Valve unit for an installation for producing a medical preparation

Abstract

The invention relates to a valve unit for a system for producing parenteral nutrition, in which unit a three-way valve is used for each pair of connections to a source container. The valve unit is a component that can be mounted on die system and removed again after use. The valve unit is in particular provided as an interchangeable disposable component.

Claims

1. A valve unit for an installation for producing a medical for parenteral nutrition, said valve unit comprising a cartridge having a plurality of inflows and an outflow, wherein the inflows are connectable to the outflow by way of valves, wherein the valves are each configured as at least 3-way valves that connect to at least two of said inflows and to said outflow such that first and second source containers can be connected to a single valve; and wherein each of said valves comprises a valve member that is rotatable about a valve axis, and wherein said valve member rotates between a first position and a second position, wherein, in said first position, said valve member connects said first source container to said outflow, and wherein, in said second position, said valve member connects said second source container to said outflow, wherein the valve axis is offset and perpendicular to an outflow axis.

2. The valve unit as claimed claim 1, wherein the outflow is connected to a duct that is disposed in the cartridge, wherein the duct has openings that, laterally, lead to the valves.

3. The valve unit as claimed in claim 2, wherein the valves are configured as 3/3-way valves having a blocked central position.

4. The valve unit as claimed in claim 1, wherein the valves are disposed in at least two straight rows, wherein the valves of one row are disposed so as to be offset in the axial direction in relation to the valves in the other row.

5. The valve unit as claimed in claim 4, wherein the duct at least in the region of the valves has a constant diameter.

6. The valve unit as claimed in claim 1, wherein the inflows and/or the outflow are/is inseparably connected to hoses.

7. The valve unit as claimed in claim 1, wherein the inflows are connected to hoses which are present in at least two different diameters, and/or in that the outflow is connected to a hose which comprises at least three portions, wherein a central portion has a cross section that is enlarged in relation to the adjacent portions.

8. The valve unit as claimed in 1, wherein the valve unit has at least four inflows.

9. The valve unit as claimed in claim 1, wherein the cartridge has latching means for fastening to a drive unit of the installation for producing a medical preparation.

10. The valve unit as claimed in claim 1, wherein the valve members are formed as plugs from an elastomer, said plugs being inserted into the housing cartridge in a lubricant-free manner.

11. The valve unit as claimed in claim 1, wherein the valve members are formed as plugs which on a lower side have an engagement element for a drive, said engagement element being configured as a slot.

12. The valve unit as claimed in claim 1, wherein the valve members are formed as plugs, wherein a fluid in an opened position is capable of being guided along an external face of the plugs.

13. The valve unit as claimed in claim 1, wherein the valve members are formed as plugs, and wherein the plugs comprise a clearance by way of which in an opened position of the valve a duct is configured between an inflow and the outflow of the valve, and/or in that the plugs are composed of an elastomer and have at least one encircling web above and below the clearance, said web acting as a seal in relation to the housing.

14. An installation for producing a medical preparation for producing parenteral nutrition, comprising a valve unit as claimed in claim 1.

15. The valve unit as claimed in claim 1, wherein the valve unit has at least eight inflows.

16. The valve unit as claimed in claim 1, wherein the valve unit has at least twelve inflows.

17. The valve unit as claimed in claim 1, wherein the valve members are formed as plugs, and wherein the plugs comprise two clearances, by way of which in an opened position of the valve a duct is configured between an inflow and the outflow of the valve, and/or in that the plugs are composed of an elastomer and have at least one encircling web above and below the clearance, said web acting as a seal in relation to the cartridge.

18. The valve unit as claimed in claim 1, in which the cartridge is an injection-molded component.

19. A valve unit for an installation for producing a medical preparation for parenteral nutrition, comprising a housing having a plurality of inflows and an outflow wherein the inflows are connectable to the outflow by way of valves, wherein the inflows are in each case connected to a hose, wherein the hoses are inseparably connected to the housing; and wherein each of said valves rotates about an axis that is offset from and perpendicular to an axis of said outflow, wherein said inflows comprise, for each valve, a first and second inflow, wherein each of said valves rotates between a first position and a second position, wherein, in said first position, said valve connects said first inflow to said outflow, and wherein in said second position, said valve connects said second inflow to said outflow.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The subject matter of the invention is to be explained hereunder with reference to an exemplary embodiment and by means of the drawings FIGS. 1 to 14, in which:

(2) FIG. 1 shows a perspective wireframe illustration of a valve unit according to the invention;

(3) FIG. 2 shows a perspective view of the valve unit without hoses;

(4) FIG. 3 shows a view onto the lower side of the valve unit;

(5) FIG. 4 shows a view onto the lower side of a housing upper part;

(6) FIG. 5 shows an exploded illustration of the valve unit; and

(7) FIG. 6 shows a sectional perspective view of the valve unit.

(8) The opening positions and the closing position of a valve are to be explained with reference to the sectional illustrations according to FIGS. 7a to 7c and FIGS. 8a to 8c.

(9) FIG. 9 shows a detailed illustration of the plug of the valve;

(10) FIG. 10 shows a section through the plug that runs perpendicularly to the axis of main extent;

(11) FIG. 11 shows a detailed illustration of the connector pieces for the source containers;

(12) FIG. 12 shows a detailed illustration of the hose of the outflow of the valve unit;

(13) FIG. 13 shows a schematic illustration of an installation for producing a medical preparation; and

(14) FIG. 14 shows a perspective view onto the receptacle on the installation for a valve unit according to the invention.

DETAILED DESCRIPTION OF THE DRAWINGS

(15) FIG. 1 in a perspective illustration shows an embodiment of a valve unit 1 which is configured as a single-use component.

(16) The valve unit 1 comprises a housing 2 from a plastics material. Said housing can be configured in the manner of a cartridge.

(17) The housing 2 that is configured in the shape of a cuboid on the upper side thereof comprises a plurality of inflows 3a-3l. There are twelve inflows 3a-3l present in this exemplary embodiment. The valve unit 1 can also be configured having more or fewer inflows.

(18) 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.

(19) In each case two inflows, the inflows 3a and 3b and the inflows 3c and 3d in this exemplary embodiment, are opened and closed by way of in each case one single 3-way valve 9.

(20) The variant of embodiment of a valve unit 1 illustrated here comprises six 3-way valves. Each inflow 3a-3l is connected to one flexible hose 4a-4l. For improved clarity, the hoses 4a-4l in this view are only in part provided with reference signs, but correspond to the inflows 3a-31, that is to say that one hose 4a-4l is assigned to each inflow 3a-31.

(21) The hoses 4a-4l are connected, preferably welded or adhesively bonded, to the inflows 3a-3l in such a manner that said hoses 4a-4l cannot be released in a non-destructive manner.

(22) In this exemplary embodiment, for example the hoses 4h and 4i have a diameter that is smaller than that of the hoses 4a and 4l. The hoses 4h and 4i serve for metering micro-quantities.

(23) A target container (not illustrated) can be filled by way of an outflow 5 and a hose 6 to which the outflow 5 is preferably likewise inseparably connected.

(24) Only that end of the hose 4a-4l, 6 that points toward the respective connector of the housing 2 is illustrated in this illustration, but not the remaining parts of the hoses that have the connectors (cf. FIG. 11 and FIG. 12).

(25) In this exemplary embodiment a further connector 7 is provided on the side opposite the outflow 5. The valve unit 1 can be closed from both sides by way of the connector 7. An outflow 5 or connector 7, respectively, that is not required can be readily closed.

(26) FIG. 2 shows a perspective view of the housing 2 of the valve unit 1, in which the hoses 4a to 4l for the inflows 3a to 3l and for the outflow 5 have been omitted. The view has been rotated by approx. 180° in relation to that of FIG. 1.

(27) The latching hook 8, in order for the valve unit 1 to be able to be latched onto the top of an installation 28, can be seen in particular in this illustration. The housing 2 on the opposite side is held by a collar 26 that engages below a form-fitting element on the installation (cf. also FIG. 3).

(28) In order for the valve unit 1 to be removed, the user only has to pull from the front the handle 27 of the sprung latching hook 8 upward, this releasing the latching mechanism, so that the valve unit 1 can be removed.

(29) 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. Only one valve 9 is marked with a reference sign in the figure.

(30) The valves 9 for in each case two inflows 3a-3l are preferably of identical configuration such that the description hereunder of a valve 9 refers to all of the valves 9 of the valve unit 1.

(31) The valve 9, identified here by the reference sign 9, serves for actuating the inflows 3a and 3b. The inflows 3a and 3b in the plan view of the upper side of the valve unit 1 overlap with the valve housing 14. The inflows 3a to 3l can thus be placed close to one another. At the same time, a duct from the respective inflow 3a, 3b can be readily provided by way of an opening (15a, 15b in FIG. 4) in the overlap region of the inflows 3a, 3b and of the valve housing 14.

(32) The valve housing 14 has an internal diameter that is preferably 1.1 to 1.5 times that of the inflow 3a, 3b. The valve housing 14 has an internal diameter of 0.5 to 2 cm, for example.

(33) The inflows 3a, 3b above the valve housing 14 are preferably spaced apart by less than half of the external diameter of said inflows 3a, 3b.

(34) FIG. 3 shows a perspective view onto the lower side of the housing 2.

(35) The valves 9 have in each case one press-fitted plug 10a-10f which comprises a slot 11 which serves as an engagement element for a drive that is activated by means of a motor (cf. to this end the entrainment elements 35 having the engagement elements 36 in FIG. 14).

(36) The complete opening of an inflow 3a-3l is performed by approximately a quarter rotation, preferably an eighth of a rotation, of the plug 10a-10f, wherein the one connector is opened by the rotating in one direction, and the other connector is opened by the rotating in the other direction. The rotation for achieving the two opening positions is thus established substantially by +/−45° in relation to the closed central position.

(37) 3/3-way valves having a closed central position are thus used.

(38) The plugs 10a-10f in a plan view are disposed in the two straight rows a and b, wherein the plugs 10d-10f of row a in relation to the plugs 10a-10c of row b are axially offset in relation to the respective opposite plugs.

(39) The plugs 10a-10c of row b are in the central position, the respective valves 9 thus being closed. The plugs 10c-10e of row a by contrast are rotated by an eighth of a rotation, in each case one inflow (3a to 3l) being open. However, it is understood that in the operation of the installation 28 for producing a medical preparation only one valve 9 is opened at any one time during a metering step. In detail, the valve 9 in this instance is open only in relation to one inflow of the inflows 3a to 3l.

(40) FIG. 4 shows the illustration of a housing upper part 2a of the housing 2 without the plugs 9. The exemplary embodiment illustrated here thus shows a housing 2 in two parts. The housing 2 in the case of another embodiment is configured integrally, but otherwise in a manner analogous to the exemplary embodiment illustrated here.

(41) It can be seen that the valve housings 14 are formed substantially by a preferably circular-cylindrically shaped duct in the housing 2 which from the lower side of the housing 2 leads into the housing 2. The plugs 10 are press-fitted into the housing 2 by way of the lower side of the housing 2.

(42) Each valve housing 14 laterally comprises an opening 15a, 15b which in each case leads to the inflow 3a-3l at the valve.

(43) In two opened positions of the plug 10 a fluid can pass the plug 10 either from the one inflow by way of the opening 15a or from the other inflow by way of the opening 15b, and make its way out of the valve housing 14 into a central duct 12 by way of the opening 13.

(44) The openings 15a, 15b in this exemplary embodiment are configured so as to be substantially slot-shaped and are level in height with a clearance 10 of the plug 10 (cf. FIG. 6).

(45) The circular-cylindrical shape of the valve housing 14 overlaps 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 by way of the opening 13.

(46) The duct 12, preferably at least in the region of the valves 9, has a consistent cross section. This ensures openings 13 of identical size in the case of all valves 9 which in turn guarantees approximately identical flow rates of all valves 9 in the opened state.

(47) The openings 15a, 15b can be implemented by way of two housing halves that are joined together, as is illustrated here.

(48) The valve housing 14 on the upper side has a ventilation hole 16. The air present in the valve housing 14 can flow out by way of the ventilation hole 16 when the plug 10 is being press-fitted.

(49) FIG. 5 shows an exploded illustration of the valve unit 1 which here is in two parts. The housing 2 comprises a housing upper part 2a and a housing lower part 2b.

(50) The lower part of the circular-cylindrically-shaped valve housing 14 for receiving the plugs 10 can now be seen. The valve housing 14 opens into the central duct 12 by way of in each case one opening 13.

(51) Furthermore to be seen are the openings 15a and 15b which lead to the inflows 3a-31.

(52) FIG. 6 shows a view that is in section along the direction of main extent of the valve unit 1.

(53) The plugs 10 that are press-fitted into the valve housing 14 can be seen. The inflow 3e or the inflow 3f can be connected to the central duct 12 of the valve unit 1 by way of the plug identified by the reference sign 10.

(54) It can furthermore be seen that the housing 2 comprises a plate 32 which serves as a support for the valves 9.

(55) The plate 32 in this exemplary embodiment is configured in two tiers since the housing 2 is embodied in two parts. In an alternative integral embodiment of the housing 2 (not illustrated here) the plate 32 would be in one tier.

(56) FIGS. 7a to 7c show sectional views of a valve 9 in various positions.

(57) The plug 10 of the valve 9 in the view according to FIG. 7a is located in the closed central position. The opening 13 between the duct 12 and the valve housing 13 is closed by the plug 10. On account thereof, no fluid can make its way into the duct 12 by way of the inflow 3h and the opening 15a, or by way of the inflow 3g and the opening 15b, respectively.

(58) FIG. 7b shows the valve 9 during opening. The clearance 18 on the jacket of the plug 10 reaches the opening 13 of the duct 12, and fluid can flow into the duct 12 through the opening 13.

(59) FIG. 7c shows the valve 9 in the completely open position. A duct is released upon an eighth of a rotation, and fluid can flow into the duct 12 from the inflow 3q by way of the external face on the jacket of the plug 10 along the clearance 18 and through the opening 13.

(60) During the operation of the installation 28, liquid can henceforth be retrieved from the source container 29 that is connected to the inflow 3g.

(61) The illustration according to FIG. 8a to FIG. 8c corresponds to that of FIG. 7a to FIG. 7c, the point of differentiation being that the plug 10, proceeding from the closed central position illustrated in FIG. 8a, is rotated by an eighth of a rotation in the opposite direction.

(62) As can be seen in FIG. 8c, the inflow 3h is henceforth connected to the duct 12. The fluid flow is symbolized by the plotted arrow 33.

(63) FIG. 9 shows a detailed illustration of the plug 10 in a perspective wireframe illustration.

(64) The plug 10 on the lower side thereof has a slot 11 as an engagement element for a drive (cf. to this end also FIG. 14).

(65) The plug 10 is configured so as to be substantially circular-cylindrically shaped and is press-fitted into the valve housing 14.

(66) The plug 10 preferably has a diameter of 0.5 to 2 cm and/or a height of 0.5 to 3 cm.

(67) In order for a duct in the valve 9 to be released in the open state, the plug 10 comprises two mutually opposite clearances 18 (only one clearance is to be seen in this view).

(68) The clearances 18 preferably occupy a quarter of the circumference of the plug 10 (cf. to this end FIG. 10).

(69) In each case two regions which have the encircling and axially mutually spaced apart webs 17a-17c and 19a-19c are provided above and below the clearances 18.

(70) The webs 19a-19c above the clearance 18 act as a lip seal, while the webs 17a-17c configure lip seals on the lower side of the housing 14, thus sealing the plug 10 on the lower side of the housing 14.

(71) In the region in which there are no clearances 18 present, the plug 10 comprises axially running webs 20a-20d which are effective as lip seals between the opening 13 to the duct 12 and the openings 15a, 15b at the inlet side of the valve housing 14.

(72) The outlet 15a and 15b at the valve side in the closed position is sealed, or the respective unopened inflow 3a-31 is blocked in the opened position, respectively, by way of the webs 20a-20d.

(73) FIG. 10 (at the height level of the clearance 18) shows a radial sectional plane of the plug 10. The two mutually opposite curved clearances 18 which extend axially across a central region of the plug 10 can be seen (cf. to this end FIG. 9).

(74) The clearances 18 occupy in each case approximately a quarter of the circumference of the jacket of the plug 10.

(75) Furthermore to be seen are the axially running webs 20a-20d which are distributed around the jacket of the plug 10 in the region in which the clearances 18 do not extend.

(76) FIG. 11 shows the connector pieces 21, 22 of the hoses 4a-4l of the inflows.

(77) The connector pieces 21, 22 can be configured, for example, as a Luer lock connector and/or comprise a spike.

(78) It can be seen that the hose 4h, for example, is shorter than the hose 4g. The hose 4h also has a smaller diameter and serves for metering micro-quantities.

(79) FIG. 12 shows an illustration of the hose 6 for the outflow 5.

(80) Said hose 6 comprises a connector 23 for the target container, said connector 23 potentially being configured as a Luer lock connector, for example.

(81) The hose 6 is subdivided into the hose portions 6a-6c which are in each case connected by means of one connection piece 24, 25.

(82) The central portion 6b has a diameter that is larger than that of the adjacent portions 6a and 6c, and serves for the use of the hose 6 in a peristaltic pump, in particular a hose pump in the design of a roller pump or a finger pump (not illustrated).

(83) FIG. 13 shows a schematic illustration of a installation 28 for producing a medical preparation, especially for producing a preparation for parenteral nutrition. The valve unit 1 is a separate component which can be fastened on top of the installation 28. The valve unit 1 can be removed again after use and in particular be disposed of conjointly with the hoses 4a-4l and 6.

(84) The valve unit 1 here is latched to a receptacle 34 on the upper side of the installation 28. The hoses 4a to 4l and 6 of the valve unit 1 are not illustrated. The hoses 4a to 4l of the inflows 3a to 3l are connected to the source containers 29. Only the source containers 29 for micro-quantities, provided in exemplary manner by vials, are illustrated here.

(85) The hose 6 of the outflow 5 is connected to a target container (not illustrated) which is placed onto a balance 31 which is connected to the installation 28.

(86) A patient-specific preparation can be transferred to the target container in a computer-controlled manner by way of a pump 30, wherein it is controlled by way of the valves 9 of the valve unit 1 from which source container 29 liquid is retrieved. The retrieved quantity can be checked by way of the balance 31.

(87) FIG. 14 shows a perspective detailed illustration of the receptacle 34 on the installation for the valve unit 1.

(88) The receptacle 34 comprises a protruding periphery 37 which serves as a form-fitting element for the latching hook 8 as well as for the collar 26 of the valve unit 1.

(89) The receptacle 34 furthermore comprises entrainment elements 35 which can be rotated by means of a motor on the installation.

(90) The entrainment elements 35, in a manner corresponding to that of the plugs 10, are disposed in two straight rows, wherein the entrainment elements 35 of the one row are axially offset in relation to the entrainment elements 35 of the other row.

(91) The entrainment elements 35 comprise engagement elements 36 which are configured in the manner of a screwdriver and which in the latched state of the valve unit 1 engage in the slots 11 of the plugs 10. The plugs 10 can thus be rotated and the valves 9 can be activated by way of the entrainment elements 35.

(92) A robust and reliable valve unit for a installation for preparing parenteral nutrition can be provided by the invention.

LIST OF REFERENCE SIGNS

(93) 1 Valve unit 2 Housing 2a Housing upper part 2b Housing lower part 3a-3l Inflow 4a-4lHose 5 Outflow 6 Hose 6a-6c Hose portion 7 Connector 8 Latching hook 9 Valve 10, 10a-10f Plugs 11 Slot 12 Duct 13 Opening 14 Valve housing 15a, 15b Opening 16 Ventilation hole 17a-17c Web 18 Clearance 19a-19c Web 20a-20d Web 21 Connector 22 Connector 23 Connector 24 Connection piece 25 Connection piece 26 Collar 27 Handle 28 Installation 29 Source container 30 Pump 31 Balance 32 Plate 33 Arrow 34 Receptacle 35 Entrainment element 36 Engagement element 37 Periphery