DE202016102660U1 - External functional device, blood treatment device for receiving an external functional device according to the invention - Google Patents

Abstract

External functional device, which is designed as a cassette (1000) for a blood treatment, comprising: at least one housing body, at least one chamber (9, 15, 21, 57) integrated in the housing body for receiving medical fluids; at least one channel (17, 19, 49) integrated in the housing body for receiving and / or guiding a medical fluid; and at least one valve device (35, 36, 39, 40, 47, 51, 53, 61) completely or partially integrated in the housing body, for controlling or regulating a fluid flowing through the external functional device, at least two connectors (11, 13, 43, 45) for peristaltic pump tubing segments (88, 90), the cassette (1000) having an arterial patient port (7), an arterial filter line (17), a venous patient port (31), and an arterial heparin delivery hub (33) wherein the arterial heparin delivery site (33) is located between the arterial filter conduit (17) and the venous patient port (31).

Description

The present invention relates to an external functional device according to claim 1. It further relates to a blood treatment device according to the preamble of claim 10.

The cleaning of the equipment used in blood treatments can be technically complicated. In order to ensure adequate hygiene with acceptable workload and for other reasons, external functional devices, such as blood cassettes are used.

Such a blood cassette may be designed to perform as many functions as possible in the preparation and execution of blood treatment procedures.

The object of the present invention is to provide a further external functional device, in particular a blood treatment cassette. Furthermore, a blood treatment device which has such an external functional device or is designed for its activation or actuation should be proposed.

The object according to the invention is achieved by an external functional device having the features of claim 1, designed as a blood cassette (short: cassette), and furthermore by a blood treatment device having the features of claim 10.

The external functional device comprises at least one housing body, at least one integrated into the housing body chamber for receiving medical fluids, at least one integrated into the housing body channel for receiving and / or guiding a medical fluid and at least one fully or partially integrated in the housing body valve means for controlling or Controlling a fluid flowing through the external functional device.

The external functional device further comprises at least two connectors for pump tubing segments for peristaltic pumps, with or without the pump tubing segments.

The blood cassette also has an arterial patient port, an arterial filter line, a venous patient port, and an arterial heparin delivery point. The arterial heparin delivery site is located between the arterial filter line and the venous patient port.

As used herein, the term "housing body" refers to a three-dimensionally shaped body formed from a material suitable for use in a medical treatment process, such as a blood treatment process, such as a plastic material. The housing body can be produced for example by means of a casting or injection molding process.

The term "chamber" as used herein refers to a volume suitable for receiving at least one medical fluid. The volume may be a closed space or circumscribed by it. But it may also be an open space or be surrounded by such a partial, and only by the presence of another body - other than the housing body - to a closed or closed up to supply or discharge lines for the fluid space.

Chambers may be designed and provided to receive valves and / or sensors or the like.

As used herein, the term "conduit" or "conduit" refers to equipment suitable for receiving and / or delivering medical fluids, such as blood, heparin or other drugs, saline, substituate, and the like.

Channels or lines may be configured in sections as closed and / or semi-open structures. They can be closed, for example, by means of a cover device on at least one open side and thus designed to be sealable against, for example, components of a blood treatment device and / or against the atmosphere.

The term "valve means" as used herein refers to a means suitable for controlling or regulating which can control the passage of fluids through conduits and / or chambers of the external functional device. Valve devices can be controlled by means provided for control or regulating devices. An activation can for example be automated. Suitable control or regulating devices may for example be provided in or on the blood treatment device.

Advantageous developments of the external functional device according to the invention are each the subject of the dependent claims.

In a preferred embodiment, the cassette has a venous filter line and a venous heparin delivery site, the venous Filter line is arranged medially to the venous heparin addition point.

In a preferred embodiment, the external functional device has a single-needle sterile membrane, which has the shape of a parallelogram.

In a preferred embodiment, the external functional device comprises a primary or first alignment center and a secondary or second alignment center, such as in the form of centering apertures. The primary alignment center and the secondary alignment center have different shapes and / or different orientations.

In a preferred embodiment, the external functional device is provided on at least one of its surfaces with a cover device which is part of at least one integrated valve device.

In a further preferred embodiment, the cover device is non-positively and / or positively and / or materially connected at least in one section with the housing body. The cover device can be connected to the housing body, for example, by means of a circumferential weld or other circumferential connection. It is also possible to provide further non-circumferential or punctiform or local welds or connections (eg adhesions or compressions) of the cover device to the housing body.

In further preferred 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 housing body. On both sides can be understood according to the invention as at least two sides of the respective structure. A bilateral connection can be understood as meaning at least two-fold connection in the region, in particular immediate region, or in the environment, in particular the immediate environment, of the structure.

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

The two-sided connection can be a weld. It can each be fluid-tight, z. B. in such a way that over the joint area (area in which, for example, glued or welded) of the compound no Fluidaustauch, in particular no fluid exchange, can take place. The bilateral connection can be used for individual fluid channels, lines or other elements, eg. In selected areas of the external functional device; it may be provided for a majority thereof or for all fluid channels, conduits or other elements.

A two-way connection can be a connection both to the left and to the right of the corresponding structure. It may be provided both above and below with respect to the structure or the like.

A bilateral connection may be one, two or more welds along the edge or circumference or the attachment of at least one structure or portion thereof.

A bilateral connection may be elongated or elongated, in whole or in portions thereof.

By means of the two-sided connection, the expenditure required for pressing the external functional device can be advantageously reduced in certain embodiments according to the invention. In particular, in some embodiments of the invention, the requirements for the precision with which the contact pressure of the external functional device z. B. to a blood treatment device, be lower in an advantageous manner. In certain embodiments according to the invention can advantageously satisfy a low contact pressure due to the two-sided connection. In some embodiments of the invention, a more reliable function of valves acting on channels covered by the bilateral connection may advantageously be achieved.

A covering device may in particular be a foil.

The film may preferably be a plastic film. For this purpose, preferably any laser-weldable film which appears suitable to the person skilled in the art may be considered.

In another preferred embodiment, the external functional device may have ports for communicating with an extracorporeal circuit in fluid communication.

The external functional device can in particular be designed as a cassette to or for a blood treatment.

More preferably, the external functional device by means of two connectors with at least one - preferably two - peristaltic pump (s) in fluid communication can be connected. Roller pumps may be suitable peristaltic pumps.

The external functional device can have at least one - preferably two - pumping tube segment (s) or can be configured or provided for receiving such.

In a further preferred embodiment, the external functional device has at least one valve device which has at least one web and a section of the cover device. The web is designed on the housing body. The bridge and covering device are arranged to be actuatable by means of an actuator of a blood treatment device acting on a web for changing a fluid flow in the sense of a valve.

Such a "web" may designate a component integrated into the external functional device or projecting from a surface thereof in any direction. This can be formed from the same material as the external functional device. A web can be configured, for example, during the production of the external functional device by means of casting or injection molding.

In a further preferred embodiment, the fluid which flows through the external functional device in its use is a substituate, heparin or another pharmacologically active substance, saline (in particular 0.9% NaCl solution), blood, air and combinations thereof.

The external functional device can in particular be coupled to a blood treatment device. Further preferably, it can be designed and provided to be connectable to the blood treatment device by means of a receiving device of the blood treatment device. The external functional device can in particular be coupled to the treatment device with the surface facing the covering device.

In a further preferred embodiment, the external functional device can be coupled backwards at an angle of inclination, preferably between 5 ° and 11 °, in particular at an angle of inclination of substantially or exactly 8 °, relative to a vertical to the blood treatment device. The external functional device is preferably inclined backward in an upper area thereof (in the use state).

In a further preferred embodiment, the external functional device has at least one substituate addition point, which has a contact protection element and / or a drip protection. Other sections, in particular any other section, of the external functional device may also have a contact protection element and / or a drip protection.

A closure function of the ports (one, some or all ports) of the external functional device can also be realized by septa or check valves.

The drip protection can be realized for example by an integrated closure sleeve.

The drip guard may preferably be used to prevent dripping or running out of substituate or blood or a mixture of substituate and blood during the removal of the external functional device from the receiving device of the blood treatment device. In this way, a hygienic handling of the used and impure external functional device can also be guaranteed outside the treatment device.

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

The patient's blood is preferably passed out of the patient through the dialyzer during the withdrawal phase, thereby dialyzed (preferably directly) after passing through the dialyzer in the single-needle chamber and returned to the patient from there in the return phase. The blood is thereby dialyzed in the "fresh" state in which it comes from the patient. Thus, the performed by means of the cartridge for blood treatment according to the invention method may advantageously differ from those conventional methods in which the patient taken blood, stored in a separate single-needle chamber, then dialyzed and returned to the patient via a venous air separator ,

The external functional device may preferably have at least one single-needle chamber in which a blood surge redirecting element is arranged.

Such a "blood flow diverting element" or blood surge element can be used to achieve a flow slowdown, to generate a turbulence and / or to divert it into the single-needle Chamber inflowing blood or to extinguish the pulse of the blood surge suitable and provided. Such Blutschwallumleitungselement can be designed in particular flow optimized. It may be configured, for example, in the form of an ellipsoidal or round column, which is connected at at least a portion of its circumference to a wall of the single-needle chamber.

Without Blutschwallumleitungselement a flow of blood flowing through the phantom could possibly cause a fountain. This could lead to sloshing of the liquid level and / or foaming. By means of the Blutschwallements the total blood surge is divided into two smaller blood swells, whereby the pulse of the total bloodstream can be extinguished and beneficial fountain formation, sloshing movement and / or foaming can be avoided.

As Blutschwallumleitungselement a Blutschwallumleitungselement can preferably be used, as in the by the applicant of the present invention in the patent application 10 2009 024 466.2 entitled "Receiving Device for Receiving Medical Fluids and External Functional Device and Medical Treatment Device" filed on 10 June 2009 at the German Patent and Trademark Office. Their disclosure in this regard is hereby incorporated by reference.

The external functional device of the present invention may preferably comprise at least one venous blood chamber.

The single-needle chamber may preferably be located above, based on the orientation of the external functional device during its use, the venous blood chamber.

The venous blood chamber may be divided into at least one upper space and at least one lower space by means of a cross-sectional taper of the housing body.

The upper space and the lower space may be in fluid communication with each other.

The upper space may be configured to allow or generate a tangential inflow of fluids flowing through the external functional device. The upper space may have a region for generating a stable rotational flow of the fluids flowing through the external functional device.

The lower space may have a region that is substantially or completely free of rotational flow of the fluids flowing through the external functional device.

Preferably, walls or wall portions of the upper space and / or the lower space of the venous blood chamber may be adapted to a slope of the external functional device against a vertical of the blood treatment device. This may advantageously allow for flow-optimized flow or flow of the blood through the venous blood chamber and the rise of air possibly in the blood for the purpose of separation.

The venous blood chamber may be configured and, in particular, have an air-separating action, as in that of the Applicant of the present invention in the patent application 10 2009 024 465.4 entitled "Air Separator, External Function Facility, Blood Circulation and Treatment Device" filed on 10 June 2009 with the German Patent and Trademark Office (DPMA). Their disclosure in this regard is hereby incorporated by reference.

In a further preferred embodiment of the external functional device, the housing body is designed as a hard part.

The hard part may be a housing body made substantially of one piece and a material. This can be an injection molded part. It may have a minimum stiffness of more than 400 N / mm ² , preferably 1200-1800 N / mm ² (bending modulus).

In a further preferred embodiment of the external functional device as a blood treatment cassette, in a further preferred embodiment, the pressure in the extracorporeal blood circulation upstream of the dialyzer can be measured through the covering device or foil.

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

The object according to the invention is also achieved by the blood treatment device according to the invention as claimed in claim 10.

In a further preferred embodiment, the blood treatment device is designed to accommodate at least one external functional device according to the present invention.

In a further preferred embodiment, the blood treatment device has at least one control device and / or actuators and / or sensors for activating and / or actuating the external functional device.

The controller may be configured as a CPU or part thereof.

The control device and / or the actuators may, for example, be used for driving, i. For example, controlling or regulating a valve device suitable and provided. They may be arranged at a position of the blood treatment device, which is opposite to a valve device of the external functional device in its coupled state.

In a further preferred embodiment, the blood treatment device has at least one receiving device for receiving at least one external functional device according to the present invention. The receiving device may have a coupling surface for coupling the external functional device according to the present invention. Such a coupling surface may, for example, be inclined at an angle to a vertical relative to the orientation of the blood treatment device during its use, in particular to the rear. Such an angle can be between 5 and 11 °, in particular substantially or exactly 8 °.

Furthermore, the blood treatment device may comprise at least one actuator for actuating an external functional device according to the present invention or a portion thereof.

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

The blood treatment device may include a controller for measuring a parameter present in the extracorporeal circuit or blood circulation of the external functional device according to the invention designed as a blood treatment cassette, for example a pressure, a 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 blood-side pressure difference of the dialyzer. The controller of the blood treatment device may be configured to calculate this difference, if necessary to compare the pressure difference with reference values (which may be stored for example in the controller or a memory), and optionally for outputting control signals.

In this case, for example, an incipient blockage of the dialyzer can advantageously be detected early or in good time. Countermeasures can be taken.

These may include the addition of anticoagulants, such as. B. heparin, z. B. on the cassette-integrated addition points or consist thereof.

Furthermore, z. For example, the predilution can be increased. It can be switched from postdilution to predilution.

The cassette-integrated measuring points can also advantageously allow transmembrane pressure measurement across the dialyzer membrane.

For this purpose, four measuring points can be present, at which by means of appropriate devices is measured and the measurement results are evaluated by means of suitable devices: one at the filter inlet and at the filter outlet, both on the blood side and dialysate side.

In some embodiments according to the invention, the external functional device in certain sections thereof is (at least) designed to be thicker or thicker than other sections in a direction perpendicular to the coupling plane (or to a main section thereof). The stronger or thicker designed sections, of which there may be one or more, serve to receive measuring devices such. As optical measuring devices, ultrasonic devices, temperature measuring devices, and the like.

The same benefits may have portions of the external functional device, which are not designed stronger or thicker, but which extend mainly in the Hauptersteckungsebene the external functional device, preferably parallel to a main coupling plane of the external functional device and / or parallel to an actuator-sensor plate treatment device. These extending the external functional means sections (one or more), at the same time be made stronger or thicker; However, this is not required according to the invention.

The measuring devices can be or are connected to the treatment device starting from one side of the door of the treatment device with which the external functional device is compressed and / or covered for use with the treatment device in certain embodiments according to the invention.

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

Measuring devices arranged in such thicker or longer or longer configured sections may be used, for example, for measuring states within in or outgoing fluid channels of the external functional device (in particular those fluid channels which remove or supply fluid from the external functional device). They can be arranged in the immediate vicinity of such fluid channels.

All or some of the thicker or thicker or longer designed sections are preferably in an edge region of the external functional device. This can advantageously allow a simple connection between the measuring device, which lies in each case in one of the aforementioned sections, and the treatment device. Furthermore, this arrangement in an edge region allow easy accessibility.

The external functional device can in the above-mentioned stronger or thicker or longer designed sections or elsewhere measuring points for coupling detectors such. B. optical detectors for detecting line or valve leakage. Such leaks can z. In the area of the phantom valves, the check valves, the supply or discharge lines (eg to or from the valves) or the like. The measuring points and / or the, in particular optical, detectors can be arranged at the appropriate place.

In some embodiments according to the invention, the external functional device may have one or more addition points, which each have at least one septum. The septum may be provided to be easily penetrated upon addition, but advantageously still provides closure and thus safety and tightness.

The addition points are preferably integrated in the external functional device or produced integrally therewith.

The addition points may be arranged in an end region or edge region of the external functional device. This arrangement may advantageously allow easier access to the addition points in some embodiments of the invention. In certain embodiments of the invention, this is particularly true in the event that the external functional device is in contact with (eg, pressed with) a pretreatment device by means of both its front and rear surfaces for coupling to a treatment device and thus front and rear for addition are difficult or laborious to reach via the septum. Thus, ergonomic advantages may result in some embodiments.

In further preferred embodiments, supply lines may be arranged on or in the external functional device such that the supply line (wholly or partially) or a connection point (such as a connection port of the supply line) to the supply line are in an upper region of the external functional device - preferably with respect to an intended position or arrangement of the external functional device during its intended use (eg in a state compressed with the treatment device).

The upper area can be a border area. The upper region may be an area above a coupling surface or a coupling region.

The supply line may be a conduit for an anticoagulant. It can be a heparin line. An associated syringe pump for the anticoagulant, z. As heparin, may be arranged in the use of the external functional device above the external functional device or the coupling plane.

Advantages to be achieved in some embodiments of the invention include ergonomic advantages, advantages associated with shorter supply line, better accessibility of the joint, and more.

In some embodiments, supply lines can be understood as conduits via which fluids can be supplied to the extracorporeally flowing blood during the use of the external functional device during blood treatment or which are provided for this purpose.

The blood treatment device may include a controller for driving the cassette valves. The controller may preferably freely programmably switch between the cartridge integrated pre and post dilution. It can preferably change the substituate flow (volume flow). Information providers may be, in particular, the cassette-integrated pressure measuring points arranged before and after the dialyzer.

Hereinafter, the present invention will be described with reference to preferred embodiments thereof with reference to the drawings. In the figures of the drawing, like reference characters designate like or identical elements. The following applies:

1 shows a front side of the external functional device according to the invention according to a preferred embodiment;

2 shows the back of the external functional device of 1 ;

3 shows the external functional device 1 and 2 from her left side;

4 shows the external functional device 2 with their pump tubing segments; and

5 shows the external functional device 2 with their pump tubing segments as well as the extracorporeal blood circulation.

1 shows a front side of an external functional device, which at the surface, on the in 1 is provided with a cover device is provided.

The external functional device is as a cassette 1000 designed.

The cassette 1000 has a hard part 1 on. As in 1 shown by way of example, has the hard part 1 Chambers, channels and valves on. As in 1 is further exemplified, the chambers, channels and valves in the hard part 1 integrated or at least partially from the hard part 1 designed.

The cassette 1000 of the 1 is at its front with a cover device, here for example a film 3 honeycomb structure in its surface. The cover device can flat, ie flat, on the hard part 1 be welded on.

The foil 3 is in 1 For better representation of the structures located behind her cut-off freehand line shown. As a result, only a small portion of the film 3 shown. In fact, the film covers 3 the entire area of within the circumferential sealing ridge 4 located portion of the hard part 1 ,

An embodiment with a three-dimensional design of the welding and sealing contour is also possible according to the invention.

The cover means may be the chambers and / or channels of the hard part 1 the cassette 1000 close, against one of the hard part 1 opposite side of the cover device and / or to the atmosphere.

As in 1 can be seen, the film lies on the peripheral sealing bar 4 on the hard part 1 the cassette 1000 on. The foil 3 is on a circumferential weld 5 with the hard part 1 the cassette 1000 welded.

The circumferential sealing bar can alternatively be performed exposed.

The foil 3 may be at other local welds (not shown) with the hard part 1 the cassette 1000 be connected. These may also be circumferential, that is closed in the sense of a final boundary similar to a ring, and / or punctiform.

The foil 3 can be punctiform or linear with the hard part of the cassette in local places 1000 connected, z. B. welded, be, in particular at the edge zones of the liquid-carrying channels.

The foil 3 Can be done by laser welding with the hard part of the cassette 1000 get connected. It is advantageous if the local heat input takes place using light-absorbing components. The light-absorbing component can be part of the material of the film and / or of the hard part or a layer which is arranged between the film and the hard part or over the film. The layer may be a foil layer.

The cassette 1000 at least with the in 1 shown front to a blood treatment device (in 1 not shown). An example procedure for the suitable coupling of a cassette 1000 to a coupling surface of a blood treatment device is in the patent applications 10 2009 012 633.3 entitled "Device for Joining an External Functional Device with an Arrangement, Device Having Such Device, and Method of Connection" filed with the DPMA on Mar. 10, 2009; and 10 2009 012 632.5 entitled "Sealing Device for Sealing a Volume of a Medical Treatment Device Against Another Volume and Arrangement and Method", also filed with the DPMA on March 10, 2009, the disclosures of which are incorporated herein by reference.

The cassette 1000 can match the plane of the slide 3 - or via this - are coupled to a coupling surface of the blood treatment device.

The coupling surface of the blood treatment device may, for example, at an in 1 upper section thereof at 8 ° to an in 1 from top to bottom vertical to the rear (in the 1 the direction extending from the viewer into the plane of the drawing).

The cassette 1000 has an arterial patient connection 7 on.

The cassette 1000 has an arterial pressure measuring chamber 9 on. This may have corresponding sensors. The sensors can preferably transmit signals via a cabling. The sensors can also be designed so that they transmit wireless signals.

The cassette 1000 has a connector 11 for the blood leakage from the cassette 1000 as well as a connector 13 for the blood entry into the cassette 1000 on.

The two connectors 11 and 13 are connected to a pump tubing segment or set of a blood pump.

The cassette 1000 also has a chamber 15 with a pressure measuring point for pressure measurement in the extracorporeal blood circulation in front of the dialyzer ("pre-filter") or after the pump ("post-pump").

At the chamber 15 can through the film 3 through or over the film 3 the pressure in the extracorporeal circuit before the dialyzer can be measured.

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

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

The upper room 23 the venous blood chamber 21 can allow a laterally tangential blood inflow. In doing so, blood can flow laterally through the inlet (the left side in 1 ) in the upper room 23 infuse and become tangent to the walls of the upper room 23 spread. A laterally tangential blood inflow may be a zone of substantially or fully stable rotational flow of the blood in the upper space 23 the venous blood chamber 21 produce.

The lower room 25 the venous blood chamber 21 may be a calming zone for blood flow. It is possible that there is substantially no or no rotational flow of the blood in such a calming zone.

The venous blood chamber 21 is through a cross-sectional taper 27 of the hard part 1 the cassette 1000 in the upper room 23 and the lower room 25 divided up. The cross-sectional rejuvenation 27 reduces the cross section of the venous blood chamber 21 so in its width and depth that results in a rapid flow, after crossing a venous blood chamber 21 the cassette 1000 flowing fluid assumes a slower flow rate. The upper room 23 and the lower room 25 are in fluid communication.

By such a construction, ie a division of the venous blood chamber 21 into a zone of substantially or fully stable rotational flow of the blood and into a calming zone for blood flow, an efficient separation for air from the blood or fluid can advantageously be achieved.

Walls of the upper room 23 and the lower room 25 the venous blood chamber 21 can suitably a slope of the upper portion of the cassette 1000 in 1 against the vertical, for example, a slope of the upper part of in 1 shown cassette 1000 8 ° backwards (into the plane of the drawing). They may be suitably rounded in such a way that they advantageously represent a flow-optimized contact surface for fluids containing the venous blood chamber 21 flow through.

The cassette 1000 has a clot trap 29 on.

As a clot trap, it is preferable to use a clot trap such as that disclosed by the assignee of the present invention in the patent application 10 2009 024 495.6 entitled "Clot Catcher, External Function Facility, Blood Circulation, and Treatment Device," filed with the DPMA on June 10, 2009. Their disclosure in this regard is hereby incorporated by reference.

At the clot trap 29 can through the film 3 through or over the film 3 the pressure in the extracorporeal circuit are measured, ie in particular after passing through the dialyzer.

The cassette 1000 has a venous patient connection 31 on.

The cassette 1000 has an arterial heparin delivery site 33 on. It should be noted that the heparin addition point 33 (as well as a venous heparin delivery site 37 ) also for the addition of others Pharmacological agents as heparin, which are only preferably anticoagulants, or combinations of active ingredients may be suitable and provided. This is always to be considered even if heparin is mentioned in any context before or in the following.

The cassette 1000 has a check valve 35 the arterial heparin delivery site 33 on.

Exemplary check valves for use as a check valve 35 the arterial heparin delivery site 33 as well as further check valves of the cassette 1000 are in the patent application 10 2009 024 469.7 by the assignee of the present invention entitled "Valve Device, Valve Core, External Function Device, Treatment Device and Method" filed with the DPMA on June 10, 2009, the entire contents of which are hereby incorporated by reference.

The cassette 1000 has an arterial heparin addition valve. With the help of the arterial heparin addition valve, the addition of heparin into the arterial filter line 17 be controlled or regulated.

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

The term "phantom valve", as used herein, refers to an element with an actuator surface achievable by means of an actuator (here, for example, an actuator membrane), which can assume the function of a valve.

The actuator membrane is on applying a force thereto, for. B. a compressive force, movable in one direction, expandable or archable or the like. By moving or expanding the actuator membrane, it can attach to or remove from an element, such as a sealing device, such as a web. The actuator membrane can thus effect, for example, a seal or strengthen or terminate or reduce.

When the force is taken back from the actuator membrane, this can be in, for example, a basic position, for. B. a non-curved state, return.

Phantom valves can be actuated by actuators of the blood treatment device.

To close a phantom valve, the section of the film 3 be pressed on the bridge section. To open the phantom valve, the section of the film 3 be lifted off the bridge section again.

Further examples and / or embodiments for phantom valves can be found in the patent application 10 2009 012 632.5 entitled "Sealing device for sealing a volume of a medical treatment device against another volume and arrangement and method" filed on March 10, 2009 by the present applicant at the DPMA. Their disclosure in this regard is hereby incorporated by reference.

The cassette 1000 has a venous heparin delivery site 37 on. The venous heparin delivery site 37 Luer connector can be configured.

The cassette 1000 has a check valve 39 the venous heparin addition site 37 on.

The cassette 1000 has a venous heparin addition valve. With the help of the venous heparin addition valve, the addition of heparin into the venous filter line 19 be controlled or regulated.

The cassette 1000 has a substituate addition site 41 or a substituate connector.

The substituate addition point 41 may be a connecting device, as in the patent application 10 2009 024 575.8 of the present applicant, which was filed with the DPMA on June 10, 2009, entitled "Connection Device and Method for Connecting at Least Two Fluid-carrying Medical Systems, and Medical Device" by the present Applicant. Their disclosure in this regard is hereby incorporated by reference.

The substituate addition point 41 may be provided with a Berührschutzelement (not shown). The substituate addition point 41 may be provided with a drip guard (not shown). The drip protection can be realized by an integrated sealing sleeve. The drip guard may cause dripping of remnants of substituate and / or blood upon release of the cartridge 1000 and then removing the cassette 1000 prevent from the blood treatment device.

The drip guard can be made removable. It can be configured as a hood or lid.

The substituate addition point 41 or another section of the cassette 1000 Further, it can provide tamper-evidence protection by which the user can easily, or at a glance, know if the cartridge is being used 1000 already used. This originality protection can be achieved by means of the contact protection element, the closure sleeve or another structure be realized. The corresponding structure may preferably have its position within or relative to the cassette 1000 change recognizably. It can preferably change its shape.

In addition, the substituate addition point 41 or another section of the cassette 1000 provide reuse protection or protection against reuse. Preferably, through a closure sleeve, the cassette 1000 - Preferably irreversible - made useless in the attempt to reuse. Should the cassette 1000 Nevertheless, sensors of the blood treatment device do not measure the waveforms that would be measured using a new cassette. This may be due to the fact that no liquid in the cassette 1000 or in the substituate addition point 41 can reach or at least not in sufficient or usual amount. The control unit of the blood treatment device can recognize this. A warning can be issued.

As tamper-evident or reusable protection, a tamper-evident or reuse protection such as that disclosed by the assignee of the present invention in patent application may be preferably used 10 2009 024 575.8 entitled "Connecting Device and Method of Connecting at Least Two Fluid-Delivery Medical Systems, and Medical Device" filed with the DPMA on June 10, 2009. Their disclosure in this regard is hereby incorporated by reference.

The cassette has a connector 43 for a substituate exit from the cassette 1000 as well as a connector 45 for a Sustituateintritt in the cassette 1000 on.

The connectors 43 and 45 are connectable to a pump tubing segment or set of a substituate pump or as in 1 shown connected.

The cassette 1000 has a check valve 47 for substituate addition.

Via actuation of the check valve 47 can substitute in a substituate line 49 be introduced.

The cassette 1000 has a pre-dilution addition valve 51 on. The pre-dilution addition valve 51 can be designed as a phantom valve.

The cassette 1000 has a post-dilution addition valve 53 on. The post-dilution addition valve 53 can be designed as a phantom valve.

The cassette 1000 has a single-needle sterile membrane 55 on.

The cassette 1000 has a single-needle chamber 57 on. The single-needle chamber 57 is in 1 above the venous blood chamber 21 arranged.

Inside the single-needle camera 57 is a blood surge redirecting element 59 arranged. The blood surge redirecting element 59 may be used to slow down a blood surge and / or extinguish its pulse.

A connection to an interior of the single-needle chamber 57 may be provided by means of a coupling device as described in the 'Applicant of the present invention entitled' Device and External Device and Device for Treating Medical Fluids' 10 2009 024 467.0 patent application filed on 10 June 2009 with the DPMA. Their disclosure in this regard is hereby incorporated by reference.

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

The cassette 1000 has a suction point 63 on. The suction point 63 can be used for vacuum coupling of the cassette 1000 serve to the blood treatment device, as for example in the patent application DE 10 2007 042 964 A1 entitled "Apparatus and Method for Treating a Medical Fluid" filed with the DPMA on Sep. 10, 2007, the disclosure of which is incorporated herein by reference in its entirety.

The cassette 1000 has a primary orientation center 65 on. The primary orientation center 65 can be advantageous for aligning and / or locking the cassette 1000 serve at the blood treatment device.

The cassette 1000 has a secondary alignment site 67 on. The secondary alignment site 67 can be used to align and / or lock the cassette 1000 serve at the blood treatment device.

The cassette 1000 is filled with gas (eg sterile air) prior to priming. When you prime the extracorporeal blood circulation this must Gas filling are displaced. A blood treatment cassette is generally a particular challenge, because there are both ascending and descending lines and also chambers in which no "air pockets" may remain. The present cassette 1000 has special design features for this purpose:
The chamber 15 For measuring the arterial pressure, it is designed so that all of the air into a pumptube segment (eg into the pumptube segment 88 or 90 ) can ascend. There are advantageously no dead spaces. Air, which rises automatically from the arterial pressure measuring chamber into the pump hose segment of the blood pump, is forcibly conveyed from the area of engagement of the blood pump (for example, by the rollers of a roller pump) through the pump hose segment. As soon as the pump has no influence (because, for example, the rollers go into action), the air automatically rises in the conveying direction into the cassette 1000 on.

The venous return line (or a venous section 93 of extracorporeal circulation such as in 5 shown) is a downpipe. From a certain volume flow (eg 200 ml / min at the in 1 shown cassette 1000 ) air bubbles in the blood are also "carried away" against the acceleration of gravity. This effect is exploited in the downpipes. The pipe cross-sections of the downpipes are designed so small that due to the flow velocity forced transport of the air bubbles also works contrary to the gravitational acceleration.

In the venous blood chamber 21 large cross-sections are provided, so that due to the slow or low flow rates there air bubbles can rise reliably against the main flow direction.

2 shows the back of the external functional device of 1 ,

In 3 is the cassette 1000 shown from the left side.

4 shows the external functional device 2 with their pump tubing segments.

5 shows the external functional device 2 with their pump tubing segments 88 and 90 as well as the extracorporeal extracorporeal circulation 3000 ,

The extracorporeal circulation 3000 has an arterial patient tube clamp 83 and a venous patient tube clamp (not shown).

The extracorporeal circulation 3000 has an arterial section 91 and a venous section 93 on.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• DE 102009024466 [0048]
• DE 102009024465 [0056]
• DE 102009012633 [0110]
• DE 102009012632 [0110, 0140]
• DE 102009024495 [0127]
• DE 102009024469 [0132]
• DE 102009024575 [0145, 0150]
• DE 102009024467 [0160]
• DE 102007042964 A1 [0162]

Claims (10)

External functional device, which can be used as a cassette ( 1000 ) to a blood treatment, comprising: at least one housing body, at least one chamber ( 9 . 15 . 21 . 57 ) for receiving medical fluids; at least one channel integrated into the housing body ( 17 . 19 . 49 ) for receiving and / or guiding a medical fluid; and at least one valve device completely or partially integrated in the housing body ( 35 . 36 . 39 . 40 . 47 . 51 . 53 . 61 ), for controlling or regulating a fluid flowing through the external functional device, at least two connectors ( 11 . 13 . 43 . 45 ), for pump tubing segments ( 88 . 90 ) for peristaltic pumps, the cassette ( 1000 ) an arterial patient connection ( 7 ), an arterial filter line ( 17 ), a venous patient connection ( 31 ) and an arterial heparin delivery site ( 33 ), wherein the arterial heparin addition site ( 33 ) between arterial filter line ( 17 ) and venous patient connection ( 31 ) is arranged. External functional device according to claim 1, which is provided on at least one of its surfaces with a covering device which is part of at least one integrated valve device ( 35 . 36 . 39 . 40 . 47 . 51 . 53 . 61 ), wherein the covering device is a film ( 3 ).  External functional device according to claim 2, wherein the cover device is at least in a portion with the housing body non-positively and / or positively and / or cohesively connected. External functional device according to claim 3, wherein the covering device is connected by means of at least one circumferential weld (FIG. 5 ) and / or connected by means of further non-circumferential or punctiform or local welds with the housing body. External functional device according to one of the preceding claims, wherein the cassette ( 1000 ) a venous filter line ( 19 ) and a venous heparin delivery site ( 37 ), wherein the venous filter line ( 19 ) medial to the venous heparin delivery site ( 37 ) is arranged.  External functional device according to one of claims 2 to 5, wherein the cover device is connected to the latter at least on two sides or on both sides of at least one structure of the housing body. External functional device according to one of the preceding claims, which comprises a single-needle sterile membrane ( 55 ), which has the shape of a parallelogram. External functional device according to one of the preceding claims, which is a primary alignment center ( 65 ) and a secondary alignment center ( 67 ), wherein the primary alignment center ( 65 ) and the secondary alignment center ( 67 ) have different shapes and / or different orientations. External functional device according to one of the preceding claims, comprising at least one valve device ( 36 . 40 . 51 . 53 . 61 ), which at least one web, which is designed on the housing body, and at least a portion of the cover means, wherein the web and cover means are arranged to be actuated by means of the cover means acting on a web actuator of a blood treatment device for changing a fluid flow. Blood treatment device, in particular a dialysis device, characterized in that it is designed to accommodate at least one external functional device according to one of claims 1 to 9 or has such.

Images