Patent Description:
Intravenous (IV) infusion sets typically include several components each having a core function, such as drip chambers, roller clamps, pinch clamps, filters and check valves. These components are typically coupled to each other by lengths of IV tubing to provide a complete IV infusion set that is packaged as a ready to use disposable IV set. Such an IV infusion set has a significant number of IV tubing connections, which provides a correspondingly increased risk of connection leakage as the number of IV tubing connections grows larger. Each separate component also provides a different interface point to a user. These factors lead to higher manufacturing complexity and costs. <CIT> discloses a metering apparatus and system for controlling the administration of intravenous fluids (IV) having a flow passage within a housing connectable to a source of IV fluid and to a delivery tube terminating at an administration needle. In the metering apparatus, a metering pin is axially moveable within the passage and relative to a valve seat and defines a flow passageway and a variable area flow notch which are positionable relative to the valve seat to regulate flow from a purge to a flow blocking position. In the preferred embodiment, positioning of the metering pin is accomplished by a cam engaging a portion of the pin forming a cam follower. The cam is manually adjustable by a dial on the device to accomplish accurate, repeatable and continuous flow adjustment over the full range. The system incorporates the metering apparatus, a source of IV fluid, a drip chamber and administration means. <CIT> discloses a fluid flow rate control device, especially adapted for controlling the flow of IV fluid to a patient, comprising a first vented fluid chamber having an upper fluid inlet end with a hollow spike which enables fluid connection with a conventional fluid container. A free floating float valve in the first chamber blocks the flow of fluid into the first chamber from the fluid container according to whether or not the fluid level in the first chamber is at a preestablished fluid level, thereby providing a constant pressure head regardless of fluid level in the fluid container. A lower end of the first chamber is connected, through a flow regulator, such as a screw-type valve, to an upper inlet end of a second, vented, drip chamber, the lower end of which is adapted for connection to a discharge tube, such as an IV tube. A second, free floating float valve in the second chamber blocks the flow of fluid from the second chamber into the discharge tube when the fluid level in the second chamber is at or below a preestablished minimum level and blocks flow of fluid into the second chamber when the fluid level in the second chamber reaches a preestablished maximum level. A first variation fluid flow control device is disclosed in which the first an second chambers are arranged in a side-by side configuration and a second variation fluid flow control device is disclosed in which fluid flow through the device is controlled in response to relative rotation between axially-aligned upper and lower shell segments of the device. <CIT> discloses a flow rate selection valve including a gate cylinder having a gate cylinder rotational axis and having at least two flow rate determining passageways and passing laterally through the gate cylinder at orientations angularly displaced from each other and having cylinder rotation structure; and a valve housing containing a flow passageway and having a cylinder receiving bore intersecting the flow passageway into which the gate cylinder is rotatably and sealingly mounted, the gate cylinder dividing the flow passageway into a passageway inlet end and a passageway outlet end, the flow passageway containing a passageway registration barrier extending across the flow passageway and sealingly abutting the gate cylinder and having several flow ports with different minimum diameters, each flow port positioned to register with one of the flow rate determining passageway.

It is desirable to provide a modular IV assembly that combines many IV component core functions into one device, thus reducing manufacturing complexity and costs, as well as improving usability by the user.

The present disclosure provides modular IV assemblies that combine core functions of several IV infusion set components.

In one or more embodiments, a modular intravenous (IV) assembly is provided. The modular IV assembly includes a drip chamber having a body and an inlet connector. The modular IV assembly also includes a base housing coupled directly to a base portion of the drip chamber, the base housing having an inlet port in fluid connection with the drip chamber and a flow path cavity in fluid connection with the inlet port. The modular IV assembly further includes a flow control assembly coupled directly to a first portion of the base housing. The flow control assembly includes a roller housing, a roller and a flow control membrane disposed between the roller and the flow path cavity in the base housing.

In one or more examples, the flow path cavity comprises a first flow area having a constant width and a varying depth, and a second flow area having a varying width and a constant depth. In one or more aspects, the flow control assembly is configured to prevent fluid flow through the base housing when the roller is engaged with the flow control membrane adjacent to a start position of the first flow area. In one or more aspects, the flow control assembly is configured to provide full fluid flow through the base housing when the roller is engaged with the flow control membrane adjacent to an end portion of the second flow area. In one or more aspects, the flow control assembly is configured to provide increasing fluid flow through the base housing as the roller engaged with the flow control membrane moves from an end portion of the second flow area.

In one or more aspects, a filter assembly is coupled directly to a second portion of the base housing. In one or more aspects, the first and second portions are on opposing surfaces of the base housing. In one or more aspects, the filter assembly includes a filter housing coupled directly to the second portion of the base housing and a filter membrane disposed between the filter housing and the second portion of the base housing. In one or more aspects, the filter membrane comprises a hydrophilic material that prevents gas from passing through the filter membrane when the filter membrane is wetted. In one or more aspects, a first surface of the filter membrane is disposed adjacently at a distance from an inner surface of the second portion of the base housing, and wherein a space between the inner surface of the second portion and the first surface of the filter membrane is configured to provide a flow path for fluid entering the second portion of the base housing from the flow control assembly. In one or more aspects, a second surface of the filter membrane is disposed adjacently at a distance from an inner surface of the filter housing, and wherein a space between the inner surface of the filter housing and the second surface of the filter membrane is configured to provide a flow path for fluid passing through the filter membrane.

In one or more aspects, an anti-run dry member including one of an individual layer disposed on the filter membrane and an integrally formed material comprising the filter membrane is included. In one or more aspects, a filter housing coupled directly to the second portion of the base housing, a fluid exit housing coupled directly to the filter housing and a one-way check valve disposed between an exit cavity in an outer surface of the filter housing and the fluid exit housing, the check valve configured to allow fluid to flow out from the exit cavity through an exit port in the fluid exit housing while preventing fluid from flowing in the opposing direction into the exit cavity. In one or more aspects, the fluid exit housing, the check valve and the exit cavity are disposed at a top portion of the base housing adjacent to the drip chamber. In one or more aspects, the fluid exit housing, the check valve and the exit cavity are disposed at a bottom portion of the base housing.

In one or more aspects, an air vent assembly is coupled directly to a second portion of the base housing, wherein the first and second portions are on opposing surfaces of the base housing, the air vent assembly including a vent cavity disposed in the second portion of the base housing, a vent port disposed in the vent cavity, the vent port coupled to an air flow path in the base housing and an air vent membrane disposed in the vent cavity. In one or more aspects, the air vent membrane comprises a small pore hydrophobic material that prevents liquid from passing through the air vent membrane into the vent port while allowing gas to pass through the air vent membrane and vent out through the vent port. In one or more aspects, the drip chamber includes a self-leveling assembly having a bottom housing portion disposed at the base portion of the drip chamber and adjacent to the base housing, a leveling outlet port aligned with the inlet port in the base housing, first and second leveling inlet ports disposed adjacent opposing sides of the leveling outlet port and a barrier disposed within the first leveling inlet port.

In one or more embodiments, an intravenous (IV) set is provided. The IV set includes a modular IV assembly having a drip chamber with a body and an inlet connector, a base housing coupled directly to a base portion of the drip chamber, the base housing having an inlet port in fluid connection with the drip chamber and a flow path cavity in fluid connection with the inlet port and a flow control assembly coupled directly to a first portion of the base housing, the flow control assembly including a roller housing, a roller and a flow control membrane disposed between the roller and the flow path cavity in the base housing. The IV set also includes a fluid container coupled to the inlet connector of the drip chamber by a first IV tube. The IV set further includes a fluid delivery member coupled to the modular IV assembly by a second IV tube.

In one or more examples, a method of delivering a medical fluid is provided. The method includes coupling a fluid container to a modular intravenous (IV) assembly with a first IV tube, the modular IV assembly including a drip chamber having a body and an inlet connector, a base housing coupled directly to a base portion of the drip chamber, the base housing having an inlet port in fluid connection with the drip chamber and a flow path cavity in fluid connection with the inlet port and a flow control assembly coupled directly to a first portion of the base housing, the flow control assembly including a roller housing, a roller and a flow control membrane disposed between the roller and the flow path cavity in the base housing. The method also includes coupling a fluid delivery member to the modular IV assembly with a second IV tube. The method further includes adjusting a fluid flow rate from the modular IV assembly to the fluid delivery member by moving the roller in the flow control assembly.

Additional features and advantages of the disclosure will be set forth in the description below and, in part, will be apparent from the description or may be learned by practice of the disclosure. The objectives and other advantages of the disclosure will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the disclosure as claimed.

The accompanying drawings, which are included to provide further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the description serve to explain the principles of the disclosure.

Accordingly, dimensions are provided in regard to certain aspects as non-limiting examples.

IV infusion sets may be formed from any combination of infusion components and tubing. Typically, the infusion components and tubing are disposable products that are used once and then discarded. The infusion components and tubing may be formed from any suitable material (e.g., plastic, silicone, rubber). An issue in manufacturing IV infusion sets is joining multiple tubing and the infusion components to obtain secure leak free joints with desired fluid flow. An issue in using IV infusion sets is that having many separate components provides many interface points to a user.

As shown in <FIG>, a typical infusion set <NUM> may include a drip chamber <NUM>, a check valve <NUM>, a roller clamp <NUM> and Y-junctions <NUM>, all connected together by tubing <NUM>. A typical infusion set <NUM> can include additional infusion components (e.g., pinch clamps, filters) and can be formed of any combination of components and the tubing <NUM>.

According to some aspects of the disclosure, a modular IV assembly combines IV component core functions into one device, thus reducing the number of tubing connections required for an IV infusion set. According to some aspects of the disclosure, the modular IV assembly provides a design architecture that can be more easily automated than a convention IV infusion set.

According to some aspects of the disclosure, the modular IV assembly provides a design architecture that easily provides for substitutions and replacements of core function elements during the manufacturing process. According to some aspects of the disclosure, the modular IV assembly provides a single interface point to the user.

A modular IV assembly <NUM> is shown in <FIG>, according to some aspects of the disclosure. The modular IV assembly <NUM> includes a drip chamber <NUM>, a flow control assembly <NUM>, a filter assembly <NUM>, an air vent assembly <NUM> (e.g., for a fluid path), an anti-run dry (ARD) member <NUM> and a check valve <NUM>. Thus, the modular IV assembly provides one device that includes many different features, such as anti-run dry fluid flow, drop visibility, flow control, fluid filtering, air venting (e.g., line de-bubbling) and flow direction control from the check valve. The modular IV assembly <NUM> may have a large area below the drip chamber <NUM>, thus providing an area for a user to grip easily.

The drip chamber <NUM> has a body <NUM> formed of a material suitable for use in infusion procedures. For example, the body <NUM> may be formed of a hard plastic that is not squeezable and thus also has an auto prime function. As another example, the body <NUM> may be formed of a flexible plastic that is squeezable and thus does not require an auto prime function. The body <NUM> may be transparent to provide drip visibility from the fluid entering the drip chamber <NUM>. The drip chamber <NUM> is coupled to a base housing <NUM>. For example, the body <NUM> may be an elongated cylinder having a base portion <NUM> that is coupled to a drip chamber coupling portion <NUM> of the base housing <NUM>. The drip chamber coupling portion <NUM> includes an inlet port <NUM> that provides a fluid pathway from the drip chamber <NUM> into the base housing <NUM> (see <FIG>). Any size and shape is contemplated for the drip chamber <NUM> and correspondingly the drip chamber coupling portion <NUM>. An inlet connector <NUM> is coupled to the body <NUM>. The inlet connector <NUM> may be configured to receive an IV tube from a fluid source (e.g., IV bag), for example. As another example, the inlet connector <NUM> may be configured to connect directly to an IV fluid container (e.g., bag, bottle) via a spike connection.

The flow control assembly <NUM> is coupled to the base housing <NUM>. The flow control assembly <NUM> includes a roller housing <NUM>, a roller <NUM>, and a flow control membrane <NUM>. The roller housing <NUM> is sized and shaped to couple with the base housing <NUM>. The roller <NUM> is movably coupled to the roller housing <NUM>. For example, axles <NUM> of the roller <NUM> may be received within channels <NUM> disposed on opposing walls of the roller housing <NUM>, where the axles <NUM> move axially along the channels <NUM> when the roller <NUM> is moved. The flow control membrane <NUM> is sized and shaped to be received within the base housing <NUM>. The flow control membrane <NUM> may be formed of a flexible material (e.g., elastomer), such that flow control membrane <NUM> may flex into a fluid flow path <NUM> when the roller <NUM> engages the flow control membrane <NUM>. In some aspects of the disclosure, the flow control assembly may include a different control member than the roller <NUM>, such as a lever, a slider or a knob, for example.

As shown in <FIG>, the base housing <NUM> may be formed of a hard plastic, where the fluid flow path <NUM> is formed by a cavity <NUM> disposed within a surface of the base housing <NUM>. The cavity <NUM> may vary in both width and depth to provide different fluid flow rates based on the position of the roller <NUM>. For example, the cavity <NUM> shown in <FIG> has a first section 174a having a length L1 of <NUM> and a width A of <NUM>, and a second section 174b having a length L2 of <NUM> and a width C of <NUM>. The depth of first section 174a increases from zero at one end to depth B of <NUM> at the other end. The depth of the second section 174b is a constant depth B of <NUM>. Any of the widths A and C, depth B and lengths L1 and L2 may be independently varied to tune the cavity <NUM>, and therefore the fluid flow path <NUM>, for a specific flow profile.

As shown in <FIG>, the portion of the roller <NUM> that engages the flow control membrane <NUM> causes the flow control membrane <NUM> to flex into the cavity <NUM>, which blocks the fluid flow path <NUM> to varying degrees based on the position of the engaged portion of the roller <NUM> over the cavity <NUM>. <FIG> shows a graph <NUM> depicting the variation in flow area over the travel length of the roller <NUM> based on the above described values for A, B, C, L1 and L2. The flow area under the portion of the roller <NUM> that engages the flow control membrane <NUM> corresponds to a resulting fluid flow rate through the cavity <NUM>, with the largest flow area providing a greater fluid flow rate and the smallest flow area providing a lesser fluid flow rate.

For example, when the roller <NUM> is positioned at the end of L1 with a depth of zero, the flow area is zero and the fluid flow path <NUM> is completely occluded (e.g., no fluid flow through the fluid flow path <NUM>). When the roller <NUM> is positioned at the junction of the second end of L1 and the first end of L2, the fluid flow area is <NUM><NUM> and the fluid flow path <NUM> is partially occluded, thus providing for a <NUM>% fluid flow rate. When the roller <NUM> is positioned at the second end of L2, the fluid flow area is <NUM><NUM> and the fluid flow path <NUM> is not occluded, thus providing for a <NUM>% fluid flow rate (e.g., full open). As shown in <FIG>, the first portion of the graph corresponding to the roller <NUM> engagement along length L1 indicates a fine adjustment portion of the flow control assembly <NUM>, while the portion of the graph corresponding to the roller <NUM> engagement along the length L2 indicates a gross adjustment portion of the flow control assembly <NUM>. According to some aspects of the disclosure, any number of flow variation areas may be provided, such as three or more, for example. Thus, there may be correspondingly more cavity sections than the first and second sections 174a, 174b, such as three or more cavity sections, for example.

Since the drip chamber <NUM> is coupled directly to the base housing <NUM>, no IV tubing is necessary to link the drip chamber to the flow control assembly <NUM>, as opposed to the infusion set <NUM> shown in <FIG> for which the drip chamber <NUM> and the roller clamp <NUM> are each coupled within the infusion set <NUM> via tubing <NUM>. Further, since the flow control assembly <NUM> does not include or engage with flexible IV tubing, the fluid flow rate can be consistently provided and maintained through the life of the modular IV assembly <NUM>. For example, the hard plastic of the base housing <NUM> does not deform (e.g., drift) over time. By contrast, a typical roller clamp <NUM> involves restricting fluid flow within soft, flexible tubing <NUM> by deforming the tubing <NUM>, and the tubing <NUM> tends to relax (e.g., lose its resilience) over time, which makes it increasingly difficult to precisely control the fluid flow rate over time. Accordingly, the flow control assembly <NUM> is configured to provide consistent and precise control of the fluid flow rate through the modular IV assembly <NUM>.

As shown in <FIG>, the base housing <NUM> is also configured to couple with a filter assembly <NUM> on an opposing side of the base housing <NUM> from the flow control assembly <NUM>. The filter assembly <NUM> includes a filter housing <NUM> that engages and traps a filter membrane <NUM> against the base housing <NUM>. The filter membrane <NUM> is formed from a hydrophilic material that prevents air from passing through the filter membrane <NUM> once the filter membrane <NUM> is wetted. Thus, only liquid may pass through the filter membrane <NUM> from the base housing <NUM>. The filter membrane <NUM> material may be designed or chosen for specific filtering properties in order to filter out particular elements from the fluid passing through the filter assembly <NUM>. For example, the filter membrane <NUM> may be formed to filter out particles larger than a particular size (e.g., <NUM>, <NUM>, <NUM>, <NUM>).

The base housing <NUM> also includes a portion on the same side as the filter assembly <NUM> on which the air vent assembly <NUM> is disposed. The air vent assembly <NUM> includes vent ports <NUM> in a vent cavity <NUM> in the base housing <NUM> and an air vent membrane <NUM> disposed in the vent cavity <NUM> over the vent ports <NUM>. The air vent membrane <NUM> is formed from a small pore hydrophobic material that prevents liquid from passing through the air vent membrane <NUM> while allowing gas (e.g., air) to vent out of the fluid flow path <NUM> through the vent ports <NUM> (e.g., back into the drip chamber <NUM>).

The ARD member <NUM> is shown in <FIG> as being integral with the filter membrane <NUM>. For example, the filter membrane <NUM> material may be designed or chosen to provide ARD features as well as filtering features. In some aspects of the disclosure, the ARD member <NUM> may be an ARD material and the filter membrane <NUM> may be a different filtering material combined together (e.g., separate layers, integrally formed) into one membrane with both filtering and ARD properties.

As shown in <FIG>, the check valve <NUM> is disposed between an exit cavity <NUM> on the outer surface of the filter housing <NUM> and a fluid exit housing <NUM>. The check valve <NUM> may be formed from a flexible material and act as a one-way valve that allows fluid to flow from a fluid port <NUM> in the exit cavity <NUM> out through an exit port <NUM> in the fluid exit housing <NUM>, while preventing fluid flow in the opposing direction from the exit port <NUM> to the fluid port <NUM>. The fluid exit housing <NUM> also includes an outlet port <NUM> configured to be coupled to IV tubing, such as IV tubing connected to an infusion pump or a catheter, for example. The check valve <NUM> and fluid exit housing <NUM> may be disposed at the top end of the base housing <NUM> as shown in <FIG>, or at the bottom or base portion of the base housing <NUM> as shown in <FIG>.

In operation, as shown in <FIG>, the modular IV assembly <NUM> provides a fluid flow path <NUM> that begins upon entry of fluid from the drip chamber <NUM> and ends upon exit of fluid from the exit port <NUM>. The fluid flow path <NUM> includes flow of fluid through the flow control assembly <NUM> at a flow rate set by the position of the roller <NUM> in relation to the cavity <NUM>. The fluid exits the cavity <NUM> and flows into contact with the filter membrane <NUM> and ARD member <NUM>. The fluid is filtered through the filter membrane <NUM> and exits into the filter housing <NUM> and out through the fluid port <NUM>. The fluid then flows past and/or through the check valve <NUM> and out through the exit port <NUM> to the outlet port <NUM>. Since air trapped in the fluid cannot pass through the filter membrane <NUM>, the air instead passes through the air vent membrane <NUM> into the vent ports <NUM> and out of the base housing <NUM> portion of the modular IV assembly <NUM>.

As shown in <FIG>, the modular IV assembly <NUM> may be configured to include any or all of the above described components while maintaining the same or similar outward package and appearance. For example, <FIG> depicts a base modular IV assembly <NUM> including the drip chamber <NUM> and the flow control assembly <NUM> only, with no filter assembly <NUM>, air vent assembly <NUM>, ARD member <NUM> or check valve <NUM>. Here, fluid flows into the base housing <NUM> from the drip chamber <NUM> and flows out the outlet port <NUM> at a flow rate set by the flow control assembly <NUM>. <FIG> depicts a more integrated modular IV assembly <NUM> by adding the check valve <NUM> to the base modular IV assembly <NUM> shown in <FIG>. Similarly, <FIG> depicts an even more integrated modular IV assembly <NUM> by adding a filter membrane <NUM> and an ARD member <NUM> to the modular IV assembly <NUM> shown in <FIG>. The air vent membrane <NUM> may further be added to any of the above-described modular IV assemblies <NUM>. Accordingly, the exterior of any modular IV assembly <NUM> may be defined by the drip chamber <NUM>, the roller housing <NUM>, the base housing <NUM>, the filter housing <NUM> and the fluid exit housing <NUM>. Here, the external form of modular IV assembly <NUM> package may remain constant regardless of the presence of absence of the internal components (e.g., filter assembly <NUM>, air vent assembly <NUM>, ARD member <NUM>, check valve <NUM>).

As shown in <FIG>, the drip chamber <NUM> may include a self-leveling assembly <NUM>, according to aspects of the disclosure. The body <NUM> of the drip chamber <NUM> may act as both an air trap and a drop visibility chamber. The self-leveling assembly <NUM> has a top housing portion <NUM> and a bottom housing portion <NUM>, where the bottom housing portion <NUM> may be disposed at the base portion <NUM> of the body <NUM>. The self-leveling assembly <NUM> includes a leveling outlet port <NUM> that is aligned with the inlet port <NUM> in the drip chamber coupling portion <NUM> of the base housing <NUM>. The self-leveling assembly <NUM> also includes leveling fluid inlets <NUM>, <NUM> disposed adjacent to the leveling outlet port <NUM>. Here, the leveling fluid inlet <NUM> has a shortened flow path and is disposed near the top housing portion <NUM> (e.g., away from the base portion <NUM>), while the leveling fluid inlet <NUM> has a lengthened flow path and is disposed near the bottom housing portion <NUM> (e.g., close to the base portion <NUM>). A barrier <NUM> (e.g., hydrophilic membrane, air check valve) is disposed within the leveling fluid inlet <NUM>.

As shown in <FIG>, when the liquid level in the drip chamber <NUM> covers leveling fluid inlet <NUM> and does not cover leveling fluid inlet <NUM>, air trapped in the body <NUM> is vented out through the leveling outlet port <NUM>. As shown in <FIG>, when the liquid level in the drip chamber <NUM> rises to cover both leveling fluid inlet <NUM> and leveling fluid inlet <NUM>, the barrier <NUM> prevents air from passing through and subsequently only liquid (e.g., saline solution) passes out through the leveling outlet port <NUM>. Here, liquid can freely enter/pass through leveling fluid inlet <NUM> and may also enter/pass through leveling fluid inlet <NUM> at a slower rate due to the barrier <NUM>. As shown in <FIG>, when enough liquid siphons out through the leveling outlet port <NUM> that the leveling fluid inlet <NUM> is again exposed to air in the body <NUM>, the liquid continues to enter/pass through the leveling fluid inlet <NUM> only while the air is blocked from passing through the barrier <NUM>.

For example, the barrier <NUM> may be a membrane formed from a hydrophilic material that prevents air from passing through the barrier <NUM> once the barrier <NUM> is wetted. Thus, in <FIG> the barrier <NUM> is not yet wetted, so air may pass through and exit the leveling outlet port <NUM>. Once the barrier <NUM> is wetted in <FIG>, the barrier <NUM> prevents air from passing through. When the liquid recedes from the barrier <NUM> in <FIG>, the barrier <NUM> is still wetted and thus continues to prevent air from passing through until it dries out.

As another example, the barrier <NUM> may be an air check valve that allows air to pass through the barrier <NUM> while preventing liquid from passing through the barrier <NUM>. Thus, in <FIG> the barrier <NUM> is open to the air in the body <NUM>, so air may pass through and exit the leveling outlet port <NUM>. Once the barrier <NUM> is submerged under the liquid level in <FIG>, the barrier <NUM> prevents liquid from passing through leveling fluid inlet <NUM> and thus the liquid only enters/passes through leveling fluid inlet <NUM> and out the leveling outlet port <NUM>. When the liquid recedes from the barrier <NUM> in <FIG>, the pressure exerted by the liquid trapped above the barrier <NUM> within the self-leveling assembly <NUM> may prevent air from passing through the barrier <NUM> while liquid continues to enter/pass through the leveling fluid inlet <NUM> and out the leveling outlet port <NUM>.

The self-leveling assembly <NUM> eliminates the need to prime the drip chamber <NUM> by squeezing a flexible body <NUM> to push air out and to allow fluid to enter through the inlet connector <NUM>. Thus, the self-leveling assembly <NUM> provides for venting air from the drip chamber <NUM> regardless of whether the body <NUM> is flexible (e.g., flexible plastic) or stiff (e.g., hard plastic). Further, the self-leveling assembly <NUM> may prevent microbubbles from entering the fluid.

It is understood that any specific order or hierarchy of blocks in the methods of processes disclosed is an illustration of example approaches. Based upon design or implementation preferences, it is understood that the specific order or hierarchy of blocks in the processes may be rearranged, or that all illustrated blocks be performed. In some implementations, any of the blocks may be performed simultaneously.

It is understood that the specific order or hierarchy of steps, operations or processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps, operations or processes may be rearranged. Some of the steps, operations or processes may be performed simultaneously. Some or all of the steps, operations, or processes may be performed automatically, without the intervention of a user. The accompanying method claims, if any, present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

Further, to the extent that the term "include," "have," or the like is used, such term is intended to be inclusive in a manner similar to the term "comprise" as "comprise" is interpreted when employed as a transitional word in a claim.

Claim 1:
A modular intravenous IV assembly (<NUM>), comprising:
a drip chamber (<NUM>) having a body (<NUM>) and an inlet connector (<NUM>);
a base housing (<NUM>) coupled directly to a base portion (<NUM>) of the drip chamber (<NUM>), the base housing (<NUM>) having an inlet port (<NUM>) in fluid connection with the drip chamber (<NUM>) and a flow path cavity (<NUM>) in fluid connection with the inlet port (<NUM>) wherein the flow path cavity (<NUM>) comprises a first flow area having a constant width and a varying depth, and a second flow area having a varying width and a constant depth;
a flow control assembly (<NUM>) coupled directly to a first portion of the base housing (<NUM>), the flow control assembly (<NUM>) comprising;
a roller housing (<NUM>);
a roller (<NUM>); and
a flow control membrane (<NUM>) disposed between the roller (<NUM>) and the flow path cavity (<NUM>) in the base housing (<NUM>), wherein the roller (<NUM>) is configured to cause the flow control membrane (<NUM>) to flex into the flow path cavity (<NUM>), which blocks a fluid flow path (<NUM>) to varying degrees based on the position of the engaged portion of the roller (<NUM>) over the flow path cavity (<NUM>).