DEVICE WITH A BAG-SHAPED CONTAINER AND METHOD FOR FILLING A PUMP-OPERATED HOLLOW LINE-SUPPORTED LIQUID CIRCUIT WITHOUT FORMING GAS BUBBLES USING THE DEVICE

Abstract

The invention relates to a container in the form of a bag having a flexible bag wall at least in a region, in which a first and a second hollow channel section, pass through the bag wall in a fluid-tight manner, wherein the hollow channel sections respectively have an open channel end that is located within the container for connecting the open channel ends to one another in a separable and fluid-tight manner.

Claims

1-19. (canceled)

20. A device comprising: a container formed as a bag, which is having a bag wall which is flexible at a region, in which a first and a second hollow channel section, pass through the bag wall in a fluid-tight manner, with the hollow channel sections each having an open channel end that is located within the bag for connecting the open channel ends to one another in a separable and fluid-tight manner; a first filter insert within the bag and at least partially encompassing a first inner filter volume with a first filter wall within another volume that is at least partially encompassed by the bag, a bag volume, with a tubular fluid line section passing through the first filter wall which is connected thereto, and with the fluid line section being open on two and leading into the first filter volume, and into the bag volume, and wherein a channel end of the first hollow channel section, which is located within the bag, and being connectable to the open fluid line section leading into the bag volume in a separable and fluid-tight manner.

21. The device according to claim 20, wherein: a second filter insert is within the first filter volume and at least partially encloses a second filter volume with a second filter wall, into which the fluid line section leads into the first filter volume, and the second filter wall is connected on the fluid line section in a fluid-tight manner.

22. The device according to claim 20, wherein: the first and second hollow channel sections respectively have a channel end that is located outside the bag and are connected to a supply line and a discharge line of a hollow line-supported liquid circuit in a fluid-tight manner.

23. The device according to claim 21, wherein: the first and second hollow channel sections respectively have a channel end that is located outside the bag and are connected to a supply line and a discharge line of a hollow line-supported liquid circuit in a fluid-tight manner.

24. The device according to claim 20, wherein: at least one degassing line leads into the first filter volume.

25. The device according to claim 21, wherein: at least one degassing line leads into the first filter volume.

26. The device according to claim 22, wherein: at least one degassing line leads into the first filter volume.

27. The device according to claim 23, wherein: at least one degassing line leads into the first filter volume.

28. The device according to claim 20, comprising: at least one filling line for filling the bag with the liquid leads into the first filter volume.

29. The device according to claim 21, comprising: at least one filling line for filling the bag with the liquid leads into the first filter volume.

30. The device according to claim 22, comprising: at least one filling line for filling the bag with the liquid leads into the first filter volume.

31. The device according to claim 24, comprising: at least one filling line for filling the bag with the liquid leads into the first filter volume.

32. The device according to claim 20, comprising: at least one fluid line leads into the first filter volume.

33. The device according to claim 21, comprising: at least one fluid line leads into the first filter volume.

34. The device according to claim 22, comprising: at least one fluid line leads into the first filter volume.

35. The device according to claim 24, comprising: at least one fluid line leads into the first filter volume.

36. The device according to claim 28, comprising: at least one fluid line leads into the first filter volume.

37. The device according to claim 24, comprising: at least the degassing line and the filling line lead into the first filter volume diametrically opposite of the fluid line section.

38. The device according to claim 28, comprising: at least the degassing line and the filling line lead into the first filter volume diametrically opposite of the fluid line section.

39. The device according to claim 32, comprising: at least the degassing line and the filling line lead into the first filter volume diametrically opposite of the fluid line section.

40. The device according to claim 20, wherein: the first filter insert is fixed in the bag.

41. The device according to claim 21, wherein: the second filter insert is fixed to at least one of in the first filter insert and fluid line section.

42. The device according to claim 39, wherein: the bag is designed to be open one of on the side of the degassing line and the filling line or the bag is closed on the side of a degassing line and the filling line, wherein the degassing line and the filling line pass through the bag wall in a fluid-tight manner.

43. The device according to claim 20, wherein: the flexible bag wall comprises a transparent plastic.

44. The utilization according to claim 20, wherein: an oxygenator is integrated into a hollow line-supported liquid circuit to oxygenate blood of a patient.

45. A method for filling a pump-operated, hollow line-supported liquid circuit with liquid without forming gas bubbles, wherein the hollow line-supported liquid circuit is interrupted at one point and has two fluid line ends, one of which is a supply line and another one of which is a discharge line of the hollow line-supported liquid circuit, comprising steps of: supplying a device according to claim 20, in which a open channel end of the first hollow channel section is connectable to the fluid line section in a fluid-tight manner within the device, connecting the supply line to the first hollow channel section in a fluid-tight manner and connecting the discharge line to the second hollow channel section in a fluid-tight manner; filling the hollow line-supported liquid circuit with liquid by introducing the liquid into the first filter volume, wherein the liquid subsequently flows into the adjacent bag volume through the first filter wall and there into the discharge line of the hollow line-supported liquid circuit, in which the liquid is pumped in the direction from the discharge line to the supply line such that the liquid flows into the first or the second filter volume through the supply line, the first hollow channel section and the fluid line section; completing filling after the hollow line-supported liquid circuit has been completely filled and the device has been filled so that the first filter volume and the adjacent bag volume respectively are partially filled; sustaining fluid flow in the liquid circuit until all liquid within the hollow line-supported liquid circuit and within the bag has passed through the first filter wall at least once; and separating a connection of the first hollow channel section from the fluid line section and producing a fluid-tight connection between the first and the second hollow channel section within the bag during fluid flow through the liquid circuit or after a standstill of the liquid circuit, wherein the separation and connection take place within the bag volume filled with liquid.

46. The method according to claim 45, wherein: liquid from the fluid line section flows through the second filter wall and subsequently through the first filter wall.

47. The method according to claim 45, wherein: at least one oxygenator integrated into the hollow line-supported, liquid circuit is filled.

48. The method according to claim 45, wherein: the bag is emptied and/or at least partially removed from the hollow channel sections after connecting first and the second hollow channel sections within the bag.

49. The method according to claim 45, wherein: filling of the hollow line-supported liquid circuit is completed after at least the fluid line section is completely surrounded by the liquid.

50. The method according to claim 45, wherein: an entire amount of liquid contained in the hollow line-supported liquid circuit and the bag is conveyed through at least the first filter wall until a lessened gas bubble content in the liquid is reached due to the filter effect of at least the first filter unit.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Exemplary embodiments of the invention are described below with reference to the drawings, but the general inventive concept is not limited to the described exemplary embodiments. In these drawings:

[0033] FIG. 1 shows a schematic illustration of the inventive device with a bag for filling a pump-operated, hollow line-supported liquid circuit; and

[0034] FIG. 2 shows an illustration of a filling process of an extracorporeal circulatory system with an oxygenator.

DETAILED DESCRIPTION OF THE INVENTION

[0035] FIG. 1 shows a highly schematic illustration of a bag 1, which a pump-operated, hollow line-supported liquid circuit F can be filled with a liquid FK without forming gas bubbles. For this purpose, the bag 1 has a light-transparent, elastic bag wall 1′ that has a biocompatible and elastically deformable plastic material. The bag wall 1′ at least partially encloses a bag volume 1V. The bag 1 is optionally designed in the form of a sack or conical bag that open on its upper side 1o. It is likewise possible to form the bag 1 with a completely closed bag wall 1′ such that the inner bag volume 1V is also sealed in a fluid-tight manner on the upper bag edge 1o as illustrated in FIG. 1.

[0036] Two hollow channel sections 2 and 3 are arranged on the lower bag edge 1u, which lies diametrically opposite of the upper bag edge 1o, and locally passes through the bag wall 1′ in a fluid-tight manner, wherein both hollow channel sections 2 and 3 respectively have an open channel end 21 and 31 located within the bag 1, as well as an open channel end 22 and 32 located outside the bag 1. Both hollow channel sections 2 and 3 respectively provide open access to the inner bag volume 1V.

[0037] A first filter insert 4 is additionally provided within the bag 1, wherein the filter wall 4′ of this first filter insert has the form of a screening filter that preferably has a filter pore size between 20 and 200 μm, and particularly 40, 80 or 120 μm. In a first variation, the first filter insert is like the bag 1 itself designed in a bag-like or sack-like manner, that is the upper side 4o of the first filter insert 4 is open whereas the filter wall 4′ otherwise encloses the first inner filter volume 4V on all sides. In a second variation, it is also possible to design the first filter insert 4 with a first filter wall 4′ that completely encloses the first filter volume 4V as illustrated in FIG. 1.

[0038] On its lower end 4u, the first filter insert 4 features a fluid line section 5 that openly passes through the filter wall 4′, wherein the outer wall of the fluid line section locally borders on the first filter wall 4′ in a fluid-tight manner. The fluid line section 5 is preferably designed in the form of a short tube section having an elastic material such as PVC. A check valve 5′ is preferably arranged along the fluid line section 5 in order to prevent liquid in the first filter volume 4V or a second filter volume 6V, which is described in greater detail below, from reaching the bag volume 1V. In addition, a flow restricting element 5″ may be arranged on the open end of the fluid line section 5 leading into the filter volume 4V in order to reduce the flow cross section on the end of the fluid line section 5 and to thereby generate a local pressure increase along the fluid line section 5, which has a positive effect on the gas separation process.

[0039] In order to produce a separable fluid-tight connection between the fluid line section 5 and the channel end 21 of the hollow channel section 2, which is located within the bag and made of a harder material than the fluid line section, preferably of polycarbonate, the diameter ratios of the fluid line section 5 and of the hollow channel section 2 are adapted to one another in such a way that the flexible fluid line section 5 can be pushed over the channel end 21 of the first hollow channel section 2 in a fluid-tight manner. The required manipulations are carried out from the outside through the light-transparent and flexible bag wall 1′. The connection produced in the above-described manner can likewise be separated again with suitable manipulations carried out from the outside through the bag wall 1′.

[0040] The second hollow channel section 3 passing through the bag wall 1′ is like the fluid line section 5 made of an elastic material, preferably of PVC, in order to produce a fluid-tight connection between this second hollow channel section and the channel end 21 of the first hollow channel section 2 located within the bag 1 by pushing the open channel end 31 of the second hollow channel section 3, which is located within the bag 1, over the open channel end 21 of the first hollow channel section 2 in a fluid-tight manner.

[0041] Alternative fluid-tight flange connecting mechanisms, which have a suitable design and are known in the art such as Luer-Lock connections, may naturally also be used for producing a separable fluid-tight connection between the fluid line section 5 and the first hollow channel section 2, as well as between both hollow channel sections 2 and 3.

[0042] In the exemplary embodiment illustrated in FIG. 1, the first and the second hollow channel section 2 and 3 are oriented parallel to one another and pass through the filter wall 1′ at a distance from one another on the lower side 1u of the bag 1. It is preferred to arrange the second hollow channel section 3 such that it is inclined toward the first hollow channel section 2 in order to thereby simplify the connection between both hollow channel sections. As an alternative to the illustrated example, it would in this context also be conceivable to arrange the second hollow channel section 3 such that its longitudinal channel axis is in the region of the lateral filter wall 1′ oriented orthogonal to the longitudinal channel axis of the second hollow channel section 2. In FIG. 1, this alternative arrangement is illustrated in the form of the second hollow channel section 3′ drawn with broken lines.

[0043] According to a preferred embodiment, a second filter insert 6 is furthermore provided within the first filter insert 4, wherein the second filter wall 6′ of this second filter insert completely or partially encloses a second filter volume 6V, into which the fluid line section 5 leads, together with the lower side 4u of the first filter wall 4′. The second filter insert 6 is like the first filter insert 4 is a screening filter and preferably has the same pore size as the first filter insert. The second filter insert 6 serves for reliably degassing fluid flows that contain gas and flow through the bag arrangement with high flow speeds amounting to five liters per minute and more, for example seven liters per minute.

[0044] The second filter insert 6 preferably has an opening 6″ that faces away from the filter wall 4′, wherein the liquid flow can reach the first filter volume 4V through the opening after a corresponding flow deviation. In this case, the second filter insert 6 not only serves for providing a first degassing stage, but also the flow deviation such that the liquid flow does not act upon the first filter wall 4′ with a high flow speed.

[0045] A filling line 8 is provided for filling the bag 1 with liquid and passes through the open or closed upper bag edge 1o, as well as the upper side of the first filter insert 4o, such that the liquid supplied through the filling line 8 is initially introduced into the first filter volume 4V. The filling line 8 preferably features a piercer 8′. Furthermore, a degassing line 7 leads into the first filter volume 4V through the upper bag edge 1o and the upper side 4o of the first filter insert 4, wherein the separated gas fractions can respectively escape or be removed by suction through the degassing line. In an alternative embodiment, the degassing line 7 leads into the upper region of the bag volume 1V. The degassing line 7 preferably features a three-way valve 7′ and a check valve 7″. Depending on the intended use, additional fluid lines 9 with a three-way valve may lead into the first filter volume 4V or the bag volume 1V in accordance with the respective pump-operated, hollow line-supported liquid circuit F to be filled with a liquid. The filling line 8 and the degassing line 7 are advantageously arranged on the bag 1 in such a way that they respectively protrude into the bag volume 1V and into the filter volume 4V over the upper bag edge 1o. The additional fluid line 9, in contrast, may be arbitrarily arranged on the bag 1 depending on its technical purpose, wherein this additional fluid line may extend, for example parallel to the first hollow channel section 2 and openly leading into the bag volume 1V or into the filter volume 4V. It is also conceivable to provide a check valve along the additional fluid line 9 in order to prevent backflow.

[0046] The above-described bag-shaped device primarily serves for filling a hollow line-supported liquid circuit F, of which only a discharge line A and a supply line Z are representatively illustrated in FIG. 1, wherein the discharge and supply lines can be respectively connected to the open ends 22 and 32 of the first and second hollow channel sections 2 and 3 in a fluid-tight manner.

[0047] The filling process of the pump-operated, hollow line-supported liquid circuit F is carried out by initially producing a fluid-tight connection between the fluid line section 5 and the end 21 of the first hollow channel section 2. The bag 1 is then filled with a liquid FK through the filling line 8. During this process, the liquid FK flows through the first filter wall 4′ and reaches the pump-operated, hollow line-supported liquid circuit F through the second hollow channel section 3, which is connected to the discharge line A in a fluid-tight manner.

[0048] The bag 1 is filled with liquid FK in such a way that a liquid level FS, which lies at least above the fluid line section 5, but preferably comprises the entire second filter volume 6V, appears within the bag 1. A preferred liquid level FS is indicated in FIG. 1, that is normal atmospheric ambient conditions exist above the liquid level FS. The filling process is completed as soon as the entire liquid circuit F is filled with liquid and the liquid level FS indicated in FIG. 1 approximately appears within the bag 1. Due to the at least one (not-shown) circulation pump integrated along the liquid circuit F, the liquid flows from the bag 1 into the first filter volume 4V, as well as into the second filter volume 6V if a second filter insert 6 is provided, through the discharge line A and the supply line Z. A gas separation respectively takes place as the liquid flows through the filter walls 6′ and 4′. As a result, the liquid FK is completely degassed, that is free of gas bubbles, after it ultimately flows into the adjacent bag volume 1V through the first filter wall 4′.

[0049] The process of degassing the liquid circulating through the bag arrangement and the pump-operated, hollow line-supported liquid circuit connected thereto in a fluid-tight manner is completed after no further gas separation occurs within the first and second filter insert 4, 4. In the simplest case, this can be assessed by a mere visual inspection.

[0050] Furthermore, the fluid line section 5 is respectively disconnected or separated from the first hollow channel section 2 and a fluid-tight connection between the first and the second hollow channel section 3 is subsequently produced. The separating and connecting processes are carried out within the bag volume 1V filled with liquid FK such that any inclusion of gas bubbles whatsoever can be precluded during the connecting process.

[0051] After the fluid-tight connection between the first and second hollow channel sections 2 and 3 has been produced, the bag 1 is emptied and removed from the first and second hollow channel sections 2 and 3. For this purpose, predetermined breaking points S are provided within the bag wall 1′.

[0052] A preferred exemplary application of the inventive bag-shaped device is illustrated in FIG. 2. In this case, the bag-shaped device 1 serves for filling a pump-operated, hollow line-supported liquid circuit F that contains an oxygenator O, as well as a fluid line section referred to as table line T.

[0053] In a first step, the bag 1 is filled with a liquid through the filling line 8. During this process, the supply line Z of the pump-operated, hollow line-supported liquid circuit F is clamped off in order to prevent liquid from reaching the hollow line-supported liquid circuit F opposite to the transport direction defined by the pumps P1/P2. Due to the operation of the pump P1, the liquid flows from the bag 1 into the oxygenator O through the discharge line A, wherein the oxygenator features a shunt line 9′ that serves for ventilating the oxygenator O and leads into the bag in the with a fluid line 9 as described above. After the oxygenator O has been filled accordingly, the second pump P2 is activated and the clamp along the supply line Z is released. Consequently, the liquid flowing out of the oxygenator O reaches the bag 1 through the fluid line section, which is combined into the table line T, and the supply line Z. The above-described degassing of the liquid flow with the help of the at least one filter insert, preferably two separate filter inserts, then takes place within the bag. After the degassing process has been successfully completed, the supply and discharge lines A, Z are connected in a fluid-tight manner and without forming gas bubbles by connecting the first and second hollow channel sections within the bag 1.

[0054] Due to the operation of the pumps P1/P2, the filling process can be completed within a very short time and it can also be ensured that the filling process takes place without forming gas bubbles.

REFERENCE LIST

[0055] 1 Bag-shaped container, bag [0056] 1V Bag volume [0057] 1′ Bag wall [0058] 1o Upper bag edge [0059] 1u Lower bag edge [0060] 2 First hollow channel section [0061] 3 Second hollow channel section [0062] 4 First filter insert [0063] 4V First filter volume [0064] 4′ First filter wall [0065] 4o Upper filter edge [0066] 4u Lower filter edge [0067] 5 Fluid line section [0068] 5′ Check valve [0069] 5″ Flow restricting element [0070] 6 Second filter insert [0071] 6′ Second filter volume [0072] 6V Second filter wall [0073] 6″ Opening [0074] 7 Degassing line [0075] 7′ Three-way valve [0076] 7″ Check valve [0077] 8 Filling line [0078] 9 Fluid line [0079] 21 Open end of first hollow channel section within bag [0080] 22 Open end of first hollow channel section outside bag [0081] 31 Open end of second hollow channel section within bag [0082] 32 Open end of second hollow channel section outside bag [0083] F Liquid circuit [0084] FK Liquid [0085] FS Liquid level [0086] A Discharge line [0087] S Predetermined breaking point [0088] Z Supply line [0089] P1/P2 Pump [0090] O Oxygenator [0091] T Tubing