Module-type venous assembly

Abstract

A modular intravenous (IV) assembly is provided. The modular IV assembly includes a drip chamber having a body and an inlet connector, a base housing directly coupled to a base portion of the drip chamber, the base housing having an inlet port in fluid communication with the drip chamber and a flow path cavity in fluid communication with the inlet port, and a flow control assembly directly coupled to a first portion of the base housing. Any of a filter assembly, a run-dry prevention element, a check valve, and an air vent assembly may be included in the modular IV assembly. An IV set and methods of use are also provided.

Description

Technical Field

[0001] None applicable

Background Art

[0002] A venous (IV) infusion set typically includes several components each having a core function, such as a drip chamber, a roller clamp, a pinch clamp, a filter, and a check valve. These components are typically connected to each other by the length of IV tubing to provide a complete IV infusion set that is packaged as ready for use as a disposable IV set. Such an IV infusion set has a significant number of IV tubing connections, and thus, as the number of IV tubing connections increases, the risk of leakage at the connections correspondingly increases. Each individual component also provides another interconnection point for the user. These factors result in higher manufacturing complexity and cost.

Summary of the Invention

Problems to be Solved by the Invention

[0003] It is desirable to provide a modular IV assembly that incorporates many of the core functions of IV components into one device, thus reducing manufacturing complexity and cost and improving usability by the user.

Means for Solving the Problems

[0004] The present disclosure provides a modular IV assembly that combines the core functions of several IV infusion set components.

[0005] 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 directly coupled to a base portion of the drip chamber, the base housing having an inlet port in fluid communication with the drip chamber and a flow path cavity in fluid communication with the inlet port. The modular IV assembly further includes a flow rate control assembly directly coupled to a first portion of the base housing. The flow rate control assembly includes a roller housing, a roller, and a flow rate control membrane disposed between the roller and the flow path cavity in the base housing.

[0006] In one or more aspects, the flow path cavity includes 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 rate control assembly is configured to prevent fluid flow through the base housing when the roller is engaged with the flow rate control membrane adjacent to a starting position of the first flow area. In one or more aspects, the flow rate control assembly is configured to supply sufficient fluid flow through the base housing when the roller is engaged with the flow rate control membrane adjacent to an end portion of the second flow area. In one or more aspects, the flow rate control assembly is configured to supply an increasing fluid flow through the base housing as the roller engaged with the flow rate control membrane moves away from the end portion of the second flow area.

[0007] In one or more embodiments, the filter assembly is directly connected to the second part of the base housing. In one or more embodiments, the first part and the second part are on opposite faces of the base housing. In one or more embodiments, the filter assembly includes a filter housing directly connected to the second part of the base housing and a filter membrane disposed between the filter housing and the second part of the base housing. In one or more embodiments, the filter membrane includes a hydrophilic material that prevents gas from passing through the filter membrane when the filter membrane is wetted. In one or more embodiments, the first face of the filter membrane is disposed adjacent to the inner face of the second part of the base housing at a distance from the inner face of the second part, and the space between the inner face of the second part and the first face of the filter membrane is configured to provide a flow path for fluid entering the second part of the base housing from the flow control assembly. In one or more embodiments, the second face of the filter membrane is disposed adjacent to the inner face of the filter housing at a distance from the inner face of the filter housing, and the space between the inner face of the filter housing and the second face of the filter membrane is configured to provide a flow path for fluid passing through the filter membrane.

[0008] In one or more embodiments, a non-drying member is included that includes one of an individual layer disposed on the filter membrane and an integrally formed material including the filter membrane. In one or more embodiments, a filter housing directly connected to the second part of the base housing, a fluid outlet housing directly connected to the filter housing, and a one-way check valve disposed between the outlet cavity on the outer surface of the filter housing and the fluid outlet housing, the one-way check valve being configured to prevent fluid from flowing in the opposite direction and entering the outlet cavity while allowing fluid to flow out of the outlet cavity through the outlet port in the fluid outlet housing, is included. In one or more embodiments, the fluid outlet housing, the check valve, and the outlet cavity are disposed in the upper part of the base housing adjacent to the drip chamber. In one or more embodiments, the fluid outlet housing, the check valve, and the outlet cavity are disposed in the lower part of the base housing.

[0009] In one or more aspects, the air vent assembly is directly connected to the second portion of the base housing, the first and second portions are on opposite faces of the base housing, and the air vent assembly includes a vent cavity disposed in the second portion of the base housing, a vent port disposed in the vent cavity and connected 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 includes a microporous hydrophobic material that allows gas to pass through the air vent membrane and out through the vent port while preventing liquid from entering the vent port through the air vent membrane. In one or more aspects, the drip chamber includes a lower housing portion disposed adjacent to the base housing at the base portion of the drip chamber, a leveling outlet port aligned with an inlet port in the base housing, first and second leveling inlet ports disposed adjacent to opposite sides of the leveling outlet port, and a barrier disposed within the first leveling inlet port, and includes a self-leveling assembly.

[0010] In one or more embodiments, an intravenous (IV) set is provided. The IV set includes a drip chamber having a body and an inlet connector, a base housing directly connected to the base portion of the drip chamber and having an inlet port in fluid connection with the drip chamber and a flow path cavity in fluid connection with the inlet port, a flow rate control assembly directly connected to the first portion of the base housing and including a roller housing, a roller, and a flow rate control membrane disposed between the roller and the flow path cavity in the base housing, and a modular IV assembly. The IV set also includes a fluid container connected to the inlet connector of the drip chamber by a first IV tube. The IV set further includes a fluid delivery member connected to the modular IV assembly by a second IV tube.

[0011] In one or more embodiments, a method of delivering a medical fluid is provided. The method includes connecting a fluid container to a modular intravenous (IV) assembly by a first IV tube, the modular IV assembly including a drip chamber having a body and an inlet connector, and a base housing directly connected 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 rate control assembly directly connected to a first portion of the base housing, the flow rate control assembly including a roller housing, a roller, and a flow rate control membrane disposed between the roller and the flow path cavity in the base housing. The method also includes connecting a fluid delivery member to the modular IV assembly by 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 rate control assembly.

[0012] Additional features and advantages of the present disclosure will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the present disclosure. The objectives and other advantages of the present 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.

[0013] 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 present disclosure as claimed.

[0014] The accompanying drawings, which are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and together with the description serve to explain the principles of the present disclosure.

Brief Description of the Drawings

[0015]

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DETAILED DESCRIPTION OF THE INVENTION

[0016] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configuration in which the subject technology may be practiced. The detailed description includes specific details for providing a thorough understanding of the subject technology. Accordingly, the dimensions are provided as non-limiting examples with respect to specific aspects. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology.

[0017] It should be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Here, various aspects of the subject technology are disclosed according to specific but non-limiting examples. The various embodiments described in the present disclosure may be implemented according to the desired application or implementation in different ways and variations.

[0018] An IV infusion set can be formed from any combination of infusion components and tubing. Typically, the infusion components and tubing are disposable products that are discarded after single use. The infusion components and tubing can be formed from any suitable material (e.g., plastic, silicone, rubber). A problem in manufacturing an IV infusion set is connecting the composite tubing to the infusion components to obtain a leak-free and secure connection with the desired fluid flow. A problem in using an IV infusion set is that having many separate components presents many connection points to the user.

[0019] As shown in FIG. 1, a typical infusion set 30 can include a drip chamber 40, a check valve 50, a roller clamp 60, and a Y-connector 70, all of which are connected together by tubing 20. A typical infusion set 30 can include additional infusion components (e.g., pinch clamp, filter) and can be formed from any combination of components and tubing 20.

[0020] According to some aspects of the present disclosure, a modular IV assembly incorporates the core functions of IV components into one device, thus reducing the number of tubing connections required for an IV infusion set. According to some aspects of the present disclosure, a modular IV assembly provides a design configuration that can be automated more easily than a conventional IV infusion set.

[0021] According to some aspects of the present disclosure, a modular IV assembly provides a design configuration that facilitates replacement and exchange of core functional elements during the manufacturing process. According to some aspects of the present disclosure, a modular IV assembly presents only one connection point to the user.

[0022] The modular IV assembly 100 is shown in FIGS. 2-10 in accordance with some aspects of the present disclosure. The modular IV assembly 100 includes a drip chamber 110, a flow control assembly 120, a filter assembly 130, an air vent assembly 140 (e.g., for a flow path), an anti-run dry (ARD) member 150, and a check valve 160. Thus, the modular IV assembly provides one device that includes many different characteristics such as anti-run dry fluid flow, droplet visibility, flow control, fluid filtration, air venting (e.g., line defoaming), and flow direction control from the check valve. The modular IV assembly 100 may have a large area under the drip chamber 110, and thus provides an area that is easily grasped by a user.

[0023] The drip chamber 110 has a body 112 formed from a material suitable for use in an infusion procedure. For example, the body 112 may be formed from a rigid plastic that is not squeezable and thus also has an automatic priming function. As another example, the body 112 may be formed from a flexible plastic that is squeezable and thus does not require an automatic priming function. The body 112 may be transparent to provide droplet visibility from the fluid entering the drip chamber 110. The drip chamber 110 is connected to a base housing 170. For example, the body 112 may be an elongated cylinder having a base portion 113 that is connected to a drip chamber connection portion 172 of the base housing 170. The drip chamber connection portion 172 includes an inlet port 173 that provides a fluid path from the drip chamber 110 to the base housing 170 (see FIGS. 6 and 7). Any size and shape is contemplated for the drip chamber 110 and correspondingly the drip chamber connection portion 172. An inlet connector 114 is connected to the body 112. The inlet connector 114 may be configured to receive an IV tube, for example, from a fluid source (e.g., an IV bag). As another example, the inlet connector 114 may be configured to connect directly to an IV fluid container (e.g., a bag, a bottle) via a spike connection.

[0024] The flow control assembly 120 is connected to the base housing 170. The flow control assembly 120 includes a roller housing 122, a roller 124, and a flow control membrane 126. The roller housing 122 is sized and shaped to connect to the base housing 170. The roller 124 is movably connected to the roller housing 122. For example, the shaft 125 of the roller 124 can be received within a channel 123 disposed in the opposing walls of the roller housing 122, and the shaft 125 moves axially along the channel 123 when the roller 124 is moved. The flow control membrane 126 is sized and shaped to be received within the base housing 170. The flow control membrane 126 can be formed from a flexible material (e.g., an elastomer), and thus, the flow control membrane 126 can flex and enter the fluid flow path 174 when the roller 124 engages the flow control membrane 126. In some aspects of the present disclosure, the flow control assembly can include different control members other than the roller 124, such as a lever, a slider, or a knob.

[0025] As shown in FIGS. 11 - 13, the base housing 170 can be formed from a rigid plastic, and the fluid flow path 174 is formed by a cavity 176 provided within the surface of the base housing 170. The cavity 176 can vary in both width and depth to provide various fluid flow rates based on the position of the roller 124. For example, the cavity 176 shown in FIG. 12 has a first cross - section 174a having a length L1 of 15 mm and a width A of 0.75 mm, and a second cross - section 174b having a length L2 of 15 mm and a width C of 2.5 mm. The depth of the first cross - section 174a increases from zero at one end to a depth B of 0.5 mm at the other end. The depth of the second cross - section 174b is a constant depth B of 0.5 mm. Any of the widths A and C, the depth B, and the lengths L1 and L2 can be individually varied to adjust the cavity 176, and thus the fluid flow path 174, for a particular flow profile.

[0026] As shown in FIG. 13, the portion of the roller 124 that engages the flow control membrane 126 causes the flow control membrane 126 to flex and enter the cavity 176, thereby blocking the fluid flow path 174 to various degrees based on the position of the engaging portion of the roller 124 with respect to the cavity 176. FIG. 14 shows a graph 1400 indicating the change in the flow area with respect to the moving length of the roller 124 based on the values described above for A, B, C, L1, and L2. The flow area below the portion of the roller 124 that engages the flow control membrane 126 corresponds to the resulting fluid flow rate through the cavity 176, with the largest flow area resulting in a higher fluid flow rate and the smallest flow area resulting in a lower fluid flow rate.

[0027] For example, when the roller 124 is positioned at the end of L1 with a depth of zero, the flow area is zero and the fluid flow path 174 is completely blocked (e.g., no fluid flow passes through the fluid flow path 174). When the roller 124 is positioned at the connection between the second end of L1 and the first end of L2, the fluid flow area is 0.375 mm 2 and the fluid flow path 174 is partially blocked, thus resulting in a 30% fluid flow rate. When the roller 124 is positioned at the second end of L2, the fluid flow area is 1.25 mm 2 and the fluid flow path 174 is not blocked, thus resulting in a 100% fluid flow rate (e.g., fully open). As shown in FIG. 14, in the graph, the first portion corresponding to the engagement of the roller 124 along the length L1 represents the fine adjustment portion of the flow control assembly 120, while the portion corresponding to the engagement of the roller 124 along the length L2 represents the coarse adjustment portion of the flow control assembly 120. According to some aspects of the present disclosure, any number of flow change areas, such as three or more, can be provided. Accordingly, there can be more cavity cross-sections than the first cross-section 174a and the second cross-section 174b, such as three or more cavity cross-sections, for example.

[0028] In contrast to the infusion set 30 shown in FIG. 1, where the drip chamber 40 and the roller clamp 60 are each connected via the tubing 20 in the infusion set 30, the drip chamber 110 is directly connected to the base housing 170, so no IV tubing is required to connect the drip chamber to the flow control assembly 120. Further, since the flow control assembly 120 does not include or engage with flexible IV tubing, the fluid flow rate can be consistently supplied and maintained throughout the life of the modular IV assembly 100. For example, the rigid plastic of the base housing 170 does not deform (e.g., drift) over time. In contrast, a typical roller clamp 60 involves restricting the fluid flow within the soft, flexible tubing 20 by deforming the tubing 20, and the tubing 20 tends to relax over time (e.g., lose its elasticity), making it increasingly difficult to accurately control the fluid flow rate over time. Accordingly, the flow control assembly 120 is configured to provide consistent and accurate control of the fluid flow rate through the modular IV assembly 100.

[0029] As shown in FIGS. 15 - 17, the base housing 170 is also configured to connect to a filter assembly 130 on the side of the base housing 170 opposite the flow control assembly 120. The filter assembly 130 includes a filter housing 132 that engages the filter membrane 134 and sandwiches the filter membrane 134 between the filter housing 132 and the base housing 170. The filter membrane 134 is formed from a hydrophilic material that prevents air from passing through the filter membrane 134 when the filter membrane 134 is wetted. Thus, only liquid can pass from the base housing 170 through the filter membrane 134. The material of the filter membrane 134 can be designed or selected for specific filtration characteristics to filter out specific components from the fluid passing through the filter assembly 130. For example, the filter membrane 134 can be formed to filter out particles larger than a specific size (e.g., 15um, 5um, 1.2um, 0.2um).

[0030] The base housing 170 also includes a portion on the same side as the filter assembly 130 where the air vent assembly 140 is disposed. The air vent assembly 140 includes a vent port 142 within a vent cavity 146 in the base housing 170 and an air vent membrane 144 disposed across the vent port 142 within the vent cavity 146. The air vent membrane 144 is formed of a microporous hydrophobic material that allows gas (e.g., air) to exit the fluid flow path 174 through the vent port 142 (e.g., back to the drip chamber 110) while preventing liquid from passing through the air vent membrane 144.

[0031] The ARD member 150 is shown in FIG. 5 as being integral with the filter membrane 134. For example, the material of the filter membrane 134 can be designed or selected to exhibit ARD characteristics as well as filtration characteristics. In some aspects of the present disclosure, the ARD member 150 can be an ARD material and the filter membrane 134 can be a different filter material (e.g., a separately formed distinct layer) incorporated together into one membrane having both filtration and ARD properties.

[0032] As shown in FIG. 5, the check valve 160 is disposed between an outlet cavity 162 on the outer surface of the filter housing 132 and the fluid outlet housing 180. The check valve 160 can be formed of a flexible material and acts as a one-way valve that allows fluid to flow out from the fluid port 164 in the outlet cavity 162 through an exit port 182 in the fluid outlet housing 180 while preventing reverse fluid flow from the exit port 182 to the fluid port 164. The fluid outlet housing 180 also includes an outlet port 184 configured to be coupled to IV tubing, such as IV tubing connected to an infusion pump or a catheter. The check valve 160 and the fluid outlet housing 180 can be disposed at the upper end of the base housing 170 as shown in FIG. 5, or can be disposed at the lower or base portion of the base housing 170 as shown in FIGS. 8 and 9.

[0033] During operation, as shown in FIG. 7, the modular IV assembly 100 provides a fluid flow path 174 that begins when fluid enters from the drip chamber 110 and ends when fluid exits from the exit port 182. The fluid flow path 174 includes a fluid flow through the flow control assembly 120 at a flow rate set by the position of the roller 124 relative to the cavity 176. The fluid exits the cavity 176 and flows into and contacts the filter membrane 134 and the ARD membrane 150. The fluid is filtered through the filter membrane 134, exits into the filter housing 132, and exits through the fluid port 164. The fluid then flows over and / or through the check valve 160 and exits through the exit port 182 to the outlet port 184. Since air trapped in the fluid cannot pass through the filter membrane 134, the air instead enters the vent port 142 through the air vent membrane 144 and exits the base housing 170 portion of the modular IV assembly 100.

[0034] As shown in FIGS. 8-10, the modular IV assembly 100 can be configured to include any or all of the components described above while maintaining the same or similar outer package and appearance. For example, FIG. 8 shows a basic modular IV assembly 100 that includes only the drip chamber 110 and the flow control assembly 120 and does not have the filter assembly 130, the air vent assembly 140, the ARD member 150, or the check valve 160. Here, fluid flows from the drip chamber 110 into the base housing 170 and out of the outlet port 184 at a flow rate set by the flow control assembly 120. FIG. 9 shows a more integrated modular IV assembly 100 by adding the check valve 160 to the basic modular IV assembly 100 shown in FIG. 8. Similarly, FIG. 10 shows an even more integrated modular IV assembly 100 by adding the filter membrane 134 and the ARD member 150 to the modular IV assembly 100 shown in FIG. 9. An air vent membrane 144 may be further added to any of the modular IV assemblies 100 described above. Thus, the outside of any of the modular IV assemblies 100 can be defined by the drip chamber 110, the roller housing 122, the base housing 170, the filter housing 132, and the fluid outlet housing 180. Here, the outer shape of the package of the modular IV assembly 100 can remain consistent regardless of the presence or absence of internal components (e.g., the filter assembly 130, the air vent assembly 140, the ARD member 150, the check valve 160).

[0035] As shown in FIGS. 18 - 22, the drip chamber 110 may include a self - leveling assembly 190 in accordance with aspects of the present disclosure. The body 112 of the drip chamber 110 can act as both an air trap and a droplet visibility chamber. The self - leveling assembly 190 has an upper housing portion 191 and a lower housing portion 193, and the lower housing portion 193 can be disposed on the base portion 113 of the body 112. The self - leveling assembly 190 includes a leveling outlet port 192 that is aligned with the inlet port 173 at the drip chamber connection portion 172 of the base housing 170. The self - leveling assembly 190 also includes leveling fluid inlets 194, 196 disposed adjacent to the leveling outlet port 192. Here, the leveling fluid inlet 194 has a shortened flow path and is disposed near the upper housing portion 191 (e.g., away from the base portion 113), while the leveling fluid inlet 196 has an extended flow path and is disposed near the lower housing portion 193 (e.g., near the base portion 113). A barrier 198 (e.g., a hydrophilic membrane, an air check valve) is disposed within the leveling fluid inlet 194.

[0036] As shown in FIG. 20, when the liquid level in the drip chamber 110 covers the leveling fluid inlet 196 but does not cover the leveling fluid inlet 194, the air trapped in the body 112 exits through the leveling outlet port 192. As shown in FIG. 21, when the liquid level in the drip chamber 110 rises to cover both the leveling fluid inlet 196 and the leveling fluid inlet 194, the barrier 198 prevents air from passing through, and then only the liquid (e.g., physiological saline) exits through the leveling outlet port 192. Here, the liquid can freely enter / pass through the leveling fluid inlet 196 and enter / pass through the leveling fluid inlet 194 at a slower pace due to the barrier 198. As shown in FIG. 22, when enough liquid that exposes the leveling fluid inlet 194 to air again in the body 112 is sucked up through the leveling outlet port 192, the liquid continues to enter / pass through only the leveling fluid inlet 196 while air is prevented from passing through the barrier 198.

[0037] For example, the barrier 198 can be a membrane formed of a hydrophilic material that prevents air from passing through the barrier 198 when the barrier 198 is wetted. Thus, in FIG. 20, the barrier 198 is not yet wetted, so air can pass through and exit through the leveling outlet port 192. When the barrier 198 is wetted in FIG. 21, the barrier 198 prevents air from passing through. When the liquid recedes from the barrier 198 in FIG. 22, the barrier 198 remains wet, and thus continues to prevent air from passing through until the barrier is completely dry.

[0038] As another example, the barrier 198 can be an air check valve that allows air to pass through the barrier 198 while preventing liquid from passing through the barrier 198. Thus, in FIG. 20, the barrier 198 is open to air in the body 112, so that air can pass through and exit the leveling outlet port 192. When the barrier 198 is immersed below the liquid level in FIG. 21, the barrier 198 prevents liquid from passing through the leveling fluid inlet 194. Thus, the liquid enters / flows through the leveling fluid inlet 196 and exits the leveling fluid outlet 192 exclusively. When the liquid recedes from the barrier 198 in FIG. 22, the pressure exerted by the liquid trapped above the barrier 198 within the self-leveling assembly 190 can prevent air from passing through the barrier 198, while the liquid continues to enter / flow through the leveling fluid inlet 196 and exits the leveling outlet port 192.

[0039] The self-leveling assembly 190 eliminates the need to prime the drip chamber 110 by squeezing the flexible body 112 to expel air and allowing fluid to enter through the inlet connector 114. Thus, the self-leveling assembly 190 provides for expelling air from the drip chamber 110 regardless of whether the body 112 is flexible (e.g., flexible plastic) or rigid (e.g., rigid plastic). Further, the self-leveling assembly 190 can prevent microbubbles from entering the fluid.

[0040] It is understood that any particular order or hierarchy of blocks in the disclosed process methods is an illustration of an exemplary approach. Based on design or implementation priorities, it is understood that the particular order or hierarchy of blocks in the process may be rearranged, or that all of the blocks shown may be performed. In some embodiments, any of the blocks may be performed simultaneously.

[0041] This disclosure is provided to enable those skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various changes to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other aspects.

[0042] References to elements in the singular are intended to mean "one or more" unless specifically stated otherwise to mean "one and only one." Unless specifically stated otherwise, the term "some" refers to one or more. Masculine pronouns (e.g., his) include feminine and neuter (e.g., her and its), and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.

[0043] The term "exemplary" as used herein means "serving as an example or illustration." Aspects or designs described herein as "exemplary" are not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, the various alternative configurations and operations described herein may be considered at least equivalent.

[0044] As used herein, the phrase "at least one of" following a series of items, when accompanied by the term "or" to separate any of the items, modifies the entire list of items rather than each item in the list. The phrase "at least one of" does not necessarily require selection of at least one of the items; rather, this phrase allows a meaning that includes at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the phrase "at least one of A, B, or C" can refer to only A, only B, only C, or any combination of A, B, and C.

[0045] Phrases such as "aspect" do not imply that such an aspect is essential to the technology of the subject matter, nor that such an aspect applies to all the components of the technology of the subject matter. The disclosure regarding an aspect may apply to all components or one or more components. An aspect may provide one or more examples. Phrases such as "aspect" may refer to one or more aspects, and vice versa. Phrases such as "embodiment" do not imply that such an embodiment is essential to the technology of the subject matter, nor that such an embodiment applies to all the components of the technology of the subject matter. The disclosure regarding an embodiment may apply to all embodiments or one or more embodiments. An embodiment may provide one or more examples. Phrases such as "embodiment" may refer to one or more embodiments, and vice versa. Phrases such as "configuration" do not imply that such a configuration is essential to the technology of the subject matter, nor that such a configuration applies to all the components of the technology of the subject matter. The disclosure regarding a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. Phrases such as "configuration" may refer to one or more configurations, and vice versa.

[0046] In one aspect, unless otherwise specified, all measurements, values, ratings, positions, sizes, dimensions, and other specifications described in this specification, including those in the following claims, are approximate and not exact. In one aspect, they are intended to have a reasonable range that does not conflict with the associated functions and the conventions of the technical field to which they belong.

[0047] The specific order or hierarchy of the disclosed steps, acts, or processes is understood to be an illustration of an exemplary approach. Based on design priorities, it is understood that the specific order or hierarchy of steps, acts, or processes may be rearranged. Some of the steps, acts, or processes may be performed simultaneously. Some or all of the steps, acts, or processes may be automatically performed without user intervention. If there are method claims, the various steps, acts, or process elements are presented in a sample order and are not meant to be limited to the specific order or hierarchy presented.

[0048] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure, whether known to those skilled in the art or later to become known, are expressly incorporated herein by reference and are intended to be encompassed by the claims. Further, nothing disclosed herein is intended to be dedicated to the public whether or not such disclosure is expressly recited in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. § 112, sixth paragraph, unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is expressly recited using the phrase "step for". Moreover, to the extent the terms "include", "have", etc. are used, such terms are intended to be inclusive in the same manner as the term "comprise" as interpreted when "comprise" is used as a transitional phrase in a claim.

[0049] The title, background art, summary of the invention, brief description of the drawings, and abstract of the present disclosure are hereby incorporated by reference into the present disclosure and are provided as illustrative examples of the present disclosure, not as a limiting description of the present disclosure. The present disclosure is submitted with the understanding that they are not used to limit the scope or meaning of the claims. Further, in the detailed description, the description provides illustrative examples, and it can be seen that various features are grouped together in various embodiments for the purpose of simplifying the present disclosure. The methods of the present disclosure should not be construed as indicating an intention that the claimed subject matter requires more features than are explicitly recited in each claim. Rather, as the appended claims indicate, the subject matter of the present invention lies in less than all of the features of a single disclosed configuration or operation. The appended claims are hereby incorporated by reference into the detailed description, and each claim stands on its own as a separately claimed subject matter.

[0050] The claims are not intended to be limited to the aspects described herein, but rather should be given the full scope that does not conflict with the language of the claims and that includes all legal equivalents. However, none of the claims are intended to cover, nor should they be construed to cover, subject matter that fails to meet the requirements of 35 U.S.C. § 101, 102, or 103.

Claims

1. A drip chamber having a body and an inlet connector, A base housing directly connected to the 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, A flow rate control assembly directly connected to a first portion of the base housing, A roller housing, A roller, and A flow rate control assembly including a flow rate control membrane disposed between the roller and the flow path cavity in the base housing, including, wherein the flow path cavity includes 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 modular intravenous (IV) assembly.

2. The flow rate control assembly is configured to prevent fluid flow through the base housing when the roller is engaged with the flow rate control membrane adjacent to the starting position of the first flow area, the modular IV assembly according to claim 1.

3. The flow rate control assembly is configured to supply sufficient fluid flow through the base housing when the roller is engaged with the flow rate control membrane adjacent to the end portion of the second flow area, the modular IV assembly according to claim 1.

4. The flow rate control assembly is configured to supply an increasing fluid flow through the base housing as the roller engaged with the flow rate control membrane moves away from the end portion of the second flow area, the modular IV assembly according to claim 1.

5. The modular IV assembly according to claim 1, further comprising a filter assembly directly connected to a second portion of the base housing.

6. The first part and the second part are on opposite faces of the base housing, the modular IV assembly according to claim 5.

7. The filter assembly comprises a filter housing directly connected to the second part of the base housing, and a filter membrane disposed between the filter housing and the second part of the base housing, the modular IV assembly according to claim 5.

8. The filter membrane comprises a hydrophilic material that prevents gas from passing through the filter membrane when the filter membrane is wetted, the modular IV assembly according to claim 7.

9. A first surface of the filter membrane is disposed adjacent to the inner surface of the second part of the base housing at a distance from the inner surface of the second part, and the space between the inner surface of the second part and the first surface of the filter membrane is configured to provide a flow path for fluid entering the second part of the base housing from the flow control assembly, the modular IV assembly according to claim 7.

10. A second surface of the filter membrane is disposed adjacent to the inner surface of the filter housing at a distance from the inner surface of the filter housing, and the 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, the modular IV assembly according to claim 9.

11. The modular IV assembly according to claim 7 further comprises a ran dry prevention member including one of an individual layer disposed on the filter membrane and an integrally formed material including the filter membrane.

12. a filter housing directly connected to the second part of the base housing, and a fluid outlet housing directly connected to the filter housing, and A one-way check valve disposed between an outlet cavity on the outer surface of the filter housing and the fluid outlet housing, configured to prevent fluid from flowing in the opposite direction and entering the outlet cavity while allowing fluid to flow out of the outlet cavity through an exit port in the fluid outlet housing. The modular IV assembly according to claim 1, further comprising . **Claim 13** The modular IV assembly according to claim 12, wherein the fluid outlet housing, the check valve, and the outlet cavity are disposed in an upper portion of the base housing adjacent to the drip chamber. **Claim 14** The modular IV assembly according to claim 12, wherein the fluid outlet housing, the check valve, and the outlet cavity are disposed in a lower portion of the base housing. **Claim 15** The modular IV assembly according to claim 1, further comprising an air vent assembly directly connected to a second portion of the base housing, wherein the first portion and the second portion are on opposite faces of the base housing, and the air vent assembly comprises a vent cavity disposed in the second portion of the base housing; a vent port disposed in the vent cavity and connected to an air flow path in the base housing; and an air vent membrane disposed in the vent cavity. **Claim 16** The modular IV assembly according to claim 15, wherein the air vent membrane comprises a microporous hydrophobic material that allows gas to pass through the air vent membrane and out through the vent port while preventing liquid from entering the vent port through the air vent membrane. **Claim 17** The drip chamber further comprises a self-leveling assembly, and the self-leveling assembly A lower housing portion disposed adjacent to the base housing in the base portion of the drip chamber; A leveling outlet port aligned with the inlet port in the base housing; A first leveling inlet port and a second leveling inlet port disposed adjacent to opposite sides of the leveling outlet port; A barrier disposed within the first leveling inlet port, the modular IV assembly of claim 1.

18. The modular IV assembly according to any one of claims 1 to 17; A fluid container connected to the inlet connector of the drip chamber by a first IV tube; A fluid delivery member connected to the modular IV assembly by a second IV tube; An intravenous (IV) set including.

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