Floater-based flow control device for gravity-type IV sets

Abstract

To prevent insufficient infusion in IV sets with a secondary line, and to prevent drug backflow from the secondary line to the primary line. [Solution] The flow control device of the present invention includes an upper housing, a lower housing, a chamber interposed between the upper housing and the lower housing and defined thereby, and a valve member. The upper housing includes a primary inlet and a secondary inlet having an inner surface that defines a cavity. The lower housing defines the outlet of the flow control device. The chamber fluidly connects the primary and secondary inlets to the outlet. The valve member is arranged at least partially in the cavity and partially in the chamber to selectively allow fluid flow to the primary inlet in a first direction when the fluid level in the chamber is below a predetermined level, and to prevent fluid backflow in a second direction opposite to the first direction when the fluid level in the chamber exceeds a predetermined level.

Description

[Technical Field]

[0001] This disclosure relates to a flow control device in general, and more particularly to a flow control device having a valve member capable of preventing under-infusion in an intravenous (IV) set having a secondary line, and preventing backflow of drug from the secondary line to the primary line. [Background technology]

[0002] Infusion IV sets are generally used in infusion therapy to deliver medication to a patient from a pre-filled container, such as an IV bottle or bag containing the desired drug. Typically, the IV tube is connected to a catheter and inserted into the local area being treated. In some cases, it may be necessary to deliver multiple medications to a patient, which may involve different dosages, thus creating the need for an IV dilation set with multiple tubular branches or fluid lines capable of administering multiple medications to the patient.

[0003] Patients are typically administered IV solutions, which are first supplied into an IV bottle or bag and then infused into the patient's vein through an IV line. Flow control devices, such as check valves, are also commonly included in the IV line to allow fluid flow only in the direction of the patient. This ensures that the medication flows downstream towards the patient and not upstream towards the IV bottle or bag.

[0004] During IV infusion, the secondary drug supply may flow back into the primary IV line, potentially causing insufficient delivery of the secondary drug. While a check valve may be placed in the primary line to prevent backflow, check valves are prone to failure. A common reason for check valve failure is debris present in the infusion fluid. Furthermore, air entering the secondary line often leads to insufficient delivery, resulting in some of the secondary drug remaining in the secondary line (undelivered). Air entering the IV line can have undesirable effects on the patient, such as causing air embolism.

[0005] Descriptions presented in the background information section should not be considered prior art simply because they are mentioned in or associated with the background information section. The background information section may contain information describing one or more aspects of the subject art. [Overview of the project]

[0006] According to some embodiments of the present disclosure, a flow control device may include an upper housing including a primary inlet having an inner surface defining a cavity and a secondary inlet; a lower housing defining an outlet of the flow control device; and a chamber interposed between the upper and lower housings and defined thereby for fluidly connecting the primary and secondary inlets to the outlet. Valve members may be arranged at least partially in the cavity and partially in the chamber to (i) selectively allow fluid flow to the primary inlet in a first direction when the fluid level in the chamber is below a predetermined level, and (ii) prevent fluid backflow in a second direction opposite to the first direction when the fluid level in the chamber exceeds a predetermined level.

[0007] According to some embodiments, an intravenous injection (IV; drip) set may include a primary IV line, a secondary IV line, and a flow control device. The flow control device may include an upper housing, a lower housing connected to the upper housing, and a chamber defined between the upper housing and the lower housing. The upper housing may include a primary inlet for fluid communication of the primary IV line to the chamber, and a secondary inlet for fluid communication of the secondary IV line to the chamber. The flow control device may further include a valve member having a base positioned within the chamber and a plurality of legs extending longitudinally from the base to the primary inlet, wherein the floating valve member is displaceable proximal by buoyancy applied to the base when the fluid level in the chamber exceeds a predetermined level.

[0008] Please understand that both the above general description and the following detailed description are illustrative and explanatory, and are intended to further present a description of the subject matter technology as claimed. Please also understand that other embodiments may be used and modifications may be made without departing from the scope of the subject matter technology.

[0009] The accompanying figures are included to illustrate specific aspects of the embodiments and should not be considered exclusive embodiments. The disclosed subject matter is subject to considerable modification, substitution, combination, and equivalents in form and function, as can be conceived by those skilled in the art and in the interest of the present disclosure. [Brief explanation of the drawing]

[0010] [Figure 1] Several embodiments of this disclosure illustrate a multi-line IV extension set including a flow control device. [Figure 2A] The following are cross-sectional views of flow control devices according to some embodiments of the present disclosure. [Figure 2B] Figure 2A shows a partially enlarged cross-sectional view of the flow control device and valve member according to some embodiments of the present disclosure. [Figure 2C] Figure 2A shows perspective views of the upper housing of the flow control device according to several embodiments. [Figure 2D] Figure 2A shows cross-sectional views of the upper housing of the flow control device according to several embodiments. [Figure 3] The following are perspective views of valve members of flow control devices according to some embodiments of the present disclosure. [Figure 4] The following are perspective views of valve members and sealing members of a flow control device according to some embodiments of the present disclosure. [Figure 5] This is a cross-sectional view of a flow control device in an open state when subjected to an upstream force, according to some embodiments of the present disclosure, where the drug level in the chamber is below a predetermined level. [Figure 6]Cross-sectional view of the flow control device of FIG. 5 in a closed state, according to some embodiments of the present disclosure, where the drug level exceeds a predetermined amount and a buoyancy force is applied to the valve member. [Figure 7] Cross-sectional view of the flow control device of FIG. 5 in a closed state, according to some embodiments of the present disclosure, where fluid flows from the secondary inlet into the chamber. [Figure 8] Cross-sectional view of the flow control device of FIG. 5 in an open state, according to some embodiments of the present disclosure, where the fluid flow from the secondary inlet to the chamber is completed and the drug level in the chamber drops below a predetermined level. [Figure 9] Shows a cross-sectional view of a flow control device having a valve member, according to some embodiments of the present disclosure. [Figure 10] Shows a cross-sectional view of a flow control device having a valve member, according to some embodiments of the present disclosure. [Figure 11] Shows a perspective view of the valve member of FIG. 10, according to some embodiments of the present disclosure. [Figure 12] Shows a cross-sectional view of a flow control device having a valve member, according to some embodiments of the present disclosure. [Figure 13] Shows a perspective view of the valve member of FIG. 12, according to some embodiments of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

[0011] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configuration in which the subject technology may be practiced. The detailed description includes specific details for providing a complete understanding of the subject technology. Accordingly, dimensions may be provided with respect to specific 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 to avoid obscuring the concepts of the subject technology.

[0012] This disclosure includes examples of the subject art and should not be understood as limiting the scope of the appended claims. Here, various aspects of the subject art are disclosed in accordance with specific, but non-limiting, examples. The various embodiments described herein may be carried out in different ways and variations according to the desired use or practice.

[0013] This description generally relates to flow control devices, and more specifically to flow control devices having a valve member capable of preventing insufficient infusion in an IV set with a secondary line and preventing backflow of drug from the secondary line to the primary run.

[0014] IV sets with a secondary line are prone to insufficient injection of the secondary drug due to check valve failure in the primary line. The most frequent cause of check valve failure is debris accumulated at the point when the drug in the secondary line rapidly rises at low pressure and leaks into the primary line. Common causes of insufficient injection are drug dilution during back-priming of the secondary IV, and also when the primary and secondary lines have equal heads. Other causes include dead volume in the secondary line and the time required to inject the drug. Flow control devices of the various embodiments described herein overcome the above problems commonly associated with IV sets having primary and secondary lines.

[0015] According to various embodiments of the present disclosure, a flow control device may include an upper housing having a primary inlet and a secondary inlet; a lower housing connected to the upper housing; a chamber defined between the upper housing and the lower housing; and a floating valve member disposed at least partially within the chamber and partially within the primary inlet. In some embodiments, the upper housing may have an inner surface having a circumferential lip at its distal end. The circumferential lip may be oriented to project radially inward toward the longitudinal central axis of the primary inlet.

[0016] In some embodiments, the valve member may have a base and a plurality of legs extending longitudinally from the base to the primary inlet. The legs may be spaced apart from each other, and adjacent pairs of legs each define a flow portion or slot through which fluid entering the primary inlet flows into the chamber. In some embodiments, each of the legs may be terminated by a flange at the proximal end of the valve member. In other embodiments, the valve member may be configured as a body having a central hole and a plurality of axially extending slots through which fluid flowing into the primary inlet can enter the chamber through the central hole and the plurality of axially extending slots.

[0017] During operation, if the fluid level in the chamber is below a predetermined level, and if the valve member is subjected to a net upstream force (i.e., a force exerted by the fluid flowing from the primary inlet into the chamber that exceeds any buoyant force exerted by the fluid in the chamber), the valve member may be moved distally (downstream) to a position where each flange seats on the circumferential lip. Thus, the valve member may be placed in an open state, allowing fluid from the primary IV line to enter the chamber through the primary inlet.

[0018] According to some embodiments, the valve member may include a sealing member coupled to at least a portion of the upper surface of the base.

[0019] During operation, if the fluid level in the chamber exceeds a predetermined level, or if the valve member is subjected to a net downstream force (i.e., buoyancy exerted by the fluid in the chamber that exceeds any upstream force exerted by the fluid flowing from the primary inlet into the chamber), the valve member may be moved parallel to a position where the sealing member contacts and seals against the inner surface of the upper housing. Thus, fluid flow from the chamber to the primary inlet is blocked, thereby preventing fluid backflow into the primary inlet. This prevents under-infusion of the secondary drug, which is commonly caused by backflow of the secondary drug from the chamber to the primary inlet. Preventing fluid backflow is advantageous in that it prevents, for example, undesirable particulate matter contained in the secondary drug from backflowing through the valve member, and prevents the patient from receiving the appropriate drug dose concentration or from being prevented from receiving the drug in a timely manner.

[0020] Figure 1 shows a multi-line IV extension set 1, including flow control devices 100, 200, and 300, according to some embodiments of the present disclosure. The IV set 1 includes a primary fluid system 15 and a secondary fluid system 25. An IV pump (not shown) can receive fluid from the primary fluid system 15 and the secondary fluid system 25 via the primary IV line 5, control the fluid, and administer the fluid from the IV pump to the patient 50.

[0021] In some embodiments, the primary fluid system 15 may include a primary fluid source, such as a primary fluid bag 10, which may contain or be able to contain saline solution or other medical fluids or drugs to be administered to the patient 50. As shown in the figure, the primary IV line 5 carries primary fluid from the drip chamber 12 to the flow control devices 100, 200, and 300. As will be further described with reference to the following drawings, the flow control devices 100, 200, and 300 may be located in the primary IV line 5 and may allow fluid flow from the primary fluid bag 10 to an IV pump (not shown) while preventing fluid from the secondary fluid system 25 from flowing backward (backflow) to the primary fluid bag 10. According to some embodiments, the secondary fluid system 25 includes a secondary fluid source, such as a secondary fluid bag 8, which may contain drugs or other secondary fluids to be supplied to the patient 50 for treatment. As shown, the IV set 1 may further include a secondary IV line 7 that carries flow from the drip chamber 22 to the flow control devices 100, 200, and 300.

[0022] Figure 2A shows a cross-sectional view of a flow control device 100 according to some embodiments of the present disclosure. Figure 2B is a partially enlarged cross-sectional view of the flow control device 100 and valve member of Figure 2A according to some embodiments of the present disclosure. As shown, the flow control device 100 may include an upper housing 120, a lower housing 140 connected to the upper housing 120, a chamber 150 defined between the upper housing 120 and the lower housing 140, and a floating valve member 110 at least partially located within the chamber. The upper housing may also include a secondary inlet 130 that fluidizes a secondary IV line 7 to the chamber 150. Referring to Figure 2A, the flow control device is shown in a cross-sectional view to more clearly illustrate some of the feature parts of the valve member 100. As shown, the flow control device 100 may take the form of a body extending axially defining a longitudinal central axis X. The body may be generally cylindrical (or tubular), or may have any other shape having a hollow interior capable of defining a chamber.

[0023] Figure 2C shows a perspective view of the upper housing of the flow control device of Figure 2A in some embodiments. Figure 2D shows a cross-sectional view of the upper housing of the flow control device of Figure 2A in some embodiments. Referring to Figures 2C and 2D, the upper housing 120 may include a primary inlet 125 that fluidly connects the primary IV line 5 to the chamber 150. As shown, the primary inlet 125 may have an inner surface 127 that defines a cavity 135 in which at least a portion of the valve member 100 is located. The cavity 135 may form part of the primary inlet 125 or, in other cases, fluidly connect with the primary inlet 125. Thus, fluid flowing from the primary inlet 125 to the channel 150 may flow through the cavity 125. In some embodiments, the inner surface 127 defining the cavity may have a circumferential lip 175 at its distal end. As shown, the circumferential lip 175 may be oriented to project radially inward toward the longitudinal central axis X1 (shown in Figure 2A) of the primary inlet 125.

[0024] Referring again to Figure 2A, in some embodiments of the present disclosure, the lower housing 140 may be distally connected to the upper housing 120, further defining an outlet 145 through which drugs or medications from the primary and secondary inlets can be delivered to the patient 50. As shown, the radial extension of the lower housing 140 at its proximal end (the end directly connected to the upper housing 120) may be larger than the radial extension at its distal end. However, various embodiments of the present disclosure are not particularly limited to the configurations described above, and the shape and configuration of the lower housing 140 may vary for the intended purpose while still embodying the operating principle described herein. The lower housing 140 and the upper housing 120 may be in axial contact with each other to cooperatively form the chamber 150 of the flow control device 100. In the embodiments shown, the floating valve member 110 may be partially mounted in the cavity 135 and partially in the chamber 150. The floating valve member 110 can selectively allow fluid flow from the primary IV line 5 to the chamber 150 via the primary inlet 120 when the fluid level in the chamber 150 falls below a predetermined level. Furthermore, the valve member 110 can operate to prevent backflow of fluid from the secondary inlet 130 and the chamber 150 to the primary inlet 120 when the fluid level in the chamber 150 exceeds a predetermined level and buoyancy is applied to the valve member 110.

[0025] Figure 3 shows a perspective view of a valve member 110 of a flow control device according to several embodiments of the present disclosure. According to various embodiments of the present disclosure, the valve member 110 may include a base 165 and a main body 160 extending proximal to the base 165. In some embodiments, the base 165 may be in the form of a disk having an upper surface 167 and a lower surface 169 or any other circular or semicircular plate. The size or surface area of ​​the base 165 may be selected to allow maximum exposure to the fluid in the chamber 150 in particular to overcome the hydrodynamic forces of the fluid entering the primary inlet 125 from the primary IV pipe 5. For example, the larger the size of the base 165, the greater the surface area that is acted upon by the fluid in the chamber. Thus, the valve member 110 may be designed to open and close the primary inlet based on a specific threshold force.

[0026] As shown, the main body 160 may have a plurality of legs 161 extending longitudinally from the base 165 to the cavity 135 of the primary inlet 125. Each leg 161 may extend longitudinally from the upper surface 167 of the base 165. In some embodiments, the legs 161 may be oriented substantially perpendicular to the upper surface 167 of the base 165. In particular, the legs 161 may extend and project substantially perpendicularly to a certain height above the upper surface 167 of the base 165. In some embodiments, the legs 161 may be spaced equally apart from each other. For example, the valve member 110 may have two or more legs 161 that are equally spaced apart from each other. In other embodiments, the legs 161 may be spaced irregularly apart from each other. As shown, each adjacent pair of legs 161 defines a flow section or slot 164 through which fluid entering the cavity 135 from the primary inlet 125 flows into the chamber 150. As shown in the figure, each of the legs 161 may terminate at a flange 166 at the proximal end of the valve member 110.

[0027] In some embodiments, the legs 161 may have a polygonal shape, for example, a rectangle, square, or any other suitable polygonal shape terminating at the flange 166. In other embodiments, the legs 161 may have a curved shape, for example, a circular, oval, or elliptical shape terminating at the flange 166. However, the various embodiments of the present disclosure are not limited to the configurations described above, and the shape and spacing of the legs 161 from one another may vary as desired.

[0028] In other embodiments, the main body 160 may be configured to have a central hole 162 and a plurality of axially extending slots 164, so that fluid flowing into the primary inlet 125 and cavity 135 can enter the chamber 150 through this central hole and the plurality of axially extending slots.

[0029] During operation, when the valve member 110 is subjected to a net upstream force (i.e., the force exerted by the fluid flowing from the primary inlet 125 into the chamber, exceeding any buoyant force exerted by the fluid in the chamber 150), it may be moved distally (downstream) to a position where the flange 166 seats on the circumferential lip, as shown in Figure 2B. Thus, the valve member 110 may be placed in an open position, allowing fluid from the primary IV line 5 to enter the chamber 150 through the primary inlet 125.

[0030] Figure 4 shows perspective views of a valve member 110 and a sealing member 170 of a flow control device 100 according to some embodiments of the present disclosure. As shown, the valve member 110 may include a sealing member 170 coupled to at least a portion of the upper surface 167 of the base 165. The sealing member 170 may be configured to contact and seal against the inner surface 122 of the upper housing 120.

[0031] During operation, when the valve member 110 is subjected to a net downstream force (i.e., buoyancy applied by the fluid in the chamber 150, exceeding any upstream force applied by the fluid flowing from the primary inlet 125 to the chamber 150), the sealing member 170 may be moved parallel to a position where it contacts and seals against the inner surface 122 of the upper housing 120, as shown in Figure 2A. Thus, the fluid flow from the chamber 150 to the primary inlet 1251 is blocked, thereby preventing fluid backflow into the primary inlet 125. Similarly, under-infusion of secondary drugs, which is commonly caused by backflow of secondary drugs from the chamber 150 to the primary inlet 125, can be prevented. Preventing fluid backflow is advantageous in that, for example, undesirable particulate matter contained in the drug administered from the secondary IV line 7 is prevented from backflowing through the valve member 100, thereby preventing the patient 50 from receiving the appropriate drug dose concentration or preventing timely delivery of the drug.

[0032] Figure 5 is a cross-sectional view of a flow control device according to some embodiments of the present disclosure, in which the drug level in the chamber is below a predetermined level and the valve member is in an open state when subjected to an upstream force that allows fluid flow from the primary inlet to the chamber. As shown, during operation, fluid enters the flow control device 100 through the primary inlet 125, passes through the cavity 135, and can flow into the chamber 150 through the flow portion between adjacent pairs of legs 161 or through the slot 164. When the fluid level in the chamber 150 is below a predetermined level, an upstream force applied to the valve member 110 (i.e., the force applied by the fluid flowing from the primary IV line 5 to the primary inlet 125) causes the valve member 110 to displace distally or otherwise move and seat on the circumferential lip 175. Thus, the primary inlet 125 is placed in an open state, with the primary inlet 125, the cavity 135, and the chamber 150 in fluid communication. In the open state, fluid from the primary IV line can flow into the chamber 150 through the cavity 135 and through the flow portion or slot 164 between adjacent pairs of legs 161. As fluid from the primary IV line continues to enter the chamber 150, the fluid level 152 rises to a point where the fluid in the chamber contacts the lower surface 169 of the base 165 of the valve member 110. When the fluid level 152 rises above a predetermined level, the fluid in the chamber exerts buoyancy on the base 165, and this buoyancy is greater than the upstream force exerted by the fluid flowing from the primary IV line 5 into the primary inlet 125. Therefore, the valve member 110 is then translated proximally to a position where the sealing member 170 contacts and seals against the inner surface 122 of the upper housing 120, as shown in Figure 6, thereby closing the primary inlet 125.

[0033] Figure 6 is a cross-sectional view of the flow control device of Figure 5 in a closed state according to some embodiments of the present disclosure, where the drug level exceeds a predetermined amount and buoyancy is applied to the valve member to block fluid flow from the primary inlet to the chamber and prevent backflow to the primary inlet. As shown, when operating, if a buoyancy exceeding the force of the fluid flowing in the primary IV line 5 is applied to the base 165 of the valve member 110, the sealing member 170 contacts and seals against the inner surface 122 of the upper housing 120. This places the primary inlet 125 in a closed state, stopping the administration of drug or other fluid from the primary inlet 125 to the chamber. At this point, secondary drug or other fluid in the secondary IV line 7 can be administered into the chamber 150 via the secondary inlet 130.

[0034] Advantageously, since the flow from the primary inlet 125 into the chamber 150 is blocked at this point, the secondary drug can be administered and flow into the chamber 150 without the possibility of flowing back into the primary inlet 125 and without diluting the drug in the primary IV line 5. Thus, insufficient delivery of the secondary drug or fluid caused by the secondary drug or fluid flowing back into the primary IV line 5 can be prevented.

[0035] Preventing fluid backflow is even more advantageous in that it prevents, for example, undesirable particulate matter contained in the drug or fluid administered through the secondary IV line 7 from flowing back through the valve member 110, thereby preventing the patient from receiving the appropriate drug dose concentration or preventing the timely delivery of the drug(s) to the patient 50.

[0036] Figure 7 is a cross-sectional view of the flow control device of Figure 5 in a closed state, according to some embodiments of the present disclosure, in which fluid flows into the chamber from the secondary inlet. As shown, during operation, the secondary drug can be administered into the chamber 150 via the secondary inlet 130 until the administration of the secondary drug is complete. During this time, the fluid in the chamber 150 can also be administered to the patient 50 via the outlet 145. As the fluid continues to be administered to the patient 50 via the outlet 145, the fluid level 152 in the chamber 150 continues to decrease until the fluid level falls below a predetermined level, as shown in Figure 8.

[0037] Figure 8 is a cross-sectional view of the flow control device of Figure 5 in an open state, according to some embodiments of the present disclosure, where fluid flow from the secondary inlet to the chamber is complete, the drug level in the chamber has fallen below a predetermined level, and the valve member is displaced by fluid force to restart flow from the primary inlet to the chamber. As the drug in the chamber 150 continues to be administered to the patient through the outlet 145, the fluid level in the chamber 150 falls below a predetermined level and the magnitude of the buoyancy decreases. As a result, the valve member 110 is displaced distally (towards the chamber 150), and fluid flow from the primary IV line to the chamber 150 through the primary inlet 125 is restarted. As shown, the upstream force applied to the valve member 110 causes the valve member 110 to seat on the circumferential lip 175. Thus, the primary inlet 125 is placed in an open state, with the primary inlet 125, the cavity 135, and the chamber 150 in fluid communication. In the open state, fluid from the primary IV line 5 can flow into the chamber 150 through the cavity 135 and through the flow section or slot 164 between adjacent pairs of legs 161.

[0038] Table 1 below provides exemplary calculations for the buoyancy and upstream force applied to the valve member 110 based on exemplary dimensions of the valve member 110. While specific dimensions of the valve member 110 are used in the following calculations, the various embodiments of this disclosure are not limited to these specific dimensions. The dimensions of the valve member 110 may vary depending on the desired purpose, and the applied buoyancy and upstream force may also vary proportionally based on the dimensions of the valve member 110. According to the various embodiments of this disclosure, the buoyancy is given by the following formula: F B =ρ f V f g It is calculated using, and in the formula, F B ρ is buoyancy, f V is the density of the displaced fluid. f θ is the volume of the displaced fluid, and g is the acceleration due to gravity, i.e., 9.8 m / s². 2 That is the case.

[0039] [Table 1]

[0040] Therefore, the various embodiments of this disclosure are advantageous in providing a flow control device capable of preventing secondary drug infusion deficiencies by preventing secondary drug from flowing backward into the primary IV line, as described above. The flow control devices of the various embodiments described herein are further advantageous in that they minimize the number of separate components in the IV set by using a single flow control device instead of check valves and Y-connectors. As a result, the cost of the IV set can be reduced. Furthermore, the various embodiments of this disclosure are advantageous in reducing workflow steps for clinicians / nurses because manual operation is not required for flow adjustment, as the flow pressure of the secondary drug or fluid is used to adjust the flow rate of the primary drug or fluid.

[0041] Advantageously, since the flow from the primary inlet 125 to the chamber 150 is blocked at this point, the secondary drug can be administered and flow into the chamber 150 without the possibility of flowing back into the primary inlet 125 and without diluting the drug in the primary IV line 5. Thus, insufficient delivery of the secondary drug or fluid caused by the secondary drug or fluid flowing back into the primary IV line 5 is prevented.

[0042] Preventing fluid backflow is further advantageous in that it prevents, for example, undesirable particulate matter contained in the drug or fluid administered through the secondary IV line 7 from flowing back through the valve member 110, thereby preventing the patient from receiving the appropriate drug dose concentration or preventing the timely delivery of the drug(s) to the patient 50.

[0043] Figure 9 shows a cross-sectional view of a flow control device 200 having a valve member 110 according to several embodiments of the present disclosure. Referring to Figure 9, similar to the embodiment in Figure 2A, the flow control device 200 may include an upper housing 220, a lower housing 240 connected to the upper housing 220, a chamber 250 defined between the upper housing 220 and the lower housing 240, and a floating valve member 110 at least partially located within the chamber 250. As shown, the upper housing 220 may include a primary inlet 225 for fluid communication of a primary IV line 5 with the chamber 250, and a secondary inlet 230 for fluid communication of a secondary IV line 7 with the chamber 250. As shown, the flow control device 100 may take the form of a body extending axially defining a longitudinal central axis Y. The body may be generally cylindrical (or tubular), or may have other shapes having a hollow interior capable of defining a chamber.

[0044] Similar to the embodiment in Figure 2A, the primary inlet 225 may have an inner surface 227 defining a cavity 235 in which at least a portion of the valve member 110 is located. The cavity 235 may form part of the primary inlet 225 or, in other cases, may be in fluid communication with the primary inlet 225. Thus, fluid flowing from the primary inlet 225 to the channel 250 may flow through the cavity 225. In some embodiments, the inner surface 227 defining the cavity may have a circumferential lip 275 at its distal end. As shown, the circumferential lip 275 may be oriented to project radially inward toward the longitudinal central axis Y1 of the primary inlet 225.

[0045] According to various embodiments of this disclosure, the lower housing 240 may be distally connected to the upper housing 220, further defining an outlet 245 through which a drug or medication from the primary inlet 225 and secondary inlet 230 can be delivered to the patient 50. Similar to the embodiment in Figure 2A, the radial extension of the lower housing 240 at its proximal end (the end directly connected to the upper housing 220) may be larger than the radial extension at its distal end. However, various embodiments of this disclosure are not particularly limited to the configurations described above, and the shape and configuration of the lower housing may vary for the intended purpose while still embodying the operating principle described herein. The lower housing 240 and the upper housing 220 may be in axial contact with each other to cooperatively form a chamber 250 of the flow control device 200. In the embodiment shown, the floating valve member 110 may be partially mounted in the cavity 235 and partially in the chamber 250 so as to selectively allow fluid flow from the primary IV line 5 to the chamber 250 via the primary inlet 220 when the fluid level in the chamber 250 falls below a predetermined level. Furthermore, the valve member 110 may operate to prevent backflow of fluid from the secondary inlet 230 and the chamber 250 when the fluid level in the chamber 250 exceeds a predetermined level and buoyancy is applied to the valve member 110.

[0046] According to various embodiments of this disclosure, the secondary inlet 230 of the flow control device 200 may be positioned at a lower axial position (distal) than the primary inlet 225 in which the valve member 110 is installed, compared to the flow control device 100. For example, the secondary inlet 230 may be positioned at a predetermined height H lower than the primary inlet 225 in which the valve member 110 is installed. The above configuration ensures that the valve member 110 remains above the height (level) of the secondary line in order to allow the valve member 210 to function as intended.

[0047] Figure 10 shows a cross-sectional view of a flow control device 300 having a valve member 310 according to several embodiments of the present disclosure. Referring to Figure 10, similar to the embodiment in Figure 2A, the flow control device 300 may include an upper housing 120, a lower housing 140 connected to the upper housing 120, and a chamber 150 defined between the upper housing 120 and the lower housing 140. As shown, the upper housing 120 may include a primary inlet 125 for fluid communication of a primary IV line 5 with the chamber 150, and a secondary inlet 130 for fluid communication of a secondary IV line 7 with the chamber 150. Since the upper housing 120 and the lower housing 140, the chamber 150, and their connections and fluid communication with each other are exactly the same as described above with respect to the flow control device 100 in Figure 2A, no further detailed description of the flow control device 300 will be provided. According to various embodiments, the control device 300 may further include a valve member 310 that is at least partially located within the chamber 150.

[0048] Figure 11 shows a perspective view of the valve member of Figure 10 according to several embodiments of the present disclosure. As shown, the valve member 310 may include a base 365 and a main body 360 extending proximal to the base 365. In some embodiments, the base 365 may be in the form of a disk having an upper surface 367 and a lower surface 369 or any other circular or semicircular plate. The size or surface area of ​​the base 365 may be selected to allow maximum exposure to the fluid in the chamber 150 in particular to overcome the hydrodynamic forces of the fluid entering the primary inlet 125 from the primary IV pipe 5. For example, the larger the size of the base 365, the greater the surface area acted upon by the fluid in the chamber 150. Thus, the valve member 310 may be designed to open and close the primary inlet 125 based on a specific threshold force. In particular, the base 365 differs in structure from the base 165 of the various embodiments described in Figures 3 and 4 in that the base 365 may have a larger surface area than the base 165. For example, as shown in the figure, the base 365 may be a semicircular plate with a radius larger than that of the circular plate-shaped base 165. The aforementioned configuration of the base 365 may be even more advantageous than the configuration of the base 165 in that a greater fluid force is required from the primary IV line 5 to displace the valve member 310 and open the primary inlet 125 when the fluid level in the chamber 150 exceeds a predetermined level. This is because the larger surface area of ​​the base 365 receives a greater buoyancy from the fluid in the chamber (see Table 2 below). Therefore, the valve member 365 is less likely to leak due to excessive fluid pressure in the primary IV line 5 or to open unintentionally in other cases.

[0049] Similar to the embodiments described above with respect to the valve member 110, the main body 360 of the valve member 310 may have a plurality of legs 361 extending longitudinally from the base 365 to the cavity 135 of the primary inlet 125. Each of the legs 361 may extend longitudinally from the upper surface 367 of the base 365. In some embodiments, the legs 361 may be oriented substantially perpendicular to the upper surface 367 of the base 365. In particular, the legs 361 may extend and project substantially perpendicularly to a predetermined height above the upper surface 367 of the base 365. In some embodiments, the legs 361 may be spaced equally apart from each other. For example, the valve member 310 may have two or more legs 361 that are equally spaced apart from each other. In other embodiments, the legs 361 may be spaced irregularly apart from each other. As shown, each pair of adjacent legs 361 defines a flow section or slot 364 through which fluid entering the cavity 135 from the primary inlet 125 flows into the chamber 150. As shown in the figure, each of the legs 161 may terminate at a flange 366 at the proximal end of the valve member 310.

[0050] In some embodiments, the legs 361 may have a polygonal shape, for example, a rectangle, square, or any other suitable polygonal shape terminating at the flange 366. In other embodiments, the legs 361 may have a curved shape, for example, a circular, oval, or elliptical shape terminating at the flange 366. However, the various embodiments of the present disclosure are not limited to the configurations described above, and the shape and spacing of the legs 361 from one another may vary as desired.

[0051] In other embodiments, the main body 360 may be configured to have a central hole 362 and a plurality of axially extending slots 364, so that fluid flowing into the primary inlet 125 and cavity 135 can enter the chamber 150 through this central hole and the plurality of axially extending slots.

[0052] The operations and functions of the flow control device 300 and the valve member 310 are the same as those of the flow control device 100 and the valve member 110. Since the detailed descriptions of how the flow control device 100 and the valve member 110 function were presented above with respect to FIGS. 2A and 5 - 8, the detailed descriptions will be omitted with respect to the flow control device 300 and the valve member 310.

[0053] Table 2 shown below presents exemplary calculations for the buoyant force and upstream force applied to the valve member 310 based on the exemplary dimensions of the valve member 310. Specific dimensions of the valve member 310 are used in the following calculations, but various embodiments of the present disclosure are not limited to these specific dimensions. The dimensions of the valve member 310 can vary based on the desired purpose, and the applied buoyant force and upstream force can also vary proportionally based on the dimensions of the valve member 310. According to various embodiments of the present disclosure, the buoyant force is calculated using the following formula, namely F B =ρ f V f g where F B is the buoyant force, ρ f is the density of the displaced fluid, V f is the volume of the displaced fluid, and g is the acceleration due to gravity, i.e., 9.8 m / s 2 .

[0054]

Table 2

[0055] Figure 12 shows a cross-sectional view of a flow control device 400 having a valve member 410 according to several embodiments of the present disclosure. Referring to Figure 12, which is similar to the embodiment in Figure 2A, the flow control device 400 may include an upper housing 120, a lower housing 140 connected to the upper housing 120, and a chamber 150 defined between the upper housing 120 and the lower housing 140. As shown, the upper housing 120 may include a primary inlet 125 for fluid communication of a primary IV line 5 with the chamber 150, and a secondary inlet 130 for fluid communication of a secondary IV line 7 with the chamber 150. Since the upper housing 120 and the lower housing 140, the chamber 150, and their connections and fluid communication with each other are exactly the same as described above with respect to the flow control device 100 in Figure 2A, no further detailed description of the flow control device 400 will be provided. According to various embodiments, the control device 400 may further include a valve member 410 that is at least partially located within the chamber 150.

[0056] Figure 13 shows a perspective view of the valve member 410 of Figure 12 according to several embodiments of the present disclosure. As shown, the valve member 410 may include a base 465 and a main body 460 extending proximal to the base 465. In some embodiments, the base 465 may be in the form of a disk having an upper surface 467 and a lower surface 469 or any other circular or semicircular plate. The size or surface area of ​​the base 465 may be selected to allow maximum exposure to the fluid in the chamber 150 in particular to overcome the hydrodynamic forces of the fluid entering the primary inlet 125 from the primary IV pipe 5. For example, the larger the size of the base 465, the larger the surface area that is acted upon by the fluid in the chamber 150. Thus, the valve member 410 may be designed to open and close the primary inlet 125 based on a specific threshold force. In particular, the base 465 differs in structure from the base 165 of the various embodiments described in Figures 3 and 4 in that the base 465 may have a larger surface area than the base 165. For example, as shown in the figure, the base 465 may have a diameter larger than that of the circular plate-shaped base 165 and may be a circular plate shape extending over the areas below both the primary inlet 125 and the secondary inlet 130. As shown, the base 465 may have a hole 464 positioned at a location corresponding to an opening at the distal end of the secondary inlet 130 to prevent the base 465 from blocking the fluid flow from the secondary inlet 7 to the chamber 150. The above-described configuration of the base 465 may be even more advantageous than the configuration of the base 165 in that a greater fluid force is required from the primary IV line 5 to displace the valve member 410 (without blocking the flow through the secondary inlet 130) and open the primary inlet 125 when the fluid level in the chamber 150 exceeds a predetermined level. This is because the larger surface area of ​​the base 465 receives greater buoyancy from the fluid in the chamber 150 (see Table 3 below). Thus, the valve member 465 is less likely to leak due to excessive fluid pressure in the primary IV line 5 or to open unintentionally in other cases.

[0057] Similar to the embodiments described above with respect to the valve member 110, the main body 460 of the valve member 410 may have a plurality of legs 461 extending longitudinally from the base 465 to the cavity 135 of the primary inlet 125. Each of the legs 461 may extend longitudinally from the upper surface 467 of the base 465. In some embodiments, the legs 461 may be oriented substantially perpendicular to the upper surface 467 of the base 465. In particular, the legs 461 may extend and project substantially perpendicularly to a predetermined height above the upper surface 467 of the base 465. In some embodiments, the legs 461 may be spaced equally apart from each other. For example, the valve member 410 may have two or more legs 461 that are equally spaced apart from each other. In other embodiments, the legs 461 may be spaced irregularly apart from each other. As shown, each adjacent pair of legs 461 defines a flow section or slot 464 through which fluid entering the cavity 135 from the primary inlet 125 flows into the chamber 150. As shown in the figure, each of the legs 461 may terminate at a flange 466 at the proximal end of the valve member 410.

[0058] In some embodiments, the legs 461 may have a polygonal shape, for example, a rectangle, square, or any other suitable polygonal shape terminating at the flange 466. In other embodiments, the legs 461 may have a curved shape, for example, a circular, oval, or elliptical shape terminating at the flange 466. However, various embodiments of the present disclosure are not limited to the configurations described above, and the shape and spacing of the legs 461 from one another may vary as desired.

[0059] In other embodiments, the main body 460 may be configured to have a central hole 462 and a plurality of axially extending slots 464, so that fluid flowing into the primary inlet 125 and cavity 135 can enter the chamber 150 through this central hole and slots.

[0060] The operation and function of the flow control device 400 and valve member 410 are the same as those of the flow control device 100 and valve member 110. A detailed explanation of how the flow control device 100 and valve member 110 function has been provided above with reference to Figures 2A and 5-8, so a detailed explanation of the flow control device 400 and valve member 410 will be omitted here.

[0061] Table 3 below presents exemplary calculations for the buoyancy and upstream force applied to the valve member 410 based on exemplary dimensions of the valve member 410. While specific dimensions of the valve member 410 are used in the following calculations, the various embodiments of this disclosure are not limited to these specific dimensions. The dimensions of the valve member 410 may vary depending on the desired purpose, and the applied buoyancy and upstream force may also vary proportionally based on the dimensions of the valve member 410. According to the various embodiments of this disclosure, the buoyancy is given by the following formula: F B =ρ f V f g It is calculated using, and in the formula, F B ρ is buoyancy, f V is the density of the displaced fluid. f θ is the volume of the displaced fluid, and g is the acceleration due to gravity, i.e., 9.8 m / s². 2 That is the case.

[0062] [Table 3]

[0063] This disclosure is provided to enable any person skilled in the art to practice the various embodiments described herein. This disclosure provides various examples of the subject art, and the subject art is not limited to these examples. Various modifications to these embodiments will be readily apparent to a person skilled in the art, and the general principles defined herein may be applied to other embodiments.

[0064] References to singular elements are intended to mean "one or more" and not "one and just one" unless specifically stated otherwise. The term "several" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and her), and vice versa. Headings and subheadings, where present, are used solely for convenience and do not limit the invention.

[0065] The term “exemplary” is used herein to mean “serving as an example or illustration.” An embodiment or design described herein as “exemplary” is not necessarily construed as being preferable or advantageous to other embodiments or designs. In one embodiment, various alternative configurations and operations described herein may be considered at least equivalent.

[0066] As used herein, the phrase “at least one of” following a set of items, when accompanied by the term “or” to separate any of those items, modifies the enumerated set as a whole, rather than each of the enumerated items. The phrase “at least one of” does not require the selection of at least one item; rather, it allows the meaning to include 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. For example, the phrase “at least one of A, B, or C” may refer to A only, B only, or C only, or any combination of A, B, and C.

[0067] The terms "aspects," etc., do not imply that such aspects are essential to the subject art, nor that such aspects apply to all configurations of the subject art. Disclosures relating to aspects may apply to all configurations or one or more configurations. Aspects may provide one or more examples. The terms "aspects," etc., may refer to one or more aspects, and vice versa. The terms "examples," etc., do not imply that such examples are essential to the subject art, nor that such examples apply to all configurations of the subject art. Disclosures relating to examples may apply to all examples or one or more examples. Examples may provide one or more examples. The terms "examples," etc., may refer to one or more examples, and vice versa. The terms "configuration," etc., do not imply that such configurations are essential to the subject art, nor that such configurations apply to all configurations of the subject art. Disclosures relating to configurations may apply to all configurations, or one or more configurations. The term "structure" may provide one or more examples. The terms "structure," etc., may refer to one or more structures, and vice versa.

[0068] In one embodiment, unless otherwise stated, all measurements, values, ratings, locations, sizes, dimensions, and other specifications described herein, including those in the following claims, are approximate and not precise. In one embodiment, they are intended to be within a reasonable range that is not inconsistent with the functions to which they relate and the conventions of the art to which they belong.

[0069] The specific sequence or hierarchy of steps or actions in the disclosed process or method is to be understood as an example of an exemplary approach. The specific sequence or hierarchy of steps, actions, or processes may be rearranged based on implementation priorities or scenarios. Some of the steps, actions, or processes may be performed simultaneously. In some implementation priorities or scenarios, certain actions may or may not be performed. Some or all of the steps, actions, or processes may be performed automatically without user intervention. The claims for the attached method present various elements of steps, actions, or processes in a sample sequence and are not intended to limit the user to the specific sequence or hierarchy presented.

[0070] All structural and functional equivalents of elements of various forms described throughout this disclosure, which are known to those skilled in the art or will become known thereafter, are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, whether such disclosure is expressly contained in the claims or not. No element of a claim should be construed under Section 112(f) of the United States Patent Act unless it is expressly described using the phrase “means for” or, in the case of a method claim, the phrase “step for.” Moreover, wherever terms such as “include” and “have” are used, such terms are intended to be as comprehensive as the term “comprise” is used, as “comprise” is construed when it is used as a transitional clause in a claim.

[0071] The Title of the Invention, Background Art, Summary of the Invention, Brief Description of the Drawings, and Abstract of the Disclosure are incorporated herein by reference and provided not as a limiting description of the Disclosure, but as exemplary examples of the Disclosure. The Disclosure is filed with the understanding that these are not to be used to limit the scope or meaning of the claims. Furthermore, in the Detailed Description, it is found that the Description provides exemplary examples, and that various features are grouped together in various embodiments for the purpose of streaming the Disclosure. The methods of the Disclosure should not be construed as indicating an intention that the claimed subject matter requires more features than expressly described in each claim. Rather, as the attached claims indicate, the subject matter of the Invention has fewer features than all the features of a single disclosed configuration or operation. The attached claims are incorporated herein by reference to the Detailed Description, and each claim is based on itself as separately claimed subject matter.

[0072] The claims are not intended to be limited to the embodiments described herein, but should be given a complete scope consistent with the language of the claims and encompass all legal equivalents. However, none of the claims are intended, nor should they be construed, to encompass subject matter that does not meet the requirements of Section 101, 102, or 103 of the U.S. Patent Act.

Claims

1. A flow control device, An upper housing including a primary inlet and a secondary inlet having an inner surface defining a cavity, A lower housing that defines the outlet of the flow control device, A chamber interposed between the upper housing and the lower housing and defined by the upper housing and the lower housing, comprising a chamber for fluidly connecting the primary inlet and the secondary inlet to the outlet, Valve members arranged at least partially within the cavity and partially within the chamber, thereby (i) selectively allowing fluid flow in a first direction in the primary inlet when the fluid level in the chamber is below a predetermined level, and (ii) preventing backflow of fluid in a second direction opposite to the first direction when the fluid level in the chamber exceeds the predetermined level. A flow control device having the following features.

2. The flow control device according to claim 1, wherein the valve member comprises a base and a main body extending proximal to the base, and the main body has a flange at its proximal end.

3. The flow control device according to claim 2, wherein the main body further comprises a central hole and a plurality of axially extending slots, and the fluid flowing into the primary inlet and the cavity enters the chamber through the central hole and the axially extending slots.

4. The inner surface defining the cavity has a circumferential lip at its distal end, the circumferential lip protruding radially inward toward the longitudinal central axis of the primary inlet, The flow control device according to claim 2, wherein the main body flange is configured to seat on the circumferential lip when the valve member is subjected to a net axial force in the first direction.

5. The flow control device according to claim 2, wherein the main body further has a plurality of legs extending longitudinally from the base into the cavity of the primary inlet.

6. The flow control device according to claim 5, wherein the plurality of legs are radially spaced apart about the longitudinal central axis of the main body, and each interval between adjacent legs defines a flow portion, and the fluid entering the primary inlet and the cavity passes through the flow portion into the chamber.

7. Each of the aforementioned legs has a part of the main body flange, and the inner surface defining the cavity has a circumferential lip at its distal end, the circumferential lip protruding radially inward toward the longitudinal central axis of the primary inlet, The flow control device according to claim 5, wherein each main body flange portion is configured to seat on the circumferential lip when the valve member is subjected to a net axial force in the first direction.

8. The flow control device according to claim 2, wherein the base has a substantially circular plate that shares a common central axis with the primary inlet.

9. The flow control device according to claim 2, wherein the base has a semicircular plate.

10. The aforementioned base is A substantially circular plate extending in the area below both the primary inlet and the secondary inlet, A hole positioned at a location corresponding to an opening at the distal end of the secondary inlet, thereby preventing the base from blocking the fluid flow from the secondary inlet into the chamber. The flow control device according to claim 2, having the following features.

11. The flow control device according to claim 2, further comprising a sealing member coupled to at least a portion of the base, wherein the sealing member is configured to contact the inner surface of the upper housing when the fluid level in the chamber exceeds a predetermined level.

12. The flow control device according to claim 1, wherein the secondary inlet is positioned at a lower axial position than the primary inlet and the valve member installed inside it.

13. The flow control device according to claim 1, further comprising an air vent positioned in the upper housing for removing air during priming.

14. Primary IV line and secondary IV line, Flow control devices and An intravenous injection (IV) set having, The flow control device is An upper housing, a lower housing connected to the upper housing, and a chamber defined between the upper housing and the lower housing, wherein the upper housing has a primary inlet for fluid communication of the primary IV line with the chamber, and a secondary inlet for fluid communication of the secondary IV line with the chamber, A valve member having a base disposed within the chamber and a plurality of legs extending longitudinally from the base into the primary inlet, wherein the floating valve member is displaceable in the proximal direction by the buoyancy acting on the base when the fluid level in the chamber exceeds a predetermined level, and A venous (IV) set that includes this.

15. The valve member prevents fluid flow through the primary inlet when the buoyancy exceeds the force of the fluid entering the primary inlet from the primary IV line, and The IV set according to claim 14, wherein the valve member allows fluid flow through the primary inlet when the fluid level in the chamber is below a predetermined level.

16. The IV set according to claim 14, wherein the plurality of legs are radially spaced apart about the longitudinal central axis of the main body, and each interval between adjacent legs defines a flow portion, and the fluid entering the primary inlet flows through the flow portion into the chamber.

17. Each of the aforementioned legs has a part of the main body flange, The primary inlet has an inner surface with a circumferential lip at its distal end, and the circumferential lip protrudes radially inward toward the longitudinal central axis of the primary inlet. The IV set according to claim 16, wherein each main body flange portion is configured to seat on the circumferential lip when the valve member receives a net upstream force.

18. The IV set according to claim 14, further comprising a sealing member coupled to the upper surface of the base, wherein the sealing member is configured to contact the inner surface of the upper housing when subjected to buoyancy from the fluid in the chamber.

19. The aforementioned base is A roughly circular plate sharing a common central axis with the aforementioned upper housing, A hole positioned at a location corresponding to an opening at the distal end of the secondary inlet, thereby enabling fluid flow from the secondary inlet to the chamber. The IV set according to claim 14, having the following features.

20. The IV set according to claim 14, wherein the secondary inlet is positioned at a lower axial position than the primary inlet and the valve member installed inside it.

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