pumping fresh dialysis fluid, which is filtered in a further filter stage F2 .
- substituate can be transferred by pre-dilution, via a pre-dilution valve 107, or by post-dilution, via a post-dilution valve 109 associated lines 107a or 109a in line sections, for example in the arterial line section 301 or in the venous line section 305 (here between a blood chamber 303b of a blood filter 303 and a venous air separation chamber 329 of the blood circuit 300) are introduced.
- the blood filter 303 has the blood chamber 303b connected to the arterial line section 301 and to the venous line section 305 .
- a dialysis fluid chamber 303a of the blood filter 303 is connected to the dialysis fluid inlet line 104 leading to the dialysis fluid chamber 303a and a dialysate outlet line 102 leading away from the dialysis fluid chamber 303a and carrying dialysate, ie used dialysis fluid.
- Suitable connectors on the dialysis liquid inlet line 104 or on the dialysate outlet line 102 on the one hand and on the dialysate ports on the other hand are used for this purpose and can be connected to one another, in particular in a detachable manner.
- Dialysis fluid chamber 303a and blood chamber 303b are separated from one another by a mostly semi-permeable membrane 303c.
- the arrangement of FIG. 1 includes an air bubble detector 315 for detecting air and/or blood, preferably in the venous line section 305, e.g. B. at the location shown.
- the arrangement of Fig. 1 optionally also includes one or two pressure sensors PS1 (upstream of the blood pump 101) and PS2 (downstream of the blood pump 101, it measures the pressure upstream of the blood filter 303 ("pre-hemofilter")) at the in Fig. 1 shown positions. Additional pressure sensors can be provided, e.g. B.
- FIG Blood lines 301, 305 is connected to the extracorporeal blood circuit 300.
- the arrangement of Figure 1 also includes an optional detector 319 for detecting air bubbles and/or blood.
- An addition point 325 for heparin can optionally be provided.
- An optional mixing device 163 is shown on the left in Fig. 1, which from the containers A (for A concentrate via the concentrate supply 166) and B (for B concentrate via the concentrate supply 168) a predetermined mixture for the respective solution for use by the blood treatment device 100 provides.
- the solution contains water from the water source 155 (online, e.g. as Reverse osmosis water or from bags), which z. B.
- a pump 171 which may be referred to as a concentrate pump or sodium pump, may be fluidly connected to and/or pump, if provided, from the mixer 163 and a source of sodium, such as container A.
- a drain 153 for the effluent can also be seen in FIG. 1 .
- An optional heat exchanger 157 and a first flow pump 159 suitable for degassing complete the arrangement shown.
- the optional pressure sensor PS4 downstream of the blood filter 303 on the water side, but preferably upstream of an ultrafiltration pump 131, as an example of a pump for conveying dialysis liquid and/or dialysate, in the dialysate outflow line 102 can be provided to measure the filtrate pressure or membrane pressure of the blood filter 303.
- Blood leaving the blood filter 303 flows through a venous air separation chamber 329 which may have a vent 318 and be in fluid communication with the pressure sensor PS3.
- the exemplary arrangement shown in FIG. 1 has the control or regulating device 150 . You can with each of the components mentioned here - in any case or in particular with the blood pump 101 - in wired or wireless Signal connection for controlling or regulating the blood treatment device 100 are available.
- the blood treatment device 100 includes means for conveying fresh dialysis fluid and dialysate on the so-called hydraulic side of the blood treatment device 100.
- a first valve can be provided between the first flow pump 159 and the blood filter 303, which opens or closes the inlet to the blood filter 303 on the inlet side. closes.
- a second, optional flow pump 169 is z. B. provided downstream of the blood filter 303, which promotes dialysate to the drain 153.
- a second valve can be provided between the blood filter 303 and the second flow pump 169, which opens or closes the outlet on the outlet side.
- the blood treatment device 100 optionally includes a device 161 for balancing the flow flowing into and out of the dialyzer 303 on the machine side.
- the device 161 for balancing is preferably arranged in a line area between the first flow pump 159 and the second flow pump 169.
- the blood treatment device 100 also includes means for the exact removal of a volume of liquid specified by the user and/or by the control or regulation device 150 from the balanced circuit, such as the ultrafiltration pump 131.
- Sensors such as the optional conductivity sensors 163a, 163b, are used to determine the, in some embodiments temperature-compensated, conductivity and the liquid flow upstream and downstream of the dialyzer 303.
- Temperature sensors 165a, 165b can be provided individually or in groups. According to the invention, temperature values supplied by them can be used to determine a temperature-compensated conductivity.
- An optional compressed air source 175, for example in the form of a compressor, can be provided on the machine side upstream of the blood filter 303.
- a leakage sensor 167 is optionally provided. Alternatively, it can also be provided elsewhere.
- Other flow pumps in addition to or as an alternative to e.g. B. that with the reference numeral 169, may also be provided.
- a number of optional valves are each labeled V in FIG. Bypass valves are marked with VB.
- the control or regulating device 150 determines the electrolyte and/or liquid balance based on the measured values of the aforementioned, optional sensors.
- Filters F1 and F2 can be connected in series.
- the filter F1 is used here, for example, to produce sufficiently pure dialysis liquid by means of the mixing device 163 itself, using impure water, which can then, for example, be B. in the countercurrent principle, through the blood filter 303 flows.
- the filter F2 is used here, for example, to remove e.g. B.
- the blood treatment device 100 shown in FIG. 1 may be a hemofiltration device, a hemodiafiltration device, or a hemodialysis device.
- the present invention is not limited to the embodiment described above, which is merely illustrative.
- the arrows and arrowheads shown in Figure 1 generally indicate the direction of flow in Figures 1 and 2, respectively.
- the arterial line section 301 and the venous line section 305 can be part of a blood tubing set or form this.
- FIG. 2 shows a schematically simplified part of the blood treatment device 100 according to the invention from FIG.
- FIG. 6 leads to a flow reversal in the venous line section 305, as indicated by the arrows and arrowheads in the opposite direction compared to FIG. 1, to prevent or noticeably reduce the flow between the venous hose clamp 306 and the patient and for liquid to pass from the blood chamber 303b into the dialysis liquid chamber 303a, as also indicated by arrows.
- FIG. 3 shows a schematically simplified part of a blood treatment device 100 according to the invention, in particular its extracorporeal blood circuit 300, in the embodiment of FIGS 329 can be held securely in position, for example on a blood cassette.
- this chamber holder serves as an example of a Oscillating device 330 by itself, for example by means of an optionally integrated actuator, offset, vibrates or moves, that is, has a stroke.
- actuators can be generated, for example, by means of a vibration motor, sound transducers (eg generated using piezoceramics or similar sound-generating materials) and/or electroactive polymers.
- the chamber holder set in vibration in this way transmits this vibration to the venous air separation chamber 329 or its contents.
- FIG. 4 shows a schematically simplified part of a blood treatment device 100 according to the invention, in particular its extracorporeal blood circuit 300, in a second embodiment. It largely corresponds to FIG. 3, so only the differences will be discussed here in order to avoid repetition.
- the venous air separation chamber 329 is more cylindrical in shape.
- a sieve-shaped clot catcher 329a is shown at its exit (bottom of FIG. 4). Air that has been conveyed downstream to the patient via the clot catcher 329a hardly rises again via this.
- the venous air separation chamber 329 is held by a bracket, for example in the form of a fork, which can hold the venous air separation chamber 329 securely in its position during use, for example on a blood cassette.
- this fork-shaped holder corresponds to an example of an oscillating device 330.
- FIG. 5 shows a schematically simplified part of a blood treatment device 100 according to the invention, in particular its extracorporeal blood circuit 300, in a third embodiment. It largely corresponds to FIG. 3 or FIG. 4, so only the differences will be discussed here in order to avoid repetition.
- the extracorporeal blood circuit 300 is connected to the vascular system of the patient (not shown) for treatment by means of double-needle access.
- the vibrating device 330 is the venous tube clamp 306 or includes these.
- the control or regulating device 150 is programmed to control the venous tube clamp 306 in such a way that it is automatically opened and closed again or otherwise actuated several times within a minute or second. This opening and closing can generate enough oscillation, vibration, or movement to dislodge any detected air bubbles or inclusions, or to aid in such a process.
- FIG. 6 shows a schematically simplified sequence of the method which can be carried out by means of the control or regulating device 150 of a blood treatment device 100 according to the invention. In the description of the method, reference is made to the reference symbols from FIGS. 1 to 4.
- the blood treatment device 100 which is to be controlled by means of the method, has a blood pump 101, an air bubble detector 315 and a pump for delivering dialysis liquid and/or dialysate on the hydraulic side of the blood treatment device 100 (see FIGS. 1 and 2).
- the method is intended to be performed during an extracorporeal blood treatment session, ie intradialytically.
- the blood treatment device 100 is connected to an extracorporeal blood circuit 300 and to a blood filter 303 .
- the blood filter 303 in turn has a semi-permeable membrane 303c.
- method step M1 includes a detection of air bubbles or air inclusions in the extracorporeal blood circuit 300, or an air bubble alarm.
- Air bubbles or air inclusions in the extracorporeal blood circuit 300 can be detected by means of the air bubble detector 315 .
- the air bubble detector 315 can be suitable or configured to trigger an air bubble alarm (alternatively: gas alarm) as a result of the detection of gas, air or air bubbles, which in turn causes the method according to the invention to be initiated or carried out. If a gas alarm occurs, the blood treatment can be stopped or suspended until the extracorporeal blood circuit 300 has been emptied of air.
- the control or regulating device 150 causes the blood pump 101 to stop or reduce the pumping capacity provided immediately before the air bubbles were detected, shown here as method step M2.
- the optional method step M3 stands for a complete or partial closing of the venous tube clamp 306.
- the method step M4 there is a negative transmembrane pressure across the semi-permeable membrane 303c of the blood filter generated. This negative transmembrane pressure can be achieved on the hydraulic side by appropriately controlling the pump, here for example the ultrafiltration pump 131, for pumping dialysis liquid and/or dialysate while the blood pump 101 is stopped or its pumping capacity is reduced.
- Method step M5 represents an opening of the venous hose clamp 306 when a negative transmembrane pressure has already been generated while maintaining a negative transmembrane pressure or when the transmembrane pressure is negative.
- the venous hose clamp 306 is opened when a negative minimum transmembrane pressure has been determined, for example by means of at least one pressure sensor PS4 of the blood treatment device 100.
- the pressure sensor PS3 (venous sensor) or the pressure sensor PS2 are used to assess the pressure situation become. In these as well as in any other embodiment, the determined pressures can be monitored in order to detect a drop in pressure and to open the venous tube clamp 306 accordingly.
- the operating pressure during treatment is mostly around 320 mmHg for PS3 and around 300 mmHg for PS2. Due to the negative transmembrane pressure, a (transmembrane) plasma water transfer takes place via the membrane 303c and the blood is hemoconcentrated in the dialyzer. Here, the volume pumped into the hydraulics is counteracted by the blood flowing in the usual direction of flow is replaced via the venous hose system from the patient. The air bubbles or air inclusions (gas and microbubbles) in the line are conveyed back into the venous air separation chamber 329 and separated there, for example to the environment.
- a negative transmembrane pressure is generated by the pump while an optional substituate pump 111 of the blood treatment device 100 is stopped or not pumping.
- Method step M6 stands for the cessation of creating or maintaining the negative transmembrane pressure as soon as a predetermined negative transmembrane pressure, which is for example in the range between -300 mmHg and -500 mmHg, reaches or by means of the created transmembrane pressure, or due to this, a volume of at least 30 to 60 ml of blood was conveyed in the direction of an arterial needle or a venous air separation chamber 329.
- a method step M7 the conveying by means of the pump for generating a negative transmembrane pressure is terminated after the air bubble detector 315 no longer detects any air bubbles or air inclusions and/or there is no longer an air bubble alarm.
- the control or regulating device 150 of the blood treatment device 100 can simultaneously or overlap with one, several or all of the method steps M2 to M7 Cause oscillating device 330 to oscillate, oscillate, vibrate or similarly move the extracorporeal blood circuit 300 or at least a portion thereof, or respectively the contents or part of the contents of the blood circuit or section. This is shown in FIG. 6 by method step MV.
- the invention also includes causing the above oscillations without carrying out the method steps M2 to M7.
- the control or regulating device 150 in certain specific embodiments causes the direction of delivery of the blood pump to be reversed, ie it delivers backwards. This is shown in FIG. 6 as method step M8.
- backward conveying could take place alternatively or additionally by generating a negative transmembrane pressure, for example by means of suitable activation of balancing chamber circuits, with the balancing chambers usually being designed as diaphragm pumps. Simultaneously, alternatively or overlapping with this alternative, i.e.
- the control or regulating device 150 can also initiate method step MV and cause the extracorporeal blood circuit 300 or sections thereof to oscillate, move or vibrate, as described above.
- List of reference symbols 100 Blood treatment device 101 Blood pump 102 Dialysate drain line 104 Dialysis liquid supply line 105 Substituate line 107 Pre-dilution valve 107a Line belonging to the pre-dilution valve 109 Post-dilution valve 109a Line belonging to the post-dilution valve 111 Substituate pump 131 Ultrafiltration pump 150 Control device 153 Outflow 155 water source 157 heat exchanger 159 first flow pump 161 device for balancing 162 heating device 163 mixing device 163a conductivity sensor 163b conductivity sensor 165a temperature sensor 165b temperature sensor 166 concentrate supply 167 leakage sensor 168 concentrate supply 169 second flow pump 171 pump, sodium pump 173 pump, bicarbonate pump 175 compressed air source; Compressor 300 extracorporeal blood circuit 301 first line (arterial line section) 302 (first)
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- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
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Abstract
Description
Claims
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102022102164.5A DE102022102164A1 (de) | 2022-01-31 | 2022-01-31 | Blutbehandlungsvorrichtung mit Schwingvorrichtung |
| PCT/EP2023/052149 WO2023144368A1 (de) | 2022-01-31 | 2023-01-30 | Blutbehandlungsvorrichtung mit schwingvorrichtung |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4472697A1 true EP4472697A1 (de) | 2024-12-11 |
Family
ID=85157293
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP23702774.3A Pending EP4472697A1 (de) | 2022-01-31 | 2023-01-30 | Blutbehandlungsvorrichtung mit schwingvorrichtung |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US20250121122A1 (de) |
| EP (1) | EP4472697A1 (de) |
| CN (1) | CN118647418A (de) |
| DE (1) | DE102022102164A1 (de) |
| WO (1) | WO2023144368A1 (de) |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5591344A (en) | 1995-02-13 | 1997-01-07 | Aksys, Ltd. | Hot water disinfection of dialysis machines, including the extracorporeal circuit thereof |
| WO2008053287A1 (en) * | 2006-10-31 | 2008-05-08 | Ehud Milo | Extraction of gas from infused fluid |
| WO2008153831A2 (en) * | 2007-06-06 | 2008-12-18 | Luna Innovations Incorporated | Method and apparatus for acoustically enhanced removal of bubbles from a fluid |
| WO2010121750A1 (de) | 2009-04-23 | 2010-10-28 | Fresenius Medical Care Deutschland Gmbh | Verfahren zum entfernen von blut aus einem extrakorporalen blutkreislauf, behandlungsvorrichtung sowie schlauchsystem |
| US10960119B2 (en) | 2017-05-03 | 2021-03-30 | Fresenius Medical Care Deutschland Gmbh | Method for operating a blood treatment apparatus, control unit and treatment apparatus for executing the method |
| US11278654B2 (en) | 2017-12-07 | 2022-03-22 | Medtronic, Inc. | Pneumatic manifold for a dialysis system |
| DE102018206633A1 (de) * | 2018-04-27 | 2019-10-31 | Fresenius Medical Care Deutschland Gmbh | Vorrichtung zum Halten eines medizinischen Einmalartikels zur Blutbehandlung, System und Betriebsverfahren |
-
2022
- 2022-01-31 DE DE102022102164.5A patent/DE102022102164A1/de active Pending
-
2023
- 2023-01-30 CN CN202380019671.XA patent/CN118647418A/zh active Pending
- 2023-01-30 US US18/834,087 patent/US20250121122A1/en active Pending
- 2023-01-30 WO PCT/EP2023/052149 patent/WO2023144368A1/de not_active Ceased
- 2023-01-30 EP EP23702774.3A patent/EP4472697A1/de active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| US20250121122A1 (en) | 2025-04-17 |
| WO2023144368A1 (de) | 2023-08-03 |
| DE102022102164A1 (de) | 2023-08-03 |
| CN118647418A (zh) | 2024-09-13 |
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