Intravenous Line Bubble Trap Device

Abstract

To provide improved bubble traps for the removal of gas bubbles degassed from a solution.SOLUTION: The present invention is directed to a device 200 suitable for separating and collecting gas bubbles entrained in a liquid. The device comprises: a housing 202 defining at least one chamber having an inlet port 204 and an outlet port 206; a diverter positioned between the inlet port and the outlet port; and an elongated exit tube 210 with an intake end and an export end. Therein: the intake end of the elongated exit tube is centrally located within the chamber; the export end of the elongated exit tube is connected to the outlet port of the chamber; and a trapped air is expelled through a gas permeable-water impermeable membrane of a venting port 212.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to a bubble trap suitable for separating and trapping gas bubbles present in a fluid. A fluid is a substance that spontaneously deforms (flows) under applied shear stress. Fluids are phases of matter and include liquids, gases, and plasmas. [Background technology]

[0002] Gases naturally exist in fluids. Such gases entrained in a fluid tend to become unstable due to various environmental factors, such as flow rate, temperature, chemical reaction, turbulence, motion, and friction. Unstable gases tend to degas from solution in the liquid, meaning that the gas separates from the liquid fraction and causes the formation of gas bubbles. As a result of the degassing phenomenon, bubbles of various sizes are formed and flow freely within the fluid, potentially exerting forces that carry the bubbles in the direction of the fluid flow. Gas bubbles naturally tend to float upward and coalesce, so that when given the opportunity, they will come together to form essentially one large gas bubble.

[0003] Gas bubbles are fluids in that they flow and deform. Gas bubbles maintain their structure due to a combination of internal gas pressure pushing outward on the gas bubble membrane and external liquid pressure pushing inward on the gas bubble membrane. The topmost portion of the bubble membrane experiences a lower external liquid pressure, while the bottommost portion of the bubble membrane experiences a higher external liquid pressure. Therefore, gas bubbles tend to rise in response to this external liquid pressure profile.

[0004] Gas bubbles attempt to maintain a uniform shape, but may deform and become elongated under forces such as being sucked into a narrow tube. Gas bubbles will attempt to return to a rounder ball shape if possible, unless there is a constriction, such as occurs in tubing. Gas bubbles will therefore tend to stick to the interior walls of long tubing and deform from their preferred round shape into an elongated oval.

[0005] To ensure the correct dosing regimen of a medication to a patient, the flow rate leaving any degassing chamber must be equal to the flow rate entering it. Any restriction to the flow through the degassing chamber will affect the dosing regimen. This is especially important for certain medications that have narrow therapeutic windows where even small deviations in the dosing regimen can be toxic to the patient.

[0006] One such scenario, where entrained gas bubbles in a fluid can degas the solution and cause problems, is in an intravenous (IV) infusion setup. A typical IV infusion setup 100 used in a hospital is shown in FIG. 1. Such an IV infusion setup 100 includes an IV pole 102 from which a primary IV infusion bag 104 hangs via an extender 106. The primary IV infusion bag 104 also includes an injection port 108, which is used to add additional final components to the IV infusion solution contained within the primary IV infusion bag 104. The primary IV infusion bag 104 is connected to primary IV tubing 110. The primary IV tubing 110 typically includes a sterile spike 112, a drip barrel 114, a check valve 116, at least one port 118, 120, a slider clamp 122, and a roller clamp 124. The primary IV tubing 110 is connected to extension tubing 126 via a luer lock 128. While a luer lock is described, it should be understood that other fastening means, such as a push-fit connection, may be used. Extension tubing 126 connects to a cannula 130, which may also include a clamp 132. A typical IV drip setup 100 may optionally include a secondary IV drip bag 134 suspended from a hook 136 on the IV pole 102, along with a secondary infusion port 138, a sterile spike 140, and a drip barrel 142. The secondary IV drip bag 134 connects to the primary IV tubing 110 via the secondary tubing 144 and at least one port 118.

[0007] In use, the liquid solution in the IV drip typically flows under the influence of a gravitational pressure gradient (i.e., from high pressure to low pressure) from an IV drip bag 104 suspended from the top of the IV pole 102 through the cannula 130, with the IV drip solution entering the patient's bloodstream, which is generally located below the IV drip bag 104.

[0008] This typical IV drip setup shows that a gravity pressure gradient is used, although a machine that induces a pressure gradient (e.g., an IV pump) may also be used to control the flow rate.

[0009] In an IV drip, entrained gas escapes from the liquid solution of the IV drip as it travels from the IV drip bag 104, 134 to the cannula 130, where the liquid solution in the IV drip bag enters the patient's bloodstream. If air or gas enters the bloodstream, gas bubbles will likely cause embolism by creating blockages that impede blood flow. Vascular air embolism (VAE) or induced vascular air embolism can occur when gas bubbles enter the venous system, often as a result of IV fluid infusion procedures, a common method of delivering fluids to patients. VAE can lead to further complications, such as cardiac arrhythmia, heart attack, stroke, and death. Another complication of microbubbles or macrobubbles entering the bloodstream is hemolysis, which is the destruction of blood cells, which can cause further strain on the body and increase the patient's recovery time. Therefore, it is important to remove the air / gas that escapes from the solution before the gas bubbles have a chance to enter the bloodstream.

[0010] Throughout this specification, the term "liquid" should be understood to encompass any type of liquid solution, liquid medicine, or other liquid or liquid-like substance intended for intravenous delivery, such as blood, liquid supplements, parenteral nutrition, suspensions, body fluids, or other similar viscous substances suitable for infusion or intravenous delivery.

[0011] Throughout this specification, the term "fluid" is understood to encompass both liquid and gas phases, where the liquid phase has a gas entrained or introduced therein.

[0012] It is common for IV drip setups to include a drip tube 114, sometimes referred to as a "Murphy Dropper" device. The Murphy Dropper 114 has two functions: first, it allows for monitoring of fluid flow rate, and second, it allows for the elimination of the risk of air or gas that may have formed in the bag entering the flexible tubing. Such drip tubes 114 may have a ball that floats on the fluid, the purpose of which is to seal off the entrance to the flexible tubing when the bag 104, 134 is emptied of liquid, a situation that could result in excess air being entrained in the line. This air could cause serious complications for the patient if the line were placed intravenously and the entrained air was not observed. Drip tubes 114, such as the Murphy Dropper, tend to be placed at the top of the line, directly below the IV drip bag 104, 134. This location is intended to allow for ease of access to manually purge the drip tube 114 of any air trapped therein. However, this location is the furthest from the point of entry into the patient (i.e., cannula 130), meaning that fluid degassing and air entrainment can occur throughout the length of the line, potentially forming air bubbles after the solution passes through the drip tube 114 and entering the patient's bloodstream via the cannula 130 into the vein.

[0013] Such IV drip setups typically require constant visual monitoring and manual removal of gas bubbles, which is time-consuming, labor-intensive, and prone to human error and unstable. Removal of bubbles tends to necessitate removal of a percentage of the IV drip solution to ensure that gas does not enter the patient's body, which is a waste of hospital resources.

[0014] Electronic bubble monitors are often attached to IV tubing to aid in the identification of gas bubbles. These monitors provide an audible alarm intended to alert nearby clinical staff to the danger, and in many cases, the bubble monitor will attempt to stop the fluid flow to allow removal by a medical professional. The constant interruption of IV fluid flow can be problematic for patients and increase workload for staff. The application of these expensive and cumbersome devices may further be limited by space, power availability, training requirements, maintenance issues, or lack of resources.

[0015] During surgical procedures, fluids are commonly warmed to match body temperature to counter the effects of anesthesia-induced vasodilation. Due to the decreased solubility of gases as temperatures increase, warmed fluids become unstable rapidly, which can cause large amounts of gas bubbles to form throughout the entire length of the IV tubing. Throughout these procedures, extra vigilance is required to monitor and eliminate the risk of VAEs, increasing time lost in costly surgical environments.

[0016] In situations where the location of the IV stand is inconveniently close to the bed, such as during surgery when multiple staff members are typically present, extension tubing is commonly added to the IV set, which poses additional challenges for clinical staff in observing air bubbles contained within the tubing and also provides additional fluid volume for gas to defuse.

[0017] Air can also be introduced into IV tubing port sites, joints, or valves due to poorly sealed fittings or improper venting of gas by staff during priming. Additionally, air can be introduced into a closed system by staff injecting refill medication into the infusion liquid solution anywhere between the IV bag and the point of entry into the patient.

[0018] Another such scenario in which gas bubbles entrained in a fluid can degas and cause problems is in blood transfusion and extracorporeal blood therapy setups. These setups share many of the same characteristics as IV setups and therefore experience many of the same problems. In addition, phlebotomists will reject poor-quality blood, so extra care must be taken in collecting, handling, and processing blood fluids. External stresses on blood cells, such as turbulence, friction, and impact, can cause hemolysis. Furthermore, blood supplies are scarce and expensive.

[0019] The removal of gas entrained in or introduced into a liquid has been a long-standing problem for which many different means of removing the gas have been attempted, e.g., U.S. Pat. No. 6,508,859 and U.S. Pat. No. 7,141,097.

[0020] U.S. Patent No. 9,533,109 describes a bubble trap device with multiple chambers, each with an outlet port extending into the chamber, and a bubble trap arranged in series. Such a device operates on the simple principle that bubbles will rise to the top of the device and the assumption that air will not enter the outlet port extending into the chamber unless the chamber is half-filled with air. This is incorrect because bubbles can still enter the outlet port as they move toward the top of the device. The device also provides a plunger for inserting the bubble trap to switch between a vent mode, in which bubbles move freely through the outlet, and an in-use mode. Switching between modes is achieved by rotating the plunger. In the bubble trap of U.S. Patent No. 6,537,356, purging of air is achieved by temporarily reversing the fluid flow.

[0021] U.S. Patent No. 6,537,356 describes a peanut-shaped chamber for trapping gases and solids in a fluid stream, with an outlet nozzle protruding into the chamber. One disadvantage of such bubble traps is that external factors can still cause air bubbles to enter the outlet nozzle protruding into the chamber. The bubble trap aims to eliminate the possibility of air bubbles entering the outlet nozzle by restricting the size of the outlet nozzle lumen to prevent larger air bubbles from escaping into the patient's bloodstream.

[0022] Another disadvantage of the narrowed outlet nozzle described in U.S. Patent No. 6,537,356 is that it does not prevent the entrapment of gas bubbles into the outlet nozzle as described in the patent application. Larger gas bubbles will simply try to deform to fit the narrowed lumen, while smaller gas bubbles will simply pass through. The net result is that the patient is still exposed to an elevated overall volume of gas, with the attendant increased risk that large gas bubbles will form within the vasculature, causing damage to the vessel lumen, blocking vascular fluid flow, and reducing oxygenation.

[0023] An additional disadvantage of the narrowed outlet nozzle described in U.S. Patent No. 6,537,356 is that the narrow outlet can more easily become an airlock condition, stopping or restricting flow through the outlet nozzle, which may increase the need for monitoring the tubing and periodic agitation to break up any air bubbles sufficiently to loosen the flow through the outlet nozzle.

[0024] A further disadvantage of the narrowed outlet nozzle described in U.S. Patent No. 6,537,356 is that the narrowing of the outlet nozzle restricts the flow of fluid exiting the degassing chamber, altering the dosage regimen of the medication received by the patient. This is particularly problematic for certain medications that have a narrow therapeutic window where even small deviations in the dosage regimen can be toxic to the patient.

[0025] The bubble trap of U.S. Patent No. 6,537,356 is stated to be intended to be disposable and therefore not suitable for repeated or continuous use. Thus, the user would need to monitor the device and move it to different locations to extend its single use time, as leaving it in one place for too long would result in the central tube no longer being submerged in the fluid, allowing air to enter the outlet nozzle and into the patient's bloodstream.

[0026] A further disadvantage of the bubble trap described in U.S. Pat. No. 6,537,356 is that any air present within the device prior to use cannot be easily flushed from the device, meaning that the device cannot perform efficiently or for long periods of time, limiting its operational capabilities.

[0027] U.S. Patent No. 5,674,199 describes a bubble trap suitable for a transfusion device in which an extracorporeal circuit is formed. In this bubble trap, an inlet tube extends into a chamber and a reservoir that reverses the direction of blood flow introduced into the chamber. The effect of changing the flow direction is to increase the opportunity for air bubbles in the blood to separate from the blood before it exits through the outlet port. The change in flow direction is also said to reduce blood stagnation and clotting within the reservoir.

[0028] A disadvantage of such devices is that they lack multi-directional movement and are intended for use in a vertical orientation. In an IV drip setup, the bubble trap may become inverted due to patient movement, especially if the bubble trap is positioned closer to the patient's entry point. If the device of U.S. Patent No. 5,674,199 were to become inverted, gas bubbles would easily move through the exit port because air naturally moves upward toward the exit port.

[0029] Another disadvantage of such devices is that sufficient fluid flow force is required to change the direction of the fluid flow and prevent stagnation within the cup, which results in turbulence, friction, and smacking of blood cells against the sides of the cup, leading to hemolysis and poor blood quality.

[0030] A further disadvantage of this cup design is that a certain percentage of blood still remains within the cup and is therefore unavailable for transfusion.

[0031] It should also be understood that just because a device is suitable for removing air bubbles from blood in an extracorporeal circuit does not automatically mean that the device is suitable for other applications where the fluid flow conditions are very different, such as an IV drip setup. [Prior art documents] [Patent documents]

[0032] [Patent Document 1] U.S. Patent No. 6,508,859 [Patent Document 2] U.S. Patent No. 7,141,097 [Patent Document 3] U.S. Patent No. 9,533,109 [Patent Document 4] U.S. Patent No. 6,537,356 [Patent Document 5] U.S. Patent No. 5,674,199 Summary of the Invention [Problem to be solved by the invention]

[0033] There has long been a need for an improved bubble trap for the removal of gas bubbles degassed from a solution.

[0034] It is an object of the present invention to provide an apparatus and / or method that overcomes at least one of the above-mentioned problems. [Means for solving the problem]

[0035] The present invention provides an apparatus suitable for separating and collecting gas bubbles entrained in a fluid, the apparatus defining at least one chamber having an inlet port and an outlet port. housing and a diverter, i.e., a first diverter, disposed between the inlet port and the outlet port; and an elongated outlet tube having an intake end and an export end, the intake end of the elongated outlet tube being centrally positioned within the chamber and the export end of the elongated outlet tube being connected to the outlet port of the chamber.

[0036] In use, when the device forms part of an IV drip setup or other system in which a device suitable for separating and collecting gas bubbles entrained in a fluid is required, fluid (i.e., a combination of liquid and gas) generally flows through inlet port 204 into chamber 302 of device 200 under the influence of a pressure gradient (i.e., from high pressure to low pressure) induced by a pump or any other means of inducing flow.

[0037] An advantage of providing the combined features of the diverter and elongated outlet tube is that fluid is directed away from the intake end of the elongated outlet tube, thereby reducing the risk of air entrainment into the elongated outlet tube.

[0038] An advantage of providing the combined features of a diverter and elongated outlet tube is that fluid is directed away from the intake end of the elongated outlet tube regardless of the orientation of the device.

[0039] A further advantage of the device of the present invention is that the combined design of the diverter and elongated outlet tube features captures gas buildup within the chamber, thereby reducing the number and frequency of pump alarms in setups intended for use with the present invention, thereby reducing alarm alerts and the resulting alarm fatigue, which is a major issue among medical staff.

[0040] A further advantage of the device of the present invention is that it provides a cost-effective solution suitable for mass production that can be seamlessly integrated with existing line connector technology.

[0041] In some further embodiments, the chamber is of a larger volume relative to the inlet and outlet tubing.

[0042] The advantage of having a chamber with a larger volume relative to the inlet and outlet tubing is that laminar flow is encouraged as the liquid spreads out to fill the chamber. Less turbulence is observed with the larger volume.

[0043] In certain further embodiments, the first diverter defines a solid shape.

[0044] In certain further embodiments, the first diverter defines a compartment within the chamber, the diverter comprising a base portion and a rim.

[0045] In certain further embodiments, the base portion of the diverter is adjacent to the inlet port.

[0046] In certain further embodiments, the base portion of the diverter abuts the inlet port.

[0047] In certain further embodiments, the rim of the diverter is adjacent to the exit port.

[0048] In certain further embodiments, the intake end of the elongated outlet tube is centrally located within the compartment formed by the diverter.

[0049] One advantage of centrally locating the elongated outlet tube within the compartment formed by the diverter is that it maintains a volume of substantially bubble-free liquid centrally within the chamber and forward of the intake end of the elongated outlet tube.

[0050] This volume of liquid tends to be less turbulent and move slower than the fluid in other parts of the chamber. Another advantage is that the slower moving volume of liquid results in a more laminar flow with less friction (drag) with increased buoyancy, which means that any air bubbles that do remain in the volume of liquid will move more quickly towards the uppermost outer part of the chamber.

[0051] In certain further embodiments, the rim of the diverter extends beyond the intake end of the elongated outlet tube.

[0052] Gas bubbles tend to "stick" to surfaces such as the chamber housing, but can become dislodged, especially when agitated or tapped. If the bubble trap is to be placed at the patient end of an IV drip setup, the problem of bubbles becoming dislodged from the trap's surface is exacerbated by patient movement.

[0053] One advantage of placing the diverter rim beyond the intake end of the elongate outlet tube is that if an air bubble does indeed break off, it will be diverted away from the intake end of the elongate outlet tube, preventing the air bubble from commuting directly past the intake end of the elongate outlet tube, thus reducing the likelihood of the air bubble entering the elongate outlet tube through the intake end and crossing towards the patient and into the patient's bloodstream.

[0054] In certain further embodiments, the diverter has a rounded contour shape.

[0055] Air bubbles tend to escape from sharp edges. An advantage of providing a rounded contour to the diverter is that the air bubbles tend to remain attached to the sides of the container. Such controlled detachment of air bubbles reduces the chance of the air bubbles escaping, floating, and passing the intake end of the elongated outlet tube. While a rounded contour is described, it is understood that other shapes may be suitable as well.

[0056] In certain further embodiments, the device comprises at least one interior surface, a portion of which comprises a surface treatment.

[0057] In certain further embodiments, the surface treatment is a chemical treatment, hi other embodiments, the surface treatment is a mechanical treatment.

[0058] One advantage of the surface treatment is that bubble desorption is controlled.

[0059] In a preferred embodiment, at least one interior surface of the device, a portion of which is provided with a surface treatment, is a diverter.

[0060] In certain further embodiments, the surface treatment comprises at least one smooth surface.

[0061] Air bubbles tend to stick to smooth surfaces. One advantage of at least one smooth surface is that air bubbles tend to stay attached to the smooth surface.

[0062] In certain further embodiments, the surface treatment comprises at least one textured surface.

[0063] Air bubbles tend to escape from rough, uneven surfaces. One advantage of the at least one textured surface is that the air bubbles can escape and form free-floating bubbles in the fluid, which then move under buoyancy towards the uppermost part of the chamber.

[0064] A textured, rough, and / or uneven surface provides a plurality of depressions in which attached air bubbles can sit.

[0065] A further advantage of textured surface treatments is that the diameter of the bubbles is accommodated by the dimensions of the depressions in which the bubbles sit. The size of each depression limits the size of the bubbles that form. Once a bubble attaches to a depression in the textured surface, the bubble continues to grow by merging of free-floating bubbles with depression-tethered bubbles. Bubble desorption occurs when the bubble size exceeds a predetermined size limit up to which the depression can hold the bubble, beyond which the bubble desorbs from the textured surface. Bubble desorption and bubble size are therefore controllable.

[0066] In certain further embodiments, the surface treatment comprises at least one smooth surface and at least one textured surface.

[0067] One advantage of combining at least one smooth surface with at least one textured surface is that the lodgement and dislodgement of gas bubbles can be controlled. In use, gas bubbles are encouraged to stick or break free at specific locations on the diverter, depending on what surface treatment is used. The result is that the bubbles are steered in such a way that they are either removed to the outer portion of the chamber or stuck to the surface treatment, so that the bubbles are either directed away from the intake end of the elongated outlet tube or prevented from flowing past the intake end of the elongated outlet tube.

[0068] Although the surface treatment is described in the context of a diverter, it should be understood that the surface treatment may also be applied to other surfaces of the device, such as the diffuser, the interior portion of the chamber housing, and any other surface of the device where control of bubble retention and detachment is desired.

[0069] In certain further embodiments, an inlet pipe is provided having an inlet end and an outlet end, the outlet end being centrally located within the chamber.

[0070] In some further embodiments, the inlet conduit is a protrusion in the chamber wall around the inlet port.

[0071] In some further embodiments, the inlet tube comprises at least one male or female connector and the chamber comprises at least one male and female connector corresponding to the at least one male or female connector of the inlet tube.

[0072] In certain further embodiments, a portion of the inlet pipe abuts a portion of the first diverter.

[0073] In certain further embodiments, a portion of the inlet pipe abuts a base portion of the first diverter.

[0074] In certain further embodiments, the device comprises a diffuser, the diffuser comprising at least one hole.

[0075] In use, gas bubbles travel through the at least one hole in the diffuser into the chamber under fluid flow parameters. The bubbles are then directed by a diverter toward an outer portion of the chamber and away from the intake end of the elongated outlet tube. In this embodiment, the at least one hole in the diffuser imparts an alternate direction of motion to the fluid entering the chamber along with any gas bubbles entrained therein.

[0076] The benefit of the diffuser is that it slows down the rate at which the fluid arrives from the inlet pipe into the chamber.

[0077] In certain further embodiments, the at least one hole is located in the topmost portion of the diffuser.

[0078] In this embodiment, the positioning of the at least one aperture encourages gas bubbles to enter the chamber in a generally upward moving motion towards the topmost outer portion of the chamber.

[0079] In some further embodiments, the diffuser comprises a plurality of holes. In some preferred embodiments, the diffuser comprises four holes. In some most preferred embodiments, each hole is approximately 0.25 mm in diameter.

[0080] One advantage of having multiple holes is the reduced occurrence of air locking, thus maintaining fluid flow and fluid pressure entering the chamber.

[0081] A further advantage of having multiple holes is that when the device is moved and reoriented, at least one hole remains in a generally uppermost position on the diffuser, thus allowing gas bubbles entering the chamber to still travel in a generally upward motion toward the uppermost outer portion of the chamber.

[0082] A further advantage of having multiple holes is that it limits the sticking or adhesion of air bubbles.

[0083] In some further embodiments, the diffuser is located between the inlet port and the outlet port. In some further embodiments, the diffuser is located between the inlet port and the first diverter. In some further embodiments, the diffuser is located at the outlet end of the inlet pipe. In some further embodiments, the diffuser is located at any point along the length of the inlet pipe.

[0084] In certain further embodiments, the diffuser is in the form of an inlet pipe.

[0085] In certain further embodiments, the inlet pipe of the diffuser is elongated.

[0086] One advantage of increasing the length of the inlet tube is that it improves structural stability when multiple holes are present.

[0087] In certain further embodiments, the inlet pipe forms a plurality of inlet pipes, each extending radially towards an outer portion of the chamber.

[0088] One advantage of having multiple inlet tubes is that the path of the bubbles is directed further out of the chamber and towards the topmost part of the chamber.

[0089] In another embodiment, the diffuser holes are smaller in size relative to the size of the bubbles arriving at the diffuser from the inlet port. In use, larger bubbles are forced through the diffuser holes under fluid flow parameters, so that the larger bubbles arriving at the diffuser become smaller bubbles once they have passed through the diffuser holes. The smaller bubbles present within the chamber are then directed toward an outer portion of the chamber by a first diverter.

[0090] One advantage of having a diffuser with multiple holes that are smaller relative to the size of the bubbles arriving at the diffuser from the inlet port is that larger bubbles entrained in the incoming fluid are broken up by the diffuser into several smaller bubbles before entering the chamber. These smaller bubbles are optimally sized to have a reduced surface area exposed to drag and therefore move faster through the liquid. While the optimal bubble size depends on the flow rate, bubble size, and other environmental conditions, the optimal bubble is one that exhibits optimal buoyancy characteristics, i.e., one that is not restricted by turbulence, drag, friction, collisions, coalescence, and other limiting factors, yet has enough gas volume to overcome liquid retention characteristics and move faster to the outer portions of the chamber, thereby being more quickly diverted away from the intake end of the elongated outlet tube.

[0091] Cavities are bubbles with diameters between 1 nm and 10 nm. Nanobubbles, or ultrafine bubbles, range in diameter from approximately 10 nm to 200 nm and have a typical transit time of approximately 0.1 cm / s. Nanobubbles therefore have lower buoyancy and remain suspended in liquids for longer periods due to Brownian motion. Bubbles with diameters between 200 nm and 10 μm are known as "micro-nanobubbles" (MNBs). Microbubbles range in diameter from approximately 10 μm to 50 μm and tend to either collapse and disappear in liquids before reaching the surface or form nanobubbles and remain suspended. Ordinary bubbles, or macrobubbles, range in diameter from approximately 100 μm to 1 mm and have a typical transit time of approximately 25 cm / s. Ordinary bubbles therefore rise rapidly to the surface of the liquid and collapse.

[0092] Another advantage of the diffuser is that the resulting smaller bubbles reduce the overall gas volume per bubble. Smaller bubbles can remain suspended in the liquid. These smaller gas bubbles are believed to be more quickly absorbed by the body. In the unlikely event that a bubble were to find its way out of the chamber and into the circulatory system of a patient using the device via the outlet tube, the associated risk of air being present in the vasculature is greatly reduced.

[0093] In another embodiment, the apparatus includes a second diverter.

[0094] In certain further embodiments, a second diverter is disposed between the first diverter and the intake end of the elongated outlet tube.

[0095] In certain further embodiments, the second diverter is in the form of a container having a base portion and a rim.

[0096] In a preferred embodiment, the base portion of the second diverter abuts the intake end of the elongated outlet tube.

[0097] One advantage of the second diverter is that the fluid flow, along with any entrained gas, is diverted away from the intake end of the elongated outlet tube, which is particularly useful for maintaining the trapped gas away from the intake end of the elongated outlet tube if the device is inverted.

[0098] In another embodiment, the device comprises an occluder adapted to block the intake end of the elongate outlet tube.

[0099] As more gas is trapped, the level of liquid contained within the chamber of the device drops, and if the level of liquid contained within the chamber of the device drops beyond a certain point, the trapped gas may escape through the intake end of the elongated outlet tube. In use, the occluder floats in the volume of liquid contained within the chamber of the device, and as the liquid level drops, the occluder abuts the intake end of the elongated outlet tube, preventing gas from leaving the chamber and entering the elongated outlet tube.

[0100] In certain further embodiments, the occluder is positioned within the elongate outlet tube.

[0101] In certain further embodiments, the device comprises at least one vent port.

[0102] The advantage of having a vent port is that any air bubbles trapped within the device can be easily removed either before or during use, meaning that the bubble trap can continue to be used with minimal impact on its ability to infuse fluid into the patient.

[0103] Another advantage of the vent port is that it creates a low pressure gradient to encourage liquid to fill the chamber quickly, while preventing air / fluid from flowing through the outlet tube towards the patient.

[0104] An additional benefit of the vent port is that it allows for priming of the bubble trap device so that any air present in the chamber of the device can be evacuated from the chamber prior to use.

[0105] A further advantage of the vent port is that it improves the efficiency and effectiveness of the device by allowing for the removal of any bubbles or air present within the device.

[0106] A further advantage of the vent port is that it results in a device suitable for continuous use. Devices without a vent port would slowly fill with gas over time, meaning that such devices would only be suitable as disposable items requiring periodic replacement to avoid the associated risks of air being present in the vasculature.

[0107] In another embodiment, the device comprises a selectively permeable membrane.

[0108] In certain further embodiments, the selectively permeable membrane comprises a gas-impermeable, liquid-permeable membrane.

[0109] In certain further embodiments, the gas impermeable, liquid permeable membrane is positioned at the intake end of the elongated outlet tube.

[0110] In use, liquid within the chamber is able to exit the chamber through the gas-impermeable, liquid-permeable membrane into the elongate outlet tube, while gas bubbles remain within the chamber.

[0111] In certain further embodiments, the selectively permeable membrane comprises a gas-permeable, liquid-impermeable membrane.

[0112] In certain further embodiments, a gas-permeable, liquid-impermeable membrane is disposed in the vent port.

[0113] In use, gas trapped within the chamber is able to pass through the gas permeable membrane of the vent port, while liquid within the chamber is prevented from exiting the chamber through the vent port.

[0114] One advantage of a gas-permeable, liquid-impermeable membrane is that no release means is required, and therefore no monitoring or switching of said release means is required: gas is automatically purged from the chamber without the need for additional action or automation.

[0115] Another advantage of a gas-permeable, liquid-impermeable membrane positioned between the chamber and the vent port is that it prevents liquid within the chamber from exiting the chamber through the vent port, thus minimizing liquid loss, reducing waste and lowering costs of use.

[0116] In another embodiment, the device includes a filter membrane disposed between the inlet and outlet ports.

[0117] Bacteria and solid particulate matter may find their way into liquids to be administered to a patient. Examples of particulate matter include, for example, glass particles from open glass ampoules, particles from rubber stoppers, or particles from agglomerates of parenteral nutrition ingredients, drug incompatibility reactions, incomplete reconstitution during liquid solution preparation, and other drug formulation problems. Bacterial and particulate contamination of liquid solutions for delivery to a patient can cause patient care complications if such contaminants end up in the patient's bloodstream.

[0118] One advantage of the filter membrane is that it traps bacteria and particulates, preventing them from leaving the chamber of the device and entering the elongated outlet tube, and thus preventing them from entering the patient's bloodstream.

[0119] In another embodiment, the filter membrane abuts the intake end of the elongated outlet tube.

[0120] In another embodiment, the vent port is coupled to a release means suitable for purging trapped gas bubbles from the device, the release means being adapted to be moved from a closed position to an open position so that, in use, when the release means is in the open position, trapped gas bubbles are purged from the chamber of the device through the vent port.

[0121] The advantage of connecting the vent to a release means is that it allows for controlled expulsion of gas bubbles, minimizing loss of the fluid being infused.

[0122] In another embodiment, the release means comprises a pushing action. In another embodiment, the release means comprises a pulling action. In another embodiment, the release means comprises a turning action. In another embodiment, the release means comprises a sliding action.

[0123] In use, when one or more actions are performed on the release means, entrained gas is released from the chamber of the device through the vent port.

[0124] In certain further embodiments, the releasing means is automated.

[0125] An advantage of automating the release means, and thus purging air from within the bubble trap, is that it reduces the amount of trap monitoring required by hospital staff, freeing up their time for other important tasks.

[0126] In certain further embodiments, the device comprises a sensor suitable for monitoring the gas level within the chamber of the device.

[0127] One advantage of the sensor is that it detects the ingress of gas bubbles into the chamber of the device and measures the amount of gas present against a predetermined acceptable level.

[0128] In certain further embodiments, the device comprises an alarm means.

[0129] One advantage of the alarm means is that it indicates that the amount of gas present in the chamber has exceeded a predetermined acceptable level and venting will be initiated.

[0130] Another advantage of the alarm means is that it indicates when the release means is about to be activated and the vent port opened to vent trapped gas from the chamber and maintain optimal operation of the device.

[0131] In some further embodiments, the chamber 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.

[0132] An advantage of the spherical shape of the device is that the trapped gas can be directed away from the elongated exit tube in either orientation.

[0133] In some further embodiments, the chamber is opaque. In some further embodiments, the chamber is translucent. In some further embodiments, the chamber is transparent.

[0134] One advantage of having a transparent chamber is that fluid and gas formation can be easily observed and monitored.

[0135] In another embodiment, the device comprises a measurement system that, in use, provides a reading of the amount or level of trapped air or trapped gas bubbles in the chamber.

[0136] In a preferred embodiment, the measurement system is a gradient rule.

[0137] One advantage of the measurement system is that it allows for an accurate measurement of the volume of gas present in the chamber of the device.

[0138] In another embodiment, the device includes a display that, in use, provides a readable indication of measurements made regarding the amount or level of trapped air or trapped gas bubbles in the chamber.

[0139] One advantage of the display is a clear communication of the volume of gas present within the chamber of the device.

[0140] The size and dimensions of the device may be modified depending on the setup in which the device needs to be used. For example, the size and dimensions of the device may be reduced for use in a blood transfusion setup. An advantage of a reduced size bubble trap is the minimization of fluid loss within the device.

[0141] In another embodiment, the device includes an injection port that, in use, allows the operator to administer a bolus injection, which is useful when very high doses of medication are required.

[0142] In a preferred embodiment, the injection port is located between the exit port of the device and the entry point via the cannula towards the patient.

[0143] An advantage of having the injection port located between the exit port of the device and the point of entry via the cannula towards the patient is that a reliable concentration of the drug is administered.

[0144] Another advantage of having the injection port located between the device exit port and the entry point via the cannula towards the patient is that it ensures that the entire bolus injection enters the patient's bloodstream.

[0145] In another embodiment, the operator is automated.

[0146] In another embodiment, the device includes a locking mechanism having an open position and a closed position.

[0147] In certain further embodiments, the locking mechanism is located adjacent the inlet port. In use, when the locking mechanism is in the open position, the liquid and any entrained gases flow into the chamber of the device. When the locking mechanism is in the closed position, the fluid and any entrained gases are prevented from leaving the chamber of the device.

[0148] In certain further embodiments, the device comprises multiple locking mechanisms, and the position of each locking mechanism is determined independently of each other.

[0149] One advantage of a locking mechanism or combination of locking mechanisms is that fluid flow can be easily controlled and can be stopped or allowed to continue flowing from or to one direction as needed.

[0150] In some further embodiments, the locking mechanism is located adjacent the outlet port. In use, when the locking mechanism is in the open position, liquid and any entrained gas in the chamber of the device exit the chamber through the elongated outlet tube and into the outlet tubing toward the patient. When the locking mechanism is in the closed position, fluid and any entrained gas are prevented from entering the chamber of the device.

[0151] In another embodiment, the device is formed from a rigid material.

[0152] In another embodiment, the device is formed from a malleable material, hi a preferred embodiment, the malleable material is a polymer.

[0153] In another embodiment, the device is formed from separate components that may require assembly to form a complete device prior to use.

[0154] In another embodiment, the device can be manufactured as a single unit.

[0155] In another embodiment, the device is manufactured by 3D printing. In another embodiment, the device is manufactured by injection molding.

[0156] In another embodiment, the device described above comprises a foot.

[0157] In another embodiment, the feet include a clamping device that serves to securely attach the device to a surface.

[0158] In use, attachment of the device to a surface by activating the clamping devices on the feet secures the device into a fixed position and provides stability.

[0159] In another embodiment, the surface is selected from clothing, bedsheets, IV poles, or other nearby structures.

[0160] In another aspect of the invention, there is provided an apparatus comprising a housing defining at least one chamber having an inlet port, an outlet port, and a diffuser disposed between the inlet port and the outlet port, the diffuser comprising at least one hole.

[0161] In use, gas bubbles travel through the at least one hole in the diffuser into the chamber under fluid flow parameters, and in this embodiment, the at least one hole in the diffuser imparts an alternate direction of motion to fluid entering a chamber comprised of liquid and entrained gas bubbles in the liquid.

[0162] The benefit of the diffuser is that it slows the rate at which fluid arrives from the inlet pipe into the chamber of the device.

[0163] In certain further embodiments, the at least one hole is located in the topmost portion of the diffuser.

[0164] In this embodiment, the positioning of the at least one aperture encourages gas bubbles to enter the chamber in a generally upward moving motion towards the topmost outer portion of the chamber.

[0165] In certain further embodiments, the diffuser comprises a plurality of holes.

[0166] One advantage of having multiple holes is the reduced occurrence of air locking, thus maintaining fluid flow and fluid pressure entering the chamber.

[0167] In another embodiment, the diffuser comprises a plurality of holes spaced apart in a generally radial array around the periphery of the diffuser.

[0168] An advantage of having multiple holes spaced apart in a generally radial array is that even if the device is moved and reoriented, at least one hole will remain in a generally uppermost position on the diffuser, so that gas bubbles entering the chamber can still travel in a generally upward motion toward the uppermost outer portion of the chamber.

[0169] In certain further embodiments, the diffuser is in the form of an inlet pipe disposed around the inlet port.

[0170] In certain further embodiments, the inlet pipe of the diffuser is elongated.

[0171] One advantage of increasing the length of the inlet tube is that it improves structural stability when multiple holes are present.

[0172] In certain further embodiments, the inlet pipe forms a plurality of inlet pipes, each extending radially towards an outer portion of the chamber.

[0173] In another embodiment, the diffuser holes are smaller in size relative to the size of the bubbles arriving at the diffuser from the inlet port. In use, larger bubbles are forced through the diffuser holes under fluid flow parameters, so that the larger bubbles arriving at the diffuser become smaller bubbles once they have passed through the diffuser holes. The smaller bubbles present within the chamber are then directed toward an outer portion of the chamber by a first diverter.

[0174] One advantage of the diffuser having smaller holes relative to the size of the bubbles arriving at the diffuser from the inlet port is that larger bubbles entrained in the incoming fluid are broken up by the diffuser into several smaller bubbles before entering the chamber. These smaller bubbles are of an optimal size with a reduced surface area exposed to drag, and therefore exhibit optimal buoyancy characteristics that allow them to move faster through the liquid, which in turn allows them to move faster to the outer portion of the chamber and thus be diverted more quickly away from the intake end of the elongated outlet tube.

[0175] Another advantage of the diffuser is that the resulting smaller bubbles reduce the overall gas volume per bubble. Smaller bubbles can remain suspended in the liquid. These smaller bubbles are believed to be more easily absorbed by the body. In the unlikely event that a bubble were to find its way out of the chamber and into the circulatory system of a patient using the device via the outlet tube, the associated risk of air being present in the vasculature is greatly reduced.

[0176] In another embodiment, the device is adapted to separate and collect gas bubbles entrained in a fluid.

[0177] In another aspect of the invention, there is provided an apparatus comprising a housing defining at least one chamber having an inlet port and an outlet port, the chamber comprising at least one surface, a portion of the at least one surface of the chamber comprising a surface treatment suitable for controlling bubbles and bubble movement within the chamber.

[0178] In use, when the air bubbles come into contact with the portion of the chamber having at least one surface treatment, the air bubbles adhere to or detach from the portion of the chamber having the surface treatment.

[0179] In another embodiment, the surface treatment promotes the attachment of air bubbles to portions of the interior surface that have the surface treatment.

[0180] In another embodiment, the surface treatment promotes the detachment of air bubbles from the portion of the interior surface that has the surface treatment, so that, in use, the air bubbles become free-floating bubbles within the volume of fluid present in the chamber.

[0181] In another embodiment, at least one interior surface is a diverter.

[0182] In another aspect of the invention, an apparatus is provided that includes a housing defining an inlet port, an outlet port, and at least one chamber having a selectively permeable membrane.

[0183] In certain further embodiments, the selectively permeable membrane comprises a gas-impermeable, liquid-permeable membrane.

[0184] In certain further embodiments, the selectively permeable membrane comprises a gas-permeable, liquid-impermeable membrane.

[0185] In certain further embodiments, a gas impermeable, liquid permeable membrane is positioned at the exit port.

[0186] In use, liquid within the chamber is able to exit the chamber through the gas-impermeable, liquid-permeable membrane, while gas bubbles remain within the chamber of the device.

[0187] In some further embodiments, the device comprises a vent port, hi some further embodiments, the gas-permeable, liquid-impermeable membrane is disposed in the vent port.

[0188] In use, gas trapped within the chamber is able to pass through the gas-permeable, liquid-impermeable membrane of the vent port, while liquid within the chamber is prevented from exiting the chamber through the vent port.

[0189] One advantage of a gas-permeable, liquid-impermeable membrane is that no release means is required, and therefore no monitoring or switching of said release means is required: gas is automatically purged from the chamber without the need for additional action or automation.

[0190] Another advantage of a gas-permeable, liquid-impermeable membrane positioned between the chamber and the vent port is that it prevents liquid within the chamber from exiting the chamber through the vent port, thus minimizing liquid loss, reducing waste, and lowering costs of use.

[0191] In another embodiment, the device is adapted to separate and collect gas bubbles entrained in a fluid.

[0192] In another embodiment, the device is suitable for use in an IV drip setup.

[0193] In another aspect of the invention, an apparatus is provided that includes a housing defining at least one chamber having an inlet port, an outlet port, and a filter.

[0194] In another embodiment, the filter membrane is disposed between the inlet port and the outlet port.

[0195] Bacteria and solid particulate matter may find their way into liquids to be administered to a patient. Examples of particulate matter include, for example, glass particles from open glass ampoules, particles from rubber stoppers, or particles from agglomerates of parenteral nutrition ingredients, drug incompatibility reactions, incomplete reconstitution during liquid solution preparation, and other drug formulation problems. Bacterial and particulate contamination of liquid solutions for delivery to a patient can cause patient care complications if such contaminants end up in the patient's bloodstream.

[0196] One advantage of the filter membrane is that it traps bacteria and particulates, preventing them from leaving the chamber of the device and thus preventing them from entering the patient's bloodstream.

[0197] In another embodiment, the filter membrane abuts the exit port.

[0198] In another embodiment, the device is adapted to separate and collect gas bubbles entrained in a fluid.

[0199] In another embodiment, the device is suitable for use in an IV drip setup.

[0200] In another aspect of the invention, there is provided an apparatus as described above, wherein the apparatus is disposed in a circuit.

[0201] A transfusion set-up is typically disposed within a circuit, and although the bubble trap described above is generally described in the context of a non-circuit IV drip, it should be understood that the bubble trap can be adapted for use in a transfusion set-up.

[0202] In another aspect of the invention, there is provided an apparatus as described above, comprising a plurality of chambers arranged in series.

[0203] The advantage of having multiple chambers arranged in series is that the trapping and removal of air bubbles can be repeated several times, which means that the risk of bubbles entering the patient's bloodstream is further reduced.

[0204] In a further embodiment, each of the plurality of chambers is connectable to one another using interconnecting tubing.

[0205] In another aspect of the invention, an intravenous line kit is provided, comprising at least one intravenous drip bag, at least one drip barrel, at least one supply tube having a proximal end and a distal end, a bubble trap, a flow control means, at least one clamp, and a cannula, wherein the bubble trap comprises a diverter.

[0206] In certain further embodiments, the bubble trap comprises the device of the present invention as described above.

[0207] The device of the present invention may be suitable for use within an IV drip setup. The device may be incorporated into the primary IV tubing, secondary tubing, or extension tubing at any point along its length.

[0208] In certain further embodiments, a preferred location for the device of the present invention is just before the cannula in an IV drip setup.

[0209] In another embodiment, the location for the apparatus of the present invention is before an air bubble monitoring device, such as an IV pump alarm system.

[0210] In another aspect of the invention, an intravenous line kit is provided, comprising at least one intravenous drip bag, at least one drip barrel, at least one supply tube having a proximal end and a distal end, a bubble trap, a flow control means, at least one clamp, and a cannula, wherein the bubble trap comprises a diffuser.

[0211] The invention will be more clearly understood from the following description of some embodiments, given by way of example in connection with the accompanying drawings, in which: [Brief explanation of the drawings]

[0212] [Figure 1] 1 is a schematic diagram of a typical IV infusion setup. [Figure 2] FIG. 1 is a 3D rendering of an external front view of a device according to the present invention. [Figure 3] FIG. 1 is a 3D rendering of an exploded view of a device according to the present invention. [Figure 4] 1 is an exploded view of a device according to the present invention showing its component parts; [Figure 5] 1 is a schematic diagram of the device according to the present invention in use. [Figure 6] 1 is a schematic representation of a device according to the invention held in a vertical plane. [Figure 7] 1 is a schematic diagram of an apparatus with a single diverter according to one embodiment of the present invention. [Figure 8] 1 is a schematic diagram of an apparatus with dual diverters according to one embodiment of the present invention. [Figure 9] 1 is a cross-sectional view of an apparatus according to one embodiment of the present invention. [Figure 10] FIG. 10 is an enlarged perspective view of the device according to FIG. 9. [Figure 11] 10 is a series of schematic diagrams of the device according to FIG. 9. [Figure 12] FIG. 1 is a 3D rendering of a side view of an apparatus according to one embodiment of the present invention. [Figure 13] Showing a ruler. [Figure 14] Illustrates typical bubble formation patterns and observable characteristics in IV tubing. [Figure 15] 1 is a graph showing gas volume as a function of temperature and flow rate. [Figure 16] 1 is a graph showing the correlation of gas volume versus bag temperature. DETAILED DESCRIPTION OF THE INVENTION

[0213] 2, an apparatus, generally designated 200, is provided according to one embodiment of the present invention. Apparatus 200 includes a housing 202, an inlet port 204, and an outlet port 206. Inlet tubing 208 is shown connected to inlet port 204, and outlet tubing 210 is shown connected to outlet port 206. In this embodiment, a vent port 212 is shown.

[0214] The fluid with the gas bubbles travels along inlet tubing 208 and into device 200 through inlet port 204. The air bubbles entrained in the fluid rise to the top, outermost portion of the device. In this embodiment, the trapped air is then vented from the system through vent port 212. The substantially bubble-free fluid exits device 200 via outlet port 206 and travels away from device 200 along outlet tubing 210.

[0215] While a vent port 212 is present in this embodiment, it should be understood that such a feature is not necessary for the purposes of separating and collecting gas bubbles entrained in the fluid. While the presence of a vent port 212 is a preferred feature, the device 200 of the present invention can operate for some time without a vent port 212. Thus, the present invention is not limited to the inclusion of a vent port 212.

[0216] While inlet tubing 208 and outlet tubing 210 are shown, in this embodiment such tubing is not necessarily an integral part of device 200 itself, but rather refers to typical tubing that might be found in an IV drip setup or the like, thus providing context for how device 200 is used. Although inlet tubing 208 and outlet tubing 210 are described as not being part of device 200, it should be understood that in alternative embodiments inlet tubing 208 and outlet tubing 210 are integrated into the device and form part of device 200 as a whole.

[0217] Referring now to Figure 3, an exploded perspective view of the device is shown. Features similar to those described above are given the same reference numerals. The device 200 includes a housing 202 defining a chamber 302 having an inlet port 204 and an outlet port 206. The device 200 further includes an elongated outlet tube 304, the intake end 306 of which is centrally located within the chamber 302. The discharge end 308 of the elongated outlet tube 304 is shown connected to the outlet port 206. In this example, a vent port 212 is also shown. As before, alternative embodiments may include a device without the vent port 212.

[0218] 4, an exploded view of the components of the device is provided. Features similar to those described above are given the same reference numerals. The device 200 includes a housing 202 that, when assembled, forms a chamber 302. The device 200 further includes an inlet port 204, an outlet port 206, an elongated outlet tube 304 having an inlet end 306 and a discharge end 308, and a diverter 402. The inlet end 306 of the elongated outlet tube 304, when assembled, is centrally located within the chamber 302, and the discharge end 308 of the elongated outlet tube 304 is connected to the outlet port 206.

[0219] Referring now to FIG. 5, a schematic diagram of the device in use is provided. Features similar to those described above are given the same reference numerals. The device 200 includes a housing 202 defining a chamber 302, an inlet port 204, an outlet port 206, and an elongated outlet tube 304 having an inlet end 306 and a removal end 308. In this embodiment, there is provided inlet tubing 208 connected to the inlet port 204 and outlet tubing 210 connected to the outlet port 206. A diverter 402 is shown including a base portion 502 and a rim 504. In this embodiment, the diverter 402 and the inlet port 204 are spaced apart such that the diverter 402 is centrally suspended within the chamber 302 of the device 200. In this embodiment, the diverter 402 and the inlet end 306 of the elongated outlet tube 304 are spaced apart such that no portion of the diverter 402 extends beyond the inlet end 306 of the elongated outlet tube 304.

[0220] In an alternative embodiment, the inlet tubing 208 or the outlet tubing 210 may not be present.

[0221] In an alternative embodiment, the diverter includes at least one tether that secures the diverter to the housing of the chamber and holds it in place.

[0222] In use, fluid arrives into the chamber 302 of the device 200 via the inlet port 204. Gas bubbles are diverted by the diverter 402 away from the elongated outlet tube 304 toward an outer portion of the chamber 302 of the device 200. The fluid arriving into the chamber 302 has a first direction of fluid flow and, upon contact with the diverter 402, a different direction of fluid flow is imparted. The different direction of fluid flow generally follows the contour of the diverter 402, resulting in the fluid, along with any entrained gas therein, being forced toward the outer portion of the chamber 302. When the fluid arriving into the chamber 302 contacts the diverter 402, the fluid velocity is slowed. The slower fluid velocity allows an extended time window during which gas bubbles can move away from the elongated outlet tube 304 toward the outer portion of the chamber 302 of the device. The now substantially bubble-free fluid collects between the diverter 402 and the intake end 306 of the elongated outlet tube 304. It will be appreciated that the substantially bubble-free fluid is centrally located within the chamber 302 and moves slower than the fluid moving along the outer portions of the chamber 302. The substantially bubble-free fluid exits the device 200 through the outlet port 206 and travels away from the device 200 along the outlet tubing 210.

[0223] 6, a schematic diagram of the apparatus is provided, held vertically. Features similar to those described above are given the same reference numerals. The apparatus includes a housing 202 defining a chamber 302 having an inlet port 204, inlet tubing 208 connected to the inlet port 204, a diverter 402 having a base portion 502 and a rim 504, an elongated outlet tube 304 having its intake end 306 centrally positioned within the chamber 302, and outlet tubing 210 connected to the outlet port 206. Substantially bubble-free fluid exits the apparatus 200 through the outlet port 206 and travels away from the apparatus 200 along the outlet tubing 210.

[0224] In this embodiment, the device 200 is held in a substantially vertical plane with the inlet port 204 and inlet tubing 208 located at the lowest portion of the device 200 .

[0225] In this embodiment, the rim 504 of the diverter 402 extends beyond the intake end 306 of the elongated outlet tube 304. Such a design should further ensure that gas bubbles remain directed away from the intake end 306 of the elongated outlet tube 304.

[0226] In use, both the fluid and entrained gas travel upward through the inlet tubing 208 and arrive at the chamber 302 via the inlet port 204, which is located at the bottom of the chamber 302. As the fluid and entrained gas travel upward through the chamber 302, they come into contact with the diverter 402. The diverter 402 interrupts the first direction of flow of the fluid and entrained gas, causing a change in direction of the fluid and entrained gas, diverting the fluid and entrained gas away from their original path (or first direction of flow) and toward the outer portion of the chamber 302. By interrupting the first direction of flow of the fluid and entrained gas, the diverter 402 slows the fluid velocity, and consequently the entrained gas bubbles. This has the effect of changing the external force exerted on the gas bubble film, causing buoyancy to become the dominant force. With buoyancy becoming the dominant force, the entrained gas bubbles travel toward the uppermost outer portion of the chamber 302.

[0227] 7, an apparatus according to another embodiment of the present invention is provided. Features similar to those described above are given the same reference numerals. The apparatus 700 includes a housing 202 defining a chamber 302 having an inlet port 204 and an outlet port 206, an inlet tube 702 having a discharge end 704 centrally located within the chamber 302 and an intake end 706 connected to the inlet port 204, an elongated outlet tube 304 having an intake end 306 centrally located within the chamber 302 and an outlet end 308 connected to the outlet port 206, and a diverter 402 having a base portion 502 and a rim 504.

[0228] In this embodiment, at least a portion of the base portion 502 of the diverter 402 is connected to the outlet end 704 of the inlet tube 702 by a tether 708, and at least a portion of the rim 504 of the diverter 402 is connected to the inlet end 306 of the elongated outlet tube 304 by a tether 708.

[0229] 8, another embodiment of a dual diverter apparatus 800 of the present invention is provided. Similar features to those previously described are given the same reference numerals. The apparatus 800 includes a housing 202 defining a chamber 302 having an inlet port 204 and an outlet port 206, an inlet tube 702 having a discharge end 704 centrally located within the chamber 302 and an intake end 706 connected to the inlet port 204, an elongated outlet tube 304 having an intake end 306 centrally located within the chamber 302 and an outlet end 308 connected to the outlet port 206, and two diverters: a first diverter 402 having a base portion 502 and a rim 504, and a second diverter 802 having a base portion 804 and a rim 806.

[0230] In this embodiment, at least a portion of the base portion 502 of the first diverter 402 is connected to the removal end 704 of the inlet conduit 702 by a tether 708, and at least a portion of the rim 804 of the second diverter 802 is connected to the intake end 306 of the elongate outlet conduit 304 by a tether 708. In this embodiment, the rim 804 of the second diverter 802 extends beyond the intake end 306 of the elongate outlet conduit 304.

[0231] 9, a cross-sectional view of the device is provided. Features similar to those described above are given the same reference numerals. The device includes a housing 202 defining a chamber 302 having an inlet port 204 and an outlet port 206, an inlet conduit 702 having a removal end 704 centrally located within the chamber 302 and an intake end 706 connected to the inlet port 204, an elongated outlet conduit 304 having an intake end 306 centrally located within the chamber 302 and an outlet end 308 connected to the outlet port 206, and a diverter, i.e., a first diverter 402. The diverter 402 defines a compartment within the chamber 302, and the diverter 402 has a base portion 502 and a rim 504. In this embodiment, the removal end 704 of the inlet conduit 702 abuts the base portion 502 of the diverter 402. The rim 504 of the diverter 402 is disposed between the base portion 502 of the diverter 402 and the intake end 306 of the elongated outlet tube 304. In this embodiment, the device further comprises a diffuser. The Equipped with a diffuser The In this embodiment, the diffuser is in the form of a plurality of holes. The The nozzle 302 includes at least three holes 904, 906, 908, the first hole 904 exiting upward into the chamber 302 and the second hole 906 9 exits downward into chamber 302, and a third hole 908 exits directly into chamber 302. Although three holes 904, 906, 908 are shown in this embodiment, this should not be read as limiting the invention in any way. It should be understood that other variations of the invention may have any number of holes.

[0232] In this embodiment, the diverter 402 and the intake end 306 of the elongated outlet tube 304 are spaced apart such that the rim 504 of the diverter 402 does not extend beyond the intake end 306 of the elongated outlet tube 304 .

[0233] In this embodiment, the device extends into the chamber and includes a diffuser. The The inlet pipe 702 is in contact with the diffuser TheIn other words, it abuts against the base portion 502 of the diverter 402 .

[0234] In an alternative embodiment, the rim 504 of the diverter 402 may extend beyond the intake end 306 of the elongated outlet tube 304. Such a design would further ensure that gas bubbles remain directed away from the intake end 306 of the elongated outlet tube 304. Alternative arrangements of the inlet tube 702 are also possible.

[0235] In use, fluid arrives through the inlet port 204 and is diffused The The gas bubbles enter the chamber 302 of the device 900 via the inlet port 204 and through a plurality of holes 904, 906, 908. The gas bubbles are then diverted by the first diverter 402 away from the elongated outlet tube 304 towards an outer portion of the chamber 302 of the device 200. The The fluid arriving at the The As soon as the air passes through the diffuser chamber 302, a different flow direction is imparted. The The subsequent fluid has a first direction of fluid flow and is imparted a different direction of fluid flow upon contact with the first diverter 402. The different direction of fluid flow imparted by the diverter 402 generally follows the contours of the diverter 402, resulting in the fluid, along with any entrained gas therein, being forced towards the outer portions of the chamber 302. TheWhen the trailing fluid contacts the diverter 402, the fluid velocity is slowed. The slowed fluid velocity allows an extended time window during which the gas bubbles can move away from the elongated outlet tube 304 and toward the outer portion of the chamber 302 of the apparatus 200. As the entrained gas in the form of gas bubbles passes through the volume of fluid within the chamber 302, friction on the outer surfaces of the gas bubbles increases, thereby altering their trajectory so that buoyancy becomes the dominant force, propelling the gas bubbles toward the uppermost outer portion of the chamber 302. The now substantially bubble-free fluid collects between the diverter 402 and the intake end 306 of the elongated outlet tube 304. It will be appreciated that the substantially bubble-free fluid is centrally located within the chamber 302 and moves more slowly than the fluid moving along the outer portions of the chamber 302. The substantially bubble-free fluid is then drawn into the intake end 306 of the elongated outlet tube 304 and exits the chamber 302 via the outlet port 206 and away from the device 900 .

[0236] 10, a perspective view of the apparatus according to the embodiment of FIG. 9 is provided. Similar features to those previously described are given the same reference numerals. The apparatus 900 includes an inlet conduit 702 having a discharge end 704 centrally located within the chamber 302 and an intake end 706 connected to the inlet port 204, a diffuser 706, and a filter 708. The , a diverter 402 having a base portion 502 and a rim 504, and an elongated outlet tube 304 having an inlet end 306 and an outlet end 308. The inlet tube 702 is The The diffuser is arranged to abut against a part of the The is disposed so as to abut a portion of the diverter 402.

[0237] In this embodiment, the diffuser The is diffused The The nozzle is in the form of a plurality of holes arranged in a generally radial array at spaced intervals around the periphery of the nozzle.

[0238] In use, the fluid and any gases entrained therein are diffused through the inlet pipe 702. TheThe fluid and entrained gases are diffused The Gas bubbles entrained in the fluid generally diffuse due to their inherent tendency to rise in an upward direction. The The fluid passes through the most upward-facing holes, while the remaining fluid is diffused. The The fluid and entrained gas pass through one or more of the holes. Diffuser , the fluid and entrained gas contact a diverter 402. The diverter 402 interrupts the first direction of flow of the fluid and entrained gas, causing a change in direction of the fluid and entrained gas, diverting the fluid and entrained gas away from their original path (or first direction of flow) in a generally outward direction and away from the intake end 306 of the elongated outlet tube 304. By interrupting the first direction of flow of the fluid and entrained gas, the diverter 402 slows the fluid velocity and, consequently, the entrained gas bubbles. This has the effect of changing the external force exerted on the gas bubble film, causing buoyancy to become the dominant force. With buoyancy becoming the dominant force, the entrained gas bubbles travel in a generally outward and upward direction, away from the intake end 306 of the elongated outlet tube 304.

[0239] Referring now to Figure 11, there is provided an apparatus according to the embodiment of Figure 10, generally designated 900. Features similar to those previously described are given the same reference numerals. The apparatus 1000 includes an inlet pipe 702, a diffuser 704, and a filter 706. The , a diverter 402 having a base portion 502 and a rim 504 , and an elongated outlet tube 304 having an inlet end 306 and a outlet end 308 .

[0240] In FIG. 11A, the inlet pipe 702 is a diffuser with at least one hole. The 708. The diverter 402 is positioned to be connected to a portion of the diverter 402 by a tether 708 forming a

[0241] In FIG. 11B, the inlet pipe 702, the diffuser The , and the diverter 402 are integrated to form at least one hole.

[0242] In FIG. 11C, the inlet pipe 702, the diffuser The , and diverter 402 are integrated to form a number of holes. In this embodiment, three holes are visible.

[0243] Referring now to FIG. 12 , there is provided a device according to another embodiment of the present invention, generally designated 1200. Features similar to those described above are given the same reference numerals. Device 1200 includes a housing 202, an inlet port 204, and an outlet port 206. In this embodiment, the device is shown including a vent port 212 and a foot 1202. Foot 1202 is connected to a portion of housing 202. Foot 1202 can be used to position the otherwise generally spherical device on a substantially flat surface. Alternatively, foot 1202 could be used as a means to secure the device to a surface, such as a patient, a bed, a pillow, or any part of the IV drip setup 100. [Example]

[0244] Example Product Needs Assessment It was determined that more information was needed to fully understand the scale of the problem, assess current limitations in the medical field, and deliver more targeted solutions to aid in product design and development.

[0245] method A brief survey was designed to determine the level of concern and any eventual interest in a solution. Each survey consisted of 10 questions, and staff were asked to select the most appropriate statement from the options. A scale was provided (Figure 13), and an open-ended comment section was also included.

[0246] Fifty questionnaires were distributed throughout the hospital and a sample of 47 were returned completed, with 56% coming from nurses across various departments and the remaining 44% from physicians.

[0247] result A total of 97% of staff said they were somewhat or very concerned about air bubbles in IV lines. 76% of staff removed air bubbles by opening the port and withdrawing some fluid or by manual syringing. A total of 58% of staff said removing air bubbles was more important than how much fluid was lost in the process.

[0248] When asked about concerns about bubble size, 53% of staff were willing to remove bubbles up to 5mm in length. A total of 65% of respondents had witnessed bubbles in a medical emergency situation, with only 16% of staff reporting being able to see all bubbles in a medical emergency.

[0249] Air bubbles were seen in heated procedures (54%) as well as in unheated fluids (44%).

[0250] A total of 89% of respondents said they would sometimes or always use the new bubble trap device to minimize the amount of monitoring required.

[0251] Pediatric care was identified as a high priority.

[0252] conclusion A need exists for a bubble trap that allows for reduced need for constant monitoring, is cost-effective, easy to use (i.e., requires minimal training), reduces attendant waste of fluid materials, can be used in multiple locations, and is suitable for use with a variety of infusion procedures, such as, but not limited to, parenteral nutrition, fluid infusion, and heated IV lines.

[0253] Proof of concept Bubble formation patterns such as coalescence and pocketing were observed depending on the line placement, height, orientation, and volume of developed gas. The role of temperature and flow rate was adjusted to identify the role each plays in bubble formation in IV lines.

[0254] A typical IV setup was set up to observe the behavior of bubbles within the tubing under various conditions. Fluid was infused through the tubing at various different flow rates and temperatures, and observations of bubble formation were made, including size / volume, location, regularity, behavior including retention and shedding, coalescence, and other significant behaviors.

[0255] Figure 14 shows a typical bubble formation pattern and observable characteristics in IV tubing. A large bubble (A = 8 mm) is shown moving in the direction of flow. Bubbles (B = 1 mm) and (C = 2 mm) are smaller in size and are observed to remain in fixed positions on the interior wall of the tubing at the indicated location [pane 1]. The smaller bubbles (B) and (C) are captured by the larger bubble (A) and are pushed under the force at the leading edge of the larger bubble (A) [pane 2]. The structure of bubbles (B) and (C) is initially maintained. Further along the tubing, the bubbles coalesce into a single bubble (ABC = 11 mm) [pane 3]. Measurements taken note that the volume of the combined bubble (ABC) now increases. As observed, large or small bubbles of gas naturally formed within the IV tubing, or equivalent or larger bubbles moved within the fluid flow of the IV tubing, collecting smaller bubbles. It was also observed (not shown) that smaller bubbles also moved freely within the fluid flow and did not always stick to the tubing, although the smaller bubbles observed very often tended to stick to the interior tubing surface. These were dislodged by flicking or moving the tubing and by the larger bubbles. It was concluded that larger bubbles were more easily pushed along by the fluid flow.

[0256] The resulting data was further analyzed by plotting the relationship between the variables. In Figure 15, the gas volume is shown graphically (as boxes) relative to the temperature of the liquid at the starting point. A polynomial fit curve was formed for the data, resulting in a degree 3 shape with two peaks or valleys. This suggests that, in general, the direction of the gas volume data points appears to trend upward as the temperature decreases. The resulting reliability factor, "R", which measures the reliability factor between x and y values, was calculated. 2 " is shown to be 0.858, which is close to 1, suggesting that the value has a high level of linearity confidence. This is consistent with the temperature-volume effect witnessed in the experiment, where the gas level increases as the temperature of the liquid increases.

[0257] The flow rate versus gas volume line (diamond) in Figure 15 graphically appears very irregular due to an inconsistent scattering of values. The fitted curve on this graph exhibits a hill-like shape with rising and falling slopes, i.e., a degree-2 polynomial. The resulting confidence value is 0.087, which indicates that the data is unreliable, meaning that it is not a reliable prediction based on the linear relationship y=mx+c. This follows the trend shown during testing, where it was determined that the volume of gas developed with flow rate does not have an easily predictable pattern.

[0258] FIG. 15 shows the gas volume as a function of temperature (square dots) and flow rate (diamond dots).

[0259] Figure 16 shows the correlation between gas volume (dark grey; spots) and bag temperature (light grey; hatched lines).

[0260] The highest gas volume generated in these experiments (2.4 mls / 1000 mls) is important for reliably determining the volumetric requirements of the device to capture gas from the line. This information helps validate the time allotted for the experimental phase.

[0261] Prototype Prototypes of various divertor designs were fabricated using standard 3D printing techniques. These resulting prototypes were then subjected to a variety of tests designed to determine the suitability of the prototype designs, i.e., their reliability and ease of use.

[0262] 360 Orientation Test A product needs assessment determined that the bubble trap must operate effectively through a full range of orientations and movements due to the routine movement of IV lines during various procedures. Thus, the prototype was tested in all orientations through 360 degrees and demonstrated the ability to retain gas far in excess of the maximum degassing volume suggested through experimentation.

[0263] Because the incidence of degassing in a heated system is more prevalent than that observed in a non-heated system, volumetric degassing capacity studies were performed using heated fluids.

[0264] A maximum level was determined from the test, whereby a mean reading was calculated using a maximum reading of 2.4 ml / 1000 ml with a built-in factor of 5X, allowing for a gas volume of at least 15 ml for safety reasons. Thus, the device can collect up to 15 mls of gas before the gas level reaches a level where the device no longer functions effectively, and before the gas level reaches the elongated outlet tube. This means that up to five fluid bags can be infused simultaneously at the maximum degassing level.

[0265] Depending on the procedure, recommended gas levels vary from zero (e.g., in pediatrics, gas is undesirable due to the small blood volume and congenital "holes in the heart" seen in infants) to 3 ml / kg body weight in healthy adults (tests have been performed on animals), with potentially adverse effects from as little as 1 ml / kg of insufflated air. Conflicting reports abound, and it is generally accepted that under ideal conditions the body can tolerate some gas (assuming no underlying disease), but that gas should not be introduced into any patient if possible. Recent studies have suggested that preventing gas bubbles from entering the venous system is due to damage to the endothelial glycocalyx layer of the vasculature.

[0266] method The tap on the IV line is closed and the hot line L1 is left off throughout the experiment to avoid unnecessary gas generation that could interfere with the experiment. An IV drip bag is hung from the top of the IV stand and connected to the IV line. The prototype to be tested is connected to the end of the lumen line closest to the patient, and an extension line is connected to the other end of the prototype. A Clave connector is then attached to the gas extraction port. Lines at 45, 90, 180, 225, 270, 315, and 360 degrees are drawn on a piece of paper and the paper is attached to a flat, vertical surface. A plastic container is filled with water. A small measuring cylinder is filled with water and an attachment is used to ensure the measuring cylinder is connected to the plastic container. The end of the extension line is placed into the graduated cylinder, which is then quickly inverted into the plastic container without escaping any liquid. The graduated cylinder attachment rests completely on the container's rim, ensuring the cylinder remains vertical throughout the experiment. The initial gas reading (zero) is taken and recorded in the inverted graduated cylinder. The tap is then turned on to allow liquid to flow from the bag, ensuring the liquid is at its maximum possible flow rate. Gas trapped in the chamber of the prototype being tested is removed using a syringe inserted through the Clave connector. Once all gas has been extracted, the prototype section of the line is attached to a flat, vertical surface, parallel to the 45-degree angle line previously drawn on paper. A syringe is filled with 1 ml of air and injected into the IV line adjacent to hotline L1, resulting in gas flow toward the prototype. Gas is observed passing through the prototype and into the extension line, and the value of the gas collected in the graduated cylinder is recorded. If no gas is observed, a value of 0 is recorded. The experiment is repeated increasing the volume of air in 1 ml increments up to 20 ml, and then for each of the following angles: 90 degrees, 180 degrees, 225 degrees, 270 degrees, 315 degrees, and 360 degrees.

[0267] The terms "comprise" and "include" and any variations thereof required for grammatical reasons are to be considered interchangeable and are to be given the broadest possible interpretation.

[0268] It should be understood that components shown in any of the figures are not necessarily drawn to scale, and that like parts shown in several figures are represented by the same reference numerals.

[0269] It should be further understood that features from any of the embodiments may be combined with alternative described embodiments, and that such combinations, even if not explicitly described above, are technically feasible by those skilled in the art. The invention is not limited to the above-described embodiments, which may vary in both structure and details.

[0270] Although the invention is described in the context of use in an IV drip setup, the device of the present invention may be adapted for use in other applications, such as, but not limited to, blood transfusion devices or any other fluid therapy setup where entrained gases require removal, capture, or evacuation. [Aspect 1] 1. An apparatus suitable for separating and collecting gas bubbles entrained in a fluid, said apparatus comprising: a housing defining at least one chamber having an inlet port and an outlet port; a diverter disposed between the inlet port and the outlet port; an elongated outlet tube having an intake end and an export end; The apparatus wherein the intake end of the elongated outlet tube is centrally located within the chamber and the removal end of the elongated outlet tube is connected to the outlet port of the chamber. [Aspect 2] 10. The device of claim 1, The diverter includes a base portion and a rim. Aspect 3 In the device of aspect 2, The apparatus, wherein the diverter defines a compartment. Aspect 4 In the device according to aspect 2 or aspect 3, the intake end of the elongated outlet tube is centrally located within the compartment of the diverter. Aspect 5 The device according to any one of aspects 2 to 4, the rim of the diverter extending beyond the intake end of the elongated outlet tube. Aspect 6 In the device according to any one of the above aspects, The device includes a diffuser. Aspect 7 In the device according to any one of the above aspects, The apparatus, wherein the diverter has a rounded contour. Aspect 8 In the device according to any one of the above aspects, The device comprises at least one interior surface, a portion of the at least one interior surface comprising a surface treatment. Aspect 9 9. The device of claim 8, The apparatus, wherein the surface treatment is suitable for controlling bubbles and bubble movement within the chamber. Aspect 10 In the device according to any one of the above aspects, The apparatus includes an elongated inlet tube having an inlet end and an outlet end, the outlet end being centrally located within the chamber. Aspect 11 10. The device of claim 6, wherein: a portion of the elongated inlet pipe abutting the diverter. Aspect 12 1. An apparatus comprising: a housing defining at least one chamber having an inlet port and an outlet port; a diffuser. Aspect 13 13. The apparatus of claim 12, The apparatus is suitable for separating and collecting gas bubbles entrained in a fluid. Aspect 14 In the device according to aspect 12 or aspect 13, The apparatus, wherein the diffuser comprises a plurality of holes, the plurality of holes being spaced apart around a circumference of the diffuser in a generally radial array. Aspect 15 1. An apparatus comprising: a housing defining at least one chamber having an inlet port and an outlet port; An apparatus comprising: at least one interior surface, a portion of which comprises a surface treatment. Aspect 16 16. The apparatus of claim 15, The apparatus, wherein the surface treatment is suitable for controlling bubbles and bubble movement within the chamber. Aspect 17

[0033] In the device of aspect 15 or aspect 16, The apparatus, wherein the surface treatment promotes adhesion of the bubbles to the portion of the at least one interior surface having the surface treatment. Aspect 18 The device of any one of Aspects 15 to 16, the surface treatment promotes the release of the bubbles from the treated surface; As a result, in use, the bubbles become free-floating bubbles within the volume of fluid present in the chamber. Aspect 19 The device of any one of Aspects 15 to 16, the portion of the at least one interior surface comprises a plurality of surface treatments, each surface treatment selectively attaching the air bubble to or detaching the air bubble from the portion of the at least one interior surface comprising the surface treatment, and each of the surface treatments can be independently selected to attach or detach the air bubble from one another. Aspect 20 The apparatus of any one of aspects 15 to 18, wherein the at least one internal surface is a diverter. Aspect 21 1. An apparatus comprising: a housing defining at least one chamber having an inlet port and an outlet port; a selectively permeable membrane. Aspect 22 1. An apparatus comprising: a housing defining at least one chamber having an inlet port and an outlet port; A device comprising: Aspect 23 In the device according to any one of the above aspects, The device comprises at least one vent port adapted to purge trapped gas bubbles from the device. Aspect 24 24. The apparatus of claim 23, the vent port is coupled to a release means, the release means being operable to move between a closed position and an open position; As a result, in use, when the release means is in the open position, the trapped gas is purged from the chamber of the device through the vent port. Aspect 25 25. The apparatus of claim 24, The device, wherein the releasing means is automated. Aspect 26 24. The apparatus of claim 23, the vent port comprises a gas-permeable, water-impermeable membrane; As a result, in use, trapped gas crosses the gas-permeable / water-impermeable membrane and is purged from the chamber, while water remains within the chamber of the device. Aspect 27 In the device according to any one of the above aspects, The chamber is spherical. Aspect 28 In the device according to any one of the above aspects, The device is disposed in a circuit. Aspect 29 In the device according to any one of the above aspects, The apparatus comprises a plurality of chambers arranged in series. Aspect 30 In an intravenous line kit, the kit comprises: at least one intravenous infusion bag; at least one drip tube; at least one supply tube having a proximal end and a distal end; Bubble trap and a fluid flow control means; at least one clamp; a cannula; An intravenous line kit, wherein the bubble trap comprises the device described in any one of aspects 1 to 29. [Explanation of symbols]

[0271] 100 Intravenous (IV) Infusion Setups 102 IV Pole 104 Primary IV Bag 106 Extender 108 Injection port 110 Primary IV tubing 112 Sterile Spike 114 Drip tube 116 Check valve Ports 118 and 120 122 Slider Clamp 124 Roller clamp 126 Extension pipe material 128 Lure Lock 130 Cannula 132 Clamp 134 Secondary IV Bag 136 Hook 138 Secondary injection port 140 Sterile Spike 142 Drip tube 144 Secondary pipe material 200 equipment 202 Housing 204 Inlet Port 206 Exit Port 208 Inlet pipe material 210 Outlet pipe material 212 Ventilation port 302 Chamber 304 Long and thin outlet pipe 306 Intake end 308 Extraction end 402 Diverter 502 base 504 Rim 700 equipment 702 Inflow pipe 704 Output end 706 Intake end 708 Tether 800 equipment 802 Second Diverter 804 base part 806 Rim 900 units Place 9 04, 906, 908 holes 1000 devices 1200 equipment 1202 Foot

Claims

1. 1. An intravenous line bubble trap device suitable for separating and collecting gas bubbles entrained in a fluid, said intravenous line bubble trap device comprising: a housing defining at least one chamber having an inlet port and an outlet port; an elongated inlet pipe (702) having an inlet end and an outlet end, the elongated inlet pipe (702) being integral with a diffuser and having a plurality of holes therein, the holes being spaced apart around the circumference of the inlet pipe in a generally radial array; a diverter disposed between the inlet port and the outlet port; an elongated outlet tube having an intake end and an export end; the intake end of the elongated outlet tube is centrally located within the chamber and the discharge end of the elongated outlet tube is connected to the outlet port of the chamber; the intravenous line bubble trap device further comprising at least one vent port adapted to purge trapped gas bubbles from the device; the vent port comprises a gas-permeable, water-impermeable membrane; As a result, in use, trapped gas crosses the gas-permeable, water-impermeable membrane and is purged from the chamber while water remains within the chamber.

2. 10. The intravenous line bubble trap device of claim 1, The diverter includes a base portion and a rim.

3. 3. The intravenous line bubble trap device of claim 2, The diverter defines a compartment.

4. The intravenous line bubble trap device according to any one of claims 1 to 3, The diverter has a rounded contour.

5. The intravenous line bubble trap device according to any one of claims 1 to 4, the intravenous line bubble trap device comprises at least one interior surface; a portion of the at least one interior surface comprising a surface treatment; An intravenous line bubble trap device, wherein the surface treatment is suitable for controlling air bubbles and bubble movement within the chamber.

6. 6. The intravenous line bubble trap device of claim 5, an intravenous line bubble trap device, wherein a portion of the elongated inflow tube abuts the diverter;

7. 7. The intravenous line bubble trap device according to claim 5 or 6, An intravenous line bubble trap device, wherein the surface treatment promotes adhesion of the air bubbles to the portion of the at least one interior surface having the surface treatment.

8. The intravenous line bubble trap device according to any one of claims 5 to 7, the surface treatment promotes the release of the bubbles from the surface; As a result, in use, the air bubbles become free-floating bubbles within the volume of fluid present in the chamber.

9. The intravenous line bubble trap device according to any one of claims 5 to 8, The portion of the at least one interior surface is provided with a plurality of surface treatments, each surface treatment selectively attaching the air bubble to or detaching the air bubble from the portion of the at least one interior surface having the surface treatment, and each of the surface treatments can be independently selected to attach or detach the air bubble from each other.

10. 10. The intravenous line bubble trap device of any one of claims 5 to 9, wherein the at least one interior surface is a diverter.

11. The intravenous line bubble trap device according to any one of claims 1 to 10, The vent port is coupled to a release means.

12. 12. The intravenous line bubble trap device of claim 11, An intravenous line bubble trap device, wherein said release means is automated.

13. 13. The intravenous line bubble trap device according to any one of claims 1 to 12, The chamber is spherical.

14. 14. The intravenous line bubble trap device according to any one of claims 1 to 13, The device is disposed within the circuit, an intravenous line bubble trap device.

15. 15. The intravenous line bubble trap device according to any one of claims 1 to 14, The intravenous line bubble trap device comprises a plurality of chambers arranged in series.

16. In an intravenous line kit, the intravenous line kit comprises: at least one intravenous bag; at least one drip tube; at least one supply tube having a proximal end and a distal end; Bubble trap and a fluid flow control means; at least one clamp; a cannula; 16. An intravenous line kit, wherein the bubble trap comprises an intravenous line bubble trap device according to any one of claims 1 to 15.

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