DE102009024469A1 - Valve device for injecting e.g. drugs into blood conducting passages of blood treatment cassette of blood treatment apparatus for extracorporeal blood treatment, has valve insert formed so that insert is switched among three valve states - Google Patents

Abstract

The device (100) has an elastic valve insert (1), and a retaining device (3) for receiving the valve insert. The valve insert is formed such that the valve insert is switched among three different valve states due to elasticity during path impression and/or force application on the valve insert. The valve states are selected from a group consisting of an opened functional state, sterilization state, check valve state, control or regulation valve state and closed valve state. The valve insert is made of elastomer material and contains impressions. Independent claims are also included for the following: (1) a method for controlling or regulating a passage of fluid (2) a method for manufacturing a valve device (3) a method for preparing an external functional device for sterile application.

Description

The The present invention relates to a valve device according to the preamble of claim 1. It further relates to a valve core according to claim 18, an external functional device according to claim 19 and a method for controlling a fluid passage according to claim 21. Furthermore, it relates to a method for producing a Valve device according to claim 27, a method of manufacturing an external functional device according to claim 28, a method for preparing an external functional device for sterile use according to claim 29, an external functional device for sterile use according to claim 31 and a treatment device according to claim 32.

Out Cost and hygiene reasons are used in technical devices, such as medical technology Treatment devices, laboratory equipment or also Devices for food or drug production often external functional devices as disposable part systems, such as Disposable cassettes, used.

such Disposable systems can channels and chambers for targeted guidance of liquids and Gases and devices, such as valve devices, for varying or controlling the flow of these fluids.

task The present invention is another valve device for such To provide disposable systems or other devices. Further should a corresponding valve insert, an external functional device and appropriate procedures are proposed.

The inventive task is achieved by a valve device having the features of claim 1 solved.

The Valve device according to the invention has at least one elastic in at least a portion thereof Valve insert and at least one receiving device for the valve core on.

Of the Valve insert of the valve device according to the invention is provided and configured such that it is impressed upon impressing and / or Force application to the valve core or to another section of the Valve device between at least three different valve states switchable or is changeable. Under the "switchability" of the valve core Below is the possibility understood in the broadest sense, by means of the valve core at least three valve states to achieve.

Under A "path stamping" is preferred according to the invention a change a variable dimension of a structure or a component Understood. So can a path impression in a coil spring their elongation or their compression mean. Relative to the valve insert of Valve device according to the invention means a way imprint its compression, extension, deformation and the like.

Of the Term "valve insert", as he is used herein, the deformable due to its elasticity body the valve device according to the invention. The valve insert is in its use of the fluid wholly or partially flows around, but at least in the presence of a fluid on the valve device with Fluid in contact. A "receiving device" for the valve core, as used herein refers to one for receiving the Valve insert designed and / or provided receiving device.

The "recording" can be Include, a bracing, establishing a functional relationship between receiving device and effect valve insert, and the like.

preferred embodiments are each the subject of the dependent claims. Further, below are Characteristics listed, which features of the valve device according to the invention or their valve insert can be. You can in each embodiment independently be realized by other characteristics.

So the receiving device may be one for receiving the valve core suitable opening exhibit.

The Switchability of the valve insert between at least three different Valve states can the valve insert in particular owe its elasticity.

The valve core can be configured according to the invention, to be alone by its elastic Verfor mung or elastic recovery or elastic deformability in different valve states to pass or allow this.

A change the position of the valve portion or a portion thereof for example, a portion of the valve device such as Receiving device, which no section of the valve section is, may be dispensable for switching between the valve states.

Of the Valve insert may become elastic due to the force - d. H. reversible - deform, for example, bend, bending folds or the like. Depending on the way impressions and / or Force application to the valve insert this can thus different valve states taking. The restoring forces due the elastic deformations can Functions such as protection against falling out, self-resetting, Effect seal and / or set pressure.

Of the Valve insert can be symmetrical. He can be a rotationally symmetric Have shape.

The Receiving device may be designed and / or provided to to receive the valve insert substantially accurate fit and / or to be kept under built-in bias.

she can be designed and / or provided to tolerances in Build up and / or pressing the valve insert to allow.

The Receiving device may be made of one or more inelastic materials, such as thermosetting plastics, metals and the like as well as combinations.

The stiffness of the receiving device may preferably be substantially higher than that of the valve core. The bending stiffness and / or the compressibility of the valve core may be, for example, 60 N / mm ² to 300 N / mm ² , and those of the receiving device may be, for example, 800 N / mm ² to 2400 N / mm ² .

The Receiving device may be in a housing element, such as a hard part, for example an external functional device, such as a disposable cassette, be arranged. For example can it in a housing element an external functional device - for example during the Production of the external functional device - be configured.

An "external functional device" may be a fluid treatment cartridge or a hose fitting. A fluid treatment cassette, blood treatment cassette or diposable cassette in the sense of the present invention is described, for example, in the applications filed by the applicant in the DPMA on April 23, 2009 and June 10, 2009 as 10 2009 018 664.6 (Representative Acts FM19A27) and ( 09/33-d01 DE; 11FM19A27), each with the title "External functional device, blood treatment device for receiving an external functional device according to the invention, as well as methods", the relevant disclosures of which are hereby incorporated by reference. A preferred embodiment of the blood cassette disclosed therein is disclosed in U.S. Pat 8th . 9 and 10 of the present application.

Of the Term "housing element", as he is used herein, a component that is part of an external Functional device, a treatment device and / or both the external functional device as well as the treatment device can be.

The housing element can come from a rigid, d. H. essentially inelastic, material be formed.

The housing element An external functional device can have various functions fill out. It can, without being limited to be a fluid passage, a sealing seat of the valve core, z. B. as a separation between an inflow channel and an outflow channel for fluids, which flow through the valve device, such as blood or substituate liquid or a sterilizing fluid (a liquid and / or a gas) or a rinsing liquid, represent.

The housing element can serve as a holder for the valve insert, ensure a correct axial displacement or compression of the valve core and the like. The indefinite articles such as "a" or "an" are - as in the entire application - not restrictive and not as number words to understand.

The housing element can channels, like inflow and outflow channels, through which fluids are introduced into the valve device or from this be discharged. Such channels can be considered semi-open or as closed channels be designed. You can for example, in a section as semi-open channels and in another section be designed as closed channels.

closed channels can especially as a transition to immediately connected connector elements, such as Luer sockets or hose sockets, are suitable.

semi-open channels can especially in external functional devices, such as a disposable cassette, be preferred. The use of semi-open channels in an external functional device can be a great freedom of design allow for "fluid layout" for example by designing guides or branches towards measuring and / or venting chambers.

in the housing element intended channels, For example, in the valve device in-leading inflow channels and / or out of the valve device outflow channels, can in be executed at any angle to each other. This can be an angle of exactly or about 180 degrees or even an angle of less than Its angle may be a value in a range from 45 degrees to 315 degrees.

Also a coaxial arrangement of the channels to an optionally existing symmetry axis of the valve core executable. Such an arrangement may be preferred. This is especially true if the valve insert is not in an external, for example Functional device, but as a so-called inline functional element is switched or inserted into a hose line.

Should For example, both flow channels coaxial can be aligned in the seating area of the valve insert housing element Interrupts be incorporated, which an axial flow around the Valve insert through the valve device flowing through the fluids allow.

In In such a case are preferably openings in a bending ring area provided the valve core. In this case, housing elements on particularly low Space, z. B. with a small diameter, be configured. The valve device Overall, it can be carried out particularly streamlined can.

Of the Valve insert can by stepped Weginprägung and / or force application, for example by means of an actuator on an upper side of the valve core, be brought into different, defined deformation states. Depending on the force applied to the valve insert and / or the path impression can be certain Valve functions or valve states or valve positions are realized. The valve insert can be in some or all of these valve states under an elastic Suspense.

One Valve condition may be an open one or an open valve state.

In an open one or open valve state is the valve core or the valve device then, when no external force on the valve core is applied. The valve insert can be in the receiving device be inserted. The valve insert can be free from this condition Bias and / or tensions generated between components be.

Of the Passage of fluids may be maximum in this state. Passage openings for fluids, which flow through the valve insert, maximum in this state open be.

One Valve state may be a sterilization state.

To the Sterilizing the valve device or an external functional device with a valve device according to the invention the valve insert is preferably in the sterilization state.

in the Sterilization state, the valve core can preferably be the same Have configuration or shape as in the open valve state or ingest.

The valve insert can again be free from external forces and / or prestressing in the sterilization state tions and / or tensions with other components, such as the receiving device, and / or be free of Weginprägungen.

in the Sterilization state can be a bidirectional flow of fluids possible through the valve device be.

in the Sterilisationszustand, the sterilizing agent preferably all structurally accessible volumes and partial volumes, openings, Undercuts and the like of the valve device reach.

One another valve state may be a check valve state.

One check valve is known from the prior art, for example as a closure body in Ball or cylindrical shape in conjunction with preloaded springs known. A check valve can also act as a pressure limiter.

The "check valve state" of the valve core or the valve device of the present invention may be used for directional determination the flow a fluid within a flow channel - or more - serve.

in the Check valve condition For example, the passage of a fluid in a flow direction can be blocked.

One another valve state may be a control or control valve state be.

in the Control or control valve state is on the valve core of the valve device a force - preferably variable - applied, by means of which a flow rate of the fluids, which the valve device flow through, is controllable or controllable.

The Valve device can, for example, active by force and / or motion-transmitting actuators be controlled.

suitable Actuators can for example, coupled to a treatment device and in particular operated by this or controlled / regulated.

The absolutely applied to the valve core and / or the force to be applied to the path Steer or control, for example, to set a specific or defined flow rate, depending on the desired or required flow rate of the fluids, which the valve device flow through, be set.

she For example, in a controller, a CPU or the like be preprogrammed.

The Force and / or the path impression (Shift) can be applied by actuators, for example on the top of the valve insert.

One further, possible Valve condition is a closed valve condition.

in the Closed valve state, the flow rate of the valve device flowing through Fluids be reduced such that no or substantially no Flow takes place.

Of the Valve insert may be arranged such that the passage provided by fluids openings essentially inaccessible or are closed. The openings can Completely inaccessible or be closed.

Of the Valve condition may be a permanently closed valve condition.

Of the Valve insert may be wholly or at least in sections thereof rotationally symmetrical be designed.

In a further preferred embodiment, the valve core has an elastomeric material in at least one section. The valve insert may be elastic at least or in portions thereof be designed.

To the suitable elastomeric materials include, but are not limited to, Rubber, Silicone, TPE (Thermoplastic Elastomers), TPE-U (partly also abbreviated to TPU); Thermoplastic elastomers based on polyurethane), plastic, PVC and the like more.

liquid crystalline Elastomers and / or thermoplastic elastomers may be added include the suitable elastomeric materials.

thermoplastic Elastomers can in this case preferably mixtures of one or more elastomers and one or more thermoplastics.

Such Thermoplastics can For example, for making rigid housing components of an external Functional device be suitable.

The thermoplastic elastomers can with sprayed housing elements glued and / or welded and / or otherwise positively and / or positively and / or materially connected be.

Of the Valve insert can imprints in the sense of sections thinner or softer material with respect to other sections thereof, which is a special elasticity or deformability of the same. Such impressions can by Printing by means of rollers, rollers, punches and the like, but also during a casting process or extrusion process can be configured.

Of the Valve insert may have a predetermined folding pattern or a wrinkled one or folded portion, which after stretching elastically traceable to a ground state.

Of the Valve insert can be considered a one-component valve set, as well be designed as a multi-component valve core.

In a further preferred embodiment the valve insert at least a first sealing device have, which is provided and designed to be in at least a portion thereof having at least a portion of a second one Sealing device of the receiving device positively and / or non-positively compressible to be.

The first Sealing device "can be an elastic sealing ring. It can be an orbiting, in particular be closed, sealing lip. The sealing lip may, for. B. a level Form, have a conical shape and / or a slightly wavy shape.

The first sealing device can, depending on the deformation state of the Valve insert on a defined sealing surface on the receiving device, for example, the second sealing device, or at the valve core rest.

The first sealing device may have a disc shape or disc-shaped be. The first sealing device may have an axial center, for Example in a central area of a disc-shaped first Seal device, be biased. At the central area it can be an inner area. The central area is preferably a region of material accumulation or "core".

The second Sealing device "can to be a rigid sealing ring.

The second sealing means may be on the valve core or on the Recording device, also provided on another device be.

The second sealing device may be a slightly wavy shape, but also have a flat shape.

By the axial bias of the first sealing device of the valve core may be an approximation of the first sealing device to the mold the second sealing device take place.

A such adjustment may preferably produce a sealing effect.

These Sealing effect can in a check valve state be further amplified by the fluid pressure. The first sealing device can be strengthened be pressed against the second sealing device. Likewise the shape possibly deviating from the ideally flat shape second and / or the first sealing means by means of a acting on the elastic disc of the first sealing device distributed load to be adapted to their shape.

The first sealing device and the second sealing device can a necessary one ensure geometric tolerance compensation.

One Such tolerance compensation may have the ability to be angled and / or bowl-shaped bending the first sealing device under the influence of bias and / or fluid pressure act.

One Geometric tolerance compensation can also be done with an axial tolerance when generating the bias voltage or at an angle tolerance or - deviation between the symmetry axis of the seat topology of Receiving device and the symmetry axis of the valve insert act.

A Possible lateral tolerance between the two axes can thereby be balanced, that the first sealing device a Diameter overlap having the second sealing device. In this way can ensure a sealing effect within the overlapping area become.

A further tolerance compensation function of the arrangement can consist of small bumps, notches and / or roughness in the sealing tops the two sealing device to bridge, including the bias in connection with the effective contact surface can be so large that the first Sealing device locally deformed such that defects, such as bumps, notches, roughness and the like with the elastic Material filled up and thus creates a tight seal.

Between the first and the second sealing means can be a sufficient surface pressure at the annular to-touch or compression zone are constructed in use due to design.

in the In the simplest case, as shown in the attached figures, a plane or substantially planar shape of the first sealing device in the zone of sealing combined with a tapered Form of the second sealing device may be provided.

Vice versa may be the pointed element of such a suitable geometry pairing also a pointed ring-shaped Seal should be at the first sealing device, which on the in this case flat or slightly curved or conical hard second sealing device can rest under prestress.

The Spacing too shallow may be preferable to a high, for leveling required surface pressure to lead and all of them ensure the aforementioned tolerance compensation types.

The Sealing and tolerance compensation functions can not only be achieved with a flat Design of the sealing devices come about. she can be equally achievable if the sealing devices aware and / or by axial bias to a fuzzy or conical Form are deformed.

At least one of the involved sealing devices can therefore in the Form of a pointed circumferential walkway be executed. This way you can There is also a tolerance or insensitivity to the different conical and / or fuzzy shape in the state of compression or Seal result. This can also be held as a semi-axial mode of sealing be referred to as purely axial sealing.

there can the advantages of lateral tolerance compensation as opposed to a purely radial sealing in the full extent remain.

In a further preferred embodiment is the first sealing device by means of power transmission and / or path impress can be pressed onto the valve insert with the second sealing device or is compressed in use.

The term "compression" as used herein refers to a positive and / or positive fit physically connecting the first sealing device of the valve insert and the second sealing device of the receiving device.

The transferred Power can be an outside supplied or applied force. The path impression can be fed from outside or applied change of direction or shift.

In a further preferred embodiment the force on the valve core is a pressing force that passes through the installation of the valve device in a treatment device can be introduced.

In a further preferred embodiment is the way impress on the valve insert a displacement caused by the installation of the Valve device can be introduced into a treatment device.

The Valve device may be provided on an external functional device be. The pressing force and / or the embossed Verpressweg can for Example by pressing the external functional device with the treatment device to be initiated. Suitable embodiments and method for pressing an external functional device with a treatment device are, for example, in the applications 10 2009 012 633.3 (representative file FM19A24) entitled "Apparatus for connecting an external functional device to an assembly, Arrangement comprising such a device and method for connecting "and 10 2009 012 632.5 (representative file FM19A25) entitled "Sealing device for Sealing a volume of a medical treatment assembly against another volume as well as arrangement and method ", which by the present Applicant on March 10, 2009 filed with the DPMA. To their respective disclosures hereby fully incorporated by reference.

In a further preferred embodiment the pressing force and / or the Verpressweg are suitable Devices by a transmission element the treatment device transferable.

One such "transmission element" can functions the compression and / or (static) sealing of the fluid system and / or function of initiating forces and actuating movements.

The transmission element For example, it can be a rubber mat. It can be an immediate coupling partner the treatment device to the external functional device.

The transmission element can be spotty by applying control fluids or by coupling plungers deformed and deflected.

The Deformation or deflection of the transmission element can be transferred to an end ring area of the valve core become.

The transmission element can be a motion transmitter, For example, an axial movement transmitter, have. An axial one Drive transmitter For example, it can be centrally located above a valve core his and one on the transmission element applied force and / or a shift to the top of the Transfer valve insert.

The transmission element can over a docking area made of elastomeric material, for sealing and / or tolerance compensation functions between the Recording device and / or the external functional device and take over the treatment device to be able to. The counterforce to the compression force can be via a counterpart of the treatment device be received, which is the end face of the receiving device supported.

It may also be possible be, an end face area to provide the valve insert, the functions of the transmission element exercise the treatment device. For example, such a face area directly with a Pestle (movable or fixed). The face area can be the desired personnel and travel paths in the fluid-functional areas of the valve core hand off.

suitable Mechanisms are for example in the o. G. Registrations of the present Applicant described, to the relevant disclosure hereby full Reference is made.

In a further preferred embodiment the valve insert at least one guide means for introducing the Valve insert in the receiving device.

A Such "leadership device" can be a Guide rib a guide rail, a pulling and / or sliding mechanism and the like.

In a further preferred embodiment the valve core can have at least one bending ring area. The bending ring area can be elastic.

Of the Bendering area can - how Guide device - axial Mobility of the valve insert relative to the receiving device with simultaneous mediation of the geometric centering between the ensure both axes of symmetry.

There but it is similar as in the deformation of the first sealing device to a elastic deformation due to a required axial Force and / or displacement can act for the valve device give a preferential position, which can be taken automatically, when the outer pathway initiated by the treatment device and force discharges are eliminated.

These Preferential position can for the main functions of the valve device are of crucial importance be.

Of the Bending ring area can take tolerance picking or compensation functions exercise. It could be possible, the valve element systematically axially deeper into the receiving device install. So can advantageously mounting tolerances are hidden, because the valve insert is independent return to the preferred position can.

Of the Bendering region may have a Stirnringbereich. The end ring area the valve core can have an outer face area, an inner end ring area, an end stop and a deformation space, for example, an annular Deformation space, exhibit.

The outer Stirnringbereich can a correct desired position of the valve core in the receiving device convey.

Around a generous diameter tolerance and a generous lateral To ensure installation tolerance can the outer Stirnringbereich preferably be conical on the circumference. He can have a sufficient radial compressibility feature.

In can advantageously such an uncritical installation situation and next to it in the final assembly position achieved a highly accurate clearance radial and axial centering become.

In Connection with the end stop can the inner Stirnringbereich an (important) function of the tolerance compensation between the treatment device and the external functional device. The relatively smaller Resiliency of the material area between the end stop and the first sealing device can be used in conjunction with the relative ensure high axial compliance of the inner end ring area, that the axial bias between the treatment device and the external functional device can be selected so that the end stop on a lower end face the seat bushing of the receiving device is locked during the inner end ring area by deformation the axial installation tolerances can record. In this way, the correct relative position of the main functional areas of the valve insert to the sealing seat area the receiving device guaranteed be.

A axial material section or a material section between the outer and The inner end ring portion may be sufficiently elastic to different installation tolerances and crimping forces between the treatment device and the external functional device take. This can be beneficial without affecting the main function-relevant events of the actual valve insert area respectively.

The outer bending ring area the valve core can be used together with a suitable bending ring area the valve insert with a suitable design of the static sealing seat the receiving device (diameter selection and any additional Equipped with static circumferential sealing webs) optionally also assume radial and / or axial sealing functions. This is special advantageous if, for example, no further cover device between the valve device and the treatment device, such as a film element is provided.

Of the annular Deformation space, such as an annular space, can be between the first sealing device, for example a circumferential one Sealing lip, and a stem of the valve core are located.

By the annular Deformation space can flow a fluid when the first sealing device on no sealing surface rests.

Of the annular Deformation space can advantageously be a saving of axial installation space for allow the valve insert. About that In addition, the annular Deformation space additional passage areas for the Fluids provide and a low-pressure distribution of fluids from Flow channel up allow the entire ring area of the sealing seat. Thus, the entire potential opening cross-section the valve device can be used.

Of the Valve insert may further include a valve seat, such as a static valve seat, and a seating area, preferably an elastic Seating area.

Of the Valve insert may be in a cylindrical or substantially cylindrical Interior, in the form of a recess integral part of Injection molding hard part of an external functional device may be, be arranged.

Of the Valve insert may, for example, in a cylindrical or substantially cylindrical seat assembly of the receiving device from a lower Seat bushing and an upper seat bushing are kept. Such geometric constellation can in particular a variety of connection options to provide for the flow channels.

A Guide device, For example, in the form of a plurality of guide ribs, a slight oversize relative to the diameter of the lower seat portion of the receiving device and / or a star-shaped Shaping and / or have a spherical shape.

The stellate Shaping can be a correct centering of the valve core guarantee. It also allows free access of the fluids to the seat area ensure at any installation rotational positions of the valve insert.

The Valve device can therefore be free of Drehpositionier requirements be installed axially in the receiving device.

A thin wall thickness of guide ribs can make the valve insert relatively yielding against radial compression do. In this way, a large diameter tolerance for lower seat bushing be accomplished.

It may be one, preferably uniform, low Clamping or pressing force can be achieved, which in an advantageous Way for it can ensure that the valve insert in the context of making the external functional device does not fall out of its seating area can.

on the other hand The clamping force can be so small that it will be used later the valve device does not lead to a distortion of Axialkraftverhältnisse or to obstruct the intended displacement movements can.

advantageously, can the clamping force in a sterilization treatment and during the Storage time of the valve device or the external functional device to decrease by one more measure until their use.

A crowned shape of the guide ribs can fulfill at least two other functions. When assembling can the convex, pointed silhouette forms a generous lead in, allowing them by hand and / or machine installation procedures as well at big lateral tolerances can be installed safely in an advantageous manner can. Second, the bale shape may have a gimbal angular mobility between the symmetry axes of the receiving device and the valve core guarantee.

Advantageously, thus material stresses and / or unwanted changes in shape of the elastic sealing ring area given tolerances in the shapes of receiving device and valve insert are prevented, which could affect the sealing or opening capabilities of the valve device.

In a further preferred embodiment is the valve device on at least one upper side with a Cover provided.

The Covering device may be on top of the housing element glued to the receiving device, welded, soldered, riveted with this and like that.

The Covering device may be a film element. She can do one be resilient film.

films are inexpensive and mechanically yielding. With them can in a cheap way valve locations in a fluid system having one or more exposure sites for valve position movements be configured by the treatment device.

Instead of the slides can to initiate the required movements, in the two-component process injected or otherwise inserted elastomeric valve mats be used. Likewise is a combination of hard parts, foils and / or elastomeric bodies of the present invention.

The Cover means may constitute fluid channels, the valve core in an axial dimension or direction, the fluid system in connection with the permeability for axial Completing control movements on the valve insert to the outside fluid-tight and pressing forces for controlling or regulating the valve insert and for sealing the receiving device or the external functional device transmitted.

The Cover device may be the fluid channel system of the receiving device by compression with the static sealing web of the receiving device to lock or seal. Here - or for this purpose - can a static sealing bar, for example in the form of a linear dent be formed.

The Foil element can have sufficient elasticity have, for example by elastic material properties and / or by suitable bellows embossing. Because of the bellows imprints local predominantly only bending stresses can occur, with the bellows embossing, for example, in embodiments of the film element as a rolling diaphragm or rolling bellows, advantageously the ones stretched at shallow, deflection-stressed membranes of the prior art often occurring in the membrane plane tensile stresses prevented or at least noticeably reduced.

by virtue of the elastic properties of the cover device can - parallel or alternatively to the static sealing function - also the function of the mechanical Movement and / or power transmission ensured by the treatment device on the valve core be.

In a further preferred embodiment the valve insert is therefore by means of a transferred from a treatment device Force or displacement through the cover means switchable.

alternative can the cover device - ever according to use case - too completely eliminated. For example, the valve insert by welding or be sealed by pressing against the receiving device and thereby the functions of sealing and motion transmission take over to the treatment device with.

This can be done in an advantageous manner in a particularly simple manner, if both flow channels as closed channels accomplished are. Likewise, there may be use cases give, for example in the case of reduced claims to the foreign matter and / or Sterility of the fluid system in which the treatment device belonging transmission element the functions of the cover device with takes over.

The inventive task is further solved by a valve insert according to claim 18, which in a valve device as described above can be used.

Such a valve insert may form the core element of the valve device according to the invention. Its main function may be to create a flow channel depending on the function mode or Ven tilzustand by an axial lifting movement of the entire valve insert in the case of valve states (eg., Sterilization, open, closed) or by a deformation such as a bend under the influence of the fluid (eg kickback, control / rule) to open or closed close.

to solution the task of the invention Furthermore, an external functional device according to claim 19 proposed which at least one valve device according to the invention having.

A such external functional device can be used, for example, for extracorporeal Blood treatment can be used. For the external functional device It can be a disposable cassette, as in the by the present applicant entitled 'External functional device, Blood treatment device for receiving an external according to the invention Functional device, and method "filed with the DPMA patent applications as listed above has been described. On their entire content in this regard is hereby full Referenced.

There all discussed in connection with the valve device according to the invention or the following advantages undiminished on the valve core and / or the external functional device is transmitted, becomes Avoid repetition on the corresponding versions directed.

The present invention proposes Furthermore, various methods in which a valve device according to the invention can be used advantageously.

One inventive method relates to a method for controlling or regulating a fluid passage according to claim 21, which comprises using a valve device according to the invention.

Under The term "fluid passage" may include Fluid passage, a fluid flow, a fluid flow and the like understood become.

The "taxes or rules of "one Fluid passage closes, without limitation being, controlling or regulating a speed, a pressure, a flow rate, a flow direction, and the like the valve device according to the invention flowing through Fluids.

In a preferred embodiment The method further comprises applying a defined force and / or a defined displacement on an upper side of the valve core for switching the valve insert.

The targeted or "defined" force and / or the targeted or "defined" shift can - like outlined above - depending of the desired or required valve state of the valve core applied become.

The particularly according to the invention preferred actuation the valve device is a path-oriented. A force-oriented activity is alike of the present invention.

In a further preferred embodiment be the force and / or displacement by means of a transmission element applied to the top of the valve core.

In a further preferred embodiment are the force and / or the displacement by a cover device, For example, a film element, through to the valve core applied.

In a further preferred embodiment is the force of a pressing force, which by installing a valve device according to the invention or an external functional device, which is a valve device according to the invention has been introduced into a treatment device.

In a further preferred embodiment the displacement is achieved by installing a valve device according to the invention or an external functional device, which is a valve device according to the invention has been introduced into the treatment device.

Suitable treatment devices may be medical treatment devices, such as a blood treatment device, such as a dialysis machine, a hemodialysis machine, a hemofiltration or hemodiafiltration device, and the like. You can also Vorrich in laboratory technology, such as analytical devices, such as chromatography devices, scales, and the like, devices in the food and / or drug production, or the like.

alternative can the forces on the valve device also by the flow of fluids, which the valve device flow through, evoked forces be.

There with the method all achievable with the valve device according to the invention Benefits undiminished are achievable, to avoid repetition on the appropriate execution the same referenced.

to solution the task of the invention beats the present invention the preparation of a valve device according to the invention with a manufacturing method according to claim 27. The procedure includes positioning a valve core over a receptacle and inserting the valve core into the receiver with the help of a leadership facility.

The Positioning of the valve core can be controlled by machine or machine, for example, with the help of a robot. Suitable tax or control devices can be provided.

The Insertion of the valve insert into the receiving device can be carried out by the valve insert during of insertion at its top held by a suction cup to an insertion device becomes.

Of course you can any other suitable device for positioning and / or insertion the valve insert can be used, and the invention is not limited to the examples given herein.

Further may be an external functional device with a manufacturing method according to claim 28 are produced, which is the manufacture of a housing element of at least one thermoplastic or thermoset, the forming a receiving device in the housing element, the insertion of a valve core and the application of a cover device on at least a portion of an upper surface of the housing member includes.

The Production of the housing element can be done for example by injection molding.

The Ausgestalten the receiving device may during the manufacture of the housing element, for example done by means of molding or injection molding techniques. It can, however also after production of the housing part by working out the recording device, such as by milling, Grinding and the like, done.

From the invention is also included, one for receiving the receiving device suitable recess in the housing element to provide or preform and a separately prepared recording device insert or insert in a suitable manner in the recess. A separately manufactured receiving device can with the housing element or the hard part, the external functional device force and / or positive and / or cohesive be connected, for example glued, welded, entangled, be meshed and the like.

Of the Valve insert can from the open side of the external functional device used in the receiving device.

Then you can a Ankoppelabschnitt, z. B. in the form of a coupling plane, the external functional device with the cover device, for Example of a foil, welded become.

Of the Valve insert can be inside the external functional device under the film are such that it by an actuator on pushes the cover device, at different defined Wegstufen and / or force levels of Actors different and in particular predetermined deep into the Captive device hineindrückbar is. It can be Thus, different, defined, elastic deformation states of Valve insert result. these can different defined flow rates of the valve device flowing through Effecting fluids.

A further method according to the invention relates to the preparation of an external functional device for sterile use with a method according to claim 29, which is the production of an external Functional device, as described above, for example, and sterilizing the external functional device obtained with the manufacturing method.

The external functional device has a valve device according to the invention on whose valve insert in - especially specially provided - sterilization state located. The sterilization state can be a flow-through position be in which the first sealing means not on the second sealing device rests. So can in advantageous A bidirectional flow of the valve device according to the invention flowing through Fluids possible be. Such a position can be used to sterilize the external functional device be particularly suitable.

The Sterilizing the external functional device can by means of a Steam process, a vapor vacuum process of an ethylene oxide process or the like. It is expressly not exemplary on this limited sterilization process mentioned. A suitable sterilization process can depending on the intended use of the external functional device and accordingly the requirements for the sterility of the external functional device be determined on an individual basis.

To sterilization can the valve device in a further preferred embodiment the method according to the invention be transferred to a locking position.

The Locking position can be a position in which the valve device is only protected against the ingress of foreign substances, but no external force and / or Bias on the valve core of the valve device acts. Of the Valve insert may be clamped in the receiving device, which the self-adjustment of the initial gap dimension in an advantageous Do not obstruct the way.

In this position, the external functional device can be stored.

The Locking position is preferably identical to the position, which the valve insert automatically assumes during use during production. This position can be advantageous falling out of a cassette built-in valve insert when turning the cassette both at production as well as during sterilization, storage, during transport and / or during prevent a treatment.

The Locking position is preferably identical to the sterilization position (Steam sterilization position) and / or with the delivery position, to exclusively the closing a cover element or a pressing door of the treatment device.

The present invention proposes Furthermore, an external functional device according to the claim 31 for sterile use, which with the above-described Procedure was sterilized.

A Such external functional device can, for example, in a medical technology and / or laboratory techniques or for Manufacture of food and / or medicines used become. Examples of this shut down a use of external functional devices with a treatment device as described above with reference to the treatment devices themselves were described.

The external functional device may be a blood treatment cassette with blood-carrying channels for the extracorporeal blood treatment, wherein the valve device ( 100 ) and designed to introduce Substituate and / or one or more drugs into the blood-carrying channels.

The present invention proposes Furthermore, a treatment device according to the claim 32, which at least one inventive valve device and / or having an external functional device. Such a treatment device can for example be designed as a blood treatment device be.

There the valve device according to the invention an essential element of all other embodiments of the invention and embodiments, arise for all other aspects and Uses and uses the same undiminished All advantages that can be achieved with the valve device.

Fluid-carrying devices, such as external functional devices, generally have to be delivered in such a way that any spaces and surfaces wetted by the fluids in later use initially damage them material-free and sterile and remain hermetically sealed during use to the outside. This can usually be made possible by housing components pressed or welded together against one another with elastomer seals. Also films can take over the task of housing components and be made by pressing or welding fluid-tight against other housing components.

In Advantageously, the elastic valve core of the valve device according to the invention by suitable geometric design different valve functions (eg "sterilization", "open", "closed", "rules", "setback") in only represent an element.

Just in the position of a check valve function can the elastic valve core due to its geometric Design, for example, opposite the known biased to be assembled check valves an advantageous require less installation effort.

By the use of the valve device according to the invention can be installed spaces and driving devices for create the valve device space and cost, which the above features on new, safe, easy and / or cost-saving Kind of fulfill can.

Of the elastic valve insert can advantageously first in a component and with only a single space requirement, the functions combine several valve types. To use these types of valves no valve device of the external functional device must be physically changed or replaced or a plurality of valves are provided. It is sufficient rather, advantageously only the design or the control or control of the treatment device for operating the valve and to switch between different valve states accordingly to vary.

Out known in the art passively operating check valve elements are generally solid and biased into the disposable housing components built-in. They are for example under bias in retaining holes of hard case components clipped or clamped between two hard housing components (for example, the mushroom-shaped "umbrella valves " Company Minivalve International, Netherlands, http://www.minivalve.com).

at Sterilization treatments at elevated temperature and in general through storage these elastomer components lose part of their bias and so the desired Lose function. Furthermore, these can Elements the fluid flow in both directions up to a certain response differential pressure in one direction and against the maximum design differential pressure prevent the fluid system in the other direction. In many cases therefore a sterilization with sterilization processes in which the flow the fluid spaces is necessary, impossible or only limited possible be (for example, steam-vacuum sterilization or ethylene oxide sterilization). A vacuum steam sterilization of external functional devices, in particular disposable parts made of films and hard parts, with closable by the films semi-open fluid channels often too destructive Deep drawing effects lead. So can for example, the films heated to their plastic limit when changing from vacuum to overpressure in the half-open fluid channels to be pulled. This may be the case in particular if the check valves so have to be arranged that they are the only fluid access of the channels close, which are arranged on the inside of the film.

Different as fixed and preloaded non-return valve devices From the prior art, the valve device according to the invention during a Sterilization a fluid flow in an advantageous manner allow in both directions. This can be particularly beneficial when sterilization procedures are used, which is a flow of fluid spaces require.

Further It may be possible in an advantageous manner be sterilized in a simpler and / or more reliable way. It can particularly inexpensive elastic materials used for the valve insert which were previously due to lack of resistance at given sterilization conditions due to their bias, or only at the expense of sterilization losses were usable.

In Advantageously, it may be possible be that suitable elastic materials no longer special resistant to creep deformation Elastomers such as technically expensive to manufacture and expensive silicone must include.

Prior art preloaded check valves may prevent the fluid flow in the opposite direction during treatment, often resulting in certain treatment programs and initiation All integrity test programs of the disposable part system are not feasible.

With the valve device according to the invention can the fluid passage through the machine control in an advantageous Way open any and closed without this one in parallel or in series switched to provide additional fluid control element in addition. The Valve device according to the invention can therefore contribute advantageously to space and / or dead space to reduce.

The Valve device according to the invention can advantageously for the first time a flow-open and mechanical enable stress-free production, treatment and storage. It is sufficient if the valve device according to the invention - different as conventional Valve devices - first by their incorporation into the treatment device in a prestressed Valve state is brought.

The ability the valve device, in addition to the check valve function also can be opened and closed by machine control advantageously an increase in procedural possibilities in fluidic arrangements.

By Use of the valve device according to the invention as a multi-stage or continuous passive acting or actively changeable Pressure or flow control valve can be in an advantageous manner Costs, design effort and space can be saved.

The Valve device according to the invention is a multi-functional valve device, which is in an advantageous Way for both direct use in reusable treatment devices as well as in uniquely usable hermetically shielded disposable arrangements in laboratory and medical applications are suitable can.

The inventive external Functional device can accommodate many different functions. It can be inexpensive be configured for receiving the valve core. Special design measures are not required for this.

There the valve device according to the invention while their manufacture and storage in a sterilization valve state, d. H. a state without bias, can, just in sterilization processes according to the positive pressure-vacuum exchange method advantageously critical areas of such a valve device having flowed through effective external functional device. Such critical areas could at the usual preloaded and thus closed built-in check valves due to insufficient sterilizable blind hole arrangements either be excluded from the access of the treatment fluids or only ineffective flushed become.

There the valve device according to the invention is present during their sterilization and storage without bias, can the mechanical dimensions and elastic properties of the valve core in an advantageous manner until the time of use completely and in full quality remain.

The stress-free storage of the valve insert can also advantageously the use of a particularly inexpensive thermoplastic Elastomers instead of the usual required conventional Elastomers (in the medical field usually silicone rubber) allow.

Further can the use of thermoplastic elastomers in an advantageous manner new constructive possibilities allow. A thermoplastic-elastomeric mixture for the valve insert, which elastomers as well as the usable for the housing elements thermoplastics may be more suitable, more advantageous and / or improved Way with the housing elements be connectable.

So For example, it may be possible in an advantageous manner, welds between the elastic valve elements and the thermoplastic hard chassis components for mounting and sealing the valve element against the housing.

By installing the external functional device in the treatment device not only the correct position, support and fluid tightness of the external functional device can be produced. In contrast to conventional arrangements with preloaded check valves can in the valve device according to the invention advantageously to further, z. B. parallel-connected fluid channels with additional machine-operated valves to open the fluid assembly bidirectionally for the flow to be dispensed with. Thus, advantageously not only installation space and manufacturing costs in the machine or Spared treatment device and the external functional device, but also unwanted flow dead spaces are avoided.

The Ability, Tolerances when installing and coupling the external functional device into the treatment device, can in an advantageous Way functional impairments avoid the individual components. In addition, it contributes to low production costs.

Besides can advantageously check the Valve functions of the valve device according to the invention via machine-controlled Routines before starting the actual treatment sessions simple and easy way to be possible. Such a review can For example, be a pressure-holding test, which is simple and easy feasible is, by the valve device according to the invention open is a test fluid in a compressible space opposite to usual check valves possible direction depressed is and the valve device according to the invention then in check valve position is brought.

There the axial, elastic seating area of the valve insert and / or designed the elastic sealing ring with defined compliance can be It may be possible in an advantageous manner be a fixed or adjustable if necessary Pressure regulator or volume flow controller low cost to realize.

The geometric freedom of the axial elastic seat area and / or the elastic sealing ring with regard to their rigidity can advantageously allow the progressivity of the elastic spring rate Sealing devices in the pressing situation of the valve device in an advantageous Set way within wide limits.

The Actuation of the valve can, in a preferred embodiment preceded by being away-oriented, the fact that with the given deformations of course also forces such as B. restoring forces and Bias associated with, is of little or no importance. The latter are u. a. therefore negligible as they are constructive can be very small. It is rather the defined Weginprägungen, which are significant advantages across from the alternative according to the invention also possible default of forces Offer. So is the exact compliance of small amounts forces due to unavoidable force tolerances and other imponderables much more complex and unreliable as keeping track impressions and shifts. A large Advantage of the valve device according to the invention is that the path changes precise in a simple way can be complied with. It can even total tolerances (eg concerning the valve body) are reliably compensated become.

A elastic construction of the valve core can be advantageous too high Tolerance insensitivity to Wegeinprägungstoleranzen to lead.

In In an advantageous manner, this can in particular be the execution of Valve device as fixed (by installation) volume flow constant control valve allow. The valve device can thus advantageously be executed as a simple and passive-acting arrangement, the dependent From the flow rate can change the resistance to passage, resulting in a regulation of the volume flow according to the principle of the proportional control can lead.

Where is always referred to in the present invention of "fluids" includes the present invention always when the particular case for the expert Recognizable also to a single fluid or mixtures of fluids can apply, alternatively exactly one fluid or a mixture. Also the reverse case is encompassed by the present invention.

there In the context of the present disclosure, it holds that the Expressions "may have", "may be" and the like synonymous with the here and elsewhere also used Expressions " preferably "," is preferred "and the like are.

in the The following will be the valve device according to the invention based on preferred embodiments thereof described with reference to the drawing. In the figures of Drawing, like reference characters designate like or identical Elements. The following applies:

1 shows an exploded view of components of a valve device according to the present invention;

2 shows a schematically simplified side view of a valve core of a valve device according to the present invention;

3 shows schematically a side view of a valve device according to the present invention in section in a valve state of a sterilization or storage position;

4 shows schematically a side view of a valve device according to the present invention in section in a valve state of a permanently open valve position;

5 schematically shows a side view of a valve device according to the present invention in section in a valve state of a closed check valve;

6 schematically shows a side view of a valve device according to the present invention in section in a valve state of an open check valve;

7 schematically shows a side view of a valve device according to the present invention in section in a valve state as a permanently closed valve or as a control valve;

8th shows a side view of a provided at its front with a cover device according to the invention external functional device according to a preferred embodiment;

9 shows the external functional device of 8th with unfolded cover device; and

10 shows the external functional device 9 and 10 from her back.

The valve device 100 indicates, as in the exploded view of 1 shown a valve core 1 on which in a receiving device 3 is used. The valve insert 1 is at its top with a cover device, such as a film element 5 , covered by a static seal 7 having.

The sealing process 7 can be designed according to the invention, for example in the form of a sealing ring or a sealing edge, a dent or the like.

Above the foil element 5 is a transmission element 9 arranged, which is a motion transformer 11 for transmitting movements or forces in the axial direction of the valve core (in 1 a "top to bottom" direction) or vice versa.

The transmission element 9 can be arranged on the machine side, ie part of an in 1 Not shown treatment device, such as a treatment device for treating blood.

The recording device 3 is in a housing element 13 intended. The housing element 13 can, as for example in the 1 shown to be part of an external functional device (not shown).

The housing element 13 can be made of a stiff or relatively stiff material, such as a thermoplastic.

The recording device 3 has a second sealing device, for example in the form of a rigid sealing ring 15 as well as an upper seat bush 17 , a static sealing ring 19 and a lower seat bush 21 on. The lower seat bush 21 has a rigid forehead 23 on.

The rigid sealing ring 15 is in 1 exemplary wavy, ie slightly curved, designed.

The recording device 3 also has a partially semi-open flow channel 25 for the the valve device 100 flowing fluids, such as blood and / or substituate and / or sterilizing liquid on. The flow channel 25 has flow channel sections 27 and 29 on. In 1 is, as indicated by the arrows, the flow channel section 27 as an inflow channel and the flow channel section 29 shown as outflow channel. The valve device 100 Of course, it can also be flowed through in another, in particular in the opposite direction.

The valve insert 1 can the flow channel 25 depending on the function mode open or close, the valve core 1 according occupies one of the valve states described above and also in the following with reference to the figures.

2 shows a schematic side view of a partially cut valve insert shown 1 a valve device according to the invention 100 ,

The valve insert 1 has a first sealing device, for example in the form of an elastic sealing ring 31 , a bending-ring area 33 , And a guide device, for example in the form of guide ribs 45 , on. Furthermore, a static valve seat 35 , an elastic seating area in the form of an elastic seating area 37 , an outer end ring area 39 , an inner front ring area 41 and a frontal stop 43 shown.

The elastic sealing ring 31 is at its bottom (ie in the representation of 2 below), ie flat, designed.

By applying an axial displacement and / or an axial force, in particular pressing force on the inner end ring area 41 can a -. B. axial - compression zone 47 of the valve insert 1 deform elastically, z. B. squeeze. 2 shows a deformation space 49 , its shape and volume depending on the valve state of the valve device 100 are variable.

The central area mentioned above is in exemplary form in 3 to recognize; he wears the reference number there 44 , As in 2 can be seen, the material accumulation of the central area 44 z. B. by the convergence of guide ribs 45 in an axis of symmetry of the valve core 1 arise.

The 3 to 7 show different, exemplarily selected valve states of the valve device 100 by applying a displacement and / or a force, such as a pressing force from a treatment device or a force of a fluid, to the valve core 1 are reachable. The valve insert 1 is switchable by applying or canceling the force between the valve states.

3 shows schematically simplified a section of the valve device 100 in a valve state, hereinafter referred to as a sterilization or storage position.

The valve insert 1 is in the receiving device 3 inserted. The valve insert 1 lies with his guide ribs 45 on the rigid forehead 23 the lower seat bush 21 the receiving device 3 on. The valve insert 1 is with the foil element 5 covered.

When designing the bending ring area 33 of the valve insert 1 is the traction between the guide ribs 45 (see. 2 ) and the inner wall of the lower seat bushing 21 the receiving device 3 preferably only so large that falling out of the valve core 1 advantageous because of its own weight just safe can be prevented.

The jump ring area 33 is preferably designed so that a temporary, for example montagebedingte, axial displacement of the end stop 43 of the valve insert 1 down to the bottom of the lower seat 21 by the restoring force of the bending ring area 33 Advantageously completely reversed. The restoring forces of the bending ring area 33 preferably overcome the frictional forces between the guide ribs 45 and the inner walls of the lower seat bushing 21 or guide bush of the receiving device 3 , In this way, a particularly simple installation can be ensured in an advantageous manner.

In the in 3 shown sterilization position has no external force on the valve core 1 , The valve insert 1 is thus essentially exposed to no bias and / or material stress. All main functional areas of the valve insert 1 are neither with the recording device 3 still with the housing element 13 (not shown here) compressed. They are free of relevant material tensions.

As well as the elastic seating area 37 in 3 no force or displacement acts, takes the deformation space 49 of the valve insert 1 a maximum volume.

The valve device 100 is located in one of the valve device 100 flowing fluid open state. The fluids may be the valve device 100 Bidirectional flow as on hand of in 3 shown double arrows can be seen.

The fluids flow through the valve device 100 through a gap 51 which extends between the elastic sealing ring 31 of the valve insert 1 and the rigid sealing ring 15 the receiving device 3 located.

Such a condition is particularly suitable for sterilizing the valve device 100 or for sterilizing one with a valve device 100 connected external functional device.

Since the individual components in such a valve state are free of stress - both to each other and in itself - are arranged, this valve state is also preferred for long-term storage of the valve device 100 or an external functional device with such a valve device 100 , A loss of tension and associated damage to the affected components do not occur due to lack of tension.

Due to the open sterilization position of the valve device 100 For example, it may now be possible to perform all sterilization or other pretreatments which involve the free bidirectional passage of sterilization or treatment fluids, such as blood and / or substituate fluid, through the flow channel 25 require.

4 schematically shows a simplified side view of the valve device 100 out 3 in a permanently open valve position as a valve state. In contrast to the representation of 3 is the valve device 100 in 4 arranged in a treatment device. This can be seen from the fact that above the film element 5 a transmission element 9 , For example, a pressure actuator of a treatment device is arranged.

The valve insert 1 is by means of the guide ribs 45 and over the outer end ring area 39 between the receiving device 3 and the transmission element 9 held.

The transmission element 9 can be designed so that the valve core 1 in the permanently open valve position is bidirectionally flowed through. The valve device 100 is thus machine-related or controlled in the open position.

The transmission element 9 lies on the foil element 5 such on that a conclusion between foil element 5 and outer end ring area 39 achieved, unlike in the

3 shown position in which a space between the film element 5 and outer end ring area 39 is kept open for the purpose of sterilization.

5 and 6 show schematically simplified side views of the valve device 100 of the 3 and 4 in a valve state of a closed check valve ( 5 ) or in a valve state of an open check valve ( 6 ).

In 5 is the Einbauverpressung the valve core 1 by shortening a path length (in the axial direction, that is in "from top to bottom" direction in FIG 5 ) between the receiving device 3 and the transmission element 9 increased and then kept constant. This can be done in passive machine arrangements without active valve functions solely by inserting the external functional device in the machine. In active machine arrangements with additional open-close functions of the valve devices 100 This can be done by a corresponding control of the transmission element 9 respectively.

5 shows the biased closed valve state of the valve device 100 when an applied fluid against the passage direction of the rigid sealing ring 15 is present, or when the fluid is present in the forward direction, the pressure difference between the inflow and outflow side but is still smaller than the set minimum response pressure of the check valve.

In a contact / grout area 53 are the elastic sealing ring 31 and the rigid seal 15 on each other or are pressed against each other.

6 shows the valve state during the flow through the valve device 100 in the forward direction. Especially in this valve state, the previously described tolerance compensation function in axial Direction between the inner Stirnringbereich 41 and the front stop 43 take place and ensures constant functional properties. This is the end stop 43 of the valve insert 1 in the check valve position already at the stop on the rigid forehead 23 the lower seat bush 21 ,

Between the elastic sealing ring 31 and the rigid sealing ring 15 there remains a gap 51 ,

7 schematically shows a simplified side view of a valve device 100 in a valve state as a permanently closed valve or as a control valve. Such a control valve can act as a pressure or flow control valve.

In this valve state, the transmission element increases 9 the compression in the axial direction (meaning a direction which extends vertically from top to bottom in the figure) by a further piece of axial displacement so far until the outer end ring area 39 in mechanical compression with the elastic sealing ring 31 in the axial direction.

In this way, the compression between the elastic sealing ring 31 and the rigid sealing ring 15 increased so far that the valve device 100 Bidirectional is completed against the design pressure difference.

In the in 7 shown valve state, the valve device according to the invention 100 act as a pressure or flow control valve.

When the axially elastic seating area 37 of the valve insert 1 or the elastic contact ring associated with the contact partner 31 designed in a defined manner yielding, such as by providing him or her with an additional groove or with resilient thin ring lands or nubs, which in the above-mentioned further axial deflection of the valve core 1 a desired contact between the axial elastic seating area 37 and the elastic sealing ring 31 As a result, it may in this valve state to a defined higher bias of the valve device 100 come.

Such a higher bias can be achieved either in two discrete steps (gap 51 between the axial elastic seating area 37 and elastic sealing ring 31 ) before axial actuation and contact after axial actuation or in a continuous manner (initial contact between said partners) away depending on the axial displacement of the transmission element 9 respectively.

8th shows a side view of an external functional device, which at the surface, on the in 8th is provided with a cover device is provided.

The external functional device is exemplified here as a blood treatment cassette 1000 designed with chamber, channels, valves and the like. The blood treatment cassette 1000 of the 8th is at its front with a cover device, here, for example, as already introduced above film 5 ,

The blood treatment cassette 1000 at least with the in 8th shown front to a blood treatment device (in 1 not shown).

The blood treatment cassette 1000 has an arterial heparin delivery site 63 on. It should be noted that the heparin addition point 63 also for the addition of pharmacological agents other than heparin, which are preferably only 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 blood treatment cassette 1000 has a check valve 65 the arterial heparin delivery site 63 on. The check valve 65 is an example of application of the valve device of the present application according to the invention.

The blood treatment cassette 1000 also has a check valve 69 for a venous heparin delivery site 67 on.

Via actuation of a check valve 71 As a further embodiment of the valve device according to the invention substituate can be in a substituate line 73 be introduced.

9 shows the blood treatment cassette 1000 of the 8th , wherein the film on the left edge of the blood treatment cassette 1000 as well cut out above and below and to the right unfolded is recognizable.

9 shows the elements to be recognized in more detail after cutting the film inside the blood treatment cassette 1000 ,

To avoid repetition, reference is made to the above in the description of the 8th referenced embodiments of the individual elements referenced.

10 shows the blood treatment cassette 1000 from her back. Is the blood treatment cassette 1000 Coupled to the blood treatment device, a viewer when opening a door of the blood treatment device for removing the blood treatment cassette 1000 look at this back.

For more details on the blood treatment cassette 1000 Reference is made to the detailed description in the above-mentioned, the above application. LIST OF REFERENCE NUMBERS reference numeral description 100 valve device 1000 Blood treatment cassette 1 valve core 3 recording device 5 film element 7 static seal 9 transmission element 11 axial movement transmitter 13 housing element 15 rigid sealing ring 17 upper seat bush 19 static sealing ring 21 lower seat bush 23 rigid forehead of the lower seat bush 25 semi-open flow channel 27 Flow channel section 29 Flow channel section 27 and 29 flow channel 31 elastic sealing ring 33 Bending ring region 35 static valve seat 37 elastic seating area 39 outer end ring area 41 inner end ring area 43 end stop 44 central area 45 guide ribs 47 compression zone 49 deformation space 51 gap 53 To-touch / compression region 63 arterial heparin delivery site 65 Check valve of the arterial heparin addition site 67 venous heparin delivery site 69 Check valve of the venous addition point 71 Check valve for substituate line 73 substituate

Claims (33)

Valve device ( 100 ) with - at least one in at least a portion thereof elastic valve insert ( 1 ) - at least one receiving device ( 3 ) for the valve insert ( 1 ) characterized in that the valve core ( 1 ) is designed such that it is switchable due to its elasticity in Weginprägung and / or force application between at least three different valve states. Valve device ( 100 ) according to claim 1, wherein a valve state is an opened functional state of the valve. Valve device ( 100 ) according to claim 1 or 2, wherein a valve state is a sterilization state. Valve device ( 100 ) according to one of the preceding claims, wherein a valve state is a check valve state. Valve device ( 100 ) according to one of the preceding claims, wherein a valve state is a control or regulating valve state. Valve device ( 100 ) according to one of the preceding claims, wherein a valve state is a closed valve state. Valve device ( 100 ) according to one of the preceding claims, wherein the valve core ( 1 ) comprises an elastomeric material at least in one section. Valve device ( 100 ) according to one of the preceding claims, wherein the valve core ( 1 ) has impressions at least in one section. Valve device ( 100 ) according to one of the preceding claims, wherein the valve core ( 1 ) has at least one first sealing device, which is provided and configured in at least a portion with at least a portion of a second sealing device of the receiving device ( 3 ) to be positively and / or non-positively compressible. Valve device ( 100 ) according to claim 9, wherein the first sealing device by way impressing and / or force transmission to the valve core ( 1 ) is compressible with the second sealing device. Valve device ( 100 ) according to claim 9 or 10, wherein the force on the valve core ( 1 ) is a pressing force by installing the valve device ( 100 ) can be introduced into the treatment device. Valve device ( 100 ) according to claim 9 or 10, wherein the path impression on the valve core ( 1 ) is a displacement caused by installation of the valve device ( 100 ) can be introduced into a treatment device. Valve device ( 100 ) according to claim 11 or 12, wherein the pressing force or the displacement by a transmission element ( 9 ) of the treatment device is transferable. Valve device ( 100 ) according to one of the preceding claims, wherein the valve core ( 1 ) at least one guide device for inserting the valve core ( 1 ) in the receiving device ( 3 ) having. Valve device ( 100 ) according to one of the preceding claims, wherein the valve core ( 1 ) at least one (elastic) bending ring region ( 33 ) having. Valve device ( 100 ) according to one of the preceding claims, wherein the valve device ( 100 ) is provided on at least one upper side with a cover device. Valve device ( 100 ) according to one of the preceding claims, wherein the valve core ( 1 ) is switchable by means of a force transmitted by a treatment device and / or Weginprägung through the cover means therethrough. Valve insert ( 1 ) for use in a valve device ( 100 ) according to one of claims 1 to 17. External functional device which comprises at least one valve device ( 100 ) according to one of the Proverbs 1 to 17 has. External functional device according to claim 19, designed as a blood treatment cassette with blood-carrying channels for extracorporeal blood treatment, wherein by means of the valve device ( 100 Substituate and / or one or more drugs in the blood-carrying channels can be introduced. Method for controlling a fluid passage, comprising the step of: - using a valve device ( 100 ) according to one of claims 1 to 17. The method of claim 21, further comprising the step of: applying a defined force and / or a defined path impact on an upper side of the valve core ( 1 ) for switching the valve core. A method according to claim 22, wherein the force and / or the path impact by means of a transmission element ( 9 ) on the top of the valve core ( 1 ) is applied. A method according to claim 22 or 23, wherein the force and / or the path impact by a cover means on the valve core ( 1 ) is applied. Method according to one of claims 22 to 24, wherein the force is a pressing force or the Weginprägung is a shift and the force and / or the Weginprägung by installing a valve device ( 100 ) according to one of claims 1 to 17 or an external functional device, which has a valve device according to one of claims 1 to 17, is introduced into a treatment device. Method according to one of claims 22 to 24, wherein the force and / or the displacement by the flow of the valve device ( 100 ) flowing through fluids caused force and / or displacement. Method for producing a valve device ( 100 ) according to one of claims 1 to 17, comprising the steps of: - positioning a valve insert ( 1 ) over a receiving device ( 3 ); and - inserting the valve insert ( 1 ) in the receiving device ( 3 ) with the help of a management facility. Method for producing an external functional device comprising the steps of: - producing a housing element ( 13 ) of at least one thermoset or thermoplastic, - forming a receiving device ( 3 ) in the housing element ( 13 ), - inserting a valve core ( 1 ) according to claim 18 and - applying a cover device to at least a portion of an upper side of the housing element ( 13 ). Method for preparing an external functional device for sterile use, with the steps: - Produce an external functional device according to the method of claim 28; and - Sterilize the external functional device obtained by the method, wherein the valve device is in a sterilization state located. The method of claim 29, further comprising the step of: - transferring the valve device ( 100 ) in a locking position. External functional device for sterile use, which with a method according to claim 29 or 30 was sterilized. Treatment device, which at least one valve device according to one the claims 1 to 17 and / or an external functional device according to a the claims 19, 20 or 31. A treatment device according to claim 32, which is designed as a blood treatment device.

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