FI20206279A1

FI20206279A1 - Mechanical infusion fluid flow regulator

Info

Publication number: FI20206279A1
Application number: FI20206279A
Authority: FI
Inventors: Mikko Savola; Seppo Puolitaival
Original assignee: Monidor Oy
Priority date: 2020-12-10
Filing date: 2020-12-10
Publication date: 2022-06-11
Also published as: FI20206279A; WO2022123113A1; EP4259243A1

Abstract

A mechanical infusion fluid flow regulator and an arrangement for providing infusion fluids are disclosed. The flow regulator includes: a base part comprising an inlet, an outlet, and a cavity providing a path for fluid flow from the inlet to the outlet; a rotating top part comprising means for controlling fluid flow through the cavity via rotation of the top part with respect to the base part; and a radially protruding control arm for rotating the top part and for visually indicating a flow rate of the fluid flow, wherein movement of the control arm is limited to a range between the inlet and the outlet. The arrangement for providing infusion fluids includes the above flow regulator, an infusion bag, a first tubing coupling the infusion bag and the inlet of the flow regulator, and a second tubing coupled to the outlet of the flow regulator.

Description

MECHANICAL INFUSION FLUID FLOW REGULATOR

FIELD Various embodiments relate to a mechanical infusion fluid flow regulator and an arrangement for providing infusion fluids and regulating flow rate of the fluids.

BACKGROUND The flow rate of infusion fluids must be carefully controlled to achieve the desired the rate of administration of medication, basic fluids, nutrition, or blood products, for example. The flow rate is traditionally controlled by compressing a tubing, through which the fluids are passed, with a clamp. A large force is required due to the stiffness of the tubing and the pressure exerted by the fluid, and accurate control of the flow rate is challenging. It is often also difficult to visually perceive the selected flow rate, especially at a distance. More complex rotary flow regulators are also available, but a simple yet accurate solution would be desirable.

BRIEF DESCRIPTION According to an aspect, there is provided subject matter of independent claims. Dependent claims define some embodiments. One or more examples of implementations are set forth in more detail in the accompanying drawings and the description of embodiments.

LIST OF DRAWINGS Some embodiments will now be described with reference to the o accompanying drawings, in which S FIG. 1 provides a front view of an embodiment the flow regulator; N 25 FIG. 2, FIG. 3 and FIG. 4 illustrate embodiments of the flow regulator; oO FIG. 5A, FIG. 5B and FIG. 5C illustrates embodiments of the control arm > of the flow regulator; E FIG. 6 and FIG. 7 illustrate the path of fluid flow in embodiments of the = flow regulator; & 30 FIG. 8 illustrates the means for controlling fluid flow in an embodiment O of the flow regulator; FIG. 9 provides a cross-section view of an embodiment; FIG. 10 and FIG. 11 illustrate embodiments of the flow regulator;

FIG. 12A and FIG. 12B illustrate the front and back sides of the flow regulator; and FIG. 13 illustrates an arrangement for providing infusion fluids and regulating the flow rate of the fluids.

DESCRIPTION OF EMBODIMENTS The following embodiments are only examples. Although the specification may refer to “an” embodiment in several locations, this does not necessarily mean that each such reference is to the same embodiment(s), or that the feature only applies to a single embodiment. Single features of different embodiments may also be combined to provide other embodiments. Furthermore, words "comprising" and "including" should be understood as not limiting the described embodiments to consist of only those features that have been mentioned and such embodiments may contain also features/structures that have not been specifically mentioned.

Reference numbers, both in the description of the embodiments and in the claims, serve to illustrate the embodiments with reference to the drawings, without limiting it to these examples only.

The embodiments and features, if any, disclosed in the following description that do not fall under the scope of the independent claims are to be interpreted as examples useful for understanding various embodiments of the invention.

The present invention is concerned with a mechanical infusion fluid flow regulator 100, comprising: a base part 102 comprising an inlet 104, an outlet 106, and a cavity 108 providing a path for fluid flow from the inlet to the outlet; a rotating top part 110 coupled on top of the base part, comprising means for N controlling fluid flow through the cavity via rotation of the top part with respect N to the base part; and a radially protruding control arm 112 comprised in or = coupled to the top part for rotating the top part and for visually indicating a flow 2 rate of the fluid flow, wherein movement of the control arm is limited to a range E 30 118 between the inlet and the outlet.

o The position of the control arm may be described in terms of a control N angle 114. The control angle represents the flow rate of fluids through the flow S regulator. The control angle corresponds to the angle of rotation of the control N arm with respect to the inlet, for example. More specifically, the control angle is — the angle between a line in the direction of fluid flow 116 through the inlet, and the direction control arm itself is pointing. This definition of the control angle holds also at times when there is no flow of fluids through the inlet, as illustrated in FIG. 3. In those situations, the direction is to be interpreted as the direction in which fluid would flow through the inlet. In simple terms, the control angle corresponds to the position of the control arm, or the direction the control arm is pointing to. Movement of the control arm may increase or decrease the control angle of the control arm. FIG. 1 illustrates a front view of an embodiment of the flow regulator, in its typical orientation when in use. The base part of the flow regulator is almost entirely behind the top part in FIG. 1. The base part may have a circular or oval shape when viewed from the front or from behind in its typical orientation when in use. The base part comprises a cavity, which provides a path for the infusion fluid to flow from the inlet to the outlet. The cavity may be considered a channel or a duct connecting the inlet and the outlet.

With reference to FIG. 1, the inlet and the outlet may be arranged on opposite sides of the base part of the flow regulator. Viewing from the front, the inlet may be on the top side of the base part, and the outlet on the bottom side of the base part. The flow regulator may also be arranged in some other orientation, especially if the infusion fluid is provided to the flow regulator using an infusion pump. However, gravity is often used to drive the flow of infusion fluids, and in that case, it is useful if the flow of fluid through the infusion pump also occurs in the direction of gravity. This corresponds to the orientation of the embodiment of FIG. 1, with the inlet above the outlet.

A rotating top part is coupled on top of the base part. Fluid flow — through the cavity is controlled with rotation of the top part with respect to the o base part. The top part and/or the bottom part comprises means for controlling O fluid flow through the cavity. A way of controlling fluid flow through the cavity is eu by controlling a cross-sectional area of the cavity, for example. In an embodiment, 5 rotation of the top part may increase or decrease, depending on the direction of — 30 rotation, the cross-sectional area of the cavity, which allows for controlling fluid E flow through the cavity and thus determining the flow rate of the fluid flow. o A radially protruding control arm is comprised in or coupled to the top N part for manually rotating the top part. The top part and the control arm may be N manufactured in one piece. Alternatively, the top part and the control arm may be N 35 manufactured separately, and the control arm attached to the top part. The control arm may be considered a lever for rotating the top part. The control arm also visually indicates the flow rate of the fluid flow through the flow regulator. Therefore, the control arm may be used to both select, and read or interpret the selected flow rate.

The flow regulator is also designed to be interpretable quickly or from a distance. As the control arm is protruding from the top part of the flow regulator, its position is easy to determine visually even at a distance of several meters away from the flow regulator. The position of the protruding control arm may also be visually determined when viewing the flow regulator from a direction other than from the front. The position of the control arm corresponds to the control angle. The control arm may be analogous to a hand of a clock or a speedometer, for example. Hence, it is easy to visually determine the control angle, and thus the flow rate of the infusion fluids.

The control arm is used to rotate the top part. The protruding control arm together with the flow control mechanism may allow the top part to be rotated with one hand only. The reason is that, unlike in the prior art, the rotation only has to overcome the internal friction between the base part and the top part. Therefore, the required force is substantially smaller than in the prior art described in Background. It may also allow the top part to be rotated with one finger only. This allows for control of the flow rate using only one hand or one finger.

The control angle is limited to a range between the inlet and the outlet, either on the left side or the right side depending on whether the flow regulator is designed to be operated left-handedly or right-handedly. The limitation ensures that the control arm is not overlapped or blocked or covered by the inlet or outlet — or tubing connected to the inlet or outlet, and can be visually distinguished from o the inlet and outlet tubing. The limitation may be implemented in various ways. S The flow regulator may comprise additional protrusions, which prevent the N rotation of the top part or the control arm past certain points. The limitation may 5 also be implemented in the means for controlling fluid flow through the cavity. A 30 The advantage of limiting the range of the control angle is that the flow E rate of the fluids flowing through the flow regulator may be determined o unambiguously whether it is viewed from the front or from behind. In general, the N flow rate may be determined regardless of the direction the flow regulator is N viewed or operated from. An example of such a scenario is when the flow N 35 regulator is attached to flexible tubing hanging down from an infusion bag, the arrangement allowed to rotate about an axis in the direction of fluid flow through the flow regulator. The flow regulator may be viewed from more than just the front direction, however the optimal viewpoint is from the front direction.

In an embodiment, the control angle may take values between 0° and 180°. A control angle of 45° may be perceived as “45° upwards”, and a control 5 angle of 135° as “45° downwards” from a horizontal position of the control arm, when in use. However, an angle of 225° which is not allowed, may also be perceived as “45° downwards”, for example. The angle of 225° is not allowed, as it may be confused with a control angle of 135° for example. The risk of such confusion may be mitigated by limiting the range of the control angle, to exclude — some angles that could lead to confusion. The confusion may be thought to arise from symmetry about the line of fluid flow. Angles that are symmetric about the line of fluid flow through the inlet may be confused with one another. The flow regulator with its control arm having a limited range of control angles may be considered asymmetric with respect to the line of fluid flow, and thus avoids confusion.

Control angles that are one or more full rotations of 360° apart, such as 45° and 305°, may also pose a risk for confusion. This is also mitigated by the limited range as it does not allow any full rotations of 360°.

Limiting the control angle also allows for a simple structure for the means for controlling fluid flow through the cavity.

In an embodiment, the flow regulator comprises only one control arm. This further reduces ambiguity in determining the flow rate.

FIG. 2 illustrates an embodiment, in which a first position 200 of the control arm corresponds to a first flow rate, and a second position 202 of the control arm corresponds to a second flow rate, the second position being different o from the first position, and the second flow rate being different from the first flow N rate. In other words, movement of the control arm from one position to another N changes the flow rate. In an embodiment, the control angle in a second position is 5 greater than the control angle in a first position, and a second flow rate is greater A 30 than a first flow rate. In other words, increasing the control angle increases the E flow rate, and decreasing the control angle decreases the flow rate. In yet other o words, rotating the control arm clockwise increases the flow rate, and rotating N the control arm anticlockwise decreases the flow rate. N In an embodiment, the range of the control arm is limited with a lower N 35 limit 120 corresponding to a zero flow rate, and an upper limit 122 corresponding to a maximum flow rate. In the embodiment of FIG. 1, the lower limit of the control angle is near the inlet, and the upper limit is near the outlet.

With the lower limit corresponding to a zero flow rate, the flow regulator may stop or halt the flow of infusion fluids.

With the upper limit corresponding to a maximum flow rate, the flow regulator may allow flow of infusion fluids at the fastest speed that is allowed.

In an embodiment, the upper and lower limits of the range of the control arm are at least 90 and less than 180 degrees apart.

This allows for a range that is large enough for fine-grained and very precise control of the flow rate.

In a traditional pipe valve with a lever, the endpoints of the range of control are only 90° apart, and a position of the lever parallel to the pipe corresponds to a maximum flow rate, and a perpendicular position of the lever corresponds to no fluid flow through the pipe.

The benefits of a larger range apply to both setting the flow rate by rotating the control arm, and visually perceiving the flow rate by looking at the control angle of the control arm.

The upper and lower limits of the range 118 shown in the embodiment of FIG. 1 fall within being 90° to 180° apart.

FIG. 3 illustrates an embodiment, wherein the inlet and the control arm are separated by an angle 300 when the flow rate is at zero.

In the embodiment of FIG, 3, the angle 300 also corresponds to the control angle.

The advantage of having an angle between the inlet and the control arm is that the user may easily grab or turn the control arm in the aforementioned position, as it is not immediately adjacent to or in parallel with the inlet.

Similarly, in another embodiment, the outlet and the control arm are separated by an angle 400 when the flow rate is at the maximum flow rate, as shown in FIG. 4, with similar benefits to the ones described above.

In an embodiment, the diameter 124 of the top part is 10-40 mm, o preferably 20-35 mm.

In an embodiment, the length 500 of the control arm is 5- S 30 mm, preferably 15-20 mm.

The length of the control arm is not included in the N diameter measure of the top part.

These ranges of lengths are suitable for 5 controlling the flow regulator with only one finger, due to the typical width of a A 30 finger being in the same order of magnitude.

In another embodiment, the sides E 502, 504 of the control arm are concave to accommodate a finger.

A concave o shape prevents slipping and losing grasp or grip of the control arm when N controlling the flow rate using the control arm.

It also increases comfort, as a N concave shape at least partly matches the contours of a finger.

These N 35 embodiments are illustrated in FIG. 5A, 5B and 5C.

FIG. 5B and FIG. 5C illustrate embodiments, where the control arm comprises a hole 506 to accommodate a finger. The hole may be an opening leading from one side of the control arm to another side of the control arm, such as from the front side to the back side. The hole may be sized in a way that a finger may be inserted into the hole. Controlling the control arm with a finger inserted in the hole allows for moving the control arm both down and up, or clockwise and anticlockwise, without changing the position of the finger. This is because the finger may be supported on all sides by the edges of the hole, and may thus push the control arm both up or down when in the aforementioned position.

In an embodiment, the flow regulator comprises a seal 904 between the top part and the base part. The seal may be in any suitable location between the base part and the top part. The purpose of the seal is to facilitate a tight coupling between the top part and the base part, to prevent leakage of infusion fluids, or to prevent mixing of foreign substances from the surroundings or air entering to the infusion fluid. In an embodiment, the seal may be an O-ring. Potential locations for the seal 904 between the base part and the top part are shown in FIG. 9, which presents a cross-section A-A of an embodiment shown in FIG. 7.

In the embodiments of FIG. 6 and FIG. 7, at least a part of the cavity is bounded at least with two semi-circular walls 600, 602, providing a semi-circular path for fluid flow around the centre of rotation 700 of the top part. By circumventing the centre of rotation, the base part and the top part may be implemented without restrictions posed by the cavity at least near the centre of rotation. FIG. 7 illustrates a possible path of fluid flow through the cavity underneath the top part along a semi-circular trail around the centre of rotation.

o In an embodiment, the coupling of the top part and the base part may S be near or around the centre of rotation of the top part. An embodiment may N comprise a hub 906 at the centre of rotation. The hub may be comprised in the 5 base part, or in the top part. In the embodiment of FIG. 9, the hub is comprised in A 30 — the base part. The hub may also be a separate part not comprised in the top part E or the base part. The top part and the base part may be coupled with the hub. The o hub may reduce forces acting on other parts of the flow regulator. The hub may N also comprise a seal 904 between the top part and the base part. N The smoothness of the movement to control the flow rate is dependent N 35 on the friction in the coupling between the top part and the base part. It is desirable that the movement is smooth and light, without causing the control to change too easily. To have accurate control it is preferred to have a mechanical fitting and design so that the maximum force of static friction and the force of kinetic friction are close to each other in magnitude. The control arm may be then moved or rotated with a similar force from the start to the end of the movement. This may be implemented with material selection and/or a certain range of roughness or smoothness of the surfaces under friction force. In an embodiment, one or more surfaces in the coupling between the top part and the base part have roughness, Ra, values of 0.25-0.7 micrometres. Preferably, the Ra values may be in the range of 0.35-0.56 micrometres. The range of 0.25-0.7 micrometres corresponds to a range of 10-28 microinches, and the range of 0.35-0.56 micrometres corresponds to a range of 14-22.4 microinches.

Such roughness of the surface may be implemented using spark machining in finalizing one or more surfaces of a mould, that is then used to manufacture the part with the desired roughness in the one or more surfaces. For example, the base part and the top part may be manufactured in their own moulds using a plastic moulding technigue, and the desired surface formation and roughness will be achieved on surfaces of the base part and/or the top part. The designed surface with the above-mentioned roughness may be applied to one or more surfaces on the top part and/or the base part, that are in contact with each other where the top part is coupled to the base part. The designed surface may also be applied to surfaces in other areas of the top part, the base part, other parts of the flow regulator such as the control arm or the hub, or to all surfaces of the flow regulator.

In an embodiment the means for controlling fluid flow through the cavity comprises an inclined plane 800 for decreasing the cross-sectional area of a o part of the cavity by rotation of the top part, the shape of the inclined plane S matching with the shape of at least a part of the cavity. FIG. 8 illustrates an N embodiment with an inclined plane in a first position 802, and an inclined plane 5 in a second position 804. In a first position where the inclined plane is A 30 overlapping with the path of fluid flow through the flow regulator, the inclined E plane may restrict the cross-sectional area of the fluid flow. In a second position o the where the inclined plane is not overlapping with the path of fluid flow N through the flow regulator, the inclined plane may restrict the cross-sectional N area of the fluid flow by a different amount than in the first position, or it may not N 35 restrict the cross-sectional area at all. The inclined plane may of course be in other positions in addition to the two described above and illustrated in FIG. 8. In a position not illustrated, the inclined plane may completely block the flow of fluids through the cavity, or equivalently, limit the cross-sectional area to zero. The different positions correspond to different angles of rotation, or control angles, of the top part. The inclined plane may rotate along with the top part. The inclined plane may be rotated from a first position to a second position, resulting in a change in the cross-sectional area of the cavity, and a change in the flow rate. The shape of the inclined plane matches the shape of at least a part of the cavity, so that it may be rotated with respect to the cavity. In the embodiment of FIG: 8, the cavity has a semi-circular shape, so the inclined plane must be also curved to — match the shape or the contours of the cavity. The flow rate of the fluid flow may thus be controlled in a continuous manner by rotation of the top part.

In an embodiment, the base part comprises an inner circular wall 900, and the top part comprises an outer circular wall 902, and the coupling of the base part and the top part is between the inner circular wall and the outer circular wall. The inner circular wall and the outer circular wall may also facilitate rotation of the top part with respect to the base part.

In an embodiment, the inner circular wall comprises one or more circular grooves 1000, and the outer circular wall comprises one or more circular formations 1100 corresponding to the grooves, to facilitate the coupling and rotation of the base part and the top part. The grooves and formations may be used to lock the top part and the base part together. The grooves and formations may result in a tighter coupling of the base part and the top part. The seal 904 may also be comprised in the formations.

FIG. 12A and 12B respectively illustrate the front and back sides of the — flow regulator. The front side of the flow regulator in FIG. 12A is filled in with o downward diagonal stripes. The back side of the flow regulator in FIG. 12B is S filled in with upward diagonal stripes. Here, downward diagonal stripes refer to N lines descending from left to right, and upward diagonal stripes refer to lines 5 ascending from left to right. In an embodiment, the flow regulator comprises at — 30 — least one marking 1200, 1202 on at least one of the front side and the back side of E the flow regulator, wherein the at least one marking is arranged to visually o distinguish the front side from the back side. The at least one marking may be a N number, a text, or a symbol, for example. In FIG. 12A, the at least one marking N 1200 is on the front side of the flow regulator and resembles the letter 'X'. In FIG. N 35 12B, the at least one marking 1202 is on the back side of the flow regulator and resembles the letter 'Y'. The at least one marking may also span or extend over the entire front and/or back side of the flow regulator, or a portion of the back side and/or the front side. In an embodiment, the at least one marking may be a colour or a pattern. With reference to FIG. 12A and 12B, the areas or portions of the areas filled with diagonal stripes may be filled with another pattern or a colour. For example, the front side may be coloured with a first colour, and the back side may be coloured with a second colour, the second colour being different to the first colour. Different markings on the front side and the back side of the flow regulator may help with deducing its orientation, especially when viewed at a distance. The at least one marking may also be limited to one or more sub-areas of the flow regulator, such as the top part, the base part, or the control arm.

The at least one marking may also serve other purposes and provide additional information in addition to helping with distinguishing the front side and the back side of the flow regulator. The at least one marking may indicate one or more flow rates corresponding to control angles of the control arm. The at least — one marking may also indicate the relationship between the direction of rotation, and its effect on the flow rate, with an arrow, for example. The at least one marking may comprise a scale. The at least one marking may be very useful, as it may provide a reference for operating the flow regulator and adjusting and interpreting the flow rate.

The flow regulator may preferably be manufactured from plastics materials, elastomers materials, or a combination thereof. The flow regulator may be manufactured with a minimal number of parts. The number of manufactured parts may be 2, for example. To reduce the number of manufactured parts, the top part and the control arm may be manufactured as one part, for example, as mentioned earlier. A small number of manufactured parts often translates to an o efficient manufacturing process. N In a broader view, the present invention is also concerned with an N arrangement for providing infusion fluids and regulating the flow rate of the 5 fluids, comprising: the mechanical infusion fluid flow regulator according to any A 30 embodiment described above; an infusion bag 1300; a first tubing 1302 coupling E the infusion bag and the inlet of the flow regulator; and a second tubing 1304 at o the outlet of the flow regulator. The flow of infusion fluids is from the infusion bag N through the first tubing to the inlet of the flow regulator, through the flow N regulator, and to the second tubing from the outlet of the flow regulator. The flow N 35 rate of infusion fluids may be determined with the flow regulator. The second tubing may be connected to a needle or a cannula for delivering the infusion fluids to a subject or a patient. An infusion pump and/or monitoring means may also be available along with the arrangement. Even though the invention has been described with reference to one or more embodiments according to the accompanying drawings, it is clear that the invention is not restricted thereto but can be modified in several ways within the scope of the appended claims. All words and expressions should be interpreted broadly, and they are intended to illustrate, not to restrict, the embodiments. It will be obvious to a person skilled in the art that, as technology advances, the inventive concept can be implemented in various ways.

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Claims

1. A mechanical infusion fluid flow regulator (100), comprising: a base part (102) comprising an inlet (104), an outlet (106), and a cavity (108) providing a path for fluid flow from the inlet to the outlet; a rotating top part (110) coupled on top of the base part, comprising means for controlling fluid flow through the cavity via rotation of the top part with respect to the base part; and a radially protruding control arm (112) comprised in or coupled to the top part for rotating the top part and for visually indicating a flow rate of the fluid — flow, wherein movement of the control arm is limited to a range (118) between the inlet and the outlet.

2. The flow regulator of claim 1, wherein the flow regulator comprises only one control arm.

3. The flow regulator of any preceding claim, wherein a first position (200) of the control arm corresponds to a first flow rate, and a second position (202) of the control arm corresponds to a second flow rate, the second position being different from the first position, and the second flow rate being different from the first flow rate.

4. The flow regulator of any preceding claim, wherein the range (118) of the control arm is limited with a lower limit (120) corresponding to a zero flow rate, and an upper limit (122) corresponding to a maximum flow rate.

5. The flow regulator of any preceding claim, wherein the upper and lower limits of the range of the control arm are at least 90 and less than 180 degrees apart.

6. The flow regulator of any preceding claim, wherein the inlet and the N control arm are separated by an angle (300) when the flow rate is at zero. N

7. The flow regulator of any preceding claim, wherein the outlet and = the control arm are separated by an angle (400) when the flow rate is at the 2 maximum flow rate. E 30

8. The flow regulator of any preceding claim, wherein the length (500) o of the control arm is 5-30 mm, preferably 15-20 mm. N

9. The flow regulator of any preceding claim, wherein the sides (502, S 504) of the control arm are concave to accommodate a finger. N

10. The flow regulator of any preceding claim, wherein the control arm comprises a hole (506) to accommodate a finger.

11. The flow regulator of any preceding claim, wherein the flow regulator comprises a seal (904) between the top part and the base part.

12. The flow regulator of any preceding claim, wherein at least a part of the cavity is bounded at least with two semi-circular walls (600, 602), providing a semi-circular path for fluid flow around the centre of rotation (700) of the top part.

13. The flow regulator of any preceding claim, wherein one or more surfaces in the coupling between the top part and the base part have roughness, Ra, values of 0.25-0.7 micrometres.

14. The flow regulator of any preceding claim, wherein the means for controlling fluid flow through the cavity comprises an inclined plane (800) for decreasing the cross-sectional area of a part of the cavity by rotation of the top part, the shape of the inclined plane matching with the shape of at least a part of the cavity.

15. The flow regulator of any preceding claim, wherein the base part comprises an inner circular wall (900), and the top part comprises an outer circular wall (902), and the coupling of the base part and the top part is between the inner circular wall and the outer circular wall.

16. The flow regulator of claim 15, wherein the inner circular wall comprises one or more circular grooves (1000), and the outer circular wall comprises one or more circular formations (1100) corresponding to the grooves, to facilitate the coupling and rotation of the base part and the top part.

17. The flow regulator of any preceding claim, comprising at least one marking (1200, 1202) on at least one of the front side and the back side of the flow regulator, wherein the at least one marking is arranged to visually o distinguish the front side from the back side.

O

18. An arrangement for providing infusion fluids and regulating the eu flow rate of the fluids, comprising: 5 the mechanical infusion fluid flow regulator according to any previous — 30 claim; E an infusion bag (1300); o a first tubing (1302) coupling the infusion bag and the inlet of the flow N regulator; and N a second tubing (1304) at the outlet of the flow regulator.

N