Drip chamber insert for an infusion device of a medical infusion system

Abstract

The present invention relates to a drip chamber insert (1) for insertion into a drip chamber (10) to be connected to a medical infusion or transfusion device. The drip chamber insert (1) is designed as a hollow body and has: a first end face (S1) that is at least partially open, a discharge opening (2) in a second end face (S2) opposite the first end face, and at least one overflow opening (3), wherein the at least one overflow opening (3) is provided in a region of the side surface of the hollow body extending from the first end face to the second end face. The drip chamber insert (1) can be inserted into the drip chamber (10). The drip chamber (10) is suitable for a medical infusion or transfusion device and, in addition to the drip chamber insert, has a drip chamber bottom having an outlet channel (4) for connection to a pipeline. The drip chamber insert (1) is positioned in the drip chamber (10) such that the second end face (S2) faces the drip chamber bottom. The drip chamber insert or the drip chamber can advantageously be used for preparing the operation of a medical infusion or transfusion device without closing and reopening the patient-side connection of the drip chamber and / or without externally pressurizing the interior of the drip chamber.

Description

Technical Field

[0001] The present invention relates to a drip chamber plug for insertion into a drip chamber connected to a medical infusion or transfusion device, the drip chamber plug being formed as a hollow body having a first front side that is at least partially open, a plurality of discharge openings in a second front side opposite the first front side, and at least one overflow opening, wherein the at least one overflow opening is formed by the at least partially open first front side or is located within a housing arranged between the first front side and the second front side. Background Art

[0002] In infusion and transfusion therapy, medical infusion devices are used for pressure and gravity infusion. B. Braun sells a well-known infusion device called Intrafix Safeset. This is a special infusion device with an air barrier and an exhaust function. The infusion device has a drip chamber which, in relation to the assembled functional state, has a piercing spike for piercing into an infusion solution container in the upper region and a drip chamber bottom in the lower region, the drip chamber bottom being incorporated into an outlet channel connected to a hose line. A fluid filter serving as an air barrier is positioned at a distance above the drip chamber bottom. The hose line has a connector (patient connector) at the end opposite the outlet channel for connection to an infusion needle. By actuating a roller clamp located on the hose line, the flow of the infusion solution through the hose line can be selectively ensured or prevented.

[0003] During delivery, the connector is equipped with a protective cap (PrimeStop) having an integrated air-permeable and liquid-impermeable membrane which prevents leakage of the infusion solution and intrusion of bacteria, but allows air to escape from the system.

[0004] During infusion preparation, the system must be vented. This process is carried out in the following sequence. First, the roller clamp is closed. Then the piercing spike is pierced into the infusion solution container. By repeatedly squeezing the flexible lower part of the drip chamber, a liquid height level is set in the drip chamber. Subsequently, the roller clamp is opened to vent the hose line.

[0005] This process is relatively laborious and has to be carried out manually, with a related risk of incorrect operation. Summary of the Invention

[0006] The object of the present invention is to provide a drip chamber of the above type, which can be used easily and quickly, and which reduces the risk of incorrect operation by a user, such as a caregiver. According to another object, the drip chamber is to be formed to reduce the risk of air embolism when the drip chamber is used in a medical infusion system for a patient, and / or to prevent uncontrolled leakage of the infusion solution from the patient connector when the roller clamp is open, and, where appropriate, in combination with a PrimeStop cap for drip-free ventilation.

[0007] This object is solved by a drip chamber insert according to claim 1. Preferred embodiments of the drip chamber insert according to the invention are defined in the dependent claims of claim 1. The drip chamber insert according to the invention is for insertion into a drip chamber which can be connected to a medical infusion or transfusion device. The drip chamber insert is formed as a hollow body and has a first front side which is at least partially open, one or more discharge openings in a second front side opposite the first front side, and at least one overflow opening. The at least one overflow opening is laterally positioned in any region of the housing extending from the first front side to the second front side; it is for allowing liquid located in the drip chamber insert to discharge laterally, in addition to the discharge openings in the second front side. The at least one overflow opening allows the infusion or transfusion fluid to discharge not only through the discharge openings in the second front side, but also simultaneously through the at least one overflow opening. This function is best ensured in the following situation: when the at least one overflow opening is spaced apart from the one or more discharge openings in the axial direction of the drip chamber insert, that is, until the infusion or transfusion fluid has risen in the drip chamber insert during use and has reached a height level not lower than the at least one overflow opening, lateral discharge begins.

[0008] According to the invention, in a first embodiment, the at least one overflow opening is located in the housing arranged between the first front side and the second front side; preferably, at a distance of at least 1 / 3H from the second front side (S2), more preferably in the range of 0.4H to 0.8H, where H is the height of the drip chamber insert (1), the height being measured as the distance from the first front side to the second front side. In particular, the at least one overflow opening is located approximately in the middle between the first and second front sides, that is, in the range of about 0.5H ± 10%.

[0009] In a further embodiment, the at least one overflow opening is formed by the at least partially open first front side, and / or the at least one overflow opening is formed as an extension of the opening of the at least partially open first front side. In other words, in this further embodiment, the opening located in the at least partially open first front side can extend into the housing at one or more positions along the circumference, such that at least one notch is formed at the upper edge of the housing (that is, at the edge adjacent to the second front side or the upstream edge during use).

[0010] The shape and dimensions of the drip chamber insert are advantageously formed such that it can be used as an insert in a conventional drip chamber, particularly in the lower region (lower part) of a conventional drip chamber - in relation to the assembled functional state. With respect to the assembled functional state, the first front side of the drip chamber insert is the upper surface (upstream during use), and the second front side is the lower surface (downstream during use). To prepare the drip chamber insert for an infusion, only the puncture portion of the drip chamber having the integrated drip chamber insert according to the invention is punctured into the infusion solution container. The infusion solution flows through the opening in the first front side due to gravity and accumulates in the drip chamber insert until the infusion height level reaches the height level of the at least one overflow opening. This is specifically achieved by the total area (discharge area) defined by the (i.e., all) discharge openings being smaller than the area (overflow area) defined by the at least one overflow opening.

[0011] In the following, for ease of reading, the singular is omitted and only multiple overflow openings are mentioned, such that the term "multiple overflow openings" in this text is synonymous with "at least one overflow opening".

[0012] After reaching the overflow opening, the infusion height level in the drip chamber remains constant at the height level of the overflow opening. The outflow rate from the drip chamber insert (i.e., the sum of the outflow rates through the outflow openings and through the overflow openings) corresponds to the inflow rate of the infusion solution entering the drip chamber insert. The discharge openings cause the drip chamber to be completely emptied towards the end of the infusion.

[0013] By eliminating most of the preparation steps, the present invention can make the infusion preparation process simpler, more time - saving and safer. In particular, the steps of closing the roller clamp, squeezing the flexible lower part of the drip chamber multiple times, and then opening the roller clamp for preparing an infusion device can be omitted. Overall, the present invention greatly simplifies the operation of gravity - (or drip chamber -) based medical infusion and blood transfusion devices, standardizes the infusion in the drip chamber, and significantly reduces the risk of incorrect operation. In addition, the present invention achieves the highest level of patient safety.

[0014] In a preferred embodiment, the discharge openings are formed as circular and / or have a diameter of 0.5 to 3 mm, preferably 0.8 to 2 mm, particularly 1.0 to 1.5 mm. On the one hand, the sieve - like design of the lower surface of the drip chamber insert is intended to ensure a smaller outflow rate relative to the feed rate and thus increase the infusion height level in the drip chamber insert. On the other hand, it ensures that the drip chamber is completely emptied together with the drip chamber insert.

[0015] In a preferred embodiment of the present invention, the overflow opening in the housing surface is formed to be elongated. In particular, the overflow opening is located in the housing at the same height in the region between the first and second front sides of the hollow body. In particular, the overflow opening is in the form of a slit, which allows the infusion fluid to pass through substantially unobstructed without causing the liquid level to increase further beyond the height of the overflow opening.

[0016] In a preferred embodiment of the present invention, the overflow opening arranged in the housing is spaced apart from the second front side and optionally the overflow opening is spaced apart from the first front side. Due to the spacing, the overflow opening is located in the housing arranged between the first front side and the second front side.

[0017] In a further embodiment of the present invention, the hollow body is of cylindrical shape. Preferably, the hollow body tapers towards the second front side. For example, the hollow body may have the shape of a cylinder, a cone or a frustum of a cone in terms of its external geometry. In a preferred embodiment of the present invention, the height of the hollow body is 1 to 10 cm, preferably 2 to 8 cm, particularly 3 to 6 cm, the height being measured as the distance from the first front side to the second front side; and / or the outer diameter of the hollow body is 0.5 to 5 cm, preferably 1 to 4 cm, particularly 2 to 3 cm, the outer diameter being measured at the height level of the first front side and / or the height level of the second front side. Such a drip chamber insert is based on the known lower part of the drip chamber in terms of geometry and dimensions and can thus be easily integrated into a known drip chamber. Furthermore, preferably, the hollow body is formed relative to the drip chamber in such a way that an intermediate space is formed between the outer housing of the drip chamber insert and the inner housing of the lower region (lower part of the drip chamber) of the drip chamber and / or between the outer second front side of the drip chamber insert and the inner side of the drip chamber bottom to ensure unobstructed outflow of the infusion solution from the drip chamber.

[0018] The drip chamber insert according to the present invention can be integrally formed and / or made of plastic, particularly rigid plastic. This enables simple manufacturing by means of a two-jaw tool.

[0019] The drip chamber insert can be ready for use, in particular it can be packaged together with other infusion devices in a common package. Preferably, the administration is sterile.

[0020] The problem is further solved by a drip chamber of a medical infusion or transfusion device, the drip chamber having a drip chamber bottom with an outlet channel for connection to a hose line and a drip chamber insert positioned in the drip chamber as described above, wherein the second end side faces the drip chamber bottom.

[0021] In a preferred embodiment of the present invention, the drip chamber has a liquid filter. It is located in the drip chamber between the bottom of the drip chamber and the drip chamber insert, preferably at a certain distance from the outlet channel (e.g., by means of a spacer). The liquid filter is particularly formed as an AirStop, as it prevents air bubbles from escaping from the drip chamber into the outlet channel and, in this way, additionally reduces the risk of air embolism in the patient. Furthermore, the liquid filter is preferably capable of acting as a particle filter to prevent particles from passing through.

[0022] According to a further (independent) preferred embodiment of the present invention, in order to ensure the unobstructed discharge of the infusion solution from the drip chamber insert and further from the drip chamber through the outlet channel, the outer housing of the drip chamber insert is at least partially spaced from the inner housing of the drip chamber. Further preferably, the drip chamber insert is located at a distance from the bottom of the drip chamber or, if present, at a distance from the liquid filter in the drip chamber. For this purpose, spacers can be provided at the corresponding positions to be spaced. For example, this distance can be from 0.1 to 10 mm, preferably from 0.2 to 5 mm, particularly from 0.5 to 3 mm.

[0023] According to a further embodiment of the present invention, the drip chamber further has a hose line which is connected to the outlet channel and has a connector for connection to an infusion or transfusion needle. Preferably, the connector is provided with a closure cap which separates the interior of the hose line from the environment by means of a gas-permeable and liquid-impermeable membrane. This measure enables maximum possible automation during the preparation process, particularly during the air venting of the infusion device.

[0024] There are no particular restrictions on the geometry and dimensions of the drip chamber, so a conventional drip chamber can be combined with the drip chamber insert according to the present invention. However, preferably, the geometries and dimensions of the drip chamber and the drip chamber insert match. For example, the drip chamber is preferably (also) cylindrical and / or the drip chamber tapers towards the outlet channel in appropriate cases.

[0025] Another aspect of the present invention relates to the use of a drip chamber insert (as described herein) or a drip chamber (as described herein) to prepare a medical infusion or transfusion device without closing and reopening the connection to the drip chamber provided on the patient side and / or without externally pressurizing the interior of the drip chamber. The term "patient-side connection" should be understood to particularly refer to the hose line connected to the outlet channel. The term "no external pressurization inside the drip chamber" means that, apart from the force of gravity acting on the infusion solution, no further force is applied to the infusion solution, and in particular, no force is applied to the drip chamber itself, such as by (multiple) compression of the drip chamber (e.g., manual squeezing). Description of the Drawings

[0026] In the following, the present invention is explained in more detail based on embodiments of the present invention as shown in the exemplary drawings, but is not limited thereto. Thereby, schematically shown is

[0027] Figure 1 a cross-sectional view of a drip chamber according to the present invention having a drip chamber insert in a preferred embodiment;

[0028] Figure 2 is Figure 1 a view of the drip chamber insert 1 of Figure 1 in a top view on the front side S2 along the cross-section A-A of

[0029] Figure 3 a cross-sectional view of a drip chamber according to the present invention having a drip chamber insert in a further embodiment. Detailed Description

[0030] Figure 1 A cross-sectional view of a drip chamber according to the present invention having a drip chamber insert according to a preferred embodiment of the present invention. The drip chamber is a conventional cylindrical drip chamber 10 composed of a lower part 6 and an upper part 7. The lower part 6 is formed as a cylinder that tapers towards the outlet channel 4. Here, the upper part 7 is shown to have a circular or hemispherical conical upper end with concentrically arranged piercing pins 8. The liquid filter 5 is located at the bottom of the drip chamber and is preferably at a distance from the bottom of the drip chamber. Adjacent thereto above is the drip chamber insert 1 that sufficiently fills the lower part 6, except for the distance between the outer housing of the drip chamber insert 1 and the inner housing of the lower part 6 and the distance between the bottom (outer side) of the drip chamber insert 1 and the bottom (inner side) of the drip chamber 10. In other words, a space is formed laterally and downwardly in the drip chamber, and the infusion fluid can flow in the space. For this purpose, the size and shape of the drip chamber insert 1 are adapted to the lower part 6 of the drip chamber 10, that is, corresponding to the geometry of the lower part 6 and preferably smaller. The drip chamber insert 1 has a groove-shaped overflow opening 3 in its housing, which is preferably at about half the height in the present embodiment. A plurality of discharge openings 2 are provided at the bottom of the drip chamber insert 1.

[0031] Figure 2 Shown is Figure 1 a view of the drip chamber insert 1 of Figure 1 (i.e., the drip chamber 10 is not shown) from the bottom, particularly in a top view from below the front side S2 along the cross-section A-A of Figure 1。It is now easier to see that the bottom of the drip chamber insert 1 has a large number of discharge openings 2 (shown here as circular), preferably in a sieve structure. Due to the relatively small discharge openings 2, the sieve-like bottom allows a very low flow rate. Also shown is a slit-shaped overflow opening 3 located in the housing - approximately in the middle of the conical / truncated spherical outer shell of the drip chamber insert 1. Due to the relatively large holes, the overflow opening 3 allows a relatively high flow rate.

[0032] Figure 3 is a cross-sectional view of another embodiment of a drip chamber according to the present invention, which shows Figure 1 an improvement of the drip chamber insert. Generally, the drip chamber is constructed in the same way as Figure 1 but the difference is that here the overflow opening 3 is not located in the housing between the first front side S1 and the second front side S2, but extends downward in the form of a cutout away from the opening of the first front side S1. Additionally, the meaning of the reference numerals is the same as in the embodiment according to Figure 1 the embodiment.

Claims

1. A drip chamber (10) for a medical infusion or transfusion device, comprising: At the bottom of the drip chamber, the bottom of the drip chamber has an outlet channel (4) for connection to a hose line; And a drip chamber insert (1) for insertion into the drip chamber (10) to be connected to the medical infusion or transfusion device, wherein the drip chamber insert (1) is formed as a hollow body and has: A first front side (S1) that is at least partially open, a plurality of discharge openings (2) in a second front side (S2) opposite the first front side (S1), and at least one overflow opening (3) that allows liquid to drain laterally, Wherein the at least one overflow opening (3) is provided in a region of the housing of the hollow body that extends from the first front side (S1) to the second front side (S2), wherein the drip chamber insert (1) is positioned in the drip chamber (10), and wherein the second front side (S2) faces the bottom of the drip chamber, Wherein the drip chamber (10) is configured to allow the infusion solution to flow through the opening of the first front side (S1) due to gravity, such that the infusion solution accumulates in the drip chamber insert (1) until the injection height level reaches the at least one overflow opening (3), which is achieved by the discharge area defined by all the discharge openings (2) being smaller than the overflow area defined by the at least one overflow opening (3), Wherein in the assembled functional state of the drip chamber (10), the first front side (S1) is the upper surface that is upstream during use, and the second front side (S2) is the lower surface that is downstream during use, A space is formed laterally and downward in the drip chamber (10), and the infusion fluid can flow in the space, Wherein the bottom of the drip chamber insert (1) is provided with the plurality of discharge openings (2), and the plurality of discharge openings (2) allow a low flow rate due to being relatively small, and Wherein the overflow opening (3) allows a relatively high flow rate due to being relatively large, Wherein the outer housing of the drip chamber insert (1) is at least partially spaced apart from the inner housing of the drip chamber (10); and wherein the drip chamber insert (1) is positioned at a distance from the bottom of the drip chamber, or if present, at a distance from the liquid filter (5) in the drip chamber (10).

2. The drip chamber according to claim 1, wherein, The at least one overflow opening (3) is provided at one of the following positions in the region of the housing: (i) The at least one overflow opening (3) is located in the region between the first front side and the second front side; (ii) The at least one overflow opening (3) is formed adjacent to the at least partially open first front side (S1); (iii) The at least one overflow opening (3) is provided in the region of the opening of the at least partially open first front side (S1), or in the case of a plurality of points along the circumference, extends into the lateral housing.

3. The drip chamber according to claim 2, wherein, The at least one overflow opening (3) extends into the lateral housing through at least one cut at the upper edge of the housing.

4. The drip chamber according to claim 1, wherein The at least one overflow opening (3) arranged in the housing has an elongated design; and / or wherein the discharge opening (2) has a circular design.

5. The drip chamber according to claim 4, wherein, The at least one overflow opening (3) arranged in the housing is at the same height in the region between the first front side and the second front side.

6. The drip chamber according to claim 4, wherein, The circular discharge opening (2) has a diameter of 0.5 to 1.5 mm.

7. The drip chamber according to claim 1, wherein, The at least one overflow opening (3) arranged in the housing is spaced apart from the second front side (S2) and, where appropriate, also from the first front side (S1).

8. The drip chamber according to claim 7, wherein, The distance from the second front side (S2) is at least 1 / 3 H, where H is the height of the drip chamber insert (1), the height being measured as the distance from the first front side to the second front side.

9. The drip chamber according to claim 7, wherein, The distance from the second front side (S2) is in the range of 0.4 H to 0.8 H, where H is the height of the drip chamber insert (1), the height being measured as the distance from the first front side to the second front side.

10. The drip chamber according to claim 1, wherein, The hollow body has a cylindrical shape, where the hollow body tapers towards the second front side (S2) where appropriate.

11. The drip chamber according to claim 1, wherein, The height of the hollow body is 1 to 10 cm, the height being measured as the distance from the first front side to the second front side; and / or the outer diameter of the hollow body is 2 to 3 cm, the outer diameter being measured at the height level of the first front side and / or at the height level of the second front side.

12. The drip chamber according to claim 1, wherein, The drip chamber insert (1) is formed of plastic, and / or wherein the drip chamber insert (1) is sterile.

13. The drip chamber according to claim 12, wherein, The drip chamber insert (1) is formed of transparent rigid plastic.

14. The drip chamber (10) according to any one of claims 1 - 13, further comprising a liquid filter (5), the liquid filter being positioned at a distance from the outlet channel (4) in the drip chamber (10).

15. The drip chamber (10) according to claim 14, wherein the liquid filter (5) prevents air and / or particles from passing through.

16. The drip chamber (10) according to any one of claims 1 - 13, further having the hose line which is connected to the outlet channel (4) and has a connector for connection to an infusion or transfusion needle, wherein the connector is further provided with a closure cap which separates the interior of the hose line from the environment by a gas-permeable liquid-impermeable membrane.

17. The drip chamber (10) according to any one of claims 1-13, wherein, The lower part of the drip chamber (6) has a cylindrical shape, and wherein the lower part of the drip chamber (6) tapers towards the outlet channel (4) where appropriate.

18. The drip chamber (10) according to any one of claims 1-13, wherein, The drip chamber (10) has a piercing spike (8) for piercing a container on the side opposite to the bottom of the drip chamber.

19. The drip chamber (10) according to any one of claims 1-13, wherein, The drip chamber (10) is for preparing the operation of a medical infusion or transfusion device without shutting off and reopening the connection to the drip chamber (10) provided on the patient side and / or without externally pressurizing the interior of the drip chamber (10).

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