Connection piece and substance exchange device with connection piece

Abstract

The invention relates to a connection piece (V) for connecting a blood pump (B) to a substance exchanger (G), comprising an elastic hose element with an inflow port (1), in particular attachable to the pressure connector of a blood pump (B), and with an outlet port (2), in particular attachable to the blood inlet port of a substance exchanger (G), wherein, starting from the inflow port (1), the hose element comprises an ascending hose section (3) which transitions via an arch (4) into a descending hose section (5), the end of the latter being formed by the outlet port (2), wherein a removal channel (6) is arranged in the arch (4), in particular at the highest point of the latter.

Description

[0001] Connector and mass transfer device with connector

[0002] The invention relates to a connecting piece for connecting a blood pump to a material exchanger, comprising an elastic hose element with an inflow connection, in particular which can be connected to the pressure port of a blood pump, and with an outlet connection, in particular which can be connected to the blood inlet port of a material exchanger.

[0003] The invention also relates to a substance exchange device for blood comprising a blood pump for conveying blood and a substance exchanger for treating the blood conveyed by the blood pump, in particular for treatment by exchanging a substance between the blood and a second exchange medium.

[0004] Preferably, such a material exchanger in the invention can be formed by a gas exchanger, in particular in which blood can be enriched with oxygen and from which carbon dioxide can be eliminated.

[0005] A mass exchanger according to the invention comprises, for example, a chamber divided into two chamber regions by at least one substance-permeable, in particular gas-permeable, membrane. Blood can be conducted through one of the chamber regions and a second exchange medium, preferably a gas, can be conducted through the other, with which a mass exchange, preferably a gas exchange, is to take place through the at least one membrane. Preferably, each chamber region has inlet and outlet ports provided for the respective medium (blood / second exchange medium or gas). According to the invention, the blood inlet port of the mass exchanger is preferably connectable to the outlet port of the connecting piece.

[0006] In the prior art, connectors of the type mentioned are often designed as simple hose pieces. This can lead to problems such as the fact that the hose and the associated

[0007] The integrity of the device components is not always guaranteed. Furthermore, the collection of blood samples from a device connected to the tube is problematic. For this purpose, the current state of the art often incorporates a rigid PC connector with a Luer connection, which promotes thrombus growth, both at the Luer connection itself and at the transition between the tube and the PC connector.

[0008] Another disadvantage is that simple tubes are often used in pre-assembled lengths that are too long for the application, which impairs clarity and unnecessarily increases the blood volume, thus impairing the blood compatibility of the entire system.

[0009] Against this background, it is an object of the invention to provide a connecting piece which overcomes these disadvantages, in particular which offers a safe venting of the guided blood and preferably also a possibility for taking samples.

[0010] Furthermore, it is an object to improve a mass transfer device of the type mentioned at the outset with a connecting piece according to the invention.

[0011] This object is achieved by a connecting piece of the type mentioned at the outset, in which the hose element, starting from the inlet connection, comprises a hose section which ascends in height and which merges via a bend into a hose section which descends in height and whose end is formed by the outlet connection, wherein a removal channel is arranged in the bend.

[0012] In a preferred embodiment, such a sampling channel can be arranged, for example, at the highest point of the arch and / or at least open into the arch at the highest point. In another preferred embodiment, it can also be provided that the sampling channel is laterally offset from the highest point of the arch, in particular so that it is arranged below the highest point of the arch and / or at least opens into the arch there. This can, for example, promote ergonomic blood sampling through the sampling channel. It can then be provided that the connecting piece is tilted to remove gas bubbles from the arch, in order to bring the sampling channel and / or at least its opening into the arch to the highest point of the arch in the tilted state solely for the purpose of removing the gas bubbles.

[0013] Such a connecting piece is preferably inherently stable, ie, despite preferably existing flexibility / elasticity, it has a predetermined shape or a predetermined profile of the type described when no external forces act on the connecting piece. The connecting piece is preferably made of at least one flexible plastic, particularly one that is compatible with blood, e.g., a silicone or PVC or several silicone components.

[0014] The above-mentioned courses are present at least in a proper use of the connecting piece when it is arranged between a blood pump and a mass exchanger and these elements are arranged in an operational position in the room.

[0015] The invention ensures that, when used as intended, any bubble-like gas components of the blood collect in the bend of the connecting piece, which forms the highest point of the connecting piece. Since the tubing sections on both sides of the bend slope downwards, any gas bubble remains in the bend when the blood flow is stopped or slowed. The extraction channel in the bend thus makes it possible, according to the invention, to remove a gas bubble from the connecting piece, in particular by simply opening the extraction channel or by suction through the extraction channel. The extraction channel can also be used to withdraw blood samples from the connecting piece through the extraction channel. The extraction channel can therefore fulfil several functions.

[0016] The preferred inherent stability further ensures that a blood pump and a connected mass exchanger maintain a positioning relative to each other that is defined by the inherent stability of the connecting piece.

[0017] In a preferred embodiment, the invention provides for a valve to be connected to the sampling channel or for a valve to be integrated into the sampling channel. Using such a valve, the sampling channel can be easily opened and closed again to fulfill a desired function, e.g., venting the connector or taking a blood sample.

[0018] When integrating the valve into the extraction channel, it is preferably provided that the extraction channel at least partially, in particular completely, forms the housing of the valve, in which a valve element of the valve is rotatably mounted. The extraction channel can, for example, have an enlarged cross-sectional area in which the valve element is rotatably mounted.

[0019] Such a valve element can be, for example, an element with a circular cross-section, in particular a pin element, which has a radially extending through-bore which can be aligned in alignment or transversely to the extraction channel by turning.

[0020] Preferably, the valve element is arranged in sections in the upper wall area of ​​the bend. Based on the diameter of the rotatable valve element, it can preferably be arranged for at least 10% of its diameter to be arranged in the upper wall area of ​​the bend.

[0021] Such at least partial integration of the valve element into the upper wall of the bend also achieves a high degree of stability for the resulting valve. In this case, the upper wall area of ​​the bend and the extraction channel preferably partially form a housing for the valve element.

[0022] In all possible embodiments, the withdrawal channel can preferably be provided with a connection element, preferably a Luer lock, at its free end. This allows standardized medical components to be connected to the withdrawal channel.

[0023] Furthermore, in all possible embodiments, it is preferred that the inlet connection and / or the outlet connection on the inside of the tube have a form-fitting structure for connecting a hose nozzle. This ensures a secure connection to the blood pump and / or gas exchanger if they have correspondingly designed hose nozzles.

[0024] A preferred embodiment provides that the length of the vertically ascending hose section between the inlet connection and the bend is shorter than the length of the vertically descending hose section between the bend and the outlet connection. This enables, for example, a preferred embodiment in which a blood pump is arranged in the upper area or even completely above a mass exchanger in a mass exchange device implemented with the connecting piece. This provides a particularly good overview of all components.

[0025] However, there may also be other configurations in which the length ratios are reversed or both hose sections on both sides of the bend are of the same length.

[0026] A preferred embodiment of the invention provides that the removal channel, in particular also areas of the bend directly adjacent to the removal channel, is made of the same, preferably elastomeric material as the remaining area of ​​the bend and the hose sections adjacent thereto. In this case, the connecting piece can be produced particularly easily from a single material, e.g. by injection molding. An alternative embodiment preferably provides that the removal channel, in particular also areas of the bend directly adjacent to the removal channel, is made of a different, preferably elastomeric material than the remaining area of ​​the bend and the hose sections adjacent thereto. For example, for the removal channel and if applicable.Adjacent areas of the bend should be made of a stronger and / or less elastic material than the remaining areas of the bend and the adjacent hose sections. Manufacturing can be achieved, for example, using two-component injection molding. This can result in more stable areas subject to greater wear and tear.

[0027] It is preferably provided that the removal channel and the bend as well as the hose sections adjacent thereto are formed in one piece, in particular are produced by 2-component injection molding, preferably are connected to one another by a material fit.

[0028] However, a design can also be provided in which the removal channel is designed separately from the bend (and the adjacent hose sections) and is detachably attached to the bend.

[0029] In such an embodiment, an outwardly projecting receiving area is preferably formed on the arch, in particular an undercut receiving area is formed.

[0030] A rotatable valve element, for example, is inserted or at least insertable into this receiving area, wherein the extraction channel, in particular at least its free end area, comprises or forms a bell that covers the valve element and the receiving area and is attached or at least attachable to the receiving area. Such attachment can be achieved, for example, by locking the bell to the receiving area.

[0031] Alternatively, the extraction channel, in particular the extraction channel having a valve, is inserted into the receiving area with a channel section facing the bend or is at least insertable, preferably clamped therein. For secure fastening, a securing element, e.g., a cable tie, can be placed around the receiving area to exert a radial securing force.

[0032] If the extraction channel is formed separately from the bend (and the adjacent tube sections), it may also be preferred in another embodiment that a fastening opening is provided on the bend, to / in which the extraction channel is attached or at least attachable. The fastening opening is preferably designed as a through-opening that opens into the lumen of the bend, in particular wherein the fastening openings are arranged in a wall region of the bend that is at least not thickened compared to other adjacent bend regions.

[0033] Furthermore, the removal channel has a collar at its end region facing the arch, wherein in one possible embodiment the collar is pushed or at least can be pushed through the opening into the interior of the arch, wherein the edge of the opening can be engaged behind with the collar and a detachable counter element is provided opposite the collar, wherein an edge region surrounding the opening is enclosed or at least can be enclosed between the collar and the counter element. On the side of the openings facing the lumen of the arch, the wall thickness of the arch can be reduced in an annular region surrounding the openings, whereby a recess is formed in which the collar is received or at least can be received, in particular without protruding beyond the inner surface of the arch.For example, the collar may be concave on the side facing the lumen of the arch, preferably with the curvature of the collar being adapted to the curvature of the inner surface of the arch.

[0034] Alternatively, it is preferably provided that the collar is fastened in the thickness of an upper wall region of the arch, preferably embedded therein in a materially bonded and / or form-fitting manner, preferably wherein a radially inwardly open annular groove is provided around the opening in the upper wall region, into which the collar is inserted.

[0035] The annular groove is preferably arranged within the thickness of the wall area of ​​the sheet, so that material of the wall area is present below and above the annular groove.

[0036] By using a connecting piece according to the invention, a mass exchange device for blood can preferably be formed, which comprises a blood pump for conveying blood and a mass exchanger for treating the blood conveyed by the blood pump, wherein the pressure port of the blood pump is connected to the blood inlet port of the mass exchanger via the connecting piece.

[0037] The blood pump and the mass exchanger can preferably be attached to each other, particularly in a positionally stable manner. Attachment can also be achieved solely through the connecting piece or through additional connecting elements.

[0038] Furthermore, it is preferably provided that the blood pump is attached to the upper housing cover of the mass exchanger, in particular next to its blood inlet port, preferably with the blood pump being integrated into the wall of the mass exchanger cover. Likewise, the blood pump can be attached to the lateral housing wall of the mass exchanger extending between the bottom and top of the mass exchanger, preferably with the blood pump being integrated into the housing wall.

[0039] Embodiments of the invention are explained in more detail with reference to the figures.

[0040] Figures 1 to 7 show different variants of a first embodiment of a connecting piece V according to the invention.

[0041] These variants share the features described below, unless the differences are expressly pointed out. The connecting piece V according to the invention is in all cases formed by a hose element having an inflow connection 1 at one end and an outlet connection 2 at the other end. In the intended arrangement of the connecting piece V shown here, the hose element has, starting from the inflow connection 1, a hose section 3 that ascends in height and, via a bend 4, transitions into a hose section 5 that descends in height, the end of which is formed by the outlet connection 2. A withdrawal channel 6 is arranged in the bend 4, preferably at its highest point. This withdrawal channel serves to withdraw blood from the connecting piece and is also suitable for withdrawing or releasing air bubbles that can collect in the bend 4 when blood flows through the connecting piece V.

[0042] In all the embodiments shown in Figures 1 to 7, the ascending hose section 3 is shorter than the descending hose section 5. This is only an example. The length ratios can also be reversed, or the lengths can be the same.

[0043] The following describes the details in which the connecting pieces V of the various versions differ.

[0044] Figures 1A to 1D show variants of an embodiment in which a valve is integrated into the extraction channel 6, wherein the valve has a rotatable valve element 7 which is arranged partially in the upper wall region of the bend 4. For this purpose, the extraction channel 6 has an enlarged cross-section in which the valve element 7 is rotatably inserted. The valve element has a circular cross-section (in all versions). Relative to its diameter, it can be provided that the valve element 7 is integrated into the thickness of the wall region to at least 10% of its diameter. In the variant of Figure 1A, both the inlet connection 1 and the outlet connection 2 have a form-closing structure on the inside of the hose for connecting a hose nozzle.In Figure 1B, only the inlet connection 1, in Figure 1C only the outlet connection 2 and in Figure 1C none of the connections has such a form-closing structure for connecting a hose nozzle.

[0045] This type of design with form-locking structures can also be provided in all other embodiments of Figures 2 to 7, although there the connections 1 and 2 are shown without form-locking structures.

[0046] In Figure 2, the design is such that the extraction channel 6 itself does not include a valve, but one can be attached to it. For example, the extraction channel 6 has a connection element, preferably a Luer lock, at its free end. A fluid line element with a valve 7 can be plugged or screwed onto this.

[0047] The embodiment of Figure 3 differs from that of Figure 2 in that the removal channel 6, in particular also regions 4a of the bend 4 immediately adjacent to the removal channel, are formed from a different, preferably stronger and / or less elastic material than the remaining region of the bend 4 and the hose sections 3 and 5 adjacent thereto, preferably from an elastomeric material.

[0048] In Figures 1 and 2, however, the removal channel 6, in particular also the regions 4a of the bend 4 immediately adjacent to the removal channel, are made of the same, preferably elastomeric material as the remaining region of the bend 4 and the hose sections 3, 5 adjacent thereto.

[0049] In all cases, silicone or PVC can preferably be selected as the material, in particular materials with different hardnesses, if the connecting piece V is not made of a single material, as in Figure 3. According to the embodiments of Figures 4 to 7, in various variants the extraction channel 6 is formed separately from the bend 4; the extraction channel 6 and the bend 4 are thus, at least originally, separately manufactured components. In Figures 4 to 6, the extraction channel 6 can be releasably attached to the bend 4, for example, while in Figure 7 it can also be integrally connected to the bend, for example by gluing.

[0050] In Figures 4 and 5, an outwardly projecting receiving area 4b is formed on the arch 4, in particular an undercut receiving area 4b.

[0051] Figure 4 shows an embodiment in which a rotatable valve element 7 is inserted into the receiving area 4b and the removal channel 6 comprises or forms a bell 6a covering the valve element 7 and the receiving area 4b, which is fastened to the receiving area 4b.

[0052] In Figure 5, the removal channel 6, which has a valve, is inserted into the undercut receiving area 4b with a channel section 6b facing the bend, preferably clamped therein. The fastening is achieved, for example, by a cable tie.

[0053] In Figures 6 and 7, a fastening opening 4c is provided on the bend 4, to / in which the removal channel 6 is fastened, the removal channel 6 having a collar 6b ​​at its end region facing the bend 4.

[0054] According to the embodiment of Figure 6, the collar 6b ​​is inserted through the opening 4c into the interior of the arch 4, i.e., its lumen, with the collar 6b ​​engaging behind the edge of the opening 4c. Furthermore, a preferably detachable counter element 6c is provided opposite the collar 6b, with an edge region surrounding the opening 4c being enclosed between the collar 6b ​​and the counter element 6c.

[0055] In the embodiment of Figure 7, the collar 6b ​​is fixed in the thickness of an upper wall area of ​​the arch 4, preferably in

[0056] REPLACEMENT LEAF (RULE 26) embedded in a material-locking and / or form-fitting manner, wherein a radially inwardly open annular groove 4d is provided around the opening 4c in the upper wall area, into which the collar 6b ​​is inserted. To achieve a material-locking connection, this annular groove 4d can be filled with an adhesive before inserting the removal channel 6.

[0057] Figures 8 to 11 show various uses of the connecting piece V in a mass exchange device for blood, each with a blood pump B for pumping blood and a mass exchanger G for treating the blood pumped by the blood pump B by mass exchange with a second exchange medium, wherein the pressure port of the blood pump B is connected to the blood inlet port of the mass exchanger G via a connecting piece V. In particular, the further blood flow is not visualized, and in particular also not the line routing and the ports used for the second exchange medium, in particular gas.

[0058] In the embodiment of Figure 8, the blood pump B is attached above the upper housing cover G of the mass exchanger G, in particular to this, here next to its blood inlet port.

[0059] It may also be provided, although not shown here, that the blood pump B is integrated into the wall of the mass exchanger cover. The attachment of the blood pump B to the cover of the mass exchanger G can be achieved, for example, only via the connecting piece or also additionally via connecting elements, e.g., extending between the underside of the blood pump B and the surface of the housing cover of the mass exchanger G.

[0060] In Figure 9, the blood pump B is also above the mass exchanger G but only partially above it. Here too, the blood pump B can be attached to the cover of the mass exchanger G, for example only via the connecting piece or additionally via connecting elements, for example which extend between the underside of the blood pump B and the surface of the housing cover of the mass exchanger G. Figure 10 shows an embodiment in which the blood pump B is arranged laterally next to the mass exchanger. Here, the blood pump B can be attached to the lateral housing wall of the mass exchanger G running between the underside and top of the mass exchanger, for example by means of connecting elements which extend between these areas.

[0061] Figure 11 shows an embodiment in which the mass transfer device consisting of blood pump B, connecting piece V, and mass exchanger G are attached to another element, e.g., a bracket. For this purpose, only blood pump B and mass exchanger G can have connections to the other element.

[0062] All embodiments show that a clear arrangement of the blood pump to the mass exchanger can be created with a connecting piece according to the invention, whereby the connecting piece combines the functionality of venting and blood withdrawal.

Claims

Patent claims 1. A connecting piece (V) for connecting a blood pump (B) to a mass exchanger (G), comprising an elastic hose element with an inflow connection (1), in particular which can be connected to the pressure port of a blood pump (B), and an outlet connection (2), in particular which can be connected to the blood inlet port of a mass exchanger (G), characterized in that the hose element, starting from the inflow connection (1), comprises a hose section (3) which ascends in height and which, via a bend (4), merges into a hose section (5) which descends in height and whose end is formed by the outlet connection (2), a removal channel (6) being arranged in the bend (4), in particular at its highest point.

2. Connecting piece according to claim 1, characterized in that a valve is connected to the extraction channel or a valve is integrated into the extraction channel, preferably wherein the valve has a rotatable valve element (7) which is arranged in regions, more preferably which is arranged to at least 10% of its diameter, in the upper wall region of the bend (4).

3. Connecting piece according to one of the preceding claims, characterized in that the removal channel (6) has a connecting element, preferably a Luer lock, at its free end.

4. Connecting piece according to one of the preceding claims, characterized in that the inlet connection (1) and / or the outlet connection (2) has a form-locking structure on the inside of the hose for connecting a hose nozzle.

5. Connecting piece according to one of the preceding claims, characterized in that the length of the vertically ascending Hose section (3) between inlet connection (1) and bend (4) is smaller than the length of the hose section (5) which decreases in height between bend (4) and outlet connection (2).

6. Connecting piece according to one of the preceding claims, characterized in that the removal channel (6), in particular also regions (4a) of the bend (4) immediately adjacent to the removal channel a. is made of the same, preferably elastomeric material as the remaining region of the bend (4) and the hose sections (3, 5) adjacent thereto, or b. is made of a different material, preferably a stronger and / or less elastic material, than the remaining region of the bend (4) and the hose sections (3, 5) adjacent thereto, preferably an elastomeric material.

7. Connecting piece according to one of the preceding claims, characterized in that the removal channel (6) and the bend (4) as well as the hose sections (3, 5) adjoining thereto are formed in one piece, in particular are produced by 2-component injection molding.

8. Connecting piece according to one of the preceding claims 1 to 6, characterized in that the removal channel (6) is formed separately from the bend (4), preferably being detachably fastened to the bend (4).

9. Connecting piece according to claim 8, characterized in that an outwardly projecting receiving area (4b) is formed on the bend (4), in particular an undercut receiving area (4b) is formed, a. into which a rotatable valve element (7) is inserted or at least insertable and the removal channel (6) comprises or forms a bell (6a) covering the valve element (7) and the receiving area (4b), which is fastened or at least fastenable to the receiving area (4b), or b. into which the removal channel (6), in particular the removal channel (6) having a valve with a channel section (6b) pointing towards the bend, is inserted or at least can be inserted, preferably can be clamped therein.

10. Connecting piece according to claim 8, characterized in that a fastening opening (4c) is provided on the bend (4), to / in which the removal channel (6) is fastened or at least can be fastened, wherein the removal channel (6) has a collar (6b) at its end region facing the bend (4) and a. the collar (6b) is pushed or at least can be pushed through the opening (4c) into the interior of the bend (4), wherein the edge of the opening (4c) can be gripped behind with the collar (6b) and a counter element (6c), preferably a detachable counter element (6c), is provided opposite the collar (6b), wherein an edge region surrounding the opening (4c) is enclosed or at least can be enclosed between the collar (6b) and the counter element (6c), or b.the collar (6b) is fastened in the thickness of an upper wall region of the arch (4), preferably being embedded therein in a materially bonded and / or form-fitting manner, preferably wherein a radially inwardly open annular groove (4d) is provided around the opening (4c) in the upper wall region, into which the collar (6b) is inserted.

11. A mass exchange device for blood comprising a blood pump (B) for pumping blood and a mass exchanger (G) for treating the blood pumped by the blood pump (B), wherein the pressure port of the blood pump (B) is connected to the blood inlet port of the mass exchanger (G) via a connecting piece (V) according to one of the preceding claims.

12. Mass exchange device according to claim 11, characterized in that the blood pump (B) and the mass exchanger (G) are fastened to one another, in particular in a positionally stable manner. characterized in that the blood pump (B) is fastened to, in particular to, the upper housing cover (G) of the mass exchanger (G), in particular next to its blood inlet port, preferably wherein the blood pump (B) is integrated into the wall of the mass exchanger cover.

14. Mass exchange device according to one of the preceding claims, characterized in that the blood pump (B) is fastened to the lateral housing wall of the mass exchanger (G) extending between the mass exchanger bottom and top, preferably wherein the blood pump (B) is integrated into the housing wall.

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