Pressure-actuated flow control device for gravity intravenous infusion sets

By designing a flow control device in the intravenous injection kit and using valve components to adjust the fluid channel according to the fluid pressure difference, the problem of drug backflow in the secondary tubing was solved, and effective drug infusion and proportional distribution were achieved.

CN114191643BActive Publication Date: 2025-12-19CAREFUSION 303 INC
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Patent Information

Application Number
CN202111095194.4
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2020-09-18
Filing Date
2021-09-17
Publication Date
2025-12-19
Estimated Expiration
2041-09-17

AI Technical Summary

Technical Problem

In existing intravenous infusion kits, medication in the secondary tubing can easily flow back into the main tubing, leading to insufficient infusion, and the check valve is prone to failure, especially in the presence of debris.

Method used

A flow control device was designed, including a main valve body, a secondary valve body, and a chamber. The valve components are reciprocated in the chamber and automatically adjust the fluid channel according to the fluid pressure difference to prevent fluid communication between the secondary inlet and outlet or between the main inlet and outlet, ensuring that the drug flows only towards the patient.

Benefits of technology

It effectively prevents drugs from flowing back from the secondary tubing into the main tubing, avoids insufficient infusion, ensures that drugs are delivered in proportion and direction, reduces the backflow of drug particles, and ensures that patients receive the appropriate drug dosage.

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Abstract

A flow control device can 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 peripheral surface of the housing. The primary inlet and the secondary inlet can share a common central axis, and a central axis of the outlet can be disposed perpendicular relative to the common central axis. The chamber can extend between the primary valve body and the secondary valve body for fluidly connecting the primary inlet and the secondary inlet with the outlet. The flow control device can further include a valve member reciprocally mounted in the chamber to (i) block fluid communication between the secondary inlet and the outlet when a fluid pressure entering the primary inlet is higher than a fluid pressure entering the secondary inlet, and (ii) block fluid communication between the primary inlet and the outlet when the fluid pressure entering the secondary inlet is higher than the fluid pressure entering the primary inlet.
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Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to flow control devices, and more particularly to flow control devices having valve members that prevent under-infusion in an IV (intravenous) set having a secondary line, and prevent backflow of medication from the secondary line into the primary line. BACKGROUND

[0002] Infusion intravenous sets are commonly used in infusion therapy in order to deliver medication from a pre-charged container, such as an intravenous bottle or bag containing the desired medication, to a patient. Typically, an intravenous tubing set is connected to a catheter and inserted into a local area to be treated. In some cases, it is necessary to deliver multiple medications to a patient at potentially different dosages, resulting in the need for an intravenous extension set having multiple branch tubing or fluid lines through which the multiple medications can be dispensed to the patient.

[0003] Patients are typically injected with an intravenous solution that is initially provided in an intravenous bottle or bag and is dripped through an intravenous line into the patient's vein. A flow control device, such as a check valve, is also commonly included in the intravenous line to allow fluid flow only in the direction of the patient. This ensures that the medication flows downstream toward the patient and not upstream toward the intravenous bottle or bag.

[0004] During infusion using an intravenous set, the secondary drug supply can flow back into the primary intravenous line, causing under-infusion of the secondary drug. Although a check valve can be positioned in the primary line to prevent backflow, the check valve is prone to frequent failure. One common cause of check valve failure is due to debris present in the infusion. In addition, under-infusion frequently occurs because the differential pressure across the diaphragm in a reverse check valve is low, which prevents the reverse check valve from fully closing, allowing backflow.

[0005] The description provided in the background section should not be taken as an admission that any of the information provided in the background section is prior art to the present subject matter. The background section can include information obtained from sources believed to be reliable and are not necessarily statements of fact or assumptions of fact. SUMMARY

[0006] According to various embodiments of the present disclosure, a flow control device can 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 inlet and the secondary inlet can share a common central axis, and a central axis of the outlet is disposed perpendicular with respect to the common central axis. The chamber can extend between the primary valve body and the secondary valve body for fluidly coupling the primary inlet and the secondary inlet with the outlet. The flow control device can further include a valve member reciprocally mounted in the chamber to (i) block fluid communication between the secondary inlet and the outlet when a fluid pressure entering the primary inlet is higher than a fluid pressure entering the secondary inlet, and (ii) block fluid communication between the primary inlet and the outlet when the fluid pressure entering the secondary inlet is higher than the fluid pressure entering the primary inlet.

[0007] According to various aspects of the present disclosure, a flow control device can include a housing having a primary inlet, a primary outlet, a secondary inlet, and a secondary outlet. The primary inlet and the secondary inlet can share a common central axis disposed perpendicular with respect to central axes of the primary outlet and the secondary outlet. A chamber can be defined by an inner circumferential surface of the housing, and the chamber can extend 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. The flow control device can further include a valve member reciprocally mounted in the chamber to (i) block fluid communication between the secondary inlet and the secondary outlet when a fluid pressure entering the primary inlet is higher than a fluid pressure entering the secondary inlet, and (ii) block fluid communication between the primary inlet and the primary outlet when the fluid pressure entering the secondary inlet is higher than the fluid pressure entering the primary inlet.

[0008] It is understood that other configurations of the subject technology will become readily apparent to those skilled in the art from the following detailed description, wherein various configurations of the subject technology are shown and described by way of illustrative examples. As will be realized, the subject technology is capable of other and different configurations and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. BRIEF DESCRIPTION OF DRAWINGS

[0009] The accompanying drawings are included to illustrate certain aspects of the embodiments and are not intended to be exclusive or limiting of the subject technology. The subject technology can be variously modified, changed, combined, and / or equivalent substituted without departing from the scope of the subject technology as will become apparent to those skilled in the art from the following detailed description.

[0010] Figure 1 An intravenous extension set including a flow control device according to some embodiments of the present disclosure is shown.

[0011] Figure 2A A perspective view of a flow control device is shown in accordance with some embodiments of the present disclosure.

[0012] Figure 2B A perspective view of a flow control device is shown in accordance with some embodiments of the present disclosure. Figure 2A A cross-sectional view of a flow control device and valve member is shown in accordance with some embodiments of the present disclosure.

[0013] Figure 2C A partial cross-sectional view of a housing of a flow control device is shown in accordance with some embodiments of the present disclosure. Figure 2A

[0014] Figure 2D A perspective view of a valve member of a flow control device is shown in accordance with some embodiments of the present disclosure. Figure 2A

[0015] Figure 2E A partial cross-sectional view of a housing of a flow control device and installed valve member is shown in accordance with some embodiments of the present disclosure.

[0016] Figure 2F A cross-sectional view of a housing of a flow control device and installed valve member is shown in accordance with some embodiments of the present disclosure.

[0017] Figure 3A A cross-sectional view of a flow control device and valve member is shown in accordance with some embodiments of the present disclosure, prior to coupling to a fluid line of an intravenous infusion set.

[0018] Figure 3B A cross-sectional view of a flow control device and valve member is shown in accordance with some embodiments of the present disclosure, when coupled to a primary fluid line and a secondary fluid line of an intravenous infusion set, wherein the fluid pressure in the primary line is higher than the fluid pressure in the secondary line. Figure 3A

[0019] A cross-sectional view of a flow control device and valve member is shown in accordance with some embodiments of the present disclosure, when coupled to a primary fluid line and a secondary fluid line of an intravenous infusion set, wherein the fluid pressure in the secondary line is higher than the fluid pressure in the primary line. Figure 3C Figure 3A A cross-sectional view of a flow control device and valve member is shown in accordance with some embodiments of the present disclosure, when coupled to a primary fluid line and a secondary fluid line of an intravenous infusion set, wherein the fluid pressure in the primary line is equal to the fluid pressure in the secondary line.

[0020] Figure 3D Figure 3A A cross-sectional view of a flow control device and valve member is shown in accordance with some embodiments of the present disclosure, when coupled to a primary fluid line and a secondary fluid line of an intravenous infusion set, wherein the fluid pressure in the primary line is equal to the fluid pressure in the secondary line.

[0021] Figure 3E A cross-sectional view of a flow control device and valve member is shown in accordance with some embodiments of the present disclosure, when coupled to a primary fluid line and a secondary fluid line of an intravenous infusion set, wherein the fluid pressure in the primary line is equal to the fluid pressure in the secondary line. Figure 3D ​​​​a cross-sectional view of a flow control device and valve member, wherein the flow slot profile of the valve member allows fluid to flow from the secondary fluid line to the outlet port when the fluid pressure in the primary line is equal to the fluid pressure in the secondary line.

[0022] Figure 4 A cross-sectional view of a flow control device is shown in accordance with some embodiments of the present disclosure.

[0023] Figure 5 A cross-sectional view of a flow control device is shown in accordance with some embodiments of the present disclosure. DETAILED DESCRIPTION

[0024] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology can be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Accordingly, it can be apparent that the subject technology can be practiced without these specific details. In some instances, well-known structures and components can be shown in block diagram form, in order to avoid obscuring the concepts of the subject technology.

[0025] It is understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology will be illustrated below with reference to specific but non-limiting examples. Various embodiments described in this disclosure can be implemented in different ways and with variations and according to intended applications and implementations.

[0026] The present description relates generally to flow control devices, and more particularly to flow control devices having valve members that can prevent under-infusion in an intravenous infusion set having a secondary line, and prevent backflow of medication from the secondary line into the primary line.

[0027] Intravenous infusion sets having secondary lines are prone to under-infusion of the secondary medication due to failure of the check valve in the primary line. The most frequent cause of failure of the check valve is due to debris that builds up when the secondary line medication flushes and seeps into the primary line at low pressure. One common cause of under-infusion is dilution of the medication at the time of back-priming of the secondary intravenous infusion, and at equal water heads in the primary and secondary lines. Other causes include dead volume in the secondary line, and the time taken to infuse the medication. The flow control devices of the various embodiments described herein overcome the above-mentioned problems commonly associated with intravenous infusion sets having primary and secondary lines.

[0028] Figure 1A multi-line intravenous extension set 1 including a flow control device 100, 200, 300 is shown in accordance with some embodiments of the present disclosure. The intravenous set 1 includes a primary fluid system 15 and a secondary fluid system 25. An intravenous pump (not shown) receives fluid from the primary fluid system 15 and the secondary fluid system 25 via a primary intravenous line 5 and can control and distribute fluid from the primary fluid system and the secondary fluid system to a patient 50.

[0029] In some embodiments, the primary fluid system 15 can include a primary fluid source, such as a primary fluid bag 10, which can include or contain a saline solution or other medical fluid or medication to be administered to the patient 50. As shown, the primary intravenous line 5 passes primary fluid from the drip chamber 12 to the flow control device 100, 200, 300. As will be further described with reference to the following figures, the flow control device 100, 200, 300 can be disposed in the primary intravenous line 5 and allow fluid flow from the primary fluid bag 10 to the intravenous pump (not shown) while preventing reverse flow (backflow) of fluid from the secondary fluid system 25 to the primary fluid bag 10. In accordance with some embodiments, the secondary fluid system 25 includes a secondary fluid source, such as a secondary fluid bag 8, which can contain a medication or other secondary fluid to be provided to the patient 50 for treatment. As shown, the intravenous set 1 can also include a secondary intravenous line 7 that passes flow from the drip chamber 22 to the flow control device 100, 200, 300.

[0030] Figure 2A is a perspective view of a flow control device in accordance with some embodiments of the present disclosure. Figure 2B is shown in accordance with some embodiments of the present disclosure Figure 2A is a cross-sectional view of the flow control device and valve member of Figure 2A and Figure 2B The flow control device 100 can have a housing 102 including a primary valve body 104 and a secondary valve body 110, a chamber 114 interposed between the primary valve body 104 and the secondary valve body 110, and a valve member 120 reciprocally mounted in the chamber 114, with reference to

[0031] 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.

[0032] 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.

[0033] 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.

[0034] Figure 2D Illustrations are shown according to some embodimentsFigure 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.

[0035] 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.

[0036] 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.

[0037] 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 3Bis a cross-sectional view of a flow control device and valve member according to some embodiments of the present disclosure, when coupled to a primary fluid line and a secondary fluid line of an intravenous infusion set, Figure 3A is a cross-sectional view of a flow control device and valve member according to some embodiments of the present disclosure, when coupled to a primary fluid line and a secondary fluid line of an intravenous infusion set,

[0038] Referring to Figure 3B In operation, when subjected to a net primary fluid pressure (i.e., a pressure exerted by fluid flowing from the primary inlet 106 to the chamber 114 that exceeds any pressure exerted by fluid in the secondary intravenous line), the valve member 120 can translate toward the secondary inlet 112 to a position in which the planar surface 128 of the valve member contacts and blocks the secondary inlet port 112. Fluid flow from the secondary intravenous line 7 into the chamber 114 can thus be blocked, and only fluid from the primary intravenous line 5 can flow into the chamber 114 via the primary inlet 106. Fluid from the primary intravenous line 5 can thus be delivered to the patient 50 through the outlet 108.

[0039] Figure 3C is a cross-sectional view of a flow control device and valve member according to some embodiments of the present disclosure, when coupled to a primary fluid line and a secondary fluid line of an intravenous infusion set, Figure 3A is a cross-sectional view of a flow control device and valve member according to some embodiments of the present disclosure, when coupled to a primary fluid line and a secondary fluid line of an intravenous infusion set,

[0040] Referring to Figure 3C In operation, when subjected to a net secondary fluid pressure (i.e., a pressure exerted by fluid flowing from the secondary inlet 106 to the chamber 114 that exceeds any pressure exerted by fluid in the primary intravenous line), the valve member 120 can translate toward the primary inlet 112 to a position in which the surface 125 of the valve member contacts and blocks the secondary inlet port 112. Fluid flow from the primary intravenous line 5 into the chamber 114 can thus be blocked, and only fluid from the secondary intravenous line 7 can flow into the chamber 114 via the secondary inlet 106. Fluid from the secondary intravenous line 7 can thus be delivered to the patient 50 through the outlet 108.

[0041] Figure 3D and Figure 3E is a cross-sectional view of a flow control device and valve member according to some embodiments of the present disclosure, when coupled to a primary fluid line and a secondary fluid line of an intravenous infusion set, Figure 3A is a cross-sectional view of a flow control device and valve member according to some embodiments of the present disclosure, when coupled to a primary fluid line and a secondary fluid line of an intravenous infusion set,

[0042] Referring to Figure 3D and Figure 3EIn operation, when subjected to a primary fluid pressure equal to a secondary fluid pressure (i.e., a pressure exerted by fluid flowing into the primary inlet 106 from the primary intravenous infusion line 5 equal to a pressure exerted by fluid flowing into the secondary inlet 112 from the secondary intravenous infusion line 7), the valve member 120 can translate toward a central portion of the chamber 114 directly above the outlet 108. Due to the equal fluid pressure at the primary inlet and the secondary inlet, the valve member 120 can be equidistant from the primary inlet 106 and the secondary inlet 112. At this position directly above the outlet, the flow slot 130 of the valve member can allow fluid to flow from the secondary intravenous infusion line 7 into the chamber 114 via the secondary inlet 112. Thus, when the fluid pressure in the primary intravenous infusion line 5 and the secondary intravenous infusion line 7 are equal, only the secondary medication can be dispensed to the patient via the flow slot 130. Due to the absence of a flow slot in the surface 125, fluid communication between the primary inlet and the outlet is blocked, preventing fluid in the intravenous infusion lines from being dispensed to the patient.

[0043] Figure 4 A cross-sectional view of a flow control device 200 is shown, in accordance with some embodiments of the present disclosure. In some embodiments, the flow control device 200 can have a housing 202 that includes a primary inlet 212, a primary outlet 210, a secondary inlet 206, a secondary outlet 208, and a chamber 214 interposed between the primary inlet 212 and the secondary inlet 206. The flow control device 200 can also include a valve member 220 reciprocally mounted in the chamber 214. The primary outlet 210 and the secondary outlet 208 can define a fluid path through which medication or drugs from the primary inlet 212 and the secondary inlet 206 can be delivered to the patient 50. The primary inlet 212 and the secondary inlet 206 can share a common central axis X3. The primary inlet 212 can fluidly communicate the primary intravenous infusion line 5 with the chamber 214. Similarly, the secondary inlet 206 can fluidly communicate the secondary intravenous infusion line 7 with the chamber 214. The primary outlet 210 and the secondary outlet 208 can each have a central axis, and each of the central axes can be disposed perpendicularly with respect to the common central axis X3 of the primary inlet 212 and the secondary inlet 206.

[0044] Reference is made to Figure 4 The flow control device 200 is shown in cross-sectional view to more clearly illustrate some features of the valve member 220. As shown, the flow control device 200 can be in the form of a generally cylindrical (or tubular) body, or can be of any other shape having a hollow interior capable of defining the 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 the primary inlet 212 and the secondary inlet 206 to fluidly connect the primary inlet 212 and the secondary inlet 206 with the respective primary outlet 210 and secondary outlet 208.

[0045] In some embodiments, the inner circumferential surface 216 can include a primary sealing surface 222 that defines the inlet port 213 of the primary inlet 212 and a secondary sealing surface 218 that defines the inlet port 207 of the secondary inlet 206. As will be described in further detail below, the primary sealing surface 222 and the secondary sealing surface 218 can be specifically configured to correspond 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 accordingly.

[0046] As shown, the valve member 220 can be in the form of a disc having a primary inlet sealing surface 226 that corresponds to the primary sealing surface 222 of the housing 202. Similarly, the valve member 220 can include a secondary inlet sealing surface 224 that corresponds to the secondary sealing surface 218 of the housing. In addition, the valve member 220 can include an outlet sealing surface 228 for selectively sealing the primary outlet 210 and the secondary outlet 208.

[0047] In operation, when subjected to a net primary fluid pressure (i.e., a pressure exerted by fluid flowing from the primary inlet 212 into the chamber 214 that exceeds any pressure exerted by fluid in the secondary intravenous line 7), the valve member 220 can translate toward the secondary inlet 112. As the valve member moves toward the secondary inlet 206 and away from the primary inlet 212, the primary inlet port 213 and the primary outlet 210 can open. Fluid from the primary intravenous line 5 can then flow into the chamber 214 via the primary inlet 212 and be dispensed to the patient via the primary outlet 210. When the valve member 220 translates to a position such that 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 can be occluded by the valve member 220.

[0048] To enable the secondary inlet sealing surface 224 of the valve member 220 to contact and seal the secondary inlet port 207, the secondary inlet sealing surface 224 and the secondary sealing surface 218 can have complementary profiles. For example, the secondary inlet sealing surface 224 and the secondary sealing surface 218 can have non-planar profiles. As shown, the secondary inlet sealing surface 224 can have a curvilinear profile, such as, but not limited to, a concave profile. Accordingly, the secondary sealing surface 218 can have a complementary curvilinear profile, such as, but not limited to, a convex profile.

[0049] At the position 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 line 7 into the chamber 214 is blocked. Accordingly, only fluid from the primary intravenous line 5 (e.g., the primary drug) can be dispensed to the patient 50 via the primary inlet port 213 and the primary outlet 210.

[0050] When subjected to a net secondary fluid pressure (i.e., a pressure exerted by fluid flowing from the secondary inlet 206 to the chamber 214 that exceeds any pressure exerted by fluid in the primary intravenous tubing 5), the valve member 220 can translate toward the primary inlet 112. As previously described, the secondary inlet sealing surface 224 and the secondary sealing surface 218 can have complementary non-planar profiles. In particular, as shown, the secondary inlet sealing surface 224 can have a concave profile, and the secondary sealing surface 218 can have a complementary convex profile. An advantage of the foregoing configuration is that the curved profile of the secondary inlet sealing surface 224 of the valve member 220 will be subjected to lower drag forces as compared to if the surface 224 were flat or planar. Accordingly, a lower fluid pressure threshold at the inlet port 207 will be required to move the valve member 220 away from the inlet port 207 so that fluid can flow from the secondary intravenous tubing into the chamber 214 for dispensing to the patient via the outlet 208.

[0051] 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 can open. Fluid from the secondary intravenous tubing 7 can then flow into the chamber 214 via the secondary inlet 206 and be dispensed to the patient via the secondary outlet 208. When the valve member 220 translates to a position such that 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 can be occluded by the valve member 220.

[0052] To cause the primary inlet sealing surface 226 of the valve member 220 to contact and seal the primary inlet port 213, the primary inlet sealing surface 226 and the primary sealing surface 222 can have complementary profiles. For example, the primary inlet sealing surface 226 and the primary sealing surface 222 can have matching or complementary flat profiles. As shown, the primary inlet sealing surface 226 can have a flat profile, and the primary sealing surface 222 can have a complementary flat profile. However, various embodiments of the present 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 can have complementary non-planar profiles.

[0053] At the location where the main inlet sealing surface 226 of the valve member 220 contacts and seals the main inlet port 213, fluid flow from the primary intravenous tubing line 7 into the chamber 214 is blocked. Thus, only fluid (e.g., the secondary drug) from the secondary intravenous tubing line 7 can be dispensed to the patient 50 via the secondary inlet port 207 and the secondary outlet 208. Accordingly, backflow of fluid from the secondary intravenous tubing line 7 into the primary intravenous tubing line 5 is prevented. Similarly, underdosing of the secondary drug (which typically occurs due to the flow of the secondary drug from the chamber 214 into the primary intravenous tubing line 5) can be prevented. Preventing backflow of fluid is advantageous because it limits unintended particulate matter (e.g., particulate matter contained in the drug dispensed from the secondary intravenous tubing line 7) from flowing back through the valve member 200 and thereby preventing the patient 50 from receiving the proper drug dosage concentration or timely delivery of the drug.

[0054] Figure 5 A cross-sectional view of a flow control device 300 is shown in accordance with some embodiments of the present disclosure. In some embodiments, the flow control device 300 can have a housing 302 that includes a main inlet 312, a main outlet 310, a secondary inlet 306, a secondary outlet 308, and a chamber 314 interposed between the main inlet 312 and the secondary inlet 306. The flow control device 300 can also include a valve member 320 reciprocally mounted in the chamber 314. The main outlet 310 and the secondary outlet 308 can define a fluid path through which a drug or medicament from the main inlet 312 and the secondary inlet 306 can be delivered to the patient 50. The main inlet 312 and the secondary inlet 306 can share a common central axis X4. The main inlet 312 can place the primary intravenous tubing line 5 in fluid communication with the chamber 314. Similarly, the secondary inlet 306 can place the secondary intravenous tubing line 7 in fluid communication with the chamber 314. The main outlet 310 and the secondary outlet 308 can each have a central axis, and each of the central axes can be disposed perpendicularly with respect to the common central axis X4 of the main inlet 312 and the secondary inlet 306.

[0055] Reference is made to Figure 5 The flow control device 300 is shown in cross-section to more clearly illustrate some features of the valve member 320. As shown, the flow control device 300 can be in the form of a generally cylindrical (or tubular) body, or can have any other shape that includes a hollow interior capable of defining the chamber 314. Similar to the previously described embodiments, the chamber 314 can be defined by an inner circumferential surface 316 of the housing 302. As shown, the chamber 314 can extend between the main inlet 312 and the secondary inlet 306 to fluidly connect the main inlet 312 and the secondary inlet 306 with the respective main outlet 310 and secondary outlet 308.

[0056] In some embodiments, the inner circumferential surface 316 can include a primary sealing surface 322 that defines the inlet port 313 of the primary inlet 312 and a secondary sealing surface 318 that defines the inlet port 307 of the secondary inlet 306. As will be described in further detail below, the primary sealing surface 322 and the secondary sealing surface 318 can 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.

[0057] As shown, the valve member 320 can be in the form of a disc having a primary inlet sealing surface 326 that corresponds to the primary sealing surface 322 of the housing 302. Similarly, the valve member 320 can include a secondary inlet sealing surface 324 that corresponds to the secondary sealing surface 318 of the housing 302. In addition, the valve member 320 can include an outlet sealing surface 328 for selectively sealing the primary outlet 310 and the secondary outlet 308.

[0058] In operation, when subjected to a net primary fluid pressure (i.e., a pressure exerted by fluid flowing from the primary inlet 312 into the chamber 314 that exceeds any pressure exerted by fluid in the secondary intravenous line 7), the valve member 320 can translate toward the secondary inlet 306. As the valve member moves toward the secondary inlet 306 and away from the primary inlet 312, the primary inlet port 313 and the primary outlet 310 can open. Fluid from the primary intravenous line 5 can then flow into the chamber 314 via the primary inlet 312 and be dispensed to the patient via the primary outlet 310. When the valve member 320 translates 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 occluded by the valve member 320.

[0059] In some embodiments, to cause 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 can have complementary profiles. For example, the secondary inlet sealing surface 324 and the secondary sealing surface 318 can have complementary non-planar profiles. As shown, the secondary inlet sealing surface 324 can have a curvilinear profile, such as, but not limited to, a concave profile. Accordingly, the secondary sealing surface 318 can have a complementary curvilinear profile, such as, but not limited to, a convex profile.

[0060] At the position 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 line 7 into the chamber 314 is blocked. Accordingly, only fluid from the primary intravenous line 5 (e.g., the primary drug) can be dispensed to the patient 50 via the primary inlet port 313 and the primary outlet 310.

[0061] When subjected to a net secondary fluid pressure (i.e., a pressure exerted by fluid flowing from the secondary inlet 306 to the chamber 314 that exceeds any pressure exerted by fluid in the primary intravenous tubing 5), the valve member 320 can translate toward the primary inlet 313. As discussed previously, the secondary inlet sealing surface 324 and the secondary sealing surface 318 can have complementary non-planar profiles. In particular, the secondary inlet sealing surface 324 can have a concave profile, and the secondary sealing surface 318 can have a complementary convex profile. An advantage of the foregoing configuration is that the curved profile of the secondary inlet sealing surface 324 of the valve member 320 will be subjected to lower drag forces as compared to if the surface 324 were flat or planar. As a result, a lower fluid pressure threshold at the inlet port 307 will be required to move the valve member 320 away from the inlet port 307 so that fluid can flow from the secondary intravenous tubing 7 into the chamber 314 for dispensing to the patient via the outlet 308.

[0062] 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 can open. Fluid from the secondary intravenous tubing 7 can then flow into the chamber 314 via the secondary inlet 306 and be dispensed to the patient via the secondary outlet 308. When the valve member 320 translates to a position such that 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 can be occluded by the valve member 320.

[0063] To cause the primary inlet sealing surface 326 of the valve member 320 to contact and seal the primary inlet port 313, the primary inlet sealing surface 326 and the primary sealing surface 322 can have complementary profiles. For example, the primary inlet sealing surface 326 and the primary sealing surface 322 can have matching or complementary planar profiles. As shown, the primary inlet sealing surface 326 can have a flat profile, and the primary sealing surface 322 can have a complementary flat profile. However, various embodiments of the present 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 can have complementary non-planar profiles.

[0064] At the location where the main inlet sealing surface 326 of the valve member 320 contacts and seals the main inlet port 313, fluid flow from the primary intravenous tubing line 7 into the chamber 314 is blocked. Thus, only fluid (e.g., the secondary drug) from the secondary intravenous tubing line 7 can be dispensed to the patient 50 via the secondary inlet port 307 and the secondary outlet 308. Accordingly, backflow of fluid from the secondary intravenous tubing line 7 into the primary intravenous tubing line 5 is limited or prevented. Similarly, under-infusion of the secondary drug (which typically occurs due to the flow of the secondary drug from the chamber 314 into the primary intravenous tubing line 5) can be prevented. Preventing backflow of fluid is advantageous because it limits the unintended backflow of particulate matter (e.g., particulate matter contained in the drug dispensed from the secondary intravenous tubing line 7) through the valve member 300 and thereby prevents the patient 50 from receiving the proper drug concentration or timely delivery of the drug.

[0065] In operation, when subjected to a main fluid pressure equal to a secondary fluid pressure (i.e., the pressure exerted by the fluid flowing into the main inlet 312 from the primary intravenous tubing line 5 is equal to the pressure exerted by the fluid flowing into the secondary inlet 306 from the secondary intravenous tubing line 7), the valve member 320 can translate between the main outlet 310 and the secondary outlet 308 toward the central portion of the chamber 314. Due to the equal fluid pressure at the main inlet 312 and the secondary inlet 306, the position of the valve member 320 can be equidistant from each of the main inlet port 313 and the secondary inlet port 307. At this position, the main inlet port 313 and the main outlet 310 and the secondary inlet port 307 and the secondary outlet 308 are all open, thereby allowing fluid to flow equally from both the primary intravenous tubing line 5 and the secondary intravenous tubing line 7 to the patient 50. Thus, given the above-described configuration, the primary drug and the secondary drug can be administered to the patient in equal proportions without the possibility of the drugs backflowing from one intravenous fluid line into the other intravenous fluid line.

[0066] In one or more embodiments of the present disclosure, a 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 a central axis of the outlet is disposed perpendicular with respect to the common central axis; and a chamber defined by an inner circumferential surface of the housing, the chamber extending between the main valve body and the secondary valve body for fluidly connecting the main inlet and the secondary inlet with the outlet. The valve member is reciprocally mounted in the chamber to (i) block fluid communication between the secondary inlet and the outlet when a fluid pressure entering the main inlet is higher than a fluid pressure entering the secondary inlet and (ii) block 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.

[0067] In aspects of the disclosure, the valve member includes a cylindrical disc slidably mounted in the chamber. In aspects of the disclosure, the housing includes at least one guide rail extending longitudinally along the inner circumferential surface within the chamber, and the valve member includes at least one slot extending longitudinally along the outer circumferential surface of the valve member, the slot defining a recess having a shape corresponding to a shape of the guide rail for mounting the valve member onto the guide rail. In aspects of the disclosure, the at least one guide rail includes two guide rails disposed symmetrically about a central longitudinal axis of the inner circumferential surface defining the chamber; the at least one slot includes two slots disposed symmetrically about a central longitudinal axis of the valve member; and the central longitudinal axis of the inner circumferential surface defining the chamber and the central longitudinal axis of the valve member are coaxially aligned. In aspects of the disclosure, the valve member further includes a flow slot extending longitudinally along the outer circumferential surface of the valve member from a planar surface of the disc. In aspects of the disclosure, the main valve body and the main valve body are integrally formed as a single unit.

[0068] In one or more embodiments of the disclosure, a flow control device includes 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 inlet and the secondary inlet share a common central axis that is disposed perpendicularly with respect to central axes of the primary outlet and the secondary outlet. The chamber is defined by an 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 fluidly connecting the secondary inlet and the secondary outlet. The valve member is reciprocally mounted in the chamber to (i) block fluid communication between the secondary inlet and the secondary outlet when a fluid pressure entering the primary inlet is higher than a fluid pressure entering the secondary inlet, and (ii) block fluid communication between the primary inlet and the primary outlet when the fluid pressure entering the secondary inlet is higher than the fluid pressure entering the primary inlet.

[0069] In aspects of the disclosure, the inner circumferential surface includes a primary sealing surface defining an inlet port of the primary inlet, 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 secondary outlet. In aspects of the disclosure, the primary inlet sealing surface includes a planar profile, and the secondary inlet sealing surface includes a non-planar profile. In aspects of the disclosure, the secondary inlet sealing surface of the valve member includes a curvilinear profile. In aspects of the disclosure, the secondary inlet sealing surface of the valve member includes a concave profile. In aspects of the 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 aspects of the disclosure, the secondary sealing surface of the housing includes a curvilinear profile.

[0070] In aspects of the disclosure, the secondary sealing surface of the housing includes a convex profile. In aspects of the disclosure, the valve member further includes a flow channel extending longitudinally from a planar surface of the disc and along an outer circumferential surface of the valve member. In aspects of the 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 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 the primary outlet and secondary outlet. In aspects of the disclosure, at least one of the primary inlet sealing surface and secondary inlet sealing surface includes a non-planar profile. In aspects of the disclosure, the primary inlet sealing surface includes a planar profile, and the secondary inlet sealing surface includes a non-planar profile. In aspects of the disclosure, the secondary inlet sealing surface of the valve member includes a curvilinear profile. In aspects of the disclosure, the secondary inlet sealing surface of the valve member includes a concave profile.

[0071] Accordingly, as previously mentioned, various embodiments of the disclosure are advantageous in providing a flow control device that is capable of preventing under-infusion of the secondary drug by preventing the secondary drug from flowing back into the primary intravenous tubing line. The flow control device of various embodiments described herein is further advantageous in that it minimizes the number of separate components of the intravenous set by replacing the check valve and y-connector with a single flow control device. As a result, the cost of the intravenous set can be reduced. Additionally, various embodiments of the disclosure are advantageous in reducing the clinician / nurse workflow steps as there is no need for manual manipulation to regulate flow as the flow pressure of the secondary drug or fluid is used to regulate the flow of the primary drug or fluid.

[0072] 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.

[0073] Unless otherwise stated, reference to an element in the singular does not imply "one and only one," but rather "one or more." Unless explicitly stated otherwise, the term "some" refers to one or more. Masculine pronouns (e.g., his) include feminine and neutral genders (e.g., her and its), and vice versa. The use of titles and subtitles (if any) is for convenience only and does not limit the invention.

[0074] 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.

[0075] 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” could refer to: only A, only B, or only C; or any combination of A, B, and C.

[0076] Phrases such as “aspect” do not imply that a particular aspect is essential to the subject technology, or that such aspect applies across all configurations of the subject technology. Disclosures relating to one aspect can apply to all or one or more aspects. An aspect can provide one or more examples. Phrases such as “in an aspect” can refer to one or more aspects, or the other way around. Phrases such as “embodiment” do not imply that a particular embodiment is essential to the subject technology, or that such embodiment applies across all configurations of the subject technology. Disclosures relating to one embodiment can apply to all or one or more embodiments. An embodiment can provide one or more examples. Phrases such as “in an embodiment” can refer to one or more embodiments, or the other way around. Phrases such as “configuration” do not imply that a particular configuration is essential to the subject technology, or that such configuration applies across all configurations of the subject technology. Disclosures relating to one configuration can apply to all or one or more configurations. A configuration can provide one or more examples. Phrases such as “in a configuration” can refer to one or more configurations, or the other way around.

[0077] In one aspect, unless otherwise indicated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification are approximate, unless otherwise indicated. In one aspect, they are intended to have a reasonable range commensurate with the functions to which they relate and with general

[0078] It should be understood that a particular order or hierarchy of steps or operations within a disclosed process or method is an example of an example method. Based upon implementation preferences or scenarios, a particular order or hierarchy of steps, operations or processes can be re-arranged. Some steps, operations or processes can be performed simultaneously. In some implementation preferences or scenarios, certain operations can or can not be performed. Some or all of the steps, operations or processes can be performed automatically, without user intervention. The following method claims are presented in a sample order of steps, operations or processes, and do not necessarily have to be presented in the particular order or hierarchy presented.

[0079] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether these aspects are explicitly recited in the claims. No claim element is to be construed as a means plus function unless the element is expressly recited using the phrase "means for." Furthermore, to the extent that the term "comprising" is used in the detailed description and claims, it is intended to be

[0080] The title, background, summary, brief description of drawings, and abstract of the disclosure are hereby incorporated into this disclosure and provide illustrative examples, not limitations. It will be apparent to one skilled in the art that aspects of the disclosure can be practiced under conditions and parameters other than those specifically set forth herein. Unless otherwise specified, any and all parameters of material, including the dimensions, types of materials, and processes used are intended to indicate the preferred embodiment within a preferred range. The disclosure is now described with reference to the following drawings.

[0081] The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language of the claims, wherein reference to an element in the singular is not intended to mean "one and only one" unless specifically so stated, but rather "one or more." No language in the specification should be construed as indicating any non-claimed element essential to the practice of the disclosure. The use herein of "one embodiment," "an embodiment," or other such phrase indicating a singular instance of the specification is not, and should not be, taken to indicate that the terminology is limited to a single instance of the described feature. Rather, the phrase is intended to encompass one of many possible implementations of the described feature. The words "example" and "exemplary" are used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as "example" or "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs.

Claims

1. A flow control device comprising: a housing comprising: 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 inlet and secondary inlet share a common central axis and a central axis of the outlet is disposed perpendicular with respect to the common central axis; and a chamber defined by an inner circumferential surface of the housing, the chamber extending between the primary valve body and secondary valve body for fluidly connecting the primary inlet and secondary inlet with the outlet; and a valve member reciprocally mounted in the chamber so as to (i) block fluid communication between the secondary inlet and the outlet when fluid pressure entering the primary inlet is higher than fluid pressure entering the secondary inlet, and (ii) block fluid communication between the primary inlet and the outlet when fluid pressure entering the secondary inlet is higher than fluid pressure entering the primary inlet, wherein the valve member is a cylindrical disc slidably mounted in the chamber, and the valve member further comprises a flow slot extending longitudinally from a planar surface of the valve member along an outer circumferential surface of the valve member, the flow slot extending only partially along a length of the valve member, the flow slot allowing fluid communication of the secondary inlet with the outlet and blocking fluid communication between the primary inlet and the outlet when fluid pressure at the primary inlet is equal to fluid pressure at the secondary inlet.

2. The flow control device of claim 1, wherein: the housing comprises at least one guide track extending longitudinally along the inner circumferential surface in the chamber; and the valve member comprises at least one slot extending longitudinally along the outer circumferential surface of the valve member, the slot defining a recess having a shape corresponding to a shape of the guide track for mounting the valve member onto the guide track.

3. The flow control device of claim 2, wherein: the at least one guide track comprises two guide tracks disposed symmetrically about a central longitudinal axis of the inner circumferential surface defining the chamber; the at least one slot comprises two slots disposed symmetrically about a central longitudinal axis of the valve member; and the central longitudinal axis of the inner circumferential surface defining the chamber and the central longitudinal axis of the valve member are coaxially aligned. the primary valve body and secondary valve body are integrally formed as a single unit.

4. The flow control device of claim 1, wherein, ​

Citation Information

Patent Citations

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