Float-based flow control device for gravity-based intravenous injection set

Abstract

A flow control device includes an upper housing, a lower housing, a chamber defined between and bounded by the upper housing and the lower housing, and a valve member. The upper housing includes a primary inlet and a secondary inlet, the primary inlet having an inner surface defining a cavity. The lower housing defines an outlet of the flow control device. The chamber fluidically connects the primary inlet and the secondary inlet with the outlet. The valve member is at least partially reciprocally disposed in the cavity and partially reciprocally disposed in the chamber to (i) selectively allow fluid to flow in a first direction into the primary inlet when a fluid level in the chamber is below a predetermined level, and (ii) prevent fluid from flowing in a second direction opposite the first direction when the fluid level in the chamber is above the predetermined level.

Description

TECHNICAL FIELD

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

[0002] Infusion IV sets are commonly used in infusion therapy in order to deliver a medicinal product from a pre-charged container, such as an IV bottle or bag containing the desired medicinal product, to a patient. Typically, the IV tubing 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 possibly different dosages, resulting in the need for an IV extension set having multiple branch tubing or fluid lines through which the multiple medications can be dispensed to the patient.

[0003] Patients are commonly infused with IV solutions that are initially set in an IV bottle or bag and dripped through an IV line into a vein of the patient. Flow control devices, such as check valves, are also commonly included in the IV line to allow fluid to flow only in the direction of the patient. This ensures that the medicinal product flows downstream toward the patient and not upstream toward the IV bottle or bag.

[0004] During injection using an IV set, secondary medication supply can flow back into the primary IV line, resulting in under-infusion of the secondary medication. Although a check valve can be positioned in the primary line to prevent backflow, the check valve can fail. A common cause of check valve failure is due to the presence of debris in the infusion. In addition, under-infusion often occurs due to air entering the secondary line, causing some of the secondary medication to remain in the secondary line (un-delivered medicinal product). Air entering the IV line can have adverse effects, such as causing an air embolism to the patient.

[0005] The description provided in the background section should not be taken as an admission that the subject matter described therein is prior art merely because it is included in the background section. The background section can include information that was not available to the public at the time of the invention. SUMMARY

[0006] According to some embodiments of the present disclosure, a flow control device can include an upper housing including a primary inlet and a secondary inlet having inner surfaces defining a cavity; a lower housing defining an outlet of the flow control device; and a chamber interposed between and defined by the upper housing and the lower housing for fluidically connecting the primary inlet and the secondary inlet with the outlet. A valve member can be reciprocally disposed at least partially in the cavity and partially in the chamber to (i) selectively allow fluid to flow in a first direction into the primary inlet when a fluid level in the chamber is below a predetermined level, and (ii) prevent fluid from flowing in a second direction opposite the first direction when the fluid level in the chamber is above the predetermined level.

[0007] According to some embodiments, an intravenous (IV) set can include a primary IV line and a secondary IV line and a flow control device. The flow control device can include an upper housing, a lower housing coupled to the upper housing, and a chamber defined between the upper housing and the lower housing. The upper housing can include a primary inlet fluidically communicating the primary IV line with the chamber, and a secondary inlet fluidically communicating the secondary IV line with the chamber. The flow control device can further include a valve member having a base disposed in the chamber and a plurality of legs extending longitudinally from the base into the primary inlet, the valve member being buoyant and displaceable in a proximal direction by a buoyant force exerted on the base when a level of fluid in the chamber exceeds a predetermined level.

[0008] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are intended to provide further explanation of the subject technology as claimed. It should also be understood that other aspects can be utilized and that changes can be made without departing from the scope of the subject technology. BRIEF DESCRIPTION OF DRAWINGS

[0009] The following drawings are included to illustrate certain aspects of the embodiments and are not intended to be exclusive embodiments. The disclosed subject matter can be substantially modified in both form and detail without departing from the scope thereof and additional aspects disclosed.

[0010] Figure 1 A multi-line IV extension set including a flow control device is shown in accordance with some embodiments of the present disclosure.

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

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

[0013] Figure 2C A perspective view of an upper housing of a flow control device according to some embodiments is shown. Figure 2A

[0014] Figure 2D A perspective view of an upper housing of a flow control device according to some embodiments is shown. Figure 2A

[0015] Figure 3 A perspective view of a valve member of a flow control device according to some embodiments of the disclosure is shown.

[0016] Figure 4 A perspective view of a valve member and a sealing member of a flow control device according to some embodiments of the disclosure is shown.

[0017] Figure 5 A cross-sectional view of a flow control device according to some embodiments of the disclosure in an open state when subjected to an upstream force, in which state the drug level in the chamber is below a predetermined level.

[0018] Figure 6 A cross-sectional view of a flow control device according to some embodiments of the disclosure in a closed state, in which state the drug level is above a predetermined amount and a buoyant force is applied to the valve member. Figure 5

[0019] A cross-sectional view of a flow control device according to some embodiments of the disclosure in a closed state, in which state fluid flows from the secondary inlet into the chamber. Figure 7 Figure 5 A cross-sectional view of a flow control device according to some embodiments of the disclosure in an open state, in which state fluid flow from the secondary inlet to the chamber is complete and the drug level in the chamber has dropped below a predetermined level.

[0020] Figure 8 Figure 5 A cross-sectional view of a flow control device according to some embodiments of the disclosure in an open state, in which state fluid flow from the secondary inlet to the chamber is complete and the drug level in the chamber has dropped below a predetermined level.

[0021] Figure 9 A cross-sectional view of a flow control device according to some embodiments of the disclosure with a valve member is shown.

[0022] Figure 10 A cross-sectional view of a flow control device according to some embodiments of the disclosure with a valve member is shown.

[0023] Figure 11 A perspective view of a valve member according to some embodiments of the disclosure is shown. Figure 10

[0024] Figure 12 ​​​​​A cross-sectional view of a flow control device having a valve member is shown in accordance with some embodiments of the present disclosure.

[0025] Figure 13 A perspective view of a valve member is shown in accordance with some embodiments of the present disclosure. Figure 12 A perspective view of a valve member is shown in accordance with some embodiments of the present disclosure. DETAILED DESCRIPTION

[0026] 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, the descriptions set forth regarding some aspects can be provided as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology can be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form, rather than in detail, in order to avoid obscuring the concepts of the subject technology.

[0027] It is to be 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 now be disclosed, in accordance with specific but non-limiting examples. The various embodiments described in this disclosure can be implemented in different ways and variations and according to the desired application or implementation.

[0028] The present description relates generally to flow control devices, and more particularly to flow control devices having a valve member that prevents under-infusion in an IV set with a secondary line, and prevents backflow of medication from the secondary line into the primary line.

[0029] IV sets with secondary lines are prone to under-infusion of secondary medications due to the failure of the check valve in the primary line. The most common cause of check valve failure is due to debris that accumulates when the medication in the secondary line surges and seeps into the primary line at low pressure. A common cause of under-infusion is dilution of the medication when back priming the secondary IV, and when there is an equal pressure head in the primary and secondary lines. Other causes include dead volume in the secondary line, and the time it takes to infuse the medication. The flow control devices of the various embodiments described herein overcome the above-mentioned problems commonly associated with IV sets having a primary line and a secondary line.

[0030] In accordance with various embodiments of the present disclosure, a flow control device can include an upper housing having a primary inlet and a secondary inlet, a lower housing coupled to the upper housing, a chamber defined between the upper housing and the lower housing, and a floating valve member at least partially disposed in the chamber and partially disposed in the primary inlet. In some embodiments, the upper housing can have an inner surface having a circumferential lip at a distal end thereof. The circumferential lip can be positioned to project radially inwardly toward a central longitudinal axis of the primary inlet.

[0031] In some embodiments, the valve member can have a base and a plurality of legs extending longitudinally from the base into the main inlet. The legs can be spaced apart from one another, with adjacent pairs of legs each defining a flow portion or slot through which fluid entering the main inlet flows into the chamber. In some embodiments, each leg can terminate at a flange of the proximal end of the valve member. In other embodiments, the valve member can be configured as a body having a central bore and a plurality of axially extending slots through which fluid flowing into the main inlet can enter the chamber.

[0032] In operation, when the fluid level in the chamber is below the predetermined level, and when the valve member is subjected to a net upstream force (i.e., the force exerted by fluid flowing from the main inlet toward the chamber exceeds any buoyant force exerted by the fluid in the chamber), the valve member can translate distally (downstream) to a position in which each flange seats on the circumferential lip. Accordingly, the valve member can be placed in an open state, such that fluid from the main IV line can enter the chamber via the main inlet.

[0033] According to some embodiments, the valve member can include a sealing member coupled to at least a portion of the upper surface of the base.

[0034] In operation, when the fluid level in the chamber is above the predetermined level, and when the valve member is subjected to a net downstream force (i.e., the buoyant force exerted by the fluid in the chamber exceeds any upstream force exerted by fluid flowing from the main inlet toward the chamber), the valve member can translate proximally (upstream) to a position in which the sealing member contacts and seals against the inner surface of the upper housing. Accordingly, fluid flowing from the chamber to the main inlet is blocked, thereby preventing backflow of fluid into the main inlet. As a result, underdosing of the secondary medication, which typically occurs due to the secondary medication flowing from the chamber back into the main inlet, is prevented. Preventing backflow of fluid is advantageous as it limits the backflow of undesirable particulate matter contained in the secondary medication, for example, through the valve member, and ensures that the patient receives the proper medication dosage concentration or timely delivery of the medication.

[0035] Figure 1 A multi-line IV extension set 1 including a flow control device 100, 200, 300 according to some embodiments of the present disclosure is shown. The IV set 1 includes a primary fluid system 15 and a secondary fluid system 25. An IV pump (not shown) receives fluid from the primary fluid system 15 and the secondary fluid system 25 via a main IV line 5 and can control and dispense fluid from the primary fluid system and the secondary fluid system to a patient 50.

[0036] 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, a primary IV line 5 conveys the 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 IV line 5 and allow fluid flow from the primary fluid bag 10 to an IV pump (not shown) while preventing reverse flow (backflow) of fluid from the secondary fluid system 25 toward the primary fluid bag 10. According to some embodiments, the secondary fluid system 25 includes a secondary fluid source, such as a secondary fluid bag 8, which can contain a medication or other secondary fluid to be supplied to the patient 50 for treatment. As shown, the IV set 1 can further include a secondary IV line 7 that conveys flow from the drip chamber 22 to the flow control device 100, 200, 300.

[0037] Figure 2A A cross-sectional view of a flow control device 100 is shown, according to some embodiments of the present disclosure. Figure 2B A perspective view of a flow control device 100 is shown, according to some embodiments of the present disclosure. Figure 2A An enlarged partial cross-sectional view of a flow control device 100 and valve member is shown, according to some embodiments of the present disclosure. As shown, the flow control device 100 can include an upper housing 120, a lower housing 140 coupled to the upper housing 120, a chamber 150 defined between the upper housing 120 and the lower housing 140, and a floating valve member 110 disposed at least partially in the chamber. The upper housing can also include a secondary inlet 130 for placing the secondary IV line 7 in fluid communication with the chamber 150. In some embodiments, an air vent 105 is located on the upper housing for air removal during priming of the infusion. Reference is made to Figure 2A A cross-sectional view of a flow control device is shown, according to some embodiments of the present disclosure, to more clearly illustrate some features of the valve member 110. As shown, the flow control device 100 can be in the form of an axially extending body defining a central longitudinal axis X. The body can be generally cylindrical (or tubular) or can be of any other shape having a hollow interior capable of defining a chamber.

[0038] Figure 2C A perspective view of an upper housing of a flow control device is shown, according to some embodiments of the present disclosure. Figure 2A A perspective view of an upper housing of a flow control device is shown, according to some embodiments of the present disclosure. Figure 2D A cross-sectional view of an upper housing of a flow control device is shown, according to some embodiments of the present disclosure. Reference is made to Figure 2A A cross-sectional view of an upper housing of a flow control device is shown, according to some embodiments of the present disclosure. Reference is made to Figure 2C and 2DThe upper housing 120 can include a primary inlet 125 for placing the primary IV line 5 in fluid communication with the chamber 150. As shown, the primary inlet 125 can have an inner surface 127 that defines a cavity 135 in which at least a portion of the valve member 110 is disposed. The cavity 135 can form a portion of the primary inlet 125 or can otherwise be in fluid communication with the primary inlet 125. Thus, fluid flowing from the primary inlet 125 to the chamber 150 can flow via the cavity 135. In some embodiments, the inner surface 127 defining the cavity can have a circumferential lip 175 at a distal end thereof. As shown, the circumferential lip 175 can be oriented to project radially inward toward a central longitudinal axis XI (as shown) of the primary inlet 125. Figure 2A

[0039] Referring back Figure 2A In some embodiments of the present disclosure, the lower housing 140 can be coupled distally to the upper housing 120 and can further define an outlet 145 through which medication or drugs from the primary and secondary inlets can be delivered to the patient 50. As shown, the radial extent of the lower housing 140 at a proximal end thereof (the end directly coupled to the upper housing 120) can be greater than the radial extent of the distal end. However, various embodiments of the present disclosure are not specifically limited to the above-mentioned configuration, and the shape and configuration of the lower housing 140 can vary for intended purposes while still embodying the working principles described herein. The lower housing 140 and the upper housing 120 can be in axial contact with one another to cooperate in forming the chamber 150 of the flow control device 100. In the illustrated embodiment, the floating valve member 110 can be partially mounted in the cavity 135 and partially mounted in the chamber 150. The floating valve member 110 can selectively allow fluid to flow from the primary IV line 5 into the chamber 150 through the primary inlet 125 when the fluid level in the chamber 150 is below a predetermined level. Further, the valve member 110 can operate to prevent fluid from flowing from the secondary inlet 130 and the chamber 150 back into the primary inlet 125 when the fluid level in the chamber 150 is above the predetermined level and exerts a buoyant force on the valve member 110.

[0040] Figure 3 ​A perspective view of a valve member 110 of a flow control device according to some embodiments of the present disclosure is shown. According to various aspects of the present disclosure, the valve member 110 can include a base 165 and a body 160 extending proximally from the base 165. In some embodiments, the base 165 can be in the form of a disc or any other circular or semi-circular plate having an upper surface 167 and a lower surface 169. The size or surface area of the base 165 can be particularly selected to allow maximum exposure to the fluid in the chamber 150 to overcome the fluidic force of the fluid entering the main inlet 125 from the main IV tubing 5. For example, the larger the size of the base 165, the greater the surface area for the fluid in the chamber to act upon. Thus, the valve member 110 can be designed to open and close the main inlet based on a particular threshold force.

[0041] As shown, the body 160 can have a plurality of legs 161 extending longitudinally from the base 165 into the cavity 135 of the main inlet 125. The legs 161 can each extend longitudinally from the upper surface 167 of the base 165. In some embodiments, the legs 161 can be oriented substantially perpendicular with respect to the upper surface 167 of the base 165. In particular, the legs 161 can extend and protrude substantially perpendicularly at a height above the upper surface 167 of the base 165. In some embodiments, the legs 161 can be spaced apart from each other at regular intervals. For example, the valve member 110 can have two or more legs 161 spaced apart equidistant from each other. In other embodiments, the legs 161 can be spaced apart from each other at irregular intervals. As shown, adjacent pairs of legs 161 each define a flow portion or slot 164 through which fluid entering the main inlet 125 into the cavity 135 flows into the chamber 150. As shown, each leg 161 can terminate at a flange 166 at a proximal end of the valve member 110.

[0042] In some embodiments, the legs 161 can have a polygonal shape, such as a rectangular, square, or any other suitable polygonal shape that terminates at the flange 166. In other embodiments, the legs 161 can have a curved shape, such as a circular, oval, or elliptical shape that terminates at the flange 166. However, various embodiments of the present disclosure are not limited to the aforementioned configurations, and the shape of the legs 161 and the spacing between each other can vary as desired.

[0043] In other embodiments, the body 160 can be configured to have a central hole 162 and a plurality of axially extending slots 164 through which fluid flowing into the main inlet 125 and the cavity 135 can enter the chamber 150.

[0044] In operation, when subjected to a net upstream force (i.e., the force exerted by the fluid flowing from the main inlet 125 toward the chamber 150 exceeds any buoyancy exerted by the fluid in the chamber 150), the valve member 110 can be translated distally (downstream) to a position where the flange 166 sits on the circumferential lip, as... Figure 2B As shown. Therefore, valve component 110 can be placed in the open state, so that fluid from main IV line 5 can enter chamber 150 via main inlet 125.

[0045] Figure 4 A perspective view of a valve member 110 and a sealing member 170 of a flow control device 100 according to some embodiments of the present disclosure is shown. As shown, the valve member 110 may include a sealing member 170 coupled to at least a portion of an upper surface 167 of a base 165. The sealing member 170 may be configured to contact and abut against an inner surface 122 of an upper housing 120 for sealing.

[0046] In operation, when subjected to a net downstream force (i.e., the buoyancy exerted by the fluid in chamber 150 exceeds any upstream force exerted by the fluid flowing from the main inlet 125 toward chamber 150), the valve member 110 can be translated proximally (upstream) to a position where the sealing member 170 contacts and abuts against the inner surface 122 of the upper housing 120 for sealing, such as... Figure 2A As shown. Therefore, the fluid flowing from chamber 150 to the main inlet 125 is blocked, thereby preventing fluid backflow into the main inlet 125. Similarly, it can prevent secondary drug infusion insufficiency that would normally occur due to secondary drugs flowing back from chamber 150 into the main inlet 125. Preventing fluid backflow is advantageous because it restricts the backflow of unwanted particulate matter (e.g., particulate matter contained in the drug dispensed from the secondary IV line 7) through valve member 110, thereby preventing the patient 50 from receiving the appropriate drug dose concentration or timely drug delivery.

[0047] Figure 5is a cross-sectional view of a flow control device in an open state when subjected to an upstream force, in which the drug level in the chamber is below a predetermined level, and the valve member allows fluid to flow from the main inlet into the chamber, according to some embodiments of the present disclosure. As shown, during operation, fluid can enter the flow control device 100 via the main inlet 125 and flow through the cavity 135 and into the chamber 150 via the flow portions or slots 164 between adjacent pairs of legs 161. In the event that the fluid level in the chamber 150 is below the predetermined level, an upstream force applied to the valve member 110 (i.e., the force applied by the fluid flowing from the main IV line 5 to the main inlet 125) causes the valve member 110 to displace or otherwise move distally and seat on the circumferential lip 175. As a result, the main inlet 125 is placed in an open state in which the main inlet 125, the cavity 135, and the chamber 150 are in fluid communication. In the open state, fluid from the main IV line can flow into the chamber 150 via the cavity 135 and the flow portions or slots 164 between adjacent pairs of legs 161. As fluid from the main IV line continues to enter the chamber 150, the fluid level 152 rises until the fluid in the chamber contacts the lower surface 169 of the base 165 of the valve member 110. Once the fluid level 152 rises above the predetermined level, the fluid in the chamber exerts a buoyant force on the base 165 that is greater in magnitude than the upstream force exerted by the fluid flowing into the main inlet 125 from the main IV line 5. As a result, the valve member 110 then translates proximally to a position in which the sealing member 170 contacts and seals against the inner surface 122 of the upper housing 120, thereby placing the main inlet 125 in a closed state, as shown in Figure 6 .

[0048] Figure 6 is a cross-sectional view of a flow control device in a closed state of Figure 5 , according to some embodiments of the present disclosure, in which the drug level is above a predetermined amount and a buoyant force is exerted on the valve member to block fluid flow from the main inlet into the chamber and prevent backflow into the main inlet. As shown, during operation, when the buoyant force of the fluid flowing in the main IV line 5 exceeds the force exerted on the base 165 of the valve member 110, the sealing member 170 contacts and seals against the inner surface 122 of the upper housing 120. The main inlet 125 is thus placed in a closed state, and dispensing of the drug or other fluid from the main inlet 125 into the chamber ceases. At this point, the secondary drug or other fluid in the secondary IV line 7 can be dispensed into the chamber 150 via the secondary inlet 130.

[0049] Advantageously, since flow from the primary inlet 125 into the chamber 150 is blocked at this time, the secondary medication can be dispensed and flow into the chamber 150 without the possibility of flowing back into the primary inlet 125 and potentially diluting the medication in the primary IV line 5. Thus, under-infusion of the secondary medication or fluid caused by its flow back into the primary IV line 5 can be prevented.

[0050] Another advantage of preventing fluid backflow is that it limits the unwanted particulate matter (e.g., particulate matter contained in the medication or fluid dispensed from the secondary IV line 7) from flowing back through the valve member 110 to prevent the patient from receiving the proper medication dosage concentration or timely delivery of the medication to the patient 50.

[0051] Figure 7 is a cross-sectional view of the flow control device of Figure 5 in a closed state in which fluid flows from the secondary inlet into the chamber. As shown, during operation, the secondary medication can be dispensed into the chamber 150 via the secondary inlet 130 until the secondary medication dispensing is complete. During this time, the fluid in the chamber 150 can also be dispensed to the patient 50 via the outlet 145. As the fluid continues to be dispensed to the patient 50 via the outlet 145, the fluid level 152 in the chamber 150 continues to decrease until the fluid level is below a predetermined level, as Figure 8 indicated.

[0052] Figure 8 is a cross-sectional view of the flow control device of Figure 5 in an open state in which fluid flow from the secondary inlet to the chamber is complete and the medication level in the chamber has dropped below the predetermined level, and the valve member is displaced by fluid forces to restore flow from the primary inlet into the chamber. As the medication in the chamber 150 continues to be dispensed to the patient via the outlet 145, the level of fluid in the chamber 150 drops below the predetermined level, and the magnitude of the buoyant force decreases. As a result, the valve member 110 is displaced distally (toward the chamber 150), and fluid flow from the primary IV line into the chamber 150 via the primary inlet 125 is restored. As shown, the upstream force applied to the valve member 110 causes the valve member 110 to seat on the circumferential lip 175. Thus, the primary inlet 125 is placed in an open state in which the primary inlet 125, the cavity 135, and the chamber 150 are in fluid communication. In the open state, fluid from the primary IV line 5 can flow into the chamber 150 via the flow portion or slot 164 between the cavity 135 and the adjacent pair of legs 161.

[0053] Table 1 shown below provides exemplary calculations of the buoyant force and upstream force applied to the valve member 110 based on exemplary dimensions of the valve member 110. Although specific dimensions of the valve member 110 are used in the calculations below, various embodiments of the present disclosure are not limited to these specific dimensions. The dimensions of the valve member 110 can vary based on the desired purpose, and the buoyant force and upstream force applied can also vary proportionally based on the dimensions of the valve member 110. According to various embodiments of the present disclosure, the buoyant force is calculated using the following equation:

[0054] F B = p f V f g,

[0055] where F B is the buoyant force, p f is the density of the displaced fluid, V f is the volume of the displaced fluid, g is the acceleration due to gravity, 9.8 m / s 2 .

[0056]

[0057]

[0058] Table 1

[0059] Thus, as discussed previously, various embodiments of the present disclosure are advantageous in providing a flow control device that is capable of preventing under-infusion of a secondary medication by preventing the secondary medication from flowing back into the primary IV line. The flow control device of various embodiments described herein is further advantageous in that it minimizes the number of separate components of an IV set by replacing a check valve and a y-connector with a single flow control device. As a result, the cost of the IV set can be reduced. Furthermore, various embodiments of the present disclosure are advantageous in reducing the workflow steps of a clinician / nurse in that no manual manipulation is required to adjust the flow of the primary medication or fluid in accordance with the flow pressure of the secondary medication or fluid to adjust the flow of the primary medication or fluid.

[0060] Advantageously, since flow from the primary inlet 125 into the chamber 150 is now blocked, the secondary medication can be dispensed and flow into the chamber 150 without the possibility of flowing back into the primary inlet 125 and potentially diluting the medication in the primary IV line 5. As a result, under-infusion of the secondary medication or fluid caused by the secondary medication or fluid flowing back into the primary IV line 5 is prevented.

[0061] Another advantage of preventing fluid backflow is that it limits unwanted particulate matter (e.g., particulate matter contained in the medication or fluid dispensed from the secondary IV line 7) from flowing back through the valve member 110, which would prevent the patient from receiving the proper medication dosage concentration or timely delivery of the medication to the patient 50.

[0062] Figure 9 A cross-sectional view of a flow control device 200 having a valve member 110 is shown in accordance with some embodiments of the present disclosure. Reference is made to Figure 9 Similar to the embodiments of Figure 2A , the flow control device 200 can include an upper housing 220, a lower housing 240 coupled to the upper housing 220, a chamber 250 defined between the upper housing 220 and the lower housing 240, and a floating valve member 110 disposed at least partially in the chamber 250. As shown, the upper housing 220 can include a primary inlet 225 for placing the primary IV line 5 in fluid communication with the chamber 250, and a secondary inlet 230 for placing the secondary IV line 7 in fluid communication with the chamber 250. As shown, the flow control device 100 can be in the form of an axially extending body defining a central longitudinal axis Y. The body can be generally cylindrical (or tubular) or can be any other shape having a hollow interior capable of defining a chamber.

[0063] Similar to the embodiments of Figure 2A , the primary inlet 225 can have an inner surface 227 defining a cavity 235 in which at least a portion of the valve member 110 is disposed. The cavity 235 can form a portion of the primary inlet 225 or can otherwise be in fluid communication with the primary inlet 225. Thus, fluid flowing from the primary inlet 225 to the chamber 250 can flow via the cavity 235. In some embodiments, the inner surface 227 defining the cavity can have a circumferential lip 275 at a distal end thereof. As shown, the circumferential lip 275 can be oriented to project radially inwardly toward the central longitudinal axis Y1 of the primary inlet 225.

[0064] According to various embodiments of the present disclosure, the lower housing 240 can be coupled distally to the upper housing 220 and can further define an outlet 245 through which medication or fluid from the primary inlet 225 and the secondary inlet 230 can be delivered to the patient 50. Similar to the embodiments of Figure 2ASimilar to other embodiments, the lower housing 240 may have a greater radial extent at its proximal end (the end directly connected to the upper housing 220) than at its distal end. However, the various embodiments of this disclosure are not specifically limited to the configurations mentioned above, and the shape and configuration of the lower housing may vary for the intended purpose while still embodying the operating principles described herein. The lower housing 240 and the upper housing 220 may be in axial contact with each other to mate and form the chamber 250 of the flow control device 200. In the depicted embodiment, the floating valve member 110 may be partially mounted in the cavity 235 and partially mounted in the chamber 250, thereby selectively allowing fluid to flow from the main IV line 5 through the main inlet 125 into the chamber 250 when the fluid level in the chamber 250 drops below a predetermined level. Furthermore, when the fluid level in the chamber 250 is above the predetermined level and buoyancy is applied to the valve member 110, the valve member 110 may be operated to prevent backflow of fluid from the secondary inlet 230 and the chamber 250.

[0065] According to various embodiments of this disclosure, and in contrast to flow control device 100, the secondary inlet 230 of flow control device 200 may be positioned at a lower axial location (distal) than the main inlet 225 in which valve member 110 is mounted. For example, the secondary inlet 230 may be positioned at a predetermined height H below the main inlet 225 where valve member 110 is mounted. The aforementioned configuration ensures that valve member 110 remains above the level of the secondary line to allow valve member 210 to function as intended.

[0066] Figure 10 A cross-sectional view of a flow control device 300 having a valve member 310 according to some embodiments of the present disclosure is shown. (See reference...) Figure 10 ,and Figure 2A Similar to other embodiments, the flow control device 300 may include an upper housing 120, a lower housing 140 coupled to the upper housing 120, and a chamber 150 defined between the upper housing 120 and the lower housing 140. As shown, the upper housing 120 may include a main inlet 125 for fluid communication of a main IV line 5 with the chamber 150, and a secondary inlet 130 for fluid communication of a secondary IV line 7 with the chamber 150. Because the upper housing 120, the lower housing 140, and the chamber 150, and their connections and fluid communication with each other, are consistent with the above description... Figure 2A The description of the flow control device 100 is the same, therefore further detailed description of the flow control device 300 will be omitted. According to various embodiments, the control device 300 may further include a valve member 310 at least partially disposed in the chamber 150.

[0067] Figure 11 Some embodiments according to this disclosure are shown.Figure 10 A perspective view of the valve member 310. As shown, the valve member 310 can include a base 365 and a body 360 extending proximally from the base 365. In some embodiments, the base 365 can be in the form of a disc or any other circular or semi-circular shaped plate having an upper surface 367 and a lower surface 369. The size or surface area of the base 365 can be specifically selected to allow maximum exposure to the fluid in the chamber 150 to overcome the fluid force of the fluid entering the main inlet 125 from the main IV tubing 5. For example, the larger the size of the base 365, the greater the surface area acted upon by the fluid in the chamber 150. Thus, the valve member 310 can be designed to open and close the main inlet 125 based on a particular threshold force. In particular, the base 365 is structurally different from the base 165 of the various embodiments described in Figure 3 and 4 The base 365 can have a greater surface area than the surface area of the base 165 because the base 365 can be in the shape of a semi-circular shaped plate having a greater radius than the radius of the circular plate shaped base 165. The above mentioned configuration of the base 365 can be more advantageous than the configuration of the base 165 because a greater fluid force from the main IV tubing 5 will be required to displace the valve member 310 and open the main inlet 125 when the fluid level in the chamber 150 is above the predetermined level. This is because the greater surface area of the base 365 is subjected to a greater buoyant force from the fluid in the chamber (see Table 2 below). Thus, the valve member 310 is less likely to leak or otherwise open when an accident occurs due to excessive fluid pressure in the main IV tubing 5.

[0068] Similar to the embodiments described above with respect to the valve member 110, the body 360 of the valve member 310 can have a plurality of legs 361 extending longitudinally from the base 365 into the cavity 135 of the main inlet 125. The legs 361 can each extend longitudinally from the upper surface 367 of the base 365. In some embodiments, the legs 361 can be oriented substantially perpendicular with respect to the upper surface 367 of the base 365. In particular, the legs 361 can extend and protrude substantially perpendicularly at a predetermined height above the upper surface 367 of the base 365. In some embodiments, the legs 361 can be spaced apart from one another at regular intervals. For example, the valve member 310 can have two or more legs 361 spaced apart equidistant from one another. In other embodiments, the legs 361 can be spaced apart from one another at irregular intervals. As shown, adjacent pairs of legs 361 each define a flow portion or slot 364 through which fluid entering the cavity 135 from the main inlet 125 flows into the chamber 150. As shown, each leg 361 can terminate at a flange 366 at a proximal end of the valve member 310.

[0069] In some embodiments, the legs 361 can have a polygonal shape, such as a rectangular, square, or any other suitable polygonal shape that terminates in the flanges 366. In other embodiments, the legs 361 can have a curved shape, such as a circular, oval, or elliptical shape that terminates in the flanges 366. However, various embodiments of the present disclosure are not limited to the aforementioned configurations, and the shape of the legs 361 and the spacing between each other can vary as desired.

[0070] In other embodiments, the body 360 can be configured to have a central bore 362 and a plurality of axially extending slots 364 through which fluid flowing into the main inlet 125 and the cavity 135 can enter the chamber 150.

[0071] Since the operation and function of the flow control device 300 and the valve member 310 are similar to the operation and function of the flow control device 100 and the valve member 110, and detailed descriptions regarding how the flow control device 100 and the valve member 110 function have been provided above with reference to Figure 2A and Figures 5-8 provided, detailed descriptions regarding the flow control device 300 and the valve member 310 will be omitted.

[0072] Table 2 shown below provides exemplary calculations of the buoyant force and the upstream force applied to the valve member 310 based on exemplary dimensions of the valve member 310. Although specific dimensions of the valve member 310 are used in the calculations below, various embodiments of the present disclosure are not limited to these specific dimensions. The dimensions of the valve member 310 can vary based on desired purposes, and the buoyant force and the upstream force applied can also vary proportionally based on the dimensions of the valve member 310. According to various embodiments of the present disclosure, the buoyant force is calculated using the following equation:

[0073] F B = p f V f g,

[0074] where F B is the buoyant force, p f is the density of the displaced fluid, V f is the volume of the displaced fluid, g is the acceleration of gravity, 9.8 m / s 2 .

[0075]

[0076] Table 2

[0077] Figure 12 A cross-sectional view of a flow control device 400 having a valve member 410 is shown in accordance with some embodiments of the present disclosure. Reference is made to Figure 12 , and Figure 2ASimilar to other embodiments, the flow control device 400 may include an upper housing 120, a lower housing 140 coupled to the upper housing 120, and a chamber 150 defined between the upper housing 120 and the lower housing 140. As shown, the upper housing 120 may include a main inlet 125 for fluid communication of a main IV line 5 with the chamber 150, and a secondary inlet 130 for fluid communication of a secondary IV line 7 with the chamber 150. Because the upper housing 120, the lower housing 140, and the chamber 150, and their connections and fluid communication with each other, are consistent with the above description... Figure 2A The description of the flow control device 100 is the same, therefore further detailed description of the flow control device 400 will be omitted. According to various embodiments, the control device 400 may further include a valve member 410 at least partially disposed in the chamber 150.

[0078] Figure 13 Some embodiments according to this disclosure are shown. Figure 12 A perspective view of valve member 410. As shown, valve member 410 may include a base 465 and a body 460 extending proximally from the base 465. In some embodiments, the base 465 may be in the form of a disc or any other circular or semi-circular plate having an upper surface 467 and a lower surface 469. The size or surface area of ​​the base 465 may be specifically selected to allow maximum exposure to the fluid in chamber 150, thereby overcoming the fluid forces of the fluid entering the main inlet 125 from the main IV fitting 5. For example, the larger the size of the base 465, the larger the surface area acted upon by the fluid in chamber 150. Therefore, valve member 410 may be designed to open and close the main inlet 125 based on a specific threshold force. In particular, the base 465 is structurally different from... Figure 3 and 4The base 165 of the various embodiments described above, as the base 465 can have a greater surface area than the surface area of the base 165. For example, as shown, the base 465 can be in the shape of a circular plate having a greater diameter than the diameter of the circular plate shaped base 165 and spanning the area below both the primary inlet 125 and the secondary inlet 130. As shown, the base 465 can have an aperture 462 positioned at the location of the opening at the distal end corresponding to the secondary inlet 130 to prevent the base 465 from obstructing fluid flow from the secondary inlet 7 into the chamber 150. The aforementioned configuration of the base 465 can be more advantageous than the configuration of the base 165, as a greater fluid force from the primary IV line 5 will be required to displace the valve member 410 (not obstructing flow through the secondary inlet 130) and open the primary inlet 125 when the fluid level in the chamber 150 is above the predetermined level. This is because the greater surface area of the base 465 is subject to a greater buoyant force from the fluid in the chamber 150 (see Table 3 below). Thus, the valve member 410 is less likely to leak or otherwise open when an accident occurs due to excessive fluid pressure in the primary IV line 5.

[0079] Similar to the embodiments described above with respect to the valve member 110, the body 460 of the valve member 410 can have a plurality of legs 461 extending longitudinally from the base 465 into the cavity 135 of the primary inlet 125. The legs 461 can each extend longitudinally from an upper surface 467 of the base 465. In some embodiments, the legs 461 can be oriented substantially perpendicular with respect to the upper surface 467 of the base 465. In particular, the legs 461 can extend and protrude substantially perpendicularly at a predetermined height above the upper surface 467 of the base 465. In some embodiments, the legs 461 can be spaced apart from one another at regular intervals. For example, the valve member 410 can have two or more legs 461 spaced apart equidistant from one another. In other embodiments, the legs 461 can be spaced apart from one another at irregular intervals. As shown, adjacent pairs of legs 461 each define a flow portion or slot 464 through which fluid entering the cavity 135 from the primary inlet 125 flows into the chamber 150. As shown, each leg 461 can terminate at a flange 466 at a proximal end of the valve member 410.

[0080] In some embodiments, the legs 461 can have a polygonal shape, such as a rectangular, square, or any other suitable polygonal shape that terminates at the flange 466. In other embodiments, the legs 461 can have a curved shape, such as a circular, oval, or elliptical shape that terminates at the flange 466. However, the various embodiments of the present disclosure are not limited to the aforementioned configurations, and the shape of the legs 461 and the spacing between one another can vary as desired.

[0081] In other embodiments, the body 460 can be configured with a central bore 462 and a plurality of axially extending slots 464 through which fluid flowing into the main inlet 125 and the cavity 135 can enter the chamber 150.

[0082] As the operation and function of the flow control device 400 and the valve member 410 are similar to the operation and function of the flow control device 100 and the valve member 110, and detailed descriptions regarding how the flow control device 100 and the valve member 110 function have been provided above with reference to Figure 2A and Figures 5-8 provided, detailed descriptions regarding the flow control device 400 and the valve member 410 will be omitted.

[0083] Table 3 shown below provides exemplary calculations of the buoyant force and the upstream force applied to the valve member 410 based on exemplary dimensions of the valve member 410. Although specific dimensions of the valve member 410 are used in the calculations below, various embodiments of the present disclosure are not limited to these specific dimensions. The dimensions of the valve member 410 can vary based on desired purposes, and the buoyant force and the upstream force applied can also vary proportionally based on the dimensions of the valve member 410. According to various embodiments of the present disclosure, the buoyant force is calculated using the following equation:

[0084] F B = p f V f g,

[0085] where F B is the buoyant force, p f is the density of the displaced fluid, V f is the volume of the displaced fluid, g is the acceleration of gravity, 9.8 m / s 2 .

[0086]

[0087]

[0088] Table 3

[0089] This disclosure is presented to enable any person skilled in the art to practice the various aspects described herein. The present disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other aspects.

[0090] Reference to items in the singular is not intended to mean "one and only one" unless specifically so stated, but rather "one or more." The term "some" refers to one or more unless the context dictates otherwise. Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa, and the singular include the plural and vice versa, unless the specifically stated. Headings and subheadings, if any, are used for convenience only and do not limit the application.

[0091] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations can be considered at least equivalent.

[0092] As used herein, the phrase "at least one of" preceding a series of items is used to denote any item from the series, the term "or" to separate any item in the series, and the listed items as a whole to be modified by the phrase "at least one of." The phrase "at least one of" does not require selection of at least one item from the series; rather, the phrase allows inclusion of at least one of any item from the series, and / or inclusion of at least one of any combination of items from the series, and / or inclusion of at least one of each item from the series. By way of example, the phrase "at least one of A, B, or C" can mean: only A, only B, or only C; or any combination of A, B, or C.

[0093] The phrase "in an aspect" is not used herein to denote a necessary aspect of the subject technology or to denote an aspect that is indispensable to the subject technology. Rather, the phrase "in an aspect" is used to indicate a recited aspect, configuration, or feature is among many alternatives. The disclosure associated with an aspect can apply to all aspects, or to one or more aspects. An aspect can provide one or more examples. The phrase "such as" is not used herein to denote necessarily a preferred implementation or configuration. Rather, the phrase "such as" is used to indicate that the item following the phrase is an example of the item preceding the phrase. The phrase "in an embodiment" is not used herein to denote a necessary embodiment of the subject technology or to denote an embodiment that is indispensable to the subject technology. Rather, the phrase "in an embodiment" is used to indicate a recited embodiment is among many alternatives. The disclosure associated with an embodiment can apply to all embodiments, or to one or more embodiments. An embodiment can provide one or more examples. The phrase "such as" is not used herein to denote necessarily a preferred implementation or configuration. Rather, the phrase "such as" is used to indicate that the item following the phrase is an example of the item preceding the phrase. The phrase "in a configuration" is not used herein to denote a necessary configuration of the subject technology or to denote a configuration that is indispensable to the subject technology. Rather, the phrase "in a configuration" is used to indicate a recited configuration is among many alternatives. The disclosure associated with a configuration can apply to all configurations, or to one or more configurations. A configuration can provide one or more examples. The phrase "such as" is not used herein to denote necessarily a preferred implementation or configuration. Rather, the phrase "such as" is used to indicate that the item following the phrase is an example of the item preceding the phrase. The phrase "such as" is not used herein to denote necessarily a preferred implementation or configuration. Rather, the phrase "such as" is used to indicate that the item following the phrase is an example of the item preceding the phrase.

[0094] In one aspect, unless otherwise indicated herein, all measurements, values, ration, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. In one aspect, they are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.

[0095] It should be understood that the particular order in which steps or operations have been presented in the disclosed processes or methods is merely illustrative. Based on the implementation preferences or scenarios, it is understood that the specific 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 might not be performed, or might be performed in a different order. Some or all of the steps, operations or processes can be performed automatically, without user intervention. The following method claims are presented in dependence on the various steps, operations or processes in the order presented, but the order presented is not meant to be limiting.

[0096] 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 are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether these disclosure is explicitly recited in the claims. The claims under the 35 U.S.C. § 112(f) paragraph are not to be construed under the doctrine of equivalents, unless the phrase "means for" or the phrase "steps for" are recited using the performing recitations. In addition, the scope of the terms "include", "has", "have" and the like are intended to be inclusive of the subject matter recited in the terms and are not meant to be exclusive.

[0097] The title, background, summary, brief description of drawings, and abstract of the disclosure are hereby incorporated into this disclosure and provided as illustrative examples of the disclosure and are not intended to be limiting. The submissions are based on the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the detailed description, it can be seen that a description of illustrative examples has been provided with the understanding that the description is provided as illustrative examples and in order to simplify the disclosure, various features are combined together in various embodiments. The disclosed methods should not be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as is reflected in the following claims, the inventive subject matter is intended to cover all modifications of the constructions and methods as set forth in the claims. The following claims are hereby incorporated into the detailed description and each claim is independently a separate claimed subject matter.

[0098] 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, and to cover all legal equivalents thereof. Regardless of, and without waiving the ineligibility of, any of the claims, neither this summary nor the following detailed description is intended to limit or otherwise restrict the scope of any claims to only the aspects disclosed in this summary or detailed description.

Claims

1. A flow control device, comprising: an upper housing, the upper housing comprising: a primary inlet having an inner surface defining a cavity; and a secondary inlet; a lower housing defining an outlet of the flow control device; a chamber interposed between and defined by the upper and lower housings for fluidically connecting the primary and secondary inlets with the outlet; and a floating valve member at least partially reciprocally disposed in the cavity and partially reciprocally disposed in the chamber to selectively (i) allow fluid to flow in a first direction into the primary inlet when a fluid level in the chamber is below a predetermined level, and (ii) prevent fluid from flowing in a second direction opposite the first direction when the fluid level in the chamber is above the predetermined level, wherein the valve member comprises a base and a body extending proximally from the base, the body comprising a flange at a proximal end thereof, wherein the body further comprises a plurality of legs extending longitudinally from the base into the cavity of the primary inlet.

2. The flow control device of claim 1, wherein, the body further comprising a central aperture and a plurality of axially extending slots through which fluid flowing into the primary inlet and the cavity enters the chamber.

3. The flow control device of claim 1, wherein: the inner surface defining the cavity comprises a circumferential lip at a distal end thereof, the circumferential lip projecting radially inward toward a central longitudinal axis of the primary inlet; and the flange of the body is configured to seat on the circumferential lip when the valve member is subjected to a net axial force in the first direction.

4. The flow control device of claim 1, wherein, the plurality of legs are radially spaced about the central longitudinal axis of the body, and each spacing between adjacent legs defines a flow portion through which fluid entering the primary inlet and into the cavity enters the chamber.

5. The flow control device of claim 1, wherein: each of the plurality of legs comprises a portion of the flange of the body, and the inner surface defining the cavity comprises a circumferential lip at a distal end thereof, the circumferential lip projecting radially inward toward a central longitudinal axis of the primary inlet; and each portion of the flange of the body is configured to seat on the circumferential lip when the valve member is subjected to a net axial force in the first direction.

6. The flow control device of claim 1, wherein, the base comprises a substantially circular plate sharing a common central axis with the primary inlet.

7. The flow control device of claim 1, wherein, the base comprises a semi-circular plate.

8. The flow control device of claim 1, wherein, the base comprises: a substantially circular plate spanning an area below both the primary inlet and the secondary inlet; and an aperture positioned at a location corresponding to an opening at a distal end of the secondary inlet to prevent the base from obstructing fluid flow from the secondary inlet into the chamber.

9. The flow control device of claim 1, further comprising a sealing member coupled to at least a portion of the base, the sealing member configured to contact an inner surface of the upper housing when a fluid level in the chamber is above a predetermined level.

10. The flow control device of claim 1, wherein, The secondary inlet is disposed at an axial position lower than the primary inlet and a valve member mounted in the primary inlet.

11. The flow control device of claim 1, further comprising an air vent positioned on the upper housing for removing air during priming of an infusion.

12. An intravenous infusion set, comprising: a primary intravenous line and a secondary intravenous line; and a flow control device, the flow control device comprising: an upper housing, a lower housing coupled to the upper housing, and a chamber defined between the upper and lower housings, the upper housing including a primary inlet fluidly communicating the primary intravenous line with the chamber and a secondary inlet fluidly communicating the secondary intravenous line with the chamber; and a floating valve member having a base disposed in the chamber and a plurality of legs extending longitudinally from the base into the primary inlet, the floating valve member being displaceable in a proximal direction by a buoyant force exerted on the base when a fluid level in the chamber exceeds a predetermined level, such that the floating valve member selectively permits fluid flow in a first direction into the primary inlet when the fluid level in the chamber is below the predetermined level and prevents fluid backflow in a second direction opposite the first direction when the fluid level in the chamber is above the predetermined level.

13. The intravenous infusion set of claim 12, wherein: the valve member blocks fluid flow through the primary inlet when the buoyant force exceeds a force of fluid entering the primary inlet from the primary intravenous line.

14. The intravenous injection kit of claim 12, wherein, the valve member includes a body including a flange at a proximal end thereof and extending proximally from the base, the plurality of legs being radially spaced about a central longitudinal axis of the body, and each spacing between adjacent legs defining a flow portion through which fluid entering the primary inlet flows into the chamber.

15. The intravenous infusion set of claim 14, wherein: each of the plurality of legs includes a portion of the flange of the body; the primary inlet includes an inner surface having a circumferential lip at a distal end thereof, the circumferential lip projecting radially inward toward a central longitudinal axis of the primary inlet; and each portion of the flange of the body is configured to seat on the circumferential lip when the valve member is subject to a net upstream force.

16. The intravenous infusion set of claim 12, further comprising a sealing member coupled to an upper surface of the base, the sealing member configured to contact an inner surface of the upper housing when subject to a buoyant force from fluid in the chamber.

17. The intravenous injection kit of claim 12, wherein, the base includes: a generally circular plate sharing a common central axis with the upper housing; and a a hole positioned at a location of an opening at a distal end corresponding to the secondary inlet to allow fluid to flow from the secondary inlet into the chamber.

18. The intravenous injection kit of claim 12, wherein, The secondary inlet is disposed at a lower axial position than the primary inlet and a valve member mounted in the primary inlet.

Images