HK1165338B - External functional device and system - Google Patents

Description

The present invention relates to an external functional device as defined in claim 1, and also to a system as defined in the general notion of claim 18.

The cleaning of equipment used in blood treatments can be technically demanding, and for other reasons, external functional devices such as blood cassettes are used to ensure adequate hygiene at acceptable workloads.

Such a blood cassette may be designed to perform as many functions as possible in preparing and performing blood treatment procedures.

The present invention is intended to provide an additional external functional device designed as a blood treatment cassette and to propose a system consisting of a blood treatment device which has such an external functional device or is designed to control or operate it.

The task of the invention is solved by an external functional device with the characteristics of claim 1.

The external functional unit shall have at least one housing, at least one chamber integrated into the housing for the reception of medical fluids, at least one channel integrated into the housing for the reception and/or delivery of medical fluids and at least one valve device integrated in whole or in part into the housing for the control or regulation of fluids flowing through the external functional unit.

Err1:Expecting ',' delimiter: line 1 column 55 (char 54)

Err1:Expecting ',' delimiter: line 1 column 55 (char 54)

Chambers may be designed and equipped to accommodate valves and/or sensors or the like.

Err1:Expecting ',' delimiter: line 1 column 55 (char 54)

The ducts or pipes may be designed as closed and/or semi-open sections, for example, they may be closed by means of a covering device on at least one open side, and thus sealed against, for example, components of a blood treatment device and/or against the atmosphere.

Err1:Expecting ',' delimiter: line 1 column 55 (char 54)

Beneficial training of the external functional device of the invention is the subject of each subclaim.

A functional device may be defined as a device which allows functions such as conduction of fluid by means of pipes, valves, clot capture and/or the like.

An external functional device may be a device which is not a permanent part of a treatment device, but is connected to the treatment device from the outside for the purpose of treatment.

The external functional unit shall have at least one cover on one of its surfaces which is part of at least one integrated valve assembly.

The cover device shall be connected to the body of the housing by means of force and/or form and/or material in at least one section. The cover device may be connected to the body of the housing, for example, by means of a circular weld or other circular connection. Other non-circular or pointed or local welds or connections (e.g. glues or compression) of the cover device to the body of the housing may also be provided.

In further embodiments, the cover device is connected in certain areas on both sides of structures (at least one structure) to the external functional device, in particular to the body of the housing. Both sides can be understood as being on at least two sides of the respective structure. A two-way connection can be understood as a connection of at least two parts in the area, in particular the immediate area, or in the environment, in particular the immediate environment, of the structure.

These structures include fluid channels, lines or other elements of the external functional device, preferably those elements which are open in cross-section perpendicular to the main extension plane of the cover device and/or are covered by the cover against an exterior or the atmosphere.

The two-sided connection may be a welding connection, which may be fluid-tight, e.g. such that no fluid exchange, in particular no fluid exchange, can take place over the joint area (the area in which the connection was glued or welded, for example), the two-sided connection may be for individual fluid channels, pipes or other elements, e.g. in selected areas of the external functional device, or it may be for a number of these or for all fluid channels, pipes or other elements.

A two-way connection may be a connection to the left or right of the corresponding structure, or it may be provided at the top or bottom of the structure, or similar.

A two-sided connection may be one, two or more welds along the edge or circumference or the intersection of at least one structure or section thereof.

A two-way connection may be fully or in parts of it, longitudinally or longitudinally extended.

The two-sided connection in certain embodiments of the invention can be used to reduce the effort required to apply pressure to the external functional device in a beneficial way. In particular, in some embodiments of the invention the requirements for the precision with which the external functional device is applied, e.g. to a blood treatment device, can be advantageously reduced. In certain embodiments of the invention a lower pressure can be achieved in a beneficial way due to the two-sided connection. In some embodiments of the invention a more reliable function can be achieved in a beneficial way by means of valves covered by a lid on both sides of the connection.

A covering device may be in particular a film.

The film may preferably be a plastic film, and any laser-welding film suitable for the professional may be used.

In another preferred embodiment, the external functional device may have connectors to connect it to an extracorporeal fluid communication circuit.

The external functional device is designed as a blood treatment cassette.

The external functional unit may also be preferably connected by two connectors to at least one, preferably two, peristaltic pumps in fluid connection.

The external functional unit may have at least one, preferably two, pump tube segments or be designed or intended to accommodate one.

In another preferred embodiment, the external functional device shall have at least one valve device, comprising at least one port and a section of the cover device. The port is designed on the body of the housing. The port and cover device are arranged so that they can be actuated by an actuator acting on a port to change the flow of a blood treatment device in the direction of a valve.

Err1:Expecting ',' delimiter: line 1 column 55 (char 54)

In another preferred embodiment, the fluid that flows through the external functional unit in its use is a substitute, heparin or another pharmacologically active substance, saline solution (especially 0.9% NaCl solution), blood, air and combinations thereof.

The external functional device may be capable of being connected in particular to a blood treatment device; preferably it may be designed and provided to be connected to the blood treatment device by means of a receiving device; the external functional device may be capable of being connected to the treatment device in particular by means of a surface facing the cover device.

In another preferred embodiment, the external functional device may be attached to the blood treatment device at a vertical angle to the rear, preferably between 5° and 11°, in particular at a substantial or exact 8° angle to the blood treatment device.

In another preferred embodiment, the external functional unit shall have at least one substitute train order which shall have a contact protector and/or a drip protection.

A closing function of the ports (one, some or all ports) of the external functional unit may also be achieved by septa or recoil valves.

The drop protection can be achieved, for example, by an integrated closing case.

The drop protection may preferably be used to prevent the drip or leakage of substitute or blood or a mixture of substitute and blood from the receiving device of the external functional unit during the expansion of the external functional unit, thus ensuring that the hygienic handling of the used and unclean external functional unit is maintained outside the treatment unit.

The external functional device according to the present invention may be suitable for use in a blood treatment procedure using a double needle access or a single needle access.

Err1:Expecting ',' delimiter: line 1 column 375 (char 374)

The external functional unit may preferably have at least a single needle chamber in which a blood vessel diversion element is located.

Err1:Expecting ',' delimiter: line 1 column 55 (char 54)

Without a blood clot diversion element, a blood clot flowing through the phantom valve could possibly cause a fountain, which could lead to fluid level swellings and/or foaming. The blood clot element divides the total blood clot into two smaller blood clots, which can cancel the pulse of the total blood clot and can help prevent foaming, movement of the blood clot and/or foaming.

Err1:Expecting ',' delimiter: line 1 column 260 (char 259)

The external functional device of the present invention has at least one venous blood chamber.

The single needle chamber is located above, relative to the orientation of the external functional device during its use, the venous blood chamber.

The external functional device of the present invention has a single needle blood valve located between the venous blood chamber and the single needle chamber.

The venous blood vessel may be divided into at least one upper chamber and at least one lower chamber by a cross-sectional junction of the body of the vessel.

The upper and lower chambers may be in fluid communication or interconnection.

The upper chamber may be designed to allow or generate tangential flow of fluids flowing through the external functional unit; the upper chamber may have an area for generating a stable rotational flow of fluids flowing through the external functional unit.

The lower chamber may have an area which is essentially or completely free of rotational flow of fluids flowing through the external functional unit.

Preferably, walls or sections of the upper and/or lower venous chamber may be adjusted to an inclination of the external functional unit against a vertical of the blood treatment device, which may favourably allow for stream-optimised flow or streams of blood through the venous chamber and the upward movement of any air present in the blood for excretion.

Err1:Expecting ',' delimiter: line 1 column 251 (char 250)

In another preferred embodiment of the external functional unit, the body is designed as a hard part.

The hard part can be a body made essentially of one piece and one material, which can be an injection moulded part, and can have a minimum stiffness of more than 400 N/mm2, preferably 1200-1800 N/mm2 (bending E-module).

In a further preferred design of the external functional device as a blood treatment cassette, the pressure in the extracorporeal bloodstream in front of the dialyser can be measured in a further preferred embodiment by means of the cover device or film.

The external functional device may preferably be a single article which is disposed of after single use.

The problem of the invention is also solved by a system according to claim 18.

The blood treatment device of the system shall have at least one external functional device according to the present invention.

The system blood treatment device shall have at least one control device and/or actuators and/or sensors to control and/or operate the external functional device.

The control may be designed as a CPU or part of a CPU.

The control device and/or actuators may, for example, be suitable and intended to operate or control, i.e. control or regulate, a valve device and may be located at a position of the blood treatment device opposite to a valve device of the external functional device in its coupled state.

The blood treatment device of the system shall have at least one receiver for receiving at least one external functional device according to the present invention, the receiver shall have a coupling surface for the receiver to connect the external functional device according to the present invention, such a coupling surface may be inclined, for example, at an angle to a vertical relative to the orientation of the blood treatment device during use, particularly backwards, and may be between 5 and 11°, particularly at or near 8°.

The blood treatment device may be suitable for carrying out a procedure or step as described below and with reference to the figures.

In another embodiment, the blood treatment device has a control, e.g. in the form of a CPU, to control or control an external functional device according to the present invention and/or to perform a procedure or step as described below and with reference to the figures.

In addition, the blood treatment device may have at least one actuator to operate an external functional device according to the present invention or a part thereof to perform a procedure or step described herein.

In particular, the blood treatment device may also have sensors as information transmitters, the information from the control unit serving as signals to operate an external functional device according to the present invention to perform a procedure or procedure step described herein.

The blood treatment device may be, for example, a dialysis device.

The blood treatment device may have a control to measure a parameter present in the extracorporeal circulation or the blood circulation of the external functional device of the invention designed as a blood treatment cassette, such as pressure, differential pressure and the like.

The differential pressure can be measured between the arterial cassette-integrated chamber and the venous cassette-integrated chamber. The differential pressure can be used as a measure of the dialyser's blood pressure differential. The control of the blood treatment device can be configured to calculate this difference, if necessary to compare the pressure difference with reference values (which may be stored, for example, in the control or a memory), and optionally to emit control signals.

This can be advantageous, for example, in detecting early or timely the onset of dialysator blockage and in taking countermeasures.

These may include or consist of the addition of anticoagulants, such as heparin, e.g. via the cassette-integrated train orders.

For example, the pre-dilution can be increased, and it can be changed from post-dilution to pre-dilution.

The cassette-integrated measuring stations can also provide a useful means of measuring transmembrane pressure across the dialysator membrane.

Four measuring points may be used for this purpose, where measurements are made by appropriate equipment and the results are evaluated by appropriate equipment: one at each filter inlet and filter outlet, on the blood side and the dialysis side.

In some embodiments of the invention, the external functional unit is designed in certain sections of it (at least also) in a direction perpendicular to the coupling plane (or to a main section of it) to be stronger or thicker than other sections.

The same use may be made of sections of the external functional device which are not of a stronger or thicker design but which extend primarily in the main connecting plane of the external functional device, preferably parallel to a main coupling plane of the external functional device and/or parallel to an actuator-sensor plate of the treatment device.

The measuring devices may be connected or covered by the treatment device from one side of the treatment device door, which compresses and/or covers the external functional device in certain embodiments of the invention for use with the treatment device.

The measuring devices may be connected or be connected to the treatment device from one side of an actuator-sensor plate of the treatment device, by means of which in some embodiments of the invention a functional or signal connection is achieved between an external functional device and the treatment device.

Measuring devices in such stronger or thicker or longer sections may be used, for example, to measure states within the fluid channels to or from the external functional device (in particular those fluid channels which draw or draw a fluid from the external functional device) and may be placed in the immediate vicinity of such fluid channels.

All or some of the stronger or thicker or longer sections are preferably located in a peripheral area of the external functional unit. This may favourably allow a simple connection between the measuring unit, which is located in one of the above sections, and the treatment unit.

The external functional unit may have measuring points in the above-mentioned stronger, thicker or longer sections or elsewhere for connecting detectors, such as optical detectors, to detect leakage of pipes or valves. Such leaks may occur, for example, in the area of the phantom valves, the reverse valves, the conduits to or from the valves, or the like. The measuring points and/or the detectors, especially optical ones, may be located in the appropriate location.

The external functional device may, in some embodiments of the invention, have one or more train orders, each having at least one septum, which may be designed to be easily penetrated during the insertion, but which, however, provides closure and thus safety and leakage.

The train orders shall preferably be integrated into the external functional unit or manufactured as an integral part thereof.

The train commands may be arranged in a frontal area or peripheral area of the external functional device. This arrangement may in some embodiments of the invention favourably facilitate access to the train commands. In certain embodiments of the invention this is particularly true if the external functional device is in contact with a treatment device by means of both its front and rear coupling (e.g. compressed) and thus both front and rear are only or only difficult to reach for an addition over the septum. This may result in ergonomic advantages in some embodiments.

In further preferred embodiments, feed lines may be arranged on or in the external functional unit such that the supply line (in whole or in part) or a connection point (such as an interface port of the supply line) to the supply line is located in an upper area of the external functional unit, preferably in relation to a design position or arrangement of the external functional unit during its design use (e.g. in a condition compressed with the treatment device).

The upper area may be a peripheral area, the upper area may be an area above a coupling surface or a coupling area.

The supply line may be a line for an anticoagulant; it may be a heparin line; an associated injection pump for the anticoagulant, e.g. heparin, may be placed above the external functional device or its coupling level when using the external functional device.

The advantages to be derived in some embodiments of the invention include ergonomic advantages, advantages associated with a shorter supply line, better access to the connecting point, and more.

In some embodiments, supply lines may be understood as lines that can be used or intended to supply extracorporeal blood fluids during the use of the external functional device in a blood treatment.

The blood treatment device may have a control to control the cartridge valves. The control can preferably switch freely programmable between the cartridge-integrated pre- and post-dilution. It can preferably change the substitute current (volume current). Information sources can be in particular the cartridge-integrated pressure measuring stations located before and after the dialyzer.

The procedures are explained below.

The blood treatment procedure is hereafter assumed as an example of a dialysis procedure, e.g. haemodifiltration. The dialysis apparatus has an extracorporeal circulation with an arterial and a venous section.

During dialysis, a patient is connected to the extracorporeal circulation via a patient access such as a fistula, shunt or catheter, for example in the form of a double needle access or single needle access.

The extracorporeal circulation may have a blood pump to pump blood and a substitute pump to pump substitute and corresponding pump tube segments.

The blood pump and the replacement pump may be designed as peristaltic pumps, e.g. rolling pumps.

Err1:Expecting ',' delimiter: line 1 column 48 (char 47)

Fluid transport (especially blood and/or substitute) in the opposite direction is called contra-transport or flow.

The blood treatment device has a dialysis device with a dialysis fluid inlet and outlet, whereby the dialysis fluid can be supplied by the dialysis device in the opposite direction to the blood (in the figures from top to bottom).

A substitute may be initiated by a substitute draw order and entered into the extracorporeal circulation by a pre-dilution draw valve and/or a post-dilution draw valve.

Err1:Expecting ',' delimiter: line 1 column 56 (char 55)

When priming or filling, the pre-dilution intake valve, post-dilution intake valve and a single needle blood valve may be opened initially.

Preferably, the arterial patient tube clamps and the venous patient tube clamps are also open.

The arterial patient port and the venous patient port are preferably connected.

Err1:Expecting ',' delimiter: line 1 column 108 (char 107)

The substitute train order is used to admit a substitute.

The replacement pump is started, preferably clockwise (relative to the character level of the attached figures).

Preferably, the substitute is supplied up to or before the post-dilution draw valve.

The substitute is pumped through the pre-dilutions valve, preferably towards the dialysis apparatus and/or towards the blood pump.

The substitute, flowing towards the dialysis apparatus, can flow through the dialysis apparatus and the venous section of the extracorporeal circulation and enter a venous blood chamber of the external functional apparatus.

The substitute, which flows towards the blood pump, can flow clockwise through the pump tube segment inserted into the blood pump, preferably through the patient's arterial-venous junction, through an external functional device clot catch, and into the venous blood chamber.

The pressure in the extracorporeal circulation can be measured on or in the collateral by means of a suitable pressure measuring device, preferably by means of a covering device for the external functional device, e.g. a blood treatment cassette, which, if it is made of a film, can be measured through it or through the film, thus preferably measuring the pressure in the extracorporeal circulation, especially after the dialysator has passed through.

It is possible that the substitute flowing towards the dialysis apparatus may be mixed with the substitute flowing towards the blood pump in the venous blood chamber.

If the venous blood chamber is full, preferably the predilution draw valve 51 and the single needle blood valve can be closed or closed automatically.

The pre-dilution intake valve, post-dilution intake valve and single needle blood valve are preferably closed.

When the blood pump is running, the substitute is supplied by the extracorporeal circulation, preferably with no or only a small amount of substitute in the single needle chamber.

The online filling procedure can also be performed as follows: (1) connection of the automatic substitute connector; (2) arterial and venous patient tubes are connected to a rinsing port of the blood treatment device, e.g. by a suitable connector, which provides access to the other patient tube for the end of one patient tube; (3) the end of the other patient tube serves as a drain into the rinsing port; (4) the connector can alternatively be connected to the arterial or venous patient tube; (3) the patient's venous venous clamp is closed, the post-dilution valve is opened, the ventilation valve is closed; (4) the venous substitute pump is filled through the vent. (5) The post-dilution valve is filled with air and pumps blood up and out of the venous tube.Err1:Expecting ',' delimiter: line 1 column 350 (char 349)Err1:Expecting ',' delimiter: line 1 column 458 (char 457)

Alternatively to online filling (the substitute is provided online in the dialysis machine), it is also possible to fill with an external bag of saline solution as a source of the filling fluid. The arterial patient line is connected to the bag of saline solution. The venous patient line is connected to a so-called waste bag as a sink for the used saline solution. The blood pump runs forward. By opening the predilusion valve and the post-dilusion valve, the line between these two valves can also be filled.

In both procedures, the patient is only connected to the extracorporeal bloodstream after a specified amount of rinsing has been achieved.

When rinsing or rinsing, preferably both the pre-dilusion intake valve, the post-dilusion intake valve and the single needle blood valve are closed first.

The arterial patient tube and venous patient tube clamps should preferably be opened at the beginning.

The arterial patient and venous patient are still connected.

The substitute is supplied by the extracorporeal circulation, with the blood pump operating, whereby, for example, there is no substitute in the single needle chamber.

Err1:Expecting ',' delimiter: line 1 column 160 (char 159)

When operating the substitute pump (preferably counter-clockwise of the plane of the symbol) and the blood pump (preferably clockwise), the substitute is preferably supplied continuously by the extracorporeal circulation.

The substitute can be excreted and eliminated from the extracorporeal circulation via a drainage line.

For dialysis, a patient is connected to the extracorporeal circulation, for example, with a double needle access or a single needle access. In a first patient connection, the pre-dilution intake valve, post-dilution intake valve and single needle blood valve may be closed preferably.

A patient can be connected to the extracorporeal circulation by means of a double needle access via an arterial needle and a venous needle.

The arterial patient tube clamps and the venous patient tube clamps may preferably be closed at first.

Then the patient's arterial tube clamps can be opened.

The blood pump can be operated (preferably counterclockwise) and preferably pump blood through the arterial needle into the extracorporeal circulation.

Substitute may be worn and discarded at the exit of dialysis fluid from the extracorporeal circulation.

If the blood to be purified arrives at a blood entry point on the dialysis apparatus, the arterial patient tube stopper may preferably be closed and the venous patient tube stopper opened.

The blood pump can be stopped.

Preferably, blood can now flow through the venous needle into the extracorporeal circulation and through the coagulant trapper into the venous blood vessel and through a venous filter line to a blood outlet from the dialysis machine.

Alternatively, a patient can be connected to the extracorporeal circulation via a patient connection according to a second variant.

The pre-dilution intake valve, post-dilution intake valve and single needle blood valve shall be preferably closed first.

For example, the patient can be connected to the extracorporeal circulation via a double needle access via an arterial needle and a venous needle.

The blood pump can now be operated (preferably counterclockwise) and carry blood through the arterial needle into the extracorporeal circulation. The blood can preferably flow through the dialysis device and the external functional device. The blood can preferably enter the patient through the venous needle.

The arterial and venous patient tube clamps may preferably remain open.

In dialysis without substitution, the pre-dilusion and post-dilusion valves may be closed; in dialysis with double needle access, the single needle blood valve may preferably be closed.

In addition, the arterial patient tube clamps and the venous patient tube clamps are preferably open, allowing blood to flow continuously through the extracorporeal circulation.

Preferably, the blood pump can pump blood through the arterial needle into the extracorporeal circulation and back to the patient through the venous needle.

The blood flows through the dialysis apparatus where it can be efficiently purified by the dialysis fluid flowing in the opposite direction to the blood through the dialysis apparatus.

Preferably, both steps, arterial and venous, can be performed simultaneously, at least over a period of time.

Err1:Expecting ',' delimiter: line 1 column 55 (char 54)

Err1:Expecting ',' delimiter: line 1 column 85 (char 84)

The arterial patient tube clamps and the venous patient tube clamps may preferably be open.

The blood pump (preferably clockwise) can pump blood through the arterial needle into the extracorporeal circulation and back through the venous needle to the patient or his vascular system, as described above in relation to dialysis treatment.

The substitute pump (preferably counterclockwise) may deliver substitute that can mix with the blood at or from the predilusion intake valve in the arterial section of the extracorporeal bloodstream.

The dialysis fluid may be, as described above, preferably passed through the dialysis apparatus in the opposite direction to the blood and used to purify the blood also flowing through the dialysis apparatus.

Err1:Expecting ',' delimiter: line 1 column 55 (char 54)

Err1:Expecting ',' delimiter: line 1 column 289 (char 288)

Err1:Expecting ',' delimiter: line 1 column 60 (char 59)

Each sub-process of pre-dilution or post-dilution can be maintained for a certain interval and each sub-process can be repeated continuously.

The time fraction of the pre- or post-dilution may be fixed or variable and may vary according to a measurement quantity.

Err1:Expecting ',' delimiter: line 1 column 239 (char 238)

A single needle access may have a Y-shaped branch in the arterial section and the venous section of the extracorporeal circulation.

The pre-dilusion and post-dilusion valves may be closed, but the single needle blood valve may be preferably open, allowing fluid communication between the venous blood chamber and a single needle chamber.

The arterial patient tube clamps and the venous patient tube clamps may be closed.

The patient is connected to the extracorporeal circulation and the patient' s arterial tube clamps may be preferentially opened.

The blood pump can pump blood through the extracorporeal circulation via the venous blood vessel preferably to the single needle chamber of the external functional unit.

When the single needle chamber is substantially or completely filled, the blood pump may preferably be stopped and the arterial patient tube stopper closed.

The venous section allows blood to flow back into the patient' s vascular system or back to the patient.

The patient's arterial tube clamps are then preferably opened.

The procedure may be repeated as often as necessary and/or desired, continuously or at certain intervals.

A combination of single needle treatment with haemodifiltration is also possible.

Following a blood treatment procedure, preferably the blood in the extracorporeal circulation after treatment can be returned to the patient.

In a first blood return variant, the pre-dilusion intake valve may be open and the post-dilusion intake valve and single needle blood valve may be closed.

The arterial patient tube clamps may preferably be closed, while the venous patient tube clamps may be open. The arterial needle and the venous needle of a double needle access may preferably remain on the patient.

The substitute pump (preferably counterclockwise) may be operated and preferably transfer the substitute into the extracorporeal circulation via the predilusion intake valve.

The substitute can flow through the dialysis apparatus and the venous section of the extracorporeal circulation, displacing the blood, preferably before the substitute reaches the venous needle.

The venous patient tube stopper can then be closed and the arterial patient tube stopper opened.

The replacement pump (preferably counterclockwise) and the blood pump (preferably clockwise) can be operated.

The substitute may be introduced into the arterial section in the direction of the patient from or at the predilution valve, preferably by stopping both pumps shortly before reaching the arterial needle.

The return by the arterial and venous needle can also be done simultaneously, with the replacement pump moving forward at a higher rate and the blood pump moving backwards at a lower rate.

In a second embodiment of the blood return process, the pre-dilusion intake valve, post-dilusion intake valve and single needle blood valve may be closed.

The arterial patient tube clamps and the venous patient tube clamps may preferably be closed.

Preferably, at least one sensor/detector may be provided in the arterial part of the extracorporeal bloodstream and at least one sensor/detector in the venous part of the extracorporeal bloodstream.

The arterial needle may be disconnected from the patient and/or the arterial line may be disconnected from the arterial needle.

The blood pump (preferably counterclockwise) can be operated and pump blood through the arterial needle into the extracorporeal circulation.

If the sensor/detector in the arterial part of the extracorporeal bloodstream detects the presence of air, the blood pump can preferably continue to pump until blood reaches the predilution draw valve, after which the blood pump can preferably be stopped.

The patient's arterial outlet can be closed.

The replacement pump can be operated (preferably counterclockwise).

The pre-dilutions intake valve can be opened and the substitution pump can preferably pump the substitute into the extracorporeal circulation through the pre-dilutions intake valve.

The substitute can flow through the extracorporeal circulation and preferably displace the blood in it. If the venous patient tube plug sensor/detector detects the presence of substitute, the substitute pump can preferably continue to deliver blood and substitute through the venous needle into the patient until all blood from the extracorporeal circulation has been returned to the patient.

Finally, the venous needle can be pulled and the pumps preferably stopped.

For draining, the pre-dilution and post-dilution injection valves may be open, while the single needle blood valve may be closed.

The arterial patient tube clamps and the venous patient tube clamps may be closed.

The arterial patient port and the venous patient port may preferably be connected.

At the beginning of the procedure, the arterial patient tube clamps and the venous patient tube clamps can be opened.

Preferably, the substitute can be introduced into the extracorporeal circulation at or via the substitute train stop.

The substitute pump can be operated (clockwise) and carry the substitute through the extracorporeal circuit to the pre-dilution intake valve and the post-dilution intake valve.

The spent substitute can be released from the extracorporeal circulation preferably at the dialysis fluid exit and discarded, and air can be introduced to displace the substitute.

The substitute may be supplied to the dialyser by the pre-dilution intake valve on the one hand and by the post-dilution intake valve on the other.

The predilution valve can be closed, the blood pump can be started.

By operating the blood pump (preferably counterclockwise) and the substitute pump (preferably counterclockwise), air can be transported through the extracorporeal circulation - starting upstream from the post-dilution draw valve - through the venous blood chamber, the coagulant tractor, the venous section, the arterial section towards the dialysis device. It can leave the extracorporeal circulation preferably through the dialysis fluid. The used substitute can be discarded.

In preferred embodiments of the invention, the external functional device shall have at least one pump, suitable and designed to withdraw a fluid other than blood or blood only from the external functional device while the external functional device is connected to a treatment device in use.

In preferred embodiments of the invention, the external functional device shall have at least one hose attachment to attach at least one section of at least one hose to the external functional device while it is connected to a treatment device.

In preferred embodiments of the invention, the fluid is part of the group comprising substitute, heparin, blood, saline, air and combinations thereof.

In preferred embodiments of the invention, the external functional device can be connected to the blood treatment device at an angle of inclination, in particular of substantially or exactly 8°, relative to a vertical.

In preferred embodiments of the invention, the external functional device shall have at least a single needle chamber in which a blood-thinning re-circulation element is located.

In preferred embodiments of the invention, walls of the upper and/or lower venous blood chamber are adapted to an inclination of the external functional unit against a vertical of the blood treatment device.

In preferred embodiments of the invention, the walls of the venous blood chamber have at least one recess.

In preferred embodiments of the invention, the body is designed as a hard part.

In preferred embodiments of the invention, the external functional unit shall have a protection of originality which is achieved by means of the design of the substitute train order.

In preferred embodiments of the invention, the protection of originality is achieved by means of a touch protective element or the closing case of the replacement train order, based on a change in its position within or in relation to the cartridge and/or a change in its shape.

In preferred embodiments of the invention, the external functional unit shall have a reuse protection effect achieved by the design of the replacement train command.

In preferred embodiments of the invention, a closing case is rendered unusable for reuse.

In preferred embodiments of the invention, the coupling surface is inclined at an angle to a vertical relative to the orientation of the blood treatment device during use or to the earth centre; in preferred embodiments of the invention, the angle to a vertical relative to the orientation of the blood treatment device during use or to the earth centre is between 5 and 11°, in particular essentially or exactly 8°.

In preferred embodiments of the invention, the blood treatment device shall have a control to control or control an external functional device of the invention.

In preferred embodiments of the invention, the blood treatment device of the invention shall have at least one actuator to operate an external functional device of the invention or a part thereof to perform a procedure described herein.

In preferred embodiments of the invention, the blood treatment device has sensors to emit signals as a basis for operating an external functional device of the invention to perform a procedure described herein.

The following describes the present invention by reference to preferred embodiments of the invention, with reference to the figure. Fig. 1 shows a side view of an external functional device of the invention with a covering device on its front side in accordance with a preferred embodiment;Fig. 2 shows the external functional device of Fig. 1 with a covering device folded up after destructive cutting;Fig. 3 shows the external functional device of Fig. 1 and Fig. 2 from its rear;Fig. 4 shows schematically simplified a stage during the execution of a preparation or priming process to demonstrate the execution of a blood treatment process;Fig. 5 shows schematically simplified a stage during the execution of a rinsing or rinsing process to demonstrate the execution of a blood treatment process;Fig.6 shows a schematically simplified phase during the first process of connecting a patient to an extracorporeal circulation of a blood treatment device;Fig. 7 shows a schematically simplified phase during the second process of connecting a patient to or with an extracorporeal circulation of a blood treatment device;Fig. 8 shows a schematically simplified phase during the first process of conducting a blood treatment;Fig. 9 shows a schematically simplified phase during the blood treatment process of Fig. 8 using pre-dilution;Fig. 10 shows a schematically simplified phase during the blood treatment of Fig. 8 using post-dilution;Fig. 11 shows a schematically simplified phase during the blood treatment of Fig. 8 using pre-dilution.Figure 12 shows a simplified schematic of a phase during the execution of the blood treatment process from Figure 8 using mixed dilution (post-dilution);Figure 13 shows a simplified schematic of a phase during the execution of a second blood treatment process using a single needle access;Figure 14 shows a simplified schematic of a phase during the execution of a first blood drawback;Figure 15 shows a simplified schematic of a phase during the execution of a second blood drawback;Figure 16 shows a simplified schematic of a phase during the execution of a de-ferment or emptying procedure;Figure 17 shows a simplified schematic of a procedure after the completion of a procedure;Figure 18 shows a simplified schematic of a procedure after the completion of a procedure;Figure 18 shows a simplified schematic of its function after the completion of a procedure.17;Fig. 19 shows the schematically simplified external functional device in a further embodiment of Fig. 17, shown in a perspective view with a view to its reverse;Fig. 20 shows a schematically simplified detail of the representation of Fig. 19;Fig. 21 shows the schematically simplified external functional device in a further embodiment in a view from its front;Fig. 22 shows a schematically simplified detail from the representation of Fig. 21;Fig. 23 shows a schematically simplified detail of the representation of Fig. 21;Fig. 24 shows a schematically simplified detail of the representation of Fig. 24;Fig. 25 shows a schematically simplified image of the external functional device;Fig. 26 shows a schematically simplified detail of the representation of Fig. 21;Fig. 24 shows a schematically simplified image of the presentation of the functional device;Fig. 25 shows a schematically simplified image of the presentation of the detail of the functional device.24 years .

For illustrative purposes of the present invention, a blood treatment device is used as a treatment device and a blood treatment method is used as a method.

The normal arrows in the figures indicate the direction of blood flow, the block arrows each indicate the direction of the substitute flow, the double block arrows each indicate the direction of the dialysis fluid flow.

Figure 1 shows a side view of an external functional device fitted with a covering device on the surface viewed in Figure 1.

The external functional unit is here exemplarily designed as a cassette 1000.

The cassette 1000 has a hard part 1 as shown in Figure 1 examples, the hard part 1 has chambers, channels and valves as shown in Figure 1 examples, the chambers, channels and valves are integrated into the hard part 1 or at least partially made up of the hard part 1. The cartridge 1000 of Fig. 1 is fitted with a covering device on its front, for example a film 3, which may be welded to the hard part 1.

The invention also permits the design of a three-dimensional version of the welding and sealing contour.

The cover device may close the chambers and/or channels of hard part 1 of the cartridge 1000 to a side of the cover device facing hard part 1 and/or to the atmosphere.

As shown in Figure 1, the film is mounted on the hard part 1 of the cassette 1000 by a circular seam 4 and welded to the hard part 1 of the cassette 1000 by a circular welding joint 5.

The circulating seal level can alternatively be run open.

The film 3 may be connected to the hard part 1 of the cassette 1000 by further local welds (not shown), which may also be circular, i.e. closed in the sense of a ring-like final boundary, and/or point-like.

The film 3 may be connected at local points, in a dotted or linear fashion, to the hard part of the cartridge 1000, e.g. welded, particularly at the edge of the fluid conducting channels.

The film 3 can be welded to the hard part of the cassette 1000 by laser welding. It is advantageous if the local heat input is made using light absorbing components. The light absorbing component can be part of the material of the film and/or the hard part or a layer arranged between the film and the hard part or above the film. The layer can be a film layer.

Err1:Expecting ',' delimiter: line 1 column 391 (char 390)

The 1000-cartridge can be connected to a blood treatment device coupling surface via or through the plane of film 3 and preferably in three dimensions.

The coupling surface of the blood treatment device may, for example, be tilted backwards by 8° at an upper section of it in Fig. 1 against a vertical line running from top to bottom in Fig. 1 (in Fig. 1 in the direction extending from the observer into the plane of the mark).

The 1000 cartridge has a patient arterial port 7.

The cassette 1000 has an arterial pressure chamber 9 which may have corresponding sensors, which may preferably transmit signals via wiring, but which may also be designed to transmit signals wirelessly.

The 1000 cartridge has a connector 11 for the exit of blood from the 1000 cartridge and a connector 13 for the entry of blood into the 1000 cartridge. The two connectors 11 and 13 are connected to a pump tube segment or set of a blood pump.

Err1:Expecting ',' delimiter: line 1 column 185 (char 184)

At chamber 15 the extracorporeal circulation pressure in front of the dialysator can be measured through or through film 3.

The 1000 cartridge has an arterial filter line 17 and a venous filter line 19.

The inside of the 1000 cartridge has a venous blood chamber 21 and the venous blood chamber 21 is divided into an upper chamber 23 and a lower chamber 25.

The upper chamber 23 of venous blood chamber 21 can allow lateral tangential blood flow, whereby blood can flow laterally through the inlet (the left side in Fig. 1) into the upper chamber 23 and spread tangentially to the walls of the upper chamber 23.

The lower chamber 25 of venous blood chamber 21 may be a region of sedimentation for blood flow, and it is possible that in such a region of sedimentation there is essentially no or no circulation of blood.

The venous blood chamber 21 is divided into upper chamber 23 and lower chamber 25 by a transverse contraction 27 of hard part 1 of cassette 1000. The transverse contraction 27 reduces the cross section of the venous blood chamber 21 in its width and depth to such an extent that a rapid flow is obtained, after which the venous blood chamber 21 of the cassette 1000 is crossed by a fluid flowing through it, which takes on a slower flow rate. The upper chamber 23 and the lower chamber 25 are in fluid communication.

Such a design, i.e. a division of the venous blood chamber 21 into a zone of substantially or completely stable blood circulation and a zone of calmness for blood flow, can advantageously achieve an efficient removal of air from the blood or fluid.

Walls of the upper chamber 23 and lower chamber 25 of the venous blood chamber 21 may be adjusted appropriately to an inclination of the upper section of the cartridge 1000 in Figure 1 against the verticals, for example, an inclination of the upper part of the cartridge 1000 in Figure 1 8° backward (into the drawing plane), and may be designed appropriately rounded to provide a flow-optimized surface for fluids flowing through the venous blood chamber 21.

The 1000 cartridge has a clot-catcher 29.

Err1:Expecting ',' delimiter: line 1 column 234 (char 233)

At the collateral 29 the pressure in the extracorporeal circulation can be measured through or through the film 3 and especially after the dialyser has passed through.

The 1000 cassette has a patient venous outlet 31. The 1000 cartridge has an arterial heparin supplement 33 It should be noted that the heparin supplement 33 (as well as a venous heparin supplement 37) may also be suitable and intended for the addition of pharmacological agents other than heparin, preferably only anticoagulants, or combinations of agents, even if heparin is used before or after any other use.

The 1000 cartridge has a 35 valve of arterial heparin draw order 33.

Err1:Expecting ',' delimiter: line 1 column 307 (char 306)

The heparin supply valve 36 can be used to control or regulate the supply of heparin to the arterial filter line 17.

The arterial heparin supply valve 36 may be designed as a so-called phantom valve.

Err1:Expecting ',' delimiter: line 1 column 55 (char 54)

The actuator membrane is movable, expandable, curvable or similar in one direction by applying a force, e.g. a compressive force, to it. By moving or extending the actuator membrane, it can attach to or remove itself from an element, such as a sealing device, such as a pier, and thus the actuator membrane can, for example, create or strengthen or terminate or reduce a sealing. When the force is taken back from the actuator membrane, it can return to, for example, a base position, e.g. an uncurved state.

A phantom valve for use as an arterial heparin infusion valve 36 and other phantom valves of cartridge 1000 may be provided with or from a channel incision on the hard part 1 of cartridge 1000 and a section on or opposite the incision of film 3.

Phantom valves can be operated by actuators in the blood treatment device.

To close a phantom valve, the section of film 3 may be pressed against the inclination.

Err1:Expecting ',' delimiter: line 1 column 166 (char 165)

The cartridge 1000 has a venous heparin extract 37 and the venous heparin extract 37 may be equipped with a Luer connector.

The 1000 cartridge has a reversal valve 39 of the venous heparin train order 37.

The cartridge 1000 has a venous heparin supply valve 40 which can be used to control or regulate the supply of heparin to the venous filter line 19.

The 1000 cartridge shall have a replacement train coupling 41 or a replacement connector.

Err1:Expecting ',' delimiter: line 1 column 224 (char 223)

The substitute train order 41 may be fitted with a contact protective element (not shown). The substitute train order 41 may be fitted with a drop protection (not shown). The drop protection can be achieved by an integrated closing case. The drop protection can prevent the dripping of residues of substitute and/or blood when dissolving the 1000 cartridge and then removing the 1000 cartridge from the blood treatment device.

The dropper may be designed to be removable and may be fitted with a hood or lid.

The replacement train order 41 or another section of the 1000 cartridge may also provide an original protection which allows the user to easily or at a glance to recognise whether the 1000 cartridge has been used. This original protection may be achieved by means of the contact protector, the closing case or another structure. The corresponding structure may preferably change its position within or in relation to the 1000 cartridge. It may preferably change its shape.

In addition, the replacement train order 41 or another section of the 1000 cartridge may provide protection against reuse or reuse. Preferably, a closing case makes the 1000 cartridge unusable - preferably irreversibly - for reuse attempts. If the 1000 cartridge is to be reused, the sensors of the blood treatment device do not measure the signal paths that would be measured if a new cartridge were used. This is because no liquid can enter the 1000 cartridge or the 41 cartridge or at least not in sufficient or greater quantity. The control unit of the blood treatment device can detect this.

Err1:Expecting ',' delimiter: line 1 column 304 (char 303)

The cassette has a connector 43 for a substitute exit from cassette 1000 and a connector 45 for a substitute entry into cassette 1000.

The connectors 43 and 45 shall be capable of connecting to a pump hose segment or set of a replacement pump.

The 1000 cartridge has a 47 valve for substitution.

The valve 47 may be operated to introduce a substitute into a substitute line 49.

The cartridge 1000 has a pre-dilutions inlet valve 51 and the pre-dilutions inlet valve 51 may be designed as a phantom valve.

The cartridge 1000 has a post-dilution draw valve 53 and the post-dilution draw valve 53 may be designed as a phantom valve.

The cassette 1000 has a single needle sterile membrane 55.

The cassette 1000 has a single needle chamber 57 and the single needle chamber 57 is located in Figure 1 above the venous blood chamber 21.

The single needle chamber 57 is equipped with a blood vessel diversion device 59 which can be used to slow down a blood vessel and/or to suppress its impulses.

Err1:Expecting ',' delimiter: line 1 column 239 (char 238)

The cassette 1000 has a single needle blood valve 61 and the single needle blood valve 61 can be designed as a phantom valve.

Err1:Expecting property name enclosed in double quotes: line 1 column 356 (char 355)

The cassette 1000 has a primary focusing centre 65 which can be used to the advantage to orient and/or attach the cassette 1000 to the blood treatment device.

The secondary target 67 may be used to orient and/or fasten the 1000 to the blood treatment device.

Err1:Expecting ',' delimiter: line 1 column 398 (char 397)

The chamber 15 for measuring arterial pressure is designed so that all the air can rise into a pump tube segment (e.g. into the pump tube segment 90, see e.g. Fig. 4). There are no dead spaces here. Air that rises independently from the arterial pressure measuring chamber into the pump tube segment of the blood pump is forced from the blood pump area (e.g. through the rollers of a roller pump) through the pump tube segment.

Err1:Expecting ',' delimiter: line 1 column 335 (char 334)

The venous blood chamber 21 has large cross-sections so that, due to the slow or low flow rates, air bubbles can reliably rise up against the main flow.

Err1:Expecting ',' delimiter: line 1 column 294 (char 293)

The line (pipeline) under the return valve 47 for substitution is designed to flow upwards for the same reason; in the event of malfunction of the pre- and/or post-dilution valves 51 and 53 and a resulting blood bypass flow, no blood can flow up to the substitution line 49; rather, the blood flows past the mouth of the corresponding line.

The inclination of the 1000 is preferably 5° to 11°, especially the 8° mentioned above.

Figure 2 shows the cassette 1000 of Figure 1, with slide 3 visible on the left edge of the cassette 1000 and at the top and bottom, cut up and folded up to the right for better illustration.

As shown in Figure 2, slide 3 has a surface structure.

Figure 2 shows the elements to be detected in more detail inside the 1000 cartridge after cutting out the film 3.

For the avoidance of repetition, reference is made to the design of the individual elements described above in Figure 1.

It is clear that the 1000 cartridge has a sealing level of 69, which can be used, for example, to form the pre-dilutions valve 51.

Figure 3 shows the back of the 1000 cartridge, when the 1000 cartridge is connected to the blood treatment device, a viewer will look at the back of the cartridge when opening a door of the blood treatment device to remove the 1000 cartridge.

The cassette 1000 has a single needle air connector 71 and a support grid (not shown) of the single needle sterile membrane 55 may be provided on the device side and/or the blood side at the single needle air connector 71.

The supporting steps are of different heights from each other, for example relative to the plane of slide 3. The supporting steps rise in the side of the cassette 1000 facing the viewer in Fig. 3, i.e. from the character plane in Fig. 3.

The cartridge 1000 has supporting rails 73 with a height of 5 mm, supporting rails 75 with a height of 8 mm, supporting rails 77 with a height of 13 mm, supporting rails 79 with a height of 24 mm and supporting rails 81 with a height of 31 mm.

Err1:Expecting ',' delimiter: line 1 column 434 (char 433)

Err1:Expecting ',' delimiter: line 1 column 225 (char 224)

The upward facing surfaces of the venous blood chamber 21 and the single needle chamber 57 have a slope such that, despite the inclination of the cassette 1000, air bubbles can still reliably rise on the inside.

Figures 4 to 16 describe various processes which can be used by the external functional device of the invention in blood treatment procedures.

The blood treatment device shall have an external functional device, for example the 1000-cartridge described in Figures 1 to 3 with the elements described in Figures 1 to 3 above.

The blood treatment device also has a dialysis device 2000 with a dialysis fluid intake in 2001 and an dialysis fluid outlet in 2003.

The blood treatment device also has an extracorporeal circuit 3000, an arterial patient tube clamp 83 and a venous patient tube clamp 85.

Extrakorporeal circulation 3000 has a blood pump 87 with a pump tube segment 88.

The extracorporeal circuit 3000 has a substitute pump 89 with a pump tube segment 90.

The blood pump 87 and the substitute pump 89 may be designed as peristaltic pumps, e.g. rolling pumps as shown in the figures.

Err1:Expecting ',' delimiter: line 1 column 55 (char 54)

Err1:Expecting ',' delimiter: line 1 column 76 (char 75)

Fluid (especially blood and substitute) flowing in the opposite direction of this flow is called flowing in the opposite direction.

Extracorporeal circulation 3000 has an arterial section 91 and a venous section 93.

The arterial section 91 of the extracorporeal circulation 3000 extends from a section to connect a patient's arteries, for example an arterial needle, through the cartridge 1000 to a blood supply at the dialysis device 2000. The arterial section 91 has several components, such as a patient's arterial connection, the arterial patient connection 7, the arterial patient tube clamps 83, the arterial pressure chamber 9, the chamber 15 with arterial post or pre-filter pressure measuring station, the blood pump tube segment 88, the arterial pump filter line 17 and a blood supply at the dialysis device 2000, each forming part of the arterial section 91 of the extracorporeal circulation 3000.

The venous section 93 of the extracorporeal circulation 3000 extends from a blood drain at the dialysis device 2000 to a section for venous connecting a patient, for example a venous needle. The venous section 93 has different components. For example, a blood drain from the dialysis device 2000, the venous filter line 19, the venous blood chamber 21, the blood clot line 29, the single needle chamber 57, the venous patient connection 31, the venous patient tube plug 85 and a venous patient connection each form part of the venous section 93 of the extracorporeal circulation 3000.

Figure 4 shows a stage during the execution of a preparation process or priming process to fill the fluid lines used according to a procedure described herein.

Arterial section 91 and venous section 93 of extracorporeal circulation 3000 are connected.

The pre-dilusion intake valve 51, the post-dilusion intake valve 53 and the single needle blood valve 61 of the 1000 cartridge are open.

Figure 4 shows the configuration described as a snapshot or a phase during the preparation or priming process.

The patient's arterial tube in the arterial section 91 of the extracorporeal circulation 3000 and the venous tube in the venous section 93 of the extracorporeal circulation 3000 are connected to a rinsing port of the blood treatment device, e.g. by a suitable connector, which provides access to the other patient's tube at the end of one patient's tube. The end of the other patient's tube serves as a drainage line into the rinsing port. The connector may alternatively be located in the patient's arterial or venous line, i.e. section 913, or section 93.

The venous patient tube clamps 85 are closed, the post-dilusion intake valve 53 is opened, the predilusion intake valve 51 is closed.

The venous blood chamber 21 is filled by means of the substitution pump 89 through the post-dilution intake valve 53 and air is removed by the single needle blood valve 61.

The 87th blood pump is moving forward and sucking in the 21st substitute from the venous blood chamber.

If the level in the venous blood chamber 21 drops, the post-dilution drain valve 53 is used to continue until the level detector detects that the level has exceeded the specified level of filling, and during this process, which is repeated as necessary, the blood pump 87 continues to run continuously.

Err1:Expecting ',' delimiter: line 1 column 72 (char 71)

The patient's venous tube clamps 85 shall be opened until pressure equalisation has taken place.

Then the extracorporeal circulation 3000 is continued.

The presence of air bubbles is detected by means of the sensor/detector 115 on the patient's venous tube clamp 85, e.g. a venous air bubble detector.

Err1:Expecting ',' delimiter: line 1 column 217 (char 216)

The arterial patient tube clamp 83 and the venous patient tube clamp 85 are open, and the blood pump 87 runs backwards, bringing part of the substitute into the rinse port.

Alternatively to online filling (the substitute is provided online in the dialysis machine), as indicated above, an external bag of saline as a source of the filling fluid can be used as an alternative. The arterial line or the arterial section 91 of the extracorporeal circulation 3000 is connected to the saline bag. The venous line or the venous section 93 of the extracorporeal circulation 3000 is connected to a sink as a pre-filled bag of saline. The blood pump 87 runs forward. Opening the dilution valve and the post-dilusion valve 51 also allows the 53 valves between these two valves to be filled.

In both procedures, the patient is not connected to extracorporeal circulation 3000 until a specified amount of flushing has been achieved.

Figure 5 shows a phase of a rinsing process according to a procedure described here.

To remove the substitute 3000 circulating in the now closed extracorporeal circulation after preparation or priming, tap 97 is opened.

The substitution pump 89 is turned back on, the pre-dilutions supply valve 51 is opened.

Blood pump 87 and substitute pump 89 transport the substitute out of the extracorporeal circulation 3000 via the 95 line.

Figure 5 shows the configuration described as a snapshot or as a phase of the rinsing or rinsing process.

The blood pump 87 and the substitute pump 89 constantly pump new substitute, so the extracorporeal circulation 3000 is flushed.

The blood pump 87 and the substitute pump 89 each pump clockwise. The blood pump 87 and the substitute pump 89 can pump opposite each other. The substitute pump 89 can rotate faster than the blood pump 87.

Figure 6 shows a phase when a patient 4000 is connected to the extracorporeal circuit 3000 in a first way by means of a double needle access according to a procedure described herein.

A double needle access 99 is used to connect a patient 4000 to the blood treatment device.

The double needle access 99 has an arterial needle 101 with a fixation 102, e.g. a cuff, a patch and the like, and a venous needle 103 with a fixation 104, e.g. a cuff, a patch and the like.

The arterial needle 101 is connected to the arterial patient junction 7 of the cassette 1000. The venous needle 103 is connected to the venous patient junction 31 of the cassette.

The venous needle 103 is placed and fixed to the patient 4000. The arterial needle 101 is placed and fixed to the patient 4000. The venous needle 103 can be connected to the patient 4000 in front of the arterial needle 101.

The extracorporeal circulation 3000 is filled with substitute due to its filling, the pre-dilution intake valve 51, the post-dilution intake valve 53 and the single needle blood valve 61 are closed.

First, both patient tube clamps 83 and 85 are closed.

The blood pump 87 is activated, the arterial tube plunger 83 is opened.

Figure 6 shows the configuration described as a snapshot with already opened arterial patient tube plunger 83, just before a start of the blood pump 87.

From patient 4000, blood is supplied via the arterial needle 101 to the arterial section 91 of the extracorporeal circulation 3000 and displaced or supplied by the substitute.

When blood from the arterial section 91 of the extracorporeal circulation 3000 arrives at a blood entry 105 at the dialysis device 2000, the patient's arterial tube plunger 83 is closed and the blood pump 87 is stopped.

The patient's venous tube clamps 85 are opened.

The venous needle 103 is used to direct blood in the opposite direction to the venous section 93 of the extracorporeal circulation 3000.

For example, blood may enter the 93rd venous section due to gravity.

Blood flows through the venous section 93 in the opposite direction and enters the coagulant 29 and the venous blood chamber 21. Blood flows through the venous filter 19 and enters the dialysis apparatus 2000 in the opposite direction through the blood outlet 107.

Figure 7 illustrates a phase of a second way or alternative process for connecting a patient 4000 to a blood treatment device.

Patient 4000 is connected to the extracorporeal circulation 3000 via an arterial needle 101 and a venous needle 103.

The arterial patient tube clamp 83 and the venous patient tube clamp 85 are open; the predilution drain valve 51, the post-dilution drain valve 53 and the single needle blood valve 61 are closed.

Substitute is present throughout the extracorporeal circulation 3000 (except in single needle chamber 57).

Blood pump 87 is being started, dialyser 2000 is not being turned on.

Fig. 7 shows the configuration described as a snapshot.

From patient 4000, blood is pumped by the blood pump 87 through the arterial needle 101 to the arterial section 91 of the extracorporeal circulation 3000, flowing into the blood at the blood inlet 105 at the dialysis apparatus 2000 and from there through the blood outlet 107 of the dialysis apparatus 2000 to the venous section 93 of the extracorporeal circulation 3000.

The venous filter line 19 allows blood to enter the cartridge 1000 and, with the post-dilution drain valve 53 closed, into the venous blood chamber 21, allowing blood to flow tangentially into the upper chamber of the venous blood chamber 21.

From the venous blood chamber 21, blood returns via the coagulant 29 from the cassette 1000 via the venous patient 103 junction to patient 4000.

Figure 8 shows a phase of dialysis treatment using a double needle access to the patient.

The arterial patient tube clamp 83 and the venous patient tube clamp 85 are open; the predilution drain valve 51, the post-dilution drain valve 53 and the single needle blood valve 61 are closed.

Figure 8 shows the configuration described as a snapshot during dialysis treatment with the blood pump operating.

The dialysis apparatus 2000 is operated so that dialysis fluid enters the dialysis apparatus 2000 at the time of entry of dialysis fluid in 2001. The dialysis apparatus is used to treat the patient's blood. The dialysis fluid is discharged from the dialysis apparatus 2000 at the time of exit of dialysis fluid in 2003. Used dialysis fluid can be discarded or cleaned.

The blood pump 87 delivers blood from patient 4000 via the arterial needle 101 to the arterial section 91 of the extracorporeal circulation 3000, with blood flowing through the cartridge 1000 and being transported to the dialysis device 2000.

At the dialysis device 2000 blood outlet 107, the purified blood leaves the dialysis device 2000 and flows through the venous filter line 19 into the cartridge 1000, enters the venous blood chamber 21 and the coagulation vessel 29 and exits the cartridge 1000 at the venous patient junction 31.

The purified blood is returned to patient 4000 via the venous outlet 103 of the patient.

No substitute is being supplied, and the substitute pump 89 is not operating.

Err1:Expecting ',' delimiter: line 1 column 186 (char 185)

The pre-dilusion intake valve 51 is opened; the post-dilusion intake valve 53 and the single-needle blood valve 61 are closed; the blood pump 87 is operated; the substitute pump 89 is started; the substitute pump 89 can be operated in parallel with the blood pump 87.

The configuration described is shown as a snapshot in Figure 9, with a substitute between the pre-dilution intake valve 51 and the post-dilution intake valve 53 and the remaining extracorporeal circulation 3000 being flowed by blood.

The substitute pump 89 delivers substitute, which is delivered to the arterial section 91 of the extracorporeal circulation 3000 by the predilusion intake valve 51 and mixed with the blood to be purified.

Err1:Expecting ',' delimiter: line 1 column 188 (char 187)

The post-dilusion draw valve 53 is opened The predilusion draw valve 51 and the single-needle blood valve 61 are closed The blood pump 87 is operated The substitute pump 89 is started The substitute pump 89 can be operated in parallel with the blood pump 87

The configuration described is shown as a snapshot in Figure 10, with a substitute between the pre-dilution intake valve 51 and the post-dilution intake valve 53 and the remaining extracorporeal circulation 3000 being flowed by blood.

The substitute pump 89 delivers substitute, which is delivered to the venous section 93 of the extracorporeal circulation 3000 by the post-dilution drain valve 53 and mixed with the purified blood.

Err1:Expecting ',' delimiter: line 1 column 198 (char 197)

Fig. 11 illustrates the pre-dilution interval of the mixture dilution by means of a snapshot, Fig. 12 the post-dilution interval of the mixture dilution by means of a snapshot.

The process shown in Fig. 11 corresponds to that shown in Fig. 9 and the process shown in Fig. 12 to that shown in Fig. 10.

The blood pump 87 and the substitute pump 89 rotate at the same rate, for example, the blood pump 87 and the substitute pump 89 can rotate faster than in the procedures or procedure sections shown in Figures 9 and 10.

Err1:Expecting ',' delimiter: line 1 column 204 (char 203)

Patient 4000 is fitted with a single needle access 109 and fixed by fixation 110.

The single needle access 109 has a Y-shaped section or Y-shaped branch 111 in the arterial section 91 and the venous section 93 of the extracorporeal circulation 3000.

The arterial patient tube clamp 83 is opened. The venous patient tube clamp 85 is closed first. This is not shown in Figure 13.

The blood pump 87 is started. The dialysis machine 2000 is operated. Through the arterial section 91 blood is pumped from patient 4000 to the dialysis machine 2000. In the dialysis machine 2000 the blood is purified. The purified blood is introduced into the venous section 93 of the extracorporeal circulation 3000.

The blood enters the venous blood chamber 21 of the 1000 cassette, the single needle blood valve 61 is open, blood flows into the single needle chamber 57.

When the single needle chamber 57 is almost full, the blood pump 87 is stopped and the venous patient tube 85 is opened as shown in Figure 13.

Blood is drawn from Single Needle Chamber 57, Venous Chamber 21 and Clot Trapper 29 from Casette 1000 and returned to Patient 4000 by gravity.

When single needle chamber 29 is almost empty of blood, the blood pump 87 is restarted.

This phase of blood treatment is repeated as often as necessary.

Figure 14 shows a phase of a first variant of a blood return process after the end of the blood treatment.

Patient's arterial tube plunger 83 is open, venous tube plunger 85 is closed, replacement pump 89 is operated.

In the extracorporeal circulation 3000 there is blood, in the substitution line 49 there is substitute.

The pre-dilusion intake valve 51, the post-dilusion intake valve 53 and the single needle blood valve 61 are closed first.

The pre-dilusion valve 51 is opened and the substitute is supplied through the arterial section 91 of the extracorporeal circulation 3000 to the dialyser device 2000.

Blood in the extracorporeal circulation 3000, in the forward direction behind and upstream of the predilusion valve 51 is brought to patient 4000 by the dialysis apparatus 2000 and the venous section 93.

Just before the substitute reaches the venous needle 103, the substitute pump 89 is stopped.

The venous patient tube clamps 85 are opened.

Fig. 14 shows the configuration of the cassette 1000 in a snapshot during the process, where the substitute is introduced upstream into the extracorporeal circulation 3000 by the open predilusion draw valve 51 and displaces the blood.

The blood pump 87 and the substitute pump 89 are operated. The blood pump 87 rotates clockwise and thus counterclockwise. The substitute pump rotates counterclockwise. The blood pump 87 and the substitute pump 89 can rotate in opposite directions.

The substitute is pumped from the post-dilusion drain valve 53 into the arterial section 91 of the extracorporeal circulation 3000 and through the pump tube segment 88 of the blood pump 87 towards patient 4000.

Just before the substitute reaches the arterial needle 101, the blood pump 87 and the substitute pump 89 are stopped.

Figure 15 illustrates a phase of an alternative blood return process. At the arterial patient tube plunger 83 and the venous patient tube plunger 85 there is a sensor/detector 113 and a sensor/detector 115 respectively for measuring the optical density of the inner line of the extracorporeal circuit 3000 and for automatic detection of the occurrence of substitute. Other and/or additional suitable sensors may be used. Sensor and detector may be realized as single components or as separate components.

The fixation 102 of the arterial needle 101 is released and the arterial needle 101 is pulled. The arterial patient tube clamping 83 is opened. The predilution draw valve 51 is closed.

The venous needle 103 remains connected to patient 4000.

The blood pump 87 is operated in the supportive direction and carries blood from the arterial section 91 of the extracorporeal circulation 3000.

A corresponding snapshot of the process showing a state shortly after the start of the process is shown in Figure 15.

The sensor/detector 113 detects the presence of substitute, the blood continues to flow until it reaches the predilution valve 51 and then the blood pump 87 is stopped.

The replacement pump 89 is started, the arterial patient tube clamp 83 is closed, the venous patient tube clamp 85 is opened.

The predilution intake valve 51 is opened, and the substitution pump 89 carries the substitute through the arterial section 91 of the extracorporeal circulation 3000, through the dialysis apparatus 2000 and the venous section 93 of the extracorporeal circulation 3000 until the sensor/detector 115 at the venous patient tube plug 85 detects the presence of substitute.

Blood is returned through the venous needle 103 to patient 4000.

Figure 16 shows the cassette 1000 and the extracorporeal circuit 3000 in a phase of emptying or emptying.

The patient is no longer connected to the treatment device, and the arterial section 91 and the venous section 93 of the extracorporeal circulation 3000 are connected. The arterial patient tube clamp 83 and the venous patient tube clamp 85 are opened; the pre-dilusion intake valve 51 and the post-dilusion intake valve 53 are opened as shown in Figure 16 in the form of a snapshot.

The substitute drawbar 41 allows 89 air to enter the extracorporeal circulation 3000 when the substitute pump is operated, and the air flows through the open pre-dilution drawbar 51 and the open post-dilution drawbar 53 and thus enters the extracorporeal circulation 3000.

Air flows through the extracorporeal circuit 3000 and the dialyser device 2000 in the opposite direction.

The pre-dilusion intake valve 51 is closed and the blood pump 87 is operated. The blood pump 87 and the substitute pump 89 supply the air in the supply direction through the cartridge 1000 to the dialyser device 2000.

Err1:Expecting ',' delimiter: line 1 column 262 (char 261)

Err1:Expecting ',' delimiter: line 1 column 158 (char 157)

Figure 17 shows a simplified schematic representation of an external functional unit 1000 in a further embodiment, as seen from the front, of the external functional unit 1000 in Figure 17, and all subsequent figures correspond in the majority of their characteristics to the embodiment of the cassette 1000 shown in Figures 1 to 16.

The 1000-cartridge embodiment shown in Fig. 17 has a handhold 117 for upgrading and/or abrasion of the 1000-cartridge before or after the end of the blood treatment, which is conveniently simple and/or quick.

The handle may be designed to be operated by means of tools, not primarily or exclusively by hand.

The cartridge 1000 shown in Fig. 17 has a slot 119 and the slot 119 of the cartridge 1000 may be used to extract a substitute from the cartridge 1000.

Section 119 may be used in addition to all the structures and lines shown in Figures 1 to 16.

The plunger 119 may be designed to avoid fluid flow during normal blood treatment of the 1000 cartridge, in which case, preferably, during the treatment, no fluid leaves the 1000 cartridge through the plunger 119 or enters the 1000 cartridge through the 1000 cartridge.

The invention may also be used for the position of the seat 119 in a position other than that shown in the figures.

The pump section 119 may, in the present invention, be used in exceptional cases, for example, as a place for the withdrawal of a fluid, e.g. a substitute; the fluid withdrawn, e.g. a substitute, may be used as a displacement fluid for the return, if necessary manually, or arterial infusion of extracorporeal blood into the patient's vascular system by means of an arterial line; the latter may be useful in the event of blockage of certain lines or failure of cassette functions or functions of the treatment device, by allowing the pump section to produce fluid suitable for the purpose of return without any special effort.

The plunger head 119 may be provided for and connected to the cassette 1000 in various ways. In certain embodiments of the invention, the plunger head is manufactured individually with the casing of the cassette 1000. The plunger head may be a luer closure injected into the cassette or have one.

In some embodiments of the invention, the pump station has a valve, in particular a switchable valve.

In certain embodiments of the invention, the pump is also suitable and intended for the addition of a fluid to the substitute.

The external functional unit 1000 of Fig. 17 also has hose attachments 121 and 123. The hose attachments 121, 123, which may be provided in any other number, can in certain embodiments prevent the hoses required when the cartridge 1000 is used from interfering with or damaging the handling of the cartridge 1000, for example by hanging in the opening of a door of the treatment device when the cartridge 1000 is connected.

Err1:Expecting ',' delimiter: line 1 column 251 (char 250)

The retractor 125 may be a draw valve of a venous line.

Fig. 17 also reveals a heparin addition site 127 which is located in the embodiment of Fig. 17 in an upper region of the 1000 cartridge above the single needle chamber 57 and above the venous blood chamber 21.

The heparin injection site 127 is connected to a heparin supply line, heparin injection site 128 for short, which extends in the figure 17 from the heparin injection site 127 down to a height of the 1000 cartridge, where the venous blood chamber 21 begins.

It is also clear from Fig. 17 that the cassette 1000 has relatively few structures which perform functions in a lower peripheral region U, e.g. in the vicinity of the collateral 29 or even below it. This has created or left space on the cassette 1000 in the peripheral region U to allow the coupling of the cassette 1000 with measuring devices or similar devices, e.g. connected to the treatment device, a door of this device or other devices. Such measuring devices may be arterial and/or venous temperature sensors, air bubble detectors, sensors for measuring optical density, and the like.

The provision of the space required for this purpose, with the associated possibility of occupying it with the above and other sensors, thus serves to ensure procedure safety and thus to eliminate risks for the patient.

It is obvious that the U-space can be provided in another area of the 1000-cartridge. Similarly, more than one such area can be provided. Especially preferable are such areas provided in a peripheral area of the 1000-cartridge and/or on or near to or from conduits.

The enlarged valve 125 shown in Fig. 18 may, for example, be integrated into the cartridge 1000 as a valve for the post-dilutions supply of substitute in such a way that it can be flushed after the end of the substitute treatment. In this way it may be advantageously possible to effectively ventilate cavities when priming and rinsing the cartridge 1000 in the area of the valve. It may be tentatively possible that this arrangement will not leave any or no visible blood residues after the blood treatment has been completed. In this way, even in the case of third-party disinfection, the cartridge 1000 can be used to prevent the discharge of blood, especially in the case of human blood.

Figure 18 also shows a phantom valve 129 and a phantom valve 130. Phantom valves are described in detail elsewhere in this application.

Fig. 19 shows in a simplified schematic the external functional device of the further embodiment, shown in a slightly perspective view, looking essentially at its rear.

In addition to the structures already discussed in other figures above, the 1000-cartridge embodiment shown in Fig. 19 also has a 131-train order which has a septum. The 131-train order with septum (also called septum-addition point for short) is arranged in the embodiment shown in Fig. 19 at the level of the upper edge of the 1000-cartridge.

Fig. 20 shows a simplified schematic enlargement of the area B of Fig. 19.

Fig. 21 shows in a simplified schematic the external functional device of the invention in a further embodiment in a slightly perspective view, essentially from its front.

In this further embodiment, the 1000 cassette, unlike the embodiment e.g. in Fig. 17, has no socket (where it is marked with reference 119).

Figure 22 shows in a simplified schematic the area A of the figure 21 enlarged. A different arrangement of the phantom valve is clearly visible from the arrangement in Figure 18.

Figure 23 shows in a simplified schematic form further details, namely the area B, the representation of Figure 21.

As shown in Fig. 23, the venous blood chamber 21 has a notch 133 or constriction or change in inclination or rejuvenation or asymmetry of the inner and/or outer wall of the venous blood chamber 21.

The inlet 133 may be located at least on the side opposite the inlet line.

The incision 133 may be for a portion or the entire circumference of the hard part of the venous chamber.

The slot 133 may be essentially horizontal in a working position of the 1000 cartridge.

In certain embodiments, the notch 133 may correspond to or include a change in the circumference and/or diameter of a section of the venous blood chamber 21 or its wall.

The notch 133 may in some embodiments of the invention indicate or include a non-semicircular diameter of the venous blood chamber 21 (at the notch 133 level) in a horizontal section (as shown in Figure 21 or in the arrangement of the notch 1000 in use).

The notch 133 may be a rejuvenation of the cross-section of the chamber in certain embodiments of the invention, in particular in the up-down direction of the figure 21.

The notch 133 may be a section or transition area in or through which a larger cross-section or larger cross-sectional area of the venous blood chamber 21 passes to a smaller cross-section or smaller cross-sectional area of the venous blood chamber 21 in some embodiments of the invention, particularly in the up-down direction of the figure 21.

The notch 133 may be an notch in certain embodiments of the invention extending over a region of the circumference of the venous blood chamber 21, particularly in the up-down direction of the figure 21.

In certain embodiments, the notch 133 may result in an asymmetrical shape of the venous blood chamber 21 as shown in Figure 21 in a top-down direction.

The incision 133, which may be partially or completely across the entire cross-section of venous blood chamber 21, has surprisingly resulted in a thin foam formation within venous blood chamber 21.

Optimization of the geometry of the venous blood chamber 21 by the puncture 133 which may optionally also have been used to optimize the geometry of a single needle valve, may in certain embodiments of the invention achieve an improved pre-treatment ventilation, in some embodiments of the invention an improved steam flow during sterilization, and in certain embodiments of the invention a reduction of dead water areas with the associated known advantages.

Fig. 24 shows the external functional device of the invention as a cassette 1000 in a simplified schematically from below and from above.

Fig. 25 shows the area C of the figure 24 in a simplified schematic enlargement. It can be seen that a valve seat 135 of the single needle (SN) valve is lowered relative to the surroundings or adjacent supports or parts of the casing of the cassette 1000. The inventors were able to achieve flow advantages which can be accompanied not least by the avoidance or reduction of turbulence formation.

Figure 26 shows in simplified schematic form the area D of the figure 24 enlarged. Figure 26 shows that valve seats 137 and 139 are lowered by phantom valves relative to the surroundings or adjacent supports or parts of the casing of the 1000 cartridge.

Claims (19)

1. An external functional means, comprising:

   at least one housing body,

   at least one chamber (9, 15, 21, 57) integrated into the housing body for receiving medical fluids;

   at least one passage (17, 19, 49) integrated into the housing body for receiving and/or conducting a medical fluid; and

   at least one valve means (35, 36, 39, 40, 47, 51, 53, 61) completely or partly integrated into the housing body for controlling or regulating a fluid flowing through the external functional means,

   wherein the external functional means is provided on at least one of its surfaces with a cover means that is part of at least one integrated valve means (35, 36, 39, 40, 47, 51, 53, 61), and

   wherein the cover means is connected by frictional and/or by form closure and/or by material connection to the housing body in at least one portion thereof,

   wherein the external functional means is configured as a cassette (1000) for a blood treatment, and

   wherein the external functional means comprises at least one venous blood chamber (21),

   wherein the at least one valve means comprises a single-needle blood valve (61) arranged between the venous blood chamber (21) and a single-needle chamber (57) of the external functional means which is arranged above the venous blood chamber (21) with regard to the alignement of the external functional means during a state of use of the external functional means.
2. The external functional means according to claim 1, wherein the cover means is connected to the housing body by means of at least one peripheral weld (5).
3. The external functional means according to claim 1 or 2, wherein the cover means is connected to the housing body by means of additional, non-peripheral or dot-shaped or local welds.
4. The external functional means according to any one of claims 1 to 3 wherein the cover means is connected at at two sides or bilaterally with at least one structure of the external functional means.
5. The external functional means according to any one of claims 1 to 4, wherein the cover means is a film (3).
6. The external functional means according to any one of the preceding claims, which comprises connections for being connected in fluid communication to an extracorporeal circuit, and which is additionally comprising at least one addition site (131) comprising at least one septum suited and provided for supplying a fluid which is not or not exclusively blood, into an interior or into a line section of the external functional means.
7. The external functional means according to any one of the preceding claims comprising:

   a supplying line which is completely or partly arranged in an upper area or in a border area of the external functional means with respect to the alignment of the external functional means during its use, and

   at least one heparin line (128) arranged at least in an area of the external functional means which is arranged in an upper area thereof during the use of the external functional means.
8. The external functional means according to any one of the preceding claims comprising at least one handle bar or handhold (117) for connecting and/or separating the external functional means with or from a treatment apparatus.
9. The external functional means according to claim 1, which comprises, in a portion of an extracorporeal circuit (3000) contained therein, at least one arterial cassette-integrated chamber and at least one venous cassette-integrated chamber, wherein the cassette (1000) comprises at least one cover means as a film (3), and wherein an arterial and/or a venous pressure present in the extracorporeal blood circuit may be measured through the intermediary of the film (3), and wherein the external functional means comprises a means for measuring the arterial and/or venous pressure above the arterial and/or venous chamber through the intermediary of the film (3).
10. The external functional means according to any one of the preceding claims comprising two connectors (11, 13, 43, 45) adapted to be connected in fluid communication with at least one peristaltic pump, and wherein the external functional means comprises or is configured for receiving at least one pump tube segment (88, 90).
11. The external functional means according to any one of the preceding claims, comprising:

    at least one valve means (36, 40, 51, 53, 61), which comprises at least one bar formed on the housing body and at least one portion of the cover means,

    wherein bar and cover means are disposed so as to be operable by means of an actor of a blood treatment apparatus acting on a bar by means of the cover means in order to alter a flow of fluid.
12. The external functional means according to any one of the preceding claims, which is intended and adapted to be coupleable to a blood treatment apparatus by means of a reception means of the blood treatment apparatus with a surface facing the cover means.
13. The external functional means according to any one of the preceding claims, comprising at least one substituate addition site (41) having a touch-protection element and/or a drip-protection element.
14. The external functional means according to claim 1, wherein the venous blood chamber (21) is subdivided into at least one upper space (23) and at least one lower space (25) by means of a cross-sectional restriction (27) of the housing body.
15. The external functional means according to claim 14, wherein the upper space (23) and the lower space (25) are in fluid communication or in fluid connection with each other, and the upper space (23) is configured for admitting or generating a tangential inflow of fluids flowing through the external functional means, wherein the upper space (23) includes a region for generating a stable rotational flow of the fluids flowing through the external functional means, and wherein the lower space (25) includes a region that is substantially or entirely free from rotational flow of the fluids flowing through the external functional means.
16. The external functional means according to any one of the preceding claims, comprising a tamper protection.
17. The external functional means according to any one of the preceding claims, comprising a protection against reuse.
18. System with a blood treatment apparatus and at least one external functional means according to any one of claims 1 to 17, wherein the blood treatment apparatus comprises at least one control means, actors and/or sensors for driving and/or operating the external functional means, and a reception means for receiving the external functional means, wherein the reception means comprises a coupling surface for coupling the external functional means.
19. System according to claim 18 wherein the blood treatment apparatus is designed as a dialysis apparatus.