Flow control device

Abstract

The present invention provides a flow control device comprising: a housing comprising a primary inlet, a primary outlet, a secondary inlet, and a secondary outlet, the primary inlet and the secondary inlet sharing a common central axis disposed perpendicularly with respect to central axes of the primary outlet and the secondary outlet; a chamber defined by the inner circumferential surface of the housing, the chamber extending between the primary inlet and the secondary inlet for fluidly connecting the primary inlet with the primary outlet and the secondary inlet with the secondary outlet; and a valve member reciprocally mounted in the chamber, preventing fluid communication between the secondary inlet and the secondary outlet when fluid pressure into the primary inlet is higher than fluid pressure into the secondary inlet, and preventing fluid communication between the primary inlet and the primary outlet when fluid pressure into the secondary inlet is higher than 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 202111095194.4 and invention title "Flow control device for pressure actuation of gravity intravenous injection kit". Technical Field

[0002] This disclosure generally relates to flow control devices, and more specifically to flow control devices having valve members capable of preventing under-infusion in an IV (intravenous) kit with secondary tubing, and preventing drug backflow from the secondary tubing into the main tubing. Background Technology

[0003] Infusion kits are commonly used in infusion therapy to deliver medications from a pre-filled container (e.g., an intravenous vial or bag containing the desired medication) to a patient. Typically, the intravenous fitting connects to a catheter and is 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 extended intravenous kit with multi-branch fittings or fluid lines through which multiple medications can be dispensed to the patient.

[0004] Patients are typically given an intravenous solution, which is initially provided in an intravenous vial or bag and dripped into the patient's vein via intravenous tubing. Flow control devices, such as check valves, are usually also included in the intravenous tubing to allow fluid to flow only in the direction of the patient. This ensures that the medication flows downstream toward the patient, rather than upstream toward the intravenous vial or bag.

[0005] During infusions using an intravenous infusion kit, the secondary drug supply may flow back into the main intravenous line, causing insufficient secondary drug delivery. Although a check valve is positioned in the main line to prevent backflow, it is prone to frequent failure. A common cause of check valve failure is debris present in the infused fluid. Furthermore, the low pressure differential across the diaphragm in a backflow check valve prevents it from closing completely, allowing backflow and resulting in frequent infusion deficiencies.

[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. Summary of the Invention

[0007] According to various embodiments of this disclosure, a flow control device may include a housing having a main valve body defining a main inlet and an outlet of the flow control device, a secondary valve body defining a secondary inlet of the flow control device, and a chamber defined by an inner circumferential surface of the housing. The main inlet and the secondary inlet may share a common central axis, and the central axis of the outlet is disposed perpendicular to the common central axis. The chamber may extend between the main valve body and the secondary valve body for fluidly connecting the main inlet and the secondary inlet to the outlet. The flow control device may further include a valve member reciprocally mounted in the chamber to (i) prevent fluid communication between the secondary inlet and the outlet when the fluid pressure entering the main inlet is higher than the fluid pressure entering the secondary inlet, and (ii) prevent fluid communication between the main inlet and the outlet when the fluid pressure entering the secondary inlet is higher than the fluid pressure entering the main inlet.

[0008] According to various aspects of this disclosure, a flow control device may include a housing having a main inlet, a main outlet, a secondary inlet, and a secondary outlet. The main inlet and the secondary inlet may share a common central axis perpendicular to the central axis of the main outlet and the secondary outlet. A chamber may be defined by an inner circumferential surface of the housing and may extend between the main inlet and the secondary inlet for fluid communication between the main inlet and the main outlet, and between the secondary inlet and the secondary outlet. The flow control device may further include a valve member reciprocally mounted in the chamber to (i) prevent fluid communication between the secondary inlet and the secondary outlet when the fluid pressure entering the main inlet is higher than the fluid pressure entering the secondary inlet, and (ii) prevent fluid communication between the main inlet and the main outlet when the fluid pressure entering the secondary inlet is higher than the fluid pressure entering the main inlet.

[0009] It is understood that other constructions of the present subject matter will become apparent to those skilled in the art from the following detailed description, wherein various constructions of the present subject matter are illustrated and described by way of illustration. As will be appreciated, the present subject matter can have other and different constructions and certain details thereof can be modified in various other respects, all without departing from the scope of the present subject matter. Therefore, the accompanying drawings and detailed description are to be considered illustrative in nature and not restrictive. Attached Figure Description

[0010] The accompanying drawings are included to illustrate certain aspects of the embodiments and should not be considered as exclusive embodiments. As those skilled in the art will appreciate with the benefit of this disclosure, the disclosed subject matter is capable of considerable modifications, alterations, combinations, and equivalent substitutions in form and function.

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

[0012] Figure 2A A perspective view of a flow control device according to some embodiments of the present disclosure is shown.

[0013] Figure 2B Some embodiments according to this disclosure are shown. Figure 2A A cross-sectional view of the flow control device and valve components.

[0014] Figure 2C Illustrations are shown according to some embodiments Figure 2A A partial cross-sectional view of the housing of the flow control device.

[0015] Figure 2D Illustrations are shown according to some embodiments Figure 2A A perspective view of the valve component of a flow control device.

[0016] Figure 2E A partial cross-sectional view of the housing and mounted valve components of a flow control device according to some embodiments of the present disclosure is shown.

[0017] Figure 2F A cross-sectional view of the housing and mounted valve components of a flow control device according to some embodiments of the present disclosure is shown.

[0018] Figure 3A This is a cross-sectional view showing a flow control device and valve component preceding a fluid line connected to an intravenous injection kit, according to some embodiments of the present disclosure.

[0019] Figure 3B This illustrates some embodiments according to the present disclosure, when connected to the main fluid line and secondary fluid line of an intravenous infusion kit. Figure 3A A cross-sectional view of the flow control device and valve components, wherein the fluid pressure in the main pipeline is higher than the fluid pressure in the secondary pipeline.

[0020] Figure 3C This illustrates some embodiments according to the present disclosure, when connected to the main fluid line and secondary fluid line of an intravenous infusion kit. Figure 3A A cross-sectional view of the flow control device and valve components, wherein the fluid pressure in the secondary pipeline is higher than the fluid pressure in the main pipeline.

[0021] Figure 3D This illustrates some embodiments according to the present disclosure, when connected to the main fluid line and secondary fluid line of an intravenous infusion kit. Figure 3A A cross-sectional view of the flow control device and valve components, wherein the fluid pressure in the main pipeline is equal to the fluid pressure in the secondary pipeline.

[0022] Figure 3E This illustrates some embodiments according to the present disclosure. Figure 3DA cross-sectional view of a flow control device and valve component, wherein the flow groove profile of the valve component allows fluid to flow from the secondary fluid line to the outlet port when the fluid pressure in the main pipeline is equal to the fluid pressure in the secondary pipeline.

[0023] Figure 4 A cross-sectional view of a flow control device according to some embodiments of the present disclosure is shown.

[0024] Figure 5 A cross-sectional view of a flow control device according to some embodiments of the present disclosure is shown. Detailed Implementation

[0025] The following detailed description illustrates various constructions of the subject matter and is not intended to represent the only constructions that can be practiced with respect to the subject matter. The detailed description includes specific details intended to provide a thorough understanding of the subject matter. Therefore, dimensions may be provided with respect to certain aspects as non-limiting examples. However, it will be apparent to those skilled in the art that the subject matter can be implemented 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.

[0026] It is 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 will now be described with reference to specific, but not limiting, examples. The various embodiments described in this disclosure may be implemented in different ways and variations, and depending on the intended application and implementation.

[0027] This description generally relates to flow control devices, and more specifically to flow control devices having valve components that prevent under-infusion in an intravenous infusion kit with secondary tubing and prevent drug backflow from the secondary tubing into the main tubing.

[0028] Intravenous infusion kits with secondary tubing are prone to underinfusion of adjuvant drugs due to check valve failure in the main line. The most frequent cause of check valve failure is debris buildup in the secondary tubing as the drug flushes into and seeps into the main line at low pressure. A common cause of underinfusion is drug dilution during reinjection of the secondary intravenous injection and at equal head levels in both the main and secondary lines. Other causes include dead volume in the secondary tubing and the time taken to infuse the drug. The flow control devices of various embodiments described herein overcome the aforementioned problems commonly associated with intravenous infusion kits with main and secondary tubing.

[0029] Figure 1A multi-line intravenous injection extension kit 1, including flow control devices 100, 200, and 300, is shown according to some embodiments of the present disclosure. The intravenous injection kit 1 includes a main fluid system 15 and a secondary fluid system 25. An intravenous injection pump (not shown) receives fluid from the main fluid system 15 and the secondary fluid system 25 via a main intravenous injection line 5, and can control and distribute the fluid from the main and secondary fluid systems to the patient 50.

[0030] In some embodiments, the main fluid system 15 may include a main fluid source, such as a main fluid bag 10, which may include or contain saline solution or other medical fluids or medications to be administered to the patient 50. As shown, the main intravenous infusion line 5 delivers the main fluid from the infusion chamber 12 to flow control devices 100, 200, 300. As will be further described with reference to the following figures, the flow control devices 100, 200, 300 may be disposed in the main intravenous infusion line 5 and allow fluid flow from the main fluid bag 10 to an intravenous infusion pump (not shown) while preventing reverse flow (backflow) of fluid from the secondary fluid system 25 to the main 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 medications or other secondary fluids to be provided to the patient 50 for treatment. As shown, the intravenous infusion kit 1 may also include a secondary intravenous infusion line 7 that delivers flow from the infusion chamber 22 to the flow control devices 100, 200, 300.

[0031] 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 A cross-sectional view of the flow control device and valve components. (Reference) Figure 2A and Figure 2B The flow control device 100 may have a housing 102 including a main valve body 104 and a secondary valve body 110, a chamber 114 between the main valve body 104 and the secondary valve body 110, and a valve member 120 reciprocally mounted in the chamber 114. As shown, the main valve body 104 and the secondary valve body 110 may be two components connected to each other. However, various embodiments of this disclosure are not limited to the foregoing construction. In some embodiments, the main valve body 104 and the secondary valve body 110 may be integrally formed as a single unit. For example, the main valve body 104 and the secondary valve body 100 may be integrally formed as a single tubular housing 102.

[0032] As shown in the figure, the main valve body 104 defines a main inlet 106 and an outlet 108 of the flow control device 100. The outlet 108 defines a fluid path through which medication or drug from the main inlet and secondary inlets can be delivered to the patient 50. The secondary valve body 110 defines a secondary inlet 112 of the flow control device 100. The main inlet 106 and the secondary inlet 112 can share a common central axis X1. The main inlet 106 can fluidly communicate the main intravenous injection line 5 with the chamber 114. Similarly, the secondary inlet 112 can fluidly communicate the secondary intravenous injection line 7 with the chamber 114. The outlet 108 can have a central axis Y, and the central axis Y can be perpendicular to the common central axis of the main inlet 106 and the secondary inlet 112.

[0033] refer to Figure 2B The flow control device 100 is shown in cross-sectional view to more clearly illustrate some features of the valve component 120. As shown, the flow control device 100 may be in the form of a housing having an axially extending body 102 defining a central longitudinal axis X. The body 102 may be generally cylindrical (or tubular), or may have any other shape having a hollow interior capable of defining a chamber 114. The chamber 114 may be defined by an inner circumferential surface 116 of the housing 102. As shown, the chamber 114 may extend between a main valve body 104 and a secondary valve body 110 for fluidly connecting a main inlet 106 and a secondary inlet 112 to an outlet 108.

[0034] Figure 2C Illustrations are shown according to some embodiments Figure 2A A partial cross-sectional view of the housing 102 of the flow control device. (Reference) Figure 2C And continue to refer to Figure 2B The housing 102 may include at least one guide rail 122 extending longitudinally within the chamber 114 along an inner circumferential surface 116. As shown, the guide rail 122 may be oriented to project radially inward toward a central longitudinal axis X1 of the housing 102. In some embodiments, the inner circumferential surface 116 may have more than one guide rail 122 projecting therefrom. For example, two guide rails 122 may project from the inner circumferential surface 116 in mirror-image positions. The two guide rails 122 may be symmetrically arranged about a central longitudinal axis X1 defining the inner surface 116 of the chamber 114. As will be described in further detail below, the guide rail 122 may serve as a guide such that the valve member 120 may be displaced or otherwise axially translated within the chamber 114 without repositioning about its central axis X2 (shown in…). Figure 2D (in the middle) rotation.

[0035] Figure 2D Illustrations are shown according to some embodiments Figure 2A A perspective view of the valve component of a flow control device. (See image.) Figure 2D As shown, and continue to refer to Figure 2C The valve member 120 may be in the form of a cylindrical disc, which is slidably mounted in the chamber 114. For this purpose, the valve member 120 may have at least one slot 124 extending longitudinally along the outer peripheral surface 132 of the valve member 120. As shown, the slot 124 may define a recess 126 having a shape corresponding to the shape of the guide rail 122 for mounting the valve member 120 onto the guide rail 122.

[0036] In some embodiments, the valve member 120 may have more than one slot, for example, two slots 124 symmetrically arranged about the central longitudinal axis X2 of the valve member 120. Thus, the valve member 120 can be mounted on the inner circumferential surface 132, with the track 122 engaging in the recess 126 of the slot 124. Therefore, when the valve member 120 is subjected to fluid pressure from the main venous injection line 5 or the secondary venous injection line 7, the valve member 120 can translate or otherwise displace within the chamber 114 along the length of the guide track 122. The aforementioned configuration is advantageous because the engagement between the guide track 122 and the slot 124 constrains the degree of movement of the valve member 120 within the chamber 114. Specifically, the aforementioned configuration serves as an anti-rotation mechanism to prevent the valve member 120 from rolling or rotating about the central axis X of the housing 102.

[0037] Figure 2E A partial cross-sectional view of the housing 102 and the mounted valve member 120 of a flow control device 100 according to some embodiments of the present disclosure is shown. Figure 2F A cross-sectional view of the housing 102 and the mounted valve member 120 of a flow control device 100 according to some embodiments of the present disclosure is shown. In some embodiments, the valve member 120 may further include a flow channel 130 extending longitudinally from a planar surface 128 of the valve member 120. The flow channel 130 may extend longitudinally along the outer periphery of the valve member 120 toward surface 132. As shown, the flow channel 130 may extend only partially along the length of the valve member 120. Therefore, when the fluid pressure at the primary inlet 106 is equal to the fluid pressure at the secondary inlet 112, the flow channel 130 can be used to fluidly communicate the secondary inlet 112 with the outlet 108.

[0038] Figure 3A This is a cross-sectional view showing a flow control device and valve component preceding a fluid line connected to an intravenous injection kit, according to some embodiments of the present disclosure. Figure 3A The flow control device 100 is shown in its initial packaging state before being used in an intravenous injection kit. Figure 3BThis illustrates some embodiments according to the present disclosure, when connected to the main fluid line and secondary fluid line of an intravenous infusion kit. Figure 3A A cross-sectional view of the flow control device and valve components, wherein the fluid pressure in the main pipeline is higher than the fluid pressure in the secondary pipeline.

[0039] refer to Figure 3B During operation, when subjected to net main fluid pressure (i.e., pressure exerted by the fluid flowing from the main inlet 106 to the chamber 114 exceeding any pressure exerted by the fluid in the secondary venous infusion line), the valve member 120 can be translated toward the secondary inlet 112 to a position where the planar surface 128 of the valve member contacts and blocks the secondary inlet port 112. Therefore, fluid flow from the secondary venous infusion line 7 to the chamber 114 is blocked, and only fluid from the main venous infusion line 5 can flow into the chamber 114 via the main inlet 106. Fluid from the main venous infusion line 5 can then be delivered to the patient 50 through the outlet 108.

[0040] Figure 3C This illustrates some embodiments according to the present disclosure, when connected to the main fluid line and secondary fluid line of an intravenous infusion kit. Figure 3A A cross-sectional view of the flow control device and valve components, wherein the fluid pressure in the secondary pipeline is higher than the fluid pressure in the main pipeline.

[0041] refer to Figure 3C During operation, when subjected to net secondary fluid pressure (i.e., pressure exerted by the fluid flowing from the secondary inlet 106 to the chamber 114 exceeding any pressure exerted by the fluid in the main venous injection line), the valve member 120 can be translated toward the main inlet 112 to a position where the surface 125 of the valve member contacts and blocks the secondary inlet port 112. Therefore, fluid flow from the main venous injection line 5 to the chamber 114 is blocked, and only fluid from the secondary venous injection line 7 can flow into the chamber 114 via the secondary inlet 106. Fluid from the secondary venous injection line 7 can then be delivered to the patient 50 through the outlet 108.

[0042] Figure 3D and Figure 3E This illustrates some embodiments according to the present disclosure, when connected to the main fluid line and secondary fluid line of an intravenous infusion kit. Figure 3A A cross-sectional view of the flow control device and valve components, wherein the fluid pressure in the main pipeline is equal to the fluid pressure in the secondary pipeline.

[0043] refer to Figure 3D and Figure 3EIn operation, when subjected to a main fluid pressure equal to the secondary fluid pressure (i.e., the pressure exerted by the fluid flowing from the main venous line 5 to the main inlet 106 is equal to the pressure exerted by the fluid flowing from the secondary venous line 7 to the secondary inlet 112), the valve member 120 can be translated toward the center portion of the chamber 114 directly above the outlet 108. Since the fluid pressure at the main inlet is equal to the fluid pressure at the secondary inlet, the valve member 120 can be positioned equidistant from the main inlet 106 and the secondary inlet 112. At this position directly above the outlet, the flow groove 130 of the valve member allows fluid to flow from the secondary venous line 7 through the secondary inlet 112 into the chamber 114. Therefore, when the fluid pressures in the main venous line 5 and the secondary venous line 7 are equal, only adjunctive medication can be dispensed to the patient via the flow groove 130. Because surface 125 lacks a flow groove, fluid communication between the main inlet and outlet is blocked, thereby preventing fluid from the venous lines from being dispensed to the patient.

[0044] Figure 4 A cross-sectional view of a flow control device 200 according to some embodiments of the present disclosure is shown. In some embodiments, the flow control device 200 may have a housing 202 including a main inlet 212, a main outlet 210, a secondary inlet 206, a secondary outlet 208, and a chamber 214 between the main inlet 212 and the secondary inlet 206. The flow control device 200 may also include a valve member 220 reciprocally mounted in the chamber 214. The main outlet 210 and the secondary outlet 208 may define a fluid path through which a drug or medication from the main inlet 212 and the secondary inlet 206 may be delivered to a patient 50. The main inlet 212 and the secondary inlet 206 may share a common central axis X3. The main inlet 212 may fluidly communicate a main intravenous infusion line 5 with the chamber 214. Similarly, the secondary inlet 206 may fluidly communicate a secondary intravenous infusion line 7 with the chamber 214. The main outlet 210 and the secondary outlet 208 may each have a central axis, and each of the central axes may be arranged perpendicularly to the common central axis X3 of the main inlet 212 and the secondary inlet 206.

[0045] refer to Figure 4 The flow control device 200 is shown in cross-sectional view to more clearly illustrate some features of the valve component 220. As shown, the flow control device 200 can be in the form of a generally cylindrical (or tubular) body, or it can be any other shape having a hollow interior capable of defining a chamber 214. Similar to the previously described embodiments, the chamber 214 can be defined by an inner circumferential surface 216 of the housing 202. As shown, the chamber 214 can extend between a main inlet 212 and a secondary inlet 206 to fluidly connect the main inlet 212 and the secondary inlet 206 to the corresponding main outlet 210 and secondary outlet 208.

[0046] In some embodiments, the inner circumferential surface 216 may include a primary sealing surface 222 defining an inlet port 213 of a primary inlet 212 and a secondary sealing surface 218 defining an inlet port 207 of a secondary inlet 206. As will be described in further detail below, the primary sealing surface 222 and the secondary sealing surface 218 may be specifically configured to correspond to the structure of the valve member 220 so that the valve member respectively seals the primary inlet port 213 and the secondary inlet port 207.

[0047] As shown in the figure, valve component 220 may be in disc form, having a main inlet sealing surface 226 corresponding to the main sealing surface 222 of housing 202. Similarly, valve component 220 may include a secondary inlet sealing surface 224 corresponding to the secondary sealing surface 218 of housing. Furthermore, valve component 220 may include an outlet sealing surface 228 for selectively sealing the main outlet 210 and the secondary outlet 208.

[0048] During operation, when subjected to net main fluid pressure (i.e., pressure exerted by the fluid flowing from the main inlet 212 to the chamber 214 exceeding any pressure exerted by the fluid in the secondary intravenous line 7), valve member 220 can be translated toward the secondary inlet 112. As valve member moves toward the secondary inlet 206 and away from the main inlet 212, the main inlet port 213 and the main outlet 210 can be opened. Fluid from the main intravenous line 5 can then flow through the main inlet 212 into the chamber 214 and be dispensed to the patient via the main outlet 210. When valve member 220 is translated to a position such that the secondary inlet sealing surface 224 of valve member 220 contacts the secondary sealing surface 218, both the secondary inlet port 207 and the secondary outlet port 208 can be blocked by valve member 220.

[0049] To enable the secondary inlet sealing surface 224 of valve member 220 to contact and seal the secondary inlet port 207, the secondary inlet sealing surface 224 and the secondary sealing surface 218 may have complementary profiles. For example, the secondary inlet sealing surface 224 and the secondary sealing surface 218 may have non-planar profiles. As shown, the secondary inlet sealing surface 224 may have a curved profile, such as, but not limited to, a concave profile. Therefore, the secondary sealing surface 218 may have a complementary curved profile, such as, but not limited to, a convex profile.

[0050] At the location where the secondary inlet sealing surface 224 of the valve member 220 contacts and seals the secondary inlet port 207, fluid flow from the secondary intravenous injection line 7 to the chamber 214 is blocked. Therefore, only fluid (e.g., the main drug) from the main intravenous injection line 5 can be dispensed to the patient 50 via the main inlet port 213 and the main outlet 210.

[0051] When subjected to net secondary fluid pressure (i.e., pressure exerted by the fluid flowing from secondary inlet 206 to chamber 214 exceeding any pressure exerted by the fluid in the main venous infusion line 5), valve member 220 can translate toward main inlet 112. As previously described, secondary inlet sealing surface 224 and secondary sealing surface 218 can have complementary non-planar profiles. In particular, as shown, secondary inlet sealing surface 224 can have a concave profile, and secondary sealing surface 218 can have a complementary convex profile. The advantage of the aforementioned configuration is that the curved profile of the secondary inlet sealing surface 224 of valve member 220 will be subject to lower drag forces compared to a flat or planar surface. Therefore, a lower fluid pressure threshold at inlet port 207 will be required to move valve member 220 away from inlet port 207, allowing fluid to flow from the secondary venous infusion line into chamber 214 for distribution to the patient via outlet 208.

[0052] As valve member 220 continues to move toward the main inlet 212 and away from the secondary inlet 206, the secondary inlet port 207 and the secondary outlet 208 can be opened. Fluid from the secondary intravenous line 7 can then flow through the secondary inlet 206 into the chamber 214 and be dispensed to the patient via the secondary outlet 208. When valve member 220 is translated to a position where the main inlet sealing surface 226 of valve member 220 contacts the main sealing surface 222, both the main inlet port 212 and the main outlet port 210 can be blocked by valve member 220.

[0053] To enable the primary inlet sealing surface 226 of valve component 220 to contact and seal the primary inlet port 213, the primary inlet sealing surface 226 and the primary sealing surface 222 may have complementary profiles. For example, the primary inlet sealing surface 226 and the primary sealing surface 222 may have matching or complementary flat profiles. As shown, the primary inlet sealing surface 226 may have a flat profile, and the primary sealing surface 222 may have complementary flat profiles. However, the various embodiments of this disclosure are not limited to the foregoing configuration. In some embodiments, similar to the secondary inlet sealing surface 224 and the secondary sealing surface 218, the primary inlet sealing surface 226 and the primary sealing surface 222 may have complementary non-planar profiles.

[0054] At the location where the main inlet sealing surface 226 of valve member 220 contacts and seals the main inlet port 213, fluid flow from the main venous injection line 7 to chamber 214 is blocked. Therefore, only fluid (e.g., adjuvant medication) from the secondary venous injection line 7 can be dispensed to the patient 50 via the secondary inlet port 207 and secondary outlet 208. This prevents backflow of fluid from the secondary venous injection line 7 into the main venous injection line 5. Similarly, it prevents under-infusion of adjuvant medication (which typically occurs due to adjuvant medication flowing from chamber 214 into the main venous injection line 5). Preventing backflow is advantageous because it restricts the backflow of unwanted particulate matter (e.g., particulate matter contained in medication dispensed from the secondary venous injection line 7) through valve member 200 and thereby prevents the patient 50 from receiving an appropriate dose concentration or timely delivery of medication.

[0055] Figure 5 A cross-sectional view of a flow control device 300 according to some embodiments of the present disclosure is shown. In some embodiments, the flow control device 300 may have a housing 302 including a main inlet 312, a main outlet 310, a secondary inlet 306, a secondary outlet 308, and a chamber 314 between the main inlet 312 and the secondary inlet 306. The flow control device 300 may also include a valve member 320 reciprocally mounted in the chamber 314. The main outlet 310 and the secondary outlet 308 may define a fluid path through which a drug or medication from the main inlet 312 and the secondary inlet 306 may be delivered to a patient 50. The main inlet 312 and the secondary inlet 306 may share a common central axis X4. The main inlet 312 may fluidly communicate a main intravenous infusion line 5 with the chamber 314. Similarly, the secondary inlet 306 may fluidly communicate a secondary intravenous infusion line 7 with the chamber 314. The main outlet 310 and the secondary outlet 308 may each have a central axis, and each of the central axes may be arranged perpendicularly to the common central axis X4 of the main inlet 312 and the secondary inlet 306.

[0056] refer to Figure 5 The flow control device 300 is shown in cross-sectional view to more clearly illustrate some features of the valve component 320. As shown, the flow control device 300 may be in the form of a generally cylindrical (or tubular) body, or may have any other shape including a hollow interior capable of defining a chamber 314. Similar to the previously described embodiments, the chamber 314 may be defined by an inner circumferential surface 316 of the housing 302. As shown, the chamber 314 may extend between a main inlet 312 and a secondary inlet 306 to fluidly connect the main inlet 312 and the secondary inlet 306 to corresponding main outlets 310 and secondary outlets 308.

[0057] In some embodiments, the inner circumferential surface 316 may include a primary sealing surface 322 defining an inlet port 313 of a primary inlet 312 and a secondary sealing surface 318 defining an inlet port 307 of a secondary inlet 306. As will be described in further detail below, the primary sealing surface 322 and the secondary sealing surface 318 may be specifically configured to correspond to the structure of the valve member 320 so that the valve member seals the primary inlet port 313 and the secondary inlet port 307 accordingly.

[0058] As shown in the figure, valve component 320 may be in disc form, having a main inlet sealing surface 326 corresponding to the main sealing surface 322 of housing 302. Similarly, valve component 320 may include a secondary inlet sealing surface 324 corresponding to the secondary sealing surface 318 of housing 302. Furthermore, valve component 320 may include an outlet sealing surface 328 for selectively sealing the main outlet 310 and the secondary outlet 308.

[0059] During operation, when subjected to net main fluid pressure (i.e., pressure exerted by the fluid flowing from the main inlet 312 to the chamber 314 exceeding any pressure exerted by the fluid in the secondary intravenous line 7), the valve member 320 can be translated toward the secondary inlet 306. As the valve member moves toward the secondary inlet 306 and away from the main inlet 312, the main inlet port 313 and the main outlet 310 can be opened. Fluid from the main intravenous line 5 can then flow through the main inlet 312 into the chamber 314 and be dispensed to the patient via the main outlet 310. When the valve member 320 is translated to a position such that the secondary inlet sealing surface 324 of the valve member 320 contacts the secondary sealing surface 318, both the secondary inlet port 307 and the secondary outlet port 308 can be blocked by the valve member 320.

[0060] In some embodiments, for the secondary inlet sealing surface 324 of the valve member 320 to contact and seal the secondary inlet port 307, the secondary inlet sealing surface 324 and the secondary sealing surface 318 may have complementary profiles. For example, the secondary inlet sealing surface 324 and the secondary sealing surface 318 may have complementary non-planar profiles. As shown, the secondary inlet sealing surface 324 may have a curved profile, such as, but not limited to, a concave profile. Therefore, the secondary sealing surface 318 may have a complementary curved profile, such as, but not limited to, a convex profile.

[0061] At the location where the secondary inlet sealing surface 324 of the valve member 320 contacts and seals the secondary inlet port 307, fluid flow from the secondary intravenous injection line 7 to the chamber 314 is blocked. Therefore, only fluid (e.g., the main drug) from the main intravenous injection line 5 can be dispensed to the patient 50 via the main inlet port 313 and the main outlet 310.

[0062] When subjected to net secondary fluid pressure (i.e., pressure exerted by the fluid flowing from secondary inlet 306 to chamber 314 exceeding any pressure exerted by the fluid in the main venous infusion line 5), valve member 320 can translate toward main inlet 313. As discussed earlier, secondary inlet sealing surface 324 and secondary sealing surface 318 can have complementary non-planar profiles. In particular, secondary inlet sealing surface 324 can have a concave profile, and secondary sealing surface 318 can have a complementary convex profile. The advantage of the aforementioned configuration is that the curved profile of the secondary inlet sealing surface 324 of valve member 320 will be subject to lower drag forces compared to a flat or planar surface 324. Therefore, a lower fluid pressure threshold at inlet port 307 will be required to move valve member 320 away from inlet port 307, allowing fluid to flow from secondary venous infusion line 7 into chamber 314 for distribution to the patient via outlet 308.

[0063] As valve member 320 continues to move toward the main inlet 312 and away from the secondary inlet 306, the secondary inlet port 307 and the secondary outlet 308 can be opened. Fluid from the secondary intravenous line 7 can then flow through the secondary inlet 306 into the chamber 314 and be dispensed to the patient via the secondary outlet 308. When valve member 320 is translated to a position where the main inlet sealing surface 326 of valve member 320 contacts the main sealing surface 322, both the main inlet port 312 and the main outlet port 310 can be blocked by valve member 320.

[0064] To enable the primary inlet sealing surface 326 of the valve component 320 to contact and seal the primary inlet port 313, the primary inlet sealing surface 326 and the primary sealing surface 322 may have complementary profiles. For example, the primary inlet sealing surface 326 and the primary sealing surface 322 may have matching or complementary planar profiles. As shown, the primary inlet sealing surface 326 may have a flat profile, and the primary sealing surface 322 may have complementary flat profiles. However, the various embodiments of this disclosure are not limited to the foregoing configuration. In some embodiments, similar to the secondary inlet sealing surface 324 and the secondary sealing surface 318, the primary inlet sealing surface 326 and the primary sealing surface 322 may have complementary non-planar profiles.

[0065] At the location where the main inlet sealing surface 326 of valve member 320 contacts and seals the main inlet port 313, fluid flow from the main venous injection line 7 to chamber 314 is blocked. Therefore, only fluid (e.g., adjuvant medication) from the secondary venous injection line 7 can be dispensed to the patient 50 via the secondary inlet port 307 and secondary outlet 308. This restricts or prevents backflow of fluid from the secondary venous injection line 7 into the main venous injection line 5. Similarly, it prevents under-infusion of adjuvant medication (which typically occurs due to adjuvant medication flowing from chamber 314 into the main venous injection line 5). Preventing backflow is advantageous because it restricts the backflow of unwanted particulate matter (e.g., particulate matter contained in medication dispensed from the secondary venous injection line 7) through valve member 300 and thereby prevents the patient 50 from receiving an appropriate dose concentration or timely delivery of medication.

[0066] During operation, when subjected to a main fluid pressure equal to the secondary fluid pressure (i.e., the pressure exerted by the fluid flowing from the main intravenous line 5 to the main inlet 312 is equal to the pressure exerted by the fluid flowing from the secondary intravenous line 7 to the secondary inlet 306), the valve member 320 can be translated towards the center of the chamber 314 between the main outlet 310 and the secondary outlet 308. Since the fluid pressure at the main inlet 312 is equal to the fluid pressure at the secondary inlet 306, the valve member 320 can be positioned equidistant from each of the main inlet port 313 and the secondary inlet port 307. At this position, both the main inlet port 313 and the main outlet 310, as well as the secondary inlet port 307 and the secondary outlet 308, are open, allowing fluid to flow equally from the main intravenous line 5 and the secondary intravenous line 7 to the patient 50. Therefore, given the above configuration, the primary and adjuvant medications can be administered to the patient in equal proportions without the possibility of medication flowing back from one intravenous fluid line to another.

[0067] In one or more embodiments of this disclosure, the flow control device includes a housing and a valve member. The housing includes a main valve body defining a main inlet and an outlet of the flow control device; a secondary valve body defining a secondary inlet of the flow control device, wherein the main inlet and the secondary inlet share a common central axis, and the central axis of the outlet is disposed perpendicular to the common central axis; and a chamber defined by an inner circumferential surface of the housing extending between the main valve body and the secondary valve body for fluidly connecting the main inlet and the secondary inlet to the outlet. The valve member is reciprocally mounted in the chamber such that (i) when the fluid pressure entering the main inlet is higher than the fluid pressure entering the secondary inlet, fluid communication between the secondary inlet and the outlet is prevented, and (ii) when the fluid pressure entering the secondary inlet is higher than the fluid pressure entering the main inlet, fluid communication between the main inlet and the outlet is prevented.

[0068] In this aspect of the disclosure, the valve member includes a cylindrical disc slidably mounted in a chamber. In this aspect of the disclosure, the housing includes at least one guide rail extending longitudinally within the chamber along an inner circumferential surface, and the valve member includes at least one slot extending longitudinally along an outer circumferential surface of the valve member, the slot defining a recess having a shape corresponding to the shape of the guide rail for mounting the valve member onto the guide rail. In this aspect of the disclosure, the at least one guide rail includes two guide rails symmetrically arranged about a central longitudinal axis defining the inner circumferential surface of the chamber; the at least one slot includes two slots symmetrically arranged about a central longitudinal axis of the valve member; and the central longitudinal axis defining the inner circumferential surface of the chamber and the central longitudinal axis of the valve member are coaxially aligned. In this aspect of the disclosure, the valve member also includes a flow groove extending longitudinally from a planar surface of the disc along the outer circumferential surface of the valve member. In this aspect of the disclosure, the main valve body and the main valve assembly are integrally formed as a single unit.

[0069] In one or more embodiments of this disclosure, a flow control device includes a housing, a chamber, and a valve member. The housing includes a main inlet, a main outlet, a secondary inlet, and a secondary outlet, wherein the main inlet and the secondary inlet share a common central axis, which is perpendicular to the central axes of the main outlet and the secondary outlet. A chamber is defined by an inner circumferential surface of the housing and extends between the main inlet and the secondary inlet for fluidly connecting the main inlet to the main outlet and for fluidly connecting the secondary inlet to the secondary outlet. The valve member is reciprocally mounted in the chamber to (i) prevent fluid communication between the secondary inlet and the secondary outlet when the fluid pressure entering the main inlet is higher than the fluid pressure entering the secondary inlet, and (ii) block fluid communication between the main inlet and the main outlet when the fluid pressure entering the secondary inlet is higher than the fluid pressure entering the main inlet.

[0070] In one aspect of this disclosure, the inner circumferential surface includes a primary sealing surface defining an inlet port of the primary inlet and a secondary sealing surface defining an inlet port of the secondary inlet; and the valve member includes a disc having a primary inlet sealing surface corresponding to the primary sealing surface and a secondary inlet sealing surface corresponding to the secondary sealing surface, and an outlet sealing surface for selectively sealing the primary outlet and the secondary outlet. In one aspect of this disclosure, the primary inlet sealing surface includes a planar profile, and the secondary inlet sealing surface includes a non-planar profile. In one aspect of this disclosure, the secondary inlet sealing surface of the valve member includes a curved profile. In one aspect of this disclosure, the secondary inlet sealing surface of the valve member includes a concave profile. In one aspect of this disclosure, the primary sealing surface of the housing includes a planar profile, and the secondary sealing surface of the housing includes a non-planar profile. In one aspect of this disclosure, the secondary sealing surface of the housing includes a curved profile.

[0071] In one aspect of this disclosure, the secondary sealing surface of the housing includes a convex profile. In another aspect of this disclosure, the valve member further includes a flow channel extending longitudinally from a planar surface of the disc and along the outer circumferential surface of the valve member. In one aspect of this disclosure, the inner circumferential surface includes a primary sealing surface defining an inlet port of the primary inlet and a secondary sealing surface defining an inlet port of the secondary inlet; and the valve member includes a column having a primary inlet sealing surface corresponding to the primary sealing surface, a secondary inlet sealing surface corresponding to the secondary sealing surface, and an outlet sealing surface for selectively sealing the primary outlet and the secondary outlet. In one aspect of this disclosure, at least one of the primary inlet sealing surface and the secondary inlet sealing surface includes a non-planar profile. In one aspect of this disclosure, the primary inlet sealing surface includes a planar profile, and the secondary inlet sealing surface includes a non-planar profile. In one aspect of this disclosure, the secondary inlet sealing surface of the valve member includes a curved profile. In one aspect of this disclosure, the secondary inlet sealing surface of the valve member includes a concave profile.

[0072] Therefore, as previously described, an advantage of the various embodiments of this disclosure is that it provides a flow control device capable of preventing under-infusion of the adjuvant medication by preventing backflow into the main intravenous infusion line. A further advantage of the flow control device of the various embodiments described herein is that it minimizes the number of separate components in the intravenous infusion kit by replacing the check valve and Y-connector with a single flow control device. Therefore, the cost of the intravenous infusion kit can be reduced. Furthermore, an advantage of the various embodiments of this disclosure is that it reduces the workflow steps for clinicians / nurses because manual operation for flow regulation is eliminated, as the flow pressure of the adjuvant medication or fluid is used to regulate the flow of the primary medication or fluid.

[0073] This disclosure is provided to enable those skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject matter, but the subject matter is not limited to these examples. Different modifications to these aspects will be clear to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0074] Unless otherwise stated, reference to an element in the singular does not imply "one and only one," but rather "one or more." Unless otherwise expressly stated, the term "some" refers to one or more. The use of titles and subtitles (if any) is for convenience only and does not limit the invention.

[0075] The term “exemplary” is used herein to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” should not be construed as preferred or advantageous to other aspects or designs. In one respect, the various alternative constructions and operations described herein may be considered at least equivalent.

[0076] As used herein, the phrase “at least one” preceding a list of items (separated by the term “or”) modifies the list as a whole, not each item in the list. The phrase “at least one” does not require the selection of at least one item; rather, it allows for the inclusion of at least one of any of the items, and / or at least one of any combination of items, and / or at least one of each of the items. 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.

[0077] Phrases such as "aspect" do not imply that such an aspect is essential to the art, or that such an aspect applies to all constructions of the art. Disclosure relating to an aspect may apply to all constructions or one or more constructions. An aspect may provide one or more examples. Phrases such as "one aspect" may refer to one or more aspects, and vice versa. Phrases such as "embodiment" do not imply that such an embodiment is essential to the art, or that such an embodiment applies to all constructions of the art. Disclosure relating to an embodiment may apply to all embodiments or one or more embodiments. An embodiment may provide one or more examples. Phrases such as "an embodiment" may refer to one or more embodiments, and vice versa. Phrases such as "construction" do not imply that the construction is essential to the art, or that the construction applies to all constructions of the art. Disclosure relating to a construction may apply to all constructions, or one or more constructions. A construction may provide one or more examples. Phrases such as "a construction" may refer to one or more constructions, and vice versa.

[0078] In one respect, unless otherwise stated, all measurements, numerical values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification (including in the following claims) are approximate, not precise. In another respect, they are intended to have a reasonable range that is consistent with the functions they address and the conventions of the field to which they belong.

[0079] 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 can be performed simultaneously. In some implementation preferences or scenarios, certain operations may or may not be performed. 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 an exemplary order, but this does not imply limitation to the specific order or hierarchy presented.

[0080] All structural and functional equivalents of the elements throughout the various aspects described in this disclosure are known to or will be known hereafter to those skilled in the art, expressly incorporated herein by reference and intended to be covered by the claims. Furthermore, the disclosure herein is not intended to be made public, whether or not it is expressly stated in the claims. No claim element is to be construed in accordance with 35 USC §112(f) unless it is clearly stated using the phrase “means for…” or, in the case of a method claim, using the phrase “steps for…”. Moreover, the scope of terms such as “comprising,” “having,” etc., is intended to be inclusive in a manner similar to the term “comprising,” as interpreted when “comprising” is used as a transitional term in the claims.

[0081] The title, background, summary, description of the drawings, and abstract of this disclosure are incorporated herein by reference and are provided as illustrative examples rather than as limiting descriptions. It should be understood that they are not intended to limit the scope or meaning of the claims. Furthermore, in the detailed description, it will be apparent that the description provides illustrative examples, and various features are combined in various embodiments to simplify the disclosure. This approach to disclosure should not be construed as reflecting an intention to require more features than expressly stated in each claim. Rather, as reflected in the appended claims, the inventive subject matter lies in all features of fewer than those in a single disclosed construction or operation. The appended claims are thus incorporated into the detailed description, and each claim is treated independently as a separately claimed subject matter.

[0082] The claims are not intended to be limited to the aspects described herein, but rather to conform to the full scope consistent with the language of the claims and to include all legal equivalents. Nevertheless, none of the claims are intended to include subject matter that fails to satisfy the requirements of 35 U.S.SC § 101, 102, or 103, nor should they be interpreted in this manner.

Claims

1. A flow control device, comprising: The housing includes a main inlet, a main outlet, a secondary inlet, and a secondary outlet, wherein the main inlet and the secondary inlet share a common central axis, which is perpendicular to the central axis of the main outlet and the secondary outlet. A chamber defined by an inner circumferential surface of the housing, extending between the main inlet and the secondary inlet for fluidly connecting the main inlet to the main outlet and the secondary inlet to the secondary outlet; and A valve component, reciprocally mounted in the chamber, thereby (i) preventing fluid communication between the secondary inlet and the secondary outlet when the fluid pressure entering the main inlet is higher than the fluid pressure entering the secondary inlet, and (ii) preventing fluid communication between the main inlet and the main outlet when the fluid pressure entering the secondary inlet is higher than the fluid pressure entering the main inlet. The inner circumferential surface includes a main sealing surface defining the inlet port of the main inlet and a secondary sealing surface defining the inlet port of the secondary inlet. The valve component includes a disc having a main inlet sealing surface corresponding to the main sealing surface, a secondary inlet sealing surface corresponding to the secondary sealing surface, and an outlet sealing surface for selectively sealing the main outlet and the secondary outlet.

2. The flow control device according to claim 1, wherein, The primary inlet sealing surface includes a planar profile, and the secondary inlet sealing surface includes a non-planar profile.

3. The flow control device according to claim 2, wherein, The secondary inlet sealing surface of the valve component includes a curved profile.

4. The flow control device according to claim 2, wherein, The secondary inlet sealing surface of the valve component includes a concave profile.

5. The flow control device according to claim 1, wherein, The primary sealing surface of the housing includes a planar profile, and the secondary sealing surface of the housing includes a non-planar profile.

6. The flow control device according to claim 5, wherein, The secondary sealing surface of the housing includes a curved profile.

7. The flow control device according to claim 5, wherein, The secondary sealing surface of the housing includes a convex profile.

8. The flow control device according to claim 1, wherein, The valve component is configured to allow fluid communication between the main inlet and the main outlet, and between the secondary inlet and the secondary outlet, when the fluid pressure entering the main inlet is equal to the fluid pressure entering the secondary inlet.

9. The flow control device according to claim 1, wherein, At least one of the main inlet sealing surface and the secondary inlet sealing surface includes a non-planar profile.

10. The flow control device according to claim 1, wherein, The main outlet and the secondary outlet are fluidly connected to the combined outlet.

11. A flow control device, comprising: The housing includes a main inlet, a main outlet, a secondary inlet, and a secondary outlet; A chamber defined by the inner circumferential surface of the housing, the chamber extending between the main inlet and the secondary inlet for fluidly connecting the main inlet and the main outlet and the secondary inlet and the secondary outlet; as well as A valve component, reciprocally mounted in the chamber, thereby (i) preventing fluid communication between the secondary inlet and the secondary outlet when the fluid pressure entering the main inlet is higher than the fluid pressure entering the secondary inlet, and (ii) preventing fluid communication between the main inlet and the main outlet when the fluid pressure entering the secondary inlet is higher than the fluid pressure entering the main inlet. This includes one of the following situations: Further comprising a primary inlet sealing surface of the valve member and a secondary inlet sealing surface of the valve member, one comprising a planar profile and the other comprising a non-planar profile; and It further includes a primary sealing surface of the housing and a secondary sealing surface of the housing, one of which includes a planar profile and the other includes a non-planar profile.

12. The flow control device according to claim 11, wherein, The inner circumferential surface includes the main sealing surface defining the inlet port of the main inlet and the secondary sealing surface defining the inlet port of the secondary inlet.

13. The flow control device according to claim 11, wherein, The valve component includes a disc having a main inlet sealing surface corresponding to the main sealing surface, a secondary inlet sealing surface corresponding to the secondary sealing surface, and an outlet sealing surface for selectively sealing the main outlet and the secondary outlet.

14. The flow control device according to claim 13, wherein, The primary inlet sealing surface includes a planar profile, and the secondary inlet sealing surface includes a non-planar profile.

15. The flow control device according to claim 14, wherein, The non-planar profile of the secondary inlet sealing surface includes a curved profile.

16. The flow control device according to claim 14, wherein, The non-planar profile of the secondary inlet sealing surface includes a concave profile.

17. The flow control device according to claim 13, wherein, The primary sealing surface of the housing includes a planar profile, and the secondary sealing surface of the housing includes a non-planar profile.

18. The flow control device according to claim 17, wherein, The secondary sealing surface of the housing includes a curved profile.

19. The flow control device according to claim 17, wherein, The secondary sealing surface of the housing includes a convex profile.

20. The flow control device according to claim 11, wherein, The valve component is configured to allow fluid communication between the main inlet and the main outlet, and between the secondary inlet and the secondary outlet, when the fluid pressure entering the main inlet is equal to the fluid pressure entering the secondary inlet.

21. The flow control device according to claim 12, wherein, The valve component includes a column having a main inlet sealing surface corresponding to the main sealing surface, a secondary inlet sealing surface corresponding to the secondary sealing surface, and an outlet sealing surface for selectively sealing the main outlet and the secondary outlet.

22. The flow control device according to claim 21, wherein, At least one of the main inlet sealing surface and the secondary inlet sealing surface includes a non-planar profile.

23. The flow control device according to claim 21, wherein, The primary inlet sealing surface includes a planar profile, and the secondary inlet sealing surface includes a non-planar profile.

24. The flow control device according to claim 23, wherein, The secondary inlet sealing surface of the valve component includes a curved profile.

25. The flow control device according to claim 23, wherein, The secondary inlet sealing surface of the valve component includes a concave profile.

26. The flow control device according to claim 21, wherein, The valve component is configured to allow fluid communication between the main inlet and the main outlet, and between the secondary inlet and the secondary outlet, when the fluid pressure entering the main inlet is equal to the fluid pressure entering the secondary inlet.

27. The flow control device according to claim 11, wherein, The main outlet and the secondary outlet are fluidly connected to the combined outlet.

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