CHECK VALVE ASSEMBLY, MEDICAL FUNCTIONAL DEVICE AND A BLOOD TREATMENT APPARATUS

Abstract

The invention relates to a check valve assembly (100) having an inlet (205) and an outlet for medical fluids, comprising a valve body (101), wherein the check valve assembly (100) in an initial state allows a flow of a working fluid and/or a sterilization fluid through the check valve assembly (100) in both directions of flow, that is from the inlet (205) to the outlet and vice versa, and wherein the check valve assembly (100) in an operating state allows only one direction of flow of the working fluid, wherein the check valve assembly (100) comprises a pin-pin-reception connection, which is embodied so that the check valve assembly (100) can be transferred from the initial state into the operating state by applying force on the pin-pin-reception connection and/or by an impression of path on the pin-pin-reception connection.

Claims

1. A check valve assembly (100) having an inlet (205) and an outlet for medical fluids, with a valve body (101), wherein the check valve assembly (100) in an initial state allows a working fluid and/or a sterilization fluid to flow through the check valve assembly (100) in both flow directions, that is, from the inlet (205) to the outlet, and vice versa, and wherein the check valve assembly (100) in an operating state allows only one direction of flow of the working fluid, wherein the check valve assembly (100) comprises a pin-pin-reception connection which is embodied such that the check valve assembly (100) can be transferred form the initial state into the operating state by applying force to the pin-pin-reception connection and/or by an impression of path on the pin-pin-reception connection.

2. The check valve assembly (100) according to claim 1, wherein in the initial state the check valve assembly (100) comprises a bypass (107) for the flow through of the sterilization fluid.

3. The check valve assembly (100) according to claim 2, wherein the pin-reception (103) of the pin-pin-reception connection is the bypass (107) or at least partially encompasses or forms the bypass (107).

4. The check valve assembly (100) according to claim 2 or 3, wherein the pin (105) of the pin-pin-reception connection is of hollow interior and at least partially encompasses or forms the bypass (107).

5. The check valve assembly (100) according to anyone of claims 2 to 4, wherein the pin (105) of the pin-pin-reception connection seals on its outer periphery, at least partially, against the valve body (101).

6. The check valve assembly (100) according to anyone of the preceding claims, wherein the valve body (101) comprises both the pin (105) and the pin-reception (103).

7. The check valve assembly (100) according to anyone of the preceding claims, wherein the check valve assembly (100) in the operating state comprises a friction-closure connection of the pin (105) with at least a section of the pin-reception (103).

8. The check valve assembly (100) according to anyone of the preceding claims, wherein the valve body (101) comprises a first section with pin-reception (103) for the pin and a second section for sealing a flow path of the working fluid in the operating state, wherein the second section is more flexibly, or softer than the first section.

9. The check valve assembly (100) according to anyone of the preceding claims, wherein the valve body (101) or a valve insert is made of resin or comprises resin.

10. The check valve assembly (100) according to anyone of the preceding claims, wherein the valve body (101) or the valve insert is produced as a 2-component-injection-molded part.

11. The check valve assembly (100) according to anyone of the preceding claims, wherein the pin-pin-reception connection is embodied so as to hold the check valve assembly (100) in the operating state by means of frictional and/or form closure.

12. A Medical functional device with at least one check valve assembly (100) according to anyone of the preceding claims.

13. The medical functional device according to claim 12, wherein the check valve assembly (100) comprises a valve seat (207) and optionally a film (203) for sealing at least of the valve seat (207), the working fluid and the sterilization fluid against the environment.

14. The medical functional device according to anyone of claims 12 to 13, wherein the pin (105) is connected to the valve seat (207) or is part thereof, and wherein the pin-reception (103) relative to the pin (105) is movable and is part of the valve body (101).

15. The medical functional device according to anyone of claims 12 to 14 having at least two check valve assemblies (100) according to anyone of claims 1 to 11, which are arranged so as to be transferable from the initial state to the operating state at the same time.

16. A blood treatment apparatus (300), preferably a dialysis apparatus, with a receiving section (301) for receiving a medical functional device (200) according to anyone of claims 12 to 14, wherein the blood treatment apparatus (300) comprises a movable limiting device (303) for limiting the receiving section (301), wherein the limiting device (303) is embodied so as to transfer by means of moving one or all check valve assemblies (100), the received medical functional device (200) in the receiving section (301) from the initial state to the operating state.

Description

[0053] FIG. 1a shows a section of check valve assembly according to a first embodiment of the present invention in its initial state;

[0054] FIG. 1b shows the section of the check valve assembly of FIG. 1a according to the present invention in an operating state;

[0055] FIG. 2a shows the section of the check valve assembly according to a second embodiment of the present invention in an exploded view;

[0056] FIG. 2b shows the section of the check valve assembly of FIG. 2a in an initial state;

[0057] FIG. 2c shows the section of the check valve assembly of FIGS. 2a and 2b in an operating state and

[0058] FIG. 3 shows in a schematically highly simplified manner, a top view on a blood treatment apparatus 300 according to the present invention

[0059] FIG. 1a shows a check valve assembly in a first embodiment as part of a medical functional device 200 according to the present invention, here in a shape of a blood cassette by way of example.

[0060] The blood cassette 200 comprises a cassette body 201, which is embodied as a hard part, and a film 203. It further comprises an inlet 205 for a working fluid (for example blood) as well as an outlet which is not shown because it is at a right angel to the drawing plane. The blood cassette 200 comprises a valve seat 207 in the area of its cassette body 201.

[0061] Fixations 209 keep the film 203 fixed to the cassette body 201. The fixation could be gluing connection, pressed connection, welded connection or the like.

[0062] The check valve assembly 100 is in the valve seat 207. This comprises a valve body 101 with a pin-reception 103 and a pin 105 inserted in the pin-reception 103. The pin-reception 103 and the pin 105 form a pin-reception-pin connection in which the pin 105 can relatively move to the pin-reception 103 and is thereby guided by it.

[0063] The valve body 101 comprises furthermore a circumferentially closed sealing lip 106 which presses against a stop face 206 of the valve body 207 and causes the check valve effect of the check valve assembly 100 or hereto contributes to it.

[0064] In addition, the check valve assembly 100 or its valve body 101 comprises a circumferential switch plate 108 which is spaced here in the shown initial state from a stop face 208 for the switch plate 108. The switch plate 108 is connected to the pin 105 and serves for simple and tilt-safe application of force F on the pin 105.

[0065] The check valve assembly 100 of FIGS. 1a and 1b is in FIG. 1a in the already closed state in which it, like a check valve, does not allow the sterilization agent to flow unlimitedly through its contained flow paths or the flow paths that are formed by it. However, it is not yet in a locked state. A fluid, for instance a sterilization gas, flowing through the inlet 205 in direction of the valve body 101 can only or basically only enter through a bypass 107 in all sterilization relevant areas of the already closed check valve assembly 100 and spread throughout the valve body 101.

[0066] The fluid can continue to spread along an inlet opening 109 which is preferably orthogonal to the pin-reception 103. Alternatively or in addition, the fluid may, in certain exemplary embodiments according to the present invention, enter the long-stretched interior of the optionally hollow pin 105, and re-exit therefrom through non-illustrated opening in the side and/or front area of the pin 105. Alternatively or in addition, the bypass 107 is formed by the space between the distance area 208 and the switch plate 108.

[0067] FIG. 1b shows the check valve assembly 100 of FIG. 1a according to the present invention in an operating state in which the check valve assembly 100 acts as a check valve. The operating state, also referred to herein as the operating position is the active state, also referred to herein as a treatment state.

[0068] By means of a force F effecting in the direction of the arrow, which is preferably being applied by means of a section, such as a door 303, of the treatment apparatus 300 shown only in FIG. 3, pressure was or is applied on the switch plate 108 and the pin 105 in a way that the pin 105 is pressed further into the valve body 101. This can lead to at least temporary dent in the film 203.

[0069] Through the application of the force F, the pin 105 was shifted so far along the pin-reception 103 towards the inside of the cassette body 200 so that the bypass 107 is now closed. A (working) fluid, for example blood, a medication or substituate, can flow through the check valve assembly 100 in the operating state shown here, in which the check valve is activated, only under correspondingly high pressure and only in the direction from the inlet 205 to the outlet, but not reversed.

[0070] The distance or space between the distance area 208 and switch plate 108 no longer exists. Both elements touch each other, which is a sign that the pin 105 was shifted sufficiently deep into the pin-reception 103.

[0071] As in the initial state of FIG. 1a the pin 103 is situated essentially in that section of the pin-reception 103, which, with respect to the illustration of FIG. 1b, lies below the inlet opening 109. Its end section 105a, in the operating state, is stuck in an end section 103a of the pin-reception which lies above the inlet opening 109 or can be recognized there.

[0072] The pin 103 still maintains the check valve position shown in FIG. 1b, even if the force F indicated or implied by an arrow subsides or is released. One can here speak of a locking of the pin 105 into the end section 103a of the pin-reception. A locking in the sense of the present invention exists or is available if the check valve assembly 100 upon release of the activation force F remains in the activated state without an effect or impact from outside of the medical functional device 200. It is thereby irrelevant whether the locking was achieved by form closure and/or by friction closure. In the shown example, this is effected solely by a friction closure between pin-reception 103 and pin 105. Therewith, the friction closure can be present in areas below the inlet opening 109. The friction closure may alternatively or in addition be present in the end section 103a. In certain embodiments according to the present invention, friction closure exists both below and above the inlet opening 109. The friction closure being present below the inlet opening 109 can be determined or pre-set such that the pin 105, already during the setting up and with a film 200 that is not yet attached, cannot fall out of the pin-reception 103 anymore. This friction does not have to be set higher, and the lower it is the easier it is to move the pin 105 against the existing friction closure from the initial state to the operating state. In the operating state, the friction closure present in the end area 103a and 105a of pin-reception and pin, can compared hereto be higher. It is anyhow so high that the friction closure is as a whole sufficient in the operating state to ensure a lock of the pin 105, while in the operating position, also beyond termination of treatment and also in case of release of the force F, in order to keep the check valve assembly 100 in the activated locked state.

[0073] Alternatively or in addition to the herein described friction closure, by means of which the pin 105, after it has been moved by means of the force F, is stuck in the position shown in FIG. 1b in the pin-reception 103, which maintains the operating state; this position can be produced and maintained by a form closure. In this manner a snap-action connection, a barb system or the like may ensure that the pin 105 remains in its (operating) position.

[0074] As shown in FIGS. 1a and 1b, the inlet opening 109 connects the interior of the valve body 101 with its exterior by means of several openings, or at least by one opening. In FIG. 1a, two such exemplary openings are shown, which are arranged by way of example on the left and right edge of the valve body 101 and are in fluid contact by means of a horizontal connection in FIG. 1a. By providing several inlet openings 109, it is possible to advantageously dispense with a positional mark or with a structural coding for ensuring a correct installation of the mostly rotationally symmetrical designed valve body.

[0075] The check valve assembly 100 shown in FIGS. 1a and 1b is already closed in the position shown in FIG. 1a (i.e. the components relevant to the check-valve effect are already in position for achieving a check-valve effect).

[0076] The flow of sterilization medium is ensured by the bypass 107. However, also encompassed by the present invention are check valve assemblies which in each unlatched (initial) state are still sufficiently permeable for the sterilization agent. Such embodiments according to the present invention do not require a bypass. An example of such an embodiment is shown in FIGS. 2a to 2c.

[0077] FIG. 2a shows a check valve assembly 100 according to the present invention in a second embodiment in an exploded view.

[0078] The embodiment of FIG. 2a differs from that of FIGS. 1a and 1b, amongst others, in that the pin 105 is part of the valve seat 207, but not of the valve body 101. The pin-reception 103 is on the other hand, as also in FIGS. 1a and 1b, part of the valve body 101. The pin-reception 103, as in the first embodiment of FIG. 1a, is in an interior of the valve body and opens out or ends herefrom into a front area of the valve body. In the second embodiment shown here, the pin-reception 103 serves as a guiding and holding pin-reception, the pin 105 serves as a guiding and holding pin. The pin-reception 103 is embodied exemplarily as a blind hole or stud hole.

[0079] The embodiment of FIG. 2a differs further from that of FIGS. 1a and 1b in that it comprises no switch plate 108, and no bypass 107.

[0080] With respect to FIG. 2a, the upper front area 111 of the valve body 101 is, in its interaction with the receiving area 211 of the valve seat 207 for the valve body 101, embodied such that these components when they get in contact with each other result in a seal as shown in FIG. 2c.

[0081] The valve body 101 is, here purely by way of example, made of resin, especially polycarbonate (abbreviated PC). The sealing lip 106, purely by way of example, is made of elastomer. The valve insert, consisting of valve body 101 and sealing lip 106 or comprising them, is thus produced as a 2-component part, preferably sprayed or casted (2-component injection molding part).

[0082] FIG. 2b shows the check valve assembly 100 of FIG. 2a in the initial state, the unlatched andconsequentlyalso the non-activated sterilization state. In this state, the check valve assembly 100 may have the flow through of gas or liquid for the purpose of sterilizationunhindered by a check valve function as this is not activated yet. Hereto, the free (flow) path 107a, which results from the fact that, always with respect to FIG. 2a, the upper front area 111 of the valve body 101 does not yet have any contact with the receiving area 211 of the valve seat 207 for the valve body 101, and these components due to lack of contact with each other, result in no seal. As a result of this, the fluid can flow also through a gap which results between the shell surface of the valve body 101 and the inner cylinder wall of the valve seat 207.

[0083] From here, the fluid may further move past the not yet closed sealing lip 106, which in FIG. 2b, unlike in FIG. 2c, does not touch the stop surface 206 of the valve seat 207 and therethrough does not seal it. Of course, a flow in the direction opposite to the flow direction mentioned here is possible as well.

[0084] The film 203 is already applied to the cassette body 201 and is affixed by fixations 209 to the latter, for example glued, welded, etc.

[0085] FIG. 2c shows the check valve assembly of FIGS. 2a and 2b in the operating state, in which the valve body 101 due to the force F, again indicated by arrow, is or was (that is, was both activated or latched) connected with the valve seat 207 by means of the pin-pin-reception connection, so that the valve body 101 would not give up or lose its check valve function even after release of the above-mentioned force.

[0086] The free path 107a is closed in the position of the valve body 101 with respect to the valve seat 207 shown in FIG. 2b. Fluids can flow only with a correspondingly high pressure and in the predetermined direction through the check valve assembly 100. The check valve assembly 100 serves, therefore, in the activated state, for the operating state of a sealing of the medical functional device 200 even after it has been loosened or removed from the blood treatment apparatus or removed from it.

[0087] FIG. 3 shows in a schematically highly simplified manner, a plan view of a blood treatment apparatus 300 which comprises a receiving section 301 for receiving a medical functional device 200, here, a blood cassette. Furthermore, it comprises a movable limiting device 303, here, a door. The door shown in a cross-section is fastened by a hinge 304 to the blood treatment apparatus 300, and can be pivoted by it from the opened position non-shown in FIG. 3 in which the blood cassette 200 can be removed from the blood treatment apparatus 300 into the position shown here in which the receiving section 301 is closed.

[0088] The blood cassette 200 comprises in addition to the check valve assembly 100 already known from the preceding figures, a second check valve assembly 100a.

[0089] The limiting device 303 or door comprises two activation plungers 305. They are arranged so that to apply activation force, denoted above with F, at the same time, on either both valve bodies 101 or both pins 105 of the check valve assemblies 100 and 100a.

[0090] The number of check valve assemblies 100, 100a shown in FIG. 3 is purely exemplary. There may be more or less check valve assemblies provided.

[0091] The fixation of the limiting device 303 or door on the blood treatment apparatus 300 is also shown by way of example as a hinge connection. Any other mechanism by means of which one or more check valve assemblies, preferably automatically, preferably at the same time, can be activated are also encompassed in the present invention.

REFERENCE NUMERALS

[0092] 100 check valve assembly [0093] 100a second check valve assembly [0094] 101 valve body [0095] 103 pin-reception [0096] 103a end section [0097] 105 pin [0098] 105a end section [0099] 106 sealing lip [0100] 107 bypass [0101] 107a free path [0102] 108 switch plate [0103] 109 inlet opening [0104] 111 front area of the valve body [0105] 200 medical functional device, blood cassette [0106] 201 cassette body [0107] 203 film [0108] 205 supply [0109] 206 stop face [0110] 207 valve body [0111] 208 stop face [0112] 209 fixations [0113] 211 receiving area [0114] 300 blood treatment apparatus [0115] 301 receiving section [0116] 303 movable limiting device, door [0117] 304 hinge [0118] 305 activation plunges