Stable flow regulator set

Abstract

The stable flow regulator assembly includes a body having a tube slot adjacent to and including an opening at the outer edge of the body for slidably receiving a portion of intravenous (IV) tubing, and a spiral sliding groove extending from the tube slot into the body, the width of the spiral sliding groove narrowing as the groove extends further into the body. A tube arm is rotatably coupled to the body, the tube arm including a slot opening to the outer edge of the body and configured to slidably receive the IV tubing when the slot is aligned with the tube slot of the body, and regulates the flow rate through the IV tubing based on compression of the IV tubing due to its position within the spiral sliding groove. A method of operating the stable flow regulator assembly is also provided.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to flow control devices for gravity intravenous (IV) sets or infusion pumps, and more particularly to stable flow regulator assemblies. [Background technology]

[0002] Flow controllers in the form of roller clamps are used in the medical field for intravenous (IV) applications and are typically attached to IV tubing during the manufacturing or assembly process. Such roller clamps are typically discarded along with the IV set or IV tubing after the IV application is complete.

[0003] A typical roller clamp allows IV tubing to be gradually occluded by pinching the tubing as the roller clamp tightens. The typical process is to adjust the fluid flow rate by fully closing the roller clamp and then rotating the roller clamp upward to release the fluid flow.

[0004] A typical roller clamp maintains the roller wheel in place by relying on a temporary fit with the roller body, engagement of the tubing with the wheel, and friction of the wheel with the roller body. However, with a typical roller clamp over a period of high flow rates, the wheel gradually moves away from its set position, causing inaccurate rates of fluid delivery through the tubing. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, it would be desirable to provide a flow regulator assembly that provides structural stability for consistently controlling fluid flow without variation from a regulated or set flow rate. It would also be desirable to provide a flow regulator assembly that can be added to IV tubing in the field as needed, thereby eliminating the need to pre-assemble the flow regulator assembly with a particular IV set or IV tubing. Additionally, it would be desirable to provide a flow regulator assembly that can be reused with different IV sets or IV tubing. [Means for solving the problem]

[0006] One or more embodiments provide a stable flow regulator assembly including a body. The body includes a tube slot disposed adjacent an outer edge of the body, the tube slot having an opening at the outer edge for slidably receiving a portion of intravenous (IV) tubing, and a spiral sliding groove extending from the tube slot into the body, the width of the spiral sliding groove narrowing as the spiral sliding groove extends further into the body. The stable flow regulator assembly also includes a tube arm rotatably coupled to the body, the tube arm having a slot opening to the outer edge of the body and configured to slidably receive the IV tubing when the slot is aligned with the tube slot of the body. The stable flow regulator assembly is configured to regulate a flow rate of a fluid through the IV tubing based on the amount of compression of the IV tubing due to the position of the IV tubing within the spiral sliding groove.

[0007] One or more embodiments provide a stable flow regulator assembly including a body with a helical sliding groove extending into the body and surrounded by an outer edge of the body, the width of the helical sliding groove narrowing as the helical sliding groove extends further into the body. The stable flow regulator assembly also includes a plurality of teeth disposed on the outer edge of the body and a tube arm rotatably coupled to the body, the tube arm having a slot opening into the helical sliding groove and configured to slidably receive an intravenous (IV) tubing when the slot is aligned with a portion of the helical sliding groove having a width equal to or greater than the diameter of the IV tubing. The stable flow regulator assembly is configured to regulate the flow rate of a fluid through the IV tubing based on the amount of compression of the IV tubing due to the position of the IV tubing within the helical sliding groove.

[0008] One or more embodiments provide a stable flow regulator assembly including a body. The body includes a tube retainer disposed adjacent an outer edge of the body, the tube retainer having an opening that slidably receives a portion of intravenous (IV) tubing. The body also includes radial tube grooves extending therein around a portion of the outer edge of the body, the depth of the radial tube grooves decreasing from the leading end to the closed end. The stable flow regulator assembly also includes a tube arm rotatably coupled to the body, the tube arm having a pressing member facing the outer edge of the body and configured to slidably compress the IV tubing when the tube arm is rotated while the IV tubing is disposed within the radial tube grooves. The stable flow regulator assembly is configured to adjust the flow rate of a fluid through the IV tubing based on the amount of compression of the IV tubing due to the position of the pressing member relative to the IV tubing within the radial tube grooves.

[0009] The foregoing and other features, aspects, and advantages of the disclosed embodiments will become more apparent from the following detailed description and accompanying drawings.

[0010] The accompanying drawings, which are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with the description, serve to explain the principles of the disclosure. [Brief explanation of the drawings]

[0011] [Figure 1] FIG. 1 is a perspective view of an exemplary infusion set with a typical roller clamp. [Figure 2] FIG. 2 is a side cross-sectional view of the roller clamp of FIG. 1. [Figure 3] FIG. 1 is a perspective view of a stable flow regulator assembly coupled to an IV tube according to an embodiment of the present disclosure. [Figure 4] FIG. 4 is a top view of the stable flow regulator assembly of FIG. 3 according to an embodiment of the present disclosure. [Figure 5] FIG. 4 is a top perspective view of the stable flow regulator assembly of FIG. 3 in an open flow position according to an aspect of the present disclosure. [Figure 6] FIG. 4 is a top perspective view of the stable flow regulator assembly of FIG. 3 in a regulated flow rate position according to an embodiment of the present disclosure. [Figure 7] FIG. 4 is a top view of the body of the stable flow regulator assembly of FIG. 3 according to an embodiment of the present disclosure. [Figure 8] FIG. 4 is a perspective view of a rotating arm of the stable flow regulator assembly of FIG. 3 according to an embodiment of the present disclosure. [Figure 9] FIG. 1 is a perspective view of a stable flow regulator assembly coupled to an IV tube according to an embodiment of the present disclosure. [Figure 10] FIG. 1 is a perspective view of a stable flow regulator assembly according to an aspect of the present disclosure. [Figure 11] FIG. 1 is a top view of a stable flow regulator assembly coupled to an IV tube according to an aspect of the present disclosure. [Figure 12] FIG. 1 is a top view of a stable flow regulator assembly coupled to an IV tube according to an aspect of the present disclosure. [Figure 13] FIG. 1 is a perspective view of a stable flow regulator assembly coupled to an IV tube according to an embodiment of the present disclosure. [Figure 14]10A-10C illustrate a method of operating a stable flow regulator assembly according to aspects of the present disclosure. [Figure 15] 10A-10C illustrate one-handed grasping and manipulation of a stable flow regulator assembly according to aspects of the present disclosure. [Figure 16] FIG. 1 is a perspective view of a stable flow regulator assembly coupled to an IV tube according to an embodiment of the present disclosure. [Figure 17] FIG. 17 is a top view of the stable flow regulator assembly of FIG. 16 according to an embodiment of the present disclosure. [Figure 18] FIG. 17 is a top perspective view of the stable flow regulator assembly of FIG. 16 in an open flow position according to an aspect of the present disclosure. [Figure 19] FIG. 17 is a top perspective view of the stable flow regulator assembly of FIG. 16 in a regulated flow rate position according to an embodiment of the present disclosure. [Figure 20] FIG. 17 is a perspective view of the body of the stable flow regulator assembly of FIG. 16 according to an embodiment of the present disclosure. [Figure 21] FIG. 21 is another perspective view of the body of FIG. 20 according to an embodiment of the present disclosure. [Figure 22] FIG. 17 is a perspective view of a rotating arm of the stable flow regulator assembly of FIG. 16 according to an embodiment of the present disclosure. [Figure 23] FIG. 23 is a side view illustrating the assembly of the rotating arm of FIG. 22 to the body of FIG. 20 according to an embodiment of the present disclosure. [Figure 24] FIG. 1 is a perspective view of a stable flow regulator assembly coupled to an IV tube according to an embodiment of the present disclosure. [Figure 25] FIG. 1 is a perspective view of a stable flow regulator assembly coupled to an IV tube according to an embodiment of the present disclosure. [Figure 26] FIG. 1 is a perspective view of a stable flow regulator assembly coupled to an IV tube according to an embodiment of the present disclosure. [Figure 27] 10A-10C illustrate one-handed grasping and manipulation of a stable flow regulator assembly according to aspects of the present disclosure. [Figure 28] 10A-10C illustrate a method of operating a stable flow regulator assembly according to aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0012] The detailed description set forth below describes various configurations of the present technology and is not intended to represent the only configurations in which the technology may be practiced. The detailed description includes specific details to enable a thorough understanding of the technology. Accordingly, dimensions for some aspects are provided as non-limiting examples. However, it will be apparent to those skilled in the art that the technology may be practiced without such specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the technology.

[0013] It should be understood that this disclosure includes examples of the present technology and does not limit the scope of the appended claims. Various aspects of the present technology will now be disclosed according to certain non-limiting examples. The various embodiments described in this disclosure can be implemented in various ways and with modifications according to a desired application or implementation.

[0014] The present disclosure relates to an alternative to roller clamps, particularly roller clamps for use in gravity infusion. Roller clamps regulate the flow rate of medical fluids (e.g., a drug solution or blood to be administered to a patient) through tubing. Typically, a standard infusion set is used to infuse the fluid. An example of a standard infusion set is shown in FIG. 1.

[0015] The infusion set includes a piercing spike 20, which can be a sharp spike for piercing a rubber stopper or a rounded, blunt spike for insertion into a bag. The spike contains one channel for fluid and optionally a second channel for venting. A vent port 21 is typically located near the piercing spike and allows air to enter the drip chamber 22. The vent port 21 may be provided with a bacterial filter to prevent bacteria from entering the device.

[0016] Drip chamber 22 has a droplet generator 23 at the top of drip chamber 22, which generates droplets of a specific size. Droplets from droplet generator 23 fall into drip chamber 22, causing drip chamber 22 to become partially filled with liquid. This prevents air bubbles, which could be harmful to the patient, from entering connector tubing 24. A particle filter may be provided at the opening at the bottom of drip chamber 22.

[0017] Connector tubing 24 connects drip chamber 22 to the patient. Connector tubing 24 is typically about 150 cm in length and can be made of PVC. Tube 24 is shown shortened in FIG. 1 for clarity. Connector tubing 24 typically has a diameter that does not change along its entire length.

[0018] At the end of connector tube 24 is a standardized luer fitting 25 for connection to any other device having a standard luer cone. Those skilled in the art will appreciate that luer fitting 25 can be attached to a hypodermic needle (not shown) for injecting medical fluids into a patient's circulatory system (e.g., intravenously).

[0019] Between drip chamber 22 and luer fitting 25 is roller clamp 26 which engages connector tubing 24. Although the present disclosure relates to an improved flow regulator assembly, a typical roller clamp 26 known in the art will now be described as background information.

[0020] The roller clamp 26 shown in Figure 2 has two opposing side walls 27 that are aligned with one another and have a pair of guide grooves 30 facing each other. A flow metering roller 28 is provided having an axially extending shaft 29 that protrudes from the center of each side of the roller 28. The roller 28 is shown in outline for clarity. The shaft 29 of the roller 28 is captured and received in the guide groove 30, allowing the roller 28 to move up and down the guide groove 30, as indicated by the arrows in Figure 2.

[0021] The entire roller clamp 26 has four walls (see FIG. 1) of an open box-like structure sized and configured to receive the connector tube 24. In use, the tube 24 passes through the roller clamp 26 between two opposing side walls 27, the rollers 28, and a guide wall 31 opposite the rollers 28.

[0022] In roller clamp 26, the surface of guide wall 31 converges along the length of the guide wall downwardly toward the location of guide groove 30 (e.g., in the direction of the arrow in FIG. 2), which tends to urge connector tube 24 within roller clamp 26 toward guide groove 30, and thus toward roller 28.

[0023] Therefore, rotating the roller 28 in the direction of the arrow downward along the guide groove 30 in the direction of the gradually approaching guide wall 31 causes the roller 28 to abut against the connector tube 24. Because the tube 24 is made of a flexible material such as PVC, when the roller 28 abuts against the tube 24, the tube 24 is crushed, and therefore the inner space of the infusion tube 24 becomes narrower. In this way, by narrowing the inner space, the flow rate of the liquid passing through the connector tube 24 can be adjusted.

[0024] The roller clamp 26 thus controls the flow rate through the infusion tube 24 by clamping the infusion tube 24 between the rollers 28 and the guide wall 31. This provides a rough flow rate change, as small movements of the rollers 28 cause large changes in the fluid flow rate through the tube 24. Furthermore, the force of the fluid within the tube 24 exerts a biasing force against the rollers 28, which often leads to deviation of the rollers 28 from their adjusted position (e.g., the rollers 28 rotating back).

[0025] Additionally, roller clamp 26 must be pre-assembled with tubing 24 if tubing 24 is to be connected to infusion components, such as drip chamber 22 and Luer fitting 25. Roller clamp 26 therefore cannot be added to an IV set if tubing 24 is already connected to other components. Similarly, because roller clamp 26 is pre-assembled as part of the IV set, the roller clamp is typically discarded with the IV set and is not reused.

[0026] In embodiments of the present disclosure, a stable flow regulator assembly functions as a tubing clamp for IV tubing and IV sets, replacing a typical roller clamp. The stable flow regulator assembly provides complete clamping (e.g., zero flow) for a wide range of tubing sizes, the ability to manually and quickly release the clamping pressure with one hand to achieve complete open flow through the tubing, and the ability to gradually adjust the clamping pressure with one hand to provide a target flow rate. The stable flow regulator assembly also provides a positive locking element to maintain the target flow rate over time. Thus, once the stable flow regulator assembly is adjusted to set the fluid flow at a desired rate, the stable flow regulator assembly will maintain that setting for the entire fluid transfer process unless specifically adjusted to a different flow rate.

[0027] 3-8, a stable flow regulator assembly 100 is shown. The stable flow regulator assembly 100 includes a body 110 having a semi-rigid or rigid structure (e.g., hard plastic) sized and configured to receive tubing, such as connector tubing 24. The body 110 may be circular, as shown. The body 110 may also have any desired shape (e.g., oval, scalloped, etc.). A tube slot 120 and a spiral sliding groove 130 are disposed in the body 110. The tube slot 120 is sized to receive a desired tube size (e.g., 4 mm), allowing the body 110 to slidably couple to any location on the tube 24. The tube slot 120 may be aligned, for example, perpendicular to the tube 24, and the body 110 and the tube 24 may then be slidably moved toward each other such that the tube 24 slides along the tube slot 120 and enters the beginning 132 of the spiral slide groove 130.

[0028] Here, the size of the tube slot 120 and the beginning 132 of the spiral sliding groove 130 may have a width that causes little or no compression of the tube 24, thus allowing full fluid flow through the tube 24. The spiral sliding groove 130 may narrow in width as it spirals inward through the body 110 toward the closed end 134 of the spiral sliding groove 130. The spiral sliding groove 130 may vary, for example, from a starting width of 4 mm and narrow to a width of 0.15 mm as it approaches the center of the body 110. Thus, as the tube 24 is slidably moved along the spiral sliding groove 130 from the beginning 132 to the closed end 134, the tube 24 is further compressed such that fluid flow within the tube 24 is correspondingly reduced. The frictional force between the tube 24 and the sides of the spiral sliding groove 130 may be sufficient to hold the tube 24 in a predetermined position within the spiral sliding groove 130 at any position where the tube 24 is engaged and / or compressed against the sides of the spiral sliding groove 130.

[0029] Compression of the tubing 24 causes the tubing 24 to become completely occluded (e.g., little or no fluid flow) at some point in the spiral sliding groove 130. The varying width of the spiral sliding groove 130 provides the ability to function with tubing 24 of various sizes (e.g., 1 mm to 4 mm). The stable flow regulator assembly 100 can therefore be used with a variety of different IV tubing 24 and / or IV sets. Thus, a single size stable flow regulator assembly 100 can be manufactured, distributed, and stocked for use in any number of plumbing situations, thereby providing a lower cost flow control component for IV sets.

[0030] One or more flaps 122 may be coupled to the body 110 within the tube slot 120 or may extend from the body 110 within the tube slot 120. The flaps 122 may bend inward or toward the sides of the tube slot 120 when the tube 24 is slidably moved into the tube slot 120. The flaps 122 may be prevented from bending outward from the body 110 and / or may maintain an inward, angled facing orientation after the tube 24 passes through the flaps 122, thereby preventing the tube 24 from passing back out of the body 110 through the tube slot 120.

[0031] Grip 112 may be disposed on the outer edge of body 110. Grip 112 may be a plurality of protrusions that protrude outward from body 110 and provide a textured surface that can be easily positioned, grasped, and turned with the hand (e.g., thumb, fingers), as shown in Figure 3. Grip 112 may be any suitable surface (e.g., toothed, rubbery, adhesive material) to enhance gripping and / or turning of body 110 of stable flow regulator assembly 100.

[0032] Retaining members 114 may be disposed on one or both sides of body 110. Retaining members 114 may be, for example, a series of bumps or protrusions disposed along the inner surface of spiral sliding groove 130. Retaining members 114 may also be arranged in any suitable pattern (e.g., along the outer surface of spiral sliding groove 130, along grips 112 on the outer edge of body 110).

[0033] The tube arm 140 is coupled to the body 110. For example, a shaft 142 of the tube arm 140 may be rotatably coupled through a shaft hole 116 in the body 110. The shaft 142 may have a snap member 144 (e.g., a sloped sidewall) that bends inward as the shaft 142 passes through the shaft hole 116 and bends outward on the opposite side of the shaft hole 116 to secure the tube arm 140 to the body 110. The tube arm 140 may have opposing arm sections 146a, 146b connected together by a hinge member 148 (e.g., a living hinge), as shown in FIG. 8 . The tube arm 140 may thus be connected to the body 110 by inserting the shaft 142 on the arm section 146a through the shaft hole 116, folding the opposite arm section 146b via the hinge member 148 around the outer edge of the body 110, and inserting the snap member 144 through the receiving hole 147 on the opposite arm section 146b, such that the snap member 144 secures the opposing arm sections 146a, 146b together to provide a secure rotational connection between the tube arm 140 and the body 110.

[0034] Arm retaining members 149 (e.g., ridges, protrusions) may be disposed on arm sections 146a, 146b for interacting with retaining members 114 on body 110. Arm retaining members 149 may be configured to rise and ride over engaged retaining members 114 based on a rotational force applied, for example, by rotating tube arm 140 relative to body 110. Arm retaining member 149 may thus be maintained between two retaining members 114 until sufficient force is applied to tube arm 140 to move arm retaining member 149 past one of the two retaining members 114. In this way, the interaction of arm retaining member 149 with retaining members 114 provides an additional securing element in addition to the frictional force between tube 24 and the sides of helical sliding groove 130.

[0035] The tube arm 140 also includes a slot 145 configured to receive the tube 24. The slot 145 in the tube arm 140 may be the same size (e.g., width) as the tube slot 120 in the body 110. Thus, when the tube 24 is disposed in the slot 145, the tube 24 is not or only slightly compressed by the tube arm 140, which provides a situation in which most or all of the compression of the tube 24 is due to the spiral sliding groove 130. The arm sections 146a, 146b and the hinge member 148 may collectively include sides 141 that define the slot 145. For example, when the tube arm 140 is in an extended position (e.g., not connected to the body 110), the arm sections 146a, 146b and the hinge member 148 may be linearly aligned, defining the slot 145 as an enclosed channel. When tube arm 140 is fully connected to body 110 (e.g., folded over the outer edge of body 110 and snapped together), slot 145 opens to the outer edge of body 110, thus providing a path for tube 24 to slide into body 110 when slot 145 is aligned with tube slot 120.

[0036] In aspects of the present disclosure, indicator indicia 118 may be disposed on body 110 (see FIG. 7 ) to provide a visual indication of the expected fluid flow rate at various positions of tube 24 within spiral sliding groove 130. Indicator indicia 118 may be any suitable indicia (e.g., text, graphics, shape, color) that quickly and easily communicates the fluid flow rate of tube 24 at that position within spiral sliding groove 130.

[0037] In use, the combined or assembled body (e.g., body 110) and tube arm (e.g., tube arm 140) of a stable flow regulator assembly (e.g., stable flow regulator assembly 100) are slid against a tube (e.g., tube 24). The tube passes through an opening in the body (e.g., tube slot 120) and an opening in the tube arm (e.g., slot 145), and then slides into a groove (e.g., spiral slide groove 130) where the tube is in an open-flow / uncompressed state (see FIG. 5). The tube is then slid along the groove until the tube is collapsed (e.g., occluded, compressed) to an amount that results in a desired flow rate of fluid through the tube (see FIG. 6). For example, as shown in FIG. 15, the tube arms may be grasped in one hand (e.g., between the thumb and index finger) on either side of the body, and the body may be rotated relative to the tube arms with another finger (e.g., index finger) of the same hand. The stable flow regulator assembly may thus be quickly and easily operated with one hand, leaving the user's other hand available to handle other tasks.

[0038] As the body is rotated (e.g., as the body 110 is rotated relative to the tube arm 140), the tube slides along the groove and is either further compressed (e.g., compressed between the narrowing sides of the spiral sliding groove 130) or widened (e.g., expanded by the widening sides of the spiral sliding groove 130). Thus, the compressive pressure of the tube increases or decreases based on the direction the tube is moved within the groove, and reduced or increased fluid flow, respectively, may pass through the tube. The flow rate can be adjusted to different flow rates by rotating the body relative to the tube arm, i.e., by changing the amount of compression of the tube by the sides of the groove. In other words, the amount of compression of the tube depends on the position of the tube within the groove, which provides different flow rates to be selected.

[0039] In embodiments of the present disclosure, the stable flow regulator assembly 100 may provide various advantages over typical roller clamps. The stable flow regulator assembly 100 provides complete clamping of a wide range of tubing sizes, for example, by having a consistently narrowing groove to provide a targeted range of compression across various tubing thicknesses or widths. In embodiments of the present disclosure, the stable flow regulator assembly 100 prevents or minimizes drift in fluid flow rate once the tubing is set into position within the body 110. The stable flow regulator assembly 100 also provides a way to quickly manually release all of the compression pressure and allow complete open flow through the tubing (e.g., the tubing 24 is moved to the beginning 132 of the spiral slide groove 130).

[0040] The stable flow regulator assembly 100 additionally provides a way to gradually release the compression pressure (e.g., the tube 24 is moved along the spiral slide groove 130 toward the starting end 132) to allow the target flow rate to be achieved. The stable flow regulator assembly 100 further provides an ergonomic human interface (e.g., the main body 110 and the tube arm 140) that allows for efficient and easy operation with one hand.

[0041] In an embodiment of the present disclosure, as shown in FIG. 9 , the stable flow regulator assembly 100 may include a locking member 150 that may be coupled to the body 110 instead of or in addition to the flap 122. The locking member 150 may be, for example, a removable clip that snaps into position over the tube slot 120 when the tubing 24 is far enough within the tube slot 120 or within the spiral slide groove 130, thereby preventing the tubing 24 from disengaging from the body 110. When the use of the tubing 24 or the IV set of which the tubing 24 is a part has ended, the locking member 150 may be opened (e.g., unclipped) so that the stable flow regulator assembly 100 can be removed from the tubing 24 and reused with another tubing or IV set. The locking member 150 may be any suitable structure (e.g., a rotating arm, a rotating clip, a removable clip, adhesive tape).

[0042] In an embodiment of the present disclosure, as shown in FIG. 10 , the stable flow regulator assembly 100 may include ratchet teeth 113 disposed on one or both sides of the body 110. The ratchet teeth 113 may be configured to interact with the tube arm 140. For example, the arm retaining member 149 may be sized and shaped (e.g., cantilevered, angled) to provide less resistance to one rotational direction of the tube arm 140 than to the opposite rotational direction of the tube arm 140, based on engagement between the arm retaining member 149 and the ratchet teeth 113. Here, the rotational direction of greater resistance may be configured to prevent or minimize rotational drift of the tube arm 140 due to fluid flow pressure within the tube 24. The ratchet teeth 113 may therefore be used in addition to or instead of the retaining member 114 to maintain the tube arm 140 in a desired position, thereby maintaining the compression of the tube 24 and the resulting fluid flow rate at a set level. In embodiments of the present disclosure, the resistance force of the ratchet teeth 113 and / or retaining member 114 on the tube arm 140 can be overcome by applying sufficient force to the tube arm 140 or the body 110 (e.g., by manually rotating the body 110 relative to the tube arm 140). Thus, the position of the tube arm 140 can be adjusted to any suitable position within the spiral sliding groove 130 to obtain a desired flow rate of the fluid in the tube 24.

[0043] In an embodiment of the present disclosure, as shown in FIG. 11 , the stable flow regulator assembly 100 may include a flap 115 disposed on one or both sides of the body 110 near the outer edge of the body 110. The flap 115 may be configured to interact with the tube arm 140. For example, opposing arm sections 146 a, 146 b may extend beyond the outer edge of the body 110, and an arm retaining member 149 may be sized and shaped (e.g., cantilevered, angled) to provide less resistance to one rotational direction of the tube arm 140 than to the opposite rotational direction of the tube arm 140 upon engagement of the arm retaining member 149 with the flap 115. Here, the rotational direction of greater resistance may be configured to prevent or minimize rotational drift of the tube arm 140 due to fluid pressure within the tube 24. The flap 115 may therefore be used in addition to or instead of the retaining member 114 to maintain the tube arm 140 in a desired position, thereby maintaining the compression of the tube 24 and the resulting fluid flow rate at a set level. In embodiments of the present disclosure, the resistance force of the flap 115 and / or retaining member 114 on the tube arm 140 may be overcome by applying sufficient force to the tube arm 140 or the main body 110 (e.g., manually rotating the main body 110 relative to the tube arm 140). In embodiments of the present disclosure, the flap 115 may be rigid, semi-rigid, or flexible and may be configured to facilitate better rotation of the main body 110 relative to the tube arm 140. Thus, the position of the tube arm 140 may be adjusted to any suitable position within the spiral sliding groove 130 using the flap 115 to achieve a desired fluid flow rate within the tube 24.

[0044] In embodiments of the present disclosure, as shown in FIG. 12 , the stable flow regulator assembly 100 may include flaps 143 disposed on one or both sides of the tube arm 140. The flaps 143 may be rigid or semi-rigid and may facilitate better rotation of the body 110 relative to the tube arm 140. The flaps 143 may, for example, provide the tube arm 140 with a larger surface area to provide additional support for gripping the stable flow regulator assembly 100, allowing the body 110 to be more easily rotated.

[0045] In an embodiment of the present disclosure, as shown in FIG. 13 , a stable flow regulator assembly 200 may include a body 210, an enclosed spiral sliding groove 230, and a tube arm 240 rotatably coupled to the body 210 by a shaft 242 disposed through a shaft hole 216. A grip 212 on the outer edge of the body 210 may be in the form of a tooth 214 having an inclined or cantilevered portion 217 and a vertical (e.g., perpendicular) portion 218. The outer end of the tube arm 240 may include an arm retaining member 250 including a stop member 252 configured to extend inward and engage the grip 212. The stop member 252 may have, for example, an inclined or cantilevered protrusion 254 that can ride along the inclined or cantilevered portion 217 of the tooth 214 in one rotational direction and a vertical stop portion 256 that can abut the vertical portion 218 of the tooth 214 in the opposite rotational direction. The gripping members 258 of the stop member 252 may extend outward to provide an ergonomic gripping surface for moving the tube arm 240. The tube arm 240 also includes a slot 245 configured to receive the tube 24.

[0046] In use, the tube 24 may be inserted through the slot 245 into the spiral slide groove 230 (e.g., similar to threading a needle), and the tube arm 240 may be rotated by pushing the gripping member 258 in a desired direction, rotating the tube arm 240 and thereby sliding the tube 24 along the spiral slide groove 230. The stop member 252 may move in a ratcheting manner along the teeth 214. Once the tube 24 is in a desired position within the spiral slide groove 230, the expansive force of fluid flow within the tube 24 may tend to urge the tube arm 240 toward the wider end of the spiral slide groove 230, but the vertical stop portion 256 abutting the vertical portion 218 of the adjacent tooth 214 prevents movement of the tube arm 240 and the tube 24 in that direction. Likewise, any further compressive force that moves the tube 24 in the narrowing direction of the spiral slide groove 230 will also prevent further movement of the tube arm 240 and the tube 24 in that direction. In this way, drift of the tube 24 from its set position within the spiral slide groove 230 is prevented or minimized.

[0047] 14, a method 300 of operating a stable flow regulation assembly (e.g., stable flow regulation assembly 100, 200) is provided. In step 310, tubing (e.g., IV tubing 24) is placed or inserted into the body (e.g., body 110, 210) such that the tubing is disposed within the spiral sliding groove (e.g., groove 130, 230). In step 320, the tubing is further disposed within a slot (e.g., tube arm slot 145, 245) of a tube arm (e.g., tube arm 140, 240) rotatably coupled to the body.

[0048] In step 330, the stable flow regulator assembly is grasped by hand so that the tube arms are grasped on either side of the body (e.g., with the thumb and middle finger of one hand) and the body is engaged with the fingers of another hand (e.g., the index finger of the same hand), as shown in Figure 15. In step 340, the body is rotated by hand (e.g., by rotating the body relative to the tube arms).

[0049] In step 350, the position of the tubing within the spiral slide groove is adjusted to produce the desired flow rate by rotating the body relative to the tube arm until the slot width of the spiral slide groove compresses the tubing the appropriate amount to achieve the desired flow rate. For example, with respect to the stable flow regulator assemblies 100, 200, as the body 110, 210 is rotated relative to the tube arm 140, 240, the width of the spiral slide groove 130, 230 narrows or widens, depending on which direction the body 110 is rotated, causing the tubing 24 within the spiral slide groove 130, 230 to compress more or less, respectively.

[0050] Non-pressure rated tubing is typically made with similar wall thicknesses. In embodiments of the present disclosure, the stable flow regulator assemblies 100, 200 can have varying amounts of compression (e.g., varying gap sizes in the spiral grooves 130, 230). Accordingly, the stable flow regulator assemblies 100, 200 may operate with small, medium, and large tubing 24 diameters or thicknesses. The varying gap sizes may include, for example, small, medium, and large gap widths of 0.027 mm, 0.036 mm, and 0.050 mm, respectively. As another example, the varying gap sizes may include small, medium, and large gap widths of 0.015 mm, 0.020 mm, and 0.030 mm, respectively. The gap sizes may therefore be designed according to the desired size of the tubing 24 anticipated and / or required. Thus, for example, a tubing with the widest desired width may not be compressed at the widest end of the spiral slide groove 130, 230 but may be fully compressed halfway along the spiral slide groove 130, 230, while a narrower tubing may not be compressed one-third of the way along the spiral slide groove 130, 230 but may be fully compressed two-thirds of the way along the spiral slide groove 130, 230.

[0051] In embodiments of the present disclosure, the outward or expansive force due to fluid flow and / or the expansibility of the tubing is radially outward. Therefore, the reaction force from the compressed tubing does not act on the tube arm along the path of the helical sliding groove, and a tangential force must be applied by the user to rotate the tube arm relative to the body. In embodiments of the present disclosure, the stable flow regulator assembly may be configured to interface with and / or be engaged by an automated device. For example, the tube arm sections on both sides of the body may be gripped or clamped by a motorized device, and a pusher member may be engaged with the body, such that turning the motor causes the pusher member to rotate the body relative to the tube arm accordingly.

[0052] In embodiments of the present disclosure, positive locking elements (e.g., retaining member 114 and arm retaining member 149) may be provided to prevent or minimize accidental movement of the body relative to the tube arm. In embodiments of the present disclosure, the positive locking elements may provide audible feedback when the body is rotated relative to the tube arm. For example, movement of arm retaining member 149 relative to retaining member 114 may produce a clicking sound (e.g., like the rotation of a padlock).

[0053] 16-23, a stable flow regulator assembly 400 is shown. The stable flow regulator assembly 400 includes a body 410 having a semi-rigid or rigid structure (e.g., hard plastic) and is sized and configured to receive tubing, such as connector tubing 24. The body 410 may be circular, as shown. The body 410 may also have any desired shape (e.g., oval, scalloped, etc.). A tube retainer 420 may extend from an outer edge 412 of the body, the tube retainer 420 having an opening configured to receive the tubing 24. A radial tube groove 430 is disposed in the body 410, such as around a portion of the outer edge 412 of the body 410. The radial tube groove 430 is sized to receive a desired tubing size (e.g., 4 mm), allowing the body 410 to be coupled to the tubing 24 at any location. The radial tube grooves 430 may, for example, be axially aligned with the tube 24, which may then be wrapped around the body 410 so that the tube 24 slides into the radial tube grooves 430 around the outer edge 412.

[0054] Here, the starting ends 432 of the radial tube grooves 430 may be sized to have a depth that fully accommodates the tubes 24 and thus causes little or no compression of the tubes 24, allowing full fluid flow through the tubes 24. The radial tube grooves 430 may decrease in depth as the tubes wrap around the outer edge 412 of the body 410 toward the closed ends 434 of the radial tube grooves 430. The radial tube grooves 430 may, for example, vary from a starting depth of 4 mm and decrease to a depth of 0.15 mm at the closed ends 434. Thus, as the tubes 24 are disposed within the radial tube grooves 430 from the starting ends 432 to the closed ends 434, the tubes 24 may be further compressed such that fluid flow within the tubes 24 is correspondingly reduced. The tension on the tube 24 disposed within the radial tube groove 430 and / or the frictional force from the tube retainer 420 on the tube 24 may be sufficient to hold the tube 24 in place within the radial tube groove 430 around the outer edge 412 of the body 410.

[0055] Compression of the tubing 24 may cause the tubing 24 to become completely occluded (e.g., little or no fluid flow) at certain points in the radial tubing grooves 430. The varying depth of the radial tubing grooves 430 provides the ability to function with tubing 24 of various sizes (e.g., 1 mm to 4 mm). The stable flow regulator assembly 400 may therefore be used with a variety of different IV tubing 24 and / or IV sets. Thus, a single size stable flow regulator assembly 400 may be manufactured, distributed, and stocked for use in any number of plumbing situations, thereby providing a lower cost flow control component for IV sets.

[0056] The retention members 414 may be disposed on one or both sides of the body 410. The retention members 414 may be, for example, a series of bumps or protrusions disposed along the outer edge 412 of the body 410. The retention members 414 may be arranged in any suitable pattern (e.g., evenly spaced along the outer edge 412). The body 410 may have an open cavity 411, as shown in FIG. 21 . The body 410 may be, for example, a three-dimensional structure or other suitable structure.

[0057] The tube arm 440 is coupled to the body 410. For example, a shaft 442 of the tube arm 440 may be rotatably coupled through a shaft hole 416 in the body 410. The shaft 442 may have snap members 444 (e.g., sloped sidewalls) that flex inward as the shaft 442 passes through the shaft hole 416 and flex outward on the opposite side of the shaft hole 416 to secure the tube arm 440 to the body 410. The tube arm 440 may have opposing arm sections 446a, 446b connected together by a hinge member 448 (e.g., a living hinge), as shown in FIG. 22 . The tube arm 440 may therefore be coupled to the body 410 by inserting the shaft 442 on the arm section 446a through the shaft hole 416, folding the opposite arm section 446b around the outer edge of the body 410 via the hinge member 448 (see FIG. 23 ), and inserting the snap member 444 through the receiving hole 447 on the opposite arm section 446b, such that the snap member 444 secures the opposing arm sections 446a, 446b together and provides a secure rotational connection between the tube arm 440 and the body 410.

[0058] Arm retaining members 449 (e.g., ridges, protrusions) may be disposed on arm sections 446a, 446b for interacting with retaining members 414 on body 410. Arm retaining members 449 may be configured to rise and ride over engaged retaining members 414 based on a rotational force applied, for example, by rotating tube arm 440 relative to body 410. Arm retaining member 449 may thus be held between two retaining members 414 until sufficient force is applied to tube arm 440 to move arm retaining member 449 past one of the two retaining members 414. In this manner, the interaction of arm retaining member 449 with retaining members 414 provides an additional securing element in addition to the tension and frictional forces applied to tube 24 within radial tube grooves 430.

[0059] The tube arms 440 may also include a pressing member 445 configured to press against the tube 24. The pressing member 445 of the tube arms 440 may be the same size (e.g., length) as the thickness of the body 110, the width of the hinge member 448, or any other suitable length. The pressing member 445 may be semi-cylindrical in shape, as shown in FIG. 22, or any other shape suitable for pressing against the tube 24. Thus, when the tube 24 is disposed within the radial tube grooves 430, when the pressing member 445 is located over the starting end 432, the tube 24 is not or only slightly compressed by the pressing member 445 of the tube arms 440, whereas when the pressing member 445 is located over the closed end 434, the tube 24 is fully or very strongly compressed by the pressing member 445. Here, the rounded surface of the pressing member 445 can provide the pressing member 445 with the ability to slidably move along the tube 24 when the tube arm 440 is rotated relative to the body 410, or the body 410 is rotated relative to the tube arm 440, or both.

[0060] In an embodiment of the present disclosure, indicator indicia 418 may be disposed on body 410 (see FIG. 20 ) to provide a visual indication of the expected fluid flow rate at various positions of push member 445 along tube 24 within radial tube groove 430. Indicator indicia 418 may be any suitable indicia (e.g., text, graphics, shape, color) that quickly and easily communicates the fluid flow rate of tube 24 at that position of tube arm 440 along radial tube groove 430.

[0061] In use, the combined or assembled body (e.g., body 410) and tube arm (e.g., tube arm 440) of a stable flow regulator assembly (e.g., stable flow regulator assembly 400) receives a tube (e.g., tube 24). The tube is then slid over and wrapped around the outer edge (e.g., outer edge 412) of the body and placed within a groove (e.g., radial tube groove 430). The portion of the tube not within the groove is forced under a tube retainer (e.g., tube retainer 420), which holds the tube in place around the outer edge of the body. The tube can then be in an open-flow / uncompressed state (see FIG. 18) because the depth of the groove prevents a pressing member (e.g., pressing member 445) from making any or minimal contact with the tube. The tube arms are rotated relative to the body (see FIG. 19) until the tube is crushed (e.g., occluded or compressed) by the pressing protrusions (e.g., pressing members 445) to an amount that results in a desired flow rate of fluid through the tube. For example, as shown in FIG. 27, the tube arms may be grasped in one hand (e.g., between the thumb and index finger) on either side of the body, and the body is rotated relative to the tube arms with another finger (e.g., the index finger) of the same hand. The stable flow regulator assembly may thus be quickly and easily operated with one hand, leaving the user's other hand available to handle other tasks.

[0062] As the body is rotated (e.g., body 410 is rotated relative to tube arms 440), the pressure member slides along the tubes within the grooves, causing the tubes to be further compressed (e.g., compressed between pressure member 445 and the shallower depth of radial tube grooves 430) or widen (e.g., expanded due to the increased depth of radial tube grooves 430). Thus, the compression pressure on the tubes increases or decreases based on the direction the tube arms are moved around the grooves, resulting in a decreased or increased fluid flow, respectively, through the tubes. The flow rate can be adjusted to various flow rates by rotating the body relative to the tube arms, i.e., varying the amount of tube compression depending on the depth of the grooves. In other words, the amount of tube compression depends on the position of the pressure member relative to the tubes within the grooves, providing various flow rates to be selected.

[0063] In embodiments of the present disclosure, the stable flow regulator assembly 400 may provide various advantages over typical roller clamps. The stable flow regulator assembly 400 provides complete clamping for a wide range of tubing sizes, for example, by having consistently shallower grooves to provide a targeted range of compression across various tubing thicknesses or widths. In embodiments of the present disclosure, the stable flow regulator assembly 400 prevents or minimizes drift in fluid flow rate once the tube arm 440 is set in position on the body 410. The stable flow regulator assembly 400 also provides a way to quickly manually release all of the compression pressure and allow complete open flow through the tubing (e.g., the tube arm 440 / pressure member 445 is moved to the beginning 432 of the radial tube groove 430).

[0064] The stable flow regulator assembly 400 additionally provides a way to gradually release the compression pressure (e.g., the tube arm 440 is moved along the radial tube groove 430 toward the starting end 432) to allow the target flow rate to be achieved. The stable flow regulator assembly 400 further provides an ergonomic human interface (e.g., the main body 410 and the tube arm 440) that provides efficient and easy operation with one hand.

[0065] In an embodiment of the present disclosure, as shown in FIG. 24 , the stable flow regulator assembly 400 may include a locking member 450 that may be coupled to the main body 410 instead of or in addition to the tube retainer 420. The locking member 450 may be, for example, a removable clip that snaps into place over the outer edge 412 when the tubing 24 is disposed within the radial tube groove 430, thereby preventing the tubing 24 from disengaging from the main body 410. When the use of the tubing 24 or the IV set of which the tubing 24 is a part has ended, the locking member 450 may be opened or removed (e.g., unclipped or pulled out) so that the stable flow regulator assembly 400 can be removed from the tubing 24 and reused with another tubing or IV set. The locking member 450 may be any suitable structure (e.g., a rotating arm, a rotating clip, a removable clip, adhesive tape).

[0066] 25, the stable flow regulator assembly 400 may include a movable roller 460 that may be coupled to the body 440 instead of the pressing member 445. The movable roller 460 may be configured to spin within the tube arm 440 (e.g., on a shaft between opposing arm sections 446a and 446b), for example. Here, the movable roller 460 may compress the tube 24 with a force factor similar to that of a conventional roller clamp, for example.

[0067] In an embodiment of the present disclosure, as shown in FIG. 26 , the stable flow regulator assembly 400 may include fasteners 470 (e.g., hooks) disposed on portions of the outer edge 412 to align the remaining tubing as needed. For example, two fasteners 470 may be coupled to opposite ends of the body 410 to align the incoming and outgoing tubing 24 with the shaft bore 416. As another example, the fasteners 470 may be used to hold the tubing 24 against only a portion (e.g., 90 degrees, 270 degrees) of the outer edge 412 of the body 410. Here, the radial tube grooves 430 may be configured as previously shown, or may be shortened to coincide with the portion of the outer edge 412 that carries the tubing.

[0068] 28, a method 500 of operating a stable flow regulation assembly (e.g., stable flow regulation assembly 400) is provided. In step 510, tubing (e.g., IV tubing 24) is placed or inserted into the main body (e.g., main body 410) such that the tubing is disposed within the radial tube grooves (e.g., radial tube grooves 430). In step 520, the tubing is further secured by a tube retainer (e.g., tube retainer 420) and disposed under a pushing member (e.g., pushing member 445) of a tube arm (e.g., tube arm 440) rotatably coupled to the main body.

[0069] In step 530, the stable flow regulator assembly is grasped by hand such that the tube arms are grasped on either side of the body (e.g., with the thumb and middle finger of one hand) and the body is engaged with the fingers of another hand (e.g., the index finger of the same hand), as shown in Figure 27. In step 540, the body is rotated by hand (e.g., by rotating the body relative to the tube arms).

[0070] In step 550, the position of the compression member relative to the tubes in the radial tube grooves is adjusted to produce the desired flow rate by rotating the body relative to the tube arms until the depth of the radial tube grooves compresses the tubing a suitable amount to achieve the desired flow rate. For example, with respect to stable flow regulator assembly 400, as body 410 is rotated relative to tube arms 440, the depth of radial tube grooves 430 becomes shallower or deeper, depending on which direction body 410 is rotated, causing more or less compression, respectively, of tubes 24 within radial tube grooves 430.

[0071] In embodiments of the present disclosure, the stable flow regulator assembly 100, 200, 400 achieves a very small (e.g., less than 5 degrees) angle between the normal to the helix and the normal to the circle (e.g., the outer edge of the body 110, 210, 410). In embodiments of the present disclosure, the outward biasing force from the compressed tube 24 is radial, which prevents tangential forces from being exerted on the tube arms 140, 240, 440, thereby preventing or minimizing drift along the outer edge of the body 110, 210, 410 due to the outward biasing force of the tube arms 140, 240, 440. Therefore, an external tangential force (e.g., by manual force from a finger) must be applied to rotate the tube arms 140, 240, 440. In embodiments of the present disclosure, a positive locking function is provided by the interaction of the retaining member 114, 414 with the arm retaining member 149, 449. This interaction also provides audible feedback (e.g., a click) when the tube arm 140, 240, 440 is rotated.

[0072] In one or more embodiments of the present disclosure, a stable flow regulator assembly includes a body including a tube slot disposed adjacent an outer edge of the body, the tube slot having an opening at its outer edge for slidably receiving a portion of intravenous (IV) tubing, and a helical sliding groove extending from the tube slot into the body, the width of the helical sliding groove narrowing as the helical sliding groove extends further into the body; and a tube arm rotatably coupled to the body, the tube arm having a slot opening to the outer edge of the body, the tube arm configured to slidably receive the IV tubing when the slot is aligned with the tube slot of the body, wherein the stable flow regulator assembly is configured to regulate a flow rate of a fluid through the IV tubing based on an amount of compression of the IV tubing due to a position of the IV tubing within the helical sliding groove.

[0073] In an embodiment of the present disclosure, the tube arm includes a shaft rotatably coupled through a shaft hole in the body. In an embodiment of the present disclosure, the shaft includes a snap member configured to compress when the shaft passes through the shaft hole and expand when the snap member exits the shaft hole on the opposite side of the body. In an embodiment of the present disclosure, the tube arm includes opposing arm sections connected together by a hinge member, the shaft and snap member disposed in a first arm section, a receiving hole disposed in a second arm section, the second section configured to fold over an outer edge of the body via the hinge member, and the snap member disposed through the receiving hole. In an embodiment of the present disclosure, the first and second arm sections and the hinge member collectively have two sides that define a slot in the tube arm.

[0074] In an embodiment of the present disclosure, a plurality of retaining members are disposed on at least one side surface of the body, the plurality of retaining members being spaced apart along a portion of the spiral sliding groove. In an embodiment of the present disclosure, the tube arm includes one or more arm retaining members configured to slidably engage with the plurality of retaining members on the body. In an embodiment of the present disclosure, a plurality of indicator marks are disposed on at least one side surface of the body, the plurality of indicator marks being spaced apart along one of a portion of the spiral sliding groove and an outer edge of the body. In an embodiment of the present disclosure, the spiral sliding groove has a widest width of 4 mm and a narrowest width of 0.15 mm. In an embodiment of the present disclosure, at least one flap extends from the body into the tube slot, the at least one flap being configured to bend inward to allow slidable lateral movement of the tube into the tube slot and to bend back to an initial position to prevent slidable lateral movement of the tube back out of the body.

[0075] In an embodiment of the present disclosure, a locking member is coupled to the body and movably disposed on the tube slot, the locking member being spaced apart from the tube slot in a first position for slidable passage of the tube into the tube slot, and the locking member being disposed to prevent slidable passage of the tube from the body in a second position. In an embodiment of the present disclosure, a grip is disposed on an outer edge of the body, the grip including a plurality of protrusions extending radially outward from the body. In an embodiment of the present disclosure, a plurality of ratchet teeth are disposed on at least one side surface of the body, the plurality of ratchet teeth being spaced around a portion of the spiral slide groove and configured to ratchetly engage with the tube arm. In an embodiment of the present disclosure, a plurality of flaps are disposed on at least one side surface of the body, the plurality of flaps being spaced around an outer edge of the body and extending outward beyond the outer edge of the body. In an embodiment of the present disclosure, one or more flaps are disposed on the tube arm.

[0076] In one or more embodiments of the present disclosure, a stable flow regulator assembly includes a body having a helical sliding groove extending into the body and surrounded by an outer edge of the body, the width of the helical sliding groove narrowing as the helical sliding groove extends further into the body; a plurality of teeth disposed on the outer edge of the body; and a tube arm rotatably coupled to the body, the tube arm having a slot opening into the helical sliding groove and configured to slidably receive an intravenous (IV) tubing when the slot is aligned with a portion of the helical sliding groove having a width equal to or wider than a diameter of the IV tubing, wherein the stable flow regulator assembly is configured to regulate a flow rate of a fluid through the IV tubing based on an amount of compression of the IV tubing due to a position of the IV tubing within the helical sliding groove.

[0077] In an aspect of the present disclosure, each of the plurality of teeth has an inclined portion and an orthogonal portion, and the tube arm includes a stop member having a corresponding inclined portion and a corresponding orthogonal portion, the stop member configured to rotatably engage with the plurality of teeth in a ratcheting manner.

[0078] In one or more embodiments of the present disclosure, a stable flow regulator assembly includes a body including a tube retainer disposed adjacent an outer edge of the body, the tube retainer having an opening for slidably receiving a portion of an intravenous (IV) tube, and radial tube grooves extending into the body around a portion of the outer edge of the body, the radial tube grooves decreasing in depth from the initial end to the closed end; and a tube arm rotatably coupled to the body, the tube arm having a pressing member facing the outer edge of the body and configured to slidably compress the IV tube when the tube arm is rotated while the IV tubing is disposed in the radial tube grooves, wherein the stable flow regulator assembly is configured to regulate a flow rate of a fluid through the IV tubing based on an amount of compression of the IV tubing due to a position of the pressing member relative to the IV tubing within the radial tube grooves.

[0079] In one or more embodiments of the present disclosure, a method of operating a stable flow regulator assembly includes the steps of inserting an intravenous (IV) tube into a slot of a tube arm rotatably coupled to a body; inserting the IV tube into a spiral sliding groove disposed within the body of the stable flow regulator assembly while the inserted IV tube is not compressed by the side walls of the spiral sliding groove; rotating the tube arm relative to the body to slide the IV tube along a varying width of the spiral sliding groove; and stopping the rotation of the tube arm relative to the body when the IV tube is positioned within a specific width of the spiral sliding groove, where the resulting compression of the IV tube corresponds to a specific flow rate of fluid through the IV tube.

[0080] In one or more embodiments of the present disclosure, a method of operating the stable flow regulator assembly includes wrapping intravenous (IV) tubing around the outer edge of the body, receiving the IV tubing within the radial tube grooves, holding the tubing in place with a tube retainer, inserting the shaft of a tube arm into the shaft hole of the body, folding the tube arm around the tubing disposed within the outer edge of the body and the radial tube grooves, inserting a snap member on the shaft of the tube arm into the receiving hole of the folded tube arm, rotating the tube arm relative to the body to slide a pressing member along the IV tubing at varying depths in the radial tube grooves, and stopping the rotation of the tube arm relative to the body when the pressing member is positioned against the IV tubing within a specific depth of the radial tube groove, where the resulting compression of the IV tubing corresponds to a specific flow rate of fluid through the IV tubing.

[0081] It should be understood that any particular order or hierarchy of blocks in the disclosed process methods is an example of an exemplary approach. Based on design or implementation preferences, it should be understood that the particular order or hierarchy of blocks in the processes may be rearranged, or all illustrated blocks may be performed. In some implementations, any of the blocks may be performed simultaneously.

[0082] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. This disclosure presents various examples of the technology, and the technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other aspects.

[0083] Reference to an element in the singular is intended to mean "one or more" rather than "one and only one" unless specifically so stated. 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 for convenience only and are not intended to 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 preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0085] As used herein, the phrase "at least one" preceding a list of items, with the term "or" separating any of the items, modifies the list as a whole, not each member of the list. The phrase "at least one" does not require the selection of at least one item, but rather allows the phrase to mean including at least one of any one of the items, at least one of any combination of the items, and / or at least one of each of the items. By way of example, 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.

[0086] Use of a phrase such as "aspect" does not imply that such aspect is essential to the technology or that such aspect applies to all configurations of the technology. Disclosure of one aspect may apply to all configurations, or to one or more configurations. One aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects, and vice versa. Use of a phrase such as "embodiment" does not imply that such embodiment is essential to the technology or that such embodiment applies to all configurations of the technology. Disclosure, elements, or features of one embodiment may apply to all embodiments, or to one or more embodiments. One embodiment may provide one or more examples. Such a phrase, "one embodiment," may refer to one or more embodiments, and vice versa. Use of a phrase such as "configuration" does not imply that such configuration is essential to the technology or that such configuration applies to all configurations of the technology. Disclosure of one configuration may apply to all configurations, or to one or more configurations. One configuration may provide one or more examples. The phrase "such a configuration" may refer to one or more configurations, and vice versa.

[0087] In one aspect, unless otherwise specified, all measurements, values, ratings, locations, dimensions, sizes, and other specifications set forth in this specification, including those in the following claims, are approximate and not exact, and are intended to have a reasonable range consistent with the function to which they relate and that which is customary in the art to which they pertain.

[0088] It is understood that the specific order or hierarchy of steps, operations, or processes disclosed is an illustration of an example approach. It is understood that the specific order or hierarchy of steps, operations, or processes may be rearranged based on design preferences. Some of the steps, operations, or processes may be performed simultaneously. Some or all of the steps, operations, or processes may be performed automatically without user intervention. The accompanying claimed methods present the various steps, operations, or process elements, if any, in an example order, and are not intended to be limited to the specific order or hierarchy presented.

[0089] 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 of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is expressly recited in the claims. A claimed element is not 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 claim, unless the element is recited using the phrase "step for." Furthermore, to the extent the terms "comprise," "have," and the like are used, such terms are intended to be inclusive in the same manner as the term "comprises" is construed when used as a transitional term in a claim.

[0090] The "Title," "Background," "Summary," "Brief Description of the Drawings," and "Abstract" of this disclosure are hereby incorporated into this disclosure and are presented as illustrative examples of the disclosure, not as a limiting description. They are presented with the understanding that they will not be used to limit the scope or meaning of the claims. Additionally, in the "Description," it will be understood that the description presents illustrative examples, and that various features, in various embodiments, have been grouped together to streamline 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 each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The following claims are hereby incorporated into the "Description," with each claim standing on its own as separately claimed subject matter.

[0091] The claims are not intended to be limited to the embodiments described herein, but are intended to be accorded the full scope consistent with the claim language and encompass all legal equivalents. Nevertheless, none of the claims are intended, and should not be interpreted, to encompass subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. The main body is a tube slot disposed adjacent an outer edge of the body, the tube slot including an opening at the outer edge for slidably receiving a portion of intravenous (IV) tubing; and a spiral slide groove extending from the tube slot into the body, the width of the spiral slide groove narrowing as the spiral slide groove extends further into the body; a main body comprising: a tube arm rotatably coupled to the body, the tube arm having a slot opening to the outer edge of the body and configured to slidably receive the IV tube when the slot is aligned with the tube slot of the body; 1. A stabilized flow regulator assembly comprising: The stable flow regulator assembly is configured to regulate the flow rate of fluid through the IV tube based on the amount of compression of the IV tube due to the position of the IV tube within the spiral sliding groove.

2. 2. The stable flow regulator assembly of claim 1, wherein said tube arm comprises a shaft rotatably coupled through a shaft bore in said body.

3. 3. The stable flow regulator assembly of claim 2, wherein the shaft includes a snap member configured to compress when the shaft passes through the shaft hole and expand when the snap member exits the shaft hole on the opposite side of the body.

4. 4. The stable flow regulator assembly of claim 3, wherein the tube arm comprises opposing arm sections connected together by a hinge member, the shaft and the snap member are disposed on a first arm section, a receiving hole is disposed on a second arm section, the second section is configured to fold over the outer edge of the body via the hinge member, and the snap member is disposed through the receiving hole.

5. 5. The stable flow regulator assembly of claim 4, wherein said first and second arm sections and said hinge member collectively have two sides that define said slot in said tube arm.

6. 2. The stable flow regulator assembly of claim 1, further comprising a plurality of retaining members disposed on a surface of at least one side of the body, the plurality of retaining members being spaced apart along a portion of the spiral sliding groove.

7. 7. The stable flow regulator assembly of claim 6, wherein the tube arm comprises one or more arm retaining members configured to slidably engage the plurality of retaining members on the body.

8. 2. The stable flow regulator assembly of claim 1, further comprising a plurality of indicator marks disposed on a surface of at least one side of the body, the plurality of indicator marks being spaced apart along one of a portion of the spiral sliding groove and the outer edge of the body.

9. 2. The stable flow regulator assembly of claim 1, wherein said spiral sliding groove has a widest width of 4 mm and a narrowest width of 0.15 mm.

10. 2. The stable flow regulator assembly of claim 1, further comprising at least one flap extending from the body into the tube slot, the at least one flap configured to flex inward to allow slidable lateral movement of the tube into the tube slot and to flex back to an initial position to prevent slidable lateral movement of the tube back out of the body.

11. 2. The stable flow regulator assembly of claim 1, further comprising a locking member coupled to the body and movably disposed on the tube slot, the locking member being spaced from the tube slot in a first position for slidable passage of the tube into the tube slot, and the locking member being positioned to prevent slidable passage of the tube from the body in a second position.

12. 2. The stable flow regulator assembly of claim 1, further comprising a grip disposed on the outer edge of the body, the grip comprising a plurality of protrusions extending radially outward from the body.

13. 2. The stable flow regulator assembly of claim 1, further comprising a plurality of ratchet teeth disposed on a surface of at least one side of the body, the plurality of ratchet teeth being spaced apart around a portion of the spiral sliding groove and configured for ratcheting engagement with the tube arm.

14. 2. The stable flow regulator assembly of claim 1, further comprising a plurality of flaps disposed on a surface of at least one side of the body, the flaps being spaced apart around the outer edge of the body and extending outward beyond the outer edge of the body.

15. 10. The stabilized flow regulator assembly of claim 1, further comprising one or more flaps disposed on said tube arms.

16. a body including a spiral slide groove extending into the body and surrounded by an outer edge of the body, the spiral slide groove narrowing in width as it extends further into the body; a plurality of teeth disposed on the outer edge of the body; a tube arm rotatably coupled to the body, the tube arm including a slot opening into the spiral sliding groove and configured to slidably receive an intravenous (IV) tube when the slot is aligned with a portion of the spiral sliding groove having a width equal to or greater than a diameter of the IV tube; 1. A stabilized flow regulator assembly comprising: The stable flow regulator assembly is configured to regulate the flow rate of fluid through the IV tube based on the amount of compression of the IV tube due to the position of the IV tube within the spiral sliding groove.

17. 17. The stable flow regulator assembly of claim 16, wherein each of the plurality of teeth has an inclined portion and an orthogonal portion, and the tube arm includes a stop member having a corresponding inclined portion and a corresponding orthogonal portion, the stop member configured to rotatably engage the plurality of teeth in a ratcheting manner.

18. The main body is a tube retainer disposed adjacent an outer edge of the body, the tube retainer including an opening for slidably receiving a portion of intravenous (IV) tubing; and a radial tube groove extending into the body around a portion of the outer edge of the body, the depth of the radial tube groove decreasing from the beginning end toward the closed end; a main body comprising: a tube arm rotatably coupled to the body, the tube arm having a pressing member opposing the outer edge of the body and configured to slidably compress the IV tube when the tube arm is rotated while the IV tube is disposed within the radial tube groove; and 1. A stabilized flow regulator assembly comprising: The stable flow regulator assembly is configured to regulate the flow rate of fluid through the IV tube based on the amount of compression of the IV tube by the position of the pressing member relative to the IV tube within the radial tube groove.

19. 10. A method of operating the stabilized flow regulator assembly of claim 1, said method comprising: inserting an intravenous (IV) tube into the slot of the tube arm rotatably coupled to the body; inserting the IV tube into the spiral sliding groove disposed within the body of the stable flow regulator assembly while the inserted IV tube is not compressed by a side wall of the spiral sliding groove; rotating the tube arm relative to the body to slide the IV tube along the varying width of the spiral sliding groove; stopping rotation of the tube arm relative to the body when the IV tube is positioned within a specific width of the spiral sliding groove, the resulting compression of the IV tube corresponding to a specific flow rate of fluid through the IV tube; A method comprising:

20. 20. A method of operating a stabilized flow regulator assembly as set forth in claim 18, said method comprising: wrapping intravenous (IV) tubing around the outer periphery of the body; receiving the IV tube within the radial tube groove; holding the tube in place with the tube retainer; inserting the shaft of the tube arm into the shaft hole of the body; bending the tube arms around the outer edge of the body and the tubes disposed within the radial tube grooves; inserting a snap member on the shaft of the tube arm into a receiving hole in the bent tube arm; rotating the tube arm relative to the body to slide the pusher member along the IV tube at varying depths of the radial tube grooves; stopping rotation of the tube arm relative to the body when the pushing member is positioned against the IV tube within a specific depth of the radial tube groove, the resulting compression of the IV tube corresponding to a specific flow rate of fluid through the IV tube; A method comprising:

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