Pressure-operated flow control device for gravity IV set

Abstract

The flow control device may include a housing having a primary valve body defining a primary 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 primary and secondary inlets may share a common central axis, and the central axis of the outlet may be disposed perpendicular to the common central axis. The chamber may extend between the primary and secondary valve bodies to fluidly connect the primary and secondary inlets with the outlet. The flow control device may further include a valve member reciprocally mounted within the chamber to (i) prevent fluid communication between the secondary inlet and the outlet when fluid pressure into the primary inlet is greater than fluid pressure into the secondary inlet, and (ii) prevent fluid communication between the primary inlet and the outlet when fluid pressure into the secondary inlet is greater than fluid pressure into the primary inlet.

Description

Technical Field

[0001] The present disclosure generally relates to a flow control device, particularly a flow control device having a valve member that can prevent under-injection in an IV set with a secondary line and prevent backflow of a drug from the secondary line into the primary line.

Background Art

[0002] An infusion IV set is generally used in infusion therapy to deliver a drug from a pre-filled container, such as an IV bottle or bag containing a desired drug, to a patient. Generally, an IV tube is connected to a catheter and inserted into a local area to be treated. In some cases, it is necessary to deliver multiple drugs to a patient at potentially different dosages, thereby creating a need for an IV extension set having multiple branches of tubes or fluid lines through which the multiple drugs are dispensed to the patient.

[0003] Patients are generally injected with an IV solution that is initially provided in an IV bottle or bag and dripped into the patient's vein through an IV line. A flow control device, such as a check valve, is also generally included in the IV line to allow fluid flow only in the patient's direction. This ensures that the drug flows downstream towards the patient rather than upstream towards the IV bottle or bag.

[0004] During infusion with an IV set, a secondary drug refill can potentially backflow into the primary IV line, leading to under-injection of the secondary drug. A check valve may be placed in the primary line to prevent backflow, but check valves tend to fail frequently. A common reason for check valve failure is debris present in the infusion fluid. Additionally, under-injection occurs frequently because the pressure difference across the diaphragm in the check valve, which prevents the check valve from fully closing and allowing backflow, is small.

[0005] The descriptions provided in the background section should not be assumed to be prior art simply because they are mentioned in or associated with the background section. The background section may contain information describing one or more aspects of the subject matter. [Overview of the Initiative]

[0006] According to various embodiments of the present disclosure, a flow control device may include a housing having a primary valve body defining a primary inlet and outlet of the flow control device, a secondary valve body defining a secondary inlet of the flow control device, and a chamber defined by the inner surface of the housing. The primary and secondary inlets may share a common central axis, and the central axis of the outlet may be positioned perpendicular to the common central axis. The chamber may extend between the primary and secondary valve bodies to fluidly connect the primary and secondary inlets to the outlet. The flow control device may further include a valve member reciprocally mounted within the chamber to (i) prevent fluid communication between the secondary inlet and the outlet when the fluid pressure into the primary inlet is higher than the fluid pressure into the secondary inlet, and (ii) prevent fluid communication between the primary inlet and the outlet when the fluid pressure into the secondary inlet is higher than the fluid pressure into the primary inlet.

[0007] According to various aspects of this disclosure, a flow control device may include a housing having a primary inlet, a primary outlet, a secondary inlet, and a secondary outlet. The primary and secondary inlets may share a common central axis positioned perpendicular to the central axes of the primary and secondary outlets. A chamber may be defined by the inner surface of the housing, and the chamber may extend between the primary and secondary inlets to fluidly connect the primary inlet to the primary outlet and the secondary inlet to the secondary outlet. The flow control device may further include a valve member reciprocatingly mounted within the chamber to (i) prevent fluid communication between the secondary inlet and the secondary outlet when the fluid pressure into the primary inlet is higher than the fluid pressure into the secondary inlet, and (ii) prevent fluid communication between the primary inlet and the primary outlet when the fluid pressure into the secondary inlet is higher than the fluid pressure into the primary inlet.

[0008] Other configurations of the subject art will be readily apparent to those skilled in the art from the following detailed description, and it will be understood that various configurations of the subject art are shown and described here as examples. As realized, other different configurations of the subject art are possible, and some of their details can be modified in various other ways without departing in any way from the scope of the subject art. Therefore, the drawings and detailed description should be considered as illustrative and not restrictive in nature.

[0009] The following 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, alteration, combination, and equivalence in form and function, which may occur to those skilled in the art and to benefit from this disclosure. [Brief explanation of the drawing]

[0010] [Figure 1] Several embodiments of this disclosure show an IV extension set including a flow control device. [Figure 2A] Perspective views of flow control devices according to some embodiments of this disclosure are shown. [Figure 2B] Figure 2A shows a cross-sectional view of a flow control device and valve member according to several embodiments of the present disclosure. [Figure 2C] The following are partial cross-sectional views of the housing of the flow control device shown in Figure 2A, according to several embodiments. [Figure 2D] The following are perspective views of the valve members of the flow control device shown in Figure 2A, according to several embodiments. [Figure 2E] The following are partial cross-sectional views of a flow control device housing and a mounted valve member according to some embodiments of the present disclosure. [Figure 2F] The following are cross-sectional views of the housing and mounted valve member of a flow control device according to some embodiments of the present disclosure. [Figure 3A] This is a cross-sectional view showing a flow control device and valve member before coupling to the IV set of fluid lines, according to some embodiments of the present disclosure. [Figure 3B]Figure 3A is a cross-sectional view showing a flow control device and valve member when coupled to IV sets of primary and secondary fluid lines, where the fluid pressure in the primary line is higher than the fluid pressure in the secondary line, according to some embodiments of the present disclosure. [Figure 3C] Figure 3A is a cross-sectional view showing a flow control device and valve member when coupled to IV sets of primary and secondary fluid lines, according to some embodiments of the present disclosure, where the fluid pressure in the secondary line is higher than the fluid pressure in the primary line. [Figure 3D] Figure 3A is a cross-sectional view showing a flow control device and valve member when coupled to IV sets of primary and secondary fluid lines, where the fluid pressure in the primary line is equal to the fluid pressure in the secondary line, according to some embodiments of the present disclosure. [Figure 3E] Figure 3D is a cross-sectional view showing a flow control device and a valve member, according to some embodiments of the present disclosure, in which, when the fluid pressure in the primary line is equal to the fluid pressure in the secondary line, the flow groove profile of the valve member allows the fluid to flow from the secondary fluid line to the outlet port. [Figure 4] Cross-sectional views of flow control devices according to some embodiments of this disclosure are shown. [Figure 5] Cross-sectional views of flow control devices according to some embodiments of this disclosure are shown. [Modes for carrying out the invention]

[0011] The detailed descriptions provided below illustrate various configurations of the subject art and are not intended to represent the only configuration in which the subject art is implemented. The detailed descriptions include designation details intended to provide a complete understanding of the subject art. Accordingly, dimensions may be provided for certain embodiments as non-limiting examples. However, it will be apparent to those skilled in the art that the subject art can be implemented without these designation details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject art.

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

[0013] This description generally relates to flow control devices, particularly flow control devices having valve members that can prevent insufficient injection in IV sets with secondary lines and also prevent backflow of chemicals from the secondary line into the primary line.

[0014] IV sets with a secondary line tend to experience insufficient injection of the secondary chemical due to check valve failure in the primary line. The most frequent causes of check valve failure are debris accumulation during spikes and the penetration of chemicals from the secondary line into the primary line at low pressure. Common causes of insufficient injection include backpriming of the secondary IV and dilution of the chemical when the heads in the primary and secondary lines are equal. Other causes include the exclusion volume in the secondary line and the time required to inject the chemical. Flow control devices in the various embodiments described herein overcome the above-mentioned problems generally associated with IV sets having primary and secondary lines.

[0015] 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) may receive fluid from the primary fluid system 15 and the secondary fluid system 25 via the primary IV line 5 and control and distribute the fluid from there to the patient 50.

[0016] In some embodiments, the primary fluid system 15 may include a primary fluid source such as a primary fluid bag 10 that contains or holds physiological saline, other pharmaceutical solutions, or drugs to be administered to the patient 50. As shown, the primary IV line 5 carries the primary fluid from the drip chamber 12 to the flow control devices 100, 200, 300. As further described with reference to the following figures, the flow control devices 100, 200, 300 are arranged in the primary IV line 5 and may allow the flow of fluid from the primary fluid bag 10 to an IV pump (not shown) while preventing reverse flow (backflow) of fluid from the secondary fluid system 25 into 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 that contains drugs or other secondary fluids supplied to the patient 50 for treatment. As shown, the IV set 1 may further include a secondary IV line 7 that carries the flow from the drip chamber 22 to the flow control devices 100, 200, 300.

[0017] FIG. 2A is a perspective view of a flow control device according to some embodiments of the present disclosure. FIG. 2B shows a cross-sectional view of the flow control device and the valve member of FIG. 2A according to some embodiments of the present disclosure. Referring to FIGS. 2A and 2B, the flow control device 100 may include a housing 102 that includes a primary valve body 104 and a secondary valve body 110, and a chamber 114 interposed between the primary valve body 104 and the secondary valve body 110, and a valve member 120 reciprocally mounted within the chamber 114. As shown, the primary valve body 104 and the secondary valve body 110 may be two components coupled to each other. However, various embodiments of the present disclosure are not limited to the foregoing configuration. In some embodiments, the primary valve body 104 and the secondary valve body 110 may be integrally formed as a single unit. For example, the primary valve body 104 and the secondary valve body 100 may be integrally formed as a single tubular housing 102.

[0018] As shown, the primary valve body 104 may define a primary inlet 106 and an outlet 108 of the flow control device 100. The outlet 108 may define a fluid path through which a drug or chemical from the primary and secondary inlets is delivered to the patient 50. The secondary valve body 110 may define a secondary inlet 112 of the flow control device 100. The primary inlet 106 and the secondary inlet 112 may share a common central axis X1. The primary inlet 106 may be in fluid communication with the primary IV line 5 and the chamber 114. Similarly, the secondary inlet 112 may be in fluid communication with the secondary IV line 7 and the chamber 114. The outlet 108 may have a central axis Y, which may be disposed perpendicular to the common central axis X1 of the primary inlet 106 and the secondary inlet 112.

[0019] Referring to FIG. 2B, the flow control device 100 is shown in cross-section to more clearly illustrate some of the features of the valve member 120. As shown, the flow control device 100 may be in the form of a housing having an axially extending body 102 that defines a central longitudinal axis X. The body 102 may generally be cylindrical (or tubular) or may have any other shape having a hollow interior that can define a chamber 114. The chamber 114 may be defined by the inner circumferential surface 116 of the housing 102. As shown, the chamber 114 extends between the primary valve body 104 and the secondary valve body 110 and fluidly connects the primary inlet 106 and the secondary inlet 112 to the outlet 108.

[0020] Figure 2C shows a partial cross-sectional view of the housing 102 of the flow control device shown in Figure 2A according to several embodiments. Continuing to refer to Figure 2B with reference to Figure 2C, the housing 102 may include at least one guide rail 122 extending longitudinally along the inner surface 116 in the chamber 114. As shown, the guide rail 122 may be oriented to project radially inward toward the central longitudinal axis X1 of the housing 102. In some embodiments, the inner surface 116 may have multiple guide rails 122 projecting therefrom. For example, two guide rails 122 may project from the inner surface 116 in positions that reflect each other. The two guide rails 122 may be symmetrically arranged about the central longitudinal axis X1 of the inner surface 116 defining the chamber 114. As will be described in more detail below, the guide rail 122 can act as a guide so that the valve member 120 is displaced or otherwise translated axially within the chamber 114 without rotating about its central axis X2 (as shown in Figure 2D).

[0021] Figure 2D shows a perspective view of the valve member of the flow control device shown in Figure 2A according to several embodiments. As shown in Figure 2D, and subsequently referring to Figure 2C, the valve member 120 may be in the form of a cylindrical disc slidably mounted in the chamber 114. In this sense, the valve member 120 may have at least one slot 124 extending longitudinally along the outer circumferential 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.

[0022] In some embodiments, the valve member 120 may have a plurality of slots, for example, two slots 124 arranged symmetrically around the central longitudinal axis X2 of the valve member 120. Thus, the valve member 120 may be mounted on the inner circumferential surface 132 with (one or more) rails 122 engaged with (one or more) recesses 126 of (one or more) slots 124. Therefore, when the valve member 120 is subjected to fluid pressure from either the primary IV wire 5 or the secondary IV wire 7, the valve member 120 is translated or otherwise displaced within the chamber 114 along the length of the guide rail 122. The above configuration is advantageous because the engagement between the guide rail 122 and the slots 124 limits the degree of movement of the valve member 120 within the chamber 114. In particular, the above configuration acts as an anti-rotation mechanism to prevent the valve member 120 from rolling or rotating around the central axis X of the housing 102.

[0023] Figure 2E shows a partial cross-sectional view of the housing 102 and the mounted valve member 120 of the flow control device 100 according to some embodiments of the present disclosure. Figure 2F shows a cross-sectional view of the housing 102 and the mounted valve member 120 of the flow control device 100 according to some embodiments of the present disclosure. In some embodiments, the valve member 120 may further include a flow groove 130 extending longitudinally from a plane 128 of the valve member 120. The flow groove 130 may extend longitudinally along the outer circumferential surface 132 of the valve member 120. As shown, the flow groove 130 may extend partially along the length of the valve member 120. Thus, the flow groove 130 may function to fluidly communicate the secondary inlet 112 with the outlet 108 when the fluid pressure at the primary inlet 106 is equal to the fluid pressure at the secondary inlet 112.

[0024] Figure 3A is a cross-sectional view showing a flow control device and valve component before coupling to the fluid lines of an IV set, according to some embodiments of the present disclosure. Figure 3A shows the state of the flow control device 100 when it is first packaged before being used in the IV set. Figure 3B is a cross-sectional view showing the flow control device and valve component of Figure 3A when coupled to the primary and secondary fluid lines of an IV set, where the fluid pressure in the primary line is higher than the fluid pressure in the secondary line, according to some embodiments of the present disclosure.

[0025] Referring to Figure 3B, during operation, when subjected to a net primary fluid pressure (i.e., the pressure applied by the fluid flowing from the primary inlet 106 to the chamber 114, exceeding any pressure applied by the fluid in the secondary IV), the valve member 120 translates toward the secondary inlet 112 to a position where the plane 128 of the valve member contacts and blocks the secondary inlet port 112. Thus, the fluid flow from the secondary IV 7 into the chamber 114 is obstructed, and only the fluid from the primary IV 5 flows into the chamber 114 through the primary inlet 106. The fluid from the primary IV 5 can thus be delivered to the patient 50 through the outlet 108.

[0026] Figure 3C is a cross-sectional view showing the flow control device and valve member of Figure 3A when coupled to IV sets of primary and secondary fluid lines, in which the fluid pressure in the secondary line is higher than the fluid pressure in the primary line, according to some embodiments of the present disclosure.

[0027] Referring to Figure 3C, during operation, when subjected to a net secondary fluid pressure (i.e., the pressure applied by the fluid flowing from the secondary inlet 106 to the chamber 114, which exceeds any pressure applied by the fluid in the primary IV), the valve member 120 translates toward the primary inlet 112 to a position where the surface 125 of the valve member contacts and blocks the secondary inlet port 112. Thus, the fluid flow from the primary IV 5 into the chamber 114 is obstructed, and only the fluid from the secondary IV 7 flows into the chamber 114 through the secondary inlet 106. The fluid from the secondary IV 7 may then be delivered to the patient 50 through the outlet 108.

[0028] Figures 3D and 3E are cross-sectional views showing the flow control device and valve member of Figure 3A when coupled to IV sets of primary and secondary fluid lines, where the fluid pressure in the primary line is equal to the fluid pressure in the secondary line, according to some embodiments of the present disclosure.

[0029] Referring to Figures 3D and 3E, during operation, when the primary fluid pressure is equal to the secondary fluid pressure (i.e., the pressure is equal to the pressure applied by the fluid flowing from the primary IV line 5 to the primary inlet 106 and the pressure applied by the fluid flowing from the secondary IV line 7 to the secondary inlet 112), the valve member 120 may be translated toward the center of the chamber 114 just above the outlet 108. Since the fluid pressure at the primary inlet is equal to the fluid pressure at the secondary inlet, the position of the valve member 120 may be equidistant from the primary inlet 106 and the secondary inlet 112. At this position just above the outlet, the flow groove 130 of the valve member allows the fluid to flow from the secondary IV line 7 to the chamber 114 via the secondary inlet 112. Therefore, when the fluid pressures at the primary IV line 5 and the secondary IV line 7 are equal, only the secondary drug may be distributed to the patient via the flow groove 130. Since surface 125 does not have flow grooves, fluid communication between the primary inlet and outlet is obstructed, thereby preventing the fluid in the IV from being distributed to the patient.

[0030] Figure 4 shows a cross-sectional view of a flow control device 200 according to some embodiments of the present disclosure. In some embodiments, the flow control device 200 may have a housing 202 including a primary inlet 212, a primary outlet 210, a secondary inlet 206, and a secondary outlet 208, and a chamber 214 interposed between the primary inlet 212 and the secondary inlet 206. The flow control device 200 may further include a valve member 220 reciprocally mounted within the chamber 214. The primary outlet 210 and the secondary outlet 208 may define a fluid path through which a drug or medicine from the primary inlet 212 and the secondary inlet 206 is delivered to the patient 50. The primary inlet 212 and the secondary inlet 206 may share a common central axis X3. The primary inlet 212 may fluidly communicate a primary IV line 5 with the chamber 214. Similarly, the secondary inlet 206 may fluidly communicate a secondary IV line 7 with the chamber 214. The primary outlet 210 and the secondary outlet 208 may each have a central axis, and each of these central axes may be positioned perpendicular to the common central axis X3 of the primary inlet 212 and the secondary inlet 206.

[0031] Referring to Figure 4, the flow control device 200 is shown in a cross-sectional view to more clearly illustrate some of the features of the valve member 220. As shown, the flow control device 200 may generally take the form of a cylindrical (or tubular) body, or it may have any other shape with a hollow interior that can define the chamber 214. Similar to the embodiments described above, the chamber 214 is defined by the inner circumferential surface 216 of the housing 202. As shown, the chamber 214 extends between the primary inlet 212 and the secondary inlet 206, fluidly connecting the primary inlet 212 and the secondary inlet 206 to the primary outlet 210 and the secondary outlet 208, respectively.

[0032] In some embodiments, the inner circumferential surface 216 may include a primary sealing surface 222 defining the inlet port 213 of the primary inlet 212, and a secondary sealing surface 218 defining the inlet port 207 of the secondary inlet 206. As will be described in more detail below, the primary sealing surface 222 and the secondary sealing surface 218 may be designated structures corresponding to the structure of the valve member 220 so that the valve member seals the primary inlet port 213 and the secondary inlet port 207, respectively.

[0033] As shown in the figure, the valve member 220 may be in the form of a disk having a primary inlet sealing surface 226 corresponding to the primary sealing surface 222 of the housing 202. Similarly, the valve member 220 may include a secondary inlet sealing surface 224 corresponding to the secondary sealing surface 218 of the housing. Furthermore, the valve member 220 may include an outlet sealing surface 228 for selectively sealing the primary outlet 210 and the secondary outlet 208.

[0034] During operation, when subjected to a net primary fluid pressure (i.e., the pressure applied by the fluid flowing from the primary inlet 212 to the chamber 214, exceeding any pressure applied by the fluid in the secondary IV line 7), the valve member 220 is translated toward the secondary inlet 206. As the valve member moves toward the secondary inlet 206, away from the primary inlet 212, the primary inlet port 213 and the primary outlet 210 are opened. The fluid from the primary IV line 5 then flows into the chamber 214 via the primary inlet 212 and may be distributed to the patient via the primary outlet 210. When the valve member 220 is translated to a position where the secondary inlet sealing surface 224 of the valve member 220 contacts the secondary sealing surface 218, both the secondary inlet port 207 and the secondary outlet port 208 are closed by the valve member 220.

[0035] The secondary inlet sealing surface 224 of the valve member 220 may have complementary profiles in order for it to contact and seal the secondary inlet port 207. For example, the secondary inlet sealing surface 224 and the secondary sealing surface 218 may have non-planar profiles. As shown in the figure, the secondary inlet sealing surface 224 may have a curved profile, for example, a concave profile, for example. Therefore, the secondary sealing surface 218 may have a complementary curved profile, for example, a convex profile, for example.

[0036] At the position where the secondary inlet sealing surface 224 of the valve member 220 contacts and seals the secondary inlet port 207, the flow of fluid from the secondary IV line 7 into the chamber 214 is obstructed. Therefore, only the fluid from the primary IV line 5 (e.g., primary medication) is distributed to the patient 50 via the primary inlet port 213 and primary outlet 210.

[0037] When subjected to net secondary fluid pressure (i.e., the pressure applied by the fluid flowing from the secondary inlet 206 toward the chamber 214, exceeding any pressure applied by the fluid in the primary IV line 5), the valve member 220 translates toward the primary inlet 213. As previously discussed, the secondary inlet sealing surfaces 224 and 218 may have complementary non-planar profiles. In particular, as shown in the figure, the secondary inlet sealing surface 224 may have a concave profile, and the secondary sealing surface 218 may have a complementary convex profile. The above configuration is advantageous in that the curved profile of the secondary inlet sealing surface 224 of the valve member 220 receives lower drag than if the surface 224 were flat or planar. Therefore, a lower fluid pressure threshold at the inlet port 207 would have been required to move the valve member 220 away from the inlet port 207 so that the fluid could flow from the secondary IV line into the chamber 214 for distribution to the patient via the outlet 208.

[0038] As the valve member 220 continues to move toward the primary inlet 212 and away from the secondary inlet 206, the secondary inlet port 207 and the secondary outlet 208 are opened. Fluid from the secondary IV line 7 then flows into the chamber 214 through the secondary inlet 206 and is distributed to the patient 50 through the secondary outlet 208. When the valve member 220 is translated to a position where the primary inlet sealing surface 226 of the valve member 220 contacts the primary sealing surface 222, both the primary inlet port 212 and the primary outlet port 210 are closed by the valve member 220.

[0039] The primary inlet sealing surface 226 of the valve member 220 may have complementary profiles in order for it to contact and seal the primary inlet port 213. For example, the primary inlet sealing surface 226 and the primary sealing surface 222 may have matching or complementary planar profiles. As shown, the primary inlet sealing surface 226 may have a flat profile, and the primary sealing surface 222 may have a complementary flat profile. However, various embodiments of the present disclosure are not limited to the above configurations. In some embodiments, the primary inlet sealing surface 226 and the primary sealing surface 222 may have complementary non-planar profiles, as may the secondary inlet sealing surface 224 and the secondary sealing surface 218.

[0040] At the position where the primary inlet sealing surface 226 of the valve member 220 contacts and seals the primary inlet port 213, the flow of fluid from the primary IV line 7 into the chamber 214 is obstructed. Therefore, only the fluid from the secondary IV line 7 (e.g., secondary medication) is distributed to the patient 50 via the secondary inlet port 207 and secondary outlet 208. Thus, backflow of fluid from the secondary IV line 7 into the primary IV line 5 is prevented. Similarly, under-infusion of secondary medication, which commonly occurs as a result of secondary medication flowing from the chamber 214 into the primary IV line 5, can be prevented. Preventing backflow of fluid is advantageous in that it limits the backflow of undesirable particulate matter (e.g., contained in the medication distributed from the secondary IV line 7) through the valve member 200, thereby ensuring that the patient 50 receives a concentrated dose of the appropriate medication or preventing timely delivery of the medication.

[0041] Figure 5 shows a cross-sectional view of a flow control device 300 according to some embodiments of the present disclosure. In some embodiments, the flow control device 300 may have a housing 302 including a primary inlet 312, a primary outlet 310, a secondary inlet 306, and a secondary outlet 308, and a chamber 314 interposed between the primary inlet 312 and the secondary inlet 306. The flow control device 300 may further include a valve member 320 reciprocally mounted in the chamber 314. The primary outlet 310 and the secondary outlet 308 can define a fluid path through which a drug or medicine from the primary inlet 312 and the secondary inlet 306 is delivered to the patient 50. The primary inlet 312 and the secondary inlet 306 may share a common central axis X4. The primary inlet 312 may fluidly communicate a primary IV line 5 with the chamber 314. Similarly, the secondary inlet 306 may fluidly communicate a secondary IV line 7 with the chamber 314. The primary outlet 310 and the secondary outlet 308 may each have a central axis, and each of these central axes may be positioned perpendicular to the common central axis X4 of the primary inlet 312 and the secondary inlet 306.

[0042] Referring to Figure 5, the flow control device 300 is shown in a cross-sectional view to more clearly illustrate some of the features of the valve member 320. As shown, the flow control device 300 may generally take the form of a cylindrical (or tubular) body, or it may have any other shape with a hollow interior that can define the chamber 314. As in the embodiments described above, the chamber 314 may be defined by the inner circumferential surface 316 of the housing 302. As shown, the chamber 314 may extend between the primary inlet 312 and the secondary inlet 306, fluidly connecting the primary inlet 312 and the secondary inlet 306 to the primary outlet 310 and the secondary outlet 308, respectively.

[0043] In some embodiments, the inner circumferential surface 316 may include a primary sealing surface 322 defining the inlet port 313 of the primary inlet 312, and a secondary sealing surface 318 defining the inlet port 307 of the secondary inlet 306. As will be described in more detail below, the primary sealing surface 322 and the secondary sealing surface 318 may have a specified structure corresponding 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, respectively.

[0044] As shown in the figure, the valve member 320 may be in the form of a disk having a primary inlet sealing surface 326 corresponding to the primary sealing surface 322 of the housing 302. Similarly, the valve member 320 may include a secondary inlet sealing surface 324 corresponding to the secondary sealing surface 318 of the housing 302. Furthermore, the valve member 320 may include an outlet sealing surface 328 for selectively sealing the primary outlet 310 and the secondary outlet 308.

[0045] During operation, when subjected to net primary fluid pressure (i.e., the pressure applied by the fluid flowing from the primary inlet 312 to the chamber 314, exceeding any pressure applied by the fluid in the secondary IV line 7), the valve member 320 translates toward the secondary inlet 306. As the valve member moves toward the secondary inlet 306, away from the primary inlet 312, the primary inlet port 313 and the primary outlet 310 open. The fluid from the primary IV line 5 then flows into the chamber 314 via the primary inlet 312 and is distributed to the patient via the primary outlet 310. When the valve member 320 translates to a position where 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 are closed by the valve member 320.

[0046] In some embodiments, the secondary inlet sealing surface 324 and the secondary sealing surface 318 of the valve member 320 may have complementary profiles in order for the secondary inlet sealing surface 324 of the valve member 320 to contact and seal the secondary inlet port 307. For example, the secondary inlet sealing surface 324 and the secondary sealing surface 318 may have complementary non-planar profiles. As shown in the figure, the secondary inlet sealing surface 324 may have a curved profile, for example, a concave profile, for example. Thus, the secondary sealing surface 318 may have a complementary curved profile, for example, a convex profile, for example.

[0047] At the position where the secondary inlet sealing surface 324 of the valve member 320 contacts and seals the secondary inlet port 307, the flow of fluid from the secondary IV line 7 into the chamber 314 is obstructed. Therefore, only the fluid from the primary IV line 5 (e.g., primary medication) is distributed to the patient 50 via the primary inlet port 313 and primary outlet 310.

[0048] When subjected to net secondary fluid pressure (i.e., the pressure applied by the fluid flowing from the secondary inlet 306 to the chamber 314, which exceeds any pressure applied by the fluid in the primary IV line 5), the valve member 320 translates toward the primary inlet 313. As previously discussed, the secondary inlet sealing surface 324 and the secondary sealing surface 318 may have complementary non-planar profiles. In particular, the secondary inlet sealing surface 324 may have a concave profile, and the secondary sealing surface 318 may have a complementary convex profile. The above configuration is advantageous in that the curved profile of the secondary inlet sealing surface 324 of the valve member 320 would have experienced lower drag than if the surface 324 were flat or planar. Therefore, a lower fluid pressure threshold at the inlet port 307 would be required to move the valve member 320 away from the inlet port 307 so that the fluid can flow from the secondary IV line 7 into the chamber 314 for distribution to the patient via the outlet 308.

[0049] As the valve member 320 continues to move toward the primary inlet 312 and away from the secondary inlet 306, the secondary inlet port 307 and the secondary outlet 308 open. Fluid from the secondary IV line 7 then flows into the chamber 314 via the secondary inlet 306 and is distributed to the patient 50 via the secondary outlet 308. When the valve member 320 is translated to a position where the primary inlet sealing surface 326 of the valve member 320 contacts the primary sealing surface 322, both the primary inlet port 312 and the primary outlet port 310 are closed by the valve member 320.

[0050] The primary inlet sealing surface 326 of the valve member 320 may have complementary profiles in order for it to contact and seal the primary inlet port 313. 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 a complementary flat profile. However, various embodiments of the present disclosure are not limited to the above configurations. In some embodiments, the primary inlet sealing surface 326 and the primary sealing surface 322 may have complementary non-planar profiles, as may the secondary inlet sealing surface 324 and the secondary sealing surface 318.

[0051] At the position where the primary inlet sealing surface 326 of the valve member 320 contacts and seals the primary inlet port 313, the flow of fluid from the primary IV line 7 into the chamber 314 is obstructed. Therefore, only fluid from the secondary IV line 7 (e.g., secondary medication) can be distributed to the patient 50 via the secondary inlet port 307 and secondary outlet 308. Thus, backflow of fluid from the secondary IV line 7 into the primary IV line 5 is limited or prevented. Similarly, under-infusion of secondary medication, which commonly occurs as a result of secondary medication flowing from the chamber 314 into the primary IV line 5, can be prevented. Preventing backflow of fluid is advantageous in that it limits the backflow of undesirable particulate matter (e.g., contained in the medication distributed from the secondary IV line 7) through the valve member 300, thereby ensuring that the patient 50 receives a concentrated dose of the appropriate medication or preventing timely delivery of the medication.

[0052] During operation, when subjected to a primary fluid pressure equal to the secondary fluid pressure (i.e., the pressure applied by the fluid flowing from primary IV line 5 to primary inlet 312, which is equal to the pressure applied by the fluid flowing from secondary IV line 7 to secondary inlet 306), the valve member 320 translates toward the center of the chamber 314 between the primary outlet 310 and the secondary outlet 308. Since the fluid pressure at primary inlet 312 is equal to the fluid pressure at secondary inlet 306, the position of the valve member 320 may be equidistant from both the primary inlet port 313 and the secondary inlet port 307. At this position, both the primary inlet port 313 and the primary outlet 310, as well as the secondary inlet port 307 and the secondary outlet 308, are open, and fluid can flow equally from both primary IV line 5 and secondary IV line 7 to the patient 50. Thus, given the above configuration, primary and secondary drugs can be administered to the patient in equal proportions without the possibility of drug backflow from one IV fluid line to the other.

[0053] In one or more embodiments of the present disclosure, the flow control device comprises a housing and a valve member. The housing comprises a primary valve body defining a primary inlet and an outlet of the flow control device, a secondary valve body defining a secondary inlet of the flow control device, wherein the primary and secondary inlets share a common central axis and the outlet's central axis is positioned perpendicular to the common central axis, and a chamber defined by the inner surface of the housing, the chamber extending between the primary and secondary valve bodies to fluidly connect the primary and secondary inlets to the outlet. The valve member is reciprocally mounted within the chamber such that (i) it prevents fluid communication between the secondary inlet and the outlet when the fluid pressure into the primary inlet is higher than the fluid pressure into the secondary inlet, and (ii) it prevents fluid communication between the primary inlet and the outlet when the fluid pressure into the secondary inlet is higher than the fluid pressure into the primary inlet.

[0054] In an embodiment of the disclosure, the valve member has a cylindrical disc slidably mounted within a chamber. In an embodiment of the disclosure, the housing has at least one guide rail extending longitudinally along its inner surface in the chamber, and the valve member has at least one slot extending longitudinally along its outer surface, 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 an embodiment of the disclosure, the at least one guide rail has two guide rails arranged symmetrically with respect to the central longitudinal axis of the inner surface defining the chamber, and the at least one slot has two slots arranged symmetrically with respect to the central longitudinal axis of the valve member, and the central longitudinal axis of the inner surface defining the chamber and the central longitudinal axis of the valve member are coaxially aligned. In an embodiment of the disclosure, the valve member further has a flow groove extending longitudinally from the plane of the disc along its outer surface. In an embodiment of the disclosure, the primary valve body and the primary valve body are integrally formed as a single unit.

[0055] In one or more embodiments of the present disclosure, a flow control device comprises a housing, a chamber, and a valve member. The housing includes a primary inlet, a primary outlet, a secondary inlet, and a secondary outlet, wherein the primary and secondary inlets share a common central axis perpendicular to the central axes of the primary and secondary outlets. The chamber is defined by the inner circumferential surface of the housing and extends between the primary and secondary inlets to fluidly connect the primary inlet to the primary outlet and the secondary inlet to the secondary outlet. The valve member is reciprocally mounted within the chamber to (i) prevent fluid communication between the secondary inlet and the secondary outlet when the fluid pressure into the primary inlet is higher than the fluid pressure into the secondary inlet, and (ii) prevent fluid communication between the primary inlet and the primary outlet when the fluid pressure into the secondary inlet is higher than the fluid pressure into the primary inlet.

[0056] In aspects of this disclosure, the inner surface includes a primary sealing surface defining the inlet port of a primary inlet and a secondary sealing surface defining the inlet port of a secondary inlet, and the valve member has a disk 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 primary and secondary outlets. In aspects of this disclosure, the primary inlet sealing surface has a planar profile and the secondary inlet sealing surface has a non-planar profile. In aspects of this disclosure, the secondary inlet sealing surface of the valve member has a curved profile. In aspects of this disclosure, the secondary inlet sealing surface of the valve member has a concave profile. In aspects of this disclosure, the primary sealing surface of the housing has a planar profile and the secondary sealing surface of the housing has a non-planar profile. In aspects of this disclosure, the secondary sealing surface of the housing has a curved profile.

[0057] In an aspect of this disclosure, the secondary sealing surface of the housing has a convex profile. In an aspect of this disclosure, the valve member further has a flow groove extending longitudinally from the plane of the disk along its outer circumferential surface. In an aspect of this disclosure, the inner circumferential surface includes a primary sealing surface defining an inlet port of a primary inlet and a secondary sealing surface defining an inlet port of a secondary inlet, and the valve member has a cylinder 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 primary and secondary outlets. In an aspect of this disclosure, at least one of the primary inlet sealing surface and the secondary inlet sealing surface has a non-planar profile. In an aspect of this disclosure, the primary inlet sealing surface has a planar profile and the secondary inlet sealing surface has a non-planar profile. In an aspect of this disclosure, the secondary inlet sealing surface of the valve member has a curved profile. In an aspect of this disclosure, the secondary inlet sealing surface of the valve member has a concave profile.

[0058] Therefore, the various embodiments of this disclosure are advantageous in that they provide flow control devices that can prevent under-injection of secondary drugs by preventing the secondary drug from flowing back into the primary IV line, as discussed earlier. 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 replacing check valves and Y-connectors with a single flow control device. As a result, the cost of the IV set can be reduced. Furthermore, the various embodiments of this disclosure are advantageous in that they reduce the workflow steps for clinicians / nurses because manual operation is not required for flow adjustment, since the flow pressure of the secondary drug or fluid is used to adjust the flow of the primary drug or fluid.

[0059] This disclosure is provided so that those skilled in the art can implement the various embodiments described herein. This disclosure provides various examples of the subject art, but the subject art is not limited to these examples. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments.

[0060] Referencing an element in the singular form does not mean "only one" unless otherwise specified, but rather "one or more." Unless otherwise specified, the term "several" refers to one or more. Masculine pronouns (e.g., his) include feminine and neuter genders (e.g., her and her), and vice versa. Titles and subtitles, if any, are used merely for convenience and do not limit the invention.

[0061] The word “exemplary” is used herein to mean “serving as an example or illustration.” Any embodiment or design described herein “exemplary” is not necessarily construed to be preferable or advantageous to other embodiments or designs. In one embodiment, various alternative configurations and operations described herein are considered to be at least equivalent.

[0062] When used herein, the phrase “at least one of” preceding a series of items, along with the term “or” used to separate any of the items, modifies the list as a whole rather than each item in the list. Rather than requiring the selection of at least one item, the phrase allows for the meaning of at least one of any 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.

[0063] The terms "aspect" and similar phrases do not imply that this aspect is essential to the subject art or that this aspect applies to all configurations of the subject art. A disclosure relating to one aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. The terms "aspect" and similar phrases may refer to one or more aspects, and vice versa. The terms "example" and similar phrases do not imply that this example is essential to the subject art or that this example applies to all configurations of the subject art. A disclosure relating to one example may apply to all examples, or to one or more examples. An example may provide one or more examples. The terms "example" and similar phrases may refer to one or more examples, and vice versa. The terms "configuration" and similar phrases do not imply that this configuration is essential to the subject art or that this configuration applies to all configurations of the subject art. A disclosure relating to one configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. Terms such as "composition" may refer to one or more compositions, and vice versa.

[0064] In one embodiment, unless otherwise specified, all measurements, values, ratings, locations, sizes, dimensions, and other specifications described herein, including those in the following claims, are approximate and not exact. In one embodiment, they are intended to have a reasonable range that is consistent with the functions to which they relate and with those that are customary in the art to which they relate.

[0065] The order or hierarchy of the specified steps or actions in the disclosed process or method is to be understood as illustrative of an exemplary technique. The order or hierarchy of the specified steps, actions, or processes may be rearranged based on the preference or scenario of implementation. Some of the steps, actions, or processes may be performed simultaneously. In some preference or scenario of implementation, 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 accompanying methods present various elements of steps, actions, or processes in a sample order and are not to be limited to the specified order or hierarchy presented.

[0066] All structural and functional equivalents of elements of various aspects described through this disclosure, whether known to those skilled in the art or to be known thereafter, are expressly incorporated by reference herein and intended to be included in the claims. Furthermore, nothing disclosed herein is intended to be made public in any way, whether such disclosure is expressly contained in the claims. Unless an element is expressly described using the phrase “means for” or, in the case of a method claim, unless an element is described using the phrase “steps for” no element of any claim shall be construed in accordance with 35 U.S. SC § 112(f). Furthermore, to the extent that the terms “includes,” “have,” etc. are used, these terms are intended to be as inclusive as the term “have” when “have” is adopted as a transitional term in a claim.

[0067] The title, background, summary, brief description of the drawings, and abstract of the disclosure are incorporated herein by reference and provided as exemplary examples of the disclosure, not as limiting descriptions. They are submitted with the understanding that they are not to be used to limit the scope or meaning of the claims. Furthermore, in the detailed description, it will be found that the description provides exemplary examples and various features are grouped into various embodiments for the purpose of streamlining the disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed subject matter requires more features than expressly cited in each claim. Rather, as reflected in the following claims, the subject matter of the invention is less than all the features of a single disclosed configuration or operation. The following claims are incorporated herein by reference and each claim stands alone as individually claimed subject matter.

[0068] The claims are not intended to be limited to the embodiments described herein, but should be given the full scope consistent with the language of the claims and should encompass all legal equivalents. Nevertheless, no claim is intended, and should not be construed as, to encompass subject matter that does not satisfy the requirements of 35 U.S. SC § 101, 102, or 103.

Claims

1. A flow control device, It is a housing, Primary valve bodies that define the primary inlet and outlet of a flow control device, A secondary valve body defining the secondary inlet of the flow control device, wherein the primary inlet and the secondary inlet share a common central axis, and the central axis of the outlet is positioned perpendicular to the common central axis, and A chamber defined by the inner circumferential surface of the housing, the chamber extending between the primary valve body and the secondary valve body to fluidly connect the primary inlet and the secondary inlet to the outlet. Housing including, A valve member reciprocatingly mounted within the chamber, wherein (i) when the fluid pressure into the primary inlet is higher than the fluid pressure into the secondary inlet, fluid communication between the secondary inlet and the outlet is prevented, and (ii) when the fluid pressure into the secondary inlet is higher than the fluid pressure into the primary inlet, fluid communication between the primary inlet and the outlet is prevented. It has, A flow control device wherein the valve member is a cylindrical disc slidably mounted within the chamber and further has a flow groove extending longitudinally from the plane of the valve member along the outer circumferential surface of the valve member, the flow groove extending only partially along the length of the valve member, thereby allowing fluid communication between the secondary inlet and the outlet and preventing fluid communication between the primary inlet and the outlet when the fluid pressure at the primary inlet is equal to the fluid pressure at the secondary inlet.

2. The housing has at least one guide rail extending longitudinally along the inner circumferential surface within the chamber, and The flow control device according to claim 1, wherein the valve member has at least one slot extending longitudinally along its outer circumferential surface, the slot defining a recess having a shape corresponding to the shape of the guide rail for mounting the valve member on the guide rail.

3. The at least one guide rail has two guide rails arranged symmetrically with respect to the central longitudinal axis of the inner circumferential surface defining the chamber, The at least one slot has two slots arranged symmetrically with respect to the central longitudinal axis of the valve member, The flow control device according to claim 2, wherein the central longitudinal axis of the inner circumferential surface defining the chamber and the central longitudinal axis of the valve member are coaxially aligned.

4. The flow control device according to claim 1, wherein the primary valve body and the secondary valve body are integrally formed as a single unit.

5. The inner circumferential surface includes a primary sealing surface defining the inlet port of the primary inlet and a secondary sealing surface defining the inlet port of the secondary inlet, The flow control device according to claim 1, wherein the cylindrical disk has 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 outlet having a primary outlet and a secondary outlet.

6. The flow control device according to claim 5, wherein the primary inlet sealing surface has a planar profile and the secondary inlet sealing surface has a non-planar profile.

7. The flow control device according to claim 6, wherein the secondary inlet sealing surface of the valve member has a curved profile.

8. The flow control device according to claim 6, wherein the secondary inlet sealing surface of the valve member has a concave profile.

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

10. The flow control device according to claim 9, wherein the secondary sealing surface of the housing has a curved profile.

11. The flow control device according to claim 10, wherein the secondary sealing surface of the housing has a convex profile.

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