Patent Description:
Infusion IV sets are generally used in infusion therapy in order to deliver medication from a pre-filled container, e.g., an IV bottle or bag containing the desired medication, to a patient. Generally, the IV tubing is connected to a catheter and inserted into the localized area to be treated. In some cases, there is a need to deliver multiple medications to the patient in potentially differing dosages, thereby causing the need for an IV extension set having multiple branches of tubings or fluid lines through which the multiple medications may be dispensed to the patient.

Patients are commonly injected with IV solutions that are initially provided in the IV bottle or bag and dripped into the vein of the patient through an IV line. A flow control device, for example, a check valve, is also commonly included in the IV line to permit fluid flow only in the direction of the patient. This ensures that the medication flows downstream toward the patient, not upstream toward the IV bottle or bag.

During infusion with IV sets, a secondary drug feed could potentially flow backwards into primary IV line leading to under infusion of the secondary drug. Though a check valve may be positioned in the primary line to prevent backflow, check valves are prone to frequent failure. A common reason for check valve failure is due to debris existing in infusates. Additionally, under-infusion frequently occurs due to low pressure difference on either sides of the diaphragm within back check valve which prevents the back check valve to close completely allowing back flow.

<CIT>discloses a valve system for use in a system including a first source of a first pressurized fluid and a second source of a second pressurized fluid includes a valve housing including a first inlet port adapted to be placed in fluid connection with the first source, a second inlet port adapted to be placed in fluid connection with the second source and an outlet port. The valve system further includes a backflow prevention system to prevent flow of the first pressurized fluid through the second inlet and to prevent flow of the second pressurized fluid through the first inlet port. The valve system is adapted to provide a fluid path between at least the first inlet port and the outlet port to enable fluid to be drawn from the outlet port to the first inlet port. Several of the valve systems of the present invention provide for flow from the first inlet port to the outlet port and concurrent flow from the second inlet port to the outlet port.

<CIT> discloses a fluid control valve for use in a fluid delivery system for delivering fluid to a patient includes a valve body defining an internal chamber, a first inlet port for receiving a first inlet tube, a second inlet port for receiving a second inlet tube, an outlet port, and a sliding valve member slidably disposed in the internal chamber. The first inlet tube defines a first inlet lumen axially aligned with the internal chamber. The second inlet tube defines a second inlet lumen axially aligned with the internal chamber. The sliding valve member includes a first sealing end and second sealing end. The sliding valve member is positionable in a first operating state, a second operating state, and a third operating state based on a flow differential between the first inlet lumen and the second inlet lumen. <CIT> discloses a check valve including a housing body and a valve member. An actuator is associated with the valve member or housing body. The housing body defines a flow passage and an inlet port and an outlet port each communicating with the flow passage. The housing body includes a seal seat in the flow passage between the inlet port and outlet port. The valve member is disposed in the flow passage and is adapted to engage the seal seat. The actuator may be operatively connected to the valve member to place the valve member in an override position permitting bi-directional fluid flow through the flow passage. The valve member may be a cantilever valve member responsive to fluid flow in the flow passage. The valve member may have multiple states or positions. The actuator may be a bypass actuator selectively placing the inlet port in fluid communication with the outlet port.

<CIT> discloses an equipment sets for the sequential administration of medical liquids wherein a primary liquid can be administered at a flow rate independent of the flow rate of a secondary liquid, and including a barrier substantially impervious to air to prevent the inadvertent administration of air when the secondary liquid is depleted. The sets of this invention employ a combined air barrier and liquid sequencing valve controlled by a common flexible membrane.

The present invention is directed to flow control devices according to independent claim <NUM> and independent claim <NUM>. Further aspects are contemplated by the dependent claims.

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 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 a central axis of the outlet is perpendicularly disposed relative to the common central axis. The chamber may extend between the primary and secondary valve bodies for fluidly connecting the primary and secondary inlets with the outlet. The flow control device may further include a valve member reciprocally mounted in the chamber to (i) block fluid communication between the secondary inlet and the outlet when fluid pressure into the primary inlet is higher than fluid pressure into the secondary inlet, and (ii) block fluid communication between the primary inlet and the outlet when fluid pressure into the secondary inlet is higher than fluid pressure into the primary inlet.

According to various aspects of the present 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 that is perpendicularly disposed relative to central axes of the primary and secondary outlets. A chamber may be defined by an inner circumferential surface of the housing, and the chamber may extend between the primary and secondary inlets for fluidly connecting the primary inlet with the primary outlet and the secondary inlet with the secondary outlet. The flow control device may further include a valve member reciprocally mounted in the chamber to (i) block fluid communication between the secondary inlet and the secondary outlet when fluid pressure into the primary inlet is higher than fluid pressure into the secondary inlet, and (ii) block fluid communication between the primary inlet and the primary outlet when fluid pressure into the secondary inlet is higher than fluid pressure into the primary inlet.

The following figures are included to illustrate certain aspects of the embodiments and should not be viewed as exclusive embodiments. The subject matter disclosed is capable of considerable modifications, alterations, combinations, and equivalents in form and function, as will occur to those skilled in the art and having the benefit of this disclosure.

The present description relates in general to flow control devices, and more particularly to flow control devices having a valve member capable of preventing under infusion in IV sets with a secondary line, as well as preventing backflow of drug from the secondary line into the primary line.

IV sets with a secondary line tend to experience under infusion of the secondary drug due to failure of the check valve in the primary line. The most frequent causes of failure of the check valve are due to debris accumulated at the time of spiking and seeping of drug in the secondary line into the primary line at low pressures. A common cause of under-infusion is dilution of drug at the time of back priming of the secondary IV and also at the time of equal head in the primary and secondary lines. Other causes include dead volume in the secondary line, as well as time taken to infuse the drug. The flow control devices of the various embodiments described herein overcome the above issues commonly associated with IV sets having primary and secondary lines.

<FIG> illustrates a multiple line IV extension set <NUM> that includes a flow control device <NUM>, <NUM>, <NUM>, in accordance with some embodiments of the present disclosure. IV set <NUM> includes a primary fluid system <NUM> and a secondary fluid system <NUM>. An IV pump (not shown) receives fluid from primary fluid system <NUM> and secondary fluid system <NUM> via a primary IV line <NUM> and may control and dispense the fluids therefrom to a patient <NUM>.

In some embodiments, primary fluid system <NUM> may include a primary fluid source such as a primary fluid bag <NUM>, which may include or contain saline solution or other medicinal fluid or drug to be administered to the patient <NUM>. As illustrated, primary IV line <NUM> carries primary fluid from a drip chamber <NUM> to flow control device <NUM>, <NUM>, <NUM>. As shall be described further with respect to the following figures, flow control device <NUM>, <NUM>, <NUM> may be disposed in primary IV line <NUM> and allow fluid flow from primary fluid bag <NUM> to the IV pump (not illustrated) while preventing reverse flow (backflow) of fluid from secondary fluid system <NUM> toward primary fluid bag <NUM>. In accordance with some embodiments, secondary fluid system <NUM> includes secondary fluid source such as a secondary fluid bag <NUM>, which may contain drugs or other secondary fluid to be supplied to the patient <NUM> for treatment. As depicted, the IV set <NUM> may further include a secondary IV line <NUM>, which carries flow from drip chamber <NUM> to the flow control device <NUM>, <NUM>, <NUM>.

<FIG> a perspective view of a flow control device, in accordance with some embodiments of the present disclosure. <FIG> illustrates a cross-sectional view of the flow control device and valve member of <FIG>, in accordance with some embodiments of the present disclosure. Referring to <FIG>, the flow control device <NUM> may have a housing <NUM> including a primary valve body <NUM> and a secondary valve body <NUM>, a chamber <NUM> interposed between the primary and secondary valve bodies <NUM> and <NUM>, a vent outlet <NUM> with a vent port <NUM>, and a valve member <NUM> reciprocally mounted in the chamber <NUM>. As depicted, the primary valve body <NUM> and secondary valve body <NUM> may be two components coupled to each other. However, the various embodiments of the present disclosure are not limited to the aforementioned configuration. In some embodiments, the primary valve body <NUM> and the secondary valve body <NUM> may be integrally formed as a single unit. For example, the primary valve body <NUM> and the secondary valve body <NUM> may be integrally formed as a single tubular housing <NUM>.

As depicted, the primary valve body <NUM> may define a primary inlet <NUM> and an outlet <NUM> of the flow control device <NUM>. The outlet <NUM> may define a fluid path through which medication or drugs from the primary and secondary inlets may be delivered to the patient <NUM>. The secondary valve body <NUM> may define a secondary inlet <NUM> of the flow control device <NUM>. The primary and secondary inlets <NUM> and <NUM> may share a common central axis X<NUM>. The primary inlet <NUM> may fluidly communicate the primary IV line <NUM> with the chamber <NUM>. Similarly, the secondary inlet <NUM> may fluidly communicate the secondary IV line <NUM> with the chamber <NUM>. The outlet <NUM> may have a central axis Y, and the central axis Y may be perpendicularly disposed relative to the common central axis X<NUM> of the primary and secondary inlets <NUM> and <NUM>.

Referring to <FIG>, the flow control device <NUM> is displayed in cross-sectional view to more clearly illustrate some of the features of the valve member <NUM>. As depicted, the flow control device <NUM> may be in the form of a housing <NUM> having an axially extending body defining a central longitudinal axis X. The housing <NUM> may be generally cylindrical (or tubular) or may have any other shape with a hollow interior capable of defining the chamber <NUM>. The chamber <NUM> may be defined by an inner circumferential surface <NUM> of the housing <NUM>. As depicted, the chamber <NUM> may extend between the primary and secondary valve bodies <NUM> and <NUM> to fluidly connect the primary and secondary inlets <NUM> and <NUM> with the outlet <NUM>.

<FIG> illustrates a partial cross-sectional view of a housing <NUM> of the flow control device of <FIG> in accordance with some embodiments. Referring to <FIG> with continued reference to <FIG>, the housing <NUM> may include at least one guide rail <NUM> extending longitudinally along the inner circumferential surface <NUM> in the chamber <NUM>. As depicted, the guide rail <NUM> may be oriented projecting radially inwards towards the central longitudinal axis X<NUM> of the housing <NUM>. In some embodiments, the inner circumferential surface <NUM> may have more than one guide rail <NUM> protruding therefrom. For example, two guide rails <NUM> may protrude from the inner circumferential surface <NUM> at positions mirroring each other. The two guide rails <NUM> may be symmetrically disposed about the central longitudinal axis X<NUM> of the inner circumferential surface <NUM> defining the chamber <NUM>. As shall be described in further detail below, the guide rails <NUM> may act as a guide so that the valve member <NUM> may be displaced or otherwise translated axially in the chamber <NUM> without rotation about its central axis X<NUM> (illustrated in <FIG>).

<FIG> illustrates a perspective view of a valve member of the flow control device of <FIG> in accordance with some embodiments. As illustrated in <FIG>, and with continued reference to <FIG>, the valve member <NUM> may be in the form of a cylindrical disc, which is slidably mounted in the chamber <NUM>. To this effect, the valve member <NUM> may have at least one slot <NUM> extending longitudinally along an outer circumferential surface <NUM> of the valve member <NUM>. As depicted, the slot <NUM> may define a recess <NUM> having a shape corresponding to that of the guide rail <NUM> for mounting the valve member <NUM> onto the guide rail <NUM>.

In some embodiments, the valve member <NUM> may have more than one slot, for example two slots <NUM> symmetrically disposed about the central longitudinal axis X<NUM> of the valve member <NUM>. As such, the valve member <NUM> may be mounted on the inner circumferential surface <NUM> with the rail(s) <NUM> engaged in the recess(es) <NUM> of the slot(s) <NUM>. Accordingly, when the valve member <NUM> is subject to fluid pressure from either of the primary IV line <NUM> or the secondary IV line <NUM>, the valve member <NUM> may be translated or otherwise displaced within the chamber <NUM> along the length of the guide rails <NUM>. The aforementioned configuration is advantageous as the engagement between the guide rails <NUM> and slots <NUM> restrain degrees of movement of the valve member <NUM> in the chamber <NUM>. In particular, the aforementioned configuration acts as an anti-rotation mechanism to prevent the valve member <NUM> from rolling or rotating about the central axis X of the housing <NUM>.

<FIG> illustrates a partial cross-sectional view of a housing <NUM> and mounted valve member <NUM> of a flow control device <NUM>, in accordance with some embodiments of the present disclosure. <FIG> illustrates a cross-sectional view of a housing <NUM> and mounted valve member <NUM> of a flow control device <NUM>, in accordance with some embodiments of the present disclosure. According to the invention, the valve member <NUM> further includes a flow groove <NUM> extending longitudinally (e.g., linearly) from a planar surface <NUM> of the valve member <NUM>. The flow groove <NUM> extends longitudinally along an outer circumferential surface <NUM> of the valve member <NUM>. As depicted, the flow groove <NUM> extends only partially along the length of the valve member <NUM>. Accordingly, the flow groove <NUM> serves to fluidly communicate the secondary inlet <NUM> with the outlet <NUM> when fluid pressure at the primary inlet <NUM> is equal to fluid pressure at the secondary inlet <NUM>.

<FIG> is a cross-sectional view illustrating a flow control device and valve member before coupling to fluid lines of an IV set, in accordance with some embodiments of the present disclosure. <FIG> illustrates a condition of the flow control device <NUM> when initially packaged, before being utilized in an IV set. <FIG> is a cross-sectional view illustrating the flow control device and valve member of <FIG> when coupled to primary and secondary fluid lines of an IV set, where fluid pressure in the primary line is higher than that in the secondary line, in accordance with some embodiments of the present disclosure.

Referring to <FIG>, in operation, when subject to a net primary fluid pressure (i.e., a pressure applied by a fluid flowing from the primary inlet <NUM> towards the chamber <NUM> that exceeds that of any pressure applied by fluid in the secondary IV line), the valve member <NUM> may be translated towards the secondary inlet <NUM> to a position where the planar surface <NUM> of the valve member contacts and blocks the secondary inlet <NUM>. Accordingly, fluid flow from the secondary IV line <NUM> into the chamber <NUM> may be blocked, and only fluid from the primary IV line <NUM> may flow into the chamber <NUM> via the primary inlet <NUM>. The fluid from the primary IV line <NUM> may thus be delivered to the patient <NUM> through the outlet <NUM>.

<FIG> is a cross-sectional view illustrating the flow control device and valve member of <FIG> when coupled to primary and secondary fluid lines of an IV set, where fluid pressure in the secondary line is higher than that in the primary line, in accordance with some embodiments of the present disclosure.

Referring to <FIG>, in operation, when subject to a net secondary fluid pressure (i.e., a pressure applied by a fluid flowing from the secondary inlet <NUM> towards the chamber <NUM> that exceeds that of any pressure applied by fluid in the primary IV line), the valve member <NUM> may be translated towards the primary inlet <NUM> to a position where the surface <NUM> of the valve member contacts and blocks the secondary inlet <NUM>. Accordingly, fluid flow from the primary IV line <NUM> into the chamber <NUM> may be blocked, and only fluid from the secondary IV line <NUM> may flow into the chamber <NUM> via the secondary inlet <NUM>. The fluid from the secondary IV line <NUM> may thus be delivered to the patient <NUM> through the outlet <NUM>.

<FIG> are cross-sectional views illustrating the flow control device and valve member of <FIG> when coupled to primary and secondary fluid lines of an IV set, where fluid pressure in the primary line equals that in the secondary line, in accordance with some embodiments of the present disclosure.

Referring to <FIG>, in operation, when subject to a primary fluid pressure that equals that of a secondary fluid pressure (i.e., a pressure applied by a fluid flowing from the primary IV line <NUM> into the primary inlet <NUM> that equals pressure applied by fluid flowing from the secondary IV line <NUM> into the secondary inlet <NUM>), the valve member <NUM> may be translated towards a central portion of the chamber <NUM> just above the outlet <NUM>. Since the fluid pressure at the primary inlet equals the fluid pressure at the secondary inlet, the position of the valve member <NUM> may be equidistant from the primary and secondary inlets <NUM> and <NUM>. At this position just above the outlet, the flow groove <NUM> of the valve member allows fluid to flow from the secondary IV line <NUM> into the chamber <NUM> via the secondary inlet <NUM>. Accordingly, when fluid pressure in the primary and secondary IV lines <NUM> and <NUM> is equal, only the secondary medication is dispensed to the patient via the flow groove <NUM>. Since the surface <NUM> has no flow groove, fluid communication between the primary inlet and the outlet is blocked, thereby stopping the fluid in the IV line from being dispensed to the patient.

<FIG> illustrates a cross-sectional view of a flow control device <NUM>, in accordance with some embodiments of the present disclosure. In some embodiments, the flow control device <NUM> may have a housing <NUM> including a primary inlet <NUM>, a primary outlet <NUM>, a secondary inlet <NUM>, a secondary outlet <NUM>, and a chamber <NUM> interposed between the primary and secondary inlets <NUM> and <NUM>. The flow control device <NUM> may further include a valve member <NUM> reciprocally mounted in the chamber <NUM>. The primary and secondary outlets <NUM> and <NUM> may define a fluid path through which medication or drugs from the primary and secondary inlets <NUM> and <NUM> may be delivered to the patient <NUM>. The primary and secondary inlets <NUM> and <NUM> may share a common central axis X<NUM>. The primary inlet <NUM> may fluidly communicate the primary IV line <NUM> with the chamber <NUM>. Similarly, the secondary inlet <NUM> may fluidly communicate the secondary IV line <NUM> with the chamber <NUM>. The primary and secondary outlets <NUM> and <NUM> may each have a central axis, and each of the central axes may be perpendicularly disposed relative to the common central axis X<NUM> of the primary and secondary inlets <NUM> and <NUM>.

Referring to <FIG>, the flow control device <NUM> is displayed in cross-sectional view to more clearly illustrate some of the features of the valve member <NUM>. As depicted, the flow control device <NUM> may be in the form of a generally cylindrical (or tubular) body or may have any other shape with a hollow interior capable of defining the chamber <NUM>. Similar to the embodiments previously described, the chamber <NUM> may be defined by an inner circumferential surface <NUM> of the housing <NUM>. As depicted, the chamber <NUM> may extend between the primary and secondary inlets <NUM> and <NUM> to fluidly connect the primary and secondary inlets <NUM> and <NUM> with the respective primary and secondary outlets <NUM> and <NUM>.

In some embodiments, the inner circumferential surface <NUM> may include a primary sealing surface <NUM> defining an inlet port <NUM> of the primary inlet <NUM> and a secondary sealing surface <NUM> defining an inlet port <NUM> of the secondary inlet <NUM>. As shall be described in further detail below, the primary and secondary sealing surfaces <NUM> and <NUM> may be structured specifically so as to correspond to a structure of the valve member <NUM> in order for the valve member to seal the primary inlet port <NUM> and the secondary inlet port <NUM> respectively.

As illustrated, the valve member <NUM> is in the form of a disc having a primary inlet sealing surface <NUM> corresponding to the primary sealing surface <NUM> of the housing <NUM>. Similarly, the valve member <NUM> includes a secondary inlet sealing surface <NUM> corresponding to the secondary sealing surface <NUM> of the housing. Additionally, the valve member <NUM> includes an outlet sealing surface <NUM> for selectively sealing the primary and secondary outlets <NUM> and <NUM>.

In operation, when subject to a net primary fluid pressure (i.e., a pressure applied by a fluid flowing from the primary inlet <NUM> towards the chamber <NUM> that exceeds that of any pressure applied by fluid in the secondary IV line <NUM>), the valve member <NUM> may be translated towards the secondary inlet <NUM>. As the valve member moves towards the secondary inlet <NUM> and away from the primary inlet <NUM>, the primary inlet port <NUM> and the primary outlet <NUM> may be opened. Fluid from the primary IV line <NUM> may then flow into the chamber <NUM> via the primary inlet <NUM> and be dispensed to the patient via the primary outlet <NUM>. When the valve member <NUM> is translated to a position where the secondary inlet sealing surface <NUM> of the valve member <NUM> contacts the secondary sealing surface <NUM>, both the secondary inlet port <NUM> and the secondary outlet <NUM> may be occluded by the valve member <NUM>.

In order for the secondary inlet sealing surface <NUM> of the valve member <NUM> to contact and seal the secondary inlet port <NUM>, the secondary inlet sealing surface <NUM> and the secondary sealing surface <NUM> may have complimentary profiles. For example, the secondary inlet sealing surface <NUM> and the secondary sealing surface <NUM> may have non-planar profiles. As depicted, the secondary inlet sealing surface <NUM> may have a curved profile, for example, but not limited to, a concave profile. Accordingly, the secondary sealing surface <NUM> may have a complimentary curved profile, for example, but not limited to, a convex profile.

At the position where the secondary inlet sealing surface <NUM> of the valve member <NUM> contacts and seals the secondary inlet port <NUM>, fluid flow from the secondary IV line <NUM> into the chamber <NUM> is blocked. Accordingly, only fluid (e.g., primary drug) from the primary IV line <NUM> may be dispensed to the patient <NUM> via the primary inlet port <NUM> and the primary outlet <NUM>.

When subject to a net secondary fluid pressure (i.e., a pressure applied by a fluid flowing from the secondary inlet <NUM> towards the chamber <NUM> that exceeds that of any pressure applied by fluid in the primary IV line <NUM>), the valve member <NUM> may be translated towards the primary inlet port <NUM>. As previously discussed, the secondary inlet sealing surface <NUM> and the secondary sealing surface <NUM> may have complimentary non-planar profiles. In particular, as depicted, the secondary inlet sealing surface <NUM> may have a concave profile and the secondary sealing surface <NUM> may have a complimentary convex profile. The aforementioned configuration is advantageous in that the curved profile of the secondary inlet sealing surface <NUM> of valve member <NUM> would be subject to a lower drag force than if the surface <NUM> was a flat or planar surface. Accordingly, a lower fluid pressure threshold at the inlet port <NUM> would be required to move the valve member <NUM> away from the inlet port <NUM> so that fluid could flow from the secondary IV line into the chamber <NUM> for dispensing to the patient via the outlet <NUM>.

As the valve member <NUM> continues to move towards the primary inlet <NUM> and away from the secondary inlet <NUM>, the secondary inlet port <NUM> and the secondary outlet <NUM> may be opened. Fluid from the secondary IV line <NUM> may then flow into the chamber <NUM> via the secondary inlet <NUM> and be dispensed to the patient <NUM> via the secondary outlet <NUM>. When the valve member <NUM> is translated to a position where the primary inlet sealing surface <NUM> of the valve member <NUM> contacts the primary sealing surface <NUM>, both the primary inlet port <NUM> and the primary outlet <NUM> may be occluded by the valve member <NUM>.

In order for the primary inlet sealing surface <NUM> of the valve member <NUM> to contact and seal the primary inlet port <NUM>, the primary inlet sealing surface <NUM> and the primary sealing surface <NUM> may have complimentary profiles. For example, the primary inlet sealing surface <NUM> and the primary sealing surface <NUM> may have matching or complimentary planar profiles. As depicted, the primary inlet sealing surface <NUM> may have a flat profile and the primary sealing surface <NUM> may have a complimentary flat profile. However, the various embodiments of the present disclosure are not limited to the aforementioned configuration. In some embodiments, similar to the secondary inlet sealing surface <NUM> and the secondary sealing surface <NUM>, the primary inlet sealing surface <NUM> and the primary sealing surface <NUM> may have complimentary non-planar profiles.

At the position where the primary inlet sealing surface <NUM> of the valve member <NUM> contacts and seals the primary inlet port <NUM>, fluid flow from the primary IV line <NUM> into the chamber <NUM> is blocked. Accordingly, only fluid (e.g., secondary drug) from the secondary IV line <NUM> may be dispensed to the patient <NUM> via the secondary inlet port <NUM> and the secondary outlet <NUM>. Accordingly, backflow of fluid from the secondary IV line <NUM> into the primary IV line <NUM> is prevented. Similarly, under-infusion of the secondary drug - which commonly occurs as a result of the secondary drug flowing into the primary IV line <NUM> from the chamber <NUM> - may be prevented. Preventing backflow of the fluid is advantageous in that it restricts undesirable particulate matter (for example, contained in the drug dispensed from the secondary IV line <NUM>) from flowing back through the valve member <NUM> , and thereby preventing the patient <NUM> from receiving the proper drug dosage concentration or from timely delivery of the drug.

As illustrated, the valve member <NUM> is in the form of a disc having a primary inlet sealing surface <NUM> corresponding to the primary sealing surface <NUM> of the housing <NUM>.

Similarly, the valve member <NUM> includes a secondary inlet sealing surface <NUM> corresponding to the secondary sealing surface <NUM> of the housing <NUM>. Additionally, the valve member <NUM> includes an outlet sealing surface <NUM> for selectively sealing the primary and secondary outlets <NUM> and <NUM>.

In some embodiments, in order for the secondary inlet sealing surface <NUM> of the valve member <NUM> to contact and seal the secondary inlet port <NUM>, the secondary inlet sealing surface <NUM> and the secondary sealing surface <NUM> may have complimentary profiles. For example, the secondary inlet sealing surface <NUM> and the secondary sealing surface <NUM> may have complimentary non-planar profiles. As depicted, the secondary inlet sealing surface <NUM> may have a curved profile, for example, but not limited to, a concave profile. Accordingly, the secondary sealing surface <NUM> may have a complimentary curved profile, for example, but not limited to, a convex profile.

When subject to a net secondary fluid pressure (i.e., a pressure applied by a fluid flowing from the secondary inlet <NUM> towards the chamber <NUM> that exceeds that of any pressure applied by fluid in the primary IV line <NUM>), the valve member <NUM> may be translated towards the primary inlet port <NUM>. As previously discussed, the secondary inlet sealing surface <NUM> and the secondary sealing surface <NUM> may have complimentary non-planar profiles. In particular, the secondary inlet sealing surface <NUM> may have a concave profile and the secondary sealing surface <NUM> may have a complimentary convex profile. The aforementioned configuration is advantageous in that the curved profile of the secondary inlet sealing surface <NUM> of valve member <NUM> would be subject to a lower drag force than if the surface <NUM> was a flat or planar surface. Accordingly, a lower fluid pressure threshold at the inlet port <NUM> would be required to move the valve member <NUM> away from the inlet port <NUM> so that fluid could flow from the secondary IV line <NUM> into the chamber <NUM> for dispensing to the patient via the outlet <NUM>.

At the position where the primary inlet sealing surface <NUM> of the valve member <NUM> contacts and seals the primary inlet port <NUM>, fluid flow from the primary IV line <NUM> into the chamber <NUM> is blocked. Accordingly, only fluid (e.g., secondary drug) from the secondary IV line <NUM> may be dispensed to the patient <NUM> via the secondary inlet port <NUM> and the secondary outlet <NUM>. Accordingly, backflow of fluid from the secondary IV line <NUM> into the primary IV line <NUM> is restricted or prevented. Similarly, under-infusion of the secondary drug - which commonly occurs as a result of the secondary drug flowing into the primary IV line <NUM> from the chamber <NUM> - may be prevented. Preventing backflow of the fluid is advantageous in that it restricts undesirable particulate matter (for example, contained in the drug dispensed from the secondary IV line <NUM>) from flowing back through the valve member <NUM>, and thereby preventing the patient <NUM> from receiving the proper drug dosage concentration or from timely delivery of the drug.

In operation, when subject to a primary fluid pressure that equals that of a secondary fluid pressure (i.e., a pressure applied by a fluid flowing from the primary IV line <NUM> into the primary inlet <NUM> that equals pressure applied by fluid flowing from the secondary IV line <NUM> into the secondary inlet <NUM>), the valve member <NUM> may be translated towards a central portion of the chamber <NUM> between the primary and secondary outlets <NUM> and <NUM>. Since the fluid pressure at the primary inlet <NUM> equals the fluid pressure at the secondary inlet <NUM>, the position of the valve member <NUM> may be equidistant from each of the primary and secondary inlets ports <NUM> and <NUM>. At this position both the primary inlet port <NUM> and primary outlet <NUM>, and the secondary inlet port <NUM> and secondary outlet <NUM> are open allowing fluid to flow equally from both of the primary and secondary IV lines <NUM> and <NUM> to the patient <NUM>. Accordingly, given the aforementioned configuration, a primary drug and a secondary drug may be administered in equal proportions to the patient without the possibility of backflow of drug from one IV fluid line into the other.

In one or more embodiments of the disclosure, a flow control device comprises a housing and a valve member. The housing includes 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 a central axis of the outlet is perpendicularly disposed relative to the common central axis; and a chamber defined by an inner circumferential surface of the housing, the chamber extending between the primary and secondary valve bodies for fluidly connecting the primary and secondary inlets 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 fluid pressure into the primary inlet is higher than fluid pressure into the secondary inlet, and (ii) block fluid communication between the primary inlet and the outlet when fluid pressure into the secondary inlet is higher than fluid pressure into the primary inlet.

In aspects of the disclosure, the valve member comprises a cylindrical disc slidably mounted in the chamber. In aspects of the disclosure, the housing comprises at least one guide rail extending longitudinally along the inner circumferential surface in the chamber; and the valve member comprises at least one slot extending longitudinally along an outer circumferential surface thereof, the slot defining a recess having a shape corresponding to that of the guide rail for mounting the valve member onto the guide rail. In aspects of the disclosure, the at least one guide rail comprises two guide rails symmetrically disposed about a central longitudinal axis of the inner circumferential surface defining the chamber; the at least one slot comprises two slots symmetrically disposed 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 co-axially aligned. In aspects of the disclosure, the valve member further comprises a flow groove extending longitudinally from a planar face of the disc and along an outer circumferential surface thereof. In aspects of the disclosure, the primary valve body and the primary valve body are integrally formed as a single unit.

In one or more embodiments of the 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 that is perpendicularly disposed relative to central axes of the primary and secondary outlets. The chamber is defined by an inner circumferential surface of the housing, the chamber extending between the primary and secondary inlets for fluidly connecting the primary inlet with the primary outlet and the secondary inlet with 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 fluid pressure into the primary inlet is higher than fluid pressure into the secondary inlet, and (ii) block fluid communication between the primary inlet and the primary outlet when fluid pressure into the secondary inlet is higher than fluid pressure into the primary inlet.

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 comprises 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 and secondary outlets. In aspects of the disclosure, the primary inlet sealing surface comprises a planar profile and the secondary inlet sealing surface comprises a non-planar profile. In aspects of the disclosure, the secondary inlet sealing surface of the valve member comprises a curved profile. In aspects of the disclosure, the secondary inlet sealing surface of the valve member comprises a concave profile. In aspects of the disclosure, the primary sealing surface of the housing comprises a planar profile and the secondary sealing surface of the housing comprises a non-planar profile. In aspects of the disclosure, the secondary sealing surface of the housing comprises a curved profile.

In aspects of the disclosure, the secondary sealing surface of the housing comprises a convex profile. In aspects of the disclosure, the valve member further comprises a flow groove extending longitudinally from a planar face of the disc and along an outer circumferential surface thereof. 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 comprises 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 and secondary outlets. In aspects of the disclosure, at least one of the primary inlet sealing surface and the secondary inlet sealing surface comprises a non-planar profile. In aspects of the disclosure, the primary inlet sealing surface comprises a planar profile and the secondary inlet sealing surface comprises a non-planar profile. In aspects of the disclosure, the secondary inlet sealing surface of the valve member comprises a curved profile. In aspects of the disclosure, the secondary inlet sealing surface of the valve member comprises a concave profile.

Accordingly, the various embodiments of the present disclosure are advantageous in providing a flow control device capable of preventing under-infusion of the secondary drug by blocking the secondary drug from flowing backwards into the primary IV line, as discussed previously. The flow control device of the various embodiments described herein is further advantageous as it minimizes the number of separate components of an IV set by replacing a check valve and a y-connector with the single flow control device. As a result, cost of the IV set may be reduced. Additionally, the various embodiments of the present disclosure are advantageous in reducing workflow steps for the clinician/nurses since no manual operation is necessary for flow regulation as the flow pressure of the secondary drug or fluid is used to regulate flow of the primary drug or fluid.

It is understood that the specific order or hierarchy of steps, or operations in the processes or methods disclosed are illustrations of exemplary approaches. Based upon implementation preferences or scenarios, it is understood that the specific order or hierarchy of steps, operations or processes may be rearranged. Some of the steps, operations or processes may be performed simultaneously. In some implementation preferences or scenarios, certain operations may or may not be performed. Some or all of the steps, operations, or processes may be performed automatically, without the intervention of a user. The accompanying method claims present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

Furthermore, to the extent that the term "include," "have," or the like is used, such term is intended to be inclusive in a manner similar to the term "comprise" as "comprise" is interpreted when employed as a transitional word in a claim.

Claim 1:
A flow control device (<NUM>), comprising:
a housing (<NUM>) including:
a primary valve body (<NUM>) defining a primary inlet (<NUM>) and an outlet (<NUM>) of the flow control device (<NUM>);
a secondary valve body (<NUM>) defining a secondary inlet (<NUM>) of the flow control device (<NUM>), wherein the primary and secondary inlets (<NUM>, <NUM>) share a common central axis (Xi) and a central axis of the outlet (Y) is perpendicularly disposed relative to the common central axis (Xi); and
a chamber (<NUM>) defined by an inner circumferential surface (<NUM>) of the housing (<NUM>), the chamber (<NUM>) extending between the primary and secondary valve bodies for fluidly connecting the primary and secondary inlets (<NUM>, <NUM>) with the outlet (<NUM>); and
a valve member (<NUM>) reciprocally mounted in the chamber (<NUM>) to (i) block fluid communication between the secondary inlet (<NUM>) and the outlet (<NUM>) when fluid pressure into the primary inlet (<NUM>) is higher than fluid pressure into the secondary inlet (<NUM>), and (ii) block fluid communication between the primary inlet (<NUM>) and the outlet (<NUM>) when fluid pressure into the secondary inlet (<NUM>) is higher than fluid pressure into the primary inlet (<NUM>),
characterized in that
the valve member (<NUM>) comprises a cylindrical disc slidably mounted in the chamber (<NUM>) and having a longitudinal length, the valve member (<NUM>) comprising a flow groove (<NUM>) extending linearly from a planar face (<NUM>) of the disc and in parallel to the common central axis (Xi) along an outer circumferential surface (<NUM>) thereof,
wherein the flow groove (<NUM>) extends only partially along the longitudinal length of the valve member (<NUM>), the flow groove (<NUM>) providing the only fluid passage past the planar face (<NUM>) of the disc,
wherein the flow groove (<NUM>) is configured to fluidly communicate the secondary inlet (<NUM>) with the outlet when the fluid pressure into the primary inlet (<NUM>) is equal to the fluid pressure into the secondary inlet (<NUM>).