A gas trap device

Abstract

A gas trap device (100) has a chamber (102), an inlet port (103) to the chamber, an outlet conduit (110) from within the chamber to the outlet port. The chamber has a venting outlet (111), and a stopcock valve (101) is arranged to control opening and closing of the venting outlet and the outlet conduit. The stopcock valve has a barrel (150) and a handle (151), valving being controlled by rotation of the handle. The valve is at a 90° angle to an axial flow direction of the outlet port when the venting port is open. For venting the barrel is in registry with both a dedicated venting outlet (111) and the outlet conduit (110, 126) for comprehensive venting through two paths.

Description

[0001] “A Gas Trap Device”

[0002] Introduction

[0003] The present invention relates to a gas trap device for applications such as medical Intravenous (“IV”) delivery.

[0004] Such gas trap devices are described in for example W02020 / 156666, W02022 / 023079, and W02023 / 148100 (all Tessen Solutions Ltd.), the contents of which are incorporated herein by reference.

[0005] These documents describe a gas trap chamber with an inlet port and an outlet port, and there is also in some examples a venting port for use in allowing gases to escape either during priming or during use.

[0006] An object of the present invention is to provide for increased versatility in outlet of fluids from a gas trap device chamber.

[0007] Summary of the Invention

[0008] We describe a gas trap device comprising: a chamber, an inlet port to the chamber, an outlet port linked with an outlet conduit extending from within the chamber volume, a chamber venting outlet, and a valve arranged to control opening and closing of the venting outlet and the outlet conduit.

[0009] In some preferred examples, the valve is of the stopcock type, comprising a barrel and a handle, valving being controlled by rotation of the handle, the barrel having a channel for registry with the chamber venting outlet and a flow channel for registry with the outlet conduit.

[0010] In some preferred examples, the valve is configured so that the handle is at an angle, preferably about 90°, to an axial flow direction of the outlet port for venting.

[0011] In some preferred examples, the barrel flow channel extends through the barrel across a barrel axis, and the barrel venting channel extends along a surface of the barrel with both axial and circumferential directions.

[0012] In some preferred examples, the valve is configured to direct flow from the chamber venting outlet to the outlet port when in a venting position, and to direct flow from the outlet conduit to the outlet port when in a flow-through position. In some preferred examples, the barrel is configured to snap fit into a valve socket. In some preferred examples, the venting outlet is adjacent the outlet conduit. In some preferred examples, the stopcock valve barrel extends transversely through an axis between the outlet conduit and the outlet port.

[0013] In some preferred examples, the valve is configured for single use, comprising features which prevent movement from a flow-through position to a venting position. In some preferred examples, the valve allows gradual opening or closing of a flow path from the outlet conduit to the outlet port. In some preferred examples, the barrel provides infinite adjustment by rotation of the barrel between extreme positions.

[0014] In some preferred examples, the venting channel of the valve is aligned in the venting position both the chamber venting port and the outlet conduit channel are in registry with the valve venting channel to ensure comprehensive evacuation of gas.

[0015] In some preferred examples, the barrel and the socket comprises features to limit extent of allowable rotation of the barrel to that which is required for movement between the venting and flow positions. In some preferred examples, the device further comprises a diffuser in the inlet port, the diffuser comprising at least one radial opening within the chamber.

[0016] In some preferred examples, the device comprises a diverter at a distal end of the inlet port, the diverter extending in a plane across an axis of the outlet conduit and being spaced apart from said conduit. In some preferred examples, the diverter has a distal surface facing the outlet conduit, said surface being convex and / or being sloped to extend radially and proximally.

[0017] In some preferred examples, the device comprises a connection port on the chamber, said port being configured to enable an external device, such as a syringe, or a third-party connector, such as a needle-less valve or a Closed System Transfer Device, to connect to the chamber for the purpose of adding or removing gas or fluids from the chamber.

[0018] In some preferred examples, the device comprises a closed system transfer device male or female Luer connector part. In some preferred examples, the chamber includes a filter to separate particulate matter, said filter having pores in the range of 0.2 pm to 3 pm in pore size. In some preferred examples, the filter is located between the inlet and the outlet. In some preferred examples, the chamber venting port comprises a hydrophobic filter to repel liquid but allow gas to pass through, such that the device does not leak during priming.

[0019] We also describe a method of use, especially priming, of a gas trap device of any example described herein, the method comprising the steps of: orientating the device so that the outlet port and the valve are uppermost, connecting the inlet port to a fluid supply until gas escapes through the venting outlet with the valve being positioned to allow said venting, and closing the venting outlet when the chamber is full of liquid, and operating the valve to open a flow from the outlet conduit to the outlet port.

[0020] In some preferred examples, the priming is back-priming.

[0021] We also describe a method of priming an infusion system, the system comprising: an inflow line for flow from a reservoir, a gas trap device having a chamber and an inlet port linked with the inflow line and having an outlet port, a venting port in chamber and being closer to the inlet port than the outlet port, an outflow line linked with the device outlet port, and an outlet side valve in the outlet port or the outflow line, the method comprising steps of: closing the outlet side valve when the venting port is open, allowing inflow of fluid to the chamber via the inlet port from the inflow line so that gas is located between the inflowing fluid and fluid leading to the outlet side valve and is forced by fluid flow and buoyance out through the venting port.

[0022] In some preferred examples, the outlet side valve is a discrete valve engaging only the outflow line distally of the gas trap device. In some preferred examples, the outlet side valve is mounted to the outlet port.

[0023] In some preferred examples, the valve comprises a barrel in a cylindrical socket and a handle to rotate the barrel to open and close the valve, the barrel having a channel for registry with the chamber for outflow when open. In some preferred examples, the inlet port and / or the outlet port have Luer connection features. In some preferred examples, the inlet port and / or the outlet port are bonded to the inflow tube and the outflow tube respectively.

[0024] We also describe a gas trap device comprising a chamber, an inlet port to the chamber, an outlet port linked with an outlet conduit from the chamber said conduit extending into the chamber volume, and in which the chamber comprises a venting outlet. Preferably, the device further comprises a valve arranged to control opening and closing of the venting outlet and the outlet conduit. In some examples, the valve is of the stopcock type, comprising a barrel and a handle, valving being controlled by rotation of the handle.

[0025] In some examples, the valve is configured so that the handle is at an angle, preferably about 90°, to an axial flow direction of the outlet port when the venting port is open. In some examples, the valve comprises a barrel having a flow channel through the barrel for flow during a flow-through position and a channel around the barrel for venting gas flow. In some examples, the valve is configured to direct flow from both the venting outlet and the outlet conduit to the outlet port when in venting and flow-through positions respectively.

[0026] In some examples, the valve is configured to snap fit into a socket of the device. In some examples, the venting outlet is adjacent the outlet conduit, but in other examples it is located elsewhere such as adjacent the inlet port. In some examples, the stopcock valve comprises a barrel which extends transversely through an axis between the outlet conduit and the outlet port. In some examples, the device further comprises a diffuser in the inlet port, the diffuser comprising at least one radial opening within the chamber.

[0027] In some examples, the device comprises a diverter at a distal end of the inlet port, the diverter extending in a plane across an axis of the outlet conduit and being spaced apart from said conduit. In some examples, the diverter has a proximal surface facing the inlet port and which is sloped radially and distally. In one example, the diverter has a distal surface facing the outlet conduit, said surface being convex and / or being sloped to extend radially and proximally.

[0028] In some examples, the valve is configured for single use, comprising features which prevent movement from a flow-through position to a venting position. In some examples, the valve allows gradual opening or closing of a flow path from the outlet conduit to the outlet port. In some examples, the valve comprises a barrel and there is infinite adjustment by rotation of the barrel between extreme positions. In some examples, the gas channel of the valve is aligned in the venting position with both the venting port and the outlet conduit channel to ensure comprehensive evacuation of gas.

[0029] In some examples, the device comprises a connection port on the chamber, said port being configured to enable an external device, such as a syringe, or a third-party connector, such as a needle-less valve or a Closed System Transfer Device, to connect to the chamber for the purpose of adding or removing gas or fluids from the chamber.

[0030] We also describe a method of use of a gas trap device of any preceding claim, the method comprising the steps of orientating the device so that the outlet port and the valve are uppermost, connecting the inlet port to a fluid supply until gas escapes through the venting outlet with the valve being positioned to allow said venting, closing the venting outlet when the chamber is full of liquid, and operating the valve to open a flow from the outlet conduit to the outlet port. In one example, the priming is back-priming.

[0031] In some examples, a device port is used to vent air from the chamber as an end-to-end closed system or to inject drugs into the chamber as a closed system. In some examples, an additional port is located at the distal end of the chamber at a position proximal or distal to the outlet port, and the additional connection port may be a multi-way tap, for example a two-way or three-way stopcock valve.

[0032] In some examples, a closed system transfer device Luer coupler is connected to the device Luer coupler, and a closed system transfer device Luer coupler is connected a device Luer coupler, and in one example the device is manufactured with male or female closed system transfer device connectors in place.

[0033] In another embodiment the internal surface of the chamber of the device is coated with a surface treatment that has properties such as chemical or medicinal properties to enhance the function of the device. Examples of advantageous uses of such a device are in the fields of drug administration or biologies. For example, the coating could be a Heparin or other agent that acts against clotting of blood, or the coating could be an agent formulation that reduces propagation of bacteria on the surface of the device or within the fluids that pass through the device.

[0034] The coating or surface treatment may be applied to one or more parts on the internal or external or both surfaces of the device, and it may be applied to components or features of the device selectively, for example the diverter, extending from the inlet tube to the outlet tube.

[0035] In some embodiments, the surface treatment is applied by gas, vapour, bonding, coating, pasting or otherwise treating the surface with a chemical, water-based or oil-based solution. In another embodiment the surface treatment is applied in the manufacturing phase. In some embodiments, the surface treatment is applied to individual components, select surfaces or entire surfaces prior to assembly. In another embodiment the surface treatment is applied to components, select surfaces or entire surfaces after assembly.

[0036] In some preferred embodiments the surface treatment is a chemical anticoagulant drug, such as Heparin, used to reduce clotting in blood that flows into the chamber and through the device. In preferred embodiments, the surface treatment is an anti-bacterial chemical agent, such as Hypochlorous Acid, Hydrogen Peroxide or other agent, used to reduce or eliminate the number of bacteria that can form on the surfaces of the material or in the fluids that flow into the chamber and through the device.

[0037] Detailed Description of the Invention

[0038] The invention will be more clearly understood from the following description of some embodiments thereof, given by way of example only with reference to the accompanying drawings in which:

[0039] Fig. 1 is an exploded view of a gas trap device of the invention with a stopcock valve member removed, and Fig. 2 is a perspective view of the gas trap device with the valve member in place,

[0040] Fig. 3 is a perspective view of the stopcock valve member in a different orientation,

[0041] Fig. 4 is a perspective view of a bottom part of the device with a top part removed, showing particularly a lower part of the chamber and an outlet conduit,

[0042] Fig. 5 is a front part sectional view showing the device in more detail, and Fig. 6 is an enlarged diagrammatic cut-away view showing the stopcock valve in a priming position, Fig. 7 is a further front sectional view, in this case showing the valve in a flow-through position,

[0043] Fig. 8 is an enlarged sectional view showing the valve in a device flow-through position,

[0044] Figs. 9 and 10 are perspective views showing the valve at its priming and flow-through positions respectively,

[0045] Fig. 11 is a diagram showing the device being primed, and Fig. 12 shows the device at the end of priming and in a flow-through position, and Fig. 13 is a diagram showing the device rotated through 180° for flow through use, and Fig. 14 is a diagram showing the device in use when orientated at an acute angle to vertical,

[0046] Figs. 15 and 16 are perspective views of an infusion system including an alternative gas trap device during and after priming respectively,

[0047] Figs. 17 and 18 are perspective views of another infusion system including a further alternative gas trap device during and after priming respectively,

[0048] Fig. 19 is an exploded view of the gas trap device of Figs. 17 and 18, with a valve component removed, and Fig. 20 is a perspective view of this device with the component inserted, and

[0049] Figs. 21 and 22 are a perspective view and a cut away perspective view of an alternative gas trap device in use.

[0050] Referring to Figs. 1 and 2, a gas trap device 100 comprises a generally spherical chamber 102 and a stopcock valve 101. The device has an inlet 103 at a proximal end and an outlet 104 at a distal end, and the stopcock valve 101 is between the chamber 102 and the outlet 104. The valve 101 has a cylindrical housing or socket 105 and an insertable component 107 having a barrel 150 which fits into the socket 105, the barrel 150 being rotatable by way of an integral handle 151, the extent of rotation being limited by a circumferential ridge 156, as described in more detail below.

[0051] There is an indicator line 115 in the form of a raised ridge in the plastics molding of the chamber 102. The line 115 is parallel to and separated from a central seal 116 joining top (proximal) and bottom (distal) chamber hemispheres. The indicator line 115 aids a caregiver in visualizing through the transparent chamber 102 wall the extent of gas within the chamber. The indicator may not be a line, as it could be a discrete mark, and whether it is a line or not it may alternatively be cut-in, or ink stamped, or laser etched for example.

[0052] Fig. 3 shows the valve member insertable component 107 in more detail. It comprises the handle 151 at right angles to the barrel 150 axis, and the barrel 150 has an annular ridge 152 around its end for engagement in a snap-fitting manner behind a corresponding ridge of the valve socket 105. The barrel also has a flow-through conduit 153 extending across the cross-section of the barrel 150, through its axis. Also, there is a groove 154 which runs circumferentially and then axially to provide a flow path for gas during priming as described in more detail below.

[0053] Fig. 4 shows that the chamber 102 has an opening 111 for gas during priming, and this is in registry with the channel 154. This view also shows an outlet conduit 110 which extends axially from the geometrical centre of the chamber to the outlet 104.

[0054] The relative positions of the parts for priming are shown in Figs. 5 and 6, and more detail is shown of the device. The inlet port 103 has a Luer connector threads and is fluidically linked with an inline diverter 120. The diverter 120 is generally disc-shaped and has a proximal surface which is tapered distally and radially. Also, it has a distal surface which is planar, but in some embodiments, it may be convex or tapered radially and proximally.

[0055] The proximal end of the device is defined as the inlet port and the distal end is defined as the outlet port.

[0056] The diverter 120 is linked by three (could be one or more) axially extending members 121 to the inlet port and these members define radial spaces or openings 123 which together act as a diffuser for fluids and bubbles to exit radially upon inflow. The outlet comprises the conduit 110, which defines a channel 126 which begins near the geometrical centre of the chamber 102 and is in fluid communication with an outlet port channel 106 via the valve conduit 153 when the latter is in the through-flow position. Figs. 5 and 6 show the valve in the priming position, with the handle at right angles to axial, and shows a link between the in-chamber channel 126 and the outlet port channel 106 such that any air entrained in the channel 126 can also be evacuated via the valve channel 154. Hence, there is a flow path for gas via the chamber gas opening 111, the in-chamber channel 126, the valve channel 154, and the outlet port channel 106. It is very advantageous that the gas channel 154 of the valve is aligned with both the venting port 111 and the outlet conduit channel 126 to ensure comprehensive evacuation of gas. Fig. 5 also shows how the valve member 101 barrel 150 is retained in the valve socket 105 by snap-fitting of an annular pawl 130 of the housing moulding behind the ridge 152 or rim at the end of the barre 150.

[0057] Figs. 7 and 8 show the flow-through position, in which there is an axial path for liquid formed by the channels 126, 153, and 106. In this position the valve member 101 is locked by a stop member 155 (shown best in Fig. 3) so that it can not be rotated back to the priming (venting) position. In more detail the stop member 155 is limited in its rotation about the barrel axis by a protrusion 156 extending into the socket 105 around 270°.

[0058] Figs. 9 and 10 also show this aspect where the valve 101 is capable of rotation through 90° between open and closed positions, the positions defined by the location of the stop member 155 and features in the socket 105.

[0059] Device Use

[0060] As shown in Fig. 11 the device 100 is turned upside down for priming with the handle 151 at right angles to axial (longitudinal device proximal-distal axis). This provides a flow path for gas bubbles G as the chamber fills with liquid L. When the chamber 102 has filled with liquid, as shown in Fig. 12, all bubbles have been expelled, and the handle may be turned through 90° to block off the gas path and leave open the (axial) liquid path. Thereafter, in use the chamber is typically mostly filled with liquid with the normal orientation with the inlet on top and a space above the liquid for bubbles to remain trapped. The bubbles are very unlikely to migrate to the outlet channel 106 because they are initially diffused out in the uppermost region of the chamber and are unlikely to migrate downwards and around the diverter 121 towards the top of the outlet conduit channel 126.

[0061] A combination of early diffusing out via the openings 123 and the presence of the diverter 120 helps to keep the bubbles in the uppermost region of the chamber, as shown in Fig. 13. Fig. 14 illustrates that the bubbles remain away from the uppermost end of the outlet conduit 110 even if the device is orientated at an angle to axial.

[0062] The device 100 is intended to function as a multi-orientation air filter and trap for the purpose of separating phases of flowing fluids and retaining air in a sealed chamber. The device can be applied in numerous scenarios where the removal of bubbles from fluids is desirable, but its primary purpose is to remove air bubbles from drugs, biologic fluids such as blood, saline or other fluids used in medical intravenous infusions.

[0063] The device 100 utilises the rotating stopcock valve 101 to vent air from its chamber 102. The stopcock 101 groove 154 aligns with the internal venting hole 111 in the device chamber 102 and with the conduit channel 126, allowing fluids such as liquid or gas to pass through from the internal chamber to the external ambient atmosphere. By rotating the stopcock through 90° the venting groove 154 becomes misaligned to the venting hole 111 and the channel 126 and the venting is shut off, while at the same time the flow port 153 through the stopcock barrel is rotated into alignment with the outlet conduit channel 126, enabling flow from the chamber 102 through the outlet port 104. In practice, for priming the device 100 is inverted such that the venting hole 111 is located in the uppermost position on the chamber 102 and fluids enter the chamber from the distal inlet port 103 (as shown in Fig. 11), to prime all entrained air from the chamber and fill the chamber with fluids, which may include saline solution, drugs or biologies such as blood, or any other fluid therapy agent.

[0064] Once the chamber is primed, fully or partially, the stopcock 101 can be rotated to end the venting phase and begin the flowing phase, where the fluids pass through the device in the direction from the reservoir towards the patient. With venting completed the device can be rotated and oriented to a more typical use, position (Fig. 13) where the inlet port 103 is now on top end and the outflow port 104 is now lowermost, or the device can function in any orientation. In one embodiment the stopcock 101 has features that limit its rotation, such that it can be locked into a position, fully or partially open or closed, to set a desired flow path. In one embodiment of this device the stopcock has a feature that engages with an opposing feature on the device housing, the purpose of this engagement being to prevent the stopcock from rotating back in the direction from which it originally resided, the feature being a slip, tongue and groove, keyway or any other feature that controls and limits or stops movement of one or more components in contact.

[0065] In one embodiment the rotating stopcock is a snap fit assembly that pushes into a receiving port on the chamber of the device and creates an interference fit with a watertight seal due to friction and contact of surfaces of the two parts. In another embodiment the rotating stopcock is fixed in a watertight seal by means of gaskets, O-rings or other additional seals.

[0066] In a preferred embodiment the venting and flow control is operated by means of a rotating stopcock valve, as illustrated. In other embodiments the venting and flow control is operated by means of a rigid or semi-rigid push button. In another embodiment the venting and flow is controlled by means of a button or elongated shaft that is actuated into position by axial or radial force to align or misalign flow or vent ports. In other embodiments the venting and flow control is operated by means of a flexible button or shaft. In another embodiment the venting and flow control is operated by means of a cap. In another embodiment the flow control is operated by means of a clip, clamp or stopcock on the tubing distal to the device outflow.

[0067] The stopcock of the illustrated embodiment is activated by rotational torque force on the lever handle 151 to turn the stopcock barrel 150 on its axis from an open venting position, where the venting groove 154 is aligned with the venting hole 111, creating an open pathway from the chamber 102 to the ambient atmosphere, to a closed venting position where the groove 154 and the venting hole 111 are not aligned and flow cannot be established between the two features. The venting channel in the stopcock barrel may in various examples be formed as a cut away, slot, hole, etching in the moulding or post-production of the stopcock. It can be shaped as a single line, multiple lines interconnecting, U-shaped, T-shaped or any other shape that constitutes a channel on and / or through the barrel of the stopcock for the purposes of communicating fluids including liquids, gas, vapours, particulates, solids, solutions or any combination of the phases of a fluid between two chambers of any size or shape.

[0068] The stopcock barrel 150 has a snap fit feature 152 that prevents removal of the stopcock from the device once it has been fitted in place. The snap fit feature is a rim or ridge 152 which engages with an opposing or retaining step feature 130 on the surface of the valve socket 105 such that the contact force between the two parts is difficult to overcome and should ensure the parts remain in contact together but that a rotational torque force is possible to rotate the stopcock between any position.

[0069] In another embodiment the chamber 102 includes a filter intended to separate particulate matter, said filter being in the range of 0.2 micron to 3 micron in pore size. In a preferred embodiment the filter is located between the inlet 103 and the outlet 104. In a preferred embodiment the venting port 253 houses a hydrophobic filter (not shown) that repels liquid but allows gas to pass through, such that the device does not leak during the priming stage.

[0070] In another embodiment the venting flow path leads to a tube, and this may have a diameter of less than 1 millimetre. In another embodiment the venting hole is a wide opening intake end leading to a tube greater than 1 millimetre in diameter. In another embodiment the venting hole features a membrane at its intake end, the purpose of the membrane being to stop gas, liquid, fluid, vapour, particulates, solids or semi-solids from passing into the venting channel. In another embodiment the venting hole comprises a membrane at its intake end that has a hydrophobic coating to repel liquid due to its increased surface energy but to allow air to pass through the membrane and into the venting channel.

[0071] The stopcock, when rotated through a minimum of 5 degrees or more, begins to close off the venting port channel as the outer surface of the stopcock barrel closes over the venting hole 111, while the flow pathway out of the chamber 102 is opened due to the hole 153 in the stopcock aligning with the channels 126 and 106. When the stopcock is rotated communication between the inlet port 103 and the outlet port 104 is opened and any liquids, gas, vapours, particulates, solids, solutions or any combination of the phases of a fluid, is freely allowed to flow under pressure gradients induced by gravity or mechanical forces.

[0072] The stopcock may have a feature that controls or limits the distance of rotation, the feature contacting, abutting, slipping over, dropping into or otherwise being acted upon by a feature on the body of the housing in which the stopcock is located. In one embodiment the feature is a slot of 90° or less along the Y-axis, the slot engaging the feature that is a block, key or protrusion of any size, to stop its rotation beyond 90°. In another embodiment the feature has a face that is angled or curved between its proximal edge abutting the stopcock and its distal edge, such that the angle or curve creates a surface with changing elevation, the surface contacting an opposing surface on the feature, itself an angled or curved surface, the interaction generating a restrictive force as the parts pass over one another, the purpose being to provide haptic feedback and resistance to the user. In another embodiment the mating faces of the stopcock feature and the housing feature are a series of indentations. In another embodiment the mating faces of the stopcock feature and the housing feature are a singular or plurality of slots and keyways that are located radially about the X-axis on which the stopcock and the housing of the device are axially aligned.

[0073] The method of priming the device is shown in Fig. 11 in which the device is inverted with the outlet port in the uppermost position and the intake port in the lowermost position, allowing air to be pushed up towards the venting hole when fluids, such as saline or other drugs or biologies, flow into the chamber. As the liquid fills the chamber the air is displaced through the open vent hole 111 to the outlet port and out to the surrounding environment or into a connected tube or IV system. As the fluids fill the chamber the outlet tube fills with fluids that are prevented from passing into the outlet tube by the position of the stopcock that is rotated such that the outlet hole 111 does not form a pathway. When the chamber 102 is full or partially full with fluids, and the air entrained in the chamber is suitably primed out, the stopcock can be rotated by its handle into the non-venting position where the venting hole is no longer in communication with the venting groove 154 on the stopcock. By rotating the stopcock 101 the channel 153 on the stopcock is positioned such that fluids can flow to the outlet 104. The device is now active and flow between the inlet to the chamber and outlet can be controlled by rotating the stopcock between the open and closed positions. In one embodiment the stopcock can be alternated between an open a closed position. In another embodiment the stopcock can be moved only once from an open venting closed flow position to a closed venting open flow position. In a preferred embodiment the stopcock can be rotated one or more times from venting to non-venting and to flow or non-flow positions. In another embodiment, the stopcock can move between more than one set positions such as venting, flowing or non-active flow or non-active venting as it may be desirable to stop the flow of fluids by rotating the stopcock into a position that does not allow venting or flow of fluids through either the vent port or the flow channel.

[0074] Once the device is active and the venting hole I l l is sealed, with flow active through the stopcock flow channel the device can be used to deliver fluids from a reservoir to a patient, the device functioning as an aspirator to trap air in the uppermost region.

[0075] In practice, when a quantity of gas such as air is collected in the chamber 102 it may be desirable to vent the air in a controlled manner, which can be achieved by inverting the device and opening the vent hole 111 by rotating the stopcock into the venting position. With the tubing connected to the distal and proximal Luer connectors, as is commonly practiced, the air evacuates from the chamber through the vent hole 111, along the vent groove 154 and into the outlet port 104 to the connected IV tube where it can be manually removed by conventional means.

[0076] In one embodiment the device 100 is connected to IV tubing by the Luer connectors on the proximal and distal ends. In another embodiment the device 100 is connected to IV tubing by push fit or other connectors on the proximal and distal ends. In another embodiment the device is bonded to IV tubing by glues, welds, mechanical force or is a component of the IV line itself or any other component of the IV line, such that it can be removed, or it is permanently fixed in place on the IV system. In another embodiment the device is connected to IV tubing proximal to an IV pump. In another embodiment the device is connected to IV tubing, or a cannula, or any other component or connecting device proximal to a patient. In another embodiment the device is connected to gravity IV tubing. In another embodiment the device is connected to IV tubing for use with an IV pump. In another embodiment the device is connected to tubing used for dialysis or extra-corporeal fluid systems to remove air from those systems.

[0077] In another embodiment the internal surface of the chamber of the device is coated with a surface treatment that has chemical, medicinal properties to enhance the function of the device when used with certain drugs or biologies, for example, the coating could be a Heparin or other agent that acts against clotting of blood, or the coating could be an agent formulation that reduces propagation of bacteria on the surface of the device or within the fluids that pass through the device. The coating or surface treatment may be applied to one or more parts on the internal or external or both surfaces of the device, and it may be applied to components or features of the device selectively, for example the diverter, extending from the inlet tube to the outlet tube. In one embodiment the surface treatment is applied by gas, vapour, bonding, coating, pasting or otherwise treating the surface with a chemical, water-based or oil-based solution. In another embodiment the surface treatment is applied in the manufacturing phase. In another embodiment the surface treatment is applied to individual components, select surfaces or entire surfaces prior to assembly. In another embodiment the surface treatment is applied to components, select surfaces or entire surfaces after assembly. In a preferred embodiment the surface treatment is a chemical anticoagulant drug, such as Heparin, used to reduce clotting in blood that flows into the chamber and through the device. In a preferred embodiment the surface treatment is an anti-bacterial chemical agent, such as Hypochlorous Acid, Hydrogen Peroxide or other agent, used to reduce or eliminate the number of bacteria that can form on the surfaces of the material or in the fluids that flow into the chamber and through the device.

[0078] Another embodiment features a connection port located on the chamber of the device, such a port enabling a third party or external device, such as a syringe, or a third-party connector, such as a needle-less valve or a Closed System Transfer Device, to connect to the chamber for the purpose of adding or removing gas or fluids from the chamber. In practice, this port can be used to vent air from the chamber as an end-to-end closed system or to inject drugs into the chamber as a closed system. In a preferred embodiment the port may be located at the distal end of the chamber at a position proximal or distal to the outlet port feature. In another embodiment the additional connection port is a multi-way tap, for example a two-way or three-way stopcock valve.

[0079] In another embodiment a Closed System Transfer Device male Luer is connected to the device female Luer connector. In another embodiment a Closed System Transfer Device female Luer is connected the device male Luer. In another embodiment the device is manufactured with male or female Closed System Transfer Device connectors in place.

[0080] Infusion Systems Including Gas Trap Devices

[0081] It is required in healthcare to prime entrained air from intravenous infusion systems before it is attached to a patient. This action of removing air is completed prior to connection of an IV tube system to the infusion site to protect patients from air embolism. The IV tube system may be attached directly to connect the patient to a fluid reservoir, with fluids delivered under gravity pressure or by use of a pressure device, such as an IV infusion pump.

[0082] A primary infusion is where a single connection is made between the reservoir and the patient. A secondary infusion is where an additional tube is connected to the primary tube for the purpose of delivering a second or complimentary drug. A device and method is described where a closed system air trap is used on the IV tube system to trap air during the delivery of the infusion fluids. A method for priming the entrained air is described herewith.

[0083] When priming the IV tube system, fluids are setup to flow from a high pressure to a low pressure. To fill the chamber of the closed air trap device the outflow is closed to ensure fluids remain in the chamber until it is completely filled with fluid while the venting port of the closed air trap is open, enabling high to low pressure venting of the entrained air. The closed air trap has a selectively sealable venting port, and preferably a hydrophobic membrane to retard flow of liquid from the device through the venting port. The outflow port of the closed air trap may include in one embodiment a shut-off valve to stop flow out of the device in the direction of the patient while priming is taking place.

[0084] In another use the outflow port is connected to flexible or rigid tubing, the tubing including a device that can be selectively activated to stop flow in the direction of the patient while priming is taking place. The selectively activated valve to stop flow may be a bull clip, roller clamp, slide clamp or any other type of mechanism that can be moved between an open state and a closed state. The action of changing the open to closed state, or vice-versa, may be done by hand. In another embodiment the tubing is placed into an IV pump or pressure device, which acts as a clamping mechanism to stop flow out of the device in the direction of the patient while priming is taking place.

[0085] During priming of the closed air trap device, the system may be configured such that the venting cap is open while the outlet side valve, such as a clip device on the outflow tube, is in a closed position. This configuration is optimal to allow the chamber of the closed air trap to fill with liquid. Once the chamber of the device is filled with liquid the cap of the venting port may be closed or open, but the outlet side valve on the distal end of the device or tubing is opened to allow fluids to flow from the chamber of the closed air trap device into the tubing and towards the patient.

[0086] During normal use of the IV tubing system the clip device may be selectively opened or closed to start or stop flow.

[0087] In some examples , the outlet valve is positioned between the distal end of the closed air trap and the IV pump, pressure device or patient end of the IV tube. In practice, this supports effective priming of the closed air trap device.

[0088] In some examples, the tubing is inserted into an IV pump device. The outlet side valve (such as a clip device) is positioned between the closed air trap and the IV pump. In other examples the outlet side valve is a roller clamp or a slide clamp.

[0089] In other examples an extension tube is connected to the open end of the primary outflow tube. The closed air trap may be bonded on the primary tube and / or the closed air trap may be bonded on the extension tube. The closed air trap may be bonded onto the IV tube with a selectively activated clip positioned between the outflow end of the closed air trap and the open end of the tubing.

[0090] In some examples the closed air trap is attached between the primary tube set and the extension tube set. In this configuration the extension tube set may include a selectively activated clip device to stop or start flow in the IV system.

[0091] As described above the outlet side valve may be a stopcock valve, and if so it may be a feature of the closed air trap. In another embodiment the stopcock valve is an add-on device to the IV system that is positioned between the outflow of the closed air trap component and the patient interface.

[0092] In one embodiment the closed air trap is located on the primary line between the reservoir and a pump segment designed to act as an interface or attachment mechanism for the tubing into the IV pump housing. In this embodiment the selectively activated clip device is located between the closed air trap and the pump segment. In one example the priming is back-priming.

[0093] When the outlet side valve is closed and the priming cap is open then the priming of the device chamber is possible, with entrained air flowing from high to low pressure through the open cap. Once the chamber is primed the cap is closed and the clip is opened to induce flow into the tubing connected to the outflow. Use of an IV pump is optional.

[0094] In some examples the air trap is on an IV line above a large volume IV pump. A clip mechanism may be located between the air trap device and the IV pump.

[0095] In some examples, the air trap device is on an IV line used for gravity infusion. The outlet side valve is located between the air trap device and the outflow end of the IV line.

[0096] In some examples, the air trap device is on any fluid tube system or fluid injection system to prevent entrained air from moving through the system. The outlet side valve is located distal to the outflow of the air trap and proximal to the outflow of the fluid tube system or fluid injection system

[0097] When the outlet side valve is a stopcock valve and this is closed and the priming cap is open then the priming of the device chamber is possible, with entrained air flowing from high to low pressure through the open cap. Once the chamber is primed the cap is closed and the stopcock is opened to induce flow into the tubing connected to the outflow. Use of an IV pump is optional

[0098] In some examples, the air trap is bonded onto a primary IV line. A stopcock mechanism may be located between the air trap and downstream portion of tubing, either as a component of the air trap or as a distal supplementary component of the IV line, as either a built-in or add-on component

[0099] In some examples, the air trap is on an IV line used for gravity infusion. A clip mechanism is located between the air trap and the outflow end of the IV line

[0100] Stopcock valve in combination with a venting cap

[0101] When priming the device, it is necessary to shut off flow in the outflow tube to enable fluids to fill the chamber and expel entrained air through a venting port. A stopcock outlet side valve may be used in a closed position, such that its flow path is blocked due to the misalignment of flow paths. Once the chamber is filled with fluid, during priming, upon rotation of the stopcock the flow paths are aligned, flow is induced from the chamber to the outlet port in the direction of the patient The stopcock can be in a first position one, blocking flow of fluid through the outlet port.

[0102] The stopcock can be in a second position, enabling venting of entrained air when the device is inverted during priming.

[0103] The stopcock valve can be in a third position, enabling flow of liquids through the device during use.

[0104] The stopcock VALVE may be locked in any of these or it may be interchangeably moved between any of those positions during priming or during use.

[0105] The stopcock valve has features that interlock with the barrel in which it resides, said features having a locking or slipping interface, such that the stopcock can be moved into a position and be fixed or it can be moved interchangeably between positions. The advantage is that, during use, the stopcock can be turned to allow flow to be in one direction or fully stopped. The user can decide to use a stopcock valve that cannot be turned once it has been moved into its preferred position, such as enabling flow. The user may prefer an embodiment in which the stopcock valve can be moved between closed, venting or to control the rate of normal flow throughout the duration of an IV infusion.

[0106] Primary Flow Method of Use

[0107] The following are steps of use of the device for only a single, primary, flow of fluid:

[0108] Connect a fluid reservoir to an IV line.

[0109] Open a valve such as a roller clamp or clip to induce flow in the IV system.

[0110] Keep a venting port of the device in the open position, by way of a port cap being open.

[0111] This venting port is preferably located close to the inlet port.

[0112] Close the downstream outlet side valve, such as a stopcock valve, clip or clamp.

[0113] Prime the chamber with the venting port of the device in the uppermost position.

[0114] Open a roller clamp on the IV line proximal to the device, allowing saline to fill the chamber fully. The chamber fills because the outlet port is closed by a downstream clip. Once the chamber is filled with the fluid, close the cap on the vent port.

[0115] Press firmly to ensure a good seal.

[0116] Open the downstream outlet side valve (e. g. stopcock, clip, or clamp) and allow IV fluids to run through as normal or, open a distal roller clamp and allow IV fluids to run through as normal.

[0117] Once priming is completed, connect the IV line to the patient, or, insert IV line into pressure device to induce or maintain flow of IV fluids as normal.

[0118] Figs. 15 and 16 show an infusion system 200 having an inflow flow line 201 from a reservoir (not shown), a gas trap device 202, an outflow line 204, and a clamp 205 on the outflow line The outflow line 204 leads to a pump 206, which delivers the flow to a patient interface. In this case the gas trap device 202 does not have a stopcock valve, merely an inlet port connected to the inlet line 201 and an outlet port connected to the outlet line 204. It has a diffuser, and a diverter as described and illustrated for the device 100, and indeed is similar in all respects except that it does not have the stopcock valve at its outlet, but it does have a priming port 203 located adjacent the inlet. The priming port 203 has a cap which is open for priming but can be pressed permanently into a closed position when priming is complete. In other examples the closure is not permanent, depending on the intended clinical situation.

[0119] In use, the clamp 205 is used to close the outflow line 204, causing fluid to be backed up within the chamber, with gas escaping through the priming port 203 and the liquid level rising, as illustrated in Fig. 15. The priming port’s cap is then sealed in place when the chamber is full of liquid only, and this continues down to the clamp 205. The only air / gas in the system is then downstream of the clamp 205, and this is pushed out under gravitational pressure when the clamp 205 is opened or with the assistance of the pump 206 to provide a fully primed system for connection to the patient.

[0120] It is very advantageous that gas is expelled for the length of the IV tubing system down to the clamp, including the full gas trap chamber, and then the remaining IV tubing system before attaching the IV tubing system to the patient. This can reduce the risk of air entering the vascular system of the patient. It is also advantageous to reduce or eliminate air in IV infusion systems so as to reduce the number of alarms on IV pump devices. One advantage of the described air trap is that it can function as a closed air trap in a position proximal to the IV pump, stopping air from activating air-in-line alarms.

[0121] One advantage of having a clip or clamp distal and at a distance from the air trap device is that, during priming, fluids can fill the IV tube into the section of IV tube between the air trap device and the clip or clamp. This section, being filled with fluids, can then be placed into an IV pump such that the tube set can be further primed using the IV pump to regulate flow.

[0122] Referring to Figs. 17 and 18 an alternative infusion system 250 has an inflow line 251, a gas trap device 252 with a priming port 253 and a stopcock valve 254 at its outlet, leading to an outflow line 255. This leads on to a pump (not shown) in some examples. The stopcock valve 254 has many features in common with the valve 101, however in this case there is no venting channel 254, nor is there a chamber vent aperture 111. The valve 254 is merely for opening / closing operation for flow to the outflow line 255. It therefore performs the same function as the clamp 205 in the system 200, and the system is used in the manner as described except in this aspect. The valve 101, as described, may alternatively be used in this setup to perform the same function..

[0123] Figs. 19 and 20 show the valve 254 in more detail. There is a removable component comprising a barrel 260 with a body 262 with a through-flow conduit 263 across its axis, and a handle 261. The barrel 260 in inserted into a cylindrical socket 265 which is affixed to an outlet port sleeve 271 which is in turn sealed to the outflow tube 255. On the inlet side there is an inlet port sleeve 270 sealed to the tube 251.

[0124] The system 250 allows for very simple priming, and there is no risk of gas or microbial ingress on the inlet and outlet sides due to the lines being bonded to the ports. The valve 254 provides for very simple closing of the outflow to allow priming to take place as shown in Figs. 17 and 18.

[0125] Referring to Figs. 21 and 22 an alternative gas trap device, 300, is illustrated. The device 300 has many parts similar to those of the device 250 and it functions in the same manner. In this case, however, the device has an inlet port 301 with Luer connection threads and an outlet port 302 also for Luer connection. Fig. 22 shows the valve 254 in more detail, having a barrel with a through- flow conduit 263 across its axis, but no venting conduit. This arrangement allows versatility for connection to a range of devices with the standard Luer connectivity.

[0126] Components of embodiments can be employed in other embodiments in a manner as would be understood by a person of ordinary skill in the art. The invention is not limited to the embodiments described but may be varied in construction and detail. The description above describes priming with the device inverted. However, the valve could be at a location other than described above. It may, for example, have its drum on-axis instead of extending across the axis, the barrel channel features are configured accordingly. Such features may for example include ribs and corresponding recesses on the barrel and socket. The device may be employed in any desired manner in an IV line, for optimum gas entrapment. In another example the device is supplied as packaged in a pre-filled or pre-primed manner, with the priming having been done in the factory. The invention includes any use of a closed system gas filter and trap with a chamber and sealable valve for use on any type of IV line or fluid line.

Claims

Claims1. A gas trap device comprising: a chamber (102), an inlet port (103) to the chamber, an outlet port linked with an outlet conduit (110) extending from within the chamber volume, a chamber venting outlet (111), and a valve (101) arranged to control opening and closing of the venting outlet (111) and the outlet conduit (110).

2. A device as claimed in claim 1, wherein the valve is of the stopcock type, comprising a barrel (150) and a handle (151), valving being controlled by rotation of the handle, the barrel having a channel (154) for registry with the chamber venting outlet (111) and a flow channel (153) for registry with the outlet conduit (110).

3. A device as claimed in claims 1 or 2, wherein the valve is configured so that the handle is at an angle, preferably about 90°, to an axial flow direction of the outlet port for venting.

4. A device as claimed in claim 2 or claim 3, wherein the barrel (150) flow channel (153) extends through the barrel across a barrel axis, and the barrel venting channel extends along a surface of the barrel with both axial and circumferential directions.

5. A device as claimed in any preceding claim, wherein the valve is configured to direct flow from the chamber venting outlet (111) to the outlet port (104) when in a venting position, and to direct flow from the outlet conduit (110) to the outlet port (104) when in a flow- through position.

6. A device as claimed in any of claims 2 to 5, wherein the barrel (150) is configured (152, 130) to snap fit into a valve socket (105).

7. A device as claimed in any preceding claim, wherein the venting outlet (111) is adjacent the outlet conduit (110).

8. A device as claimed in any of claims 2 to 7, wherein the stopcock valve barrel (150) extends transversely through an axis between the outlet conduit (110) and the outlet port (104).

9. A device as claimed in any preceding claim, wherein the valve is configured for single use, comprising features which prevent movement from a flow-through position to a venting position.

10. A device as claimed in any preceding claim, wherein the valve allows gradual opening or closing of a flow path from the outlet conduit (110, 126) to the outlet port (104, 106).

11. A device as claimed in any of claims 2 to 10, wherein the barrel (150) provides infinite adjustment by rotation of the barrel between extreme positions.

12. A device as claimed in any preceding claim, wherein when the venting channel (154) of the valve is aligned in the venting position both the chamber venting port (111) and the outlet conduit channel (126) are in registry with the valve venting channel (154) to ensure comprehensive evacuation of gas.

13. A device as claimed in any of claims 2 to 12, wherein the barrel and the socket comprises features (155, 156) to limit extent of allowable rotation of the barrel to that which is required for movement between the venting and flow positions.

14. A device as claimed in any preceding claim, wherein the device further comprises a diffuser (121, 123) in the inlet port (103), the diffuser comprising at least one radial opening (123) within the chamber (102).

15. A device as claimed in any preceding claim, wherein the device comprises a diverter (120) at a distal end of the inlet port, the diverter extending in a plane across an axis of the outlet conduit (110) and being spaced apart from said conduit.

16. A device as claimed in claims 14 or 15, wherein the diverter has a distal surface facing the outlet conduit, said surface being convex and / or being sloped to extend radially and proximally.

17. A device as claimed in any preceding claim, wherein the device comprises a connection port on the chamber, said port being configured to enable an external device, such as a syringe, or a third-party connector, such as a needle-less valve or a Closed System TransferDevice, to connect to the chamber for the purpose of adding or removing gas or fluids from the chamber.

18. A device as claimed in any preceding claim, wherein the device comprises a closed system transfer device male or female Luer connector part.

19. A device as claimed in any preceding claim, wherein the chamber (102) includes a filter to separate particulate matter, said filter having pores in the range of 0.2 pm to 3 pm in pore size.

20. A device as claimed in claim 19, wherein the filter is located between the inlet (103) and the outlet (104).

21. A device as claimed in claim 19 or 20, wherein the chamber venting port (111, 253) comprises a hydrophobic filter to repel liquid but allow gas to pass through, such that the device does not leak during priming.

22. A method of use of a gas trap device of any preceding claim, the method comprising the steps of: orientating the device (100) so that the outlet port (104, 106) and the valve (101) are uppermost, connecting the inlet port (103) to a fluid supply until gas escapes through the venting outlet (111) with the valve being positioned to allow said venting, and closing the venting outlet (111) when the chamber (102) is full of liquid, and operating the valve (101) to open a flow (153) from the outlet conduit (110, 126) to the outlet port (104, 106).

23. A method as claimed in claim 22, wherein the priming is back-priming.

24. A method of priming an infusion system (200), the system comprising: an inflow line (201) for flow from a reservoir, a gas trap device (202) having a chamber and an inlet port linked with the inflow line and having an outlet port, a venting port (203) in chamber and being closer to the inlet port than the outlet port,an outflow line (204) linked with the device outlet port, and an outlet side valve (205) in the outlet port or the outflow line, the method comprising steps of: closing the outlet side valve (205, 254) when the venting port (203) is open, allowing inflow of fluid to the chamber via the inlet port from the inflow line (201) so that gas is located between the inflowing fluid and fluid leading to the outlet side valve and is forced by fluid flow and buoyance out through the venting port.

25. A method as claimed in claim 24, wherein the outlet side valve is a discrete valve (205) engaging only the outflow line (204) distally of the gas trap device.

26. A method as claimed in claim 25, wherein the outlet side valve (254) is mounted to the outlet port.

27. A method as claimed in claim 26, wherein the valve comprises a barrel (260) in a cylindrical socket and a handle (261) to rotate the barrel to open and close the valve, the barrel having a channel (262) for registry with the chamber for outflow when open.

28. A method as claimed in any of claims 24 to 27, wherein the inlet port and / or the outlet port have Luer connection features.

29. A method as claimed in any of claims 24 to 28, wherein the inlet port and / or the outlet port are bonded to the inflow tube and the outflow tube respectively.

Images