Sliding flow controller

The sliding flow controller addresses the challenges of adjusting IV fluid flow rates and clinician discomfort by using a non-linear sloped surface and ergonomic design for precise and reproducible flow control, enhancing usability and reducing fatigue.

JP2026002866APending Publication Date: 2026-01-08CAREFUSION 303 INC
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Patent Information

Application Number
JP2025162992
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2020-09-29
Filing Date
2025-09-30
Publication Date
2026-01-08

AI Technical Summary

Technical Problem

Existing IV fluid administration systems face challenges in accurately adjusting flow rates, particularly at low flow rates, and cause clinician discomfort due to small and knurled roller wheels, leading to thumb fatigue.

Method used

A sliding flow controller with a non-linear sloped surface on the lower housing and a flexible clamp mechanism that allows for precise adjustment of fluid flow rates by sliding the upper housing relative to the lower housing, featuring graduations for reproducible settings and ergonomic design.

Benefits of technology

Enhances usability and reproducibility of flow rate adjustments across a wide range, reduces clinician fatigue, and provides tactile feedback for precise control, improving the ergonomic and functional performance of IV fluid administration.

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Abstract

To provide an improved linear actuation flow controller for IV fluid administration.SOLUTION: The flow controller 100 having an inner tube 32 includes an upper housing 10 having a plurality of graduations 16, a lower housing 20 engaged with the lower housing and slidably connected to the lower housing, and a cavity defined between the upper housing and the lower housing for receiving at least a part of the inner tube. The flow controller may further include a flexible clamp 40 having an upper section 41 mounted within the upper housing and a lower section 43 slidably disposed within the lower housing. The upper and lower housings can be slidably coupled to one another to transition the inner tube from an open position to a closed position clamped by the flexible clamp.SELECTED DRAWING: Figure 3
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Description

[Technical Field]

[0001] The present disclosure relates generally to intravenous (IV) fluid administration, and more particularly to a linearly actuated flow controller for IV fluid administration. [Background technology]

[0002] Intravenous (IV) administration sets for the infusion of medical fluids, sometimes simply referred to as IV sets, typically include IV tubing that connects a medical fluid container, such as an IV bag, to a patient interface, such as a patient catheter assembly. In some scenarios, gravity infusion of medical fluids uses gravity rather than an infusion pump to deliver the medical fluid through the IV set. Regulation of the flow rate through the tubing is often provided by roller clamps on the IV tubing. However, providing the desired flow rate using roller clamps can be difficult. Summary of the Invention

[0003] According to various embodiments of the present disclosure, a flow controller having an internal tube may include an upper housing including a plurality of graduations, a lower housing engaging with and slidably coupled to the lower housing, and a cavity defined between the upper and lower housings for receiving at least a portion of the internal tube. The flow controller may further include a flexible clamp having an upper section mounted within the upper housing and a lower section slidably disposed within the lower housing. The upper and lower housings may be slidably coupled to each other to transition the internal tube from (i) an open position in which the internal lumen of the tube is not constrained by the flexible clamp to (ii) a closed position in which the internal lumen of the internal tube is at least partially constricted by the flexible clamp.

[0004] According to various embodiments of the present disclosure, a flow controller for intravenous (IV) tubing may include an upper housing including a plurality of graduations and a lower housing having an inclined surface and slidably coupled to the upper housing. The flow controller may further include a flexible clamp mounted within the upper housing and extending into the lower housing, and a flexible inner tubing disposed within a cavity defined between the upper and lower housings. The flexible tubing may extend through a guide portion of the flexible clamp, and the upper housing may be configured to slide relative to the lower housing such that the flexible clamp compresses a portion of the flexible tubing.

[0005] Further advantages of the subject technology will become readily apparent to those skilled in the art from the following detailed description, wherein only certain aspects of the subject technology are shown and described by way of example only. As will be recognized, the subject technology is capable of other and different configurations, and its several details are capable of modification in various other respects without departing from the subject technology. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

[0006] The accompanying figures are included to illustrate certain aspects of the embodiments and should not be considered as exclusive examples. The disclosed subject matter is capable of considerable modification, substitution, combination, and equivalents in form and function, as will occur to those skilled in the art and having the benefit of this disclosure. [Brief explanation of the drawings]

[0007] [Figure 1] 1 illustrates a perspective view of a sliding flow controller in an open position according to some embodiments of the present disclosure. FIG. [Figure 2] FIG. 2 is a cross-sectional view of the sliding flow controller of FIG. 1 according to some embodiments of the present disclosure. [Figure 3]1 illustrates a perspective view of a sliding flow controller in a closed position according to some embodiments of the present disclosure. FIG. [Figure 4] FIG. 4 is a cross-sectional view of the sliding flow controller of FIG. 3 according to some embodiments of the present disclosure. [Figure 5A] FIG. 10 is a perspective view of a flexible clamp of a sliding flow controller according to some embodiments of the present disclosure. [Figure 5B] FIG. 5B is a perspective view of the flexible clamp of FIG. 5A with a tube received therein, according to some embodiments of the present disclosure. [Figure 5C] FIG. 5B is a top view of the flexible clamp of FIG. 5A with a tube received therein, according to some embodiments of the present disclosure. [Figure 6] FIG. 10 is a perspective view of an upper housing and flexible clamp of a sliding flow controller according to some embodiments of the present disclosure. [Figure 7] FIG. 10 is a perspective view of a flexible clamp attached to an upper housing according to some embodiments of the present disclosure. [Figure 8] FIG. 1 is a perspective view of the top surface of an upper housing of a sliding flow controller according to some embodiments of the present disclosure. [Figure 9] FIG. 12 is a perspective view of the underside of the upper housing of a sliding flow controller according to some embodiments of the present disclosure. [Figure 10A] FIG. 10 is a perspective view of a lower housing of a sliding flow controller according to some embodiments of the present disclosure. [Figure 10B] FIG. 10 is a perspective view of a lower housing of a sliding flow controller according to some embodiments of the present disclosure. [Figure 11A] FIG. 10 is a perspective view of a lower housing of a sliding flow controller according to some embodiments of the present disclosure. [Figure 11B] FIG. 10 is a perspective view of a lower housing of a sliding flow controller according to some embodiments of the present disclosure. [Figure 12A]FIG. 10 is a perspective view of a lower housing of a sliding flow controller according to some embodiments of the present disclosure. [Figure 12B] FIG. 10 is a perspective view of a lower housing of a sliding flow controller according to some embodiments of the present disclosure. [Figure 13A] 1 is a cross-sectional view of a lower housing of a sliding flow controller according to some embodiments of the present disclosure. [Figure 13B] 1 shows the friction reducing surface of the sloped surface of the lower housing. [Figure 14A] FIG. 1 is a perspective view of an assembly of an upper housing, a flexible clamp, and a lower housing of a sliding flow controller in a fully open position according to some embodiments of the present disclosure. [Figure 14B] FIG. 14B is a cross-sectional view of the upper housing, flexible clamp, and lower housing assembly of FIG. 14A according to some embodiments of the present disclosure. [Figure 14C] FIG. 1 is a perspective view of an assembly of an upper housing, a flexible clamp, and a lower housing of a sliding flow controller according to some embodiments of the present disclosure. [Figure 14D] FIG. 1 is a perspective view of an assembly of an upper housing, a flexible clamp, and a lower housing of a sliding flow controller in a closed state, according to some embodiments of the present disclosure. [Figure 14E] FIG. 14E is a cross-sectional view of the upper housing, flexible clamp, and lower housing assembly of FIG. 14D according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0008] 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 may be practiced. The detailed description includes specific details to provide a thorough understanding of the subject technology. Thus, dimensions may be provided with respect to particular embodiments as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology.

[0009] It should 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 are disclosed herein according to specific, but non-limiting examples. The various embodiments described in this disclosure can be implemented in different ways and variations according to a desired application or implementation.

[0010] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present disclosure. However, it will be apparent to those skilled in the art that embodiments of the present disclosure may be practiced without some of the specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the present disclosure.

[0011] As used herein, the terms "tubing," "fluid line," and any variations thereof refer to medical lines or tubing used to deliver liquids, solvents, or fluids (including gases) to or from a patient under medical care. For example, fluid lines (tubing) may be used for intravenous (IV) delivery of fluids, fluid drainage, oxygen delivery, combinations thereof, etc.

[0012] As used herein, the terms "medical connector," "connector," "fitting," and any variations thereof, refer to any device used to provide a fluid flow path between two or more fluid lines that are connected.

[0013] When administering infusion therapy through a gravity-fed IV set, clinicians regulate the amount of medication delivered through a flow controller, such as a roller clamp or in-line flow controller. Roller clamps regulate the flow rate of medication by partially or completely compressing the IV set tubing. The IV tubing is compressed by pinching the tubing between a clinician-operated wheel and an angled groove within the body of the roller clamp. In-line flow controllers regulate the flow rate of medication as it flows through a tortuous path within the in-line flow controller. Clinicians can adjust the flow rate by rotating the in-line flow controller to increase or decrease the flow rate of medication as the length of the tortuous path within the in-line flow controller increases or decreases.

[0014] Various embodiments of the present disclosure relate to a sliding flow controller including an upper housing including a plurality of graduations, a lower housing engaging with and slidably coupled to the lower housing, and a cavity defined between the upper and lower housings for receiving at least a portion of a tube. The sliding flow controller may include a flexible clamp having an upper section mounted within the upper housing and a lower section slidably disposed within the lower housing. The upper and lower housings are slidably coupled to each other to transition the tube from (i) an open position in which the lumen of the tube is not constrained by the flexible clamp to (ii) a closed position in which the lumen of the tube is at least partially constricted by the clamp.

[0015] In some embodiments, a clinician can adjust the fluid flow rate in IV tubing fluidly connected to the tubing of the sliding flow controller by sliding the upper housing along the lower housing. Fully open fluid flow through the tubing occurs at zero actuation, while fully closed flow occurs at maximum actuation (0 ml / hr markings). The clinician can set a given flow rate by actuating the sliding flow controller between the fully open and fully closed flow positions.

[0016] According to various aspects of the present disclosure, the sliding flow controller may operate to gradually pinch or constrict the lumen of the low-durometer inner tubing as the upper housing slides linearly over the lower housing. To this effect, a portion of the low-durometer inner tubing may extend through the sliding flow controller. In some embodiments, a luer is coupled to each end of the low-durometer inner tubing. IV tubing may then be connected to each of the luers to fluidly connect the low-durometer inner tubing with the IV tubing so that fluid may flow through the low-durometer tubing within the sliding flow controller.

[0017] According to various embodiments of the present disclosure, the inner tube can be positioned within the openings of the pair of guide members of the flexible clamp. As the upper housing slides distally relative to the lower housing, the polygonal inclined surfaces of the lower housing engage the lower arms of the flexible clamp. The upper arms of the flexible clamp can be held captive (fixed) within the upper housing. Upon actuation, engagement of the flexible clamp with the polygonal inclined surfaces of the lower housing forces the flexible clamp to close as the lower mounting arm pivots or rotates toward the upper arm. This closing action reduces the opening between the upper and lower arms, thereby pinching and constricting the lumen of the inner tube and reducing fluid flow therethrough. Thus, as the upper housing translates proximally toward the proximal face of the lower housing, the opening action of the sliding flow controller increases the opening between the upper and lower arms, thereby increasing fluid flow.

[0018] According to some embodiments, the slope angle of the polygonal sloped surface can be adjusted relative to the internal tube dimensions such that actuation of several millimeters can be required to adjust the flow rate over a high flow rate range and actuation of several millimeters can be required to adjust the flow rate over a low flow rate range. For example, in some embodiments, the slope angle of the first sloped section of the lower housing can be greater than the slope angle of the second sloped section of the lower housing. Thus, the sliding flow controllers of various embodiments described herein offer several advantages over currently existing roller clamp flow controllers, as described in more detail below.

[0019] In particular, a common problem with current roller clamps is that fluid flow rates are difficult to adjust at low flow rates (below approximately 45 ml / hr). Often, the roller wheel must move several millimeters along the roller clamp body to adjust a flow rate from fully open to 150 ml / hr, while adjustments between 45 ml / hr and 25 ml / hr require barely noticeable movement of the roller wheel. The sliding flow controllers described herein offer increased usability (ease of use) across a range of clinically relevant flow rates compared to current roller clamps. For example, in some embodiments, the sliding flow controller can be designed so that several millimeters of actuation are required to adjust fluid flow at high flow rates, as well as several millimeters of actuation to adjust fluid flow at low flow rates. Accordingly, the sliding flow controllers of various embodiments described herein enhance flow rate adjustment at both low and high flow rates by featuring a non-linear sloped surface on the lower housing. The non-linear sloped surface on the lower housing features a range of slope angles that are specifically tailored for various ranges of flow rates. A few millimeters of movement of the upper housing relative to the lower housing may be required to adjust for either low or high flow ranges.

[0020] Furthermore, a common problem with current roller clamps is that the roller wheels are often small and knurled, and the small wheel geometry and knurling can concentrate excessive and / or prolonged pressure on the clinician's thumb. Therefore, clinicians can experience thumb fatigue and pain from shifting their work from operating the roller clamp multiple times, especially when the IV tubing has a relatively high durometer. The sliding flow controller described herein has superior ergonomic characteristics to current roller clamps, thereby enhancing clinician comfort. For example, as described above, a clinician can operate the sliding flow controller by either sliding the upper and lower housings together to open the flow or apart to close the flow. The overall dimensions of the sliding flow controller are similar to current flow controllers (e.g., the roller clamp flow controller described above) and fit easily in the hand. As such, the sliding flow controller can be actuated with one hand, gripping the entire surface of the upper and lower housings during actuation, rather than just the top of the wheel surface characteristic of current roller clamps. Because the sliding flow controller has a larger surface area to grip during actuation, its ergonomics are superior to current roller clamps.

[0021] Additionally, current roller clamps are often designed to fit a range of IV tubing inner and outer diameters. Tubing position is also not strictly constrained within the roller clamp body. The combination of variations in where the tubing is positioned within the roller clamp body groove and multiple tubing geometries results in variations in wheel position along the roller clamp body when setting a given flow rate. Due to variations in wheel position, current roller clamps cannot have any features or markings that indicate the flow rate for a given wheel position along the roller clamp body. Setting a given flow rate using a sliding flow controller is intentionally repeatable, and the sliding flow controller has a feature (gradation mark) that indicates the flow rate setting.

[0022] Furthermore, the sliding flow controllers of various embodiments described herein are intentionally designed to be highly reproducible because the inclination angle of the non-linear inclined surface can be adjusted for use with specific diameters of low-durometer tubing. The sliding flow controllers described herein also feature tubular guide members to keep the tubing oriented and held perpendicular to the lower and upper tube-clamping arms of the flexible clamp. Because the low-durometer inner tubing geometry can be adjusted and the tubing position within the upper and lower arms of the flexible clamp can be adjusted, the amount of tubing clamped (and therefore fluid flow rate) for a given actuation amount is reproducible. To this effect, the sliding flow controllers can feature markings that can be used to assist clinicians in quickly adjusting the fluid flow rate as desired.

[0023] FIG. 1 illustrates a perspective view of a sliding flow controller in an open position according to some embodiments of the present disclosure. FIG. 2 illustrates a cross-sectional view of the sliding flow controller of FIG. 1 according to some embodiments of the present disclosure. As shown in FIGS. 1 and 2, a flow controller 100 for intravenous (IV) tubing can include an upper housing 10 including a plurality of graduations 16 and a lower housing 20 that engages with and is slidably coupled to the lower housing 20. As depicted, a cavity 15 that receives at least a portion of a tubing 32 can be defined between the upper housing 10 and the lower housing 20. For example, the upper housing 10 can have a first surface 51 that defines a portion of the cavity 15 on a first side of the tubing 32, and the lower housing 20 can have a second surface (i.e., an angled surface 22) that defines a portion of the cavity 15 on a second side of the tubing 32. In some embodiments, the tubing 32 can be fluidly connected to IV tubing of an IV set. In these embodiments, a pair of connectors 30 that connect the flexible tubing 32 to the IV tubing may be disposed on opposite ends of the flexible tubing 32. For example, the pair of connectors 30 may be luer connectors that fluidly connect the flexible inner tubing 32 of the sliding controller 100 with the IV tubing of the IV set. However, various embodiments of the present disclosure are not limited to the foregoing configurations, and the tubing 32 may be IV tubing.

[0024] 2, the flow controller 100 may further include a flexible clamp 40 having an upper section 41 mounted within the upper housing 10 and a lower section 43 slidably disposed within the lower housing 20. As will be described in further detail below, the upper housing 10 and the lower housing 20 may be slidably coupled to one another to transition the tubing 32 from (i) an open position (shown in FIGS. 1 and 2) in which the lumen of the tubing 32 is not constrained by the clamp 40, to (ii) a closed position (shown in FIGS. 3 and 4) in which the lumen of the tubing 32 is at least partially constricted by the clamp 40.

[0025] FIG. 5A is a perspective view of a flexible clamp of a sliding flow controller according to some embodiments of the present disclosure. As depicted, the upper section 41 of the flexible clamp 40 may include an upper arm 42 that mounts the flexible clamp 40 within the upper housing 10. In particular, the upper arm 42 may be in the form of a longitudinally extending body including a pair of tethering contact members 44 that tether the upper arm 42 within the upper housing 10. In particular, the tethering contact members 44 may be located at opposite ends of the upper arm 42 with the longitudinally extending body connecting the tethering contact members 44 to one another. As depicted, the tethering contact member 44 may have a square shape. However, various embodiments of the present disclosure are not limited to the foregoing configuration. In other embodiments, the tethering contact member 44 may have a rectangular or other suitable polygonal shape capable of retaining or otherwise restraining the upper arm within the upper housing 10. In particular, because the upper arm is retained or otherwise constrained within the upper housing, movement or translation of the upper housing 10 results in corresponding movement of the flexible clamp 40 relative to the lower housing. The lower section 43 of the flexible clamp 40 may include a lower arm 46 in the form of a longitudinally extending body disposed within the lower housing 20. As the upper housing 10 translates or otherwise slides relative to the lower housing 20, the lower arm 46 also translates and slides against the sloped surface of the lower housing, thereby causing the lower arm 46 to pivot or otherwise rotate toward the upper arm 42 to pinch the tube 32 and constrict the lumen of the tube to adjust or otherwise selectively restrict the amount of fluid flowing through the tube 32. Thus, the tube 32 may be a low durometer tube that can be deflected or otherwise pinched or compressed by the flexible clamp 40. For example, the geometry and properties of the tubing (durometer, inner diameter, outer diameter, concentricity) can be adjusted and the body of the sliding flow controller can be tailored to work specifically with the tubing so that the expected flow rate can be predicted given the degree of actuation.

[0026] FIG. 5B is a perspective view of the flexible clamp of FIG. 5A with the inner tube 32 received therein, according to some embodiments of the present disclosure. FIG. 5C shows a top view of the flexible clamp of FIG. 5A with the inner tube 32 received therein, according to some embodiments of the present disclosure. With reference to FIGS. 5B and 5C, the flexible clamp 40 may further include a flexible guide member 48 connecting the upper arm 42 and the lower arm 46 to one another. In particular, as depicted, the flexible guide member 48 may include a pair of hinge arms 49 extending from the upper arm 43 to the lower arm 46, respectively. In some embodiments, each of the hinge arms 49 may be in the form of a curved body having a hinge portion 45 about which the lower arm 46 pivots or rotates toward the upper arm 42 as the upper housing translates or slides relative to the lower housing 20. As depicted, the hinge arms 49 may be spaced apart to define an opening 47 through which the tube 32 may extend. For example, the tube 32 may extend through the hinge arms 49 of the guide member 48, thereby allowing the tube 32 to be oriented perpendicular to the flexible clamp 40.

[0027] Thus, when upper housing 10 translates or slides relative to lower housing 20, lower arm 46 translates and slides relative to lower housing inclined surface 22, causing hinge arms 49 to flex inward and move lower arm 46 toward upper arm 42. Thus, tube 32 may be pinched or otherwise compressed as the lower arm pivots or rotates toward upper arm 42. As such, the portion of the lumen of tube 32 that extends through opening 47 may be pinched to reduce fluid flow through tube 32.

[0028] In some embodiments, at least one of the upper arm 42 and the lower arm 46 may have a friction-reducing surface. For example, at least one of the upper arm 42 and the lower arm 46 may be polished or may be coated or otherwise formed with a friction-reducing material (e.g., grease, oil, smooth plastic, etc.). Thus, as the upper housing moves relative to the lower housing 20, the lower arm 46 may easily translate and slide relative to the inclined surface 22 of the lower housing without frictional delay or otherwise resisting its movement.

[0029] 6 and 7 are perspective views of an upper housing and a flexible clamp of a sliding flow controller according to some embodiments of the present disclosure, respectively.

[0030] According to some embodiments, upper housing 10 may include a pair of mounting openings 17 positioned axially opposite one another at a distance corresponding to opposite ends of upper arm 42. Thus, in an assembled state of flow controller 100 with flexible clamp 40 mounted within upper housing 10, captive contact 44 is mounted within opening 17. As such, upper arm 42 is captively held within upper housing 10 and prevented from tilting or otherwise rotating about the central longitudinal axis of the cylindrical body of upper arm 42.

[0031] FIG. 8 is a perspective view of the top of an upper housing of a sliding flow controller according to some embodiments of the present disclosure. FIG. 9 is a perspective view of the bottom of an upper housing of a sliding flow controller according to some embodiments of the present disclosure. With continued reference to FIGS. 6 and 7 , and with reference to FIGS. 8 and 9 , the upper housing 10 can have a proximal surface 18 and a distal surface 23. Accordingly, the upper housing 10 can extend longitudinally from the proximal surface 18 to the distal surface 23. As depicted, the proximal surface 18 can include an upper protrusion 14, a lower protrusion 19, and a groove 13 defined between the upper protrusion 14 and the lower protrusion 19. The lower protrusion 14 can extend longitudinally from the proximal surface 18 to the distal surface 23. As will be described in further detail below, the lower protrusion 19 can interact with and be slidably disposed in a corresponding guide groove 24 of the lower housing 20. The lower protrusion 19 can have an upper surface 9 and a lower surface 11. 8 and 9, the upper surface 9 and the lower surface 11 may have respective friction-increasing surfaces. For example, the upper surface 9 and the lower surface 11 may have textured surfaces such as roughened surfaces 34 and 36 to increase friction between the upper surface 9 and the lower surface 11 and the guide groove 24 of the lower housing. The above-described configuration is advantageous in preventing unintended actuation of the sliding flow controller 100 (i.e., sliding of the upper housing 10 relative to the lower housing 20).

[0032] 10A-12B are perspective views of a lower housing of a sliding flow controller according to some embodiments of the present disclosure. Like the upper housing, the lower housing can include a proximal surface 26 and a distal surface 30. As depicted, the lower housing can extend longitudinally from the proximal surface 26 to the distal surface 30. A guide groove 24 can be defined along the length of the lower housing 20, extending from the proximal surface 26 to the distal surface 30. As described above, the lower protrusion 19 can be slidably mounted in the guide groove 24 to allow the upper housing 10 to slide relative to the lower housing 20. In some embodiments, as described above, the lower housing 20 can have a surface 22 that defines a portion of a cavity on the second side of the tube 32. As depicted, the second surface 22 can be an inclined surface. In operation, as the upper housing 10 moves or slides linearly relative to the lower housing 20, the lower arm 46 of the flexible clamp 40 also slides along the inclined surface 22. Because the inclined surface 22 is angled, as the flexible clamp 40 moves or otherwise slides toward the distal face 30 of the lower housing 20, the lower arm 46 flexes, pivots, or otherwise deflects upward a distance corresponding to the vertical component of the gradient or slope of the inclination angle. As the lower arm 46 is deflected upward toward the upper arm 42, the tube 32 is pinched and compressed between the upper arm 42 and the lower arm 46, reducing or otherwise blocking and stopping the flow of medical fluid through the lumen of the tube 32.

[0033] According to various embodiments of the present disclosure, the upper surface 37 of the lower housing 20 can include a first section 27, a second section 39, and a transition step 29 between the first section 27 and the second section 39. The transition step 29 can include a lower end 29A and an upper end 29B. As depicted, the first section 27 can extend from the proximal surface 26 of the lower housing 20 to the lower end 29A of the transition step 29, and the second section 39 can extend from the upper end 29B of the transition step 29 to the distal surface 30 of the lower housing 20. Thus, as shown in FIGS. 10A and 10B , the second section 39 can be elevated above the first section 27 by a distance corresponding to the height of the transition step 29. In some embodiments, the transition stage 29 can be a stop surface such that, in the closed state of the sliding flow controller 100, the upper protrusion 14 of the upper housing 10 abuts the stop surface 29, thereby limiting further distal movement of the upper housing 10 relative to the lower housing 20. In particular, the upper protrusion can include an interface surface 12 that contacts the stop surface 29 when the upper housing 10 reaches the fully closed (0 ml / hr) position.

[0034] The stop surface 29 may be configured to limit movement of the upper housing 10 relative to the lower housing 20 to provide a tactile indication that the upper housing 10 has reached the closed position of FIG. 3 and / or to lock or hold the upper housing 10 in the closed position until an opening force or pressure is applied to move the upper housing 10 toward the proximal surface 26 of the lower housing 20. Although the stop surface 29 is shown in the form of a transition step 29, the stop surface 29 may be provided in other locations or using other structural forms. For example, the stop surface 29 may be embodied by complementary structures on the upper and lower housings 10 and 20 that interact (e.g., snap together, abut, and / or otherwise interact) to stop movement of the upper housing 10 and lock the sliding flow controller 100 in the closed configuration.

[0035] According to various embodiments of the present disclosure, the proximal surface 26 of the lower housing 20 may have a proximal stop surface 25 extending across at least a portion of the guide groove 24 at the proximal surface 26 of the lower housing 20. In particular, as shown, the proximal stop surface 25 may be in the form of a sloped surface that is angled inward (i.e., distally toward the stop surface 29). Thus, as shown in FIG. 1 , in the fully open state of the sliding flow controller 100, the lower protrusion 19 of the upper housing 10 abuts the stop surface 25, thereby limiting further proximal movement of the upper housing 10 relative to the lower housing 20. In particular, the proximal stop surface 25 may include an interface surface 25A that contacts the lower protrusion 19 when the upper housing 10 reaches the fully open position.

[0036] Thus, similar to stop surface 29, proximal stop surface 25 may be configured to limit movement of upper housing 10 relative to lower housing 20 to provide a tactile indication that upper housing 10 has reached the fully open position of FIG. 1 and / or to lock or hold upper housing 10 in the open position until a closing force or pressure is applied to move upper housing 10 distally toward stop surface 29 on lower housing 20. Although stop surface 29 is shown as being in the form of an inclined surface 25, stop surface 25 may be provided in other locations or using other structural forms. For example, stop surface 25 may be embodied by complementary structures on upper housing 10 and lower housing 20 that interact (e.g., snap-fit, abut, and / or otherwise interact) to stop movement of upper housing 10 and lock sliding flow controller 100 in the fully open configuration.

[0037] According to various embodiments of the present disclosure, the guide groove 24 may include at least one friction-increasing surface. For example, as shown in FIGS. 11A and 11B, the guide groove 24 may include a first friction-increasing surface 21. In some embodiments, as shown in FIGS. 12A and 12B, the guide groove 24 may include an additional or second friction-increasing surface 35. For example, similar to the textured or roughened surface 34 or 36 of the upper housing 10, the friction-increasing surfaces 21 and 35 may be textured or roughened to increase friction between the upper surface 9 and the lower surface 11 and the guide groove 24 of the lower housing 20, respectively. The above-described configuration is advantageous in preventing unintended actuation of the sliding flow controller 100 (i.e., sliding of the upper housing 10 relative to the lower housing 20).

[0038] 13A is a cross-sectional view of the lower housing 20 of a sliding flow controller 100 according to some embodiments of the present disclosure. As depicted, the inclined surface 22 may include a first inclined section 28A having a first inclination angle and a second inclined section 28B having a second inclination angle different from the first inclination angle. In some embodiments, the inclination angle of the first inclined section 28A may be greater than the inclination angle of the second inclined section 28B. For example, as depicted, the gradient or slope of the first inclined section 28A may be steeper or greater than the gradient or slope of the second inclined section 28B. In some embodiments, the gradient angle of the first inclined section 28A may be steeper or greater than the gradient or slope of the second inclined section 28B to adjust the fluid flow through the tube 32 at a higher fluid flow range of the sliding flow controller 100. For example, the slope angle of first sloped section 28A may be configured to adjust the flow through tubing 32 in a region of higher fluid flow rates (e.g., between fully open and 80 ml / hr flow rate markings). Similarly, the slope angle of second sloped section 28B may be configured to be flatter or smaller than the slope angle of first section 28 to adjust the fluid flow through tubing 32 in a lower fluid flow range of sliding type flow controller 100. For example, the slope angle of second sloped section 28B may be configured to adjust the flow through tubing 32 between fully closed (0 ml / hr) and 80 ml / hr flow rate markings.

[0039] As explained above, the non-linear inclined surface 22 of the lower housing, having multiple inclined sections 28A and 28B with various inclination angles, can be configured such that the inclination angle in high-flow regions is higher than the inclination angle in low-flow regions. Thus, when operating in high-flow regions, the rate of tube closure occurs more quickly than when operating in low-flow regions. As such, the inclination angle of the first inclined section 28A and the inclination angle of the second inclined section 28B can be adjusted relative to the tube geometry so that the actuation required to set a low flow rate uses only a few millimeters of actuation.

[0040] 13B illustrates the friction-reducing surface of the inclined surface 22 of the lower housing 20. According to various embodiments of the present disclosure, the inclined surface 22 may have a friction-reducing surface. For example, the inclined surface 22 may be polished or may be coated or otherwise formed with a friction-reducing material (e.g., grease, oil, smooth plastic, etc.). Thus, as the upper housing moves relative to the lower housing 20, the lower arm 46 may easily translate and slide relative to the inclined surface 22 of the lower housing 20 without frictional delay or otherwise resisting its movement.

[0041] 14A-14E illustrate the assembly of the upper housing 10, flexible clamp 40, and lower housing 20 of a sliding flow controller 100 in a fully open position, according to some embodiments of the present disclosure. FIG. 14A is a perspective view of the assembly of the upper housing, flexible clamp, and lower housing of the sliding flow controller in a fully open position, according to some embodiments of the present disclosure. FIG. 14B is a cross-sectional view of the assembly of the upper housing, flexible clamp, and lower housing of FIG. 14A, according to some embodiments of the present disclosure. In the example of FIGS. 14A and 14B, the flow controller 100 is shown in a fully open configuration, with the upper housing 10 positioned in an open position where the tubing 32 (not shown to facilitate viewing of the interconnections of the components of the assembly) is not compressed. As depicted, in the fully open position, the flexible clamp 40 is positioned with its lower arm 46 on the first angled section 28A of the lower housing 20. In the fully open position, the flexible clamp 40 may be in the undeflected or uncompressed state shown in Figure 14B.

[0042] In operation, in response to pressure from a user exerted directly on the exterior surface of the upper housing 10, the upper housing 10 may translate or slide relative to the lower housing 20. In response, the lower arm 46 may translate and slide against the first angled section 28A toward the second angled section 28B of the lower housing 20, causing the hinge arm 49 to flex radially inward and move the lower arm 46 toward the upper arm 42. Thus, the tube 32 may be pinched or otherwise compressed as the lower arm 46 pivots or rotates toward the upper arm 42. As such, a portion of the lumen of the tube 32 (shown in FIG. 5B ) extending through the opening 47 in the guide member 48 may be pinched to reduce fluid flow through the tube 32.

[0043] 14A and 14B to a partially open position in which a portion of the tubing 32 (not shown for clarity in viewing the interconnection of the components of the assembly) may be partially compressed by the flexible clamp 40 between the upper housing 10 and the lower housing 20. As the upper housing 10 translates or otherwise slides further relative to the lower housing 20, the lower arm 46 similarly translates and slides against the second angled section 28B of the lower housing, thereby further pivoting or otherwise rotating the lower arm 46 toward the upper arm 42 to further pinch the tubing 32 and further constrict the lumen of the tubing 32 to regulate or otherwise selectively restrict the amount of fluid flowing through the tubing 32.

[0044] 14D is a perspective view of an upper housing, flexible clamp, and lower housing assembly of a sliding flow controller in a closed state, according to some embodiments of the present disclosure. FIG. 14E is a cross-sectional view of the upper housing, flexible clamp, and lower housing assembly of FIG. 14D, according to some embodiments of the present disclosure. In operation, as the upper housing 10 translates or otherwise slides further distally relative to the lower housing 20, the lower arm 46 similarly translates and slides further distally against the second angled section 28B of the lower housing, thereby further pivoting or otherwise rotating the lower arm 46 toward the upper arm 42, further pinching the tube 32 and fully constricting the lumen of the tube 32, preventing fluid from flowing through the tube 32.

[0045] As previously mentioned, stop surface 29 (shown in FIGS. 10A-13A ) may limit movement of upper housing 10 relative to lower housing 20 and provide a tactile indication that upper housing 10 has reached the closed position of FIG. 14D . Stop surface 29 may also lock or hold upper housing 10 in the closed position until an opening force or pressure is applied to move upper housing 10 proximally toward proximal face 26 of lower housing 20.

[0046] Thus, the upper housing 10 may be slidable relative to the lower housing 20 and may be linearly movable (e.g., slidable) between (i) an open position, shown in FIGS. 14A and 14B , in which the tubing 32 cannot be compressed within the opening 47 of the guide member 48, and (ii) a closed position, shown in FIGS. 14D and 14E , in which the tubing 32 is linearly spaced from the open position and the tubing 32 is compressed between the upper and lower arms 42, 46 of the flexible clamp, thereby stopping the flow of medical fluid therethrough. As such, the sliding flow controllers of the various embodiments described herein advantageously provide improved fluid flow performance compared to currently existing roller clamp flow controllers. In particular, as the upper housing 10 moves distally relative to the lower housing 20 and the lower arm 46 of the flexible clamp 40 is flexed, rotated, or otherwise pivoted toward the upper arm 42, the low durometer inner tubing progressively compresses, thereby reducing fluid flow therethrough.

[0047] According to various embodiments of the present disclosure, the linearly slidable upper housing 10 is continuously slidable between an open position of Figures 14A and 14B and a closed position of Figures 14D and 14E. Each intermediate position of the linearly slidable upper housing 10 between the open and closed positions can be associated with an intermediate compression of the tubing 32 between the upper and lower arms 42, 46 of the flexible clamp to set a corresponding intermediate flow rate through the tubing, as shown in Figure 14C.

[0048] Thus, the sliding flow controllers of the various embodiments described herein offer several advantages over currently existing roller clamp flow controllers, as detailed below.

[0049] In particular, a common problem with current roller clamps is that fluid flow rates are difficult to adjust at low flow rates (below approximately 45 ml / hr). Often, the roller wheel must move several millimeters along the roller clamp body to adjust a flow rate from fully open to 150 ml / hr, while adjustments between 45 ml / hr and 25 ml / hr require barely noticeable movement of the roller wheel. The sliding flow controllers described herein offer increased usability (ease of use) across a range of clinically relevant flow rates compared to current roller clamps. For example, in some embodiments, the sliding flow controller can be designed so that several millimeters of actuation are required to adjust fluid flow at high flow rates, as well as several millimeters of actuation to adjust fluid flow at low flow rates. Accordingly, the sliding flow controllers of various embodiments described herein enhance flow rate adjustment at both low and high flow rates by featuring a non-linear sloped surface on the lower housing. The non-linear sloped surface on the lower housing features a range of slope angles that are specifically tailored for various ranges of flow rates. A few millimeters of movement of the upper housing relative to the lower housing may be required to adjust for either low or high flow ranges.

[0050] Furthermore, a common problem with current roller clamps is that the roller wheels are often small and knurled, and the small wheel geometry and knurling can concentrate excessive and / or prolonged pressure on the clinician's thumb. Therefore, clinicians can experience thumb fatigue and pain from shifting their work from operating the roller clamp multiple times, especially when the IV tubing has a relatively high durometer. The sliding flow controller described herein has superior ergonomic characteristics to current roller clamps, thereby enhancing clinician comfort. For example, as described above, a clinician can operate the sliding flow controller by either sliding the upper and lower housings together to open the flow or apart to close the flow. The overall dimensions of the sliding flow controller are similar to current flow controllers (e.g., the roller clamp flow controller described above) and fit easily in the hand. As such, the sliding flow controller can be actuated with one hand, gripping the entire surface of the upper and lower housings during actuation, rather than just the top of the wheel face characteristic of current roller clamps. Because the sliding flow controller has a larger surface area to grip during actuation, its ergonomics are superior to current roller clamps.

[0051] Additionally, current roller clamps are often designed to fit a range of IV tubing inner and outer diameters. Tubing position is also not strictly constrained within the roller clamp body. The combination of variations in where the tubing is positioned within the roller clamp body groove and multiple tubing geometries results in variations in wheel position along the roller clamp body when setting a given flow rate. Due to variations in wheel position, current roller clamps cannot have any features or markings that indicate the flow rate for a given wheel position along the roller clamp body. Setting a given flow rate using a sliding flow controller is intentionally repeatable, and the sliding flow controller has a feature (gradation mark) that indicates the flow rate setting.

[0052] Additionally, the sliding flow controllers of various embodiments described herein are intentionally more reproducible because the slope angle of the non-linear sloped surface is tailored for use with low durometer tubing of a specific diameter. Because the tubing geometry and properties (durometer, inner diameter, outer diameter, concentricity) can be adjusted and the upper and lower housings (i.e., bodies) of the sliding flow controller can be tailored to work specifically with the desired tubing, the expected flow rate for a given degree of actuation can be more easily predicted.

[0053] The sliding flow controllers described herein also feature tube guide members for maintaining and holding the tubing perpendicular to the lower and upper tube-pinching arms of the flexible clamp. Because the low-durometer inner tubing geometry can be adjusted and the tubing position within the upper and lower arms of the flexible clamp can be adjusted, the amount of tubing pinched (and therefore fluid flow rate) given an actuation amount is reproducible. To this effect, the sliding flow controllers can feature markings that can be used to assist clinicians in quickly adjusting the fluid flow rate as desired.

[0054] In one or more embodiments of the present disclosure, a flow controller having an internal tube includes an upper housing including a plurality of graduations, a lower housing engaging with and slidably coupled to the lower housing, a cavity defined between the upper and lower housings for receiving at least a portion of the internal tube, and a flexible clamp having an upper section mounted within the upper housing and a lower section slidably disposed within the lower housing, the upper and lower housings slidably coupled to one another, and the flexible clamp transitioning the internal tube from (i) an open position in which the internal lumen of the tube is not constricted by the flexible clamp to (ii) a closed position in which the internal lumen of the internal tube is at least partially constricted by the flexible clamp.

[0055] In an embodiment of the present disclosure, the upper section of the flexible clamp has an upper arm, and the lower section has a lower arm, and the flexible clamp further has a flexible guide member connecting the upper and lower arms to each other. In an embodiment of the present disclosure, the upper arm has a pair of mooring contact members respectively disposed at opposite ends of the upper arm, and the upper housing further has a pair of mounting openings positioned axially opposite each other at a distance corresponding to the opposite ends of the upper arm, and the mooring contact members are each mounted in the respective mounting openings. In an embodiment of the present disclosure, the upper and lower arms each have a cylindrical, longitudinally extending body, the cylindrical, longitudinally extending body of the upper arm connecting the mooring contact members to each other, the cylindrical, longitudinally extending body of the lower arm being slidably mounted within the lower housing, and the flexible guide member has a pair of hinge arms, each hinge arm connecting the cylindrical, longitudinally extending bodies of the upper and lower arms to each other.

[0056] In an embodiment of the present disclosure, the hinge arms are spaced apart to define an opening through which the inner tube extends. In an embodiment of the present disclosure, the upper housing has a first surface defining a portion of a cavity on a first side of the tube, and the lower housing has a second surface defining a portion of a cavity on a second side of the tube, the second surface being an inclined surface. In an embodiment of the present disclosure, the inclined surface has a first inclined section having a first inclination angle and a second inclined section having a second inclination angle different from the first inclination angle. In an embodiment of the present disclosure, the first inclination angle is greater than the second inclination angle. In an embodiment of the present disclosure, the upper housing has a proximal surface and a distal surface, the upper housing extending longitudinally from the proximal surface to the distal surface, the proximal surface having an upper protrusion, a lower protrusion, and a groove defined between the upper and lower protrusions, the lower protrusion extending longitudinally from the proximal surface to the distal surface.

[0057] In an aspect of the disclosure, the lower housing has proximal and distal surfaces, where the lower housing extends longitudinally from the proximal surface to the distal surface, and a guide groove extending from the proximal surface to the distal surface, where the lower protrusion is slidably mounted within the guide groove to move the upper housing relative to the lower housing. In an aspect of the disclosure, the upper surface of the lower housing has a first section, a second section, and a transition step between the first and second sections, the transition step having a lower end and an upper end, the first section extending from the proximal surface of the lower housing to the lower end of the transition step, and the second section extending from the upper end of the transition step to the distal surface of the lower housing.

[0058] In an embodiment of the present disclosure, the second section is elevated above the first section by a distance corresponding to the height of the transition step, the transition step having a stop surface, and in a closed state of the flow controller, the upper protrusion of the upper housing abuts the stop surface. In an embodiment of the present disclosure, the proximal surface of the lower housing has a proximal stop surface extending across at least a portion of the guide groove at the proximal surface of the lower housing, and in an open state of the flow controller, the lower protrusion of the upper housing abuts the proximal stop surface. In an embodiment of the present disclosure, the inner tube comprises low durometer tubing, and the flow controller further has a pair of Luer fittings disposed on opposite ends of the tubing to connect the inner tube to intravenous (IV) set tubing.

[0059] In one or more embodiments of the present disclosure, a flow controller for intravenous (IV) tubing includes an upper housing including a plurality of graduations; a lower housing having an inclined surface and slidably coupled to the upper housing; a flexible clamp mounted within the upper housing and extending into the lower housing; and a flexible inner tube disposed within a cavity defined between the upper and lower housings and extending through a guide portion of the flexible clamp, the upper housing configured to slide relative to the lower housing such that the flexible clamp compresses a portion of the flexible inner tube.

[0060] In an embodiment of the present disclosure, a pair of Luer connectors that connect the flexible inner tube to the IV tubing are disposed on opposite ends of the flexible tubing. In an embodiment of the present disclosure, the inclined surface has a first section having a first inclination angle and a second section having a second inclination angle that is smaller than the first inclination angle. In an embodiment of the present disclosure, the upper housing has a proximal surface and a distal surface, the upper housing extending longitudinally from the proximal surface to the distal surface, the proximal surface having an upper protrusion, a lower protrusion, and a groove defined between the upper protrusion and the lower protrusion, the lower protrusion extending longitudinally from the proximal surface to the distal surface.

[0061] In an embodiment of the present disclosure, the lower housing has proximal and distal surfaces extending longitudinally from the proximal surface to the distal surface, and a guide groove extending from the proximal surface to the distal surface, wherein a lower protrusion is slidably mounted within the guide groove to move the upper housing relative to the lower housing. In an embodiment of the present disclosure, at least one of the lower protrusion and the guide groove has at least one friction-increasing surface. In an embodiment of the present disclosure, the flexible clamp has an upper arm mounted within the upper housing and a lower arm having a friction-reducing surface extending into the lower housing to engage the ramped surface. In an embodiment of the present disclosure, the proximal surface of the lower housing has a proximal stop surface extending across at least a portion of the guide groove at the proximal surface of the lower housing, and the lower protrusion of the upper housing abuts the proximal stop surface when the flow controller is in an open state.

[0062] The subject technology is illustrated, for example, in accordance with the various aspects described above. This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. This 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 may be applied to other aspects.

[0063] Reference to an element in the singular is intended to mean "one or more," not "one and only one," unless specifically stated so. The term "some" refers to one or more, unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter (e.g., her and its), and vice versa. Headings and subheadings, if any, are used merely for convenience and do not limit the invention.

[0064] 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 described herein may be considered at least equivalent.

[0065] As used herein, the phrase "at least one of," following a list of items, when followed by the word "or" separating any of those items, modifies the list as a whole and not each item in the list. The phrase "at least one of" does not require the selection of at least one item; rather, the phrase allows for the inclusion of at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. Illustratively, the phrase "at least one of A, B, or C" can refer to A only, B only, or C only, or any combination of A, B, and C.

[0066] The use of a phrase such as "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure of an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. A phrase such as "aspect" may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. Disclosure of an embodiment may apply to all embodiments or one or more examples. An embodiment may provide one or more examples. A phrase such as "embodiment" may refer to one or more examples, and vice versa. A phrase such as "configuration" does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. Disclosure of a configuration may apply to all configurations or one or more configurations. A configuration may provide one or more instances. A phrase such as a configuration may refer to one or more configurations, and vice versa.

[0067] In one aspect, unless otherwise stated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications set forth herein, including those in the claims that follow, are approximate and not exact, and are intended to have a reasonable range consistent with the function to which they relate and the practice in the art to which they pertain.

[0068] It is understood that the specific order or hierarchy of steps or acts in any disclosed process or method is an illustration of a sample approach. It is understood that based on implementation priorities or scenarios, the specific order or hierarchy of steps, acts, or processes may be rearranged. Some of the steps, acts, or processes may be performed simultaneously. In some implementation priorities or scenarios, certain acts may or may not be performed. Some or all of the steps, acts, or processes may be performed automatically, without user intervention. The method claims may be provided to present elements of the various steps, acts, or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0069] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those skilled in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for" or, in the case of a method, the element is recited using the phrase "step for." Moreover, to the extent terms such as "include," "have," and the like are used, such terms are intended to be inclusive in the same manner as the term "comprise," as "comprise" would be interpreted when used as a transitional phrase in a claim.

[0070] The title, background art, summary of the invention, and brief description of the drawings of this disclosure are hereby incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description of the disclosure. This disclosure is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. Furthermore, in the detailed description, it will be appreciated that the description provides exemplary illustrations and that various features have been grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in any claim. Rather, as the appended claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation.

[0071] The claims are not intended to be limited to the embodiments described herein, but are to be accorded full scope consistent with the language of the claims and encompass all legal equivalents. However, none of the claims are intended, and should not be construed, to encompass subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. 1. A flow controller having an internal tube, an upper housing including a plurality of scales; a lower housing engaged with and slidably coupled to the lower housing; a cavity defined between the upper housing and the lower housing for receiving at least a portion of the inner tube; a flexible clamp having an upper section mounted within the upper housing and a lower section slidably disposed within the lower housing, the upper and lower housings slidably coupled to one another to transition the inner tube from (i) an open position in which the lumen of the tube is not compressed by the flexible clamp to (ii) a closed position in which the lumen of the inner tube is at least partially constricted by the flexible clamp; A flow controller having:

2. 2. The flow controller of claim 1, wherein the upper section of the flexible clamp has an upper arm and the lower section has a lower arm, the flexible clamp further comprising a flexible guide member connecting the upper arm and the lower arm to one another.

3. the upper arm having a pair of anchoring contact members disposed at opposite ends of the upper arm; 3. The flow controller of claim 2, wherein the upper housing further includes a pair of mounting openings positioned axially opposite one another at a distance corresponding to the opposite ends of the upper arm, and wherein each of the captive contact members is mounted within a respective one of the mounting openings.

4. the upper arm and the lower arm each have a cylindrically shaped longitudinally extending body; the cylindrical longitudinally extending body of the upper arm connects the tether contact members to one another; the cylindrical longitudinally extending body of the lower arm is slidably mounted within the lower housing; 4. The flow controller of claim 3, wherein the flexible guide member has a pair of hinge arms, each of the hinge arms connecting the cylindrical longitudinally extending bodies of the upper and lower arms to one another.

5. 5. The flow controller of claim 4, wherein the hinged arms are spaced apart to define an opening, the inner tube extending through the opening.

6. 3. The flow controller of claim 2, wherein the upper housing has a first surface defining a portion of the cavity on a first side of the tube, and the lower housing has a second surface defining a portion of the cavity on a second side of the tube, the second surface being an inclined surface.

7. 7. The flow controller of claim 6, wherein the inclined surface has a first inclined section having a first inclined angle and a second inclined section having a second inclined angle different from the first inclined angle.

8. 8. The flow controller of claim 7, wherein the first tilt angle is greater than the second tilt angle.

9. 3. The flow controller of claim 2, wherein the upper housing has a proximal surface and a distal surface, the upper housing extending longitudinally from the proximal surface to the distal surface, the proximal surface having an upper protrusion, a lower protrusion, and a groove defined between the upper protrusion and the lower protrusion, the lower protrusion extending longitudinally from the proximal surface to the distal surface.

10. The lower housing includes: proximal and distal surfaces, the lower housing extending longitudinally from the proximal surface to the distal surface; a guide groove extending from the proximal surface to the distal surface, the lower protrusion slidably mounted within the guide groove, thereby moving the upper housing relative to the lower housing; 10. The flow controller of claim 9, comprising:

11. the upper surface of the lower housing has a first section, a second section, and a transition step between the first section and the second section; the transition stage has a lower end and an upper end; the first section extends from the proximal surface of the lower housing to the lower end of the transition step; The flow controller of claim 10 , wherein the second section extends from the upper end of the transition stage to the distal face of the lower housing.

12. 12. The flow controller of claim 11, wherein the second section is raised above the first section by a distance corresponding to a height of the transition step, the transition step having a stop surface against which the upper protrusion of the upper housing abuts when the flow controller is in a closed state.

13. 11. The flow controller of claim 10, wherein the proximal surface of the lower housing has a proximal stop surface extending across at least a portion of the guide groove at the proximal surface of the lower housing, and wherein the lower protrusion of the upper housing abuts the proximal stop surface when the flow controller is in an open state.

14. 10. The flow controller of claim 1, wherein the inner tubing comprises low durometer tubing, and the flow controller further comprises a pair of Luer fittings disposed on opposite ends of the tubing to connect the inner tubing to intravenous (IV) set tubing.

15. 1. A flow controller for intravenous (IV) tubing, comprising: an upper housing including a plurality of scales; a lower housing having an inclined surface and slidably coupled to the upper housing; a flexible clamp mounted within the upper housing and extending into the lower housing; a flexible inner tube disposed within a cavity defined between the upper housing and the lower housing, the flexible inner tube extending through a guide portion of the flexible clamp, the upper housing configured to slide over the lower housing, whereby the flexible clamp compresses a portion of the flexible tube; and A flow controller having:

16. 16. The flow controller of claim 15, further comprising a pair of luer connectors disposed on opposite ends of the flexible tubing, thereby connecting the flexible inner tubing to the IV tubing.

17. 16. The flow controller of claim 15, wherein the inclined surface has a first section having a first inclination angle and a second section having a second inclination angle less than the first inclination angle.

18. 16. The flow controller of claim 15, wherein the upper housing has a proximal surface and a distal surface, the upper housing extending longitudinally from the proximal surface to the distal surface, the proximal surface having an upper protrusion, a lower protrusion, and a groove defined between the upper protrusion and the lower protrusion, the lower protrusion extending longitudinally from the proximal surface to the distal surface.

19. The lower housing includes: proximal and distal surfaces, the lower housing extending longitudinally from the proximal surface to the distal surface; a guide groove extending from the proximal surface to the distal surface, the lower protrusion slidably mounted within the guide groove, thereby moving the upper housing relative to the lower housing; 20. The flow controller of claim 18, comprising:

20. 20. The flow controller of claim 19, wherein at least one of the lower protrusion and the guide groove has at least one friction-increasing surface.

21. 20. The flow controller of claim 18, wherein the flexible clamp has an upper arm mounted within the upper housing and a lower arm extending into the lower housing to engage the inclined surface, the lower arm having a friction-reducing surface.

22. 19. The flow controller of claim 18, wherein the proximal surface of the lower housing has a proximal stop surface extending across at least a portion of the guide groove at the proximal surface of the lower housing, and wherein the lower protrusion of the upper housing abuts the proximal stop surface when the flow controller is in an open state.