Slip flow controller

Abstract

A flow controller having an internal tubing is provided. The flow controller can include an upper housing having a plurality of graduations, a lower housing engaged with and slidably coupled to the lower housing, and a cavity defined between the upper housing and the lower housing for housing at least a portion of the internal tubing. The flow controller can further include a flexible clamp having an upper section mounted in the upper housing and a lower section slidably disposed in the lower housing. The upper housing and the lower housing can be slidably coupled relative to one another to transition the internal tubing from (i) an open position in which a lumen of the internal tubing is not compressed by the flexible clamp to (ii) a closed position in which the lumen of the tubing is at least partially pinched by the flexible clamp.

Description

TECHNICAL FIELD

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

[0002] Intravenous (IV) administration sets for infusing medical fluids, sometimes referred to simply as IV sets, generally include IV tubing for coupling a medical fluid container, such as an IV bag, to a patient interface, such as a catheter assembly for a patient. In some cases, gravity infusion of medical fluids uses gravity rather than an infusion pump to deliver the medical fluid through the IV set. Flow rate control through the tubing is generally provided by a roller clamp on the IV tubing. However, it is difficult to provide a desired flow rate using a roller clamp. SUMMARY

[0003] According to various embodiments of the present disclosure, a flow controller having an internal tube can include an upper housing including a plurality of graduations, a lower housing engaged with and slidably coupled to the lower housing, and a cavity defined between the upper housing and the lower housing for housing at least a portion of the internal tube. The flow controller can further include a flexible clamp having an upper section mounted in the upper housing and a lower section slidably disposed in the lower housing. The upper housing and the lower housing can be slidably coupled relative to one another to transition the internal tube from (i) an open position in which a lumen of the tube is not compressed by the flexible clamp to (ii) a closed position in which the lumen of the internal tube is at least partially pinched by the flexible clamp.

[0004] According to various embodiments of the present disclosure, a flow controller for an intravenous (IV) tube can include an upper housing including a plurality of graduations and a lower housing including a ramp surface and slidably coupled to the upper housing. The flow controller can further include a flexible clamp mounted in the upper housing and extending into the lower housing, and a flexible internal tube disposed in a cavity defined between the upper housing and the lower housing. The flexible tube can extend through a guide portion of the flexible clamp, and the upper housing can be configured to slide on the lower housing such that the flexible clamp compresses a portion of the flexible tube.

[0005] Additional advantages of the subject technology will be apparent from the detailed description that follows, taken in conjunction with the accompanying drawings, which illustrate, by way of example, certain aspects of the subject technology. As will be realized, the subject technology is capable of other and different BRIEF DESCRIPTION OF DRAWINGS

[0006] The following drawings are included to illustrate certain aspects of embodiments and are not be considered exclusive of one another. The disclosed subject matter can be modified, changed, combined and / or equivalents in form and function as will be apparent to those skilled in the art having the benefit of this disclosure.

[0007] Figure 1 depicts a perspective view of a sliding flow controller in an open position in accordance with some embodiments of the present disclosure.

[0008] Figure 2 is a cross-sectional view of a sliding flow controller in accordance with some embodiments of the present disclosure. Figure 1

[0009] Figure 3 depicts a perspective view of a sliding flow controller in a closed position in accordance with some embodiments of the present disclosure.

[0010] Figure 4 is a cross-sectional view of a sliding flow controller in accordance with some embodiments of the present disclosure. Figure 3

[0011] Figure 5A is a perspective view of a flexible clamp of a sliding flow controller in accordance with some embodiments of the present disclosure.

[0012] Figure 5B is a perspective view of a flexible clamp in accordance with some embodiments of the present disclosure, the flexible clamp having a tube received therein. Figure 5A

[0013] Figure 5C is a top view of a flexible clamp in accordance with some embodiments of the present disclosure, the flexible clamp having a tube received therein. Figure 5A

[0014] Figure 6 is a perspective view of an upper housing and a flexible clamp of a sliding flow controller in accordance with some embodiments of the present disclosure.

[0015] Figure 7 is a perspective view of a flexible clamp mounted to an upper housing in accordance with some embodiments of the present disclosure.

[0016] Figure 8 is a perspective view of a top face of an upper housing of a sliding flow controller in accordance with some embodiments of the present disclosure.

[0017] Figure 9 is a perspective view of a bottom face of an upper housing of a sliding flow controller in accordance with some embodiments of the present disclosure.

[0018] Figure 10A and 10B ​​​​is a perspective view of a lower housing of a sliding flow controller according to some embodiments of the present disclosure.

[0019] Figure 11A and 11B is a perspective view of a lower housing of a sliding flow controller according to some embodiments of the present disclosure.

[0020] Figure 12A and 12B is a perspective view of a lower housing of a sliding flow controller according to some embodiments of the present disclosure.

[0021] Figure 13A is a cross-sectional view of a lower housing of a sliding flow controller according to some embodiments of the present disclosure.

[0022] Figure 13B shows a friction-reducing surface of a ramp surface of a lower housing.

[0023] Figure 14A 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 state according to some embodiments of the present disclosure.

[0024] Figure 14B is a cross-sectional view of an assembly of an upper housing, a flexible clamp, and a lower housing of Figure 14A according to some embodiments of the present disclosure.

[0025] Figure 14C 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.

[0026] Figure 14D 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.

[0027] Figure 14E is a cross-sectional view of an assembly of an upper housing, a flexible clamp, and a lower housing of Figure 14D according to some embodiments of the present disclosure. DETAILED DESCRIPTION

[0028] 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 can provide details regarding certain aspects of the subject technology 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 can be shown in block diagram form, rather than in detail, in order to avoid obscuring the concepts of the subject technology.

[0029] It should be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the claims. Various aspects of the subject technology will now be disclosed, by way of specific but non-limiting examples. The various embodiments described in this disclosure can be implemented in different ways and with variations and according to desired applications or implementations.

[0030] 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 one of ordinary skill in the art that embodiments of the present disclosure can be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail in order not to obscure the present disclosure.

[0031] As used herein, the terms "tubing," "fluid line," and any variations thereof refer to medical tubing or tubing used to deliver a liquid, solvent, or fluid (including gas) to or from a patient receiving medical care. For example, a fluid line (tubing) can be used for intravenous (IV) delivery of a fluid, fluid removal, oxygen delivery, combinations thereof, and the like.

[0032] 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 coupled thereto.

[0033] During administration of an infusion therapy via a gravity IV set, a clinician will adjust the rate of medication delivery through a flow controller, such as a roller clamp or an in-line flow controller. A roller clamp adjusts the flow rate of medication by partially or completely occluding the tubing of the IV set. The IV tubing is occluded by pinching the tubing between a wheel manipulated by the clinician and an angled groove within the body of the roller clamp. An in-line flow controller adjusts the flow rate of medication as the medication flows through a tortuous path within the in-line flow controller. The clinician can adjust the flow rate by rotating the in-line flow controller, increasing or decreasing the flow rate of the medication as the length of the tortuous path within the in-line flow controller increases or decreases.

[0034] Various embodiments of the present disclosure are directed to a sliding flow controller including an upper housing including a plurality of graduations, a lower housing engaged with and slidably coupled to the lower housing, and a cavity defined between the upper housing and the lower housing for accommodating at least a portion of a tubing. The sliding flow controller can include a flexible clamp having an upper section mounted in the upper housing and a lower section slidably disposed in the lower housing. The upper housing and the lower housing can be slidably coupled relative to each other to transition the tubing from (i) an open position in which a lumen of the tubing is not compressed by the flexible clamp to (ii) a closed position in which the lumen of the tubing is at least partially pinched by the clamp.

[0035] In some aspects, a clinician can adjust a fluid flow rate in an IV tubing fluidically coupled to the tubing of the sliding flow controller by actuating the upper housing along the lower housing with a sliding motion. Fluid flow through the tubing occurs at zero actuation for full open, and at maximum actuation for full closed (0 ml / hr graduation). The clinician can set a given flow rate by actuating the sliding flow controller between the full open and full closed flow positions.

[0036] According to various aspects of the present disclosure, the sliding flow controller can operate to gradually pinch or constrict a lumen of an internal low durometer tubing as the upper housing linearly slides through the lower housing. To this end, a portion of the low durometer internal tubing can extend through the sliding flow controller. In some embodiments, a luer fitting is incorporated to each end of the low durometer internal tubing. An IV tubing can then be coupled to each luer fitting so as to fluidically couple the low durometer internal tubing with the IV tubing, whereby fluid can flow through the low durometer tubing within the sliding flow controller.

[0037] According to various embodiments of the present disclosure, the internal tubing can be positioned within a bore of a guide member of a pair of flexible clamps. As the upper housing slides distally relative to the lower housing, a multi-angled ramp surface of the lower housing engages a lower arm of the flexible clamp. An upper arm of the flexible clamp can be held captive (fixed) within the upper housing. During actuation, as the lower mounting arm pivots or rotates toward the upper arm, engagement of the multi-angled ramp surface of the lower housing with the flexible clamp forces the flexible clamp to close. This closing actuation causes the bore between the upper and lower arms to decrease, thereby pinching and constricting the lumen of the internal tubing and reducing fluid flow therethrough. Thus, when the upper housing translates proximally toward the proximal face of the lower housing, opening actuation of the sliding flow controller causes the bore between the upper and lower arms to increase, thereby increasing fluid flow.

[0038] According to some embodiments, the angle of inclination of the multi-angled ramp surface can be adjusted to the internal tubing dimensions such that multiple millimeters of actuation can be required to adjust flow rates in a high flow rate range, and multiple millimeters of actuation can be required to adjust flow rates in a low flow rate range. For example, in some embodiments, the angle of inclination of the first ramp section of the lower housing can be greater than the angle of inclination of the second ramp section of the lower housing. Accordingly, the sliding flow controllers of the various embodiments described herein provide several advantages over current existing roller clamp-based flow controllers, as detailed below.

[0039] In particular, a common problem with current roller clamps is that at low flow rates (about 45 ml / hr and below), fluid flow rates are difficult to adjust. Typically, the roller wheel must be moved several millimeters along the roller clamp body to adjust the flow rate from fully open to 150 ml / hr, while adjusting from 45 ml / hr to 25 ml / hr requires almost imperceptible movement of the roller wheel. In contrast to current roller clamps, the sliding flow controllers described herein have increased usability (ease of use) over a clinically relevant flow rate range. For example, in some embodiments, the sliding flow controllers can be designed such that multiple millimeters of actuation are required to adjust fluid flow at high flow rates, and multiple millimeters of actuation are also required to adjust fluid flow at low flow rates. Accordingly, the sliding flow controllers of the various embodiments described herein improve flow rate adjustability at low flow rates and high flow rates by featuring non-linear ramp surfaces in the lower housing. The non-linear ramp surfaces of the lower housing feature a range of ramp angles that are specifically tuned for different flow rate ranges. Several millimeters of actuation of the upper housing relative to the lower housing can be required to make adjustments in a low flow rate or high flow rate range.

[0040] Further, a common problem with current roller clamps is that the roller wheels are typically small and knurled, and the small wheels with knurling over concentrate and / or long periods of time concentrate pressure on the clinician's thumb. As a result, the clinician can experience thumb fatigue and soreness from the multiple actuations of the roller clamp through their work shift, especially if the IV tubing has a relatively high durometer. The sliding flow controller described herein has better ergonomic properties than current roller clamps, thereby improving the comfort of the clinician. For example, as previously described, the clinician can actuate the sliding flow controller by sliding the upper and lower housings together to open the flow or sliding the upper and lower housings apart to close the flow. The overall size of the sliding flow controller is similar to current flow controllers (e.g., the previously mentioned roller clamp-based flow controllers), and it is easily held in the hand. As such, the sliding flow controller can be actuated with one hand, and the entire surface of the upper and lower housings can be grasped during actuation, rather than just the top of the wheel surface as is characteristic on current roller clamps. Because the sliding flow controller has a greater grasping surface area than the roller clamp during actuation, its ergonomics are superior to current roller clamps.

[0041] Further, current roller clamps are typically designed to be compatible over a range of inner and outer diameters of IV tubing. The tubing position is also not tightly constrained within the body of the roller clamp. Combining the variety of tubing geometries with the variation in positioning of the tubing within the groove of the roller clamp body results in variation in the wheel position along the roller clamp body when setting a given flow rate. Because of the variation in wheel position, current roller clamps cannot have any features or indicia to indicate the flow rate at a given wheel position along the roller clamp body. Setting a given flow rate with the sliding flow controller is repeatable by design, and there are features (graduations) on the sliding flow controller that indicate the flow rate setting.

[0042] Further, the sliding flow controller of the various embodiments described herein improves repeatability by design because the angle of inclination of the non-linear ramp surface is tailored for use with a particular diameter of low durometer tubing. The sliding flow controller described herein also has features of a tubing guide member to maintain the tubing orientation and maintain the lower and upper arms of the flexible clamp that clamp the tubing perpendicularly. Because the geometry of the low durometer inner tubing can be controlled, and the tubing position within the upper and lower arms of the flexible clamp can be controlled, the amount that the tubing is clamped (and thus the fluid flow rate) is repeatable given an amount of actuation. To this end, the sliding flow controller can have features of indicia that the clinician can use as an aid to quickly adjust the fluid flow rate as needed.

[0043] Figure 1A perspective view of a sliding flow controller in an open position is depicted in accordance with some embodiments of the present disclosure. Figure 2 is a cross-sectional view of a sliding flow controller in accordance with some embodiments of the present disclosure. Figure 1 is a cross-sectional view of a sliding flow controller in accordance with some embodiments of the present disclosure. Figure 1 and Figure 2 As shown, the flow controller 100 for an intravenous (IV) tubing can include an upper housing 10 including a plurality of graduations 16 and a lower housing 20 engaged with the upper housing 10 and slidably coupled to the upper housing. As shown, a cavity 15 can be defined between the upper housing 10 and the lower housing 20 for housing at least a portion of the tubing 32. For example, the upper housing 10 can have a first surface 51 defining 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., ramp surface 22) defining a portion of the cavity 15 on a second side of the tubing 32. In some embodiments, the tubing 32 can be fluidly coupled to an IV tubing of an IV set. In these embodiments, a pair of connectors 30 can be disposed at opposite ends of the flexible tubing 32 for connecting the flexible tubing 32 to the IV tubing. For example, the pair of connectors 30 can be luer connectors that fluidly couple the inner flexible 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 aforementioned configuration, and the tubing 32 can be the IV tubing.

[0044] In some embodiments, as shown in Figure 2 the flow controller 100 can further include a flexible clamp 40 having an upper section 41 mounted in the upper housing 10 and a lower section 43 slidably disposed in the lower housing 20. As will be described in further detail below, the upper housing 10 and the lower housing 20 can be slidably coupled relative to one another to transition the tubing from (i) an open position (as shown in Figure 1 and Figure 2 to (ii) a closed position (as shown in Figure 3 and Figure 4 in which the lumen of the tubing 32 is not compressed by the clamp 40, and in which the lumen of the tubing 32 is at least partially pinched by the clamp 40, respectively.

[0045] Figure 5Ais a perspective view of a flexible clamp of a sliding flow controller according to some embodiments of the present disclosure. As shown, the upper section 41 of the flexible clamp 40 can include an upper arm 42 for mounting the flexible clamp 40 in the upper housing 10. In particular, the upper arm 42 can be in the form of a longitudinally extending body including a pair of tethered contact members 44 for retaining the upper arm 42 tethered in the upper housing 10. Specifically, the tethered contacts 44 can be disposed at opposite ends of the upper arm 42, with the longitudinally extending body coupling the tethered contact members 44 to one another. As shown, the tethered contacts 44 can have a square shape. However, various embodiments of the present disclosure are not limited to the aforementioned configuration. In other embodiments, the tethered contacts 44 can have a rectangular or other suitable polygonal shape that is capable of retaining or otherwise constraining the upper arm in the upper housing 10. In particular, as the upper arm is retained or otherwise constrained in the upper housing, movement or translation of the upper housing 10 relative to the lower housing results in corresponding movement of the flexible clamp 40. The lower section 43 of the flexible clamp 40 can include a lower arm 46 in the form of a longitudinally extending body disposed in 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 ramped surface of the lower housing, thereby causing the lower arm 46 to pivot or otherwise rotate toward the upper arm 42 so as to clamp and compress the lumen of the tubing 32 to control or otherwise selectively restrict the amount of fluid flow through the tubing 32. Accordingly, the tubing 32 can be a low durometer tubing that is capable of being flexed or otherwise clamped or compressed by the flexible clamp 40. For example, as the geometry and properties (durometer, inner diameter, outer diameter, concentricity) of the tubing can be controlled and the body of the sliding flow controller can be adjusted to work exclusively with the tubing, the expected flow rate for a given degree of actuation can be predicted.

[0046] Figure 5B is a perspective view of a flexible clamp of a sliding flow controller according to some embodiments of the present disclosure. As shown, the upper section 41 of the flexible clamp 40 can include an upper arm 42 for mounting the flexible clamp 40 in the upper housing 10. In particular, the upper arm 42 can be in the form of a longitudinally extending body including a pair of tethered contact members 44 for retaining the upper arm 42 tethered in the upper housing 10. Specifically, the tethered contacts 44 can be disposed at opposite ends of the upper arm 42, with the longitudinally extending body coupling the tethered contact members 44 to one another. As shown, the tethered contacts 44 can have a square shape. However, various embodiments of the present disclosure are not limited to the aforementioned configuration. In other embodiments, the tethered contacts 44 can have a rectangular or other suitable polygonal shape that is capable of retaining or otherwise constraining the upper arm in the upper housing 10. In particular, as the upper arm is retained or otherwise constrained in the upper housing, movement or translation of the upper housing 10 relative to the lower housing results in corresponding movement of the flexible clamp 40. The lower section 43 of the flexible clamp 40 can include a lower arm 46 in the form of a longitudinally extending body disposed in 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 ramped surface of the lower housing, thereby causing the lower arm 46 to pivot or otherwise rotate toward the upper arm 42 so as to clamp and compress the lumen of the tubing 32 to control or otherwise selectively restrict the amount of fluid flow through the tubing 32. Accordingly, the tubing 32 can be a low durometer tubing that is capable of being flexed or otherwise clamped or compressed by the flexible clamp 40. For example, as the geometry and properties (durometer, inner diameter, outer diameter, concentricity) of the tubing can be controlled and the body of the sliding flow controller can be adjusted to work exclusively with the tubing, the expected flow rate for a given degree of actuation can be predicted. Figure 5A Figure 5C is a perspective view of a flexible clamp of a sliding flow controller according to some embodiments of the present disclosure. As shown, the upper section 41 of the flexible clamp 40 can include an upper arm 42 for mounting the flexible clamp 40 in the upper housing 10. In particular, the upper arm 42 can be in the form of a longitudinally extending body including a pair of tethered contact members 44 for retaining the upper arm 42 tethered in the upper housing 10. Specifically, the tethered contacts 44 can be disposed at opposite ends of the upper arm 42, with the longitudinally extending body coupling the tethered contact members 44 to one another. As shown, the tethered contacts 44 can have a square shape. However, various embodiments of the present disclosure are not limited to the aforementioned configuration. In other embodiments, the tethered contacts 44 can have a rectangular or other suitable polygonal shape that is capable of retaining or otherwise constraining the upper arm in the upper housing 10. In particular, as the upper arm is retained or otherwise constrained in the upper housing, movement or translation of the upper housing 10 relative to the lower housing results in corresponding movement of the flexible clamp 40. The lower section 43 of the flexible clamp 40 can include a lower arm 46 in the form of a longitudinally extending body disposed in 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 ramped surface of the lower housing, thereby causing the lower arm 46 to pivot or otherwise rotate toward the upper arm 42 so as to clamp and compress the lumen of the tubing 32 to control or otherwise selectively restrict the amount of fluid flow through the tubing 32. Accordingly, the tubing 32 can be a low durometer tubing that is capable of being flexed or otherwise clamped or compressed by the flexible clamp 40. For example, as the geometry and properties (durometer, inner diameter, outer diameter, concentricity) of the tubing can be controlled and the body of the sliding flow controller can be adjusted to work exclusively with the tubing, the expected flow rate for a given degree of actuation can be predicted. Figure 5A Figure 5B Figure 5C ​​​In particular, as shown, the flexible guide member 48 can include a pair of hinged arms 49, each extending from the upper arm 43 to the lower arm 46. In some embodiments, each hinged arm 49 can be in the form of a curved body having a hinged portion 45 that pivots or rotates about when the upper housing is translated or slid relative to the lower housing 20. As shown, the hinged arms 49 can be spaced apart from one another so as to define an aperture 47 through which the tubing 32 can extend. For example, the tubing 32 can extend through the hinged arms 49 of the guide member 48, thereby allowing it to be oriented vertically relative to the flexible clamp 40.

[0047] Accordingly, as the upper housing 10 is translated or slid relative to the lower housing 20, the lower arm 46 translates and slides against the ramped surface 22 of the lower housing, causing the hinged arms 49 to bend inwardly and move the lower arm 46 toward the upper arm. As such, as the lower arm pivots or rotates toward the upper arm 42, the tubing 32 can be clamped or otherwise compressed. In this way, a portion of the lumen of the tubing 32 extending through the aperture 47 can be pinched to reduce fluid flow through the tubing 32.

[0048] In some embodiments, at least one of the upper arm 42 and the lower arm 46 can have a friction-reducing surface. For example, at least one of the upper arm 42 and the lower arm 46 can be a polished surface, or can be coated or otherwise formed with a friction-reducing material (e.g., grease, oil, smooth plastic, etc.). Accordingly, as the upper housing is moved relative to the lower housing 20, the lower arm 46 can easily translate and slide against the ramped surface 22 of the lower housing without frictional resistance or otherwise impeding movement.

[0049] Figure 6 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 is a perspective view of a flexible clamp mounted to an upper housing according to some embodiments of the present disclosure.

[0050] According to some embodiments, the upper housing 10 can include a pair of mounting holes 17 positioned axially opposite one another a distance corresponding to the opposite ends of the upper arm 42. Accordingly, in an assembled state of the flow controller 100, in which the flexible clamp 40 is mounted in the upper housing 10, the tethered contact 44 is mounted in the holes 17. In this way, the upper arm 42 remains tethered in the upper housing 10 and is prevented from canting or otherwise rotating about the central longitudinal axis of the cylindrical body of the upper arm 42.

[0051] Figure 8 is a perspective view of a top face of an upper housing of a sliding flow controller according to some embodiments of the present disclosure. Figure 9is a perspective view of a bottom face of an upper housing of a sliding flow controller according to some embodiments of the present disclosure. Reference is made to Figure 8 and Figure 9 , with continued reference to Figure 6 and Figure 7 , the upper housing 10 can have a proximal face 18 and a distal face 23. Thus, the upper housing 10 can extend longitudinally from the proximal face 18 to the distal face 23. As shown, the proximal face 18 can include an upper protrusion 14, a lower protrusion 19, and a recess 13 defined between the upper protrusion 14 and the lower protrusion 19. The lower protrusion 14 can extend longitudinally from the proximal face 18 to the distal face 23. As will be described in further detail below, the lower protrusion 19 can interface with and be slidably disposed within a corresponding guide recess 24 of the lower housing 20. The lower protrusion 19 can have an upper surface 9 and a lower surface 11. In some embodiments, as shown in Figure 8 and Figure 9 , the upper surface 9 and the lower surface 11 can have respective friction-increasing surfaces. For example, the upper surface 9 and the lower surface 11 can each be a textured surface, such as rough surfaces 34 and 36, so as to increase the friction between the upper surface 9 and the lower surface 11 and the guide recess 24 of the lower housing. The aforementioned configurations facilitate preventing accidental actuation of the sliding flow controller 100 (i.e., sliding of the upper housing 10 relative to the lower housing 20).

[0052] Figures 10A-12B is a perspective view of a lower housing of a sliding flow controller according to some embodiments of the present disclosure. Similar to the upper housing, the lower housing can include a proximal face 26 and a distal face 30. As shown, the lower housing can extend longitudinally from the proximal face 26 to the distal face 30. A guide recess 24 can be defined along the length of the lower housing 20, extending from the proximal face 26 to the distal face 30. As described above, the lower protrusion 19 can be slidably mounted within the guide recess 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 defining a portion of the cavity on a second side of the tubing 32. As shown, the second surface 22 can be a ramped surface. In operation, as the upper housing 10 moves or slides linearly over the lower housing 20, the lower arm 46 of the flexible clamp 40 also slides along the ramped surface 22. Because the ramped 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 and pivots or otherwise deflects upward a distance corresponding to the vertical component of the slope or gradient of the ramp angle. As the lower arm 46 deflects upward toward the upper arm 42, the tubing 32 is clamped and compressed between the upper arm 42 and the lower arm 46 to reduce or otherwise impede the flow of medical fluid through the lumen of the tubing 32.

[0053] According to various embodiments of this disclosure, the upper surface 37 of the lower housing 20 may include a first segment 27, a second segment 39, and a transition step 29 between the first segment 27 and the second segment 39. The transition step 29 may include a lower end portion 29A and an upper end portion 29B. As shown, the first segment 27 may extend from the proximal side 26 of the lower housing 20 to the lower end portion 29A of the transition step 29, and the second segment 39 may extend from the upper end portion 29B of the transition step 29 to the distal side 30 of the lower housing 20. Furthermore, as... Figure 10A and Figure 10B As shown, the second segment 39 can be raised above the first segment 27 by a distance corresponding to the height of the transition step 29. In some embodiments, the transition step 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 may include an contact surface 12 that contacts the stop surface 29 when the upper housing 10 reaches the fully closed (0 ml / hr) position.

[0054] The stop surface 29 can be configured to restrict the movement of the upper housing 10 relative to the lower housing 20, to provide a indication that the upper housing 10 has reached its destination. Figure 3 The tactile indication of the closed position, 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 side 26 of the lower housing 20. Although the stop surface 29 is shown as a transition step 29, the stop surface 29 can be provided in other locations or use other structural forms. For example, the stop surface 29 can be implemented using complementary structures on the upper housing 10 and the lower housing 20 that interact (e.g., snap together, abut, and / or otherwise interact) to stop the movement of the upper housing 10 and lock the sliding flow controller 100 in the closed configuration.

[0055] According to various embodiments of this disclosure, the proximal side 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 side 26 of the lower housing 20. Specifically, as shown, the proximal stop surface 25 may be in the form of an inwardly angled (i.e., distally toward the stop surface 29) ramp surface. Furthermore, as... Figure 1 As shown, 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 restricting further proximal movement of the upper housing 10 relative to the lower housing 20. In particular, the proximal stop surface 25 may include an engagement surface 25A, which is contacted by the lower protrusion 19 when the upper housing 10 reaches the fully open position.

[0056] Therefore, similar to stop surface 29, proximal stop surface 25 can be configured to restrict movement of upper housing 10 relative to lower housing 20 to provide a sense of arrival of the upper housing 10. Figure 1 The tactile indication of the fully open position, and / or to lock or hold the upper housing 10 in the open position until a closing force or pressure is applied to move the upper housing 10 distally toward the stop surface 29 of the lower housing 20. Although the stop surface 29 is shown in the form of a ramp surface 25, the stop surface 25 can be provided in other locations or use other structural forms. For example, the stop surface 25 can be implemented using complementary structures on the upper housing 10 and the lower housing 20 that interact (e.g., snap together, abut, and / or otherwise interact) to stop the movement of the upper housing 10 and lock the sliding flow controller 100 in the fully open configuration.

[0057] According to various embodiments of this disclosure, the guide groove 24 may include at least one surface with increased friction. For example, such as Figure 11A and Figure 11B As shown, the guide groove 24 may include a first friction-increasing surface 21. In some embodiments, such as Figure 12A and Figure 12B As shown, the guide groove 24 may include additional or second friction-increasing surfaces 35. For example, similar to the textured or rough surfaces 34 and 36 of the upper housing 10, each of the friction-increasing surfaces 21 and 35 may be textured or rough to increase the friction between the upper surface 9 and the lower surface 11 and the guide groove 24 of the lower housing. The aforementioned configuration helps to prevent accidental actuation of the sliding flow controller 100 (i.e., sliding of the upper housing 10 relative to the lower housing 20).

[0058] Figure 13Ais a cross-sectional view of a lower housing 20 of a sliding flow controller 100 according to some embodiments of the present disclosure. As shown, the ramp surface 22 can include a first ramp section 28A having a first angle of inclination and a second ramp section 28B having a second angle of inclination that is different than the first angle of inclination. In some embodiments, the angle of inclination of the first ramp section 28A can be greater than the angle of inclination of the second ramp section 28B. For example, as shown, the slope or gradient of the first ramp section 28A can be steeper or greater than the slope or gradient of the second ramp section 28B. In some embodiments, the angle of inclination of the first ramp section 28A can be formed to be steeper or greater than the angle of inclination of the second ramp section 28B in order to control fluid flow through the tubing 32 in a higher fluid flow range of the sliding flow controller 100. For example, the angle of inclination of the first ramp section 28A can be formed to control flow through the tubing 32 in a region of higher fluid flow rates (e.g., between full open and 80 ml / hr flow scale). Similarly, the angle of inclination of the second ramp section 28B can be formed to be flatter or less than the angle of inclination of the first section 28 in order to control fluid flow through the tubing 32 in a lower fluid flow range of the sliding flow controller 100. For example, the angle of inclination of the second ramp section 28B can be formed to control flow through the tubing 32 between full closed (0 ml / hr) and 80 ml / hr flow scale.

[0059] As noted above, the non-linear ramp surface 22 of the lower housing having multiple ramp sections 28A and 28B having different angles of inclination can be formed such that the angle of inclination in the high flow rate region is higher than the angle of inclination in the low flow rate region. Thus, the rate of tubing occlusion for a given actuation will occur more quickly in the high flow rate region than in the low flow rate region. As such, the angles of inclination of the first and second ramp sections 28A and 28B can be adjusted to the tubing geometry such that the actuation required to set a low flow rate uses multiple millimeters of actuation.

[0060] Figure 13B A friction-reduced surface of the ramp surface 22 of the lower housing 20 is shown. According to various embodiments of the present disclosure, the ramp surface 22 can have a friction-reduced surface. For example, the ramp surface 22 can be a polished surface or can be coated or otherwise formed with a friction-reducing material (e.g., grease, oil, smooth plastic, etc.). Thus, when the upper housing is moved relative to the lower housing 20, the lower arm 46 can easily translate and slide against the ramp surface 22 of the lower housing 20 without frictional resistance or otherwise impeding movement.

[0061] Figures 14A-14E An assembly of the upper housing 10, flexible clamp 40, and lower housing 20 of the sliding flow controller 100 in a fully open state according to some embodiments of the present disclosure is shown. Figure 14AThis is a perspective view of the upper housing, flexible clamp, and lower housing components of a sliding flow controller in a fully open state according to some embodiments of the present disclosure. Figure 14B According to some embodiments of this disclosure Figure 14A A cross-sectional view of the upper housing, flexible clamp, and lower housing assembly. Figure 14A and Figure 14B In the example, the flow controller 100 is shown in a fully open configuration, with the upper housing 10 positioned in the open position where the tubular component 32 (not shown for ease of observation of the interconnections of the components) is not compressed. As shown, in the fully open position, the flexible clamp 40, together with the lower arm 46, is positioned on the first ramp section 28A of the lower housing 20. In the fully open position, the flexible clamp 40 can be positioned... Figure 14B The image shows the unbent or uncompressed state.

[0062] In operation, the upper housing 10 can translate or slide relative to the lower housing 20 in response to pressure applied directly to its outer surface by the user. Therefore, the lower arm 46 can translate and slide against the first ramp section 28A toward the second ramp section 28B of the lower housing 20, causing the hinged arm 49 to bend radially inward and move the lower arm 46 toward the upper arm 42. Thus, as the lower arm 46 pivots or rotates toward the upper arm 42, the tube 32 can be clamped or otherwise compressed. This extends through the hole 47 of the guide member 48 (e.g., Figure 5B A portion of the lumen of the fitting 32 (as shown) can be compressed to reduce fluid flow through the fitting 32.

[0063] Figure 14C It shows that the upper shell has been removed from Figure 14A and Figure 14B The diagram shows a perspective view of the flow controller 100 after linearly sliding from the fully open position to the partially open position, in which a portion of the tube 32 (not shown for ease of observation of the interconnections of the components) can be partially compressed by the flexible clamp 40 between the upper housing 10 and the lower housing 20. As the upper housing 10 further translates or slides relative to the lower housing 20, the lower arm 46 also translates and slides against the second ramp section 28B of the lower housing, causing the lower arm 46 to further pivot or otherwise rotate toward the upper arm 42, thereby further clamping the tube 32 and further compressing the lumen of the tube 32 to control or otherwise selectively restrict the amount of fluid flowing through the tube 32.

[0064] Figure 14D This is a perspective view of the 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. Figure 14E According to some embodiments of this disclosure Figure 14DFIG. 6 is a cross-sectional view of the assembly of the upper housing, the flexible clamp, and the lower housing. In operation, as the upper housing 10 is translated or otherwise slid further distally relative to the lower housing 20, the lower arm 46 is also translated and slid further distally against the second ramped section 28B of the lower housing, causing the lower arm 46 to further pivot or otherwise rotate toward the upper arm 42, thereby further clamping the tubing 32 and fully compressing the lumen of the tubing 32 to stop fluid flow through the tubing 32.

[0065] As previously mentioned, the stop surface 29 (as shown in Figures 10A-13A ) can limit the 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. The stop surface 29 can also 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 proximally toward the proximal face 26 of the lower housing 20. Figure 14D

[0066] Thus, the upper housing 10 can be slid relative to the lower housing 20 and can be linearly moved (e.g., slid) between (i) an open position in which the tubing 32 can be uncompressed within the bore 47 of the guide member 48 and (ii) a closed position linearly separated from the open position and shown in Figure 14A and Figure 14B in which the tubing 32 is compressed between the upper arm 42 and the lower arm 46 of the flexible clamp to stop medical fluid flow through the tubing 32. Thus, the sliding flow controller of the various embodiments described herein advantageously provides improved fluid flow capabilities as compared to current existing roller clamp-based flow controllers. In particular, as the upper housing 10 is moved distally relative to the lower housing 20 and the lower arm 46 of the flexible clamp 40 is bent, rotated, or otherwise pivoted toward the upper arm 42, the low durometer inner tubing is progressively occluded, thereby reducing fluid flow therethrough. Figure 14D Figure 14E According to various embodiments of the present disclosure, the linearly slidable upper housing 10 can be continuously slid between an open position and

[0067] and a closed position Figure 14A and Figure 14B . Each intermediate position of the linearly slidable upper housing 10 between the open position and the closed position can be associated with an intermediate compression of the tubing 32 between the upper arm 42 and the lower arm 46 of the flexible clamp to set a corresponding intermediate flow rate through the tubing, as shown in Figure 14D Figure 14E Figure 14C

[0068] ​​​​Accordingly, the sliding flow controllers of the various embodiments described herein provide several advantages over current existing roller clamp-based flow controllers, as detailed below.

[0069] In particular, a common problem with current roller clamps is that fluid flow rates are difficult to adjust at low flow rates (about 45 ml / hr and below). Typically, the roller wheel must be moved a few millimeters along the roller clamp body to adjust the flow rate from fully open to 150 ml / hr, while adjusting from 45 ml / hr to 25 ml / hr requires almost imperceptible movement of the roller wheel. In contrast to current roller clamps, the sliding flow controllers described herein have increased usability (ease of use) over a clinically relevant range of flow rates. For example, in some embodiments, the sliding flow controllers can be designed such that multiple millimeters of actuation are required to adjust fluid flow at high flow rates, and also multiple millimeters of actuation are required to adjust fluid flow at low flow rates. Accordingly, the sliding flow controllers of the various embodiments described herein improve flow rate adjustability at low flow rates and high flow rates by featuring a non-linear ramp surface in the lower housing. The non-linear ramp surface of the lower housing features a range of ramp angles that are specifically tuned for different flow rate ranges. Several millimeters of actuation of the upper housing relative to the lower housing can be required to make adjustments within the range of low flow rates or high flow rates.

[0070] Furthermore, a common problem with current roller clamps is that the roller wheel is typically small and knurled, and the small wheel geometry and knurling over-concentrate and / or concentrate pressure on the clinician’s thumb for extended periods of time. Accordingly, the clinician can experience thumb fatigue and soreness from actuating the roller clamp through their work shift, particularly if the IV tubing has a relatively high stiffness. The sliding flow controllers described herein have better ergonomic properties than current roller clamps, thereby improving clinician comfort. For example, as previously described, the clinician can actuate the sliding flow controller by sliding the upper and lower housings together to open the flow or sliding the upper and lower housings apart to close the flow. The overall size of the sliding flow controller is similar to current flow controllers (e.g., the previously mentioned roller clamp-based flow controllers), and it is easily held in the hand. In this way, the sliding flow controller can be actuated with one hand, and the entire surface of the upper and lower housings can be grasped during actuation, rather than just the top of the wheel surface that is featured on current roller clamps. Because the sliding flow controller has a larger grasping surface area than the roller clamp during actuation, it is ergonomically superior to current roller clamps.

[0071] Further, current roller clamps are typically designed to be compatible over the range of inner and outer diameters of IV tubing. The tubing position is also not tightly constrained within the body of the roller clamp. Combining the variety of tubing geometries with the variation in the positioning of the tubing within the groove of the roller clamp body results in variation in the wheel position along the roller clamp body when setting a given flow rate. Due to the variation in the wheel position, current roller clamps do not have any features or markings to indicate the flow rate at a given wheel position along the roller clamp body. Setting a given flow rate using a sliding flow controller can be repeatable by design, and there are features (graduations) on the sliding flow controller that indicate the flow rate setting.

[0072] Further, the sliding flow controller of the various embodiments described herein improves repeatability by design, as the angle of inclination of the non-linear ramp surface is adjusted for use with a specific diameter of low durometer tubing. Because the geometry and properties (durometer, inner diameter, outer diameter, concentricity) of the tubing can be controlled, and the upper and lower housings (i.e., body) of the sliding flow controller can be adjusted to work specifically with the desired tubing, the expected flow rate at a given degree of actuation can be more easily predicted.

[0073] The sliding flow controller described herein also features a tubing guide member to keep the tubing oriented and the lower and upper arms of the flexible clamp to keep the tubing clamped perpendicular. Because the internal tubing geometry of low durometer can be controlled, and the tubing position within the upper and lower arms of the flexible clamp can be controlled, the amount that the tubing is clamped (and thus the fluid flow rate) is repeatable given a degree of actuation. To this end, the sliding flow controller can have features that are marked that a clinician can use as an aid to quickly adjust the fluid flow rate as needed.

[0074] In one or more embodiments of the present disclosure, a flow controller having an internal tubing includes an upper housing including a plurality of graduations, a lower housing engaged with the lower housing and slidably coupled to the lower housing, a cavity defined between the upper housing and the lower housing for accommodating at least a portion of the internal tubing, and a flexible clamp having an upper section mounted in the upper housing and a lower section slidably disposed in the lower housing, the upper housing and the lower housing being slidably coupled relative to each other to transition the internal tubing from (i) an open position in which a lumen of the tubing is not compressed by the flexible clamp to (ii) a closed position in which the lumen of the internal tubing is at least partially pinched by the flexible clamp.

[0075] In aspects of the present disclosure, the upper section of the flexible clamp includes an upper arm, the lower section includes a lower arm, and the flexible clamp further includes a flexible guide member coupling the upper arm and the lower arm to one another. In aspects of the present disclosure, the upper arm includes a pair of tether contact members, each tether contact member disposed at an opposite end of the upper arm; and the upper housing further includes a pair of mounting holes positioned axially opposite one another at a distance corresponding to the opposite ends of the upper arm, each tether contact member mounted within a respective mounting hole. In aspects of the present disclosure, the upper arm and the lower arm each include a cylindrical longitudinally extending body; the cylindrical longitudinally extending body of the upper arm couples the tether contact members to one another; the cylindrical longitudinally extending body of the lower arm is slidably mounted in the lower housing; and the flexible guide member includes a pair of articulated arms, each articulated arm coupling the cylindrical longitudinally extending bodies of the upper arm and the lower arm to one another.

[0076] In aspects of the present disclosure, the articulated arms are spaced apart from one another to define a bore through which the internal tubing extends. In aspects of the present disclosure, the upper housing has a first surface defining a portion of the cavity on a first side of the tubing, the lower housing has a second surface defining a portion of the cavity on a second side of the tubing, and the second surface is a ramped surface. In aspects of the present disclosure, the ramped surface includes a first ramped section having a first angle of inclination and a second ramped section having a second angle of inclination different than the first angle of inclination. In aspects of the present disclosure, the first angle of inclination is greater than the second angle of inclination. In aspects of the present disclosure, the upper housing includes a proximal face and a distal face, the upper housing extending longitudinally from the proximal face to the distal face, and wherein the proximal face includes an upper protrusion, a lower protrusion, and a recess defined between the upper protrusion and the lower protrusion, the lower protrusion extending longitudinally from the proximal face to the distal face.

[0077] In aspects of the present disclosure, the lower housing includes a proximal face and a distal face, the lower housing extending longitudinally from the proximal face to the distal face, and a guide recess extending from the proximal face to the distal face, wherein the lower protrusion is slidably mounted in the guide recess to move the upper housing relative to the lower housing. In aspects of the present disclosure, the upper surface of the lower housing includes a first section, a second section, and a transition step between the first and second sections, and wherein: the transition step includes a lower end and an upper end; the first section extends from the proximal face of the lower housing to the lower end of the transition step; the second section extends from the upper end of the transition step to the distal face of the lower housing.

[0078] In aspects of the present disclosure, the second section can be raised above the first section by a distance corresponding to a height of the transition step, and the transition step includes a stop surface, wherein, in the closed state of the flow controller, the upper protrusion of the upper housing abuts the stop surface. In aspects of the present disclosure, the proximal face of the lower housing includes a proximal stop surface extending across at least a portion of the guide groove at the proximal face of the lower housing, wherein, in the open state of the flow controller, the lower protrusion of the upper housing abuts the proximal stop surface. In aspects of the present disclosure, the inner tube includes a low durometer tube, the flow controller further including a pair of luer connectors disposed at opposite ends of the tube for coupling the inner tube to an intravenous (IV) set tube.

[0079] In one or more embodiments of the present disclosure, a flow controller for an intravenous (IV) tube includes an upper housing including a plurality of graduations, a lower housing including a ramp surface and slidably coupled to the upper housing, a flexible clamp mounted in the upper housing and extending into the lower housing, and a flexible inner tube disposed in a cavity defined between the upper and lower housings, the flexible tube extending through a guide portion of the flexible clamp, wherein the upper housing is configured to slide on the lower housing such that the flexible clamp compresses a portion of the flexible tube.

[0080] In aspects of the present disclosure, a pair of luer connectors are disposed at opposite ends of the flexible tube for connecting the flexible inner tube to an IV tube. In aspects of the present disclosure, the ramp surface includes a first section having a first angle of inclination and a second section having a second angle of inclination less than the first angle of inclination. In aspects of the present disclosure, the upper housing includes a proximal face and a distal face, the upper housing extending longitudinally from the proximal face to the distal face, and wherein the proximal face includes 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 face to the distal face.

[0081] In aspects of the present disclosure, the lower housing includes a proximal face and a distal face, the lower housing extending longitudinally from the proximal face to the distal face, and a guide groove extending from the proximal face to the distal face, wherein the lower protrusion is slidably mounted in the guide groove to move the upper housing relative to the lower housing. In aspects of the present disclosure, at least one of the lower protrusion and the guide groove includes at least one friction-increasing surface. In aspects of the present disclosure, the flexible clamp includes an upper arm mounted in the upper housing and a lower arm extending into the lower housing to engage the ramp surface, the lower arm including a friction-reducing surface. In aspects of the present disclosure, the proximal face of the lower housing includes a proximal stop surface extending across at least a portion of the guide groove at the proximal face of the lower housing, wherein, in the open state of the flow controller, the lower protrusion of the upper housing abuts the proximal stop surface.

[0082] This subject matter, for example, is described according to 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 matter, and the subject matter is not limited to these examples. Various modifications to these aspects will be apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0083] Unless otherwise specified, the singular form of an element in the design does not mean "one and only one," but rather "one or more." Unless otherwise specified, the term "some" refers to one or more. Masculine pronouns (such as his) include feminine and neuter pronouns (such as her and its), and vice versa. Titles and subtitles, if any, are used for convenience only and do not limit the invention.

[0084] 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 being superior or more advantageous than other aspects or designs. In one respect, the various alternative constructions and operations described herein may be considered at least equivalent.

[0085] As used herein, the phrase "at least one" preceding a series of items, separated by the term "or," modifies the listed items as a whole, not each individual item listed. The phrase "at least one" does not require the selection of at least one item; rather, it allows for the inclusion of at least one of any one item, and / or at least one of any combination of items, and / or at least one of each item. For example, the phrase "at least one of A, B, or C" could refer to: only A, only B, or only C; or any combination of A, B, and C.

[0086] The phrase, such as“aspect,” does not imply that a particular aspect is critical, essential, or mandatory to the subject technology. The various aspects related to an aspect can apply to all aspects, or one or more aspects. An aspect can provide one or more examples. The phrase, such as“aspect,” can refer to one or more aspects, and vice versa. The phrase, such as“embodiment,” does not imply that a particular embodiment is critical, essential, or mandatory to the subject technology. The various aspects related to an embodiment can apply to all embodiments, or one or more embodiments. An embodiment can provide one or more examples. The phrase, such as“embodiment,” can refer to one or more embodiments, and vice versa. The phrase, such as“configuration,” does not imply that a particular configuration is critical, essential, or mandatory to the subject technology. The various aspects related to a configuration can apply to all configurations, or one or more configurations. A configuration can provide one or more examples. The phrase, such as“configuration,” can refer to one or more configurations, and vice versa.

[0087] In one aspect, unless otherwise indicated, all measurements, values, ratings, 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 commensurate with the functions to which they relate and with general

[0088] It should be understood that a particular order or hierarchy of steps or operations within a disclosed process or method is an example and can be re-arranged. Certain steps, operations, or processes can be performed simultaneously or in different order. Some or all steps, operations, or processes can be performed automatically, without user intervention. Method claim elements can be presented in any order that is sufficiently related to other elements as to effectively perform the desired action.

[0089] 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 of this disclosure are hereby expressly defined to encompass the claims of the United States of America, including all equivalents thereof. Under 35 U.S.C. § 112(f), claims that do not specifically recite an element using the phrase "means for" or "steps for" are not intended to be interpreted under 35 U.S.C. § 112(f). Furthermore, to the extent that the use of the terms "including", "includes", "in" or "contains" are used in either the detailed description or the claims, such terms are intended to be inclusive in a manner similar to the term "comprising" as that term is interpreted when employed as a transitional word in the introductory clauses of the claims.

[0090] The titles of the accompanying drawings, the background, summary or abstract and the brief description of drawings are hereby incorporated into this disclosure and provided as illustrative examples of the disclosure and are not intended to be limiting in any way. Submission is based on the understanding that they will not be used to limit the scope or meaning of the claims. Furthermore, in the detailed description, it can be seen that a description of illustrative examples is provided and various features are combined in various embodiments for the purpose of simplifying this disclosure. The methods of this disclosure should not be interpreted as reflecting an intention that the claimed subject matter require more features than are expressly recited in any claim. Rather, as reflected in the claims below, the inventive subject matter is directed to less than all of the features of a single disclosed construction or operation.

[0091] The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language of the claims, wherein, for purposes of comprehension of the claims, all structure and functionality that is put forth as a portion of the aspects described throughout this disclosure is deemed to be incorporated by reference to the claims. Nonetheless, no claim is intended to embrace subject matter that fails to satisfy the requirements of 35 U.S.C. § 101, 102, or 103, nor should such claims be interpreted in a manner that would encompass non-mono- polytic equivalents.

Claims

1. A flow controller comprising: an upper housing comprising a plurality of graduations; a lower housing engaged with and slidably coupled to the upper housing; an inner tube; a cavity defined between the upper and lower housings for housing at least a portion of the inner tube; and a flexible clamp having an upper section mounted in the upper housing and a lower section slidably disposed in the lower housing, the upper and lower housings being slidably coupled relative to one another to transition the inner tube from (i) an open position in which a lumen of the tube is uncompressed by the flexible clamp to (ii) a closed position in which the lumen of the inner tube is at least partially pinched by the flexible clamp, wherein the upper section of the flexible clamp comprises an upper arm, the lower section comprises a lower arm, and the flexible clamp further comprises a flexible guide member coupling the upper and lower arms to one another, and wherein the lower housing comprises a ramp surface having a first ramp section and a second ramp section, the first ramp section having a first angle of inclination and the second ramp section having a second angle of inclination different from the first angle of inclination, such that actuation of the upper housing relative to the lower housing provides a plurality of millimeters of movement to adjust a low flow range and a high flow range, thereby allowing fine tuning of flow rates in the low flow range and the high flow range.

2. The flow controller of claim 1, wherein: the upper arm comprises a pair of tether contact members, each tether contact member being disposed at an opposite end of the upper arm; and the upper housing further comprises a pair of mounting holes positioned axially opposite one another and having a distance corresponding to the opposite ends of the upper arm, the tether contact members each being mounted within a respective mounting hole.

3. The flow controller of claim 2, wherein: the upper and lower arms each comprise a cylindrical longitudinally extending body; the cylindrical longitudinally extending body of the upper arm couples the tether contact members to one another; the cylindrical longitudinally extending body of the lower arm is slidably mounted in the lower housing; and the flexible guide member comprises a pair of hinged arms, each hinged arm coupling the cylindrical longitudinally extending bodies of the upper and lower arms to one another. the hinged arms are spaced apart from one another to define a bore through which the inner tube extends. the upper housing has a first surface defining a portion of the cavity on a first side of the inner tube, the lower housing has a second surface defining a portion of the cavity on a second side of the inner tube, and the second surface is the ramp surface.

4. The flow controller of claim 3, wherein, the first angle of inclination is greater than the second angle of inclination.

5. The flow controller of claim 1, wherein, the upper housing comprises a first proximal face and a first distal face, the upper housing longitudinally extending from the first proximal face to the first distal face, and the first proximal face comprises an upper protrusion, a lower protrusion, and a groove defined between the upper and lower protrusions, the lower protrusion longitudinally extending from the first proximal face to the first distal face.

6. The flow controller of claim 1, wherein, the lower housing comprises:

7. The flow controller of claim 1, wherein, ​ 8. The flow controller of claim 7, wherein, ​ a second proximal face and a second distal face, the lower housing extending longitudinally from the second proximal face to the second distal face; and a guide groove extending from the second proximal face to the second distal face, wherein the lower protrusion is slidably mounted in the guide groove to move the upper housing relative to the lower housing.

9. The flow controller of claim 8, wherein, an upper surface of the lower housing comprises a first section, a second section, and a transition step between the first section and the second section, and wherein: the transition step comprises a lower end and an upper end; the first section extends from a second proximal face of the lower housing to the lower end of the transition step; and the second section extends from the upper end of the transition step to a second distal face of the lower housing.

10. The flow controller of claim 9, wherein, the second section is elevated above the first section by a distance corresponding to a height of the transition step, and the transition step comprises a stop surface, wherein, in a closed state of the flow controller, an upper protrusion of the upper housing abuts the stop surface.

11. The flow controller of claim 8, wherein, the second proximal face of the lower housing comprises a proximal stop surface extending across at least a portion of the guide groove at the second proximal face of the lower housing, wherein, in an open state of the flow controller, a lower protrusion of the upper housing abuts the proximal stop surface.

12. The flow controller of claim 1, wherein, the inner tubing comprises low durometer tubing, the flow controller further comprising a pair of luer connectors disposed at opposite ends of the tubing for coupling the inner tubing to an intravenous set tubing.

13. A flow controller for an intravenous tubing, the flow controller comprising: an upper housing comprising a plurality of graduations; a lower housing comprising a ramp surface and slidably coupled to the upper housing; a flexible clamp mounted in the upper housing and extending into the lower housing; and a flexible inner tubing disposed in a cavity defined between the upper and lower housings, the flexible inner tubing extending through a guide portion of the flexible clamp, wherein the upper housing is configured to slide on the lower housing such that the flexible clamp compresses a portion of the flexible inner tubing, wherein the ramp surface of the lower housing has at least a first ramp section and a second ramp section, the first ramp section having a first angle of inclination and the second ramp section having a second angle of inclination different from the first angle of inclination, such that actuation of the upper housing relative to the lower housing provides a plurality of millimeters of movement to adjust a low flow range and a high flow range, thereby allowing fine tuning of flow rates in the low flow range and the high flow range.

14. The flow controller of claim 13, further comprising a pair of luer connectors disposed at opposite ends of the flexible inner tubing for connecting the flexible inner tubing to an intravenous tubing.

15. The flow controller of claim 13, wherein, the upper housing comprises a first proximal face and a first distal face, the upper housing extending longitudinally from the first proximal face to the first distal face, and the first proximal face comprises an upper protrusion, a lower protrusion, and a groove defined between the upper and lower protrusions, the lower protrusion extending longitudinally from the first proximal face to the first distal face.

16. The flow controller of claim 15, wherein, the lower housing comprises: a second proximal face and a second distal face, the lower housing extending longitudinally from the second proximal face to the second distal face; and a guide groove extending from the second proximal face to the second distal face, wherein the lower protrusion is slidably mounted in the guide groove to move the upper housing relative to the lower housing.

17. The flow controller of claim 16, wherein, At least one of the lower protrusion and the guide groove includes at least one friction-increasing surface.

18. The flow controller of claim 15, wherein, The flexible clamp includes an upper arm mounted in the upper housing and a lower arm extending into the lower housing to engage the ramp surface, the lower arm including a friction-reducing surface.

19. The flow controller of claim 16, wherein, The second proximal face of the lower housing includes a proximal stop surface extending across at least a portion of the guide groove at the second proximal face of the lower housing, wherein in the open state of the flow controller, the lower protrusion of the upper housing abuts the proximal stop surface.

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