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
  • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
  • A61M1/342—Adding solutions to the blood, e.g. substitution solutions
• • 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
  • A61M1/3643—Priming, rinsing before or after use
  • A61M1/3644—Mode of operation
  • A61M1/3646—Expelling the residual body fluid after use, e.g. back to the body
• • 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
  • A61M2205/14—Detection of the presence or absence of a tube, a connector or a container in an apparatus
• • 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
• • 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
  • A61M2205/60—General characteristics of the apparatus with identification means
  • A61M2205/6018—General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration

Definitions

• the present invention describes a method and a device for removing rinsing liquid from a rinsing bag, which (s) allows that only one rinsing bag must be used per patient and per dialysis session.
• An average hemodialysis treatment takes 4 to 5 hours. Night dialysis lasts up to 8 hours. Such treatment is required at least three times a week for most patients.
• the frequency of treatment depends i.a. the body weight, kidney function and cardiac output of the patient. The tendency, however, is to rather perform several short treatments.
• rinsing bags are connected, as a rule, to a connection to the tube system of the dialysis machine.
• irrigation bags containing 1, 5L or 2L of isotonic saline are used to rinse the tubing and dialyzer while preparing for therapy.
• the amount of approximately 1 - 1, 5L of the used washing bags is removed via the hose system and the roller pump of the device. After this amount is passed through the tube and dialyzer, it is discarded.
• the remaining fluid in the irrigation bag is circulated through the irrigation bag through a return loop until the patient arrives and connects to the tube system via the cannula for dialysis treatment.
• the dialyzer is further rinsed to remove air from the individual capillaries and to ensure optimum wetting and performance.
• hypotensive events occur in up to 25% of cases.
• a second rinsing bag (usually 500mL) is used for infusion of isotonic saline and connected to the blood tube system.
• the cost of the purging bag is made up of the cost of the rinse solution contained and the cost of making the rinse bag.
• the costs for the preparation of the rinse solution form the much smaller proportion and can be optimized by the amount of rinsing liquid is adapted to the equipment components used in particular the dialyzer and the tube system used. If, for example, the type of dialyzer used and the tube system used are known, then the required amount of rinsing fluid can also be predicted by the dialysis machine. The thus determined amount of rinsing liquid is lower and sometimes significantly lower than the amount to be used if the tube system and dialyzer type are not known, because then for safety reasons larger amounts of rinsing liquid must be used to meet the hygiene requirements.
• Another aspect of the present invention is directed to the automatic calculation of the required amount of rinsing liquid, as long as the dialysis machine, the tubing system and the dialyzer used are known.
• the extracorporeal blood treatment device according to the invention therefore preferably has means such as e.g. a data processing unit such as a CPU, which calculates the required amount of rinsing liquid for a given dialyzer and a given tube system and displays the rinsing bag to be used.
• the extracorporeal invention has means such as e.g. a data processing unit such as a CPU, which calculates the required amount of rinsing liquid for a given dialyzer and a given tube system and displays the rinsing bag to be used.
• the extracorporeal invention has
• Blood treatment device preferably via mitel such as e.g. Sensors for automatic recognition of the dialyzer and / or for automatic detection of the tube system and more preferably sensors for both to automatically display the rinsing bag to be used.
• mitel such as e.g. Sensors for automatic recognition of the dialyzer and / or for automatic detection of the tube system and more preferably sensors for both to automatically display the rinsing bag to be used.
• the rinsing bag from the first or the second phase is only conditionally available because, for reasons of hygiene, a renewed connection of the rinsing bag to the same outlet, which is now no longer sterile, may only be carried out within a narrow time window.
• the invention is therefore based on the object to provide a method which makes it possible to make do with only one rinsing bag per patient and per dialysis session and thereby meet the high necessary hygienic and legal requirements. There is a lot of potential for savings in this area, which has not been exhausted so far.
• the extracorporeal blood treatment device is a dialysis system suitable for conventional dialysis, hemodialysis, hemodiafiltration, hemofiltration, cordial dialysis or apheresis.
• a preferred embodiment also relates to purging bags which are not subdivided into different segments or chambers, i. the rinsing bag has only one chamber or an undivided cavity.
• the contents of the rinsing bag remains hygienic and can be used for further withdrawals.
• rinsing of the extracorporeal blood treatment device a portion of its contents is removed from the rinsing bag to prevent the circulation of the Rinse dialysis machine.
• the amount withdrawn depends on the extracorporeal blood treatment device used, the filter, the tubing system, and other factors. For economic reasons, it is preferable to remove only the same amount of rinsing solution from the rinsing bag in order to rinse the circuit once. In some cases, however, it may be necessary to use a multiple of the volume of the circuit to rinse it several times. In both cases, the rinsing solution once removed is no longer returned to the rinsing bag, recirculated or otherwise returned to the rinsing bag. The excess rinse solution, ie the rinse solution that has passed through the circuit once, is discarded and not reused as usual.
• the rinsing solution is considered removed as soon as it has been removed from the rinsing bag, that is no longer present within the rinsing bag.
• the introduction of the rinsing solution is usually achieved by pumping the rinsing solution out of the rinsing bag through the hose pump installed in the extracorporeal tube from the rinsing bag into the extracorporeal blood treatment device.
• initiation is meant in particular that the rinsing solution is pumped into the tube system of the extracorporeal blood treatment device.
• one rinsing bag per patient and dialysis session suffices, without the need for further rinsing bags.
• An average hemodialysis treatment takes 4 to 5 hours. Night dialysis lasts up to 8 hours.
• the patient can be cared for throughout the duration of the treatment.
• only one rinsing bag is used for each patient.
• a dialysis session begins with the rinsing of the extracorporeal blood treatment device for the preparation of the therapy and ends with the return of the blood by means of the rinsing solution.
• the next dialysis session begins with purging the extracorporeal blood treatment device to prepare for the next patient's therapy, using a new purging bag for the next patient.
• the components used filter, tube system, dialyzer
• the extracorporeal blood treatment device eg RFID detection.
• the necessary amount of liquid and speed for initial rinsing is determined from a table stored in the control unit of the extracorporeal blood treatment device and transmitted to the control of the peristaltic pumps.
• the necessary flushing volume and speed can either be taken in advance either from the product descriptions of the individual articles or better determined in the form of a test for specific component combinations.
• Dialyzers are disposable items that are disposed of after a single use after a dialysis session.
• the rinsing bag remains connected to the extracorporeal blood treatment device via a connection and more preferably via two or both connections.
• the backflow of the rinsing liquid into the rinsing bag is prevented by at least one check valve or one-way valve on the rinsing bag and / or by at least one backflow preventer (4) on the extracorporeal blood treatment device.
• the backflow of the rinsing liquid into the rinsing bag is prevented by at least one pressure control in the extracorporeal blood treatment device.
• the irrigation bag may be applied over the second sterile port upon reapplication to the blood-side circuit of the extracorporeal blood treatment device.
• the second sterile connection prevents a contamination of the rinsing bag being caused by a renewed connection of the rinsing bag to the already used first connection.
• the sterile connections are each sealed separately.
• a rinsing bag having two, three or more sterile ports. These can be used individually and independently of each other by "breaking" the sterility seal.Today connections to rinsing pouches lose their sterility at the same time as opening the outer packaging, and the connection is already exposed to the environment, resulting in use after a time
• the rinsing bags used in accordance with the invention preferably have at least 2 connections which are designed so that they can be connected individually and in particular one after the other without impairing the sterility of the respective other connection.
• the rinsing bag it is possible to leave the rinsing bag on the extracorporeal blood treatment device during the dialysis treatment, thus the rinsing bag remains connected when the patient is put on. Also in this case, the contents of the rinse bag remain sterile because the rinse solution is not recirculated into the bag and backflow of the rinse solution from the extracorporeal blood treatment device into the rinse bag is prevented.
• This has the advantage that the rinsing bag does not have to be changed, but rinsing solution can be removed directly from the rinsing bag.
• the arterial connection has to be widened via a corresponding T-piece so that the patient can be connected to the one connection and the rinsing bag remains at the second connection.
• the same irrigation bag is used in hypotensive events.
• hypotensive events occur in up to 25% of cases.
• a second irrigation bag (usually 500mL) is usually used for infusion of isotonic saline and connected to the bloodline system.
• This second purge bag is no longer necessary according to the invention.
• the rinsing bag already used for rinsing can be connected via its second sterile connection to the extracorporeal blood treatment device, whereby contamination from the first connection can be prevented.
• the rinsing bag already used for rinsing is not separated from the extracorporeal blood treatment device and therefore can continue to be used directly without reconnecting.
• one aspect of the invention is to perform the procedure so that it serves only non-therapeutic purposes such as purging the tubing system.
• the rinsing bag is connected to the blood treatment device via both connections and a multi-way valve or multi-way valve is adjustable such that rinsing solution can be withdrawn from the first or the second connection or both connections are blocked, so that none Removal of rinsing solution can be done.
• a timer which also controls the multi-way valve or the multi-way valve can be used to determine whether flushing solution can still be withdrawn from the first connection or sterility requirements can no longer be met and flushing solution can be withdrawn via the second connection.
• the rinsing bag it is not even necessary for the operating personnel of the extracorporeal blood treatment device to deposit the rinsing bag and possibly re-apply it via the second connection.
• the rinsing solution can be withdrawn completely automatically via the first or the second connection on the rinsing bag.
• the device according to the invention is an extracorporeal blood treatment device, which has at least one backflow preventer (4) which prevents the backflow of the withdrawn rinsing liquid into the rinsing bag.
• a preferred device is an extracorporeal blood treatment device with a rinsing bag having at least two sterile connections for withdrawing rinsing fluid and introducing the rinsing fluid into the blood-side circuit of the extracorporeal blood treatment device and a backflow preventer (4), which prevents the backflow of the removed rinsing fluid into the rinsing bag the tubing system is designed so that the rinsing bag is only for removal and no liquid can be returned to the rinsing bag or circulated over the rinsing bag and, moreover, a backflow of the removed rinsing solution into the rinsing bag is prevented.
• a further preferred embodiment according to the invention relates to an extracorporeal blood treatment device having a rinsing bag with two or at least two sterile connections for withdrawing rinsing fluid and introducing the rinsing fluid into the blood-side circulation of the extracorporeal blood treatment device, a backflow preventer (4), which returns the rinsing fluid withdrawn into the rinsing bag prevents and a multi-way valve or multi-way valve to control the removal of Rinsing fluid from the rinsing bag, wherein the tube system is designed so that the rinsing bag is only for removal and no liquid can be returned to the rinsing bag or circulate on the rinsing bag and also a backflow of the removed rinse solution is prevented in the rinsing bag. More preferably, the multi-way valve or the multi-way valve is controlled in such a way, for example via a Zeitsell or timer that rinsing solution is removed via the second port, if the first connection no longer
• the extracorporeal blood treatment device has sensors for the automatic detection of dialyzer, tube system and filter and predetermines the rinsing bag to be used over this detection.
• a particularly preferred embodiment according to the invention relates to an extracorporeal blood treatment device with a rinsing bag with two sterile connections for withdrawing rinsing fluid and introducing the rinsing fluid into the blood-side circuit of the extracorporeal blood treatment device, a backflow preventer (4), which prevents the backflow of the removed rinsing fluid into the rinsing bag and a Multi-way valve or multi-way valve for controlling the removal of rinsing liquid from the rinsing bag, wherein the first connection of the rinsing bag via a first supply line and connected via a second supply line from the second supply line, the second connection of the rinsing bag and the arterial connection are connected to the multi-way valve or multi-way valve, wherein the hose system is designed so that the purge bag is only for removal and no liquid is returned to the purge bag or circulate over the purge bag In addition, a backflow of the removed rinsing solution is prevented in the rin
• the multi-way valve or the multi-way valve is so controlled, e.g. via a timer or timer, that rinse solution is withdrawn via the second port if the first port no longer meets the sterility requirements.
• Reflux of rinse in the rinse bag is also in this embodiment by the possibilities disclosed herein such as:. Pump flow direction, free fall distance (drip chamber) or check valve reached.
• a backflow preventer (4) is defined as being a component which prevents backflow of the withdrawn rinse solution from the extracorporeal blood treatment device back into the rinse bag, but further allows flow of the rinse solution into the extracorporeal blood treatment device, particularly the tube system. This excludes hose clamps or magnetic clamps, which either allow the flow of the rinse solution in the open state in both directions or no flow in the closed state is possible, but not a flow only from the rinsing bag in the tube system of the dialysis machine but allow no flow back into the tubular bag ,
• the backflow preventer (4) is positioned in the arterial tubing near the arterial access.
• the backflow preventer (4) may also be positioned directly in the arterial access.
• a position immediately behind the outflow of the rinsing bag or in the immediate vicinity of the rinsing bag is preferred.
• FIG. 1 shows the construction of a blood-side circuit with a component which prevents the backflow of the removed rinsing liquid into the rinsing bag.
• the rinsing bag (1) is connected to the arterial connection, through which the circuit is rinsed.
• the next component is followed by the non-return valve (4), which prevents the backflow of the rinse solution from the extracorporeal blood treatment device into the rinse bag (1), but still allows the rinse solution to flow into the extracorporeal blood treatment device.
• the arterial pressure monitor (5) which measures the suction pressure of the blood pump (6).
• the blood is conveyed through the blood pump (6), enters the arterial chamber (10), is subsequently cleaned in the dialyzer (12) and returned to the patient via the venous chamber (3).
• the structure may vary depending on the method used, but essential to the invention is only that the backflow of the rinsing solution from the extracorporeal blood treatment device into the rinsing bag by at least one backflow preventer (4) is prevented.
• the backflow preventer (4) is arranged between the rinsing bag (1) and the arterial pressure monitor (5).
• the pressure monitor (5) is the first component which follows the backflow preventer (4) in the blood-side circuit.
• the backflow preventer (4) can also be installed at another point in the blood-side circuit.
• a backflow preventer (4) which would be installed only after the dialyzer, for example, would not do justice to its purpose and purpose as backflow preventer (4).
• the backflow preventer (4) is preferably arranged in the vicinity of the arterial port to which the rinsing bag (4) is connected.
• the backflow preventer (4) is preferably mounted no further than 5 cm, or 10 cm or 15 cm or 20 cm or 25 cm or 30 cm or 35 cm away from the arterial port to which the rinsing bag (4) is connected is, whereby the lengths refer to the length of the hose system, so how many cm hose system has flowed through the rinsing solution from the purge bag to the backflow preventer.
• the backflow preventer (4) follows as the first component on the arterial connection to which the rinsing bag (1) is connected. That after the outflow of the rinsing bag, the next component in the extracorporeal blood treatment device is the backflow preventer (4). This is preferably not more than 35 cm hose distance from the purge bag.
• the non-return valve (4) is a one-way valve or a check valve.
• the backflow preventer (4) can be realized in the form of a drip chamber.
• the backflow of rinse fluid from the extracorporeal blood treatment device into the rinse bag is prevented by at least one pressure control by controlling the blood pump such that the pressure to the atmosphere at the port of the rinse bag is negative.
• the extracorporeal blood treatment device is further characterized in that a timer located on the blood treatment device measures the time the rinse bag is attached to the extracorporeal blood treatment device.
• timer is hereby understood to mean a timer which measures the time and, if appropriate, can trigger an alarm.
• a corresponding message may appear on the service monitor of the extracorporeal blood treatment device.
• the timer may also be realized in the form of a running clock appearing in the service monitor so that the operator can see at any time how much time has already elapsed since the rinsing bag is connected to the extracorporeal blood treatment device or if the first one has already been used Reconnect can be reused or the second sterile connection must be used.
• FIG. 1 LIST OF FIGURES FIG. 1
• FIG. 1 A first figure.
• Blood-side circuit of an extracorporeal blood treatment device with a component which prevents the return flow of the removed rinsing liquid into the rinsing bag.
• the extracorporeal blood circulation essentially consists of an arterial and a venous hose system, with the dialyser in between.
• the rinsing bag (1) When rinsing, the rinsing bag (1) is connected to the arterial port and the rinsing solution is delivered through the arterial tube system from the arterial, i. Blood collection cannula, led to the dialyzer (12).
• the backflow preventer (4) Immediately after the arterial connection (4) is the backflow preventer (4), which allows the flow of the rinsing solution into the tube system, but prevents a backflow of the rinsing solution into the rinsing bag.
• the transport of the rinse solution is done by a blood pump (6).
• the rinse solution is pumped into the arterial chamber (10).
• the rinsing solution / blood is pumped into the dialyzer (12), passes from there via the venous tube system to the venous chamber (3) and is discarded via the venous connection.
• Both in the arterial and venous hose system is ever a pressure monitor (2, 5), which monitors the pressure conditions in the bloodstream during dialysis.
• another pressure monitor (9) monitors the dialyzer inlet. Since blood has the property of coagulating outside the body, an anticoagulant may be delivered through a heparin reservoir (8) in the arterial tubing system during dialysis.
• Dialysate side pump (13) pumps the dialysis fluid into the dialyzer (12). The used dialysate is discarded via the outflow (1 1).
• a CPU monitors the various pressure monitors and controls the pumps.
• the timer (7) is also controlled by the CPU and measures the time the rinse bag is attached to the extracorporeal blood treatment device.

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• Health & Medical Sciences (AREA)
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• Vascular Medicine (AREA)
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• 2012
  • 2012-03-16 DE DE102012102268A patent/DE102012102268A1/de not_active Withdrawn
• 2013
  • 2013-03-18 WO PCT/EP2013/055517 patent/WO2013135902A1/fr not_active Ceased

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