VALVE UNIT FOR A SYSTEM FOR PRODUCING A MEDICAL PREPARATION

Abstract

The invention relates to a valve unit for a system for producing a parenteral nutrition, in which a three-way valve is used for respectively two connections to a source container. The valve unit is a component which is mounted on the system and can be removed again following use. The valve unit is in particular provided as a replaceable disposable component.

Claims

1. A valve unit (1) for a system (28) for producing a medical preparation, in particular a preparation for parenteral nutrition, comprising a housing (2) having a plurality of inlets (3a-3l) and an outlet (5), wherein the inlets (3a-3l) by way of valves (9) which are configured at least as 3-way valves are connectable to the outlet (5), characterized in that at least part of the outlets (3a-3l) are disposed laterally on the housing (2).

2. The valve unit (1) as claimed in one of the preceding claims, characterized in that the outlet (5) is connected to a duct (12) that is disposed in the housing (2), wherein the duct (12) has openings (13) which preferably lead off laterally to the valves (9).

3. The valve unit (1) as claimed in the preceding claim, characterized in that the valves (9) are configured as 3/3-way valves, preferably having a blocked central position.

4. The valve unit (1) as claimed in one of the preceding claims, characterized in that the valve unit (1) has at least four, preferably at least eight, and particularly preferably at least twelve, inlets (3a-3l).

5. The valve unit (1) as claimed in one of the preceding claims, characterized in that two inlets (3a-3l) are assigned to each of the valves (9).

6. The valve unit (1) as claimed in one of the preceding claims, characterized in that the two inlets (3a-3l) are disposed at dissimilar height levels and provide an upper inlet (3a, 3c, 3e, 3g, 3i, 3k) and a lower inlet (3b, 3d, 3f, 3h, 3j, 3l).

7. The valve unit (1) as claimed in one of the preceding claims, characterized in that the upper inlet (3a, 3c, 3e, 3g, 3i, 3k) and the lower inlet (3b, 3d, 3f, 3h, 3j, 3l) are in each case disposed on top of one another.

8. The valve unit (1) as claimed in one of the preceding claims, characterized in that the valves (9) have cock plugs (10) which are inserted into the housing (2) so as to be rotatable preferably in a lubricant-free manner.

9. The valve unit (1) as claimed in one of the preceding claims, characterized in that the valves (9) comprise cock plugs (10), wherein in an opened position a fluid is guidable through an interior space of the cock plugs (10) which in portions is hollow.

10. The valve unit (1) as claimed in one of the preceding claims, characterized in that that the cock plugs (10) comprise at least two through holes (15, 16) by way of which in an opened position of the valve (9) a duct is in each cased configured between an inlet and the outlet of the valve (9), wherein the two through holes (15, 16) preferably extend through a longitudinal axis of the cock plugs (10).

11. The valve unit (1) as claimed in one of the preceding claims, characterized in that the cock plugs (10) are fastened so as to snap into the valve housing (14).

12. The valve unit (1) as claimed in one of the preceding claims, characterized in that the cock plugs (10) on an external side of the shell have at least one web (17), and the valve housings (14) for receiving the web (17) have a depression (14c) or a protrusion (14c).

13. The valve unit (1) as claimed in one of the preceding claims, characterized in that the two through holes (15, 16) in a shell face of the cock plugs (10) have in each case one entry (15a, 16a) and one exit (15b, 16b), wherein the entries (15a, 16a) of the two through holes (15, 16) lie at dissimilar height levels and define an upper entry (15a) and a lower entry (16a), and/or the exits (15b, 16b) of the two through holes (15, 16) lie at substantially identical height levels.

14. The valve unit (1) as claimed in one of the preceding claims, characterized in that the upper entry (15a) of the upper through hole (15) lies at a substantially identical height level as the upper inlet (3a, 3c, 3e, 3g, 3i, 3k), and in that the lower entry (16a) of the lower through hole (16) lies at a substantially identical height level as the lower inlet (3b, 3d, 3f, 3h, 3j, 3l), and/or in that the exits (15b, 16b) of the two through holes lie at a substantially identical height level as the opening (13) which from the duct (12) leads off laterally to the valves (9).

15. A system (28) for producing a medical preparation, in particular a system for producing a parenteral nutrition, comprising a valve unit (1) as claimed in one of the preceding claims.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0061] The subject matter of the invention is to be explained hereunder with reference to an exemplary embodiment by means of the drawings in FIG. 1 to FIG. 8b, in which:

[0062] FIG. 1 shows a schematic illustration of a system for producing a medical preparation;

[0063] FIG. 2 shows a perspective wireframe illustration of a valve unit according to the invention (without hoses);

[0064] FIGS. 3a and 3b show a view onto the upper side and onto the lower side of the valve unit;

[0065] FIGS. 3c and 3d show in each case a perspective view onto the two lateral walls of the valve unit;

[0066] FIGS. 4a and 4b show a perspective sectional view of the valve unit along the longitudinal axis L (FIG. 4a) and along the transverse axis Q (FIG. 4b) from FIG. 2;

[0067] FIG. 5a shows a view onto the lower side of the valve unit, having inserted cock plugs;

[0068] FIG. 5b shows a perspective view onto the associated receptacle on the system for the valve unit;

[0069] FIGS. 6a and 6g show various views of a cock valve to be inserted into the valve unit in a view onto the upper side (FIG. 6A), in a lateral illustration which is in each case rotated by approximately 90 (FIGS. 6b to 6d), in a cut-away lateral view (FIG. 6e), and in a view onto the lower side (FIG. 6f); as well as in a further rotated cut-away lateral view (FIG. 6f);

[0070] FIGS. 7a and 7c show a sectional view of the valve unit having inserted cock plugs in various valve positions: in the closed position (FIG. 7a) and in the opened position having an opened upper passage opening (FIG. 7b), as well as having an opened lower passage opening (FIG. 7c); and

[0071] FIGS. 8a and 8b show in each case a perspective view onto the receptacle on the system for a plurality of valve units, without valve units (FIG. 8a) and having valve units placed thereon (FIG. 8b).

DETAILED DESCRIPTION OF THE DRAWINGS

[0072] FIG. 1 in a perspective view shows a system 101 for producing a medical preparation in the form of a parenteral nutrition preparation.

[0073] The system 101 here is of modular construction and comprises a main module 102. The main module 102 comprises a pump 109 which is preferably configured as a hose pump (for example a peristaltic pump). The main module 102 furthermore comprises a scanner 112 by way of which formula data, bar codes on target containers 106 and/or source containers 105 and/or associated hoses can be read.

[0074] The target container 106 per se is not illustrated, but only the position thereof on the balance 103 is. A receptacle 21 for a valve unit 1 is disposed on the upper side of the main module 102. However, a plurality of valve units 1 can also be provided so as to be connected in a cascading manner (see to this end FIGS. 8a and 8b). A valve unit can also be referred to as a valve node.

[0075] Apart from the main module 102, the system 101 comprises a balance module 103 as well as a display screen module 104. The balance module 103 comprises a balance tray 107 into which a target container 106 (not illustrated here) can be placed. The balance module 103 and the main module 102 here are placed onto a sub-frame 111 which ensures that the balance module 103 and the main module 102 are mutually positioned in a consistent manner.

[0076] The intermediate space between the balance module 103 and the main module 102 is partially spanned by the balance tray 107 such that the connection of the target container 106 lies close to the upper side of the housing of the main module 102. Furthermore, the balance tray 107 in relation to a horizontal plane is inclined upward in the direction of the main module 102. On account thereof, the connector of the target container 106 is likewise moved close to the upper side of the main module 102. This reduces the length of a hose for connecting the target container 106 to the valve unit 1. The hoses are not illustrated in this view.

[0077] Furthermore to be seen are bars 108 on which a plurality of source containers 105 are disposed. In order for the system 101 to be operated, the source containers 105 are connected to the valve unit, or valve units, 21, respectively, by way of hoses. The hose used for connecting the target container 106 herein is guided through the hose pump 109. By means of the hose pump 109, the desired preparation can be transferred in a computer-controlled manner into the target container 106 by way of the valve unit, which here is composed of the single valve node 21.

[0078] In a filling procedure, one of the valves 9 is opened such that in a metering step liquid from a source container 105 is pumped into the target container 106 by the pump 109. Thereafter, the next valve 9 is opened. Liquids are retrieved from the various source containers 105 until the filling procedure is completed.

[0079] During each individual metering step, only a single valve 9 which leads to a source container 105 is preferably opened at any one time. Liquid is thus preferably retrieved from only one source container 105 at any one time.

[0080] FIGS. 2 and 3a to 3d in various illustrations show an embodiment of a valve unit 1 which is preferably configured as a single-use component. The valve unit 1 is preferably configured so as to be integral.

[0081] The valve unit 1 comprises a housing 2 from plastics material. Said housing 2 can be configured in the manner of a cartridge. The housing 2 possesses an upper side, a lower side, in the direction of the outlet 5 a front side, and in the direction of the connector 7 a rear side. The lateral walls are laterally disposed. Said lateral walls are situated between the front side and the rear side.

[0082] The housing 2, configured so as to be cuboidal, here laterally comprises in each case a plurality of inlets 3a-3l. In this exemplary embodiment, twelve inlets 3a-3l are present, of which only the six inlets 3a to 3f on one side can be seen. The valve unit 1 can also be configured so as to have more or fewer inlets 3a-3l. The inlets 3a-3l here are disposed so as to be substantially parallel to the upper side of the housing 2, or (in the assembled state) so as to be parallel to the upper side of the system 101. The inlets 3a-3l are disposed so as to be substantially horizontal.

[0083] The housing 2 preferably has a height of 2 to 6 cm, a width of 6 to 12 cm, and a depth of 3 to 8 cm.

[0084] Two inlets, in this exemplary embodiment for example the inlets 3a and 3b, as well as the inlets 3c and 3d, and 3e and 3f, respectively, are in each case opened and closed by in each case one single valve 9, here configured as a 3-way valve 9.

[0085] The variant of embodiment of a valve unit 1 illustrated comprises six 3-way valves. Each inlet 3a-3l is connected to one flexible hose 4 (not illustrated). In one embodiment the hoses 4 are connected, preferably welded or adhesively bonded, to the inlets 3a-3l in such a manner that said hoses 4 cannot be released in a non-destructive manner. The hoses 4 can possess a smaller and a larger diameter. The hoses 4 having smaller diameters can serve for metering micro-quantities.

[0086] A target container 106 (not illustrated) can be filled by way of an outlet 5 and a hose 6 (not illustrated here) to which the outlet 5 is preferably connected in a likewise non-separable manner.

[0087] In this exemplary embodiment a further connector 7 is provided on the side opposite the outlet 5. The valve unit 1 can be connected from both sides by way of the connector 7. An outlet 5 or connector 7, respectively, which is not required can simply be closed.

[0088] Also to be seen in the illustration in FIG. 3b is in particular the latching hook 8 for latching the valve unit 1 to a system 101. On the opposite side, the housing 2 is held by way of a collar 19 which engages below a form-fitting element on the system.

[0089] In order for the valve unit 1 to be removed, the user only needs to pull from the front upward on the handle 20 of the sprung latching hook 8, and the latching mechanism is released such that the valve unit 1 can be removed.

[0090] Furthermore to be seen are the valves 9. The valve housing 14 of the valves 9 protrudes from the upper side of the housing 2. In the figure, only one valve 9 is marked with a reference sign.

[0091] The valves 9 for in each case two inlets 3a-3l are preferably configured so as to be identical such that the description hereunder of a valve 9 refers to all of the valves 9 of the valve unit 1.

[0092] The valve 9 identified here by the reference sign 9 serves for actuating the inlets 3a and 3b. The inlets 3a and 3b are disposed laterally on the housing 2. The inlets 3a and 3b are mutually adjacent. Said inlets 3a and 3b here lie on top of one another.

[0093] The valve housing 14 preferably has an internal diameter which is 1.1 to 1.5 times the internal diameter of the inlet 3a, 3b. For example, the valve housing 14 has an internal diameter of 0.5 to 1.5 cm, and/or the inlet 3a, 3b has an internal diameter of 0.25 cm to 0.75 cm.

[0094] FIG. 5a shows a view onto the lower side of the valve unit, having inserted cock plugs. The valves 9 have in each case one press-fitted cock plug 10 which comprises a slot 11 which serves as an engagement element for a drive activated by means of a motor (see to this end the entrainment elements 22 having the engagement elements 23 in FIGS. 5b and 8a).

[0095] The complete opening of an inlet 3a-3l is performed by approximately a rotation of the cock plug 10 of 45 to 70, or of >45 to 70. The complete opening of an inlet 3a-3l is preferably performed by approximately a sixth of a rotation of the cock plug 10, wherein the one connector is opened when rotating in one direction, and the other connector is opened when rotating in the other direction. The rotation for reaching the two open positions is thus performed by substantially +/60 in relation to the closed central position. 3/3-way valves, preferably having a closed central position, are thus used.

[0096] In a plan view the cock plugs 10 are disposed in the two straight rows a and b (see FIG. 5a), wherein the cock plugs 10 of the row a are offset axially in relation to the respective opposite cock plugs 10 of the row b.

[0097] The cock plugs 10 of the row b are in the central position, the corresponding valves 9 are thus closed. The central cock plug in the row a is likewise closed. By contrast, the left cock plug 10 in the row a is rotated to the right by approximately a sixth of a rotation, and the lower inlet 3b is open. By contrast, the right cock plug 10 in the row a is rotated to the left by approximately a sixth of a rotation, and the upper inlet 3a is open.

[0098] It is however understood that in the operation of the system 101 for producing a medical preparation, only one valve 9 is generally opened at any one time during a metering step. In detail, the valve 9 in this instance is opened only to one inlet of the inlets 3a to 3l.

[0099] It can be seen that the valve housings 14 are formed substantially from a preferably circular-cylindrical duct in or on the housing 2, said duct leading from the lower side of the housing 2 into or to the housing 2. The cock plugs 10 are press-fitted into the housing 2, or into the valve housing 14, respectively, by way of the lower side of the housing 2. The locking of the cock plug 10 in the valve housing 14 is also performed by way of a snap-fit connection. To this end, a web 17 configured on the external side of the cock plug 10 engages in a depression 14c in the internal side of the valve housing 14. Alternatively, the web 17 can engage behind a protrusion 14c in the valve housing 14.

[0100] Each valve housing 14, in a manner lateral toward the external side, comprises two openings 14a, 14b, which in each case lead to the inlet 3a or 3b, respectively, on the valve.

[0101] In two opened positions of the cock plug 10, a fluid can pass through the cock plug 10 either from the one inlet 3a by way of the opening 14a, or from the other inlet 3b by way of the opening 14b, and by way of the opening 13 makes its way out of the valve housing 14 into a central duct 12. The openings 14a, 14b in this exemplary embodiment are configured substantially as round, preferably circular, holes. Said openings 14a, 14b preferably lie at a height level above and below the center of the central duct 12 (to this end see FIGS. 4b and 7a).

[0102] The circular-cylindrical shape of the valve housing 14 overlaps in particular the duct 12. The opening 13 of the valve housing 14 thus formed opens into the duct 12. The fluid can flow into the duct 12 through the opening 13.

[0103] FIG. 4 presents a perspective sectional view of the valve unit 1 along the longitudinal axis L. The duct 12 preferably possesses a substantially consistent cross section, at least in the region of the valves 9. This ensures openings 13 of identical size in the case of all valves 9, this in turn guaranteeing an approximately identical flow rate of all valves 9 in the opened state. The openings 13 are substantially oval, preferably having the longer extent in the direction of the longitudinal axis L of the housing 2.

[0104] FIG. 4b presents a perspective sectional view of the valve unit 1 along the transverse axis Q. The sectional illustrations of the inlets 3e and 3f are illustrated. Said inlets 3e and 3f are disposed laterally on the housing 2. The inlets 3e and 3f extend from the housing external side 2 up to the valve housing 14. Said inlets 3e and 3f possess an inwardly tapered cross section from the external side and by way of the openings 14a and 14b, respectively, open in each case into the valve housing 14.

[0105] The respective inlet 3e or 3f can be connected to the central duct 12 of the valve unit 1 by way of the cock plug 10 which is press-fitted into the valve housing 14 (see to this end FIGS. 7a to 7c).

[0106] The valve housing 14 can have a ventilation hole on the upper side (not illustrated in the figures). By contrast, a depression 18 is provided in the upper side of the cock plug 10 in the present example (see to this end FIG. 6g). The air present in the valve housing 14 can escape by way of said depression 18 when the cock plug 10 is being press-fitted.

[0107] FIGS. 7a to 7c show sectional views of a valve 9 in various positions.

[0108] In the view according to FIG. 7a, the cock plug 10 of the valve 9 is initially situated in the closed position, preferably the closed central position. The opening 13 between the duct 12 and the valve housing 13 is closed by the cock plug 10. On account thereof, no fluid can make its way into the duct 12 by way of the inlet 3e and the opening 14a, or the inlet 3f and the opening 14b, respectively. The sealing of the valve 1, or of the cock plug 10, respectively, in relation to the valve housing 14 takes place by way of a surface seal. The external side of the cock plug 10 herein bears in a sealing manner on the internal side of the valve housing 14.

[0109] FIG. 7b shows the valve 9 in a first opened position. The upper passage opening 15 in the cock plug 10 connects the opening 14a at the inlet to the opening 12 at the duct. In the operation of the system 1, liquid can henceforth be retrieved from a source container 105 which is connected to the inlet 3e. In detail, the liquid from the inlet 3e herein by way of the opening 14a flows into the upper entry 15a of the upper passage opening 15 and into the cock plug 10. The liquid then flows into the duct 12 by way of the lower exit 15b of the passage opening 15 and the opening 13 at the duct. The fluid flow is indicated by the two plotted arrows.

[0110] FIG. 7c now shows the valve 9 in a second opened position. The illustration according to FIG. 7c corresponds to that of FIG. 7b with the difference that the cock plug 10, proceeding from the closed central position illustrated in FIG. 7a, is rotated in the opposite direction by approximately a sixth of a rotation. As can be seen in FIG. 7c, the inlet 3f is henceforth connected to the duct 12. The lower passage opening 16 in the cock plug 10 now connects the opening 14b at the inlet to the opening 12 at the duct. In the operation of the system 1, liquid can henceforth be retrieved from a source container 105 which is connected to the inlet 3f. In detail, the liquid herein from the inlet 3f flows by way of the opening 14b into the lower entry 16a of the lower passage opening 16 and into the cock plug 10. The liquid flows into the duct 12 by way of the upper exit 16b of the passage opening 16 and the opening 13 at the duct. The fluid flow is indicated by the two plotted arrows.

[0111] FIGS. 6a and 6g show various views of a cock plug 10 to be inserted into the valve unit 1.

[0112] The cock plug 10 on the lower side thereof has a slot 11 as an engagement element for a drive (see to this end also FIGS. 5a and 5b).

[0113] The cock plug 10 is at least partially or substantially configured so as to be circular-cylindrical. Said cock plug 10 possesses an upper portion 10-1 and a wider lower portion 10-2. The cock plug 10 preferably has a height of 1 to 3 cm. The upper portion 10-1 possesses a diameter of 0.5 to 1.5 cm, and/or the lower portion 10-2 possesses a diameter of 1 to 2 cm.

[0114] The cock plug 10 by way of the upper portion 10-1 thereof is press-fitted into the valve housing 14. The upper portion 10-1 herein substantially provides the surface seal. By contrast, the lower portion 10-2 provides a detent when press-fitting. An annular elevation 17 is provided in the lower region of the upper portion 10-1. This formed web 17, in conjunction with a protrusion 14c on or of a depression 14c in the valve housing 14, provides a latching connection.

[0115] In order for a duct in the valve 9 to be released in the opened state, the cock plug 10 comprises two passage openings 15 and 16. The passage openings 15 and 16 extend through the central axis of the cock plug 10. However, said passage openings 15 and 16 do not intersect. Said passage openings 15 and 16 are mutually separated.

[0116] There is a first upper passage opening 15 having an entry 15a at the top, and a second passage opening 16 having an entry 16a at the bottom. The exit 15b of the upper passage opening 15 and the exit 16b of the lower passage openings 16 lie at a height level of the cock plug 10. By a rotation of the cock plug 10, either the upper passage opening 15 or the lower passage openings 16 can thus be connected to the duct 12 by way of the opening 13 at the duct.

[0117] The exits 15b and 16b of the two passage openings 15 and 16 are in each case disposed in the shell of the cock plug 10 so as to be mutually offset by approximately 120. The entries 15a and 16a of the two passage openings 15 and 16 are also in each case disposed in the shell of the cock plug 10 so as to be mutually offset by approximately 120. The passage openings 15 and 16 possess a diameter of 2 to 5 mm.

[0118] FIG. 5b shows a perspective detailed illustration of a single receptacle 21 on the system for the valve unit 1.

[0119] The receptacle 21 comprises a plinth 25 and a protruding periphery 24 which serves as a form-fitting element for the latching hook 8 as well as the collar 19 of the valve unit 1. The receptacle 21 furthermore comprises entrainment elements 22 which can be rotated by means of a motor on the system.

[0120] The entrainment elements 22 are disposed in two straight rows, in a manner corresponding to that of the cock plugs 10, wherein the entrainment elements 22 of the one row are offset axially in relation to the entrainment elements 22 of the other row.

[0121] The entrainment elements 22 comprise engagement elements 23 formed in the manner of a screw driver, which in the state latched to the valve unit 1 engage in the slots 11 of the cock plugs 10. The cock plugs 10 can thus be rotated and the valves 9 activated by way of the entrainment elements 22.

[0122] While FIG. 5b shows a single receptacle 21 for fastening a single valve unit 1, FIG. 8a by contrast shows an embodiment in which a plurality of receptacles 21 are provided for fastening a plurality of valve units 1. In detail, three receptacles 21 for assembling three valve units 1 are illustrated here in an exemplary manner.

[0123] Finally, the receptacle 21 on the system, having valve units 1 placed thereon, is illustrated in FIG. 8b. The valve units 1 shown here serve only for illustration but are not a subject matter of the present invention. The individual valve units 1 can be connected to one another by way of hoses 6 indicated here. On account thereof, a system 1 having more than twelve source containers 15 can be operated.

[0124] A robust and reliable valve unit for a system for producing a medical preparation, for example for parenteral nutrition, can be provided by way of the invention.

LIST OF REFERENCE SIGNS

[0125] 1 Valve unit

[0126] 2 Housing

[0127] 101 System

[0128] 102 Main module