US20230149627A1 - Modular intravenous assembly - Google Patents

Abstract

Modular intravenous (IV) assemblies are provided. The modular IV assembly includes 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. Any of a filter assembly, an anti-run dry member, a check valve and an air vent assembly may be included in the modular IV assembly. IV sets and methods of use are also provided.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS
• This is a continuation of patent application Ser. No. 16/886,388, filed on May 28, 2020, entitled “MODULAR INTRAVENOUS ASSEMBLY,” the contents of which is hereby incorporated by reference in its entirety, for all purposes.
BACKGROUND
• 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.
• 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.
SUMMARY
• 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 aspects, 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 embodiments, 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.
BRIEF DESCRIPTION OF THE DRAWINGS
• 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.
• FIG.1 depicts a schematic view of a typical assembled infusion set.
• FIG.2 is a perspective view of a modular IV assembly, according to some aspects of the disclosure.
• FIG.3 is another perspective view of the modular IV assembly ofFIG.2, according to some aspects of the disclosure.
• FIG.4 is a front view of the modular IV assembly ofFIG.2, according to some aspects of the disclosure.
• FIG.5 is an exploded perspective view of the modular IV assembly ofFIG.2, according to some aspects of the disclosure
• FIG.6 is a cross-sectional side view of the modular IV assembly ofFIG.2, according to some aspects of the disclosure.
• FIG.7 is an enlarged partial view of the modular IV assembly ofFIG.6, according to some aspects of the disclosure.
• FIG.8 is a cross-sectional side view of a modular IV assembly, according to some aspects of the disclosure.
• FIG.9 is a cross-sectional side view of a modular IV assembly, according to some aspects of the disclosure.
• FIG.10 is a cross-sectional side view of a modular IV assembly, according to some aspects of the disclosure.
• FIG.11 is a front view of a base housing of a modular IV assembly, according to some aspects of the disclosure.
• FIG.12 is a partial perspective view of the base housing ofFIG.11, according to some aspects of the disclosure.
• FIG.13 is a partial perspective view of a flow control assembly of a modular IV assembly, according to some aspects of the disclosure.
• FIG.14 is a graph depicting a variation in flow area based on the flow control assembly ofFIG.13.
• FIG.15 is a partial perspective view of a modular IV assembly, according to some aspects of the disclosure.
• FIG.16 is an exploded perspective view of the modular IV assembly ofFIG.15, according to some aspects of the disclosure.
• FIG.17 is a front view of a portion of an air vent assembly of a modular IV assembly, according to some aspects of the disclosure.
• FIG.18 is a front view of a drip chamber of a modular IV assembly, according to some aspects of the disclosure.
• FIG.19 is a front view of a self-leveling assembly of the drip chamber ofFIG.18, according to some aspects of the disclosure.
• FIGS.20-22 are schematic views depicting the operation of the self-leveling assembly ofFIG.19.
DETAILED DESCRIPTION
• The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Accordingly, dimensions are provided in regard to certain aspects as non-limiting examples. 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 in order to avoid obscuring the concepts of the subject technology.
• It is to be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed according to particular but non-limiting examples. Various embodiments described in the present disclosure may be carried out in different ways and variations, and in accordance with a desired application or implementation.
• 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 inFIG.1, a typical infusion set30 may include adrip chamber40, acheck valve50, aroller clamp60 and Y-junctions70, all connected together bytubing20. A typical infusion set30 can include additional infusion components (e.g., pinch clamps, filters) and can be formed of any combination of components and thetubing20.
• 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.
• Amodular IV assembly100 is shown inFIGS.2-10, according to some aspects of the disclosure. Themodular IV assembly100 includes adrip chamber110, aflow control assembly120, afilter assembly130, an air vent assembly140 (e.g., for a fluid path), an anti-run dry (ARD)member150 and acheck valve160. 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. Themodular IV assembly100 may have a large area below thedrip chamber110, thus providing an area for a user to grip easily.
• Thedrip chamber110 has abody112 formed of a material suitable for use in infusion procedures. For example, thebody112 may be formed of a hard plastic that is not squeezable and thus also has an auto prime function. As another example, thebody112 may be formed of a flexible plastic that is squeezable and thus does not require an auto prime function. Thebody112 may be transparent to provide drip visibility from the fluid entering thedrip chamber110. Thedrip chamber110 is coupled to abase housing170. For example, thebody112 may be an elongated cylinder having abase portion113 that is coupled to a dripchamber coupling portion172 of thebase housing170. The dripchamber coupling portion172 includes aninlet port173 that provides a fluid pathway from thedrip chamber110 into the base housing170 (seeFIGS.6 and7). Any size and shape is contemplated for thedrip chamber110 and correspondingly the dripchamber coupling portion172. Aninlet connector114 is coupled to thebody112. Theinlet connector114 may be configured to receive an IV tube from a fluid source (e.g., IV bag), for example. As another example, theinlet connector114 may be configured to connect directly to an IV fluid container (e.g., bag, bottle) via a spike connection.
• Theflow control assembly120 is coupled to thebase housing170. Theflow control assembly120 includes aroller housing122, aroller124, and aflow control membrane126. Theroller housing122 is sized and shaped to couple with thebase housing170. Theroller124 is movably coupled to theroller housing122. For example,axles125 of theroller124 may be received withinchannels123 disposed on opposing walls of theroller housing122, where theaxles125 move axially along thechannels123 when theroller124 is moved. Theflow control membrane126 is sized and shaped to be received within thebase housing170. Theflow control membrane126 may be formed of a flexible material (e.g., elastomer), such thatflow control membrane126 may flex into afluid flow path174 when theroller124 engages theflow control membrane126. In some aspects of the disclosure, the flow control assembly may include a different control member than theroller124, such as a lever, a slider or a knob, for example.
• As shown inFIGS.11-13, thebase housing170 may be formed of a hard plastic, where thefluid flow path174 is formed by acavity176 disposed within a surface of thebase housing170. Thecavity176 may vary in both width and depth to provide different fluid flow rates based on the position of theroller124. For example, thecavity176 shown inFIG.12 has afirst section174ahaving a length L1 of 15 mm and a width A of 0.75 mm, and asecond section174bhaving a length L2 of 15 mm and a width C of 2.5 mm. The depth offirst section174aincreases from zero at one end to depth B of 0.5 mm at the other end. The depth of thesecond section174bis a constant depth B of 0.5 mm. Any of the widths A and C, depth B and lengths L1 and L2 may be independently varied to tune thecavity176, and therefore thefluid flow path174, for a specific flow profile.
• As shown inFIG.13, the portion of theroller124 that engages theflow control membrane126 causes theflow control membrane126 to flex into thecavity176, which blocks thefluid flow path174 to varying degrees based on the position of the engaged portion of theroller124 over thecavity176.FIG.14 shows agraph1400 depicting the variation in flow area over the travel length of theroller124 based on the above described values for A, B, C, L1 and L2. The flow area under the portion of theroller124 that engages theflow control membrane126 corresponds to a resulting fluid flow rate through thecavity176, 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 theroller124 is positioned at the end of L1 with a depth of zero, the flow area is zero and thefluid flow path174 is completely occluded (e.g., no fluid flow through the fluid flow path174). When theroller124 is positioned at the junction of the second end of L1 and the first end of L2, the fluid flow area is 0.375 mm²and thefluid flow path174 is partially occluded, thus providing for a 30% fluid flow rate. When theroller124 is positioned at the second end of L2, the fluid flow area is 1.25 mm²and thefluid flow path174 is not occluded, thus providing for a 100% fluid flow rate (e.g., full open). As shown inFIG.14, the first portion of the graph corresponding to theroller124 engagement along length L1 indicates a fine adjustment portion of theflow control assembly120, while the portion of the graph corresponding to theroller124 engagement along the length L2 indicates a gross adjustment portion of theflow control assembly120. 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 andsecond sections174a,174b, such as three or more cavity sections, for example.
• Since thedrip chamber110 is coupled directly to thebase housing170, no IV tubing is necessary to link the drip chamber to theflow control assembly120, as opposed to the infusion set30 shown inFIG.1 for which thedrip chamber40 and theroller clamp60 are each coupled within the infusion set30 viatubing20. Further, since theflow control assembly120 does not include or engage with flexible IV tubing, the fluid flow rate can be consistently provided and maintained through the life of themodular IV assembly100. For example, the hard plastic of thebase housing170 does not deform (e.g., drift) over time. By contrast, atypical roller clamp60 involves restricting fluid flow within soft,flexible tubing20 by deforming thetubing20, and thetubing20 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, theflow control assembly120 is configured to provide consistent and precise control of the fluid flow rate through themodular IV assembly100.
• As shown inFIGS.15-17, thebase housing170 is also configured to couple with afilter assembly130 on an opposing side of thebase housing170 from theflow control assembly120. Thefilter assembly130 includes afilter housing132 that engages and traps afilter membrane134 against thebase housing170. Thefilter membrane134 is formed from a hydrophilic material that prevents air from passing through thefilter membrane134 once thefilter membrane134 is wetted. Thus, only liquid may pass through thefilter membrane134 from thebase housing170. Thefilter membrane134 material may be designed or chosen for specific filtering properties in order to filter out particular elements from the fluid passing through thefilter assembly130. For example, thefilter membrane134 may be formed to filter out particles larger than a particular size (e.g., 15 um, 5 um, 1.2 um, 0.2 um).
• Thebase housing170 also includes a portion on the same side as thefilter assembly130 on which theair vent assembly140 is disposed. Theair vent assembly140 includes ventports142 in avent cavity146 in thebase housing170 and anair vent membrane144 disposed in thevent cavity146 over thevent ports142. Theair vent membrane144 is formed from a small pore hydrophobic material that prevents liquid from passing through theair vent membrane144 while allowing gas (e.g., air) to vent out of thefluid flow path174 through the vent ports142 (e.g., back into the drip chamber110).
• TheARD member150 is shown inFIG.5 as being integral with thefilter membrane134. For example, thefilter membrane134 material may be designed or chosen to provide ARD features as well as filtering features. In some aspects of the disclosure, theARD member150 may be an ARD material and thefilter membrane134 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 inFIG.5, thecheck valve160 is disposed between an exit cavity162 on the outer surface of thefilter housing132 and afluid exit housing180. Thecheck valve160 may be formed from a flexible material and act as a one-way valve that allows fluid to flow from afluid port164 in the exit cavity162 out through anexit port182 in thefluid exit housing180, while preventing fluid flow in the opposing direction from theexit port182 to thefluid port164. Thefluid exit housing180 also includes anoutlet port184 configured to be coupled to IV tubing, such as IV tubing connected to an infusion pump or a catheter, for example. Thecheck valve160 andfluid exit housing180 may be disposed at the top end of thebase housing170 as shown inFIG.5, or at the bottom or base portion of thebase housing170 as shown inFIGS.8 and9.
• In operation, as shown inFIG.7, themodular IV assembly100 provides afluid flow path174 that begins upon entry of fluid from thedrip chamber110 and ends upon exit of fluid from theexit port182. Thefluid flow path174 includes flow of fluid through theflow control assembly120 at a flow rate set by the position of theroller124 in relation to thecavity176. The fluid exits thecavity176 and flows into contact with thefilter membrane134 andARD member150. The fluid is filtered through thefilter membrane134 and exits into thefilter housing132 and out through thefluid port164. The fluid then flows past and/or through thecheck valve160 and out through theexit port182 to theoutlet port184. Since air trapped in the fluid cannot pass through thefilter membrane134, the air instead passes through theair vent membrane144 into thevent ports142 and out of thebase housing170 portion of themodular IV assembly100.
• As shown inFIGS.8-10, themodular IV assembly100 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.8 depicts a basemodular IV assembly100 including thedrip chamber110 and theflow control assembly120 only, with nofilter assembly130,air vent assembly140,ARD member150 orcheck valve160. Here, fluid flows into thebase housing170 from thedrip chamber110 and flows out theoutlet port184 at a flow rate set by theflow control assembly120.FIG.9 depicts a more integratedmodular IV assembly100 by adding thecheck valve160 to the basemodular IV assembly100 shown inFIG.8. Similarly,FIG.10 depicts an even more integratedmodular IV assembly100 by adding afilter membrane134 and anARD member150 to themodular IV assembly100 shown inFIG.9. Theair vent membrane144 may further be added to any of the above-describedmodular IV assemblies100. Accordingly, the exterior of anymodular IV assembly100 may be defined by thedrip chamber110, theroller housing122, thebase housing170, thefilter housing132 and thefluid exit housing180. Here, the external form ofmodular IV assembly100 package may remain constant regardless of the presence of absence of the internal components (e.g.,filter assembly130,air vent assembly140,ARD member150, check valve160).
• As shown inFIGS.18-22, thedrip chamber110 may include a self-levelingassembly190, according to aspects of the disclosure. Thebody112 of thedrip chamber110 may act as both an air trap and a drop visibility chamber. The self-levelingassembly190 has atop housing portion191 and abottom housing portion193, where thebottom housing portion193 may be disposed at thebase portion113 of thebody112. The self-levelingassembly190 includes a levelingoutlet port192 that is aligned with theinlet port173 in the dripchamber coupling portion172 of thebase housing170. The self-levelingassembly190 also includes levelingfluid inlets194,196 disposed adjacent to the levelingoutlet port192. Here, the levelingfluid inlet194 has a shortened flow path and is disposed near the top housing portion191 (e.g., away from the base portion113), while the levelingfluid inlet196 has a lengthened flow path and is disposed near the bottom housing portion193 (e.g., close to the base portion113). A barrier198 (e.g., hydrophilic membrane, air check valve) is disposed within the levelingfluid inlet194.
• As shown inFIG.20, when the liquid level in thedrip chamber110 covers levelingfluid inlet196 and does not cover levelingfluid inlet194, air trapped in thebody112 is vented out through the levelingoutlet port192. As shown inFIG.21, when the liquid level in thedrip chamber110 rises to cover both levelingfluid inlet196 and levelingfluid inlet194, thebarrier198 prevents air from passing through and subsequently only liquid (e.g., saline solution) passes out through the levelingoutlet port192. Here, liquid can freely enter/pass through levelingfluid inlet196 and may also enter/pass through levelingfluid inlet194 at a slower rate due to thebarrier198. As shown inFIG.22, when enough liquid siphons out through the levelingoutlet port192 that the levelingfluid inlet194 is again exposed to air in thebody112, the liquid continues to enter/pass through the levelingfluid inlet196 only while the air is blocked from passing through thebarrier198.
• For example, thebarrier198 may be a membrane formed from a hydrophilic material that prevents air from passing through thebarrier198 once thebarrier198 is wetted. Thus, inFIG.20 thebarrier198 is not yet wetted, so air may pass through and exit the levelingoutlet port192. Once thebarrier198 is wetted inFIG.21, thebarrier198 prevents air from passing through. When the liquid recedes from thebarrier198 inFIG.22, thebarrier198 is still wetted and thus continues to prevent air from passing through until it dries out.
• As another example, thebarrier198 may be an air check valve that allows air to pass through thebarrier198 while preventing liquid from passing through thebarrier198. Thus, inFIG.20 thebarrier198 is open to the air in thebody112, so air may pass through and exit the levelingoutlet port192. Once thebarrier198 is submerged under the liquid level inFIG.21, thebarrier198 prevents liquid from passing through levelingfluid inlet194 and thus the liquid only enters/passes through levelingfluid inlet196 and out the levelingoutlet port192. When the liquid recedes from thebarrier198 inFIG.22, the pressure exerted by the liquid trapped above thebarrier198 within the self-levelingassembly190 may prevent air from passing through thebarrier198 while liquid continues to enter/pass through the levelingfluid inlet196 and out the levelingoutlet port192.
• The self-levelingassembly190 eliminates the need to prime thedrip chamber110 by squeezing aflexible body112 to push air out and to allow fluid to enter through theinlet connector114. Thus, the self-levelingassembly190 provides for venting air from thedrip chamber110 regardless of whether thebody112 is flexible (e.g., flexible plastic) or stiff (e.g., hard plastic). Further, the self-levelingassembly190 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.
• The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. The disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.
• A reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.
• The word “exemplary” is used herein to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered to be at least equivalent.
• As used herein, the phrase “at least one of” preceding a series of items, with the term “or” to separate any of the items, modifies the list as a whole, rather than each item of the list. The phrase “at least one of” does not require selection of at least one item; rather, the 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” may refer to: only A, only B, or only C; or any combination of A, B, and C.
• A phrase such as an “aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects and vice versa. A phrase such as an “embodiment” does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. A phrase such an embodiment may refer to one or more embodiments and vice versa. A phrase such as a “configuration” does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. A disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. A phrase such a configuration may refer to one or more configurations and vice versa.
• In one aspect, unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. In one aspect, they are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.
• 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.
• All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. § 112 (f) unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step for.” Furthermore, 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.
• The Title, Background, Summary, Brief Description of the Drawings and Abstract of the disclosure are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. It is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the Detailed Description, it can be seen that the description provides illustrative examples and the various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed configuration or operation. The following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.
• The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language claims and to encompass all legal equivalents. Notwithstanding, none of the claims are intended to embrace subject matter that fails to satisfy the requirement of 35 U.S.C. § 101, 102, or 103, nor should they be interpreted in such a way.

Claims (20)

1. A modular intravenous (IV) assembly, comprising:

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;

a flow control assembly coupled directly to a first portion of the base housing, the flow control assembly comprising;

a roller housing;

a roller; and

a flow control membrane disposed between the roller and the flow path cavity in the base housing; and

a filter assembly coupled directly to a second portion of the base housing, the filter assembly comprising:

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.

2. The modular IV assembly ofclaim 1, wherein 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 a flow area, the flow area having a constant width and a varying depth.

3. The modular IV assembly ofclaim 1, wherein 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 a flow area, the flow area having a varying width and a constant depth.

4. The modular IV assembly ofclaim 1, wherein 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 a flow area, the flow area having a varying width and a constant depth.

5. The modular IV assembly ofclaim 1, wherein the first and second portions are on opposing surfaces of the base housing.

6. The modular IV assembly ofclaim 1, wherein the filter membrane comprises a hydrophilic material that prevents gas from passing through the filter membrane when the filter membrane is wetted.

7. The modular IV assembly ofclaim 1, wherein 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.

8. The modular IV assembly ofclaim 7, wherein 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.

9. The modular IV assembly ofclaim 1, further comprising an anti-run dry member comprising one of an individual layer disposed on the filter membrane and an integrally formed material comprising the filter membrane.

10. The modular IV assembly ofclaim 1, further comprising:

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 an opposing direction into the exit cavity.

11. The modular IV assembly ofclaim 10, wherein one of:

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; and

the fluid exit housing, the check valve and the exit cavity are disposed at a bottom portion of the base housing.

12. The modular IV assembly ofclaim 1, wherein the drip chamber further comprises a self-leveling assembly, the self-leveling assembly comprising:

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.

13. A modular intravenous (IV) assembly, comprising:

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;

a flow control assembly coupled directly to a first portion of the base housing, the flow control assembly comprising;

a roller housing;

a roller; and

a flow control membrane disposed between the roller and the flow path cavity in the base housing; and

an air vent assembly 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 comprising:

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, wherein 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.

14. The modular IV assembly ofclaim 13, wherein 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 a flow area, the flow area having a constant width and a varying depth.

15. The modular IV assembly ofclaim 13, wherein 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 a flow area, the flow area having a varying width and a constant depth.

16. The modular IV assembly ofclaim 13, wherein 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 a flow area, the flow area having a varying width and a constant depth.

17. The modular IV assembly ofclaim 13, further comprising a filter assembly comprising:

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.

18. The modular IV assembly ofclaim 17, wherein 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, 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, wherein 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.

19. The modular IV assembly ofclaim 17, further comprising an anti-run dry member comprising one of an individual layer disposed on the filter membrane and an integrally formed material comprising the filter membrane.

20. The modular IV assembly ofclaim 13, wherein the drip chamber further comprises a self-leveling assembly, the self-leveling assembly comprising:

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.

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