Infusion apparatus

Abstract

To provide a bubble trap apparatus suitable for infusion.SOLUTION: A bubble trap apparatus (100) has a chamber, an inlet to a bubble entrapment chamber with multiple inlet ports (104, 105), and an outlet with an outlet tube (110). The ports and the chamber are arranged to allow mixing of gases from the different fluids and allow the gases to be trapped in the chamber. The inlet ports merge at a confluence space and the chamber comprises diffuser apertures (107) around an inflow tube for inflow of fluids into the chamber with a lateral dimensional component. When the inlet ports have a diameter in the range of 1.5 mm to 8.0 mm, and the distance between an upper end of the confluence space between the ports and the diffuser apertures is not more than 20 mm. This promotes turbulence as the fluids mix, and this turbulence continues through the diffuser, thereby enhancing bubble formation and hence migration of the gas as bubbles away from the outlet, towards an upper end of the chamber in use.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present invention relates to a bubble trap device suitable for medical applications, particularly for infusions using primary and secondary lines of infusion fluid. [Background technology]

[0002] Natural degassing can occur during intravenous (IV) infusion, and there are two This is especially true when infusing 100 or more chemically incompatible fluids, which can result in gas bubbles that could pose a threat to the patient's health. When toxic biological agents or dangerous drugs are used, such as in chemotherapy, the released gases can also be toxic and must be contained within a safe chamber. In particular, the development of closed system aspirators (CSAs) would advance the state of the art and improve safety during medical practice.

[0003] IV infusion of drugs is common in modern medicine. The clinical practice of combining fluid drugs for direct intravenous infusion is standard practice, especially in oncology, where expensive or highly targeted drug doses are required. In this case, drug volume is critical, and fluid loss due to adhesion to IV tubing is unacceptable. The primary fluid, often normal saline (NS) or lactated Ringer's solution, is used as a carrier fluid to maximize the drug volume into the patient's vascular system. The secondary fluid can contain a wide range of biologics, drugs, or dangerous drugs (HDs) such as Etoposide™ or Paclitaxel™. Some drugs are contraindicated for certain tubing types, such as PVC tubing, due to adhesion to the sidewalls and benefit from the lower frictional properties when mixed with NS as a solution.

[0004] When two or more liquid drugs are combined into a mixture, a chemical reaction may occur. As a result of the chemical reaction, the drug may dissolve or degas. This degassing may also occur due to turbulent reactions between liquid molecules. Turbulence occurs due to the frictional response of the fluid as it moves across a surface and due to flow vortices formed when liquid molecules suddenly change direction and interact with the changing geometry of their surroundings.

[0005] Fluids in this situation are a combination of liquid, gas, and plasma into a single phase. When a fluid degasses, gas bubbles are released into the fluid. Bubbles form when the gas pressure pushes from the inside out, while the surrounding water molecules tend to stick together and form a film. The greater the pressure from the gas on the bubble film, the larger the bubbles that form. Where bubbles interact, the bubble films can coalesce and combine to create larger bubbles. Within a body of fluids, bubbles tend to float upward under the buoyancy force, acted upon by the surrounding pressure.

[0006] During use, certain mixtures or drugs are gaseous and unstable due to their chemical structure. These liquids tend to give off large amounts of gas, requiring responsive action from medical professionals to reduce the risk to the patient. One of these important actions is the removal of gas bubbles from the liquid. In cases where gas bubbles form from toxic biologicals or dangerous drugs, the resulting vapors have properties that can be harmful to human health. Contact with these drug vapors must be avoided.

[0007] It is known to provide a "piggyback" IV infusion setup, which is illustrative of various connection devices and techniques for infusing additional medication into the primary line. A commonly used setup infuses a maintenance fluid, such as saline or lactated Ringer's solution, as the primary fluid. Chemotherapy is infused through a secondary port or Y-port. This is sometimes called the "piggyback" method because the secondary fluid is infused into the primary fluid. The secondary IV solution bag is suspended above the level of the primary bag. The position of the IV solution affects the flow of the IV fluid into the patient. The setup is the same whether the medication is given by gravity or via an IV infusion pump. The equipment setup and the mixing ratio of the two fluids can affect flow rate and dosing accuracy.

[0008] As much as 75% of chemotherapy is administered intravenously in the form of hazardous drugs (HDs) that are antitumor, mutagenic, carcinogenic, and harmful to human health. Intravenously administered drugs can be classified into five categories based on their damaging potential: vesicants, exfoliants, irritants, inflammitants, and neutral. Closed system devices are used to minimize exposure and associated adverse effects to medical staff administering these HDs. A closed system transfer device (CSTD) is defined as "a drug transfer device that mechanically prevents the migration of environmental contaminants into the system and the escape of hazardous drug or vapor condensates from the system" [NIOSH 2004]. While many forms of CSTDs exist for transferring drugs into IV systems, there remains a need to efficiently remove problematic air bubbles and protect the surrounding environment from exposure.

[0009] Administration of multiple intravenous (IV) infusions to a single patient via infusion pumps is a common occurrence in healthcare. The formation of problematic air bubbles in the IV tubing can disrupt pump function. Modern IV pumps utilize sensor technology to monitor for air bubbles in the line and halt the infusion, leading to medication errors, inefficiencies, and, for drugs characterized by short half-lives, loss of efficacy. Microbubbles are small bubbles with diameters of 10–50 μm that decrease in size and eventually disappear in water. Ordinary air bubbles have diameters in the 1 μm and larger range. Removal of ordinary air bubbles and microbubbles from IV lines should contribute to improved drug delivery, accuracy, safety, and time-efficiency in healthcare. Air bubbles in IV infusions typically trigger infusion pump device alarms, causing noise pollution, a major cause of alarm fatigue among healthcare professionals. Therefore, removing these naturally forming air bubbles before they reach the IV pump can have a beneficial effect on healthcare delivery.

[0010] When joining two infusion lines, a Y-connector device is typically used. This device can take the form of a rubber stopper and spike or a male luer-to-female luer connection. When HDs are used, luer-to-luer connections are more common and preferred to minimize the risk of disconnection or improper sealing between components, which could allow vapors to escape to the atmosphere. While many hospitals and medical facilities prepare HDs in well-ventilated, controlled pharmacy departments, the act of removing problematic air bubbles occurs at the bedside. Attending nurses typically use syringes and manual manipulation techniques to gently tap or flick the IV line, displacing the air bubbles toward the junction, where they are manually removed by drawing the air bubbles and a small amount of liquid into the syringe. This necessitates close contact with HD vapors, the potential risk of spillage, and the waste of a critical volume of medication. The actions required to remove the bubble are often undertaken by nursing staff using inappropriate tools and non-standardized techniques that may put nurses at risk of exposure and harm. Summary of the Invention [Problem to be solved by the invention]

[0011] The invention addresses the above problems. [Means for solving the problem]

[0012] We have described various aspects of the gas trap device as set out in claim 1 of the accompanying claims and as set out in claims 2 to 26. The method of use is described in claims 27 and 28.

[0013] We describe a gas trapping device for medical fluids that includes a chamber, an inlet to the bubble trapping chamber having multiple inlet ports, and an outlet having at least one outlet port.

[0014] The apparatus preferably includes a flow diverter within the chamber arranged to divert flow from the inlet with a radial or transverse component relative to the flow direction from the inlet. The diverter preferably has a shape arranged to divert flow distally and radially from the inlet before allowing the flow to move radially inward past the diverter toward the outlet. The inlet port preferably is adapted to allow the fluids to mix as they enter the chamber.

[0015] The chamber preferably houses a diverter and the inlet port is adapted to allow the fluids to mix before encountering the diverter. The inlet port preferably includes a dedicated vent port. The inlet section preferably includes a turbulence-inducing flow barrier.

[0016] Preferably, at least one inlet port includes a turbulence-inducing flow barrier. Preferably, the chamber includes a hydrophilic membrane. Preferably, the membrane is attached to a distal end of the diverter.

[0017] Preferably, at least one port includes a valve for fully or partially closing the port, and in some embodiments, multiple valves are provided interconnected for synchronized operation. Preferably, the apparatus further includes a membrane, preferably a selectively sealable membrane, to maintain the integrity of the closed system when an external device is connected to the port for the purpose of transferring liquid or gas into or out of the chamber.

[0018] We further describe an infusion device comprising a gas trap device according to any of the embodiments described herein, preferably connected to a primary line and a secondary line.

[0019] We further describe a method of use of the devices described herein, comprising directing the flow of different fluids distally through a chamber via an inlet port toward an outlet, and mixing and confining gases from the fluids within the chamber, preferably further comprising aspirating the gases through the inlet port or a dedicated vent port.

[0020] The invention will be more clearly understood from the following description of some embodiments of the invention, given by way of example only, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0021] [Figure 1] FIG. 1 is a diagram of an infusion system incorporating a trap at the junction of the primary and secondary lines. [Figure 2] FIG. 2 is a schematic side view of the trap of FIG. 1 arranged primarily for laminar flow entry. [Figure 3] FIG. 1 is a schematic side view of a trap positioned primarily for turbulent ingress. [Figure 4] FIG. 1 is a schematic side view of a trap arranged for use of a secondary port primarily to vent the primary fluid. [Figure 5]FIG. 1 is a schematic side view showing a trap with a dedicated vent port for venting the combined primary and secondary fluid solution. [Figure 6] FIG. 1 is a schematic side view of an inlet port assembly for a primary infusion port and a secondary infusion port. [Figure 7] FIG. 7 is a view similar to FIG. 6 of an inlet port assembly having three inlet ports and selectively sealable membranes. [Figure 8(a)] FIG. 1 is a diagram of a trap incorporating a hydrophilic membrane material to capture and retain artifacts. [Figure 8(b)] FIG. 1 is a diagram of a trap incorporating a hydrophilic membrane material to capture and retain artifacts. [Figure 8(c)] FIG. 1 is a diagram of a trap incorporating a hydrophilic membrane material to capture and retain artifacts. [Figure 9(a)] FIG. 1 is a diagram of a trap with multiple inlet ports arranged in staggered positions. [Figure 9(b)] FIG. 1 is a diagram of a trap with multiple inlet ports arranged in staggered positions. [Figure 10(a)] 1 is a set of diagrams of a trap with an arrangement for fixing or being fixed in its position relative to an IV pole. [Figure 10(b)] 1 is a set of diagrams of a trap with an arrangement for fixing or being fixed in its position relative to an IV pole. [Figure 11(a)] FIG. 10 is a diagram of a trap having an arrangement including valves for controlling flow between primary and secondary ports and for controlling flow into the chambers for each port. [Figure 11(b)] FIG. 10 is a diagram of a trap having an arrangement including valves for controlling flow between primary and secondary ports and for controlling flow into the chambers for each port. [Figure 11(c)] FIG. 10 is a diagram of a trap having an arrangement including valves for controlling flow between primary and secondary ports and for controlling flow into the chambers for each port. [Figure 11(d)]FIG. 10 is a diagram of a trap having an arrangement including valves for controlling flow between primary and secondary ports and for controlling flow into the chambers for each port. [Figure 12(a)] FIG. 1 is a diagram of a trap apparatus having a manifold for joining multiple lines. [Figure 12(b)] FIG. 1 is a diagram of a trap apparatus having a manifold for joining multiple lines. [Figure 13] 1 is a diagram showing a port and its sealing arrangement. [Figure 14] 10 shows an alternative port cap with a more positive sealing engagement. [Figure 15] FIG. 10 is a plan view of a further alternative port cap, in this case having a notch for engaging a tool. [Figure 16] FIG. 10 is a plan view of a further alternative port cap, in this case having a notch for engaging a tool. [Figure 17] FIG. 10 is a perspective view showing an alternative port, in this case the caps are connected by a ribbon. [Figure 18] FIG. 10 is a perspective view showing an alternative port, in this case the caps are connected by a ribbon. [Figure 19] FIG. 10 is a perspective view showing an alternative port, in this case the caps are connected by a ribbon. [Figure 20] 1 is a set of side and cross-sectional views of an alternative port, in this case the port having luer threads. [Figure 21] FIG. 10 is a side view of an alternative port, in this case the port having a threaded portion and a connector ribbon. [Figure 22] FIG. 10 is a side view of an alternative port, in this case the port having a threaded portion and a connector ribbon. DETAILED DESCRIPTION OF THE INVENTION

[0022] We have described an infusion device and a gas / bubble trap device for an infusion device. The trap has two or more inlets for liquid, and the trap retains bubbles and resulting gas within the trap in a manner that is safe for medical personnel by preventing the escape of undesired gas into the surrounding atmosphere. Further, in various embodiments, the trap retains the gas in a safe manner. In operation, the trap allows the unsafe gas to be neutralized, allowing the entire gas to be removed.

[0023] The device is suitable for infusing a first drug and a second drug, either individually or in combination, and for collecting gas bubbles entrained in a liquid within a sealed chamber. There is a housing defining at least one chamber, at least one inlet port, and an outlet port. There are preferably multiple inlet ports for mixing the inlet fluids.

[0024] The bubble trap includes a chamber, which in some embodiments is spherical. The inlet pipe delivers fluid in a radially deflected manner by a diverter, preferably conical in shape. The outlet pipe has an inlet downstream of the diverter, and is therefore unlikely to receive any bubbles deflected by the diverter. The inlet pipe preferably has a diffuser upstream of the diverter, such as a ring of circumferential openings. The liquid and gas diffuse through the diffuser, which tends to restrict the flow, resulting in a more controlled lateral flow from the diffuser, which causes bubbles to collect against the interior surface of the chamber and away from the inlet of the outlet pipe.

[0025] Generally speaking, the device includes a housing defining at least one chamber, the chamber having an inlet and an outlet, and a diverter positioned within the chamber between the inlet and outlet. The outlet is preferably provided by an outlet pipe having an inlet end within the chamber. The inlet provides fluid longitudinally into the chamber, and the diverter diverts the flow transversely relative to this direction. The outlet may be aligned with the inlet, or the outlet may be angled relative to the inlet. The outlet pipe has an inlet located within the chamber. The diverter preferably has a base portion and a rim, and preferably defines a downstream-facing volume into which air bubbles have little opportunity to enter. The outlet pipe inlet is preferably located within a central volume defined by within 40-60% of any transverse dimension of the chamber.

[0026] In various embodiments, A portion of the inlet pipe abuts against the diverter or is integral with the diverter; The diverter has a rounded profile. the device comprises at least one vent port adapted to purge trapped gas bubbles from the device; There is at least one vent port suitable for purging trapped air bubbles from the device; There may be a vent port connected to the release means, the release means operable to move between a closed position and an open position so that, in use, when the release means is in the open position, trapped gas is purged from the chamber of the device through the vent port; At least one vent port is suitable for purging trapped gas bubbles from the device; The release means is automated; The vent port comprises a gas-permeable, water-impermeable membrane such that during use, trapped gas crosses the gas-permeable / water-impermeable membrane and is purged from the chamber, while water is retained within the chamber of the device. The chamber is spherical; The device is disposed within a circuit or infusion system for delivery to a patient; The device comprises a plurality of chambers arranged in series, the chamber and diverter having interior surfaces with a surface treatment for hydrophilic control of bubbles and their movement within the chamber; The diverter rim surrounds the intake end of the discharge pipe. The device includes a gas-impermeable, liquid-permeable membrane at the intake end of the discharge tube. The device includes a filter to remove particulates before the liquid enters the intake end of the discharge line.

[0027] We further disclose an intravenous line kit comprising at least one intravenous drip bag, at least one drip chamber, at least one supply tube having a proximal end and a distal end, a bubble trap, a fluid flow control means, at least one clamp, and a cannula, wherein the bubble trap comprises: a housing defining at least one chamber having an inlet port and an outlet port; an inlet pipe having an inlet end and a outlet end, the outlet end being located within the chamber; a diverter positioned between the chamber inlet port and the chamber outlet port, the diverter comprising a base portion and a rim; a discharge pipe having an inlet end and a outlet end, the inlet end of the discharge pipe being located within the chamber and the outlet end of the discharge pipe being connected to an outlet port of the chamber; and An intravenous line kit is described that includes a diffuser in an inflow tube between an inlet port and a diverter, the diffuser including at least one hole in the inflow tube and configured to impart an alternate direction of motion of fluid entering a chamber in the inflow tube.

[0028] These features are combined in some embodiments with inlet conduits that provide for the merging of different flows either upstream of the chamber or within the chamber but upstream of a diverter within the chamber, as described in more detail below.

[0029] The inlet section preferably includes multiple inlet ports for mixing different fluids for optimal patient administration. The bubble trap has the primary advantage of preventing bubbles from flowing out through the outlet section, even in the event of abnormally high levels of gas due to mixing of fluids through different ports.

[0030] There may be a vent port, preferably sealable with a cap. There may be a diffuser channel to separate infusion fluids or actively combine fluids to accelerate degassing. There may be a diffuser section to control the behavior of air bubbles as they enter the chamber. A diverter may be positioned between the inlet and outlet ports to control the direction of fluid flow.

[0031] There may be a self-sealing membrane that allows fluid or gas to be forced into or withdrawn from the chamber through one of the infusion ports or through a vent port.

[0032] There may be an elongated discharge tube having a discharge end located in the most central region of the chamber, the discharge end being connected to an outlet port of the chamber.

[0033] We further describe a closed system aspirator device having some or all of the above features. Referring to FIG. 1 , a "piggyback" IV drip setup 1 includes a primary fluid bag 2, a secondary fluid bag 3, a piggyback set 4, a primary set 5, a roller clamp 6, a Y-connector port 7, an IV pole 8, a clamp 9, a dropper 10, and a bubble trap device 100. FIG. 1 illustrates various connection devices and techniques for infusing additional medications. The chamber may be completely sealable to retain all fluids or gases. The bubble trap device 100 is described below, but generally speaking, the device can include any of the features described in various embodiments herein.

[0034] Referring to Figure 2, trap 100 has a spherical chamber 101 and an inlet section with first and second inlet ports 104 and 105 leading to a frusto-conical diverter 102, primarily positioned to smooth out fluid vortices and convert turbulent flow to laminar flow within the entrance gallery. Arrows indicate the upward flow of air bubbles from diffuser opening 107 and the flow of liquid entering and exiting through outlet pipe 110 at inlet 111. This trap device may be used to accommodate different fluids that mix within chamber 101; upward-moving air bubbles can combine to become less harmful, but the air bubbles will be trapped within chamber 101 anyway.

[0035] Trap 100 has the benefit of addressing many of the situations described in the Background section, where there is a greater risk of gas being transported to the patient. Having inlet 103 in the form of a Y-junction with two inlet ports provides an opportunity for the fluids to mix immediately upstream of the chamber, and for collisions between fluid particles from the two streams to accelerate degassing, fluid mixing, and associated phase separation. Any entrained gas or gas generated by this mixing is immediately diverted laterally through diffuser 107 toward the wall of chamber 101 and away from outlet tube inlet 111. Importantly, diffuser 107 has the effect of slowing and redirecting the flow, thereby helping to ensure that lateral flow is controlled in a manner that promotes separation via the buoyancy effect, and helps to maintain gas bubbles within the chamber near the interior chamber surfaces and away from inlet 111. The inter-port spaces within the chamber, including the junction of multiple inlet ports, the spaces within and exiting the diffuser, and the spaces adjacent to the diffuser, are turbulent during use and promote the formation of bubbles from the gas, which then rise efficiently and become trapped within the chamber.For inlet ports with round cross-sections and diameters in the range of 1.5 to 8.0 mm, the distance from the diffuser hole to the top of the inlet port junction is preferably 20 mm or less.

[0036] This arrangement, in use, induces and promotes turbulence as the fluids mix, and this turbulence continues through the diffuser, thereby accelerating degassing of the mixture and enhancing subsequent bubble formation and therefore the movement of gas as bubbles away from the outlet towards the top of the chamber.

[0037] As the gas bubbles rise under the pressure applied from the fluid mass, the chamber volume is optimized to hold around 10 milliliters of liquid in the fully primed state, with a relative capacity to hold up to 50% of that volume in the gaseous state. The inlet section has the advantage of providing a junction for the different fluids located a measured distance at least equal to the inner diameter of the inlet tubes (104, 105) immediately upstream of the diffuser (107), which is useful for the common practice of administering combined fluid drug formulations, thereby allowing immediate lateral outflow of any gas bubbles that form.

[0038] 3 shows a trap 100 configured primarily for turbulent entry, with a spiral-shaped barrier 120 in the inlet ports 104 and 105. Like parts are designated by the same reference numerals.

[0039] Referring to Figure 4, trap 200 is arranged to use the secondary port primarily to vent the primary fluid. Trap 200 includes chamber 201, diverter 202, inlet section 203 having inlet ports 204 and 205 and diffuser hole 207, and outlet port 210 having inlet 211. In this case, inlet port 204 is used to vent the primary fluid delivered via port 205. For many use cases, it is particularly advantageous to leave the second inlet port open to vent gas entering via the other inlet port. This arrangement allows for the gas to be vented to the ambient atmosphere. This is particularly suitable for situations where the fluid can be safely vented to the atmosphere, providing flexibility for a second port and vent. If desired, the inlet port 204 may be capped or sealed with a selectively releasable cap 208. The cap 208 can be opened if the port 204 is needed as an inlet for additional fluid. In scenarios where the fluid is toxic, such as chemotherapy, the cap 208 may be indicated by color or design as not suitable for reopening.

[0040] 5, trap 300 has a similarly configured chamber and diverter and an inlet 303 with three ports 304, 305, and 306. Two are used for fluid entry, while the third is selectively used as a dedicated vent port for safe removal to vent the combined primary and secondary fluid solution. Port 306 has a removable cap 307 for selective venting.

[0041] 6 shows a one-piece component 400 that is attached to the chamber during manufacture. Component 400 has inlet ports 404 and 405, a frusto-conical diverter 402, and a diffuser opening 407 that allows fluid to have a radial component and flow into and around diverter 402. Such a one-piece component provides for simple and accurate assembly.

[0042] Referring to FIG. 7 , an integrated inlet port assembly 500 includes a primary infusion port 504, a secondary infusion port 505, and a third port 506, all of which converge at the base of a diverter 502 at a diffuser 507, with an opening 505 between the infusion ports. This component includes a selectively sealable membrane located within one or more of the infusion or vent ports 504-506. The membrane is activated by insertion of a compatible needleless connector device. The purpose of the permanently sealing or self-healing membrane is to maintain the integrity of the closed system when venting toxic gas from the chamber into a selectively attached closed system transfer device with unnecessary connectivity. The membrane also maintains the closed system for drug uptake directly into the chamber via the port via the closed system transfer device, a conventional syringe, tubing, or any other suitable device. Such a membrane may be formed from rubber, silicone, or other materials capable of elastic deformation and returning to its normal shape. This membrane, which is normally closed but deformable to allow fluid to pass through the channel, is actuated by a needleless connector, which forces the normally sealing membrane to deform, opening the channel and allowing fluid to pass through. In such cases, liquid can be injected into or withdrawn from the chamber by activating a needleless syringe. Similarly, any other device or IV tubing with an appropriate needleless connector may be attached by a Luer connection, push-fit, or other connection. For example, a self-healing membrane, commercially available as B. Braun's CARESITE®, attempts to return to its normally closed position, sealing the port, once the needleless connector device is removed. The port may be further secured by a tap or cap closure that can be pushed, twisted, or pressed into place, or by any other method of sealing the end of the port.

[0043] 8(a), 8(b), and 8(c), trap 600 includes a spherical chamber 601, a conical diverter 602, an outlet tube 610, and inlet ports 611 and 612. Trap 600 further includes a hydrophilic membrane 603 for capturing and retaining artifacts. Trap 600 includes chamber 601, diverter 602, and inlet section 600 with inlet ports 611 and 612. Membrane 603 is located below diverter 602 and includes a fine mesh of fibers forming a fabric of a material such as PTFE with micron-level pores, allowing only fluid particles to flow through. The mesh 601 allows the flow of fluid through the membrane, while trapping solid or gas particles that exceed the size of the mesh pores. Hydrophilic membrane materials are commonly used in medicine to prevent particulates and artifacts larger than 0.2 microns in size from being transported into a patient's bloodstream. In the illustrated embodiment, the membrane is attached to the base of the conical diverter 602 and abuts the opening of the outflow tube 610, with dimensions that ensure the gap between the diverter and the outflow tube is sealed. In another embodiment, the membrane may be stretched across the opening of the outflow tube 610 within the chamber 601.

[0044] Referring to Figures 9(a) and 9(b), a trap 700 includes a chamber 701 with a diverter 702 and an inlet section 703 with multiple inlet ports arranged in a staggered fashion. In this case, there are inlet ports 703, 704, 705, and 706, with a single inlet conduit 708 having two ports (704 and 705). This arrangement allows for great flexibility, particularly in allowing multiple fluid lines to be attached distally to the diverter 702, with the benefit that phase separation can occur by flowing through a diffuser 707 and across the diverter 702 where they then enter the chamber. Port 703 is used for the primary inlet, port 706 for the secondary inlet, and ports 704 and 705 for additional inlets. Having a single conduit with multiple ports flowing into it offers compactness and simplicity of manufacture. Preferably, the ports closest to the chamber, i.e., ports 703 and 706, are used typically, while ports 704 and 705, which are further away and communicate with a single conduit 708, are used exceptionally. Any or all of the ports have caps 709 for selective sealing.

[0045] Figures 10(a) and 10(b) are a set of diagrams of traps with arrangements for fixing or being fixed in position relative to an IV pole. Trap 800 has a mounting fixture 801 arranged to surround the pole, while trap 805 also has such a bracket but with a different inlet port arrangement. Trap 810 has a mounting fixture 811 shown attached to pole P, intermediate its inlet and outlet sections. Manifold trap 850 has a pair of mounting fixtures 851 and 852 arranged to support both chamber 860 and elongated inlet section 853, which has inlet conduit 861 and several inlet ports 854 extending radially from conduit 853, relative to the pole. Device 850 is secured to chamber 860 in its lowest position, so that fluid flows in through the manifold's multiple inlet ports or inlet conduits 861 and downward through chamber 860.

[0046] 11(a) and 11(b), a trap 900 includes a chamber 901, a diverter 902, and an inlet section 903 with inlet ports 904 and 905. In this example, stopcock valves 906 are included to control flow between inlet ports 904 and 905, as well as to control flow into the chamber for each port. The stopcock valves 906 can be manually controlled to fully or partially close flow from each port. The stopcock valves 906 are controlled by an external lever-type handle that rotates a barrel within the matching chamber along its central axis. The chamber 901 includes a vent port 920. As with the previous embodiment, there is an outlet tube 910 with an inlet inherent within the chamber 901.

[0047] 11(c), trap 950 includes chamber 951, diverter 952, outlet pipe 960, two inlet ports 954 and 955, and a valve 956 at their junction. Valve 956 includes concave surface 957 and concave surface 954. These surfaces provide a flow path when the valve is pivoted to the relevant position, with concave surface 957 permitting flow through port 955 when facing upstream into port 955, and concave surface 958 permitting flow through port 954 when facing upstream into port 954. do.

[0048] 11(d) shows a trap 970 having a chamber 971, a diverter 972, inlet ports 974 and 975, and a valve 976. The valve 976 has a barrel 985 with a cross-hole 986 therethrough, and a handle 987 that allows flow by pivoting the hole 986 into position to align with one port or the other.

[0049] The barrel sections are press-fit into place until the grooves are positioned and secured under frictional pressure. When a moderate force is applied rotationally about a common central axis, the stopcock barrel rotates, selectively opening or sealing the channels depending on the position of the channel openings. When aligned with the fluid path, the channels allow fluid to flow through the stopcock barrel. When not aligned with the fluid path, the walls of the stopcock barrel form a seal that does not allow fluid to flow therethrough.

[0050] The stopcock valve may be formed as a single molded plastic part having a low coefficient of friction.

[0051] Figure 12(a) shows a trap 1000 having a manifold 1001 with multiple individual control valves 1002 that control the mixing and flow ratio into the inlet manifold 1001 on the way to the chamber 1005. Figure 12(b) shows an alternative arrangement where a manifold 1050 is attached at its end to the chamber 1051.

[0052] Caps for Hazardous Drug / Toxic Biological Agent Chambers Below we describe various vent ports with a vent opening and a cap that is easy to put in place to seal the port but impossible or difficult to remove. This allows for initial venting to purge the line, but allows for subsequent sealing when toxic fluids are administered. If the cap is configured to be difficult to remove, it may have a recess for turning with a removal tool, but cannot be removed by hand.

[0053] Such vent opening features are applicable to bubble traps having only a single inlet port, not necessarily those having inlets with multiple ports, and therefore this aspect of the invention applies to any bubble trap having a chamber for trapping bubbles.

[0054] Chemotherapy is a toxic drug commonly used to provide medical treatment for a wide range of cancers. It is most often delivered intravenously as a liquid drug infused directly into the patient's veins in either a hospital, clinic, or home environment. Chemotherapy is a form of dangerous drug intended to destroy human cells to provide a therapeutic solution. Dangerous drugs can include a wide range of agents other than chemotherapy, including toxic biological agents or drugs with carcinogenic, mutagenic, and antitumor properties, all of which are harmful to human health.

[0055] Toxic biologicals or hazardous drugs (HDs) are preferably administered in closed systems that do not allow environmental contaminants to be exposed in the lines or toxic substances to be exposed to the surrounding environment. During intravenous (IV) infusion of drugs, trace amounts of toxic fluids may escape from the IV system and settle on surrounding surfaces. These may be in liquid and / or gas form, and HDs have been observed to vaporize at room temperature and when exposed to the ambient atmosphere. In modern medicine, to ensure that HDs are administered without exposure and to ensure the safety of both patients and healthcare workers, devices known as Closed System Transfer Devices (CSTDs) are used. Devices that deliver HD to healthcare professionals are used by healthcare professionals. Harmful outcomes from exposure to HD in liquid or gas form can result in a range of health problems, including reproductive issues such as reduced fertility and increased risk of miscarriage, as well as dizziness, nausea, cancer, and death. Repeated exposure to low doses over long periods of time has been shown to directly harm the health of healthcare professionals in the vicinity of toxic biologic or hazardous drug infusions.

[0056] During administration, it is not uncommon for IV lines to be opened to aspirate air bubbles from HD infusion lines, which pose a subsequent risk to the patient's health. In the process of removing air or toxic vapor bubbles, healthcare workers put their own health at risk. Clearly, devices that reduce exposure can have a positive impact on healthcare delivery.

[0057] Maintaining a closed chamber is important to protect healthcare workers and their patients from unknown or unintended contact with chemotherapy or toxic drugs flowing through the IV. Having an open port to expel air during IV setup, such as priming to expel entrained air in the IV tubing to ensure the correct and safe performance of the procedure, is necessary. When the device is used to purge problematic air bubbles from IV lines where the chamber is intended to hold liquids and gases, a vent port is required to expel air. The purpose of the open port is to allow air to escape the chamber so that the desired volume of fluid can enter the chamber. Once the chamber is filled with the desired fluid, it is then necessary to seal the chamber to prevent drug exposure in an unsafe environment, such as the bedside. When blood or hazardous drugs are being administered, it is often preferable and safer to ensure the chamber cannot be easily opened to ensure there is no risk of toxic drug exposure.

[0058] Therefore, any method to ensure a reliable seal is in place could potentially reduce chamber opening. Preferably, the cap cannot be opened or removed by hand. Once secured in place, such a device would provide an airtight seal that ensures that liquid or vapor cannot pass into or out of the chamber.

[0059] The cap may be a push-fit mechanism, a rotating mechanism, a latching mechanism, or any other mechanism that allows the cap to be placed into an active position and not easily removed. The cap may be fixed in place, or the cap may be selectively sealable so that it can be opened to allow critical functions to be performed. The cap may seal against the passage of fluids or vapors of environmental contaminants by press-fit contact between mating surfaces, or the cap may utilize a sealing ring or membrane device.

[0060] 13, vent port 2100 includes a cap 2101 that fits into vent opening 2110, the cap 2101 intended to seal chamber opening 2110 in a manner that is difficult to open. Seal 2100 can form part of or all of a trap chamber that contains a fluid intended to be isolated from the internal and external environments. With cap 2101 in place, opening 2110 is completely sealed with an airtight seal, preventing fluid from passing through. Cap 2101 can be pushed, twisted, squeezed, or otherwise forced into place into the orifice opening.

[0061] In this embodiment, cap 2101 has downwardly depending legs 2106 separated by a V-shaped gap 2103 to provide a split feature intended to flexibly deform when pressed into a mating vent opening 2110 of the chamber. The mouth of opening 2110 locks into place against a circumferential groove 2104 in cap 2101. 2101 has a radially inward facing rim or protrusion 2105 that is clamped to the chamber opening 2110. When fully installed, the downwardly angled, inwardly angled walls of the cap base legs 2106 contact the interior surface of the wall of the chamber opening 2110 to form an airtight seal. The top of the cap 2101 has a convex surface 2108 that is intentionally difficult to grasp, thereby reducing the likelihood of the cap being removed by a human hand, and thus the cap 2101 and chamber 2111 are forced to seal and stay together to form a sealed unit.

[0062] FIG. 14 is a set of views of an alternative vent 2200 having a cap 2201 and a vent opening 2210. In this case, cap 2201 has legs 2206 with outer surfaces that taper inward to narrow the end that is inserted into opening 2100 and are separated by a V-shaped gap 2203. There is again a circumferential groove 2204; however, in this case, the top 2208 has a lower profile and is diametrically crossed by a shallow recess 2209 at its center. Additionally, below groove 2204 are additional circumferential grooves 2215 and 2216. Opening 2210 has corresponding ridges 2210, 2211, and 2212 to tightly engage grooves 2204, 2215, and 2216.

[0063] In other embodiments, there may be a pair of cross-shaped notches similar to notch 2203, which allows for more uniform flexibility around the circumference.

[0064] As shown in Figures 15 and 16, cap 2301 may have a diametrically extending slot 2302 for gripping by a tool, or cap 2401 may have a cross-shaped groove 2402 for engaging a tool.

[0065] The cap, preferably a cap with a split base, may have any of a variety of shapes and materials. Some materials may be chosen for their low or high coefficient of friction characteristics, or for their elastic properties, allowing the material to distort or flex as needed to fit into the opening. The split may be any of a variety of notch shapes to allow for flexible distortion. The material may be required to return to its given geometric shape once the force is removed.

[0066] The cap top can be the same or different material as the cap base, and the shape of the cap top can be round, flat, convex, concave, or any other geometric shape that is intentionally difficult to grip or pull.

[0067] As noted above, the cap may have one or more notches that interface with the projections so that once the notches clear the upper edges of the projections, the cap is firmly held and locked in place using friction or surface-to-surface contact.

[0068] For convenience, it is practical to place the cap on or near the device requiring closure. In one embodiment shown in Figures 17 and 18, cap 2501 is attached to opening 2510 of chamber 2511 using a flexible connector or ribbon 2530, allowing the cap to be manipulated into the opening. The ribbon can be attached to the chamber by tying, connecting, clipping, or molding into place. Cap 2501 is attached to opening 2510 in this case using a ring 2531 that slides over opening 2510 by ribbon 2530. The purpose of the ring is to allow the cap to be twisted or pressed into place by rotating the ring to a convenient position without shearing or twisting ribbon 2530.

[0069] In one embodiment shown in FIG. 19, ribbon 2530 has a ring 2531 on its inner end for engaging the opening and a disk 2532 on its outer end for engaging the cap. 33. These ends are connected by a band 2532 having narrower geometric shapes or necks 2534 and 2535 at the inner and outer ends, respectively. These shapes form a frangible tether that can be easily pulled and disconnected by hand or with a suitable tool once the cap is in its permanent place. The reason for removing the ribbon is to reduce the likelihood that someone could pull on the cap and remove it from its intended permanent place as a seal.

[0070] During the priming process, the cap is placed into its permanent home location to seal the chamber and the ribbon section may be broken off to indicate that the chamber is sealed. In one embodiment, the material is flexible, in another embodiment, the material is rigid, and in another embodiment, the material is brightly colored to identify its location.

[0071] In certain further embodiments, the cap is formed with internal threads in a typical luer style, allowing the cap to be screwed and sealed into place on the exterior section of a luer fitting as commonly practiced in medical procedures.

[0072] In certain further embodiments, the cap is formed with a push fit that uses surface-to-surface friction contact to seal in place on the outer section of the fitting.

[0073] In another embodiment shown in FIG. 20 , a port 2600 has a sealing cap 2601 connected to a port opening 2610 by luer threads 2605 that mate with threads 2613 on the outer surface of the port, i.e., the exterior surface of the port opening 2610. The cap 2601 has a split 2603 on the inner section so that it will distort and narrow when the radially outward facing cap surface 2606 contacts the port opening edge 2611. When fully turned into place, the inner cap surface 2604 contacts the port surface 2612, and the flexible port expands, trapping the cap 2601 in the port opening 2610. By turning the luer threads of the cap 2601, the cap 2601 remains permanently fixed in place due to the internal split section being trapped by the contact surfaces 2604 and 2612 and is essentially unable to be removed once in place. The cap 2601 has hand grip knurling 2608 on its outer surface to aid in the initial manual tightening of the cap device.

[0074] In another embodiment, the cap can be attached by bonding, connecting, molding, or some other process such that the cap is always connected to a device with an open port.

[0075] In another embodiment shown in Figure 21, cap portion 2700 has many of the same features as Figure 20, but in this case cap 2701 is connected to opening 2710 by ribbon 2730. Figure 22 shows a variation in which cap portion 2800 has cap 2801 similar to cap 2701, except that cap 2801 has a pair of narrow knurled gripping surfaces 2801 and 2802 separated by ring 2831 integral with ribbon 2830.

[0076] use The following describes the use of any of the devices described herein. Fluid flows into a chamber through a primary inlet port and is diffused into the chamber through a plurality of diffuser holes. The diffuser holes are located distal to the conical diverter and proximate to where the inlet pipe abuts the conical diverter, so that fluid enters the chamber via the inlet pipe, through the diffuser holes, and over the conical diverter. These one or more diffuser holes may be circular, oblong, or rectangular, and are arranged on the body of the device in such a way that the sum of the diameters of the holes is equal to the diameter of the inlet pipe so as not to affect the flow rate into the chamber. The inlet port may be a slot. If necessary, the primary fluid may be combined with fluid from the secondary inlet port before being diffused into the chamber, thereby facilitating mixing and aspiration of the two fluids. The fluid may flow under the force of gravity, or may be induced by a pump or other means of inducing flow when the device forms part of an IV administration system.

[0077] The primary benefit of allowing the primary and secondary flows to enter and mix within the chamber is that any naturally occurring outgassing is prevented from entering the distal tubing of the device. The device can act as an in-line air aspirator, promoting efficient release of entrained gas from the liquid phase. The controlled release of gas from the various fluids within the closed chamber reduces the risk of gas passing into the outlet port. The benefit of this is a significant reduction in "air in the line" alarms that can cause interruptions in medication delivery in electronic IV pump devices that monitor liquids for problematic air bubbles.

[0078] Another advantage is that attending nursing staff will need less time to constantly interrupt a closed system, less time spent maneuvering the gas into a convenient position for removal, and no additional equipment is required to aspirate trapped gas, resulting in efficiency and lower costs for healthcare providers. Another advantage is that harmful drug vapors are contained within the device's sealed chamber, protecting healthcare workers from exposure to toxic drugs.

[0079] Having multiple infusion ports on one closure device allows a mixture of solutions to be administered without the problem of air bubbles being present in the mixture.

[0080] Diffusing the solution into the chamber helps buoyancy forces overcome the fluid flow rate, so any gas bubbles are forced to rise to the top of the fluid more easily. By spreading the bubbles and coalescing the microbubbles as they enter, the effect of buoyancy is enhanced. The advantage is that gas bubbles are less likely to penetrate into the fluid mass within the chamber; instead, they tend to float to the air-liquid interface region where they will collapse.

[0081] An additional advantage of the device is that it utilizes a conical diverter to redirect fluid particles toward the outer edge of the fluid body as they enter the chamber. At the outer edge of the chamber, any entrained air is furthest from the intake end of the outlet port, where the slower particle motion induces laminar flow, making it more likely that air bubbles will rise under the buoyancy effect. Additionally, any entrained particles are more likely to fall toward the lower portion of the chamber, farthest from the outlet port.

[0082] The primary inlet is used to flood the chamber with the primary fluid. In this case, the outlet port is closed with a tap or clamp to stop flow from that port, and the secondary inlet tube is opened to allow a pressure differential, so that the primary fluid is urged to flow into the chamber and any entrained air can be expelled out through the open secondary inlet tube. The secondary inlet tube can then be sealed, for example, using a cap, seal, or activation of a tap. With the secondary tube closed, the outlet tube would then be opened to create a liquid path from the primary inlet tube to the outlet tube. Furthermore, the secondary inlet tube can then be attached to the secondary inlet port, and a mixture of the primary and secondary fluids can be infused into the chamber, with the combined solution being expelled through the outlet tube.

[0083] In another embodiment, the vent port or secondary inlet conduit can feature a permanently sealing or self-healing membrane. Such a membrane may be made of rubber, silicone, or other material that can be elastically deformed and return to its normal shape. is normally closed but deformable to allow fluid to pass through the channel and is acted upon by a needleless connector that forces the normally sealing membrane to deform, opening the channel and allowing fluid to pass through. In such cases, liquid can be injected into the chamber by a needleless syringe, a closed system transfer device, or another IV tubing with an appropriate connector that can be attached by a Luer connection or push-fit or other connection.

[0084] The advantage of having a permanently sealing membrane on the secondary inlet port is that it allows toxic liquids that may be contained in the secondary connection device to enter the chamber through the secondary inlet port while still maintaining a sealed system.

[0085] In one embodiment, the primary and secondary inlet conduits are separated by a septum, promoting a laminar flow profile in which each fluid enters the chamber in its own channel without mixing. These separate fluids are diffused into the chamber through multiple inlet holes in the diffuser section. An advantage of this embodiment is that the primary inlet can be attached to an IV line and used to fill the chamber with fluid, while the separate secondary inlet conduit can remain open until the chamber is fully primed to serve as a vent port for entrained air. In use, the secondary inlet conduit can then be selectively sealed, or an IV line of fluid can be attached to the secondary inlet conduit and used as the secondary inlet, allowing fluid to flow into the chamber via the diffuser and diverter as previously described.

[0086] In some further uses, the primary and secondary fluids, or additional fluids, are mixed together before the diffuser, this mixing being to encourage degassing between the liquids.

[0087] In another application, separation of the liquid and gas phases of the fluid, as well as separation of particles and artifacts, is accelerated by including a vortex that directs the fluid toward the outer wall of the fluid channel in a swirling motion, forcing air and particles toward the outer region of the fluid body. In this case, the outer region of the fluid body is the central-most region of the chamber. When two or more fluids combine in this manner, particles collide, creating a turbulent mixing regime in which air bubbles of various sizes are formed. These bubbles, along with the combined solution, enter the chamber through the diffuser holes and are carried through the fluid body as intended, with gas bubbles floating upward under buoyancy and particles sinking into the fluid body due to their relative weights.

[0088] In some further uses, the outlet port may be protected from the ingress of artifacts by incorporating a filtering membrane which may be secured to the surface of the diverter, the top of the outlet tubing, or any other interior surface of the chamber. The advantage of using a filtering membrane on the diverter surface is the increased surface area, which is less likely to clog, meaning the membrane can swell as intended without unduly affecting the intended flow rate, and solid particles are prevented from entering the outlet tubing leading to the pump or patient.

[0089] In one use, the primary inlet tube is connected to the air aspirator device using a luer lock. In another embodiment, the primary inlet tube is connected to the air aspirator device using a push-fit. In another embodiment, the primary inlet tube is connected to the air aspirator device using a tie such that the primary tube is permanently secured in place on the tubing.

[0090] In one use, the secondary and additional inlet conduits are connected to the air aspirator device using a luer lock. In another embodiment, the secondary and additional inlet conduits are connected to the air aspirator device using a push fit. In another embodiment, the secondary and additional inlet conduits are connected to the air aspirator device using a tie such that the secondary and additional conduits are permanently secured in place on the tubing.

[0091] In another use, the primary and secondary inlet ports are used solely to infuse fluid into the chamber through the diffusion holes of the air aspirator device. In this case, there is a separate vent port with a hole feature that only allows air entrained during priming to pass through the hole feature, up the channel, and out through the vent port. In this embodiment, the primary and secondary ports only allow infusion fluid to flow in. The primary and secondary ports may be capped, tapped, or otherwise sealed, or filled with liquid while the vent port is open, thereby creating a pressure gradient that forces air to escape through the open port.

[0092] In another use, the vent port may include a self-healing, normally closed membrane as previously described. An advantage of this embodiment is that aspirated gases can collect in the upper section of the chamber. If excess gases collect, it may be desirable to vent these gases without stopping the infusion process. In this situation, a suitable closed system transfer device (CSTD) is attached to the vent port, and the membrane is activated to allow gas to pass from the chamber to the CSTD, allowing the entrained gas to be aspirated into a device, such as a CSTD, syringe, or other device.

[0093] An advantage of having a series of multiple inlet lines is that it allows more than one fluid to be infused through the air aspirator device at a time. This can increase the efficiency of medication delivery and provide a single observation point for clinicians to monitor for air or other obstructions affecting the overall delivery of IV fluids. Another advantage of this embodiment is that it reduces manufacturing steps and costs, resulting in a cost-effective solution for healthcare providers.

[0094] In many applications, the primary line is back-primed into the secondary line to purge any initially entrained air from the secondary line. Typically, the secondary line is connected to the primary line using a Y-connector. The secondary fluid bag is held lower than the primary fluid bag, thereby forcing the liquid into the secondary line. Using this method, the primary fluid is allowed to fill the entire secondary line. Once the secondary line is completely purged of air, the secondary bag of fluid is raised higher than the primary bag, thereby forcing the liquid in the secondary line to dominate, and the liquid flows into the primary line. In some cases, a mechanical IV pump is used to control the flow rates of the primary and secondary fluids. The primary and secondary fluids then flow as a mixture into the chamber of the invention, causing air aspiration of the mixture as described.

[0095] In one use, the primary fluid enters the chamber with the discharge port tubing clamped to stop flow in that direction and the secondary port open to encourage flow in that direction. As the chamber primes with fluid from the primary line, the primary fluid fills the chamber and passes through the diffuser holes into the secondary line, where priming of the secondary line is performed as described. An advantage of this is that back-priming the secondary line in this manner to expel entrained air is common clinical practice. A second advantage is that entrained air is expelled from the chamber through the secondary line into the secondary IV bag, where it is trapped, effectively maintaining a closed system essential for patient and staff safety. Once the chamber is primed and the secondary line is primed, flow is reversed, allowing the secondary line to flow into the chamber as needed to complete therapy. The device can then remove air bubbles from the primary and secondary lines as described above.

[0096] In some applications, to create a passage between a primary port, a secondary port, or a chamber. A two-way or three-way stopcock tap device is selectively opened or closed. An advantage of including a two-way or three-way tap device is that the flow of fluid from the primary line into the secondary line can be conveniently controlled and stopped. Another advantage is that in the event of an adverse patient reaction to a drug in the secondary line, the port can be quickly and conveniently closed to stop further infusion of the drug. Another advantage of selectively opening and closing the port is that it allows priming of the secondary line before fluid enters the chamber. The combined fluid can then enter the chamber through the diffuser holes, and air is aspirated as previously described.

[0097] Alternative Embodiments In one embodiment, the air aspirator device is stand-alone and disposable. In another embodiment, the air aspirator device is a component of a primary dispensing set and is disposable along with the dispensing set. In some further embodiments, the air aspirator forms a three-dimensional shape. In some further embodiments, the air aspirator is formed from sub-parts manufactured using an injection molding process. In some further embodiments, the air aspirator sub-parts are assembled into a three-dimensional component.

[0098] In certain further embodiments, an air aspirator is assembled onto the chamber section, its purpose being to capture aspirated gas. The air aspirator is located in the upper section of the chamber so that all fluid enters the chamber from the top and exits through an outlet port at the bottom. The device is intended to function in either orientation, and thus the terms "upper" and "lower" refer to inflow and outflow, respectively, and not to absolute coordinates in a fixed sense.

[0099] In certain further embodiments, the outlet port is elongated, with the intake end of the outlet port located approximately in the center of the chamber. One advantage of having an elongated outlet port with its intake end located in the center of the chamber is that particles trapped in the fluid are positioned at the bottom of the chamber where they abut the outlet tube, and they may be restricted from entering the outlet tube. Other particles may be free floating in the body of liquid due to buoyancy forces.

[0100] In another embodiment, a hydrophilic membrane abuts the intake end of the outflow tube to prevent the intrusion of airborne particles or solid artifacts. In another embodiment, a hydrophilic membrane is attached to the base surface of the diverter body. The membrane is shaped to surround the intake end of the outflow tube to prevent the intrusion of airborne particles or solid artifacts. In a further embodiment, the surface of the diverter is polished to prevent air bubbles from "sticking" or spreading to the diverter surface.

[0101] In another embodiment, the trap includes a chamber with an attachment device that securely attaches the device to a local surface. In practice, when the primary line is attached to the trap, the inlet port of the air aspirator component is positioned in the uppermost position and the outlet port is positioned in the lowermost position. Thus, the device can be fixed in place using split rings, clips, or other fastening methods. The advantage of fixing the device in place is that additional infusion tubing can be easily attached and the device can be positioned at a convenient height for clinical staff.

[0102] In another embodiment, the chamber of the trap is spherical. In some further embodiments, the chamber is rectangular. In some further embodiments, the chamber is oval. In some further embodiments, the chamber is triangular.

[0103] The advantage of the spherical shape of the device is that it allows trapped gas to cluster away from the elongated exit tube in either orientation. The advantage of having a fixed position device that is oval or taller is that the chamber can hold a larger volume of gas.

[0104] In some preferred embodiments, the trap is free to move and rotate in either orientation and is not fixed to any particular position. In some further embodiments, the chamber is opaque. In some further embodiments, the chamber is translucent. In some further embodiments, the chamber is transparent.

[0105] One advantage of a transparent chamber is that fluid and gas formation can be easily observed and monitored. In another embodiment, the device includes a measurement system. During use, the measurement system reads the amount or level of trapped air or trapped gas bubbles in the chamber. In a preferred embodiment, the measurement system is a gradient meter.

[0106] One advantage of the measurement system is that it allows for accurate measurement of the volume of gas present in the chamber of the device. In another embodiment, multiple inlet ports can be turned on or off depending on whether an infusion tube is connected to transfer fluid into the chamber. In this case, a tap mechanism allows each port to be opened or closed independently of the others.

[0107] The advantage of having two-way or three-way taps is that each port can be isolated from adjacent ports, thereby minimizing fluid loss. When an infusion fluid line is attached, closing the tap between the proximal and infusion ports ensures that all fluid enters only the intended infusion port. If an additional infusion line is added to the proximal port, the tap can then be opened to allow the fluids to mix. Fluid will flow freely from the top port through the open ports into the lowest chamber.

[0108] One advantage of placing the chamber in the lowest position is that all fluid will flow into the chamber, allowing for maximum efficiency in the release of entrained gases. Degassing of the fluid solution will occur in the ports and through the diffuser device within the chamber. Gas will be trapped in the uppermost section of the chamber, and the fluid mass will remain substantially free of problematic gas bubbles.

[0109] In another embodiment, the device is formed of a malleable material. In another embodiment, the device is formed of a rigid material. In a preferred embodiment, the rigid material is a polymer. In another embodiment, the device is formed of individual components that may require assembly to form a complete device prior to use. In another embodiment, the device can be manufactured as a single unit.

[0110] In another embodiment, the device is manufactured using 3D printing. In another embodiment, the device is manufactured using injection molding. In a preferred embodiment, the device can connect to various types of tubing, including various pumps, using standard connections. In another embodiment, the device is scalable in size, with the optimal size assessed by the user depending on the use case. In a preferred embodiment, the device can automatically capture and retain 1 cc or more of gas and retain the gas in a sealed chamber. This may be beneficial when dangerous drugs or toxic biologicals, such as blood products, are being used and vapors should not be released into the atmosphere.

[0111] The invention is not limited to the described embodiments, which may be varied in arrangement and detail. [Explanation of symbols]

[0112] 1. "Piggyback" IV Infusion Setup 2 Primary fluid bags 3 Secondary fluid bags 4 Piggyback Set 5 Primary Set 6 Roller clamp 7 Y-connector port 8 IV poles 9 Clamp 10 Dropper 100 Bubble trap device 101 Chamber 102 Divertor 103 Entrance 104 First inlet port 105 Second Inlet Port 107 Diffuser opening 110 Outflow pipe 111 Outlet pipe inlet 120 Barrier 200 Traps 201 Chamber 202 Diverter 203 Entrance 204, 205 inlet ports 207 Diffuser hole 208 Cap 210 Exit Port 211 Exit Port Inlet 300 Traps 303 Entrance Ports 304, 305, and 306 307 Cap 400 Integrated Components 402 Diverter 404, 405 inlet ports 407 Diffuser opening 500 Integrated Inlet Port Assembly 502 Diverter 504, 505 Infusion port 506 tertiary port 507 Diffuser 600 Traps 601 Chamber 602 Diverter 603 Membrane 610 Outflow pipe 611, 612 inlet ports 700 Trap 701 Chamber 702 Diverter 703, 704, 705, 706 inlet ports 707 Diffuser 708 Conduit 709 Cap 800 Traps 801 Mounting jig 805 Trap 810 Trap 811 Mounting jig 850 Manifold Trap 851, 852 Mounting jig 853 Entrance 854 Inlet Port 860 Chamber 861 Inlet conduit 900 Trap 901 Chamber 902 Diverter 903 Entrance 904, 905 inlet ports 906 Stopcock valve 910 Outflow pipe 920 Vent Port 950 Trap 951 Chamber 952 Diverter 954, 955 Inlet ports 956 Valve 957, 958 concave surface 960 Outflow pipe 970 Trap 971 Chamber 972 Diverter 974, 975 inlet ports 976 Valve 985 barrels 986 Through Hole 987 Handle 1000 Traps 1001 Inlet manifold 1002 Individual control valve 1005 Chamber 1050 Manifold 1051 Chamber 2100 Vent Port 2101 Cap 2103 V-shaped gap 2104 Circumferential groove 2105 Rims or protrusions 2106 Legs 2108 Convex surface 2110 Vent opening, chamber opening 2111 Chamber 2200 Vent 2201 Cap 2203 V-shaped gap 2204 Circumferential groove 2206 Legs 2208 Upper 2209 Shallow depression 2210 Vent opening 2210, 2211, 2212 Ridge 2215, 2216 Additional circumferential groove 2301 Cap 2302 Slots 2401 Cap 2402 Cross shaped groove 2501 Cap 2510 Opening 2511 Chamber 2530 Flexible connector or ribbon 2531 Ring 2532 bands 2533 disk 2534, 2535 neck 2600 port 2601 Sealing Cap 2603 Split 2604 Internal cap surface 2605 Luer thread 2606 Cap surface 2608 Hand Grip Knurling 2610 Port opening 2611 Port opening edge 2612 Port side 2613 Threaded part 2700 Cap 2701 Cap 2710 Opening 2730 Ribbon 2800 Cap 2801 Cap 2801, 2802 Knurled Grip Surface 2830 Ribbon 2831 Ring P pole

Claims

1. A gas trap device for medical fluids, comprising: a bubble trapping chamber (101); an inlet section (103) to the bubble trapping chamber having a plurality of inlet ports (104, 105); and an outlet section having at least one outlet port (110).

2. 10. The apparatus of claim 1, The apparatus includes a flow diverter (102) within the chamber positioned to divert flow from the inlet (103) away from the outlet port and towards an interior surface of the chamber with a directional component transverse to the longitudinal flow direction from the inlet (103).

3. 3. The device according to claim 1 or 2, The inlet ports (104, 105) are adapted to allow fluids flowing through them to mix as they enter the chamber (101).

4. 4. The device according to claim 1, wherein: The inlet port includes a dedicated vent port (306).

5. 5. The device according to claim 1, wherein: The apparatus, wherein the inlet section includes a turbulence-inducing flow barrier (120).

6. 6. The device according to any one of claims 1 to 5, An apparatus wherein at least one inlet port includes a turbulence-inducing flow barrier (120).

7. 7. The device according to any one of claims 1 to 6, The chamber includes a hydrophilic membrane (603).

8. 8. The apparatus of claim 7, The device, wherein the membrane (603) is attached to the distal end of the diverter.

9. 9. The device according to any one of claims 1 to 8, A device wherein at least one port includes a valve (705) for fully or partially closing the port.

10. 10. The apparatus of claim 9, An apparatus wherein a plurality of inlet ports are provided with valves, said apparatus comprising a mechanism for interconnecting said valves and for their synchronized operation.

11. 11. The device according to claim 9 or 10, The inlet section comprises a single valve (906) mounted to alternately open and close a plurality of the inlet ports.

12. 12. An apparatus according to any one of claims 1 to 11, comprising: The device further comprises a membrane, preferably selectively sealable, at either the inlet port or the outlet port to maintain the integrity of the closed system when an external device is connected to the port for the purpose of transferring liquid or gas into or out of the chamber.

13. 13. The device according to any one of claims 1 to 12, The inlet comprises a common conduit (708, 853) for a plurality of ports (709-706, 854).

14. 14. The apparatus of claim 13, The common conduit extends parallel to the longitudinal direction.

15. 15. The device according to any one of claims 1 to 14, The device includes a bracket (811) for attachment to a support as part of an infusion set.

16. 16. The device according to any one of claims 1 to 15, The device comprises a vent port (920) that is sealable.

17. 17. The apparatus of claim 16, The device, wherein the vent port comprises a vent opening (2110) and a cap (2101) engageable with the vent opening.

18. 18. The apparatus of claim 17, The device wherein the cap and the vent opening have interengaging features (2104, 2105) that are engageable by forcing the cap into the opening.

19. 19. The device according to claim 17 or 18, The device wherein the cap and the opening comprise interengaging ridges (2105) and grooves (2104).

20. 20. The device according to any one of claims 17 to 19, The device, wherein the cap has a curved exposed surface without a hand grip.

21. 21. The device according to any one of claims 17 to 20, The cap is connected to the vent opening by a ribbon (2530).

22. 22. The apparatus of claim 21, The ribbon has a ring engaged around the vent opening to allow rotation about the axis of the vent opening.

23. 23. The device according to any one of claims 17 to 22, The device, wherein the cap is configured to limit closure without being removed.

24. 24. The apparatus of claim 23, The device, wherein the cap and the vent opening have interengaging features (2602, 2612) that provide a snap-fit ​​lock with pressing the cap into the vent opening.

25. 25. The device according to any one of claims 1 to 24, The inlet ports merge at a junction space, the chamber comprises a diffuser having an opening (107) around an inlet pipe for allowing fluid to enter the chamber with a lateral dimension, the inlet ports (104, 105) have a diameter in the range of 1.5 to 8.0 mm, and the distance between the upper end of the junction space between the ports (104, 105) and the diffuser opening (107) is 20 mm or less.

26. 26. An infusion device comprising a gas trap device according to any one of claims 1 to 25, an infusion line connected to the inlet port, and an infusion line connected to the outlet port.

27. 27. A method of use of the device of any one of claims 1 to 26, comprising the steps of directing flows of different fluids through the inlet ports and mixing and trapping gases from the fluids within the chamber and as the fluids enter the chamber.

28. 28. The method of claim 27, The method further comprising the step of drawing the gas through an inlet port or a dedicated vent port.

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