Pressure-actuated one-way flow control apparatus for gravity IV device

Abstract

A flow control device includes a housing having a primary inlet, a secondary inlet, and an outlet disposed downstream of the primary inlet and the secondary inlet. The flow control device further includes a chamber defined by an inner circumferential surface of the housing. The chamber fluidly connects the primary inlet and the secondary inlet with the outlet. A valve member is mounted in the chamber that pivots toward and blocks the primary inlet by the fluid pressure in the secondary inlet when the fluid pressure into the secondary inlet is higher than the fluid pressure into the primary inlet.

Description

[0001] This application is a divisional application of the application filed on September 17, 2021, with application number 202111095211.4 and invention title "Pressure-Actuated One-Way Flow Control Device for Gravity IV Device". Technical Field

[0002] The present invention relates generally to flow control devices, and more specifically to flow control devices having a valve member capable of preventing insufficient infusion in IV (intravenous) devices with auxiliary lines, and preventing medication from flowing back from the auxiliary lines into the main lines. Background Technology

[0003] Intravenous IV devices are commonly used in infusion therapy to deliver medications from pre-filled containers (e.g., IV bottles or bags containing the desired medication) to a patient. Typically, an IV fitting is connected to a catheter and inserted into the local area to be treated. In some cases, it is necessary to deliver multiple medications to a patient at potentially different doses, resulting in the need for an IV extension device with multiple branches or fluid lines, through which multiple medications can be dispensed to the patient.

[0004] IV solutions are typically administered to patients via injection. These solutions are initially provided in an IV bottle or bag and then dripped into the patient's vein through an IV line. Flow control devices (e.g., check valves) are usually also included in the IV line to allow fluid to flow only in the direction of the patient. This ensures that the medication flows downstream towards the patient, rather than upstream towards the IV bottle or bag.

[0005] During IV infusion, auxiliary medication supply may potentially flow backward into the main IV line, leading to insufficient auxiliary medication infusion. Although check valves are positioned in the main line to prevent backflow, they are prone to frequent failure. A common cause of check valve failure is the presence of debris in the infusion. Furthermore, insufficient infusion frequently occurs because air enters the auxiliary line, causing some auxiliary medication to remain in the auxiliary line (undelivered medication). Air entering the IV line can have adverse effects, such as causing air embolism in the patient.

[0006] The descriptions provided in the background section should not be considered prior art simply because they are mentioned in or associated with the background section. The background section may include information describing one or more aspects of the subject matter art. Summary of the Invention

[0007] According to various embodiments of this disclosure, a flow control device may include a housing having a main inlet, an auxiliary inlet, and an outlet disposed downstream of the main inlet and the auxiliary inlet. A chamber may be defined by an inner circumferential surface of the housing. The chamber may fluidly connect the main inlet and the auxiliary inlet to the outlet. The flow control device may further include a valve member mounted in the chamber, such that when the fluid pressure entering the auxiliary inlet is higher than the fluid pressure entering the main inlet, the valve member pivots toward the main inlet by the fluid pressure in the auxiliary inlet and blocks the main inlet.

[0008] According to various embodiments of this disclosure, the flow control device may include a housing having an inner circumferential surface defining a chamber. The housing may include a main inlet configured to receive a main fluid line, an auxiliary inlet configured to receive an auxiliary fluid line, and an outlet disposed downstream of the main inlet and the auxiliary inlet. The flow control device may further include a valve member mounted on the inner circumferential surface. The valve member may include a lever having a first end and a second end, a fulcrum on which the lever is supported and pivoted, a main line sealing member disposed at the first end corresponding to the main inlet, and an auxiliary line sealing member disposed at the second end corresponding to the auxiliary inlet.

[0009] It should be understood that other configurations of the subject matter will readily become apparent to those skilled in the art from the following detailed description, wherein various configurations of the subject matter are shown and described by way of illustration. As will be appreciated, the subject matter can have other and different configurations, and certain details thereof can be modified in various other respects, all without departing from the scope of the subject matter. Therefore, the accompanying drawings and detailed description should be considered illustrative in nature, rather than limiting. Attached Figure Description

[0010] The following figures are included to illustrate certain aspects of the embodiments and should not be considered as exclusive embodiments. As will be appreciated by those skilled in the art and those who benefit from this disclosure, the disclosed subject matter is capable of considerable modifications, alterations, combinations, and equivalents in form and function.

[0011] Figure 1 An IV extension device including a flow control device is shown according to some embodiments of the present disclosure.

[0012] Figure 2A Some embodiments according to this disclosure are shown. Figure 1 A perspective view of the flow control device.

[0013] Figure 2B Some embodiments according to this disclosure are shown. Figure 2A An enlarged view of the flow control equipment and valve components.

[0014] Figure 3A The non-actuated operation state of the flow control device and valve component according to some embodiments of the present disclosure is shown.

[0015] Figure 3B Some embodiments according to this disclosure are shown. Figure 3A The operating state of the flow control equipment and valve components, in which the main fluid line is used and fluid flows only through the main line.

[0016] Figure 3C Some embodiments according to this disclosure are shown. Figure 3A The operating status of the flow control equipment and valve components, wherein both the main fluid line and the auxiliary fluid line are used, and the fluid pressure in the auxiliary line is higher than the fluid pressure in the main fluid line.

[0017] Figure 3D Some embodiments according to this disclosure are shown. Figure 3A The operating status of the flow control equipment and valve components, at which point the pressure of the fluid discharged from the auxiliary fluid pipeline into the main fluid pipeline is equal to the pressure of the fluid in the auxiliary fluid pipeline.

[0018] Figure 4A and 4B The configuration of a flow control device according to some embodiments of the present disclosure is shown. Detailed Implementation

[0019] The detailed description below illustrates various configurations of the subject matter and is not intended to represent the only configuration in which the subject matter can be practiced. For the purpose of providing a thorough understanding of the subject matter, the detailed description includes specific details. Therefore, dimensions regarding certain aspects may be provided as non-limiting examples. However, it will be apparent to those skilled in the art that the subject matter can be practiced without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject matter.

[0020] It should be understood that this disclosure includes examples of the subject matter and does not limit the scope of the appended claims. Various aspects of the subject matter are now disclosed based on specific, but not limiting, examples. The various embodiments described in this disclosure may be practiced in different ways and variations, and may conform to desired applications or implementations.

[0021] This specification relates generally to flow control devices, and more specifically to flow control devices having valve components that prevent insufficient infusion in IV devices with auxiliary fluid lines and prevent backflow of medication from the auxiliary fluid lines into the main fluid lines.

[0022] IV systems with auxiliary fluid lines often experience under-infusion of auxiliary medication due to check valve failure in the main fluid line. The most common cause of check valve failure is debris buildup in the auxiliary fluid line as medication rushes in and seeps into the main fluid line under low pressure. Common causes of under-infusion include medication dilution during auxiliary IV reinjection and when the head in the main and auxiliary fluid lines is equal. Other causes include dead volume in the auxiliary fluid line and the time taken to infuse the medication. The flow control devices of various embodiments described herein overcome the aforementioned problems commonly associated with IV systems having main and auxiliary fluid lines.

[0023] Figure 1 A multi-line IV extension device 1 including a flow control device 100 is shown according to some embodiments of the present disclosure. As shown, the IV device 1 includes a main fluid system 15 and an auxiliary fluid system 25. An IV pump (not shown) receives fluid from the main fluid system 15 and the auxiliary fluid system 25 via the main IV fluid line 5 and the auxiliary IV fluid line 7, and can control the fluid and distribute it to the patient 50.

[0024] In some embodiments, the primary fluid system 15 may include a primary fluid source or container, such as a primary intravenous (IV) fluid bag 10, which may include or contain a first medical fluid, such as a saline solution or other medical fluid or agent to be administered to the patient 50. According to some embodiments, the auxiliary fluid system 25 may include an auxiliary fluid source or container, such as an auxiliary IV fluid bag 20, which may contain a second medical fluid, such as an agent or other auxiliary fluid to be supplied to the patient 50 for treatment. In some embodiments, the second medical fluid may be different from the first medical fluid. However, various embodiments of this disclosure are not limited to the configuration described above. In other embodiments, the first and second fluids may be the same.

[0025] According to various embodiments of this disclosure, such as Figure 1 As shown, the main IV fluid bag 10, which contains the main fluid, can be positioned at a lower axial position or height than the auxiliary IV fluid bag 20. For example, the main IV fluid bag 10 can be suspended on a suspension system or hanger, and then the auxiliary IV fluid bag 20 can be suspended above the main IV fluid bag and connected to the auxiliary fluid line 7, which is connected to the main fluid line 5 via a flow control device 100.

[0026] As shown in the figure, the main IV fluid line 5 delivers the main fluid from the drip chamber 12 to the flow control device 100. As will be further described with reference to the following figures, the flow control device 100 may be an external flow control device that fluidly connects or communicates the main IV fluid line 5 and the auxiliary IV fluid line 7 to the outlet fluid line 9 to allow fluid to flow from the main fluid bag 10 and / or the auxiliary fluid bag 20 via the outlet 9 to the IV pump (not shown), while preventing reverse flow (backflow) of fluid from the auxiliary fluid system 25 toward the main fluid bag 10.

[0027] Figure 2A This is a perspective view of a flow control device according to some embodiments of the present disclosure. Figure 2B Some embodiments according to this disclosure are shown. Figure 2A Enlarged view of the flow control equipment and valve components. (Reference) Figure 2A and 2B The flow control device 100 may have a housing 102 including a main inlet 104 and an auxiliary inlet 106. As shown, the main inlet 104 and the auxiliary inlet 106 may be disposed on the upper surface 105 of the housing. The housing 102 may further include an outlet 108 disposed downstream of the main inlet 104 and the auxiliary inlet 106. For example, the outlet 108 may be disposed on the lower surface 104 of the housing 102. The outlet 108 may define a fluid path through which a drug or agent (e.g., a first or main fluid and / or an auxiliary fluid) from the main inlet 104 and the auxiliary inlet 106 may be delivered to the patient 50.

[0028] A main inlet 104 can be configured to receive a main fluid line 5, and an auxiliary inlet 106 can be configured to receive an auxiliary fluid line 7. An outlet 108 can be configured to receive an outlet fluid line 9. The flow control device 100 may further include a chamber 110 defined by an inner circumferential surface 115 of the housing 102. The chamber 110 may include an upper surface 112 in fluid communication with the main inlet 104 and the auxiliary inlet 106, and a lower surface 114 in fluid communication with the outlet 108. As shown, the chamber 110 can fluidly connect the main inlet 104 and the auxiliary inlet 106 to the outlet 108. Therefore, medical fluid from each fluid bag 10 and 20 can flow from the corresponding main fluid line 5 and auxiliary fluid line 7 into the chamber 110 and be delivered to the patient 50 via the outlet 9.

[0029] According to various aspects of this disclosure, the flow control device may include a valve member 120 mounted in a chamber 110. The valve member 120 may be pivotally mounted on the upper surface 112 of the chamber 110. In some embodiments, such as Figure 2BAs shown, the valve member 120 can be in the form of a lever having a first end 122 and a second end 124. The lever 125 can have a fulcrum 155 located between the first end 122 and the second end 124 of the lever 125. Therefore, the valve member 120 can be in the form of a single-stage lever, wherein the fulcrum is located between the load and the applied force.

[0030] According to various embodiments of this disclosure, the first end 122 and the second end 124 of the lever 120 can be positioned axially offset from each other. For example, in the non-actuated state of the valve member 120, the first end can be positioned at a position axially higher than the second end 124. Figure 2B As shown, in the non-actuated state, the first end 122 can be positioned upstream of the second end 124. For this purpose, the lever 120 may include a transition step 160 disposed between the first end 122 and the second end 124, and the transition step has a height corresponding to the axial offset or height between the first end 122 and the second end 124. As shown, the lever 120 may include a main portion 123 and an auxiliary portion 125. The main portion 123 extends from the first end 122 and terminates at the transition step 160. The auxiliary portion 125 extends from the transition step 160 and terminates at the second end 124.

[0031] In some embodiments, the fulcrum 155 may be positioned on the main portion 123. Thus, the main portion 123 of the lever 120 may be coupled to the upper surface 112 of the chamber 110 to allow the lever 120 to pivot about the fulcrum 155.

[0032] According to various embodiments of this disclosure, lever 120 may further include a main conduit sealing member 130 disposed on the main portion 123 at a position corresponding to the main inlet 104. Furthermore, lever 120 may further include an auxiliary conduit sealing member 140 disposed on the auxiliary portion 125 at a position corresponding to the main inlet 104. For example, in the non-actuated state of lever 120, the main conduit sealing member 130 may be axially aligned with the main inlet port 140. Similarly, in the non-actuated state of lever 120, the auxiliary conduit sealing member 140 may be axially aligned with the auxiliary inlet port 106. The distance between the main conduit sealing member 130 and the fulcrum 155 may be less than the distance between the auxiliary conduit sealing member 140 and the fulcrum 155. Therefore, as will be described in further detail below, when an auxiliary medical fluid is applied from the fluid bag 20 and the fluid pressure entering the auxiliary inlet 106 is higher than the fluid pressure entering the main inlet 104, the valve member or lever 120 can be actuated by the fluid pressure in the auxiliary inlet 106 to pivot toward the main inlet 104 and block the main inlet.

[0033] In some embodiments, the flow control device 100 may further include a vent 170 disposed on the upper surface 105 of the housing 102. The vent 170 may be in fluid communication with the chamber 110 for discharging air trapped in the auxiliary medical fluid entering the chamber. Therefore, an advantage of the flow control devices of the various embodiments described herein is that it eliminates the need for pre-filling the auxiliary fluid line 7. When the auxiliary fluid line 7 is fluidly connected to the flow control device 100 such that the auxiliary medical fluid flows into the chamber 110, any air trapped in the auxiliary medical fluid entering the chamber can be discharged through the vent 170. In some embodiments, the vent 170 may have a hydrophilic membrane that allows air, but not liquid, to pass through and be discharged to the outside of the flow control device 100.

[0034] Figure 3A The diagram illustrates the non-actuated operating state of a flow control device and valve component according to some embodiments of the present disclosure. As shown, in the non-actuated state of lever 120, the main portion 123 of the lever is positioned upstream of the auxiliary portion 125 of lever 120. For example, in the non-actuated state of valve component 120, the main line sealing member 130 may contact and abut against the upper surface 112 of chamber 110, while the auxiliary line sealing member 140 may be axially spaced from the upper surface 112 of chamber 110.

[0035] Figure 3B Some embodiments according to this disclosure are shown. Figure 3A The flow control device and valve components are in operation, wherein the primary IV (PIV) fluid line 5 is in use, and fluid flows only through the primary fluid line 5. As shown, the primary fluid line 5 is attached, fluidly connected to the fulcrum chamber, and then infused as in the existing IV device. Due to the fluid flowing through the primary fluid line 5, the fluid pressure in the primary fluid line 5 is higher than the fluid pressure in the auxiliary IV (SIV) fluid line 7, through which no fluid flows. The higher pressure head at the primary fluid line 5 causes the lever 120 to pivot about the fulcrum 155, causing the first end 122 of the lever 120, which has the primary line sealing component, to tilt or otherwise rotate downstream away from the upper surface 112 of the chamber 110. Thus, fluid communication is established between the primary fluid line 5 and the chamber 110, and the primary medical fluid flows into the chamber. When the first end 122 is tilted or rotated away from the upper surface 112, the second end 124 of the lever 120 tilts or otherwise rotates upstream toward the auxiliary inlet 106 until the auxiliary line sealing member 140 contacts and seals the auxiliary inlet. In this state, the auxiliary line sealing member 140 engages with the auxiliary fluid line 7 and blocks fluid communication between the auxiliary fluid line 7 and the chamber 110. Therefore, the main fluid can flow from the main fluid line 5 through the chamber and outlet 9 to the patient 50.

[0036] Figure 3C Some embodiments according to this disclosure are shown. Figure 3A The flow control device and valve assembly are in operation, wherein both the main fluid line 5 and the auxiliary fluid line 7 are used, and the fluid pressure in the auxiliary fluid line 7 is higher than the fluid pressure in the main fluid line 5. When auxiliary medical fluid needs to be applied, the auxiliary fluid line 7 can then be directly connected to the flow control device 100 to allow fluid connection between the auxiliary fluid line 7 and the chamber 110. Because the auxiliary fluid bag 10 can be positioned at a higher axial position or height than the main fluid bag 10, the pressure head (fluid pressure) at the auxiliary fluid line 7 is higher than the pressure head (fluid pressure) at the main fluid line 5. Because the main fluid bag 10 connected to the main fluid line 5 is positioned at a height below the auxiliary fluid bag 20 connected to the auxiliary fluid line 7, the fluid in the auxiliary fluid line 7 can generate a greater hydrostatic pressure on the valve assembly or lever 120 than the fluid in the main fluid line 5.

[0037] In some embodiments, a higher pressure head at the auxiliary fluid line 7 causes the lever 120 to pivot about the fulcrum 155, causing the second end 124 of the lever 120, on which the auxiliary line sealing member is located, to tilt or otherwise rotate downstream away from the upper surface 112 of the chamber 110, such as... Figure 4A As shown. Therefore, fluid communication is established between the auxiliary fluid line 7 and the chamber 110, and auxiliary medical fluid flows into the chamber 110. When the second end 124 is tilted or rotated away from the upper surface 112, the first end 122 of the lever 120 tilts towards the main inlet 104 or otherwise rotates upstream towards the main inlet 104 until the main line sealing member 130 contacts and seals the main inlet. In this state, the main line sealing member 130 engages with the main fluid line 5 and blocks the fluid communication between the main fluid line 5 and the chamber 110. The hydrostatic pressure of the fluid from the auxiliary fluid line 7 is transmitted to pivot the lever 120, such that during the infusion of the auxiliary medical fluid, fluid flow from the main fluid line 5 into the chamber 110 is blocked. Therefore, only fluid from the auxiliary fluid line 7 can flow into the chamber 114 via the auxiliary inlet 106. Thus, fluid from the auxiliary fluid line 7 can be delivered to the patient 50 through the outlet 108 and the outlet fluid line 9.

[0038] Therefore, backflow of fluid from the auxiliary fluid line 7 into the main fluid line 5 is prevented. Similarly, insufficient administration of auxiliary medications can be prevented—which typically occurs due to the flow of auxiliary medical fluid from chamber 110 into the main fluid line 5. Preventing or limiting fluid backflow is advantageous because it restricts the backward flow of unwanted particulate matter (e.g., unwanted particulate matter contained in the medical fluid dispensed from the auxiliary fluid line 7) from chamber 110 (and the auxiliary fluid line 7) into the main fluid line 5, which would otherwise prevent the patient 50 from receiving the appropriate dose concentration of medical fluid (medication) or timely delivery of medication.

[0039] Refer back Figure 3C The flow of medical fluid from the auxiliary fluid line 7 to the chamber 110 will continue until the medical fluid in the auxiliary bag 20 is depleted. In some cases, a small amount of auxiliary medical fluid can be retained in the auxiliary fluid line 7. For example, when the fluid pressures in the main fluid line 5 and the auxiliary fluid line 7 are equal, this small amount of medical fluid can be slowly infused into the chamber along with the main medical fluid, such as... Figure 3D As shown.

[0040] Figure 3D Some embodiments according to this disclosure are shown. Figure 3A The flow control equipment and valve components are in an operating state where the auxiliary fluid line 7 has been discharged to the point where the fluid pressure in the main fluid line 5 is equal to the fluid pressure in the auxiliary fluid line 7. During operation, when subjected to a main fluid pressure equal to the auxiliary fluid pressure (i.e., the pressure exerted by the fluid flowing from the main IV fluid line 5 into the main inlet 104, which is equal to the pressure exerted by the fluid flowing from the auxiliary IV fluid line 7 into the auxiliary inlet 106), the auxiliary medical fluid can continue to flow into the chamber 110. Specifically, due to the structure of the lever 120 having a transition step 160 and a fulcrum 155 positioned on the main portion 123 of the lever 120, which is positioned in an axially elevated position relative to the auxiliary portion 125, the auxiliary line sealing member 140 will be spaced apart from the upper surface 112 of the housing, thereby allowing the auxiliary medical fluid to continue flowing, while the main medical fluid is blocked from entering by the elevated main seal 130. Therefore, when the fluid pressures in the main IV fluid line 5 and the auxiliary IV fluid line 7 are equal, only the auxiliary medical fluid can be dispensed to the patient.

[0041] Once the auxiliary medical fluid has been depleted or is nearing the end of the auxiliary infusion—due to the lack of hydrostatic pressure in the auxiliary fluid line 7—lever 120 can pivot about fulcrum 155, causing the main line sealing member 130 to separate from the main fluid line 5. Therefore, fluid communication between the main fluid line 5 and chamber 110 can be re-established, and the main medical fluid can flow into chamber 110. Since the auxiliary fluid line 7 closes only when the pressure in the main fluid line 5 is higher than the pressure in the auxiliary fluid line 7, the auxiliary medical fluid will flow upwards until then, thus advantageously eliminating dead volume in the auxiliary fluid line 7.

[0042] Figure 4A and 4B A flow control device according to some embodiments of the present disclosure is shown. Although it has been described herein... Figure 4A The configuration shown describes the flow control device 100, but various embodiments of this disclosure are not limited to this configuration. In some embodiments, the housing 102 may have, as Figure 4B The shape shown. In these embodiments, the structure and function of all other components of the flow control device 100 as previously described can remain the same. Figure 4B The housing 102 of the illustrated embodiment may offer the advantage of a smaller footprint or size, which may make it more suitable for use in IV device 1.

[0043] According to some embodiments of this disclosure, the flow control device 100 may include a spring or other elastic body for preloading the lever 120. For example, the flow control device 100 may include a compression spring disposed between the auxiliary line sealing member 140 and the housing 102 to ensure that a preload or positive force is continuously applied to the auxiliary portion 125 of the lever 120.

[0044] In some embodiments, lever 120 may be a lever with a single arm. For example, lever 120 may be designed without a transition step 160. In these embodiments, the single-arm lever may be configured, assembled, or otherwise formed to selectively open and close the main inlet 104 based on the fluid level within chamber 110. When the agent flowing into chamber 110 from the main inlet 104 or the auxiliary inlet 106 raises the fluid level in the chamber above the base of the single-arm lever, the single-arm lever may begin to float upward or upstream due to the buoyancy of the fluid in chamber 110 acting on the base of the single-arm lever. Therefore, the main sealing conduit member 130 may contact and close the main inlet 104, allowing only auxiliary fluid to flow into chamber 110.

[0045] In one or more embodiments of this disclosure, the flow control device includes a housing having a main inlet, an auxiliary inlet, and an outlet disposed downstream of the main inlet and the auxiliary inlet; a chamber defined by an inner circumferential surface of the housing that fluidly connects the main inlet and the auxiliary inlet to the outlet; and a valve member mounted in the chamber that, when the fluid pressure entering the auxiliary inlet is higher than the fluid pressure entering the main inlet, pivots toward the main inlet by the fluid pressure in the auxiliary inlet and blocks the main inlet.

[0046] In one aspect of this disclosure, the chamber includes an upper surface in fluid communication with a main inlet and an auxiliary inlet, and a lower surface in fluid communication with an outlet; and a valve member is pivotally mounted on the upper surface of the chamber. In another aspect of this disclosure, the valve member includes a lever having a first end and a second end; and a fulcrum of the lever is disposed between the first and second ends of the lever. In yet another aspect of this disclosure, the first and second ends of the lever are axially offset from each other; and the lever includes a step having a height corresponding to the axial offset of the first and second ends.

[0047] In this aspect of the disclosure, the lever includes a main portion and an auxiliary portion; the main portion extends from a first end of the lever to a step; and the auxiliary portion extends from the step to a second end of the lever. In this aspect of the disclosure, a fulcrum is positioned on the main portion. In this aspect of the disclosure, the lever further includes: a main pipe sealing member disposed on the main portion at a position corresponding to a main inlet; and an auxiliary pipe sealing member disposed on the auxiliary portion at a position corresponding to an auxiliary inlet. In this aspect of the disclosure, the distance between the main pipe sealing member and the fulcrum is less than the distance between the auxiliary pipe sealing member and the fulcrum. In this aspect of the disclosure, in the non-actuated state of the valve member: the main pipe sealing member contacts the upper surface of the chamber; and the auxiliary pipe sealing member is axially spaced from the upper surface of the chamber.

[0048] In one or more embodiments of this disclosure, the flow control device includes a housing having an inner circumferential surface defining a chamber, and including a main inlet configured to receive a main fluid line, an auxiliary inlet configured to receive an auxiliary fluid line, and an outlet disposed downstream of the main inlet and the auxiliary inlet; and a valve member mounted on the inner circumferential surface. The valve member includes a lever having a first end and a second end; a fulcrum on which the lever is supported and pivoted; a main line sealing member disposed at the first end at a position corresponding to the main inlet; and an auxiliary line sealing member disposed at the second end at a position corresponding to the auxiliary inlet.

[0049] In this aspect of the disclosure, the distance between the main pipe sealing member and the fulcrum is less than the distance between the auxiliary pipe sealing member and the fulcrum. In this aspect of the disclosure, the first and second ends of the lever are axially offset from each other; and the lever includes a step having a height corresponding to the axial offset between the first and second ends. In this aspect of the disclosure, the lever includes a main portion and an auxiliary portion; the main portion extends from the first end of the lever to the step; and the auxiliary portion extends from the step to the second end of the lever. In this aspect of the disclosure, the fulcrum is positioned on the main portion. In this aspect of the disclosure, in the non-actuated state of the valve member, the main portion of the lever is positioned upstream of the auxiliary portion of the lever. In this aspect of the disclosure, in the non-actuated state of the valve member: the main pipe sealing member contacts the upper surface of the chamber; and the auxiliary pipe sealing member is axially spaced from the upper surface of the chamber.

[0050] In this aspect of the disclosure, a main fluid line is connected to a main fluid container, and an auxiliary fluid line is connected to an auxiliary fluid container, the main fluid container being positioned at a lower height than the auxiliary fluid container; and because the main fluid container is positioned at a lower height than the auxiliary fluid container, the fluid in the auxiliary fluid line generates a greater hydrostatic pressure on the valve member than the fluid in the main fluid line. In this aspect of the disclosure, the main fluid container includes a main intravenous (IV) fluid bag containing a main medical fluid, and the auxiliary fluid container includes an auxiliary IV fluid bag containing an auxiliary medical fluid different from the main medical fluid. In this aspect of the disclosure, a vent is provided on the upper surface of the housing, the vent being in fluid communication with a chamber for discharging air trapped in the fluid entering the chamber through the auxiliary fluid line. In this aspect of the disclosure, the vent includes a hydrophilic membrane that allows air to exit through the vent and prevents liquid from passing through it.

[0051] Therefore, as previously described, various embodiments of this disclosure advantageously provide a flow control device capable of preventing insufficient infusion of auxiliary medications by blocking the backward flow of auxiliary medications into the main IV fluid line. The flow control device of the various embodiments described herein is further advantageous because it minimizes the number of separate components in the IV device by replacing check valves and Y-connectors with a single flow control device. Consequently, the cost of the IV device can be reduced. Furthermore, various embodiments of this disclosure advantageously reduce the workflow steps for clinicians / nurses because flow regulation does not require manual operation when the flow pressure of the auxiliary medication or fluid is used to regulate the flow of the main medication or fluid, and the auxiliary fluid line does not require perfusion.

[0052] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject matter, and the subject matter is not limited to these examples. Various modifications to these aspects will be apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0053] Unless otherwise specified, references to elements in the singular form are not intended to mean "one and only one," but rather "one or more." Unless otherwise specified, the term "some" refers to one or more. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. Titles and subtitles, if any, are used for convenience only and do not limit the invention.

[0054] The term “exemplary” as used herein means “serving as an example or illustration.” Any aspect or design described herein as “exemplary” is not necessarily to be construed as being superior or more advantageous than other aspects or designs. In one aspect, the various alternative configurations and operations described herein may be considered at least equivalent.

[0055] As used herein, the phrase "at least one" preceding a series of entries, separated by the term "or," modifies the list as a whole, rather than each entry in the list. The phrase "at least one" does not require the selection of at least one entry; rather, it allows for the meaning of including at least one of any one entry, and / or at least one of any combination of entries, and / or at least one of each entry. For example, the phrase "at least one of A, B, or C" can refer to: only A, only B, or only C; or any combination of A, B, and C.

[0056] For example, phrases such as "aspect" do not imply that such an aspect is necessary for the subject matter art, or that such an aspect can be applied to all configurations of the subject matter art. Disclosure relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. For example, phrases such as "aspect" may refer to one or more aspects, and vice versa. For example, phrases such as "embodiment" do not imply that such an embodiment is necessary for the subject matter art, or that such an embodiment can be applied to all configurations of the subject matter art. Disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. For example, phrases such as "embodiment" may refer to one or more embodiments, and vice versa. For example, phrases such as "configuration" do not imply that such a configuration is necessary for the subject matter art, or that such a configuration can be applied to all configurations of the subject matter art. Disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. For example, phrases such as "configuration" may refer to one or more configurations, and vice versa.

[0057] In one aspect, unless otherwise stated, all measurements, numerical values, ratings, positions, magnitudes, sizes, and other specifications set forth in this specification (including in the following claims) are approximate, not precise. In one aspect, they are intended to have a reasonable range consistent with the function they pertain to and with custom in the field to which they belong.

[0058] It should be understood that the specific order or hierarchy of steps or operations in the disclosed process or method is an illustration of an exemplary method. Depending on implementation preferences or scenarios, it should be understood that the specific order or hierarchy of steps, operations, or processes can be rearranged. Some steps, operations, or processes may be performed simultaneously. In some implementation preferences or scenarios, some operations may be performed or not. Some or all steps, operations, or processes can be performed automatically without user intervention. The appended method claims present elements of various steps, operations, or processes in a sample order and are not intended to limit one to the specific order or hierarchy presented.

[0059] All structural and functional equivalents of elements throughout the various aspects of this disclosure that are known to or will be known hereafter by one of ordinary skill in the art are expressly incorporated herein by reference and are intended to be covered by the claims. Furthermore, nothing disclosed herein is intended to be exclusive to the public, whether or not such disclosure is expressly stated in the claims. No claim element may be construed under 35 U.S.C. § 112(f) unless it is expressly stated using the phrase “means for…” or, in the case of a method claim, using the phrase “steps for…”. Furthermore, with regard to the use of terms such as “comprising,” “having,” etc., such terms are intended to be included in a manner similar to how the term “comprising” is interpreted when used as a transitional word in a claim.

[0060] The title, background, overview, brief description of the drawings, and abstract of this disclosure are thus incorporated into this disclosure and are provided as illustrative examples rather than limiting descriptions. This application is filed on the understanding that they are not intended to limit the scope or meaning of the claims. Furthermore, it will be apparent from the detailed description that it provides illustrative examples, and various features are grouped together in various embodiments for the purpose of simplification. The method disclosed should not be construed as reflecting an intention to require more features than expressly stated in each claim. Rather, as reflected in the following claims, the inventive subject matter lies in all features of fewer than those in a single disclosure configuration or operation. The following claims are thus incorporated into the detailed description, each claim existing independently as a separate claimed subject matter.

[0061] The claims are not intended to be limited to the aspects described herein, but are given the full scope consistent with the language of the claims and cover all legal equivalents. Nevertheless, none of the claims are intended to cover subject matter that fails to meet the requirements of Sections 101, 102, or 103 of Title 35 of the United States Code, nor should they be interpreted in this manner.

Claims

1. A gravity flow control device, comprising: The housing includes a main inlet and an auxiliary inlet respectively disposed on the upper surface of the housing, and an outlet disposed on the lower surface of the housing, downstream of the main inlet and the auxiliary inlet by gravity; A chamber disposed within the housing and fluidly connected to the main inlet and auxiliary inlet and the outlet; as well as A valve member pivotally mounted on the upper surface of the chamber, the valve member being configured to pivot in response to higher fluid pressure generated from gravity fluid flow through one of the main inlet and the auxiliary inlet.

2. The gravity flow control device according to claim 1, wherein, The valve member is configured to pivot toward the main inlet and block the main inlet when the fluid pressure entering the auxiliary inlet is higher than the fluid pressure entering the main inlet, and to pivot toward the auxiliary inlet and block the auxiliary inlet when the fluid pressure entering the main inlet is higher than the fluid pressure entering the auxiliary inlet.

3. The gravity flow control device according to claim 1, wherein, The valve component further includes: lever; The main pipeline sealing component is disposed on the lever at a position corresponding to the main inlet; and An auxiliary pipeline sealing component is disposed on the lever at a position corresponding to the auxiliary inlet.

4. The gravity flow control device according to claim 3, wherein, In the non-actuated state of the valve component: The main pipeline sealing component contacts the upper surface of the chamber; and The auxiliary pipeline sealing component is axially spaced from the upper surface of the chamber.

5. The gravity flow control device according to claim 3, wherein, The lever includes a first end and a second end that are axially offset from each other.

6. The gravity flow control device according to claim 5, wherein, The lever includes a step having a height corresponding to the axial offset of the first end and the second end.

7. The gravity flow control device according to claim 6, wherein, The lever includes a main portion extending from the first end to the step and an auxiliary portion extending from the step to the second end.

8. The gravity flow control device according to claim 7, wherein, The lever includes a fulcrum disposed on the upper surface of the main part of the lever.

9. The gravity flow control device according to claim 8, wherein, The fulcrum is located between the first end and the step, and is separate from both the first end and the step.

10. The gravity flow control device according to claim 8, wherein, The distance between the main pipeline sealing component and the fulcrum is less than the distance between the auxiliary pipeline sealing component and the fulcrum.

11. The gravity flow control device according to claim 1, wherein, The housing includes a circular housing having an inner circumferential surface that defines the chamber as a circular chamber.

12. The gravity flow control device according to claim 1, wherein, The housing includes a cylindrical housing with a circular outer wall between a flat upper surface and a flat lower surface.

13. The gravity flow control device according to claim 1, wherein, The housing is an octagonal housing having an upper surface comprising a flat top portion between two angled portions, wherein the main inlet and the auxiliary inlet are respectively disposed on the two angled portions.

14. The gravity flow control device according to claim 1, further comprising a vent disposed on the upper surface of the housing and fluidly connected to the chamber.

15. The gravity flow control device according to claim 1, wherein, The vent includes a hydrophilic membrane to prevent fluid from passing through it.

16. An intravenous injection device, comprising: Main fluid container; Auxiliary fluid container; Main intravenous fluid lines; Assisted intravenous fluid lines; and The gravity flow control device according to claim 1.

17. The intravenous injection device according to claim 16, wherein, The main intravenous fluid line is connected to the main fluid container, and the auxiliary intravenous fluid line is connected to the auxiliary fluid container. The main fluid container is positioned at a height lower than that of the auxiliary fluid container.

18. The intravenous injection device according to claim 17, wherein, The valve member is configured to pivot and block the main inlet due to the height difference between the main fluid container and the auxiliary fluid container, based on the greater hydrostatic pressure generated on the valve member by the auxiliary fluid in the auxiliary fluid line than the main fluid in the main fluid line.

19. The intravenous injection device according to claim 18, wherein, The valve member is configured to pivot and not block the main inlet due to the depletion of auxiliary fluid in the auxiliary fluid container, based on the fact that the hydrostatic pressure of the auxiliary fluid from the auxiliary fluid line on the valve member is lower than the hydrostatic pressure of the main fluid from the main fluid line.

20. The intravenous injection device according to claim 16, wherein, The primary fluid container includes a primary intravenous fluid bag containing a primary medical fluid, and the secondary fluid container includes a secondary intravenous fluid bag containing a secondary medical fluid different from the primary medical fluid.

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