A flushing apparatus for use with an iv infusion set and an iv infusion set having an automatic flushing function

Abstract

A flushing apparatus for use with an IV infusion set and an IV infusion set having an automatic flushing function. The IV set comprises a rigid and / or non-collapsible flushing liquid chamber (2), that is connected to a fluid flow path for IV fluid from a source of IV fluid to a patient via a flushing port at a flushing height (FH) and via a venting port at a venting height (VH). The venting port comprises an outlet opening (19) that connects to the flushing liquid chamber (2) and an inlet opening (17) that connects to an IV fluid flow path. The outlet opening (19) is arranged higher than the inlet opening (17) and higher than the initial level of the flushing liquid in the flushing liquid chamber (2). The flushing height (FH) is lower than the venting height (VH). When the level of IV liquid in the fluid flow path falls below the venting height (VH) the venting port allows air from the fluid flow path to enter the flushing liquid chamber (2) and flushing liquid from the flushing liquid chamber (2) to enter the fluid flow path via the flushing port when, during use of the IV infusion set the IV liquid level falls below the venting height (VH), thereby allowing the flushing liquid chamber (2) to be drained at least partially by gravity into the fluid flow path.

Description

[0001] A FLUSHING APPARATUS FOR USE WITH AN IV INFUSION SET AND AN IV INFUSION SET HAVING AN AUTOMATIC FLUSHING FUNCTION

[0002] TECHNICAL FIELD

[0003] The disclosure relates to medical intravenous (IV) administration of fluids, specifically IV infusion sets and components thereof for medical applications.

[0004] BACKGROUND

[0005] Nowadays, IV liquid is administered to patients using an IV infusion set. Such an IV infusion set typically comprises an IV bag, a drip chamber downstream of the IV bag, and a tube provided with a roller clamp leading to a needle connector. The needle connected to the needle connector is either directly inserted into the patient or into an IV port that has been inserted into the patient beforehand. These IV infusion sets are either gravity-driven or gravity and pressure-driven using an IV pump.

[0006] A problem with the current way of administering intravenous medicine is that on average 15-25 mL (15-50%) of the dose remains in the infusion line as residual medicine. For example, mean residual volume of the administration sets was 13.1 mL and 16.7mL for gravity and pump sets, respectivelv:”https: / / pharmaceutical- ioumal.com / article / opinion / patients-are-beinq-underdosed-we-need-new-Quidance- on-small-volume-d rug-infusions”. In small-volume drug infusions, 10-32% of the prescribed dose may not be administered: https: / / www.bbraun.com / en / products-and- solutions / therapies / infusion-therapy / b-braun-for-safety / reducinq underdosinq.html”.

[0007] Nurses will either perform a manual flush with saline or discard the infusion set with the result that the patient is being underdosed, placing patient safety at risk. Furthermore, delayed flushing increases the risk of phlebitis (chemical irritation of the vein) and occlusion of the vein catheter. This is a common complication seen in up to 30% of admitted patients, and necessitates replacement of the vein catheter, adding additional expenses for healthcare professionals in both time and costs as well as discomfort for the patients.

[0008] US5242392 discloses an IV piggyback tubing flush apparatus that includes a flush chamber attached to an intravenous (IV) set on the vertical tube and located lower than an IV medication bag for following administration of medication with a flush solution of normal saline from the flush chamber, which flushes the medication from the IV tubing and from a venous access device that is inserted into the patient, thereby preventing clotting of the venous access device. The flush solution automatically follows administration of the medication. An air vent on the flush chamber and a separate air vent on the medication bag facilitate the flow of medication and flush solution through the IV tubing and the venous access device. The flush chamber is located lower than the medication bag. This IV piggyback tubing flush apparatus requires the user to ensure that the flush chamber is located lower than the medication bag, requiring an adapted rack or stand, further, this apparatus requires two drip chambers, a flush chamber, and an additional bag with flushing liquid. Hence, this apparatus has the advantage of automatic flushing, but the apparatus is relatively cumbersome to set up and studies have shown that this complexity severely hampers patient safety. Further, this apparatus does not flush the complete flow path from the IV bag to the patient, typically leaving 7 ml of IV liquid (medicine) that is not flushed.

[0009] US2020246535 discloses a dual-chamber drip controlling device for intravenous infusion sets enabling spontaneous gravity-driven flushing and a method for flushing a dual-chamber drip controlling device, wherein the dual chamber comprises a flushing chamber configured as a closed compartment, the flushing chamber being fillable with flushing fluid; an administration chamber configured as a gravity-based drip chamber with an inlet and outlet is filled with IV liquid; and two conduits (ports), namely conduit A and conduit B connecting the administration chamber to the flushing chamber, wherein each fluid conduit is provided with restriction means for restricting passage from the flushing chamber to the administration chamber, the restriction means being openable so as to render the administration chamber flushable. Conduit A is arranged higher than conduit B. Although this device allows for automatic flushing, it has the disadvantage that it is relatively complicated to manufacture since it requires at least two conduits and flow restriction means, as well as a drip chamber, hence making this apparatus relatively expensive to manufacture and complicated to use.

[0010] US20190290837A1 discloses an IV bag for the delivery of liquid medicine in an intravenous (IV) delivery system according to the preamble of claim 24. The collapsible bag is provided with a flushing device that uses a tubular member that acts as a float to keep the tubular member upright such that the float valve is closed and allows the flushing solution to exit the to the tubular member when the float valve is open.

[0011] SUMMARY

[0012] It is an object to provide an automatic flushing function for IV infusion sets that overcomes or at least reduces at least one of the drawbacks mentioned above. According to a first aspect, there is provided An IV infusion set having an automatic flushing function, the IV infusion set defining at least partially gravity-driven fluid flow path for IV liquid that extends from a preferably collapsible IV liquid container for containing IV liquid that is, when in use positioned at the highest height of the IV infusion set, to a connector for connecting to a needle for insertion into a patient or to an IV catheter placed in a patient at a lower height, the IV liquid container having an upper end and a lower end, the IV infusion set comprising a body defining a rigid and / or non-collapsible flushing liquid chamber for containing a flushing liquid and preferably containing the flushing liquid, the flushing liquid chamber having an upper end and a lower end, wherein the flushing liquid chamber being a closed chamber, except for at least one flushing port at or near the lower end of the flushing liquid chamber for allowing flushing liquid to flow into the fluid flow path and at least one venting port for allowing air from the fluid flow path to enter the flushing liquid chamber, the venting port fluidically connects the fluid flow path to the flushing liquid chamber, the venting port comprises an inlet opening that opens to the fluid flow path at a venting height, the venting port having an outlet opening that opens to the flushing liquid chamber at a height above the venting height, the at least one flushing port being fluidically connected to the fluid flow path at a flushing height, the flushing height being lower than the venting height and the flushing height being equal to or lower than the lower end of the IV liquid container for allowing air from the fluid flow path to enter the flushing liquid chamber via the venting port and simultaneously allowing flushing liquid from the flushing liquid chamber to enter the fluid flow path via the flushing port when, during use of the IV infusion set, the level of IV liquid in the fluid flow path has become lower than the venting height, thereby allowing the flushing liquid chamber to be drained at least partially by gravity into the fluid flow path.

[0013] When the IV liquid container has been emptied of IV liquid remaining air from the IV liquid container or air introduced into the IV liquid container via an air inlet will enter the conduit and when the IV liquid level in the conduit falls below the venting height, air will enter the flushing liquid chamber and displace the flushing liquid, thereby allowing spontaneous or automatic flushing of the components downstream of the flushing liquid chamber with flushing liquid after emptying the IV liquid from the IV liquid container, and thereby flushing out IV liquid from the downstream components of the IV infusion set and ensuring that practically all the IV liquid that was present in the IV liquid container at the start of the procedure enters the patient.

[0014] The inventors have realized that one or more air bubbles in the fluid flow path can cause a flow restriction. Such air bubbles are sometimes introduced during priming. During priming air is pumped from a downstream component from the lower access port through the fluid flow path into the IV medication liquid container which is situated upstream from the flushing apparatus. An air bubble of substantial size may get stuck inside the fluid flow path during the priming. As medication flows from the IV liquid container through the fluid flow path to the downstream components, the air bubble is pushed down towards the access port, however, the buoyancy force of the air bubble equals the force of the fluid flow of the IV medication, with the air bubble stuck inside the lumen below the venting port. Such an air bubble can cause a substantial flow restriction and prevent or at least reduce proper operation of the flushing apparatus.

[0015] As the head height from the fluid flow restriction and the medication level inside the IV medication liquid container is substantial, a high pressure region is formed above the air bubble. This, in effect, may force IV medication liquid into the flushing chamber if no countermeasures are taken, thereby filling the flushing liquid chamber with IV liquid and thus substantially lowering the effectiveness of the flush. The inventors had the insight that a venting port design that comprises an outlet opening that is situated above the flushing liquid level and is separated from the lumen fluid flow path by a partition wall creates a head height between the IV medication liquid level inside the vent port and the lowest height of the partition wall. This head height creates a backpressure that is equal to the high pressure region above the flow restricting bubble inside the lumen. The height added to the venting port causes a back-and-forth flow in the system that starts when the IV liquid height in the main conduit drops to the level of the venting height for the first time and continues until the level of the flushing liquid in the flushing chamber also reaches the venting height. This back-and-forth movement causes air bubbles to be “released” and prevents air bubbles blocking flow of IV liquid through the main conduit. The inventors had the insight that this causes the IV liquid to flow past the bubble instead of flowing inside the flushing liquid chamber, thereby solving the flow restriction problem caused by an air bubble.

[0016] By providing an IV infusion set according to the first aspect a simplified workflow is provided for Healthcare Professionals, mainly nurses, with one less work process to be done in relation to IV medication. Thus, ensuring that IV flushing guidelines will be followed, and the patient is more likely to reach the full dose of medication and reduce flushing delay leading to the occurrence of phlebitis and occlusion, by securing sequential flushing after every IV dose. Simplifying the procedure saves time so Healthcare Professionals can allocate resources to improve general patient care.

[0017] The inventors have observed that the need for flushing is often unrecognized or neglected due to more urgent tasks in patient care and even when flushing is performed it is most often delayed or performed sub-optimally, e.g. by using non-closed IV systems with a higher risk of introducing microbial agents into the bloodstream. These practices put patients at risk of increased treatment duration and stay in hospitals as well as catheter-related complications such as occlusion and phlebitis and the rare, but potentially fatal sepsis.

[0018] The IV infusion set according to the first aspect is a solution for ensuring automated, sequential flushing after every dose of IV liquid. The apparatus is simple and compatible with the current equipment, so it offers healthcare professionals an optimized workflow and saves Healthcare Professionals at least one patient visit each time an IV dose is infused. Investigations have shown that Healthcare Professionals save approx. 5 minutes with each IV infusion using the apparatus according to the first aspect. Healthcare guidelines state that flushing should be performed directly after every infusion, however, this demand is not easily compatible with the busy life in hospitals where Healthcare Professionals must care for many patients and balance many tasks at the same time.

[0019] The IV infusion set according to the first aspect ensures that every administration of IV liquid is flushed, leading to more effective treatment and potentially shorter stay in hospital. At the same time, the automated sequential flushing prevents residual medicine and the risk of phlebitis significantly. All this while saving manhours in the hospital.

[0020] By providing a dedicated venting port, it is ensured that the flushing procedure starts reliably.

[0021] In a possible implementation form of the first aspect, the venting port comprises a venting channel extending from the inlet opening to the outlet opening, the venting channel preferably extending substantially vertically. In a possible implementation form of the first aspect, the at least one flushing port forms a permanently open or unoccluded fluidic connection between the flushing liquid chamber and the fluid flow path, and / or wherein the at least one venting port forms a permanently open or unoccluded fluidic connection between the flushing liquid chamber and the fluid flow path.

[0022] In a possible implementation form of the first aspect, the flushing chamber is prefilled to a given level, and wherein the venting height is below the given level.

[0023] In a possible implementation form of the first aspect, the height of the outlet opening is above the given level.

[0024] In a possible implementation form of the first aspect, the at least one flushing port and / or the at least one venting port is an always open fluidic connection that directly connects the flushing port to the fluid flow path, preferably the at least one flushing port comprising an opening of a flushing channel that extends between the fluid flow path and the liquid chamber, the flushing channel preferably extending substantially horizontally.

[0025] In a possible implementation form of the first aspect, the at least one flushing port and or the venting port forms one or more of: an unoccluded fluidic connection a permanently open fluidic connection without substantial flow restriction, a permanently or unoccluded open fluidic connection without flow control elements, a permanently open or unoccluded fluidic connection without valves, a permanently open or unoccluded fluidic connection comprising neither tubing nor piping.

[0026] In a possible implementation form of the first aspect, the flushing liquid chamber is arranged at a height below the IV liquid container or inside the IV liquid container.

[0027] In a possible implementation form of the first aspect, the infusion set comprises a flushing apparatus, the flushing apparatus comprising: the flushing liquid chamber, and a first conduit forming a portion of the fluid flow path, an upper end of the first conduit being fluidically coupled to an inlet coupling component for accessing an IV liquid container and for receiving an at least partially gravity-driven flow of IV liquid from the IV liquid container, a lower end of the first conduit being flu idical ly connected to an outlet coupling component for coupling to a downstream component of the IV infusion set and for delivering an at least partially gravity-driven flow of IV liquid or flushing liquid to the downstream component, the at least one flushing port being fluidically connected to the conduit, preferably at or near the lower end of the first conduit and the at least one venting port being fluidically connected to the conduit.

[0028] In a possible implementation form of the first aspect, the venting port comprises a venting channel that extends between the inlet opening and the outlet opening.

[0029] In a possible implementation form of the first aspect, the first conduit and the venting channel share a wall.

[0030] In a possible implementation form of the first aspect, the first conduit extends substantially vertically during use, and wherein at least a portion of the venting channel extends substantially vertically during use of the IV infusion set.

[0031] In a possible implementation form of the first aspect, the inner and / or outer surface of the first conduit is tapered.

[0032] In a possible implementation form of the first aspect, an inner and / outer surface of the first conduit is tapered except for of one or more sections of the length of the first conduit that have a non-tapering inner and / or outer surface.

[0033] In a possible implementation form of the first aspect, the venting channel is an integral part of the first conduit.

[0034] In a possible implementation form of the first aspect, the first conduit and the venting channel are part of a single molded product.

[0035] In a possible implementation form of the first aspect, the conduit extends through the flushing liquid chamber.

[0036] In a possible implementation form of the first aspect, a cross-sectional area of the venting port is smaller than a cross-sectional area of the flushing port.

[0037] In a possible implementation form of the first aspect, the inlet opening is a substantially downwardly facing opening. According to a second aspect, there is provided a flushing apparatus for use with an IV infusion set, the flushing apparatus comprising: a rigid and / or non-collapsible flushing liquid chamber for containing a flushing liquid and preferably containing the flushing liquid, an inlet coupling component for accessing an IV liquid container and for receiving an at least partially gravity-driven flow of IV liquid from the IV liquid container, the inlet coupling component being arranged, when in use, at an upper end of the flushing apparatus and the IV liquid container preferably being an IV bag, an outlet coupling component for coupling to a downstream component and for delivering an at least partially gravity-driven flow of IV liquid and flushing liquid to the downstream component, the outlet coupling component being arranged, when in use, at a lower end of the flushing apparatus and the downstream component preferably comprising a drip chamber, and a conduit fluidically connecting the inlet coupling component to the outlet coupling component, the flushing liquid chamber having an upper end and a lower end, wherein the flushing liquid chamber being a closed chamber, except for at least one flushing port at or near the lower end of the flushing liquid chamber for allowing flushing liquid to flow into the conduit and at least one venting port for allowing air from the conduit to enter the flushing liquid chamber, the venting port fluidically connects the conduit to the flushing liquid chamber, the venting port having an outlet opening that opens to the flushing liquid chamber at a height above the venting height and an inlet opening that opens to the conduit at the venting height, the at least one flushing port being fluidically connected to the conduit at a flushing height and the flushing height being lower than the venting height, for simultaneously allowing air from the conduit to enter the flushing liquid chamber via the venting port and flushing liquid from the flushing liquid chamber to enter the conduit via the flushing port, when, during use of flushing apparatus, the level of IV liquid in the conduit has become lower than the venting height, thereby allowing the flushing liquid chamber to be drained at least partially by gravity into the conduit.

[0038] When the IV liquid container has been emptied of IV liquid the remaining air from the IV liquid container (or air entering the IV liquid container through an air inlet) will enter the conduit and subsequently the flushing chamber through the venting port and displace the flushing liquid, thereby allowing an automated flush of the components downstream of the flushing liquid chamber with flushing liquid after emptying the IV liquid from the IV liquid container, and thereby flushing out IV liquid from the downstream components of the IV infusion set and attempting that almost all of the IV liquid that was present in the IV liquid container at the start of the procedure enters the patient.

[0039] By providing an infusion apparatus according to the second aspect a simplified workflow is provided for Healthcare Professionals, mainly nurses, with one less work process to be done in relation to IV medication. Thus, ensuring that IV flushing guidelines will be followed, and the patient will receive the full dose of medication and reduce flushing delay leading to the occurrence of phlebitis and occlusion, by securing sequential flushing after every IV dose. Simplifying the procedure saves time so Healthcare Professionals can allocate resources to improve general patient care.

[0040] The inventors have observed that the need for flushing is often unrecognized or neglected due to more urgent tasks in patient care and even when flushing is performed it is most often delayed or performed sub-optimally, e.g. by using non-closed IV systems with a higher risk of introducing microbial agents into the bloodstream. These practices put patients at risk of increased treatment duration and stay in hospitals as well as catheter-related complications such as occlusion and phlebitis and the rare, but potentially fatal sepsis.

[0041] The flushing apparatus according to the second aspect is a solution for ensuring automated, sequential flushing after every dose of IV liquid. The apparatus is simple and compatible with the current equipment, so it offers the Healthcare Professionals an optimized workflow and saves Healthcare Professionals at least one patient visit each time an IV dose is infused. Tests have shown that Healthcare Professionals save approx. 5 minutes with each IV infusion using the apparatus according to the first aspect. Healthcare guidelines state that flushing should be performed directly after every infusion, however, this demand is not easily compatible with the busy life in hospitals where Healthcare Professionals have to care for many patients and balance many tasks at the same time.

[0042] The flushing apparatus according to the second aspect ensures that every patient gets the full dose every time, leading to more effective treatment and potentially shorter stay in hospital. At the same time, the automated, sequential flushing prevents residual medicine and the risk of phlebitis. All this while saving manhours in the hospital. In a possible implementation form of the second aspect, the flushing chamber is prefilled with flushing liquid to a given level, and wherein the venting height is below the given level.

[0043] In a possible implementation form of the second aspect, the height of the outlet opening is above the given level.

[0044] In a possible implementation form of the second aspect, the venting port comprises a channel that extends between the inlet opening and the outlet opening.

[0045] In a possible implementation form of the second aspect, the conduit and the channel share a wall or have a common wall.

[0046] In a possible implementation form of the second aspect, the conduit extends substantially vertically during use, and wherein at least a portion of the channel extends substantially vertically during use.

[0047] In a possible implementation form of the second aspect, an inner and / or outer surface of the conduit is tapered.

[0048] In a possible implementation form of the second aspect, the inner and / or outer surface of the conduit is tapered except for one or more sections of the length of the conduit that have a non-tapering shape.

[0049] In a possible implementation form of the second aspect, the channel is an integral part of the conduit.

[0050] In a possible implementation form of the second aspect, the conduit and the channel are part of a single molded product.

[0051] In a possible implementation form of the second aspect, the inlet opening is a substantially downwardly facing opening.

[0052] In a possible implementation form of the second aspect, the conduit extends through the flushing liquid chamber.

[0053] In a possible implementation form of the second aspect, the at least one flushing port is arranged closer to the lower end of the flushing liquid chamber than to the upper end of the flushing liquid chamber, the at least one flushing port preferably being arranged at or near the lower end of the flushing liquid chamber.

[0054] In a possible implementation form of the second aspect, the at least one flushing port comprises an opening in a wall of the conduit.

[0055] In a possible implementation form of the second aspect, at least a portion of the conduit comprises a main channel that extends from the inlet coupling component to the outlet coupling component, and wherein the at least one flushing port and / or the at least one venting port is preferably branched off from the main channel.

[0056] In a possible implementation form of the second aspect, the inlet coupling component comprises an IV spike, and / or wherein the outlet coupling component comprises a port for receiving an IV spike.

[0057] In a possible implementation form of the second aspect, the conduit, the venting channel, the inlet coupling component and / or the outlet coupling component are integrally formed.

[0058] In a possible implementation form of the second aspect, the at least one flushing port and / or the at least one venting port is an always open fluidic connection that directly connects the flushing port and / or the venting port to the fluid flow path.

[0059] In a possible implementation form of the second aspect, the least flushing port comprises a flushing channel flu idical ly connecting the conduit to the flushing chamber.

[0060] In a possible implementation form of the second aspect, the at least one flushing port and the at least one venting port form one or more of: an unoccluded fluidic connection a permanently open or unoccluded fluidic connection without substantial flow restriction, a permanently open or unoccluded fluidic connection without flow control elements, a permanently open or unoccluded fluidic connection without valves.

[0061] In a possible implementation form of the second aspect, wherein the apparatus comprises a fluid flow path for IV infusion liquid to pass through the apparatus, the conduit forming part of the fluid flow path. According to the third aspect, there is provided an IV infusion set comprising a flushing apparatus according to the second aspect or any possible implementation thereof.

[0062] In a possible implementation form of the first, second or third aspect, the IV liquid is a fluid with some medicine in it and the flushing liquid is a fluid with no medicine in it.

[0063] In a possible implementation form of the first, second or third aspect, the IV liquid is a fluid with some nutrients in it and the flushing liquid is a fluid with no nutrients in it.

[0064] In a possible implementation form of the first, second or third aspect, the IV liquid is a fluid with a dose medicine in it and the flushing liquid is a liquid with some medicine different from the dose medicine.

[0065] The foregoing and other objects are achieved by the features of the independent claims. Further implementation forms are apparent from the dependent claims, the description, and the figures.

[0066] BRIEF DESCRIPTION OF THE DRAWINGS

[0067] In the following detailed portion of the present disclosure, the aspects, embodiments, and implementations will be explained in more detail with reference to the example embodiments shown in the drawings, in which:

[0068] Fig. 1 is a cross-sectional view of a flushing device according to an embodiment,

[0069] Fig. 2 is the view of the flushing device of Fig. 1 illustrating IV liquid, flushing liquid, and air in the flushing device,

[0070] Fig. 3 is a longitudinal-section view of the flushing device of Fig. 1 ,

[0071] Fig. 4 shows a sectional elevation of the flushing device of Fig. 1 ,

[0072] Fig. 5 is a cross-sectional diagrammatic representation of the flushing device of Fig. 1 filled with flushing liquid and connected to an IV bag and to a downstream line, with IV liquid in a portion of a fluid flow path extending through the flushing device,

[0073] Fig. 6 is a cross-sectional diagrammatic representation of the flushing device of Fig. 1 at the subsequent stage where the IV liquid level has fallen below the venting height for the first time,

[0074] Fig. 7 is a cross-sectional diagrammatic representation of the flushing device of Fig. 1 at a subsequent stage where the IV liquid level has risen back to the venting height for the first time,

[0075] Fig. 8 is a cross-sectional diagrammatic representation of the flushing device of Fig. 1 at a subsequent stage where the IV liquid level has fallen below the venting height again, Fig. 9 is a cross-sectional diagrammatic representation of the flushing device of Fig. 1 at a subsequent stage where the IV liquid level has risen back to the venting height again,

[0076] Fig. 10. is a cross-sectional diagrammatic representation of the flushing device of Fig. 1 at a subsequent stage where the level of the flushing liquid in the flushing chamber has fallen below the venting height,

[0077] Fig. 11 is a diagrammatic illustration of an IV infusion set comprising the flushing device of Fig. 1 , and

[0078] Fig. 12 is a sectional view of another embodiment of the spike of the flushing device in which the spike of the flushing device is provided with an air inlet feature.

[0079] DETAILED DESCRIPTION

[0080] Figs. 1 to 4 illustrate an embodiment of a flushing device 1 for use with a standard or bespoke IV infusion set. The flushing device 1 can also be used with intraoral feeding sets, parenteral delivery systems, and the like. Fig. 11 illustrates an IV infusion set comprising a flushing device 1 that can be used for gravity, pump-assisted infusions and / or pressure infusions.

[0081] The IV infusion set comprises a collapsible IV liquid container 20, preferably in the form of a collapsible bag 20, preferably made from transparent polymer sheet material, which is the highest component of the IV infusion set, e.g. by hanging the collapsible IV liquid container on a hook of an IV stand (not shown) using the hole 25 at the upper end of the collapsible IV liquid container 20. The lower end of the collapsible IV liquid container 20 is provided with an inlet port 23 and an outlet port 22 and the interior of the IV liquid container 20 comprises a collapsible infusion liquid chamber 21 that has an upper end and a lower end and that is at least partially filled with IV liquid and partially filled with air during or before use. In an embodiment (not shown), the IV liquid container 20 is not collapsible, e.g. a glass or plastic vial, and is connected to an air vent. The IV liquid container 20 is configured to contain an IV liquid and air. The IV liquid is typically a solution of medicine in water. The IV liquid container 20 is, during use, partially filled with IV liquid and partially filled with air. At the start of an infusion procedure, the amount of IV liquid (medical solution) to be infused to a patient is present in the IV liquid container 20, together with some air. At the end of the infusion period, the IV liquid container 20 contains no or very little IV liquid.

[0082] The flushing apparatus 1 comprises a housing 3, a spike 4 forming an inlet coupling component, and an outlet port 5 forming an outlet coupling component. The spike 4 is in Fig. 11 shown inserted with the spike 4 into the outlet port 22 of the collapsible IV solution container 20. The outlet port 22 of the collapsible IV solution container 20 is covered by a membrane to be pierced by the spike 4 of the flushing apparatus 1 . The spike 4 forms an inlet coupling component for accessing the content of the collapsible IV liquid container 20 and for receiving an at least partially gravity-driven or pump- assisted flow of IV liquid from the collapsible IV liquid container 20. The inlet coupling component 4 is arranged, when in use, at an upper end of the flushing apparatus 1. The flushing apparatus 1 comprises an outlet coupling component 5 for coupling to a downstream component 11 and for delivering an at least partially gravity-driven or pump-assisted flow of IV liquid or flushing liquid to the downstream component 11 of the IV infusion set. The outlet coupling component 5 comprises an outlet port for receiving an IV spike of a downstream component of the IV infusion set, for example, the IV spike 14 of the drip chamber 11 . The outlet port of the outlet coupling component 5 is covered by a membrane to be pierced by the IV spike of the downstream component.

[0083] The inlet coupling component 4 and the outlet coupling component 5 are both connected to a body of the apparatus 1 , and the outlet coupling component 5 is, when in use, arranged at a lower end of the flushing apparatus 1 , and preferably, the inlet coupling component 4 is, when in use, arranged at an upper end of the flushing apparatus 1 . The body or housing 3 of the flushing apparatus 1 forms a container that defines a rigid and / or non-compressible and / or non-collapsible flushing liquid chamber 2. In this relation, rigid and / or non-compressible and / or non-collapsible is understood to mean that the volume of the flushing liquid chamber 2 does not substantially change during use, i.e. when exposed to pressures and forces that can only be expected during use, to ensure that there is no fluid exchange in or out of the flushing liquid chamber2 due to deformation of the flushing liquid chamber 2.

[0084] In the shown embodiment, the downstream component 11 is a preferably transparent drip chamber 11. Preferably, an air vent (not shown) is provided at the upper end of the drip chamber 11 . The upper end of the drip chamber 11 is provided with a spike 14 that allows the drip chamber 11 to be connected to an upstream component of the IV set, in this embodiment the flushing apparatus 1 , by inserting the spike 14 in the outlet connector component 5 of the flushing apparatus 1 . The lower end of the drip chamber 11 is preferably provided with an air filter (known also as air stop with Braun® IV sets) to ensure no air enters the downstream tubing which could cause air embolisms in the patient. A tube 31 is provided with an adjustable flow rate roller clamp 34. The tube 31 extends from the drip chamber 11 to a needle connector 35 for example a Luer connector 35. A hypodermic needle 41 can be connected to the needle connector 35. The hypodermic needle 41 is either directly inserted into a patient or into an IV port that has already been inserted into a patient.

[0085] The IV infusion set defines an at least partially gravity-driven fluid flow path for IV liquid that extends from the preferably collapsible container 20 which is positioned as the highest component of the IV infusion set to the needle connector 35 at a lower height. The flow of liquid through the fluid flow path may be assisted by an infusion pump (not shown), thereby resulting in a partially gravity-driven and partially pressure-driven fluid flow through the IV infusion set.

[0086] The flushing apparatus 1 comprises a housing or container 3 defining the rigid and / or non-collapsible flushing liquid chamber 2 for containing a flushing liquid and preferably containing the flushing liquid before use. The flushing liquid chamber 2 has an upper end and a lower end. The flushing liquid chamber 2 is a hermetically closed chamber, except for one or more flushing ports at a flushing height FH at or near the lower end of the flushing liquid chamber 2 and one or more venting ports, arranged at a venting height VH that is higher than the flushing height FH. In the shown embodiment, there is one flushing port and one venting port, but it is understood that there could be a plurality of flushing ports and a plurality of venting ports.

[0087] The flushing port is fluidical ly connected to the fluid flow path of the IV infusion set at a flushing height FH (indicated by an interrupted line in the Figs.) by a flushing conduit 7. The venting conduit is fluidically connected to the fluid flow path of the IV infusion set at a venting height VH (indicated by an interrupted line in the Figs.) at an inlet opening 17. The flushing liquid chamber 2 is a closed chamber, except for the at least one flushing port at or near the lower end of the flushing liquid chamber for allowing flushing liquid to flow into the conduit 6 and at least one venting port for allowing air from the conduit 6 to enter the flushing liquid chamber 2. The venting port fluidically connects the conduit 6 to the flushing liquid chamber 2. The venting port has an outlet opening 19 that opens to the flushing liquid chamber 2 at a height above the venting height VH and an inlet opening 17 that opens to the conduit 6 at the venting height VH. 21. The flushing chamber 2 is prefilled with flushing liquid to a given level (shown by the interrupted line in Fig. 2), and the venting height VH is below the prefill level. The height of the outlet opening 19 is above the prefill level. The venting port comprises a venting channel 18 that extends between the inlet opening 17 and the outlet opening 19. The flushing height FH is equal to or lower than the lower end of the preferably collapsible container 20 and the venting height VH is higher than the flushing height FH for simultaneously allowing air from the fluid flow path to enter the flushing liquid chamber 2 via the one or more venting ports and flushing liquid from the flushing liquid chamber 2 to enter the fluid flow path via one or more flushing ports, when, during use of the IV infusion set, the level of IV liquid in the fluid flow path has become lower than the venting height VH, thereby allowing the flushing liquid chamber 2 to be drained by gravity or pump assistance into the fluid flow path. Since the flushing chamber 2, is substantially incompressible and is a closed chamber except for the at least one flushing port, flushing liquid, due to its substantially incompressible nature will not leave the flushing chamber 2 through the at least one flushing port unless air from the conduit 6 enters the flushing chamber 2 through the at least one venting port. The exchange of flushing liquid and air through at least one flushing port and the at least one venting port happens simultaneously. In this embodiment, the fluid flow path is formed by a conduit 6 that extends through the flushing chamber 2 and is formed by a pipe-like element that is a part of the flushing apparatus 1 . In this embodiment, the conduit 6 is shown as a pipe that extends vertically through the flushing chamber, but it should be understood that the conduit 6 does not need to be straight and does not need to be arranged exactly vertically through the flushing chamber, it merely needs to fluidically connect the upper inlet coupling component 4 to the lower outlet coupling component 5.

[0088] In this embodiment, the conduit 6, the spike 4, the housing bottom / lid, the outlet coupling component 5, and the venting port are formed as one integral element, preferably one integral element that is made from an injection molded polymer. The housing 3, with its open bottom that is to be closed by the lid bottom / lid is formed as one integral element, preferably one integral element is made from an injected molded polymer.

[0089] The at least one flushing port is arranged closer to the lower end of the flushing chamber 2 than to the upper end of the flushing chamber 2. The at least one flushing port is preferably arranged at or near the lower end of the flushing chamber 2. The at least one venting port is arranged higher than the flushing port, and either above or below the height of the upper surface of the flushing liquid in the chamber, which is a level defined by the amount of flushing liquid with which the chamber 2 is filled before use, and with the flushing device 1 in the intended orientation for use with the outlet coupling component 5 arranged at a lower end of the flushing apparatus 1 , and the inlet coupling component 4 arranged at an upper end of the flushing apparatus 1 . The least one flushing port is fluidly connected to the fluid flow path (in this embodiment the conduit 6 is part of the fluid flow path) by an always open fluid connection, preferably an always open fluid connection that directly connects at least one flushing port to the fluid flow path. Preferably, the at least one flushing port is fluidly connected to the fluid flow path by an always open fluidic connection without any substantial flow restriction or flow control elements. Preferably the at least one flushing port is fluidly connected to the fluid flow path by an always open fluidic connection without any valves, more preferably without any tubing or piping, most preferably the at least one flushing port comprises a substantially horizontally extending flushing channel 8 with a flushing outlet opening that opens to the conduit 6 and a flushing inlet opening that opens to the flushing liquid chamber 2, with the flushing conduit 7 connecting the flushing inlet opening to the flushing outlet opening. In this embodiment, the flushing channel 8 is shown extending horizontally, but it is understood that the flushing channel 8 can be arranged in slightly different directions, including upwardly, and does not need to be straight as shown, but could also be curved and does not need to extend perpendicularly from conduit 6.

[0090] The least one venting port is fluidly connected to the fluid flow path by an always open fluid connection, preferably an always open fluid connection that connects at least comprises having a horizontal extent between an inlet opening 17 that connects to the fluid flow path at the venting height VH and an outlet opening 19 that is arranged at a level that is higher than the venting height and preferably higher than the prefilled level of the flushing chamber 2. Preferably, the at least one venting port is fluidly connected to the fluid flow path by an always open fluidic connection without any substantial flow restriction or flow control elements. Preferably the at least one venting port is fluidly connected to the fluid flow path by an always open fluidic connection without any valves, more preferably without any tubing or piping. In the shown embodiment, the venting channel 18 is shown extending vertically, but it is understood that the flushing conduit can be arranged comprise non-vertical sections and curved sections.

[0091] The cross-sectional area of the at least one flushing port is preferably larger than the cross-sectional area of the at least one venting port, since the flushing liquid will have a higher restriction to flow through an opening of a given size than air, and in this way the perceived resistance to flow will be the same or at least similar for the air and the flushing liquid. Preferably, the venting port is unoccluded or forms a permanently open fluidic connection between the flushing liquid chamber 2 and the fluid flow path. Preferably, the at least one venting port is unoccluded or forms a permanently open fluidic connection between the flushing liquid chamber 2 and the fluid flow path. Preferably, neither the venting port nor the flushing port comprise flow control elements, such as valves, membranes, filters.

[0092] In the embodiment of Figs. 1 to 4, the flushing apparatus 1 comprises a conduit 6 that forms part of the flow path of the IV infusion set, and the conduit 6 extends from the spike 4, through the flushing liquid chamber 2 to the outlet port 5. In this embodiment, the pipe that forms the conduit 6 is preferably a rigid pipe that will not substantially deform during use of the apparatus 1 .

[0093] The conduit 6 is arranged in a main tube extending from the inlet coupling component 4 to the outlet coupling component 5.

[0094] The conduit 6 and the venting channel 18 share a wall or have a common wall. The conduit 6 extends substantially vertically during use, and at least a portion of the venting channel 18 extends substantially vertically during use. The venting inlet opening 17 is preferably a substantially downwardly facing opening, although it should be understood that the inlet opening can also be angled in any other suitable angle, such as a laterally facing opening. The outlet opening 19 is preferably an upwardly facing opening, but it should be understood that it could be angled in any other direction, including laterally and downwardly, and anything in between upwardly and downwardly.

[0095] The inner and / or outer surface of the conduit 6 is tapered for facilitating production in a mold. The inner and / or outer surface of the conduit 6 is in an embodiment tapered except for of one or more sections of the length of the conduit 6 that have a nontapering (straight) shape. In the embodiment of Figs. 1 to 4 the venting channel 18 is an integral part of the conduit 6. The conduit 6 and the venting channel 18 are in embodiment manufactured as a single molded product.

[0096] In an embodiment, the conduit 6, the venting channel 18, the inlet coupling component 4 and / or the outlet coupling component 5 are integrally formed. The main body 3 may be provided with one or more circumferential grooves and / or indentations for improving grip on the device by a user and for enhancing the rigidity of the flushing liquid chamber 2.

[0097] Generally, the flushing liquid chamber 2 is arranged at a height below the IV liquid container 20, or inside the IV liquid container 20.

[0098] Preferably, a rigid and / or non-collapsible body 3 defines the rigid and / or non- compressible flushing liquid chamber. Preferably, the inlet coupling component 4 is rigidly connected to body 3 at an upper end thereof, and the outlet coupling element 5 is rigidly connected to rigid body 3 at the lower end thereof. Preferably, the rigid body 3 is made of transparent material to allow visual inspection of its content.

[0099] In the embodiment of Figs. 1 to 4, and in other conceivable embodiments, the flushing liquid chamber 2 tapers, preferably gradually towards its upper end.

[0100] In the embodiment of Figs. 1 to 4 the conduit 6 extends through the flushing liquid chamber 2, but it should be understood that it is possible to conceive embodiments, in which the flow path does not pass through the flushing chamber 2.

[0101] Fig. 5 illustrates the flushing apparatus 1 filled with flushing liquid. The flushing chamber 2 is filled with a predetermined amount of flushing liquid to the prefill level and there is a predetermined volume of air in the flushing chamber 2 above the flushing liquid. Before connecting to the other parts of the IV set, the same applies to the conduit 6, which is filled with flushing liquid to the same level as the flushing chamber 2, with air being above the flushing liquid. Fig. 5 illustrates the flushing apparatus 1 connected to an IV liquid container 20 arranged above the flushing device 1 , and to a downstream part of an IV set. The IV liquid flows from the IV liquid container 20 through the fluid flow path through the flushing apparatus 1 and into the downstream part of the IV set as indicated by the black arrow. The flushing liquid remains in the flushing chamber 2 since air cannot enter the flushing chamber 2 when the level of the IV liquid is higher than the venting level as shown in Fig. 5.

[0102] Fig. 6 illustrates the flushing apparatus 1 in a subsequent stage, where the level of liquid in the conduit 6 has fallen below the venting height VH for the first time with the flushing chamber 2 being filled with a slightly reduced amount of flushing liquid due to some flushing liquid entering the conduit 6 due to the level of liquid in the conduit 6 being lower than the level of flushing liquid in the flushing chamber 2. Simultaneously, a small volume of IV liquid, equivalent to the volume of the channel 18, is pushed out of the channel 18 into flushing chamber 2, followed by a substantially larger volume of air, as illustrated by the light grey arrow showing the flow of air and the curved thick dark gray arrow showing IV liquid leaving the channel 18 into the flushing chamber 2.

[0103] As shown in Fig. 7 the flow of flushing liquid into the conduit 6 pushes the level of liquid (now in some areas a mixture of IV liquid and flushing liquid) back to the venting height VH, to maintain equal pressure on both sides of the flushing port. When the liquid level in the conduit 6 reaches the venting height VH again, as shown in Fig. 7, the inlet opening 17 to the venting channel 18 is blocked and no air can enter the flushing chamber 2, thereby preventing flow of flushing liquid from the flushing chamber into the conduit 6.

[0104] This causes the liquid level in the conduit 6 to fall again below the venting height VH, as shown in Fig. 8, which is essentially the same situation as that of Fig, 6, except that the amount of flushing liquid in the flushing chamber 2 is now slightly less than in the situation of Fig 6.

[0105] Next, as shown in Fig. 9, the liquid level in the conduit 6 has returned to the venting height VH and the situation is the same as that of Fig. 7, except that the liquid level of flushing liquid in the flushing chamber 2 is now slightly lower. Fig. 10 shows a subsequent stage where the level of the flushing liquid in the flushing chamber has fallen below the venting height.

[0106] The process of the liquid level in the conduit 6 falling below the venting height VH and being pushed back to the venting height VH repeated several times. The actual number of times that the process repeats itself will depend mainly on the ratio between the cross-sectional area of the conduit 6 and the cross-sectional area of the flushing chamber 2, as well on the height difference between the filling level and the venting height VH. Tests of a prototype designed in accordance with the present embodiment have shown that the process typically repeats itself 5 to 6 times. This reciprocal pumping mechanism / motion of lowering and raising of the IV liquid level in the conduit 6 at the beginning of the flushing procedure allows for most of the IV medication, present in the conduit 6 in the beginning of the flushing procedure to be flushed out of the conduit 6 followed by the majority of the undiluted flushing liquid volume, thereby increasing the efficiency of the flush.” Thereafter the level of flushing liquid in the flushing chamber 2 has fallen below the venting height VH which allows a constant stream of air to enter the flushing chamber 2 (shown by the thin grey arrow) and the level of the liquid in the conduit 6 falls now with the same speed as the level in the flushing chamber 2, as indicated by the black arrows.

[0107] This process of air flowing into the flushing chamber 2 and flushing liquid flowing into the liquid flow path / conduit 6 towards the downstream section of the IV set continues until the level of the flushing liquid in the flushing chamber 2 reaches the flushing height FH defined by the flushing port. The initial predetermined amount of flushing liquid in the flushing chamber 2 is selected to be sufficient to flush a substantial amount of IV liquid from the IV set.

[0108] In an embodiment, the flushing liquid is saline or a saline solution, e.g. a mixture of sodium chloride (salt) and water.

[0109] In an embodiment, the IV liquid is a fluid with some medicine in it. In an embodiment, the flushing liquid is a fluid with no medicine in it,

[0110] In an embodiment the IV liquid is a fluid with a dose medicine in it and the flushing liquid is a liquid with some medicine different from the dose medicine.

[0111] In an embodiment, the IV liquid is a fluid with some nutrients in it. In an embodiment, the flushing liquid is a fluid with no nutrients in it.

[0112] In an embodiment, the flushing chamber 2 is prefilled, preferably completely prefilled, with flushing liquid. In an embodiment, the conduit 6 is also prefilled with flushing liquid before use of the flushing apparatus 1 in an IV infusion set.

[0113] In an embodiment, the volume of the flushing liquid chamber 2 correlates to a predetermined flushing volume, preferably a pre-determine flushing volume that substantially corresponds to or slightly exceeds the volume of the flow path in the IV infusion set downstream of the flushing height FH. In an embodiment, the volume of the flushing liquid chamber 2 allows for approximately 15 to 50 mL, preferably approximately 20 to 30 mL, most preferably approximately 25 mL flush to be delivered to the downstream components of the IV infusion set, i.e. the components of the IV infusion set that are downstream of the flushing height FH. In an embodiment, the IV liquid is a medical solution or a medical solution with a medical substance dissolved in saline.

[0114] The flushing port is configured to minimize diffusion and mixing between IV liquid and the flushing liquid. The venting port is configured to only allow air to enter coming from the upstream component of the IV set, e.g. the IV liquid containing 20, and to minimize air entering from the downstream component of the IV infusion set, e.g. the drip chamber 11 .

[0115] In an embodiment shown in Fig. 12, the spike 4 of the flushing device 1 is provided with an air inlet, preferably an integral air inlet with an air filter and closure. A channel 54 is integrated into spike 4, whereas one end of the channel terminates at the upper end of the spike 4 and a second end terminates below the threads of the spike cap. The second opening is covered by an air filter 52 that allows only ambient air to flow into the channel. A closure 50 is situated over the air filter 52 and the second opening of the channel 54 to protect the air filter 52 from ingress of foreign material or contact with liquid and humidity during transport, storage, and use and may pose as a sterile barrier. The closure may be opened when the device is in use to let ambient air flow through the channel in the spike 4 and out the opening that is situated at the upper end of the spike.

[0116] For the flushing device 1 , to release the flushing solution through the flushing port, gas (air) has to enter the flushing chamber 2 through the vent port to effectively displace the volume of the flushing solution in the flushing chamber 2. When the flushing device 1 is used with collapsible IV liquid bags that are filled with a volume of gas in the bag that is lower than the volume of flushing solution contained in the flushing chamber 2, the flushing device 1 only flushes out a volume of flushing liquid that is equal to the gas volume retained in the IV liquid bag and thus does not flush the intended amount of flushing liquid out of the flushing port. In these situations, the closure 50 of the integrated air-inlet may be opened / removed by the user to introduce ambient air into the IV liquid bag, which will subsequently flow through the conduit 6 and vent port into the flushing liquid chamber and displace the intended amount of flushing liquid. The same applies to cases where the device is used with semi-rigid bags that are not filled with a sufficient volume of gas.

[0117] In some cases, the device may be used in combination with semi-rigid IV liquid containers in a gravity-driven setup, wherein the IV liquid container is filled with a volume of gas greater than the volume of flushing liquid container in the flushing liquid chamber. During the infusion, the semi-rigid IV liquid container collapses as the volume of IV medication is reduced, due to atmospheric pressure on the container. However, the material properties of the semi-rigid iv liquid container allow the container to not fully collapse and thus create rising negative pressure in the system as compared to the atmospheric pressure. Due to this negative pressure in the semi-rigid IV liquid container, gas may not flow from the bag into the flushing liquid chamber 2 to displace the flushing liquid. In these situations the closure 50 of the integrated air-inlet may be opened or removed by the user to introduce ambient air into the semi-rigid IV liquid container to equalize the pressure differential between the inside of the semi-rigid IV liquid container and the ambient air, thus allowing air into the semi-rigid IV liquid container, which will subsequently flow through the lumen and vent port into the flushing liquid chamber and displace the intended amount of flushing liquid.

[0118] In some cases, the device may be used in combination with a rigid IV liquid container, for example, a glass vial, in a pump, or gravity-driven setup. For IV medication to flow out of the rigid IV liquid container, an equivalent volume of air needs to be introduced into the container to displace the IV medication. In these instances, the closure of the integrated air-inlet may be opened or removed by the user to introduce ambient air into the rigid IV liquid container to displace the IV medication. Subsequently, after the full dose of IV medication has been released from the rigid IV liquid container, air from the rigid IV liquid container, can flow through the conduit 6 and vent port into the flushing liquid chamber and displace the intended amount of flushing liquid.

[0119] For all the embodiments above, during an IV infusion procedure, the IV liquid container 20 is emptied from IV liquid, and when the level of IV liquid falls below the venting level, air that originates from the IV liquid container 20 enters the flushing liquid chamber 2 through the venting port, displacing liquid fluid from the flushing liquid chamber through the flushing port into the fluid flow path.

[0120] Below is a non-exhaustive list of the advantages of the above-described IV infusion set, flushing apparatus 1 , and the IV liquid bag 20 including the flushing chamber 2.

[0121] - provision of an automated sequential flushing liquid flush to be used in conjunction with small volume intravenous medicine bags and standard infusion sets.

[0122] - significant reduction of residual medicine in the infusion set.

[0123] - a closed system with little risk of medicine contamination for staff and reduced risk of infection caused by contamination of the intravenous tube set and access.

[0124] - an automatic flushing system that can be set up in less than 30 seconds, - ensures adherence to patient safety by a spontaneous sequential saline flush, thus securing the minimal risk of catheter occlusion and chemical phlebitis.

[0125] - ensures that all medication will be delivered at the same rate

[0126] -reduction of the risk that an air bubble in the fluid flow path / conduit obstructs the fluid flow.

[0127] The various aspects and implementations have been described in conjunction with various embodiments herein. However, other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed subject-matter, from a study of the drawings, the disclosure, and the appended claims. In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality.

[0128] The reference signs used in the claims shall not be construed as limiting the scope. Unless otherwise indicated, the drawings are intended to be read (e.g., cross-hatching, arrangement of parts, proportion, degree, etc.) together with the specification, and are to be considered a portion of the entire written description of this disclosure. As used in the description, the terms “height”, “horizontal”, “vertical”, “left”, “right”, “up” and “down”, as well as adjectival and adverbial derivatives thereof (e.g., “horizontally”, “rightwardly”, “upwardly”, etc.), simply refer to the orientation of the illustrated structure as the particular drawing figure faces the reader. Similarly, the terms “inwardly” and “outwardly” generally refer to the orientation of a surface relative to its axis of elongation, or axis of rotation, as appropriate.

Claims

CLAIMS1 . An IV infusion set having an automatic flushing function, said IV infusion set defining at least partially gravity-driven fluid flow path for IV liquid that extends from a preferably collapsible IV liquid container (20) for containing IV liquid that is, when in use positioned at the highest height of the IV infusion set, to a connector (35) for connecting to a needle (41 ) for insertion into a patient or to an IV catheter placed in a patient at a lower height, said IV liquid container (20) having an upper end and a lower end, said IV infusion set comprising a body (3) defining a rigid and / or non-collapsible flushing liquid chamber (2) for containing a flushing liquid and preferably containing said flushing liquid, said flushing liquid chamber (2) having an upper end and a lower end, wherein said flushing liquid chamber (2) being a closed chamber, except for at least one flushing port at or near the lower end of said flushing liquid chamber (2) for allowing flushing liquid to flow into said fluid flow path and at least one venting port for allowing air from said fluid flow path to enter said flushing liquid chamber (2), said venting port fluidically connects said fluid flow path to said flushing liquid chamber (2), said venting port comprises an inlet opening (17) that opens to said fluid flow path at a venting height (VH), said venting port having an outlet opening (19) that opens to said flushing liquid chamber (2) at a height above said venting height (VH), and said at least one flushing port being fluidically connected to said fluid flow path at a flushing height (FH), said flushing height (FH) being lower than said venting height (VH), and said flushing height (FH) being equal to or lower than said lower end of said IV liquid container (20) for allowing air from said fluid flow path to enter said flushing liquid chamber (2) via said venting port and simultaneously allowing flushing liquid from said flushing liquid chamber (2) to enter said fluid flow path via said flushing port when, during use of the IV infusion set, the level of IV liquid in the fluid flow path has become lower than said venting height (VH), thereby allowing the flushing liquid chamber (2) to be drained at least partially by gravity into the fluid flow path.

2. The IV infusion set according to claim 1 , wherein said venting port comprises a venting channel (18) extending from said inlet opening (17) to said outlet opening (19), said venting channel preferably extending substantially vertically.

3. The IV infusion set according to claim 1 or 2, wherein said at least one flushing port is unoccluded or forms a permanently open fluidic connection between said flushingliquid chamber (2) and said fluid flow path, and / or wherein said at least one venting port is unoccluded or forms a permanently open fluidic connection between said flushing liquid chamber (2) and said fluid flow path.

4. The IV infusion set according to any one of claims 1 to 3, wherein said flushing chamber (2) is prefilled to a given level, and wherein said venting height (VH) is below said given level.

5. The IV infusion set according to claim 4, wherein the height of said outlet opening (19) is above said given level.

6. The IV infusion set according any one of claims 1 to 5, wherein said at least one flushing port and / or said at least one venting port is an always open fluidic connection that directly connects said flushing port to the fluid flow path, preferably said at least one flushing port comprising an opening (7) of a flushing channel (8) that extends between said fluid flow path and said liquid chamber (2), said flushing channel (8) preferably extending substantially horizontally.

7. The IV infusion set according to any one of claims 1 to 6 wherein said at least one flushing port and or said venting port forms one or more of: an unoccluded fluidic connection, a permanently open fluidic connection without substantial flow restriction, a permanently open or unoccluded fluidic connection without flow control elements, a permanently open or unoccluded fluidic connection without valves.

8. The IV infusion set according to any one of claims 1 to 7, wherein said flushing liquid chamber (2) is arranged at a height below said IV liquid container (20) or inside said IV liquid container (20).

9. The IV infusion set according to any one of claims 1 to 8, comprising a flushing apparatus (1 ), said flushing apparatus (1 ) comprising: said flushing liquid chamber (2), and a first conduit (6) forming a portion of said fluid flow path, an upper end of said first conduit (6) being fluidically coupled to an inlet coupling component (4) for accessing an IV liquid container (20) and for receiving an at least partially gravity-driven flow of IV liquid from said IV liquid container (20), a lower end of said first conduit (6) being fluidically connected to an outlet coupling component (5) for coupling to adownstream component (11 ) of said IV infusion set and for delivering an at least partially gravity-driven flow of IV liquid or flushing liquid to said downstream component (11 ), said at least one flushing port being fluidically connected to said conduit (6), preferably at or near said lower end of said first conduit (6) and said at least one venting port being fluidically connected to said conduit (6).

10. The IV infusion set according to claim 9, wherein said venting port comprises a venting channel (18) that extends between said inlet opening (17) and said outlet opening (19).

11. The IV infusion set according to claim 10, wherein said first conduit (6) and said venting channel (18) share a wall.

12. The IV infusion set according to claim 10 or 11 , wherein the first conduit (6) extends substantially vertically during use, and wherein at least a portion of the venting channel (18) extends substantially vertically during use of the IV infusion set.

13. The IV infusion set according to any one of claims 9 to 12, wherein an inner and / or outer surface of the first conduit (6) is tapered.

14. The IV infusion set according to claim 13, wherein an inner and / outer surface of the first conduit (6) is tapered except for one or more sections of the length of the first conduit (6) that have a non-tapering inner and / or outer surface.

15. The IV infusion set according to any one of claims 10 to 14, wherein the venting channel (18) is an integral part of the first conduit (6).

16. The IV infusion set according to claim 15, wherein the first conduit (6) and the venting channel (18) are part of a single molded product.

17. The IV infusion set according to any one of claims 9 to 16, wherein said conduit (6) extends through said flushing liquid chamber (2).

18. The IV infusion set according to any one of claims 9 to 17, wherein a cross-sectional area of said venting port is smaller than a cross-sectional area of said flushing port.

19. The IV infusion set according to any one of claims 9 to 18, wherein said inlet opening (17) is a substantially downwardly facing opening.

20. A flushing apparatus (1 ) for use with an IV infusion set, the flushing apparatus (1 ) comprising: a rigid and / or non-collapsible flushing liquid chamber (2) for containing a flushing liquid and preferably containing said flushing liquid, an inlet coupling component (4) for accessing an IV liquid container (20) and for receiving an at least partially gravity-driven flow of IV liquid from the IV liquid container (20), the inlet coupling component (4) being arranged, when in use, at an upper end of the flushing apparatus (1 ) and the IV liquid container preferably being an IV bag (20), an outlet coupling component (5) for coupling to a downstream component (11 ) and for delivering an at least partially gravity-driven flow of IV liquid and flushing liquid to the downstream component (11 ), the outlet coupling component (5) being arranged, when in use, at a lower end of the flushing apparatus (1 ) and the downstream component (11 ) preferably comprising a drip chamber (25), and a conduit (6) fluidically connecting the inlet coupling component (4) to the outlet coupling component (5), said flushing liquid chamber (2) having an upper end and a lower end, wherein said flushing liquid chamber (2) being a closed chamber, except for at least one flushing port at or near the lower end of said flushing liquid chamber (2) for allowing flushing liquid to flow into said conduit (6) and at least one venting port for allowing air from said conduit (6) to enter said flushing liquid chamber (2), said venting port fluidically connects said conduit (6) to said flushing liquid chamber (2), said venting port having an outlet opening (19) that opens to said flushing liquid chamber (2) at a height above said venting height (VH) and an inlet opening (17) that opens to said conduit (6) at said venting height (VH), and said at least one flushing port being fluidically connected to said conduit (6) at a flushing height (FH) and said flushing height (FH) being lower than said venting height (VH), for simultaneously allowing air from said conduit (6) to enter said flushing liquid chamber (2) via said venting port and flushing liquid from said flushing liquid chamber (2) to enter said conduit (6) via said flushing port, when, during use of flushing apparatus (1 ), the level of IV liquid in the conduit (6) has become lower than said venting height (VH), thereby allowing the flushing liquid chamber (2) to be drained at least partially by gravity into the conduit (6).

21. The flushing apparatus (1 ) according to claim 20, wherein said flushing chamber (2) is prefilled with flushing liquid to a given level, and wherein said venting height (VH) is below said given level.

22. The flushing apparatus (1 ) according to claim 21 , wherein the height of the outlet opening (19) is above said given level.

23. The flushing apparatus (1 ) according to any one of claims 20 to 22, wherein said venting port comprises a venting channel (18) that extends between said inlet opening (17) and said outlet opening (19).

24. The flushing apparatus (1 ) according to claim 23, wherein said conduit (6) and said venting channel (18) share a wall or have a common wall.

25. The flushing apparatus (1 ) according to claim 23 or 24, wherein the conduit (6) extends substantially vertically during use, and wherein at least a portion of the venting channel (18) extends substantially vertically during use.

26. The flushing apparatus (1 ) according to any one of claims 20 to 25, wherein at least one inner and / or outer surface of the conduit (6) is tapered.

27. The flushing apparatus (1 ) according to claim 26, wherein the inner and / or outer surface of the conduit (6) is tapered except for one or more sections of the length of the conduit (6) that have a non-tapering shape.

28. The flushing apparatus (1 ) according to any one of claims 23 to 27, wherein the venting channel (18) is an integral part of the conduit (6).

29. The flushing apparatus (1 ) according to claim 28, wherein the conduit (6) and the venting channel (18) are part of a single molded product.

30. The flushing apparatus (1 ) according to any one of claims 20 to 29, wherein said said inlet opening (17) is a substantially downwardly facing opening.

31. The flushing apparatus (1 ) according to any one of claims 20 to 30, wherein the conduit (6) extends through the flushing liquid chamber (2).

32. The flushing apparatus (1 ) according to any one of claims 20 to 31 , wherein the at least one flushing port is arranged closer to said lower end of the flushing liquid chamber (2) than to the upper end of the flushing liquid chamber (2), the at least oneflushing port preferably being arranged at or near the lower end of the flushing liquid chamber (2).

33. The flushing apparatus (1 ) according to any one of claims 20 to 32, wherein the at least one flushing port comprises an opening in a wall of the conduit (6).

34. The flushing apparatus (1 ) according to any one of claims 20 to 33, wherein at least a portion of the conduit (6) comprises a main channel that extends from said inlet coupling component (4) to said outlet coupling component (5), and wherein the at least one flushing port and / or the at least one venting port is preferably branched off from said main channel.

35. The flushing apparatus (1 ) according to any one of claims 20 to 34, wherein the inlet coupling component (4) comprises an IV spike, and / or wherein the outlet coupling component (5) comprises a port for receiving an IV spike.

36. The flushing apparatus (1 ) according to any one of claims 20 to 35, wherein the conduit (6), the venting channel (18), the inlet coupling component (4), and / or the outlet coupling component (5) are integrally formed.

37. The flushing apparatus according to any one of claims 20 to 36, wherein said at least one flushing port and / or said at least one venting port is an always open fluidic connection that directly connects said flushing port and / or said venting port to said conduit (6).

38. The flushing apparatus according to any one of claims 20 to 37, wherein said at least one flushing port comprises a flushing channel (8) fluidically connecting the conduit (6) to the flushing chamber (2).

39. The apparatus according to any one of claims 20 to 38, wherein said at least one flushing port and said at least one venting port form one or more of: an unoccluded fluidic connection, a permanently open or unoccluded fluidic connection without substantial flow restriction, a permanently open or unoccluded fluidic connection without flow control elements, a permanently open or unoccluded fluidic connection without valves, anda permanently open or unoccluded fluidic connection comprising neither tubing nor piping.

40. The flushing apparatus (1 ) according to any one of claims 20 to 39, wherein the apparatus (1 ) comprises a fluid flow path for IV infusion liquid to pass through the apparatus (1 ), said conduit (6) forming part of said fluid flow path.

41. An IV infusion set comprising a flushing apparatus (1 ) according to any one of claims 20 to 41 .

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