Stable flow regulator assembly

Abstract

A stable flow regulator assembly includes a body having a bore for receiving a tube. The assembly also includes a worm gear extending through the body and rotatably movable relative to the body. A worm wheel is rotatably disposed within the body and pivotally moved within the body by engagement with the worm gear. The worm wheel also includes a slot configured to align with the bore, through which the tube can extend, such that as the worm wheel is moved within the body, the slot and bore move in and out of alignment to compress and release the compression on the tube.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to gravity fed intravenous (IV) set or infusion pump flow control devices, and more particularly to a stable flow regulator assembly. [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. Once the IV application is complete, such typical roller clamps are then disposed of along with the IV set or IV tubing.

[0003] A typical roller clamp allows the IV tubing to be incrementally occluded by pinching the tubing as the roller clamp is tightened. The typical process is to fully close the roller clamp and then regulate fluid flow by rolling the roller clamp upward to release fluid flow. Summary of the Invention [Problem to be solved by the invention]

[0004] Some roller clamps maintain the roller wheel in place based on a temporary fit with the roller body, engagement of the tubing with the wheel, and friction between the wheel and the roller body. However, over a period of time at high flow rates, as is the case with typical roller clamps, the wheel will move away from its set position, causing inaccurate rates of fluid delivery through the tubing.

[0005] Therefore, it would be desirable to provide a flow regulator assembly that provides structural stability for consistently controlling fluid flow without fluctuating the adjusted 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, thus 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] Some embodiments described herein include a stable regulator assembly, the stable regulator assembly including a body including a first side configured to be coupled to a second side, the first side and the second side each having a respective first hole and a second hole, the first hole and the second hole configured to be aligned when the first side is coupled to the second side, and a first gear mount and a second gear mount aligned with an axis, and a gear thread having a gear thread rotatably disposed along the axis through the first gear mount and the second gear mount. a worm wheel having a worm gear configured to rotate within the body, a rotation axis, worm wheel teeth spaced from the rotation axis, and a tube slot, the worm wheel configured to be rotatably held within the body, the worm wheel teeth configured to engage the gear threads, and the tube slot configured to align with the first and second holes, wherein rotation of the worm gear is translated into rotation of the worm wheel, causing the tube slot to move relative to the first and second holes.

[0007] In some embodiments, the flow regulator assembly can include a body including an enclosing housing having a hole extending therethrough; a worm gear having gear threads and configured to be rotatably disposed through the body; and a worm wheel configured to be rotatably disposed within the enclosing housing and configured to be rotatably moved by rotation of the worm gear, the worm wheel having a tube slot configured to align with the hole, wherein rotation of the worm gear translates into rotation of the worm wheel within the body, moving the tube slot relative to the first hole and the second hole.

[0008] Certain embodiments described herein relate to a stable regulator assembly including: a body including an enclosing housing having a bore extending therethrough; a worm gear having a first gear thread and a second thread extending in an opposite direction to the first gear thread, the worm gear configured to be rotatably disposed within the enclosing housing; and a worm wheel having a first arm and a second arm, the first arm configured to engage the first gear thread and the second arm configured to engage the second gear thread, the worm wheel further having a tube slot configured to align with the bore, wherein rotation of the worm gear in a first direction moves the first arm and the second arm toward each other.

[0009] Some embodiments herein describe a stable regulator assembly for regulating fluid flow, the stable regulator assembly including: a body having a first side configured to be coupled to a second side; first and second gear mounts aligned with an axis between the first and second sides; and a tube passage configured to receive and retain a tube extending through the body; a worm gear having a gear thread and configured to be rotatably disposed through the first and second gear mounts along an axis; and an actuator disposed within the body and configured to be movable relative to the body, the actuator having teeth configured to engage the gear thread, wherein rotation of the worm gear translates into movement of the actuator within the body to move the actuator from an open configuration in which the regulator allows fluid flow to a closed configuration in which the regulator restricts fluid flow. In some embodiments, the first side and the second side each have a respective first hole and a second hole, the first hole and the second hole configured to align when the first side is coupled to the second side, the actuator includes a worm wheel having an axis of rotation, teeth spaced from the axis of rotation, and a tube slot, the worm wheel configured to be rotatably held within the body, the teeth configured to engage the gear threads, the tube slot configured to align with the first hole and the second hole, rotation of the worm gear translated into rotation of the worm wheel, moving the tube slot relative to the first hole and the second hole. In certain embodiments, the actuator includes a rack configured to be movable along a linear track within the body.

[0010] These and other features, aspects, and advantages of the disclosed embodiments will become more apparent from the following detailed description and accompanying drawings.

[0011] The accompanying drawings, which are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification, illustrate examples of the disclosure and, together with the description, serve to explain the principles of the disclosure. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 shows a perspective view of an exemplary infusion set with a typical roller clamp. [Figure 2] Figure 1 shows a side cross-sectional view of the roller clamp. [Figure 3] 1 shows a perspective view of a stable regulator assembly as described in connection with embodiments disclosed herein; [Figure 4] 1 illustrates an exploded view of a stable flow regulator assembly as described herein. [Figure 5] 1 shows a partial perspective front view of a stable regulator assembly described herein. [Figure 6] 1 illustrates a partial cross-sectional view of a stable regulator assembly as described herein. [Figure 7A] 1A-1D illustrate cross-sectional views of a stable regulator assembly during various stages of operation. [Figure 7B] 1A-1D illustrate cross-sectional views of a stable regulator assembly during various stages of operation. [Figure 7C] 1A-1D illustrate cross-sectional views of a stable regulator assembly during various stages of operation. [Figure 7D] 1A-1D illustrate cross-sectional views of a stable regulator assembly during various stages of operation. [Figure 8] 1 is a partial cross-sectional view of a stable regulator assembly as described herein. [Figure 9] 1 shows a partial perspective front view of a stable regulator assembly described herein. [Figure 10] 1 illustrates a partial cross-sectional view of a stable regulator assembly as described herein. [Figure 11]FIG. 2 is a partial perspective front view of a stable regulator assembly described herein. [Figure 12] 1 illustrates an exploded view of a stable flow regulator assembly as described herein. [Figure 13A] 1A-1C show partial perspective front views of a stable regulator assembly in various stages of operation; [Figure 13B] 1A-1C show partial perspective front views of a stable regulator assembly in various stages of operation; [Figure 13C] 1A-1C show partial perspective front views of a stable regulator assembly in various stages of operation; [Figure 13D] 1A-1C show partial perspective front views of a stable regulator assembly in various stages of operation; DETAILED DESCRIPTION OF THE INVENTION

[0013] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Accordingly, dimensions are provided with respect to particular embodiments as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology.

[0014] It should be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology are disclosed herein according to specific, but non-limiting examples. The various embodiments described in this disclosure can be implemented in various ways and with modifications according to a desired application or implementation.

[0015] The present disclosure relates to an alternative to roller clamps, and more particularly to roller clamps for use in gravity infusion. The roller clamp regulates the flow of medical fluid (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.

[0016] The infusion set includes a piercing spike 20, which may be sharp for piercing a rubber stopper or rounded and blunt for insertion into a bag. The spike includes one channel for fluid and, optionally, a second channel for ventilation. A vent 21 is typically present near the piercing spike to allow air to flow into the drip chamber 22. The vent 21 may be provided with a bacterial filter to prevent bacteria from entering the equipment.

[0017] Drip chamber 22 has a droplet generator 23 at the top of drip chamber 22 that creates droplets of a specific size. Droplets from droplet generator 23 fall into drip chamber 22 so that drip chamber 22 is partially filled with liquid. This prevents air bubbles from entering connector tubing 24, which would be harmful to the patient. A particle filter may be provided at the bottom hole of drip chamber 22.

[0018] Connector tubing 24 connects drip chamber 22 to the patient. Connector tubing 24 is typically approximately 150 cm long and may be manufactured from PVC. Tube 24 is shown shortened in FIG. 1 for clarity. Connector tubing 24 typically has a continuous diameter throughout its length.

[0019] At one end of connector tube 24 is a luer fitting 25 that is standardized for connection to all other pieces of equipment with a standard luer cone. Those skilled in the art will appreciate that luer fitting 25 can mate with a hypodermic needle (not shown) for injecting medical fluids into a patient's circulatory system (e.g., intravenously).

[0020] Between drip chamber 22 and luer fitting 25 is roller clamp 26, which engages connector tubing 24. While this disclosure relates to an improved flow regulator assembly, a typical roller clamp 26 known in the art will now be described for background information.

[0021] The roller clamp 26 shown in Figure 2 has two opposing side walls 27 with a pair of guide grooves 30 that are aligned with and face each other. A flow metering roller 28 is provided with an axially extending shaft 29 that projects 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 by and seated in the guide groove 30, allowing the roller 28 to move back and forth within the guide groove 30, as shown by the arrows in Figure 2.

[0022] The entire roller clamp 26 has four walls in an open-ended, box-like configuration (see FIG. 1) and is sized and configured to receive the connector tubing 24. In use, the tubing 24 passes through the roller clamp 26 between two opposing side walls 27, the rollers 28, and the guide wall 31 opposite the rollers 28.

[0023] Within roller clamp 26, the surfaces of guide wall 31 converge along their lengths toward the location of guide groove 30 and downwardly of guide groove 30 (e.g., in the direction of the arrow in FIG. 2 ). This tends to urge connector tube 24 within roller clamp 26 toward guide groove 30 and thus toward roller 28.

[0024] Therefore, by rolling the roller 28 downward along the guide groove 30 in the direction of the arrow so as to gradually approach the guide wall 31, the roller 28 collides with the connector tube 24. As the roller 28 collides with the tube 24, the tube 24 is crushed because it is made of a flexible material such as PVC, and therefore the lumen of the infusion tube 24 becomes smaller. In this way, by narrowing the lumen, the flow rate of the liquid passing through the connector tube 24 can be adjusted.

[0025] Thus, roller clamp 26 controls the flow rate through infusion tube 24 by clamping infusion tube 24 between roller 28 and guide wall 31. This results in gross flow rate changes because small movements of roller 28 cause large changes in the flow rate of fluid through tube 24. Also, the force of the fluid within tube 24 exerts a biasing force on roller 28, which often leads to roller 28 slipping out of its adjusted position (e.g., roller 28 retracting).

[0026] Additionally, roller clamp 26 requires pre-assembly with tubing 24 when tubing 24 is connected to infusion components, such as drip chamber 22 and luer fitting 25. Thus, roller clamp 26 cannot be added to an IV set when tubing 24 is already connected to other components. Similarly, because roller clamp 26 is pre-assembled as part of the IV set, it is typically disposed of with the IV set and not reused.

[0027] 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 described herein provides perfect clamping (e.g., no flow) for a wide range of tubing sizes, provides the ability to apply and release clamping pressure by turning a dial, and provides the ability to gradually adjust clamping pressure to provide a target flow rate. The stable flow regulator assembly also provides for maintaining the target flow rate over time. Thus, once the stable flow regulator assembly is adjusted so that fluid flow is set to a desired flow rate, the stable flow regulator assembly will maintain that setting for the entire fluid transfer process unless specifically adjusted to a different flow rate.

[0028] 3-7D, an embodiment of a stable flow regulator assembly 100 is shown. The stable flow regulator assembly 100 includes a body 110 having a semi-rigid or rigid construction (e.g., hard plastic) and is sized and configured to receive tubing, such as the connector tube 24. The body 110 is sized to accommodate a worm wheel 120 that is pivotally disposed within the body 110. The body 110 is also configured to couple to a worm gear 130. As shown in FIG. 3, the worm gear 130 includes worm threads 135 configured to engage gears or teeth 140 on the worm wheel 120. The worm gear 130 includes a worm gear dial 145 that extends outside the body 110. Although body 110 is shown as being at least partially transparent in some aspects of the present disclosure, such as in Figures 3, 5, 9, 11, and 13A-13D, it should be understood that the present disclosure contemplates embodiments in which any of body 110 and / or other portions of the stable flow regulator assembly may be made from a material that is translucent or completely transparent, or opaque.

[0029] The worm wheel 120 is rotatably disposed within the body 110 such that as the worm gear dial 145 is rotated, the worm wheel 120 moves between a raised position and a lowered position. As the worm gear dial 145 is rotated in a first angular direction, the worm gear threads 135 rotate and engage with the teeth 140 on the worm wheel 120, causing the worm wheel 120 to orbit in a first direction. As the worm gear dial 145 is rotated in a second angular direction opposite the first angular direction, rotation of the worm gear threads 135 engaging the teeth 140 causes the worm wheel 120 to orbit in a second direction opposite the first direction. The worm wheel 120 preferably includes a worm wheel rotation shaft 150 that extends through a body shaft bore 155. The worm wheel 120 rotates within the body 110 about an axis formed by the worm wheel rotation shaft 150 .

[0030] The body 110 preferably includes a body tube passage 160 through which the tube 24 can extend. The worm wheel 120 also includes a worm wheel tube slot 165. When the worm wheel 120 is positioned within the body 110, the body tube passage 160 and the worm wheel tube slot 165 are aligned to allow the tube 24 to pass through the passage 160 and slot 165, respectively. The stable flow regulator assembly 100 may include tube holders 170 on either side of the body 110 to help hold down the tube 24 during operation.

[0031] 4 shows an exploded view of the stable regulator assembly 100, showing the worm gear 130, the body 110, and the worm wheel 120 as three separate pieces. In some embodiments, the body 110 may be comprised of two separate pieces: a first body part 210 and a second body part 220 that are coupled together to form the body 110. In some embodiments, the first body part 210 and the second body part 220 may be attached by a living hinge 230, while in other embodiments, the first body part 210 and the second body part 220 may be separate pieces. The first part 210 and the second part 220 are preferably attached to one another by a snap-fit ​​mechanism, or the parts 210, 220 may be joined by adhesive, ultrasonic bonding, or other manufacturing processes.

[0032] First part 210 includes a first part inner surface 240 that engages or faces a second part inner surface 250 of second part 220. First part inner surface 240 preferably defines worm gear mounts 260, 265, which are shown as two semi-cylindrical channels aligned with living hinge 230 of first part 210. Second part inner surface 250 preferably defines worm gear mounts 270, 275, which are also shown as two semi-cylindrical channels aligned with living hinge 230 in second part 220. When first part 210 and second part 220 are coupled together, the worm gear mounts 260, 270 in each of first part 210 and second part 220 form a first cylindrical channel or passageway. Similarly, when the first part 210 and the second part 220 are coupled together, the worm gear mounts 265, 275 on the respective first part 210 and second part 220 form a second cylindrical channel or passageway.

[0033] The worm gear 130 preferably includes a first worm gear support segment 280 located between the worm gear thread 135 and the worm gear dial 145. The first worm gear support segment 280 consists of a substantially cylindrical segment of the worm gear 130. In addition to the first worm gear support segment 280, the worm gear 130 preferably also includes a second worm gear support segment 285 located on the opposite side of the worm gear thread 135. The second worm gear support segment 285 also consists of a substantially cylindrical segment of the worm gear 130.

[0034] The first worm gear post segment 280 and the second worm gear post segment 285 are configured to be received between the first body part 210 and the second body part 220 and are aligned along the worm gear axis 190, with the first worm gear post 280 and the second worm gear post 285 positioned within a cylindrical channel or passage formed by the worm gear mounts 260, 270 on one side of the body 110 and the worm gear mounts 265, 275 on the other side of the body 110. The worm gear 130 is positioned within the body 110, with the first gear worm post 280 and the second gear worm post 285 acting as bearings to allow the worm gear 130 to rotate freely in either a clockwise or counterclockwise direction.

[0035] As shown in FIG. 4 , the worm wheel 120 is configured to be rotatably or pivotally positioned within the body 110 when the body 110 is assembled. The worm wheel 120 pivots about a worm wheel shaft axis 290 that is aligned along the worm wheel rotation shaft 150 when the shaft 150 is inserted through the body shaft hole 155. Because the worm wheel 120 has a rotation shaft 150 on either side of the wheel 120, each of the shafts 150 passes through a respective body shaft hole 155 in the body 110. When the first part 210 and the second part 220 are coupled together, the worm wheel 120 is held in place by the internal structure along the surfaces 240, 250 and the shaft 150 passing through the hole 155. As explained with reference to FIG. 3, which shows the dimensions of the body 110, the worm wheel 120, and the worm gear 130, as well as the dimensions and positions of their respective features, the teeth 140 of the worm wheel 120 are configured to engage with the worm gear threads 135, so that when the worm gear 130 is rotated, the rotational movement of the threads 135 causes the worm wheel 120 to move upward or downward depending on the direction of rotation.

[0036] As the worm wheel 120 is rotated within the body 110, the body tube passage 160 relative to the worm wheel tube slot 165 changes the passage cross-sectional dimension. As the tube 24 extends through the passage 160, a relative change in the position of the worm wheel 120 with respect to the body 110 changes the passage width dimension. For example, at one position of the worm wheel 120, the passage 160 and slot 165 can be aligned, allowing a fully open tube 24, thereby allowing full flow through the tube 24. As the worm wheel 120 is rotated within and relative to the body 110, the passage 160 and slot 165 move to a position where the passage 160 and slot 165 are offset from one another, thereby reducing the passage width dimension. As the tube 24 extends through the passage 160 and slot 165, the tube 24 is tightly or firmly clamped at the interface between the worm wheel 120 and the body 110, and the clamping of the tube 24 due to the offset alignment of the passage 160 and slot 165 thereby increasingly restricts flow through the tube 24.

[0037] FIG. 4 shows that the body tube passage 160 can include a tube passage support 295. As shown, the support 295 can have a flat surface configured to engage the tube 24 extending through the passage 160. In some embodiments, the support 295 can have surfaces of various shapes and configurations to vary the degree of clamping provided by misalignment of the passage 160 and slot 165 during use. The flat surface of the support 295 can provide a flat surface against which the worm wheel 120 and tube slot 165 can press the tube 24. In some embodiments, the tube passage support 295 of the first part 210 is configured to extend toward the second part 220 and can have a contour that aligns with the worm wheel tube slot 165 so that the support 295 extends into the tube slot 165 when the body 110 is coupled together. In some embodiments, the support 295 on the second part 220 is configured to extend toward the first part 210 and can have a contour that similarly aligns with the worm wheel tube slot 165, such that the support 295 on the second part 220 extends into the tube slot 165 when the bodies 110 are coupled together. In some embodiments, the track support 295 is configured to extend completely through the worm wheel tube slot 165 when the bodies 110 are coupled together. This configuration provides a more stable and consistent platform against which the tube 24 can press when the worm wheel 120 is rotated relative to the body 110. The track support 295 in some embodiments has the same or similar contour as the tube slot 165, so that it does not interfere with the rotation or pivoting ability of the worm wheel 120 within the body 110.

[0038] FIG. 5 shows a partial perspective front view of stable regulator assembly 100, with tube 24 extending through body 110. Tube 24 is shown as descending on one side of body 110, passing through body 110, and continuing on the opposite side of body 110. Tube 24 may be held in place on both sides of body 110 by tube holders 170. FIG. 6 shows a partial cross-sectional view of stable regulator assembly 100 more clearly showing tube 24 traversing body 110. As shown, tube 24 extends from one side of body 110 to the other through body tube passage 160 and worm wheel tube slot 165. Tube 24 extends along tube passage supports 295 and may be held in place on both sides of body 110 by tube holders 170.

[0039] 7A-7D illustrate one mode of operation of the stable flow regulator assembly 100. In FIG. 7A, the assembly 100 is shown with the worm wheel 120 in a position within the body 110 such that the worm wheel tube slot 165 is aligned with the body tube passage 160. In this position, the tube 24 extends through the tube slot 165 and the tube passage 160 with little or no compression on the tube 24, thereby allowing full flow of fluid through the tube 24.

[0040] 7B, rotation of worm gear dial 145 rotates worm gear threads 135, causing worm wheel 120 to rotate or pivot downward. As worm wheel 120 rotates, tube slot 165 and tube passage 160 are slightly misaligned or out of alignment, causing tube slot 165 to press downward against tube 24, slightly forcing tube 24 against tube passage support 295.

[0041] Further rotation of the worm gear dial 145 continues to rotate the worm wheel 120 downward, as shown in FIG. 7C. In this orientation, significant compression of the tube 24 is shown as the tube slot 165 continues to press the tube 24 further toward the tube passage support 295. A stable flow regulator assembly 100 can be maintained in this or a similar position, with a slight or significant reduction in fluid flow through the tube 24 caused by deformation of the tube 24 as it presses against the tube passage support 295. The tube 24 can be further opened by reverse rotation of the worm gear dial 145, or further blocked by continuing to rotate the dial 145 in the same indicated direction as in FIGS. 7A-7C. Because the rotation or orbiting of the worm wheel 120 is limited or prevented by the engagement of the worm wheel teeth 140 and the worm gear threads 135, the worm wheel will not rotate or slip on its own without user intervention.

[0042] 7D shows the tube 24 as being fully compressed as the worm wheel 120 continues to rotate or pivot downward, thereby completely restricting fluid flow through the tube 24. In some embodiments, to prevent shearing of the tube 24 between the tube passage support 295 and the worm wheel tube slot 165, the bottom wall 300 of the worm wheel 120 may be configured to contact or engage an inner wall 305 of the body 110, thereby preventing or restricting further rotation of the worm wheel 120. The tube 24 may be released by rotating the worm gear dial 145 in a direction opposite to the direction used to compress the tube 24.

[0043] In the above-described embodiments, the stable flow regulator assembly 100 is used by inserting one end of the tubing through the body tube passage 160 and the worm wheel tube slot 165 prior to use of the assembly 100. In some embodiments, the assembly 100 can be used in an intravenous system or tubing that is already in use. For example, FIG. 8 illustrates an embodiment of the assembly 100 that can be used in a tubing system that is already in use and that does not have a free end for extending through the body tube passage 160 and the worm wheel tube slot 165. In some embodiments, the assembly 100 can include a body 110 and a worm wheel 120 with slight modifications that allow the tubing 24 to be inserted into the body tube passage 160 and the worm wheel tube slot 165 without having to advance one end of the tubing 24 through the passage 160 and the slot 165. As shown, the body 110 can include a transverse channel 310 extending from one side of the body 110 to the other side of the body 110. In some embodiments, this cross channel 310 can be configured to align with the worm wheel channel 315 and form a loading passage 320 that allows the tube 24 to slide into place and extend through the body tube passage 160 and the worm wheel tube slot 165. In these embodiments, the assembly 100 can be added or removed from a tube 24 or tubing system that is in use.

[0044] 9 shows additional embodiments of assembly 100 that can be used with tubing systems that are already in use and that do not have free ends to extend through body tube passage 160 and worm wheel tube slot 165. In some embodiments, assembly 100 has tube passage 160 and tube slot 165 that are sized sufficiently to allow double tube 24 to be inserted through tube slot 165. Tube 24 can be folded over and inserted through larger sized tube passage 160 and tube slot 165 to allow the tubing to be passed through tube passage 160 and tube slot 165. In these embodiments, assembly 100 can be used with tube 24 or tubing systems that are already in use.

[0045] FIG. 10 illustrates embodiments of the assembly 100 that provide a different operation for securely clamping the tube 24. In these embodiments, the body 110 is similar to the other embodiments described above, but the worm wheel 120 and worm gear 130 have differences from those described in the other embodiments. As shown, in some embodiments, the worm gear 130 has a first set of worm gear threads 330 and a second set of worm gear threads 340. The first set of worm gear threads 330 and the second set of worm gear threads 340 are spaced apart from each other and have opposite orientations. The worm wheel 120 is configured to be within the body 110, but in some embodiments, the worm wheel 120 includes a first arm 350 and a second arm 360, both of which extend toward the worm gear 130 when assembled. As shown, first arm 350 and second arm 360 extend toward worm gear 130 at a slight departure angle, forming a gap between arms 350 and 360. At the ends of arms 350, 360, first arm 350 has a first set of gears or teeth 370 and second arm 360 has a second set of teeth 380. First set of teeth 370 is configured to engage first set of worm gear threads 330 on worm gear 130, and second set of teeth 380 is configured to engage second set of worm gear threads 340.

[0046] As the worm gear dial 145 is rotated, the worm gear 130 rotates, driving the opposing worm gear threads 330, 340 to draw the first arm 350 and the second arm 360 closer together and reduce the starting angle between the two arms 350, 360. As the arms 350, 360 are drawn together, the tube 24, shown extending between the arms 350, 360, is compressed between the arms 350, 360. Further rotation of the worm gear dial 145 draws the arms 350, 360 closer together, further compressing the tube 24. Rotating the worm gear dial 145 in the opposite direction causes the worm gear threads 330, 340 to drive the first arm 350 and the second arm 360 away from each other and increase the departure angle between the two arms 350, 360, thereby applying less force to the tube 24 and allowing more fluid to flow through the tube 24.

[0047] FIG. 11 illustrates an embodiment of the assembly 100 that provides an alternative operation for securely clamping the tube 24. In these embodiments, the body 110 is similar to the other embodiments described above and will be described with similar reference numeral designations, but in these embodiments, the worm gear 130 operates a rack 405 that is linearly driven within the body 110 along a rack track 410 that extends along the interior surface of the body 110. The rack 405 has a complementary channel 415 that is configured to linearly ride along the track 410 during operation of the assembly 100. As described for the other embodiments, the worm gear 130 includes worm gear threads 135 that engage teeth 140 on the rack 405 to move the rack 405 to a plurality of positions. As the worm gear 130 rotates, the worm gear threads 135 also rotate, and the rack teeth 140 engaging the gear threads 135 move the rack 405 up and down depending on the direction of rotation of the worm gear 130, and the rack 405 slides linearly within the body 110 as the rack channel 415 slides along the rack track 410.

[0048] The body includes an entrance opening 420 through which the tube 24 can enter the body and an exit opening 425 through which the tube 24 can exit the body. The body includes an internal compression portion 430 along a compression section 435 of the tube 24 against which the tube 24 can be pressed between the rack 405 and the body 110. As shown in FIG. 11 , the compression portion 430 can form a wedge along which the tube 24 abuts. In use, as the rack 405 is moved up and down within the body 110 by the worm gear 130, the rack 405 compresses or releases the tube 24 against the compression portion 430. As the rack 405 moves downward, in the embodiment shown in FIG. 11 , the rack 405 compresses the tube 24 along the compression section 435. As rack 405 continues to move downward, it compresses compression section 435 to a closed position, thereby completely restricting fluid from flowing through tube 24. When the rotation of worm gear 130 is reversed, rack 405 moves upward, releasing the compression of compression section 435 and allowing fluid to flow through tube 24. The flow of fluid through tube 24 can be adjusted by the rotation of worm gear 130.

[0049] FIG. 12 shows an exploded view of the assembly 100. As shown, the worm gear 130 includes a worm gear dial 145 and one or more worm gear threads 135. As described in other embodiments discussed herein, the worm gear is configured to be retained within the body 110 in a similar manner as described above. The body 110 can be secured together by a snap-fit ​​mechanism, or by adhesive, ultrasonic bonding, or other manufacturing processes. As shown in the embodiment of FIG. 12, snap-fit ​​protrusions 440 and recesses 445 can be used to secure the body 110 together. The body 110 has similar features and functionality as described in the embodiments discussed herein.

[0050] The rack 405 is shown as having rack channels 415 on either side of the rack 405. While the embodiment shown in FIG. 12 depicts the rack 405 as having rack channels 415 and the body 110 as having rack tracks 410, in some embodiments, the channels 415 may be located on the body 110 and the rack tracks 410 may be located on the rack 405. The rack 405 includes a compression surface 450 that is angled from the normal plane of the rack 405. In FIG. 12, the compression portion 430 includes a complementary pressing surface 455 that is preferably angled from the normal plane at the same angle as the compression surface 450. In some embodiments, when the rack 405 is received within the body 110 and the track 410 is received within the channels 415, the compression surface 450 of the rack 405 is generally parallel to the pressing surface 455 of the body 110, such that the rack 405 can move linearly along the tracks 410. This configuration provides a generally flat pressing surface against the tube 24 as the rack 405 moves relative to the compression portion 430 .

[0051] 12 depicts compression surface 450 and pressing surface 455 as generally flat structures aligned at an oblique angle from the normal plane of rack 405 or body 110, surfaces 450, 455 can have a variety of shapes or contours. For example, in some embodiments not shown, compression surface 450 can have a convex or bulbous shape, and pressing surface 455 can have a complementary concave surface such that convex compression surface 450 is configured to fit against concave pressing surface 455. Other complementary contours can also be used to provide a closing force on tube 24. As illustrated, surfaces 450, 455 can move gradually together to convert linear movement of rack 405 into an oblique pressing force, pinching or closing tube 24 between surfaces 450, 455. Additionally, this angled configuration creates two directional components of force, one in the linear perpendicular direction and one normal to the worm thread, when the rack 405 presses against the pressure surface 455. These two components of force help to keep the teeth 140 pressed against the worm gear threads 135, which serves to limit movement of the rack 405 after a position has been set for the rack 405 within the body 110.

[0052] 13A-13D illustrate a mode of operation of a stable flow regulator assembly 100, according to some embodiments. In FIG. 13A, the assembly 100 is shown with the worm gear 130 rotatably disposed within the body 110. The worm gear threads 135 engage the teeth 140 of the rack 405 to hold the rack 405 in an upward position so that the tube 24 extends through the body 110. The rack 405 is positioned against the compression portion 430 so that the tube 24 is not compressed, allowing free flow through the tube 24.

[0053] 13B, worm gear 130 is rotating, causing worm gear threads 135 to rotate and teeth 140 on rack 405 to drive rack 405 downward. As rack 405 is driven downward, rack 405 approaches compression portion 430, and rack 405 presses against tube 24 extending between rack 405 and compression portion 430. As rack 405 presses against tube 24, rack 405 slightly presses tube 24 against compression portion 430.

[0054] As the worm gear 130 is further rotated, the rack 405 continues to be driven downward within the body 110, as shown in FIG. 13C. In this configuration, significant compression of the tube 24 is shown as the rack 405 is moved closer to the compression portion 430. A stable flow regulator assembly 100 can be maintained in this or a similar position, with a slight or significant reduction in fluid flow through the tube 24 caused by deformation of the tube 24 as it is compressed between the rack 405 and the compression portion 430. The tube 24 can be further opened by reversing the rotation of the worm gear 130, or further closed by continuing rotation in the same illustrated direction as in FIGS. 13A-13C. As previously mentioned, the rack 405 will not move or slide upward on its own without user intervention because its movement is limited or prevented by the engagement of the rack 405's teeth 140 with the worm gear threads 135.

[0055] 13D shows the tube 24 as being fully compressed as the rack 405 continues to descend within the body 110, thereby completely restricting fluid flow therethrough. As described for some embodiments, to prevent cutting the tube 24 between the rack 405 and the compression portion 430, the body 110 may include a bottom wall that operates to restrict the rack 405 from moving too far downward within the body 110. The tube 24 may be released, allowing fluid to begin flowing through the tube 24, by rotating the worm gear 130 in a direction opposite to the direction used to compress the tube 24.

[0056] Examples are described herein, including but not limited to the following clauses.

[0057] Clause 1. A stable flow regulator assembly comprising: a body including a first side configured to be coupled to a second side, the first side and the second side each having a respective first hole and a second hole, the first hole and the second hole configured to be aligned when the first side is coupled to the second side; a first gear mount and a second gear mount aligned with an axis; a worm gear having gear threads and configured to be rotatably disposed along the axis through the first gear mount and the second gear mount; a rotating shaft; and a worm wheel having worm wheel teeth spaced from a rotation axis and a tube slot, the worm wheel configured to be rotatably held within the body, the worm wheel teeth configured to engage gear threads, and the tube slot configured to align with the first and second holes, wherein rotation of the worm gear translates into rotation of the worm wheel, causing the tube slot to move relative to the first and second holes.

[0058] Clause 2. The stable flow regulator assembly of clause 1, wherein the tube slot and the first and second holes are each configured to receive and pass a tube.

[0059] Clause 3. The stable flow regulator assembly of clause 2, wherein the tube slot is configured to compress the tube when the tube slot is moved relative to the first hole and the second hole.

[0060] Clause 4. The stable flow regulator assembly of clause 3, wherein when the worm gear is rotated in the reverse direction, the tube slot moves toward alignment with the first hole and the second hole, releasing the compressive force on the tube.

[0061] Clause 5. The stable flow regulator assembly of clause 1, wherein the worm wheel has oppositely extending shafts received by the first and second sides of the body, the shafts about which the worm wheel pivots.

[0062] Clause 6. A stable flow regulator assembly as described in clause 1, wherein the body has a flat surface along the inner surface of the first hole and the second hole, and the tube slot is configured to press the tube against the flat surface when the worm wheel moves in the first closing direction.

[0063] Clause 7. A stable flow regulator assembly as described in clause 1, wherein the body and worm wheel are configured to receive a tube without one end of the tube extending through the first hole, the second hole and the tube slot.

[0064] Clause 8. The stable flow regulator assembly of clause 7, wherein the body has a first channel and the worm wheel has a second channel, the first channel and the second channel align to form a charging passage.

[0065] Clause 9. The stable flow regulator assembly of clause 7, wherein the first hole and the first hole and the tube slot are sized to receive and pass the folded-over tubing.

[0066] Clause 10. A flow regulator assembly comprising: a body including an enclosing housing having an aperture extending therethrough; a worm gear having gear threads and configured to be rotatably disposed through the body; a worm wheel configured to be rotatably disposed within the enclosing housing and configured to be rotatably moved by rotation of the worm gear, the worm wheel having a tube slot configured to align with the hole; Including, A flow regulator assembly, wherein rotation of the worm gear translates into rotation of a worm wheel within the body, causing the tube slot to move relative to the first and second holes.

[0067] Clause 11. The regulator assembly of clause 10, wherein the tube slot and the hole are each configured to receive and pass a tube therethrough.

[0068] Clause 12. The regulator assembly of clause 11, wherein the tube slot is configured to compress a tube extending through the hole when the tube slot is moved relative to the hole.

[0069] Clause 13. A flow regulator assembly as described in clause 10, wherein the body has a flat surface along an inner surface of the hole, and the tube slot is configured to press the tube against the flat surface when the worm wheel moves in the first closing direction.

[0070] Clause 14. The flow regulator assembly of clause 10, wherein the body and worm wheel are configured to receive a tube without one end of the tube extending through the first hole, the second hole and the tube slot.

[0071] Clause 15. The flow regulator assembly of clause 14, wherein the body has a first channel and the worm wheel has a second channel, the first channel and the second channel align to form a charging passage.

[0072] Clause 16. The stable flow regulator assembly of clause 14, wherein the first hole and the first hole and the tube slot are sized to receive and pass the folded-over tubing.

[0073] Clause 17. A stable flow regulator assembly including: a body including an enclosing housing having a bore extending therethrough; a worm gear having a first gear thread and a second thread extending in an opposite direction to the first gear thread, the worm gear configured to be rotatably disposed within the enclosing housing; and a worm wheel having a first arm and a second arm, the first arm configured to engage the first gear thread and the second arm configured to engage the second gear thread, the worm wheel further having a tube slot configured to align with the bore, wherein rotation of the worm gear in a first direction moves the first arm and the second arm toward each other.

[0074] Clause 18. The stable flow regulator assembly of clause 17, wherein the tube slot and the hole are each configured to receive and pass a tube therethrough.

[0075] Clause 19. The stable flow regulator assembly of clause 18, wherein the first arm and the second arm are configured to compress a tube extending through the hole when the first arm and the second arm approach each other.

[0076] Clause 20. The stable flow regulator assembly of clause 18, wherein rotation of the worm gear in a second direction opposite the first direction moves the first arm and the second arm away from each other.

[0077] Clause 21. A stable regulator assembly for regulating fluid flow, comprising: a body having a first side configured to be coupled to a second side; first and second gear mounts aligned with an axis between the first and second sides; and a tube passage configured to receive and retain a tube extending through the body; a worm gear having a gear thread and configured to be rotatably disposed through the first and second gear mounts along an axis; and an actuator disposed within the body and configured to be movable relative to the body, the actuator having teeth configured to engage the gear thread, wherein rotation of the worm gear translates into movement of the actuator within the body to move the actuator from an open configuration in which the regulator allows fluid flow to a closed configuration in which the regulator restricts fluid flow.

[0078] Clause 22. The stable flow regulator assembly of clause 21, wherein the first side and the second side each have a respective first hole and a second hole, the first hole and the second hole configured to align when the first side is coupled to the second side, the actuator including a worm wheel having an axis of rotation, teeth spaced from the axis of rotation, and a tube slot, the worm wheel configured to be rotatably held within the body, the teeth configured to engage the gear threads, the tube slot configured to align with the first hole and the second hole, and rotation of the worm gear is translated into rotation of the worm wheel, causing the tube slot to move relative to the first hole and the second hole.

[0079] Clause 23. The stable flow regulator assembly of clause 21, wherein the actuator includes a rack configured to be movable along a linear track within the body.

[0080] It is understood that any particular order or hierarchy of blocks in the disclosed process methods is an example of an example approach. Based on design or implementation preferences, it is understood that the particular order or hierarchy of blocks in the processes may be rearranged, or all of the illustrated blocks may be performed. In some implementations, any of the blocks may be performed simultaneously.

[0081] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0082] Reference to an element in the singular is intended to mean "one or more" and not "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 merely for convenience and do not limit the invention.

[0083] 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.

[0084] As used herein, the phrase "at least one of," following a list of items, when followed by the word "or" separating any of those items, modifies the list as a whole and not each item in the list. The phrase "at least one of" does not require the selection of at least one item; rather, the phrase allows for the inclusion of at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. Illustratively, the phrase "at least one of A, B, or C" can refer to A only, B only, or C only, or any combination of A, B, and C.

[0085] The use of a phrase such as "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure of an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. A phrase such as "aspect" may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. Disclosure of an embodiment, element, or feature may apply to all embodiments or one or more embodiments. An embodiment may provide one or more examples. A phrase such as "embodiment" may refer to one or more embodiments, and vice versa. A phrase such as "configuration" does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. Disclosure of a configuration may apply to all configurations or one or more configurations. A configuration may provide one or more instances. A phrase such as a configuration may refer to one or more configurations, and vice versa.

[0086] In one aspect, unless otherwise stated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications set forth herein, including those in the claims that follow, are approximate and not precise, and are intended to have a reasonable range consistent with the function to which they relate and the practice in the art to which they pertain.

[0087] It is understood that the specific order or hierarchy of steps, operations, or processes disclosed is an illustration of example approaches. Based on design preferences, it is understood that the specific order or hierarchy of steps, operations, or processes may be rearranged. Some of the steps, operations, or processes may be performed simultaneously. Some or all of the steps, operations, or processes may be performed automatically, without user intervention. The accompanying method claims, if any, present elements of the various steps, operations, or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0088] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those skilled in the art are intended to be specifically incorporated herein by reference and encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, unless the element is recited using the words "step for." Moreover, to the extent terms such as "include," "have," and the like are used, such terms are intended to be inclusive in the same manner as the terms "comprise," "have," and "comprise," as they would be interpreted when used as transitional phrases in a claim.

[0089] The title, background art, summary, brief description of the drawings, and abstract of this disclosure are hereby incorporated into this disclosure and are provided as illustrative examples, not as a limiting description of the disclosure. This disclosure is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. Furthermore, in the detailed description, it will be appreciated that the description provides illustrative examples and that various features have been grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the appended claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The appended claims are hereby incorporated into the detailed description, with each claim standing on its own as separately claimed subject matter.

[0090] The claims are not intended to be limited to the embodiments described herein, but are to be accorded full scope consistent with the language of the claims and encompass all legal equivalents. However, none of the claims are intended, and should not be construed, to encompass subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. 1. A stable flow regulator assembly for regulating fluid flow, comprising: The main body is a first side configured to be coupled to a second side; a first gear mount and a second gear mount aligned with an axis between the first side and the second side; a tube passage configured to receive and retain a tube extending through the body; a main body comprising: a worm gear having gear threads and configured to be rotatably disposed along the axis through the first gear mount and the second gear mount; an actuator disposed within the body and configured to be movable relative to the body, the actuator having teeth configured to engage the gear threads; Including, A stable flow regulator assembly, wherein rotation of the worm gear translates into movement of the actuator within the body to move the actuator from an open configuration, in which the regulator allows fluid flow, to a closed configuration, in which the regulator restricts fluid flow.

2. 2. The stable flow regulator assembly of claim 1, wherein the first side and the second side each have a respective first hole and a second hole, the first hole and the second hole configured to align when the first side is coupled to the second side, the actuator including a worm wheel having an axis of rotation, teeth spaced from the axis of rotation, and a tube slot, the worm wheel configured to be rotatably held within the body, the teeth configured to engage the gear threads, the tube slot configured to align with the first hole and the second hole, and rotation of the worm gear is translated into rotation of the worm wheel, causing the tube slot to move relative to the first hole and the second hole.

3. 10. The stable regulator assembly of claim 1, wherein the actuator includes a rack configured to be movable along a linear track within the body.

4. 1. A stable flow regulator assembly comprising: The main body is a first side configured to be coupled to a second side, a first side, the first side and the second side each having a respective first hole and a second hole, the first hole and the second hole configured to align when the first side is coupled to the second side; a first gear mount and a second gear mount aligned with respect to an axis; a main body comprising: a worm gear having gear threads and configured to be rotatably disposed along the axis through the first gear mount and the second gear mount; a worm wheel having an axis of rotation, worm wheel teeth spaced from the axis of rotation, and a tube slot, the worm wheel configured to be rotatably held within the body, the worm wheel teeth configured to engage the gear threads, and the tube slot configured to align with the first hole and the second hole; Including, A stable flow regulator assembly, wherein rotation of the worm gear is translated into rotation of the worm wheel, causing the tube slot to move relative to the first hole and the second hole.

5. 5. The stable regulator assembly of claim 4, wherein the tube slot and the first and second holes are each configured to receive a tube therethrough.

6. 6. The stable regulator assembly of claim 5, wherein the tube slot is configured to compress the tube when the tube slot is moved relative to the first hole and the second hole.

7. 7. The stable flow regulator assembly of claim 6, wherein when the worm gear is rotated in the reverse direction, the tube slot moves toward alignment with the first hole and the second hole, relieving compression force on the tube.

8. 5. The stable regulator assembly of claim 4, wherein the worm wheel has oppositely extending shafts received by the first and second sides of the body and about which the worm wheel pivots.

9. 5. The stable flow regulator assembly of claim 4, wherein the body has flat surfaces along inner surfaces of the first hole and the second hole, and the tube slot is configured to press the tube against the flat surfaces when the worm wheel moves in a first closing direction.

10. 5. The stable flow regulator assembly of claim 4, wherein the body and the worm wheel are configured to receive the tube without one end of the tube extending through the first hole, the second hole and the tube slot.

11. 11. The stable flow regulator assembly of claim 10, wherein the body has a first channel and the worm wheel has a second channel, the first channel and the second channel align to form a loading passage.

12. 1. A flow regulator assembly comprising: a body including an enclosing housing having an aperture extending therethrough; a worm gear having gear threads and configured to be rotatably disposed through the body; a worm wheel configured to be rotatably disposed within the enclosing housing and configured to be rotatably moved by rotation of the worm gear, the worm wheel having a tube slot configured to align with the hole; Including, A flow regulator assembly wherein rotation of the worm gear is translated into rotation of the worm wheel within the body, causing the tube slot to move relative to the hole.

13. 13. The regulator assembly of claim 12, wherein the tube slot and the hole are each configured to receive a tube therethrough.

14. 14. The regulator assembly of claim 13, wherein the tube slot is configured to compress a tube extending through the hole when the tube slot is moved relative to the hole.

15. 13. The regulator assembly of claim 12, wherein the body has a flat surface along an inner surface of the bore, and the tube slot is configured to press the tube against the flat surface when the worm wheel moves in a first closing direction.

16. 13. The regulator assembly of claim 12, wherein the body has a first channel and the worm wheel has a second channel, the first channel and the second channel align to form a charging passage.

17. 1. A stable flow regulator assembly comprising: a body including an enclosing housing having an aperture extending therethrough; a worm gear having a first gear thread and a second gear thread extending in an opposite direction to the first gear thread, the worm gear configured to be rotatably disposed within the enclosing housing; a worm wheel having a first arm and a second arm, the first arm configured to engage the first gear thread and the second arm configured to engage the second gear thread, the worm wheel further having a tube slot configured to align with the hole; Including, A stable flow regulator assembly, wherein rotation of the worm gear in a first direction causes the first arm and the second arm to move toward each other.

18. 18. The stable regulator assembly of claim 17, wherein the tube slot and the hole are each configured to receive a tube therethrough.

19. 20. The stable flow regulator assembly of claim 18, wherein when the first arm and the second arm approach each other, the first arm and the second arm are configured to compress a tube extending through the hole.

20. 20. The stable regulator assembly of claim 18, wherein rotation of the worm gear in a second direction opposite the first direction moves the first arm and the second arm away from each other.

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