Pediatric drip chamber

Abstract

The invention relates to a device for separating gas bubbles from a medical fluid, in particular blood, comprising a venous chamber with a reduced volume and comprising an optionally removable filling body. The invention also relates to a tubing set for use in a device for extracorporeal blood treatment.

Description

[0001] 240062W001

[0002] Fresenius Medical Care Deutschland GmbH

[0003] D-61352 Bad Homburg

[0004] Pediatric drip chamber

[0005] Technical field

[0006] The invention relates to a venous chamber with reduced volume and a tubing set for use in a device for extracorporeal blood treatment.

[0007] background

[0008] In extracorporeal hemodialysis (ECH), blood is continuously drawn from the patient and purified outside the body. The blood is then returned to the patient. During the treatment, some of the blood remains outside the patient. The volume of blood outside the patient during treatment depends on the total volume of the extracorporeal blood circuit. The total volume of the ECH is the sum of the volumes of its individual components, such as the blood tubing, the dialyzer, and the venous drip chamber. The total volume of the ECH influences the minimum weight a patient must have to safely undergo ECH. For most adult patients, this is not a problem.However, there is a need to also be able to perform extracorporeal blood therapy for patients with low body weight.

[0009] For the treatment of patients with low body weight, especially children, there are special dialyzers with a smaller diameter. The length and diameter of the blood tubing can be shortened or reduced within certain limits to save volume. This allows the minimum weight requirement for patients to be further lowered, ultimately making life-saving hemodialysis treatment possible even for lightweight patients.

[0010] However, a persistent problem is that in most cases, dialysis machines must be used whose extracorporeal blood treatment module (EBM) is designed for treating adults. This means that the volume of some components of the external blood circulation cannot be reduced without affecting the dialysis machine's function. Venous drip chambers are one example. These are used to remove air bubbles and clots from the treated patient's blood before it is re-infused.

[0011] Venous drip chambers, as known to those skilled in the art, have a cylindrical or conical shape and comprise an inlet on the top and at the bottom end a clot catcher and an outlet to which the venous line to the patient is attached.

[0012] This venous chamber is held in place by a device, such as a clamp, which may incorporate a sensor for measuring the fill level. The measurement is performed using ultrasonic or capacitive evaluation of the chamber. The fill level sensor monitors the fill level of the venous chamber and triggers an alarm as soon as the fill level falls below a certain value.

[0013] The volume of the venous chamber cannot be reduced by decreasing its length or outer diameter without impairing the function of the level sensor. Likewise, treatment should not be performed when the level in the venous drip chamber is too low to prevent the infusion of microbubbles.

[0014] A solution to this problem is a venous drip chamber according to claim 1. This venous drip chamber has the same external dimensions and a similar structure as a conventional drip chamber, for example from Figure 2, but includes a modified lid with a cylindrical or conical insert (50) that extends along the longitudinal axis of the venous chamber and projects into it, thus reducing the volume of the venous chamber. This arrangement does not affect the level measurement or the flow or air separation properties of the chamber. In pediatric treatment, lower flow rates are used, so that the remaining annular gap between the outer wall of the venous chamber and the insert (50) exhibits approximately the same flow velocities as a venous drip chamber according to Figure 2.

[0015] Further embodiments are the subject of the dependent claims.

[0016] Since the embodiments of the venous drip chambers shown in Figures 2 and 3 differ only in the lid and the other components are the same, the costs for a pediatric chamber are reduced accordingly.

[0017] No different procedure needs to be learned for upgrading a dialysis machine with a blood tubing set comprising a venous chamber according to claim 1. Since a pediatric venous drip chamber according to claim 1 and a venous drip chamber from Figure 2 have the same external dimensions, upgrading a dialysis machine with a blood tubing set according to claim 9 comprising a venous chamber according to claim 1 or Figure 3 proceeds in the same way as upgrading with a venous chamber from Figure 2. This applies analogously to the venous chambers shown in Figures 4 and 5.

[0018] Terms relating to spatial orientation, such as "above" and "above" as well as "below" and "below", refer to the orientation of the venous drip chamber, which is ready for operation and attached to a dialysis machine.

[0019] The term "inside" refers to the interior of the venous chamber or filling material. The term "outside" refers to the space surrounding the venous chamber. Flow direction terms, such as "downstream" and "upstream," refer to the direction of flow of the medical fluid in the extracorporeal circuit during treatment or preparation for treatment. An example of a conventional venous chamber is shown in Figure 1.

[0020] Summary of the invention

[0021] The present invention relates to a device for separating gas bubbles from a medical fluid, in particular blood, comprising a chamber and a packing element. The packing element allows the volume of the chamber to be reduced.

[0022] The present invention further relates to a device (1) for separating gas bubbles from a medical fluid, in particular blood, wherein the chamber segment (33) has a substantially cylindrical or conical shape and has an axis of rotation C1.

[0023] The present invention relates to a device (1) for separating gas bubbles from a medical fluid, in particular blood, comprising a substantially cylindrical or conical chamber (33) with an axis of rotation C1 and with an outlet nozzle (11) and a clot catcher (12) arranged above the outlet nozzle, as well as a lid (40) with an inlet nozzle (42) and a pipe section (30) connected thereto, projecting into the chamber segment (33) and having an outlet opening (31) directed into the chamber (33), wherein the inlet nozzle (42) and the pipe section (30) projecting into the chamber segment (33) are arranged laterally offset between the axis of rotation C1 and the wall of the chamber (33). The device further comprises a filling element (50) attached to the lid (40) and projecting into the chamber segment (33).

[0024] The present invention further relates to a device (1) for separating gas bubbles from a medical fluid, in particular blood, comprising a substantially cylindrical or conical chamber (33) with an axis of rotation C1 and with an outlet nozzle (11) and a clot catcher (12) arranged above the outlet nozzle, as well as a lid (40) with an inlet nozzle (42) and a pipe section (30) connected thereto, projecting into the chamber segment and having an outlet opening (31) directed laterally along the circumferential direction of the chamber (33), wherein the inlet nozzle (42) and the pipe section (30) projecting into the chamber segment (33) are arranged laterally offset between the axis of rotation C1 and the wall of the chamber (33), further comprising a filling body (50) attached to the lid (40) which projects into the chamber segment (33).

[0025] In a preferred embodiment, the device comprises a pipe section (30) projecting into the chamber segment (33) with a laterally directed outlet opening (31) along the circumferential direction of the chamber (33). The outlet opening, directed along the circumferential direction of the chamber, generates a fluid flow circulating along the chamber wall, which advantageously affects the separation of air bubbles.

[0026] In a preferred embodiment, the surface of the filler (50) is essentially smooth. In further embodiments of the present invention, the surface of the filler (50) can be structured, patterned, sintered, ground, sandblasted, etched, porous, rough, grained, foamed, grooved, cross-hatched, striped, dimpled, or otherwise shaped to promote the nucleation and fusion of trappable gas bubbles from microbubbles in the drip chamber. In another embodiment, both the filler (50) and the inner surface of the chamber segment wall (33) are structured as described above. In a particularly preferred embodiment, the surface of the filler (50) and the inner surface of the chamber (33) are unstructured and essentially smooth.

[0027] In one embodiment, the filler has a substantially cylindrical or conical shape. Preferably, the filler has a shape similar to that of the chamber (33). This creates an annular gap or a hollow cylinder between the filler and the chamber wall. In one embodiment, the distance between the filler and the chamber wall is constant.

[0028] In a further embodiment, the packing material has a substantially cylindrical or conical shape, and its surface further comprises ridges, protrusions, or steps. Preferably, these are rotationally symmetrical about the axis of rotation C1 of the packing material. In a preferred embodiment, the surface of the packing material (50) is substantially smooth and—apart from the ridges, protrusions, or steps described above—has no further fine structuring suitable for removing microbubbles. In a preferred embodiment, the distance between the packing material and the chamber wall is substantially constant.

[0029] In one embodiment, the packing material projects into the chamber segment (33) along the axis of rotation C1. In another embodiment, the packing material preferably projects from the lid segment (40) to the clot catcher (12). In a further embodiment, the packing material preferably projects from the clot catcher (12) to the lid segment (40).

[0030] In one embodiment, the lid segment (40) and the filler (50) are formed integrally. Preferably, the filler (50) is part of the lid segment, hollow inside, and open to the outside at the top of the lid. This offers potential savings in raw plastic material and facilitates manufacturing by injection molding. In another embodiment, the lid segment (40) and the filler (50) are made of separate parts. To attach the filler (50) to the lid segment (40), the latter has a fastening element (41) directed into the interior of the chamber, to which the filler (50) can be attached. The fastening element (41) has a cylindrical or conical shape and can optionally be rounded at its lower end. The fastening element can also be in the form of a pin.To attach the filler body (50) to the lid segment (40), the filler body (50) is connected to the fastening element (41) by means of a form-fit, force-fit or material-fit connection, in which the filler body is placed onto the fastening element (41) and / or glued or both parts are welded together.

[0031] In one embodiment, the fastening means (41) and the filler body (50) have a thread or a bayonet connection and are positively connected to each other.

[0032] In another embodiment, the fastening element (41) is a hollow body and is open at least towards the lid. In another embodiment, the fastening element (41) is a hollow body and is open downwards towards the chamber or the filling element.

[0033] In another embodiment, the fastening means (41) is a hollow body and is open towards the lid and downwards in the direction of the chamber or the filling body.

[0034] In a preferred embodiment, the fastening element (41) has a cylindrical or conical hollow shape, is open at the lid, and rounded at the lower end. To fasten the filler element (50), it is placed onto the fastening element (41) and / or glued in place. This makes it possible to use the lid segment (40) for the fabrication of a venous chamber according to claim 1 as well as for a venous chamber according to Figure 2. Since the lid segment (40) and the chamber segment (33) can already be used for both applications, further cost savings are possible.The present invention also relates to a lid segment (40) for a device (1) for separating gas bubbles from a medical fluid, in particular blood, comprising an inlet nozzle (42) and a pipe section (30) connected thereto with a laterally directed outlet opening (31), wherein the lid segment includes a fastening means (41) to which a filling element (50) can be attached. Preferably, the fastening means (41) is arranged in the center of the underside of the lid along an axis of rotation C1.

[0035] In a further embodiment, the lid segment (40) has at least one additional port (43). Substitution solution or medication can be added or air removed via these additional ports.

[0036] The embodiments described above relate to a device for separating gas bubbles from a medical fluid, in particular blood, comprising a filling body that projects from the lid into a venous chamber - similar to a dripstone, in particular a stalactite.

[0037] Further embodiments include a device for separating gas bubbles from a medical fluid, in particular blood, comprising a venous chamber in which a packing element – ​​like a stalagmite – projects from bottom to top into the venous chamber. In one embodiment, the packing element is attached to the clot catcher (12).

[0038] In one embodiment, the clot catcher (12) comprises a fastening means (41), for example a pin, for fastening the filler body.

[0039] In another embodiment, the clot catcher and the packing material are formed in one piece. Since the lid segment (40) and the chamber segment (33) can be used for applications with and without the packing material (50) and only the clot catcher needs to be adapted, further savings potential arises in these embodiments as well.

[0040] One embodiment of the present invention relates to a device (1) for separating gas bubbles from a medical fluid, in particular blood, comprising a chamber segment (33), optionally cylindrical or conical, with an outlet nozzle (11) and a clot catcher (12) arranged upstream of the outlet nozzle, as well as a cover segment (40) connected to the chamber segment (33) with an inlet nozzle (42) and a pipe section (30) connected thereto and projecting into the chamber segment, the pipe section (30) having a laterally directed outlet opening (31) along the circumferential direction of the chamber segment (33), wherein the inlet nozzle (42) and the pipe section (30) projecting into the chamber segment (33) are arranged laterally offset between the axis of rotation C1 and the wall of the chamber (33). The device further comprises a packing body (50) attached to the clot catcher (12), wherein the packing body projects into the chamber segment (33).Preferably the filler body (50) extends to the lid (40).

[0041] In another embodiment, the clot catcher (12) and the packing body (50) are formed in one piece. In this embodiment, the clot catcher (12) does not have a fastening element (41).

[0042] Further embodiments of the present invention relate to a device for separating gas bubbles from a medical fluid, in particular blood, comprising a filling body in which the inlet to the venous chamber is provided from below or laterally and the outlet to the venous line is provided from above or laterally.

[0043] Further embodiments of the present invention relate to a device for separating gas bubbles from a medical fluid, in particular blood, comprising a filling element in which the inlet to the venous chamber is located laterally in the upper half of the chamber and the outlet to the venous line is located at the bottom or laterally in the lower half of the chamber. In a further embodiment of the present invention, both the lid segment (40) and the clot catcher (12) have fastening means (41), and the filling element (50) is connected to both the lid and the clot catcher. The present invention further relates to a blood tubing set comprising a device (1) for separating gas bubbles from a medical fluid, as described in more detail above, with a filling element.

[0044] The present invention further relates to a device for extracorporeal blood treatment comprising a blood tubing set with the device described above.

[0045] Brief description of the drawings

[0046] Figure 1 shows a venous drip chamber (1) known from the prior art, comprising a substantially cylindrical or conical chamber segment (33) with an axis of rotation C1, a cover segment (40) with an inlet nozzle (42), and at least one further connection (43). A tube section 30 projects longitudinally from the inlet nozzle (42) into the chamber segment (33) along the axis of rotation C1 and has a lateral opening (31). The opening (31) is oriented towards the chamber wall. An outlet nozzle (11) is located at the bottom of the chamber, and above it, a clot catcher (12) is mounted in the chamber floor. In the embodiment shown in Figure 1, the inlet nozzle (42) and the tube section 30 extend along an axis of rotation C1. The venous chamber shown in Figure 1 is known to those skilled in the art, for example, from hemodialysis machines of type 5008 manufactured by Fresenius Medical Care.Due to the total volume of the extracorporeal circuit including the chamber volume, the venous chamber shown in Figure 1 is only suitable for use in blood tubing sets for the treatment of patients with a body weight of 20 kg or more.

[0047] When the drip chamber (1) is used in a dialysis machine, the drip chamber is held by a holder (20) which may include a level sensor.

[0048] Figure 2 shows a device (1) for separating gas bubbles from a medical fluid, in particular blood, comprising a substantially cylindrical or conical chamber (33) with an axis of rotation C1 and with an outlet nozzle (11) and a clot catcher (12) arranged above the outlet nozzle, as well as a cover (40) with an inlet nozzle (42) and a pipe section (30) connected thereto, projecting into the chamber and having an outlet opening (31) directed laterally along the circumferential direction of the chamber segment (33). The inlet nozzle (42) and the pipe section (30) projecting into the chamber segment (33) are arranged laterally offset between the axis of rotation C1 and the wall of the chamber (33). The device further comprises a fastening element (41) attached to the cover (40), which projects in the direction of the chamber segment (33). Preferably the fastening means (41) projects along the axis of rotation C1 in the direction of the chamber segment (33).The venous chamber shown in Figure 2 is suitable, due to its chamber volume, for use in blood tubing sets for the treatment of patients with a body weight of, for example, 20 kg or more.

[0049] Figure 3 shows a device (1) for separating gas bubbles from a medical fluid, in particular blood, comprising a substantially cylindrical or conical chamber (33) with an axis of rotation C1 and with an outlet nozzle (11) and a clot catcher (12) arranged above the outlet nozzle, as well as a lid (40) with an inlet nozzle (42) and a pipe section (30) connected thereto and projecting into the chamber, the pipe section having an outlet opening (31) directed laterally along the circumferential direction of the chamber segment (33). The inlet nozzle (42) and the pipe section (30) projecting into the chamber segment (33) are arranged laterally offset between the axis of rotation C1 and the wall of the chamber (33). Furthermore, the device includes a packing body (50) attached to the fastening means (41) on the lid (40), which projects into the chamber segment (33) along the axis of rotation C1.

[0050] The venous chamber shown in Figure 3 is suitable for use in blood tubing sets for the treatment of patients with low body weight, especially children, due to its reduced chamber volume.

[0051] In another embodiment, the device shown in Figure 3, the tube section (30) projects towards the chamber segment (33) without, however, protruding into it. In the embodiment shown in Figure 3, the filling element (50) is attached to the lid by means of the fastening element (41). In a further embodiment, the lid segment (40) and the filling element (50) are formed in one piece. In this embodiment, the lid segment (40) does not have a fastening element (41).

[0052] Figure 4 shows a further embodiment of the device (1) for separating gas bubbles from a medical fluid, in particular blood, comprising a substantially cylindrical or conical chamber (33) with an axis of rotation C1 and with an outlet nozzle (11) and a clot catcher (12) arranged above the outlet nozzle, as well as a cover (40) with an inlet nozzle (42) and a pipe section (30) connected thereto, projecting into the chamber and having an outlet opening (31) directed laterally along the circumferential direction of the chamber segment (33). The inlet nozzle (42) and the pipe section (30) projecting into the chamber segment (33) are arranged laterally offset between the axis of rotation C1 and the wall of the chamber (33). Furthermore, the device includes a fastening element (41) attached to the clot catcher (12), which projects upwards towards the chamber segment (33).Preferably, the fastening element (41) projects along the axis of rotation C1 in the direction of the chamber segment (33). Due to its chamber volume, the venous chamber shown in Figure 4 is suitable for use in blood tubing sets for treating patients with a body weight of, for example, 20 kg or more.

[0053] Figure 5 shows a device (1) for separating gas bubbles from a medical fluid, in particular blood, comprising a substantially cylindrical or conical chamber (33) with an axis of rotation C1 and with an outlet nozzle (11) and a clot catcher (12) arranged above the outlet nozzle, as well as a lid (40) with an inlet nozzle (42) and a pipe section (30) connected thereto, projecting into the chamber segment and having an outlet opening (31) directed laterally along the circumferential direction of the chamber segment (33). The inlet nozzle (42) and the pipe section (30) projecting into the chamber segment (33) are arranged laterally offset between the axis of rotation C1 and the wall of the chamber (33). The device further comprises a packing element (50) which is attached to the clot catcher (12) by the fastening means (41) and which projects into the chamber segment (33) along the axis of rotation C1.

[0054] The venous chamber shown in Figure 5 is suitable for use in blood tubing sets for the treatment of patients with low body weight, especially children, due to its reduced chamber volume.

[0055] Since the embodiments of the venous drip chambers shown in Figures 4 and 5 differ only in the clot catcher and the other components are the same, the costs for a pediatric chamber are reduced accordingly.

[0056] In another embodiment, the clot catcher (12) and the packing body (50) are formed in one piece. In this embodiment, the clot catcher (12) does not have a fastening element (41).

Claims

Patent claims 1. Device (1) for separating gas bubbles from a medical liquid, in particular blood, comprising a chamber and a filling body (50).

2. Device (1) according to claim 1, wherein the chamber has a substantially cylindrical or conical shape and has an axis of rotation C1.

3. Device (1) for separating gas bubbles from a medical fluid, in particular blood, according to claim 1 or 2, comprising a chamber segment (33) with an outlet nozzle (11) and a clot catcher (12) arranged upstream of the outlet nozzle, as well as a cover segment (40) connected to the chamber segment (33) with an inlet nozzle (42) and a pipe section (30) connected thereto, projecting into the chamber segment and having an outlet opening (31) directed laterally along the circumferential direction of the chamber segment (33), wherein the inlet nozzle (42) and the pipe section (30) projecting into the chamber segment (33) are arranged laterally offset between the axis of rotation C1 and the wall of the chamber (33), wherein the device comprises a filling body (50) attached to the cover (40) and wherein the filling body projects into the chamber segment (33).

4. Device (1) for separating gas bubbles from a medical liquid according to one of claims 2 or 3, wherein the packing body projects along the axis of rotation C1 into the chamber segment (33), preferably up to the clot catcher (12).

5. Device according to one of claims 1 to 4 characterized in that the lid segment (40) and the filling body (50) are made of separate parts.

6. Device according to one of claims 1 to 5, characterized in that the lid segment (40) has a direction directed into the interior of the chamber The fastening means (41) includes the filler body (50) to which it can be attached.

7. Device according to one of the preceding claims, characterized in that the lid segment (40) and the filling body (50) are made in one piece.

8. Device according to one of claims 1 to 7, characterized in that the cover segment (40) has at least one further connection (43).

9. Device (1) for separating gas bubbles from a medical fluid, in particular blood, according to claim 1 or 2, comprising a chamber segment (33) with an outlet nozzle (11) and a clot catcher (12) arranged upstream of the outlet nozzle, as well as a cover segment (40) connected to the chamber segment (33) with an inlet nozzle (42) and a pipe section (30) connected thereto, projecting into the chamber segment and having an outlet opening (31) directed laterally along the circumferential direction of the chamber segment (33), wherein the inlet nozzle (42) and the pipe section (30) projecting into the chamber segment (33) are arranged laterally offset between the axis of rotation C1 and the wall of the chamber (33), wherein the device comprises a filling body (50) attached to the clot catcher (12) and wherein the filling body projects into the chamber segment (33).

10. Blood tubing set comprising a device (1 ) for separating gas bubbles from a medical fluid according to any one of claims 1 to 8.

11. Device for extracorporeal blood treatment comprising a blood tubing set according to claim 8 or a device (1) for separating gas bubbles from a medical fluid, in particular blood, according to any one of claims 1 to 8.

12. Lid segment (40) for a device (1) for separating gas bubbles from a medical fluid, in particular blood, comprising 16 an inlet nozzle (42) and a pipe section (30) with a lateral outlet opening (31) wherein the lid segment comprises a fastening means (41) for fastening a fill body (50).

13. Lid segment (40) for a device (1 ) for separating gas bubbles from a medical fluid, in particular blood, comprising a filling body (50).

14. Clot catcher (12) for a device (1 ) for separating gas bubbles from a medical fluid, in particular blood, comprising a fastening means (41 ) for fastening a filling body (50).

15. Clot catcher for a device (1 ) for separating gas bubbles from a medical fluid, in particular blood, comprising a packing body (50).

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