Reinfusion Tube System, Package and Methods

Abstract

The present disclosure relates to a reinfusion tube system that includes a reinfusion fluid tubing with a pre-pump loop section, a post-pump loop section, and a pump loop section; and one of

a check valve positioned at an end or between the ends of the reinfusion fluid tubing such that it is provided to block fluid flow through the check valve in a direction from the post-pump loop section to the pre-pump loop section, and a check valve adapter including a check valve. The check valve adapter can be configured to be connected to an end or to be positioned between the ends of the reinfusion fluid tubing such that the check valve is provided to block fluid flow through the check valve in a direction from the post-pump loop section to the pre-pump loop section.

Claims

1-15. (canceled)

16. A reinfusion tube system comprising: a reinfusion fluid tubing comprising a pre-pump loop section, a post-pump loop section, and a pump loop section; and either: a check valve positioned at an end or between the ends of the reinfusion fluid tubing, such that the check valve is provided to block fluid flow through the check valve in a direction from the post-pump loop section to the pre-pump loop section, or a check valve adapter comprising a check valve, the check valve adapter being configured to be connected to an end or to be positioned between the ends of the reinfusion fluid tubing such that the check valve is provided to block fluid flow through the check valve in a direction from the post-pump loop section to the pre-pump loop section, wherein a free end of the reinfusion fluid tubing or a free end of the check valve adapter comprises a female Luer lock connector configured for a connection with a male Luer lock connector arranged at an end of an arterial blood line.

17. The reinfusion tube system according to claim 16, wherein the check valve adapter is configured to be connected to an arterial blood line with a first end for providing a fluid connection from the post-pump loop section to the arterial line.

18. The reinfusion tube system according to claim 16, wherein the check valve is arranged in a housing and irremovably attached or removably attachable to the pre-pump loop section, the post-pump loop section, the pump loop section, and/or the check valve adapter.

19. The reinfusion tube system according to claim 16, wherein the check valve has a blocking characteristic such that in the closing direction, the maximum backpressure at which the check valve still blocks a flow is between 6.9 bar and 2.5 bar.

20. The reinfusion tube system according to claim 16, wherein the check valve has an opening characteristic such that the minimum opening pressure is between 200 and 500 mbar.

21. The reinfusion tube system according to claim 16, wherein the check valve has a flow-passing characteristic such that a ratio between a minimum opening pressure and the maximum backpressure is or is below 0.2, wherein the opening pressure is the pressure difference across the check valve in a flow direction from the pre-pump loop section to the post-pump loop section and the backpressure is the pressure difference across the check valve in a flow direction from the post-pump loop section to the pre-pump loop section.

22. The reinfusion tube system according to claim 21, wherein the ratio between the minimum opening pressure and the maximum backpressure is 0.1.

23. The reinfusion tube system according to claim 21, wherein the ratio between the minimum opening pressure and the maximum backpressure is 0.05.

24. A reinfusion tube system package comprising: a system container; and a reinfusion tube system according to claim 16; wherein the reinfusion tube system is comprised within the system container.

25. The reinfusion tube system package of claim 24, wherein the system container comprises a bag or a blister pack.

26. The reinfusion tube system package according to claim 24, the package further comprising an element container, wherein the check valve adapter is comprised within the element container, and wherein the element container is comprised within the system container.

27. The reinfusion tube system package according to claim 26, wherein the element container comprises a bag or a blister pack.

28. A system comprising: an extracorporeal blood treatment device with a priming or reinfusion pump, and the reinfusion tube system according to claim 16, wherein the pump-loop section is positioned in a pump bed of the priming or reinfusion pump.

29. A method for reinfusing blood in a blood tubing set, the method comprising: connecting the reinfusion tube system according to claim 16 or the package according to claim 24 to both a reinfusion port of an extracorporeal blood treatment device and to an arterial line; and supplying a reinfusion fluid from a reinfusion fluid source via the reinfusion port to the reinfusion tube system.

30. A method for preparing an extracorporeal blood treatment device with a reinfusion fluid tubing before reinfusing blood into a patient's vessel, the method comprising: connecting the reinfusion tube system according to claim 16 or the package according to claim 24 to a reinfusion port of the extracorporeal blood treatment device, such that the check valve is positioned or orientated so as to block fluid flow through the check valve in a direction from the post-pump loop section to the pre-pump loop section and/or towards the extracorporeal blood treatment device; or connecting the check valve adapter of the reinfusion tube system or the package to the reinfusion fluid tubing.

31. The method of claim 30, wherein connecting the check valve adapter to the reinfusion fluid tubing comprises connecting the check valve adapter to the post-pump loop. section

32. The method according to claim 30, wherein connecting the check valve adapter to the post-loop section takes place after having primed the arterial blood line via the reinfusion fluid tubing.

33. The method according to claim 30, further comprising priming the arterial blood line via the reinfusion tube system.

34. A method for priming or emptying a blood tubing, the method comprising: connecting the reinfusion tube system according to claim 16 or the package according to claim 24 to both a reinfusion port of an extracorporeal blood treatment device and an arterial line; and supplying liquid via the reinfusion port, and/or air from an air source, to the reinfusion tube system, wherein during the step of supplying liquid or air, no patient is connected to the reinfusion tube system, to the arterial line, and/or to the extracorporeal blood treatment device.

35. A check valve adapter comprising a first tubular element, a second tubular element in fluid communication with the first tubular element, and a check valve arranged in the fluid communication between first and second tubular element.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0093] The attached drawings and associated written description disclose exemplary embodiments:

[0094] FIG. 1 shows a high-level schematic drawing of a reinfusion tube system line with a check valve, the different letters show positions of the check valves according to different embodiments,

[0095] FIG. 2 illustrates schematically some concrete examples of reinfusion tube system with check valve positions,

[0096] FIG. 3 shows schematically embodiments of the check valve adapter having a check valve,

[0097] FIG. 4 shows schematically embodiments of the reinfusion tube system package,

[0098] FIG. 5 shows schematically an embodiment of a dialysis device with a mounted reinfusion tube system for supplying a liquid or air,

[0099] FIG. 6 shows schematically an embodiment of the reinfusion tube system with the reinfusion fluid tube and the arterial and venous blood tubes and the dialyzer with a method for supplying liquid to the extracorporeal blood circuit, and

[0100] FIG. 7 shows schematically embodiments of the method for reinfusion with a reinfusion tube system.

DETAILED DESCRIPTION

[0101] In the drawings, same or similar elements are denoted with the same reference numbers.

[0102] FIG. 1 illustrates a schematic drawing of a reinfusion tube system 10. The reinfusion tube system 10 comprises a flexible fluid tubing with at least three sections, e.g., a pre-pump loop section 20, a post-pump loop section 30, and a pump loop section 40. The pump loop section 40 is positioned between the pre-pump loop section 20 and the post-pump loop section 30.

[0103] The connection between both the pre-pump loop section 20 and the post-pump loop section 30 to the pump loop section 40, respectively, may be provided by a loop connector 50, which may be a hard plastic part to which the ends of the tube sections are attached, for example by gluing or by mechanical fixing.

[0104] For example, by connecting two ends of the pump loop section 40 to the loop connector 50, a loop may be formed. The reinfusion tube system 10 may further comprise a port connector 60 that may be firmly fixed or removably attachable to the pre-pump loop section 20. The port connector 60 may serve as a connector with a lumen to guide fluid out of an extracorporeal blood treatment device into the reinfusion tube system 10.

[0105] Further, the reinfusion tube system 10 includes a check valve 70. The check valve 70 may be positioned anywhere along the reinfusion tube system 10. The check valve 70 blocks fluid flow from entering the reinfusion tube system 10 at the post-pump loop section 30 and exiting the reinfusion tube system 10 at the pre-pump loop section 20 or the port connector 60. This blocking function allows for blocking a flow into the reinfusion tube system 10 at the post-pump loop section 30 and out of the reinfusion tube system 10 at the pre-pump loop section 20 or the port connector 60. With such an orientation, liquid may be supplied from the extracorporeal blood treatment device towards a line that has been connected to the post-pump loop section 30, but flow in the opposite direction is blocked. This also includes the situation that fluid may enter the reinfusion tube system 10, for example at the post-pump loop section 30, but not exit the pre-pump loop section 20. Thus, it is to be understood that the check valve 70 may also be positioned at one of the ends of the reinfusion tube system 10. This positioning at the ends of the reinfusion tube system may be realized in embodiments of the reinfusion tube system using a connector, for example the check valve adapter I, II, III, or a connector (not shown) changing the gender of the line connector 80 at the end of the post-pump loop section 30 from a male Luer lock connection to a female Luer lock connection.

[0106] In another embodiment, the check valve 70 may be integrated into the loop connector 50.

[0107] FIG. 1 schematically shows possible positions for the check valve 70 with respect to the elements of the reinfusion tube system 10. The position of the check valve 70 may be any one of the group of positions, including a position A which corresponds to a position in the post-pump loop section 30, a position B which corresponds to a position between the post-pump loop section 30 and the loop connector 50, a position C which corresponds to a position in the post-pump loop section 30 at a downstream end of the post-pump loop section 30, a position D which corresponds to a position in the pre-pump loop section 20, a position E which corresponds to a position between the pre-pump loop section 20 and the loop connector 50, a position F which corresponds to a position in the pre-pump loop section 20 at an upstream end of the pre-pump loop section 20, a position G which corresponds to a position at a downstream end of the post-pump loop section 30, a position H which corresponds to a position at an upstream end of the pre-pump loop section 20, a position I which corresponds to a position at a downstream end of the port connector 60, a position J which corresponds to a position within the port connector 60, a position K which corresponds to a position at an upstream end of the port connector 60, and a position L which corresponds to a position integrated into the loop connector 50.

[0108] The reinfusion tube system 10, may be fully, partially modular, or a non-modular system.

[0109] In a non-modular system, elements of the reinfusion tube system 10 that are used to reinfuse the blood are non-removably attached to or integral with each other, and only connectors, such as the port connector 60 and the line connector 80 used to connect the reinfusion tube system 10 to the blood line system may be provided. In such a system, the check valve 70 is firmly fixed in its position within the reinfusion tube system 10 as part of the reinfusion tube system 10.

[0110] In a partially modular system, some elements are or may be removably attached to other elements of the system using specific connectors while other elements are firmly fixed to each other. Such a firmly fixed connector may be a line connector 90 that may be used to connect the pre-pump loop sections 20 to the port connector 60. Also, the check valve 70 may be provided as a removably attachable element as part of the reinfusion tube system 10. The pump loop section 40 may be non-removably fixed, for example, glued, to the pump loop connector 50. Also, the pre-pump loop section 20 and/or the post-pump loop section 30 may be non-removably fixed to the pump loop connector 50.

[0111] In the fully modular system, all elements may be removably or releasably fixed to each other.

[0112] The removable or releasable connections between the different elements may be provided, e.g., by Luer connectors and/or other key-lock types of connectors.

[0113] The reinfusion tube system 10 may also comprise one or more, for example, two, three, or more check valves in any one of the positions A, B, C, D, E, F, G, H, I, J, K, L.

[0114] In the exemplary embodiment of FIG. 1, the shape of the reinfusion tube system 10 is call alpha-shaped due to the closed loop formed by the pump loop section 30 and the loop connector 50 and the shape of the pre-pump loop section 20 and the post-pump loop section 30.

[0115] The height of the port connector is optionally greater (by, e.g., 10% to 50% or even more) at a side that corresponds to the two connecting sites for connecting it to the pump-loop section 40 (i.e., in FIG. 1 on its bottom left side) than on its opposing side (i. e., in FIG. 1 on its upper right side).

[0116] In FIG. 2, some embodiments of the pump tube system 10 described with respect to FIG. 1 are schematically shown. The check valve 70 is described in its potential positions as 70A to 70I. The check valve 70A is positioned in the post-pump loop section 30. The check valve 70A is integrated, either directly or via a separate housing into the post-pump loop section 30. The check valves 70B and 70C are positioned at two opposite ends of the post-pump loop section 30, respectively. In some embodiments, the check valve 70C may be connected via a Luer (male-female) connection to the post-pump loop section 30, wherein one of the Luer connectors is connected to the post-pump loop section 30 while the other Luer connector is part of the separate housing in which the check valve is comprised. The separate housing may have a female Luer connector. In a similar manner to check valve 70A the check valve 70D is positioned in the pre-pump loop section 20 and the check valve 70H is positioned at the upstream end of the pre-pump loop section 20. Also comparable to the check valve 70C, the check valve 70H may be connected via a Luer connector to the pre-pump loop section 20. The check valve 70I is connected to the port connector 60. It is noted that the check valve 70H and 70I, in a fully assembled status, may correspond to each other with respect to their respective position and may differ basically only before the reinfusion tube system is assembled.

[0117] It is noted that in FIG. 2 not all possible positions are explicitly illustrated. Rather, with respect to possible positions it is referred FIG. 1.

[0118] FIG. 3 schematically shows three exemplary embodiments I, II, and III of the check valve adapter, each comprising a check valve 70. Check valves are known in the art; for example, they are described in U.S. Pat. No. 6,390,120 B1, the entire, respective disclosure of which is incorporated by reference into this application.

[0119] The check valve adapters I, II, III may each comprise a first tubular element 100I, 100II, and 100III and a second tubular element 110I, 110II, and 110III that respectively define an upstream and a downstream passageway.

[0120] Each first tubular element 100I, 100II, and 100III may optionally be coaxial to its corresponding second tubular element 110I, 110II, and 110III, respectively.

[0121] Each first tubular element 100I, 100II, and 100III and each second tubular element 110I, 110II, and 110III may be embodied as a connector for connecting with the end of a tubing section, e.g., the pre-pump loop section 20, the post-pump section 30 or the pump loop section 40.

[0122] In any of the first tubular elements or in any of the second elements, or between each first tubular element 100I, 100II, and 100III and its corresponding second tubular element 110I, 110II, and 110III, respectively, the check valve may be positioned. In the example of FIG. 3, the check valve is embodied as a diaphragm 120 of elastically deformable material. The diaphragm 120 may be transversely positioned, sealingly cooperating with an optional annular valve seat of the said first tubular element 100I, 100II, and 100III or second tubular element 110I, 110II, and 110III, to form a fluid seal that maintains the check valve 70 in a normally closed position, and in which a predetermined fluid pressure in the said upstream passageway causes a deflection of the diaphragm 120 and consequently or accompanying an opening of the check valve 70.

[0123] It goes without saying that in FIG. 3 the check valve 70 is exemplarily arranged to block fluid flow from the second tubular element 110I, 110II, and 110III into the first tubular element 100I, 100II, and 100III.

[0124] Alternative embodiments of the check valve 70 may encompass as movable element a ball or a piston or any other element, wherein the movable element is configured to close the flow-through opening in the blocking direction.

[0125] The different embodiments I, II, III feature different combinations of the first and second tubular elements to generate fluid connections. It is understood that tubular elements of different types or embodiments may be combined in any combination as the connecting tubing or fluid lines they are connected with are independent from each other.

[0126] In the embodiment I, the first tubular element 100I is a female Luer lock and the second tubular element 110I is a male Luer lock. In the embodiment II, the first tubular element 100II is a hose to which, either on the inside or on the outside, a tube may be attached, for example by gluing or by mechanical fixing such as a friction, and the second tubular element 110II is a hose to which, either on the inside or on the outside, a tube may be attached, for example by gluing or mechanical fixation such as friction or clamping. In the embodiment III, the first tubular element 100III is a female Luer lock and the second tubular element 110III is also a female Luer lock.

[0127] The Luer lock connections may be used for removable or releasable connections, whereas the simple hose structure is preferred for non-removable or non-releasable connections.

[0128] The material of the check valve adapter I, II, III or any other check valve housing may be, e.g., any hard plastic or resin such as polycarbonate. Also, the deformable material of the diaphragm 120 may be any flexible polymer, e.g., silicone.

[0129] FIG. 4 schematically illustrates three embodiments of the reinfusion tube system package, denoted by reference numerals 130, 140 and 150, respectively.

[0130] In each embodiment shown in FIG. 4 the reinfusion tube system package 130, 140 or 150 comprises a system container 160 encompassing the reinfusion tube system 10, e.g., under sterile conditions. Alternatively, the reinfusion tube system package 130, 140 or 150 may consist of the system container 160 and its reinfusion tube system 10.

[0131] The system container 160 may be flexible and may be fully or partially transparent.

[0132] The system container 160 may comprise or be made of a plastic, coated paper, or both, for example the plastic forming a first side and the coated paper forming a second side.

[0133] The system container 160 may be sterilized internally or at the inside thereof.

[0134] The reinfusion tube system 10 may be provided as two, three or more physically separate elements. This is schematically shown in the exemplary package 130 wherein the sections 20, 30 and 40 are connected to each other via the loop connector 50, whereas the check valve 70 is provided as a separate component within the system container 160 as is the port connector 60.

[0135] In another embodiment, the package 140 corresponds to the package 130 with the difference that the check valve 70 is provided within the system container 160 inside a separate element container 170. The same may apply to the port connector 60.

[0136] It is noted that in any one of the embodiments the element container 170 may comprise only one item and/or only one check valve 70 or only one check valve adapter I, II, III.

[0137] What has been stated for the system container 160 herein may hold true for the element container(s) 170 as well, e.g., with respect to sterility, transparency, material and the like.

[0138] In yet another embodiment of the package 150, all elements are pre-assembled and provided together as one physical system or unit in the system container 160.

[0139] In any embodiment, another tubing or further tubing lines such as an arterial blood tube and/or a venous blood tube and/or additional accessories may be comprised within the system container 160.

[0140] Hence, in the package 130 the system container 160 comprises both the reinfusion fluid tubing and the check valve 70 (which can be provided as part of a check valve adapter) (and optionally also the port connector 60), the reinfusion fluid tubing still being separate from the check valve 70 (and also from the port connector 60). For using the reinfusion tube system 10, the check valve 70 (and also the port connector 60) have to be connected to the reinfusion fluid tubing before reinfusing blood. Providing them separately from each other may allow use of the reinfusion fluid tubing also during the priming step during which a check valve is not required.

[0141] As in the package 130, in the package 140 the reinfusion fluid tubing and the check valve 70 (and optionally also the port connector 60) are separate from each other. In this embodiment, they are separately comprised in separate containers.

[0142] In the package 150, however, the components comprised in the package are pre-connected to each other which may contribute to avoiding hygienic risk.

[0143] In FIG. 5, an exemplary embodiment of the extracorporeal blood treatment device 210 with a mounted or set-up reinfusion tube system 10, an arterial line 180, a venous line 190, and a dialyzer 200 is illustrated.

[0144] The extracorporeal blood treatment device 210 may further comprise one or more of the following elements: a priming and/or reinfusion pump 220 to position the pump loop section 40 of the reinfusion tube system 10 and to pump liquid from the liquid port through the reinfusion tube system 10, a blood pump 230 to pump blood through the arterial line 180, an arterial clamp 240 and a venous clamp 250 to block the flow in the arterial line 180 and the venous line 190, respectively, an arterial pressure sensor 260, a Heparin pump 270 that may be used to pump Heparin from an Heparin source to the arterial line 180 via a tubing line 280. The arterial pressure sensor 260 may be in a separate housing connected to the arterial line 180, the housing may have a circular base body, an inlet and an outlet, one side of the housing being optionally open and optionally covered by a flexible membrane so that the pressure prevailing within the housing has an effect on the form of the membrane.

[0145] This configuration in which the venous line 190 is connected to a drain port of the treatment device 210 may be used for priming or emptying the tube system comprising the reinfusion tube system 10, the arterial line 180 and the venous line 190.

[0146] FIG. 6 schematically shows the tubing of FIG. 5 in a connected state including the reinfusion tube system 10 in combination with an extracorporeal blood system comprising an arterial line 180, a venous line 190 and a dialyzer 200.

[0147] The arrangement illustrated in FIG. 6 is prepared or suitable for blood reinfusion as for the blood reinfusion process the venous line 190 is still connected to the patient's blood system. Hence, when liquid is entered along the reinfusion tube system 10 and into the arterial line 180, the blood is pushed along the arterial line 180 and back into the patient P.

[0148] A check valve (not shown in FIG. 6 and, hence, not denoted) in, or attached to, the reinfusion fluid tubing of the reinfusion tube system 10 reduces the risk that blood or other potentially problematic liquids can move, in a retrograde direction, from the blood tubing lines 180, 190 along the sections of the reinfusion fluid tubing and flow into the dialysis device's fluid circuit. The position of the check valve may be any position, e.g., as described when referring to FIGS. 1 and 2.

[0149] FIG. 7 illustrates an embodiment of the method for reinfusion.

[0150] Before the reinfusion is started, the followings steps may be conducted, wherein the sequence of the steps shall not be defined by the listing below unless explicitly stated. For example, the separate elements may be attached to the extracorporeal blood treatment device 210 first and they may then be connected, or they may be first connected and then attached, or one element may be attached first before connecting and another one may be connected first before attaching:

[0151] In step 290, the tubing and the dialyzer 200 may be attached to the extracorporeal blood treatment device 210, meaning they are being brought in a functional position in which they are used during the following processes. For example, the reinfusion fluid tubing is positioned with its pump-loop section 40 in contact with a rotor of a pump of the extracorporeal blood treatment device 210. The arterial blood line 180 may be positioned with a blood pump-loop thereof in contact with a rotor of a blood pump 230 and in contact with the arterial pressure sensor 260 housed in an arterial pressure sensor housing.

[0152] In a step 300, the tubing is connected. This means the reinfusion fluid tubing is connected with a first end to a supply port of the extracorporeal blood treatment device 210, which may be a dialysis device, and with the second end to an end of the arterial blood line 180, either directly or via a check valve adapter I, II, III, wherein the check valve adapter I, II, III may comprise the check valve 70.

[0153] The second end of the arterial line 180 is connected to a port of the dialyzer 200, e.g., the blood chamber of the dialyzer 200, whereas another port, e.g., another port of the blood chamber of the dialyzer 200, is connected to an end of the venous blood line 190, and the second end of the venous blood line 190 is connected to a drain port of the extracorporeal blood treatment device 210 (here: dialysis device), the drain port being part of a fluid circuit for guiding the fluid towards a drain.

[0154] In step 310, the extracorporeal blood circuit including the dialyzer 200 may be filled or primed with fluid via the reinfusion tube system 10.

[0155] In step 320, the reinfusion tube system 10 is disconnected from the end of the arterial blood line 180, and the venous blood line 190 is disconnected from the drain port. The arterial end and the venous end which have been disconnected from each other are connected to the blood circuit of the patient, e.g., via needles.

[0156] In step 330, the treatment is conducted by conveying liquid through the extracorporeal blood circuit.

[0157] After the treatment, in step 340, the arterial blood line 180 is being disconnected from the patient's blood circuit and is being connected to the reinfusion fluid tubing. If the check valve 70 is integrated into a separate transfer piece or connector element such as the check valve adapter I, II, III, this component must be used when the fluid connection from the supply port to the arterial blood line 180 via the reinfusion fluid tubing is established, either between the supply port and the reinfusion fluid tubing or between the reinfusion fluid tubing and the end of the arterial blood line 180.

[0158] In step 350, the liquid is being transferred from the supply port towards the arterial blood line 180 and the blood is being pushed by this liquid into the patient.

[0159] When the reinfusion is finished, in step 360, the venous blood line 190 may be disconnected from the patient P.

REFERENCE NUMERALS

[0160]

TABLE-US-00001 10 reinfusion tube system 20 pre-pump loop section 30 post-pump loop section 40 pump loop section 50 loop connector 60 port connector 70 check valve 70A to 70I check valves in particular positions 80 line connector 90 line connector 100I, 100II, 100III first tubular element 110I, 110II, 110III second tubular element 120 diaphragm 130 reinfusion tube system package 140 reinfusion tube system package 150 reinfusion tube system package 160 system container 170 element container 180 arterial blood line 190 venous blood line 200 dialyzer 210 extracorporeal blood treatment device 220 priming or reinfusion pump 230 blood pump 240 arterial clamp 250 venous clamp 260 arterial pressure sensor 270 Heparin pump 280 tubing line 290 step 300 step 310 step 320 step 330 step 340 step 350 step 360 final step A to L position of check valve I, II, III check valve adapter with check valve P patient