Patent ID: 12208234

DETAILED DESCRIPTION

FIGS.1and2illustrate an embodiment of a flushing device1for use with a standard or bespoke IV infusion set. The flushing device1can also be used with intraoral feeding sets, parenteral delivery systems, and the like.FIG.3illustrates an IV infusion set for gravity infusions and pressure infusions.

The IV infusion set comprises a collapsible IV liquid container20, preferably in the form of a collapsible bag20, 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 hole25at the upper end of the collapsible IV liquid container20. The lower end of the collapsible IV liquid container20is provided with an inlet port23and an outlet port22and the interior of the IV liquid container20comprises a collapsible infusion liquid chamber21that 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 container20is not collapsible, e.g. a glass or plastic vial, and is provided with an air vent. The IV liquid container20is configured for containing an IV liquid and air. The IV liquid is typically a solution of medicine in water. The IV liquid container20is, 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 container20, together with some air. At the end of the infusion period, the IV liquid container20contains no or very little IV liquid.

The flushing apparatus1comprises a housing3, a spike4forming an inlet coupling component, and an outlet port5forming an outlet coupling component. The spike4is inFIG.6shown inserted with the spike4into the outlet port22of the collapsible IV solution container20. The outlet port22of the collapsible IV solution container20is covered by a membrane to be pierced by the spike4of the flushing apparatus1. The spike4forms an inlet coupling component for accessing the content of the collapsible IV liquid container20and for receiving a gravity-driven flow of IV liquid from the collapsible IV liquid container20. The inlet coupling component4is arranged, when in use, at an upper end of the flushing apparatus1. The flushing apparatus1comprises an outlet coupling component5for coupling to a downstream component11and for delivering a gravity-driven flow of IV liquid or flushing liquid to the downstream component11of the IV infusion set. The outlet coupling component5comprises an outlet port for receiving an IV spike of a downstream component of the IV infusion set, for example, the IV spike14of the drip chamber11. The outlet port of the outlet coupling component5is covered by a membrane to be pierced by the IV spike of the downstream component.

The inlet coupling component4and the outlet coupling component5are both connected to a body of the apparatus1, and the outlet coupling component5is, when in use, arranged at a lower end of the flushing apparatus1, and preferably, the inlet coupling component4is, when in use, arranged at an upper end of the flushing apparatus1. The body or housing3of the flushing apparatus1forms a container that defines a rigid and/or noncompressible and/or non-collapsible flushing liquid chamber2. In this relation, rigid and/or noncompressible and/or non-collapsible is understood to mean that the volume of the flushing liquid chamber2does 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 chamber due to deformation of the flushing liquid chamber.

In the shown embodiment, the downstream component11is a preferably transparent drip chamber11. Preferably, an air vent (not shown) is provided at the upper end of the drip chamber11. The upper end of the drip chamber11is provided with a spike14that allows the drip chamber11to be connected to an upstream component of the IV set, in this embodiment the flushing apparatus1, by inserting the spike14in the outlet connector component5of the flushing apparatus1. The lower end of the drip chamber11is 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 tube31is provided with an adjustable flow rate roller clamp34. The tube31extends from the drip chamber11to a needle connector35for example a Luer connector35. A hypodermic needle41can be connected to the needle connector35. The hypodermic needle41is, either directly inserted into a patient or into an IV port that has already been inserted into a patient.

The IV infusion set defines an at least partially gravity-driven fluid flow path for IV liquid that extends from the preferably collapsible container20which is positioned as the highest component of the IV infusion set to the needle connector35at 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.

The flushing apparatus1comprises a housing or container3defining the rigid and/or non-collapsible flushing liquid chamber2for containing a flushing liquid and preferably containing the flushing liquid before use. The flushing liquid chamber2has an upper end and a lower end. The flushing liquid chamber2is a hermetically closed chamber, except for one or more flushing ports7at or near the lower end of the flushing liquid chamber2and one or more venting ports17, arranged above the one or more flushing ports7. In the shown embodiment, there is one flushing port7and one venting port17, but it is understood that there could be a plurality of flushing ports7and a plurality of venting ports17.

The flushing port7is fluidically connected to the fluid flow path of the IV infusion set at a flushing height FH (indicated by an interrupted line in the FIGS.). The venting port17is 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.). The flushing height FH is equal to or lower than the lower end of the collapsible container20and 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 chamber2via the one or more venting port17and flushing liquid from the flushing liquid chamber2to enter the fluid flow path via one or more flushing ports7, 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 chamber2to be drained by gravity into the fluid flow path. since the flushing chamber2, is substantially incompressible and is a closed chamber except for the at least one flushing port7, flushing liquid, due to its substantially incompressible nature will not leave the flushing chamber2through the at least one flushing port7unless air from the conduit6enters the flushing chamber2through the at least one venting port17. The exchange of flushing liquid and air through at least one flushing port7and the at least one venting port17happens simultaneously. In this embodiment the fluid flow path is formed by a conduit6that extends through the flushing chamber2and is formed by a pipe like element that is a part of the flushing apparatus1. In this embodiment, the conduit6is shown as a pipe that extends vertically through the flushing chamber, but it should be understood that the conduit6does 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 component4to the lower outlet coupling component5.

In this embodiment the conduit6, the spike4and a lid for closing the upper end of the housing3is formed as one integral element (the cap is not an integral element), preferably one integral element that is made from an injection molded polymer. The housing3, with its open top that is to be closed by the cap/lid is formed as one integral element, preferably one integral element is made from an injected molded polymer.

The at least one flushing port7is arranged closer to the lower end of the flushing chamber2than to the upper end of the flushing chamber2. The at least one flushing port7is preferably being arranged at or near the lower end of the flushing chamber2. The at least one venting port17is arranged higher than the flushing port7, 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 chamber2is filled before use, and with the flushing device1in the intended orientation for use with the outlet coupling component5arranged at a lower end of the flushing apparatus1, and the inlet coupling component4arranged at an upper end of the flushing apparatus1.

The least one flushing port7is fluidly connected to the fluid flow path (in this embodiment the conduit6is 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 port7to the fluid flow path. preferably, the at least one flushing port7is 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 port7is 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 port7is being formed by an opening in a wall separating the flushing liquid chamber2from the conduit6(not shown), or an opening at a flushing conduit8that branches off from the conduit as shown in the embodiments ofFIGS.1to6. In this embodiment, the flushing conduit8is shown extending horizontally, but it is understood that the flushing conduit can be arranged directly or upwardly, and does not need to be straight as shown, but could also be curved.

The least one venting port17is fluidly connected to the fluid flow path by an always open fluid connection, preferably an always open fluid connection that directly connects at least one venting port17to the fluid flow path. preferably, the at least one flushing port7is 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 port17is 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 venting port17is being formed by an opening in a wall separating the flushing liquid chamber2from the conduit6(not shown), or as an opening of a flushing conduit18that branches off from the conduit as shown in the embodiments ofFIGS.1to6. In this embodiment, the flushing conduit18is shown extending horizontally, but it is understood that the flushing conduit can be arranged directly or upwardly, and does not need to be straight as shown, but could also be curved.

The cross-sectional area of the at least one flushing port7is preferably larger than the cross-sectional area of the at least one venting port17, 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.

In the embodiment ofFIGS.1and2, the flushing apparatus1comprises a conduit6that forms part of the flow path of the IV infusion set, and the conduit6extends from the spike4, through the flushing liquid chamber2to the outlet port5. In this embodiment, the pipe that forms the conduit6is preferably a rigid pipe that will not substantially deform during use of the apparatus1.

The conduit6is arranged in a main tube extending from the inlet coupling component4to the outlet coupling component5. The at least one flushing port7is connected to the main tube by a fluidic connection element8connecting the flushing port7to the lumen of the main tube. The at least one venting port17is connected to the main tube by a fluidic connection element18connecting the flushing port17to the lumen of the main tube.

In the embodiment ofFIGS.1and2, the inlet coupling component4and the outlet coupling component5are integrally formed with the element3that defines the flushing liquid chamber2. The main body3may be provided with one or more circumferential grooves for improving grip on the device by a user and for enhancing the rigidity of the flushing liquid chamber2.

Generally, flushing liquid chamber2is arranged at a height below the IV liquid container20, or inside the IV liquid container20.

Preferably, a rigid and/or non-collapsible body3that defines the rigid and/or noncompressible flushing liquid chamber2and an element defining the conduit6are connected to form a single unit. Preferably, the inlet coupling component4is rigidly connected to body3at an upper end thereof, and the outlet coupling element5is rigidly connected to rigid body3at the lower end thereof. Preferably, the rigid body is made of transparent material to allow visual inspection of its content.

In the embodiment ofFIGS.1and2, and in other conceivable embodiments, the flushing liquid chamber2tapers, preferably gradually towards its lower end.

In the embodiment ofFIGS.1to6the conduit6extends through the flushing liquid chamber2, but it should be understood that it is possible to conceive embodiments, in which the flow path does not pass through the flushing chamber2.

FIG.3illustrates the flushing apparatus1filled with flushing liquid but not (yet) connected to any other parts of an IV set. The flushing chamber2is filled with a predetermined amount of flushing liquid and there is a predetermined volume of air in the flushing chamber2above the flushing liquid. The same applies to the conduit6, which is filled with flushing liquid to the same level as the chamber, with air being above the flushing liquid.FIG.4illustrates the flushing device of1connected to an IV liquid container20arranged above the flushing device1, and to a downstream part of an IV set. The IV liquid flows from the IV liquid container20through the fluid flow path through the flushing apparatus1and into the downstream part of the IV set as indicated by the thick arrows. The flushing liquid remains in the flushing chamber2since air cannot enter the flushing chamber2when the level of the flushing liquid is as high as inFIG.4.

FIG.5illustrates the flushing apparatus1in a subsequent stage, with the flushing chamber2is filled with a reduced amount of flushing liquid and the level of the flushing liquid in the flushing chamber2being sufficiently low to allow air entering the flushing chamber2(shown by the thin arrow and the bubbles in the flushing liquid in the flushing chamber2) and showing flushing liquid flowing into the flow path for flushing the IV liquid, as indicated by the thick arrows. This process of air flowing into the flushing chamber2and flushing liquid flowing into the liquid flow path towards the downstream section of the IV set continues until the level of the flushing liquid in the flushing chamber reach the flushing height defined by the flushing port7. The initial predetermined amount of flushing liquid in the flushing chamber2is selected to be sufficient to flush a substantial amount of IV liquid from the IV set.

In the embodiments ofFIGS.7and8, the conduit does not extend through the flushing liquid chamber2, but instead extends along the flushing chamber2. In the embodiments where the conduit6does not extend to the flushing chamber2, the conduit can be made of relatively soft and flexible material so that the conduit is compressible. Thus, the housing3of the embodiments ofFIGS.9and10andFIGS.8and9may comprise a hard and rigid part that encloses the flushing liquid chamber2and a relatively soft and flexible part that encloses conduit6, although the part of encloses conduit6can also be rigid.

In an embodiment (shown and explained with reference toFIG.6), the IV liquid container20is provided with an air vent.

In an embodiment, the flushing liquid is saline. In an embodiment, the flushing chamber2is prefilled, preferably completely prefilled, with flushing liquid. In an embodiment, the conduit6is also prefilled with flushing liquid before use of the flushing apparatus1in an IV infusion set.

In an embodiment, the volume of the flushing liquid chamber2correlates to a pre-determined 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 chamber2allows 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.

The flushing port7is configured to minimize diffusion and mixing between IV liquid and the flushing liquid. The venting port17is 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 chamber11.

FIGS.7and8illustrate another embodiment of the flushing device. In this embodiment, structures, and features that are the same or similar to corresponding structures and features previously described or shown herein are denoted by the same reference numeral as previously used for simplicity.

In this embodiment, the conduit6extends next to, i.e. adjacent the flushing liquid chamber2. In this embodiment, both the flushing liquid chamber6, and the conduit6are formed within one housing, separated by a separation wall63. The flushing port7is formed by an opening in the separation wall, and the flushing port7is arranged at the lower part of the flushing device1, close to the lower end of the flushing chamber2. The venting port17is formed by another opening in the separation wall, arranged higher than the opening for the flushing port7. InFIGS.7and8the housing that encompasses both the flushing liquid chamber2and the conduit6is shown as a perfect cuboid, but it should be understood that there is no need for this shape to be completely right-angled and could be carried out by the skilled person in more rounded form. In an embodiment, the complete housing3is made of a stiff and/or rigid material, preferably a transparent material to allow visual inspection of its content. In a variation of this embodiment, the portion of the housing3that encapsulates the flushing liquid chamber2is made of a stiff and/or rigid material, but the rest of the housing is made of flexible material so that the conduit is allowed change shape and/or volume.

FIG.9shows an embodiment in which the flushing liquid chamber2is arranged in the IV liquid bag20. In this embodiment, structures and features that are the same or similar to corresponding structures and features previously described or shown herein are denoted by the same reference numeral as previously used for simplicity. In this embodiment, the IV liquid container20is a bag that defines a collapsible IV liquid chamber21. The collapsible IV liquid chamber21will also contain air. The collapsible infusion liquid chamber21has an upper end and a lower end. The infusion bag20comprises a container3defining the rigid and/or non-collapsible flushing liquid chamber2for containing the flushing liquid. The rigid and/or non-collapsible flushing chamber preferably contains already before use of the FE liquid bag. The flushing liquid chamber2has an upper end and a lower end. The flushing liquid chamber2is a preferably hermetically closed chamber2, except for at least one flushing port7at or near the lower end of the flushing liquid chamber2and at least one venting port17that is arranged at least slightly higher than the flushing port7. The at least one flushing port7is fluidically connected to the collapsible infusion liquid chamber21at or near the lower end of the collapsible infusion liquid chamber21, and for simultaneously allowing air from the collapsible infusion liquid chamber21to enter the flushing liquid chamber2via the venting port17and flushing liquid from the flushing liquid chamber2to enter collapsible infusion liquid chamber21via the flushing port7when, during use of IV bag20, the level of IV liquid in the collapsible infusion liquid chamber21has become lower than the at least one venting port17, thereby allowing the flushing liquid chamber2to be drained by gravity into the collapsible infusion liquid chamber21.

The at least one flushing port7and the at least one venting port17are obstructed by a user destructible barrier, preferably a rupture disk, break-away seal, or puncture membrane, for preventing diffusion between the flushing liquid and the IV liquid before use of the IV liquid bag20.

The flushing port7and the venting port17are arranged in a wall separating the infusion liquid chamber2from the collapsible IV liquid chamber21.

The flushing liquid chamber2is arranged inside the flexible and collapsible container20with the at least one flushing port7connecting directly to the IV liquid chamber21in the collapsible container20at a height at or close to the lower end of the collapsible container20with the venting port17arranged slightly higher. in an embodiment, not shown, the lower part of the collapsible container20is tapered with the flushing liquid chamber2arranged in the lowest part of the container to minimize the amount of residual IV liquid at the end of an infusion procedure.

In an embodiment shown inFIG.10, the spike4of the flushing device1is provided with an air inlet, preferably an integral air inlet with an air filter and closure. A channel54is integrated into into spike4, whereas one end of the channel terminates at the upper end of the spike4and a second end terminates below the threads of the spike cap. The second opening is covered by an air filter52that allows only ambient air to flow into the channel. A closure50is situated over the air filter52and the second opening of the channel54to protect the air filter52from 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 spike4and out the opening that is situated at the upper end of the spike.

For the flushing device1, to release the flushing solution through the flush port, gas (air) has to enter the flushing chamber2through the vent port17to effectively displace the volume of the flushing solution in the flushing chamber2. When the flushing device1is used with collapsable 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 chamber2, the flushing device1only 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 closure50of 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 lumen 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.

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 chamber2to displace the flushing liquid. In these situations the closure50of 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.

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 lumen and vent port into the flushing liquid chamber and displace the intended amount of flushing liquid.

For all the embodiments above, during an IV infusion procedure, the IV liquid container20is emptied from IV liquid, and when the level of IV liquid falls below the venting level, air that originates from the IV liquid container20enters the flushing liquid chamber2through the venting port17, displacing liquid fluid from the flushing liquid chamber through the flushing port7into the fluid flow path.

Below is a non-exhaustive list of the advantages of the above-described IV infusion set, flushing apparatus1, and the IV liquid bag20including the flushing chamber2.provision of an automated sequential flushing liquid flush to be used in conjunction with small volume intravenous medicine bags and standard infusion sets.siginificant reduction of residual medicine in the infusion set.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.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.ensures that all medication will be delivered at the same rate.

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.

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.