Precision Roller Clamp Assembly

Abstract

A precision roller clamp assembly for regulating fluid flow within a tubing of an infusion set is provided. The roller clamp assembly includes a housing for receiving the tubing and a roller wheel in movably engaging the housing. The housing includes a tube groove disposed within a guide wall, the dimensions of the tube groove configured to provide precise fluid flow regulation over a majority of the travel path of the roller wheel. A method of operating the precision roller clamp assembly is also provided.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Application No. 63 / 319,444, entitled "Precision Roller Clamp Assembly," filed March 14, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to gravity fed intravenous (IV) set or infusion pump flow control devices, and more particularly to a precision roller clamp assembly. [Background technology]

[0003] During the administration of infusion therapy through a gravity-fed IV set, roller clamps are often used to control the flow rate of infusion fluid. The roller clamp consists of a body that holds the IV tubing down under a wheel. As the user moves the roller clamp wheel from the top to the bottom of the roller clamp body, the tubing is progressively crushed into a slot or channel in the roller clamp body. The crushing action of the tubing between the roller clamp body and the wheel reduces the inside diameter of the tubing as the wheel progresses along the length of the roller clamp body. The gradual reduction in the inside diameter of the tubing as the roller wheel progresses along the roller clamp body results in a similar reduction in the flow rate, allowing the clinician to control the infusate flow by moving the wheel up and down along the body of the roller clamp. The roller clamp also serves to stop the infusate flow altogether, as well as to stop the flow during pressure build-up phases such as when a syringe bolus is delivered downstream of the roller clamp or when the IV set is replaced with a new IV bag.

[0004] Clinicians most often set continuous infusion rates controlled by a roller clamp at flow rates ranging from approximately 250 mL / hr to 25 mL / hr. Flow rates greater than 250 mL / hr for full flow are not frequently used to deliver sustained drug delivery.

[0005] Current roller clamps often limit the total travel length of the wheel to set a flow rate of about 250 mL / hr to about 25 mL / hr to a distance of about 7 mm on average at most, while the remainder of the distance the wheel can travel does not match the flow rate of about 250 mL / hr to about 25 mL / hr. The 7 mm distance is a fairly small window to efficiently and easily titrate the infusion. This provides a limited flow control range because the roller wheel is inherently too sensitive in that small movements or dimensional changes of the roller wheel cause large changes in the flow rate of the fluid through the tubing. Thus, the relatively rough flow rate changes provided by typical roller clamps make it difficult to provide precise flow control.

[0006] Additionally, typical roller clamps suffer from flow drift issues, where flow rate stability is lost due to stress relaxation caused by the tubing being compressed between the roller clamp body and the wheel, and flow rate changes over time due to changes in the diameter of the constricted fluid orifice that controls the set flow rate.

[0007] Additionally, a typical roller clamp can reach its full occlusion state even when the wheel is partway along the roller body, leaving clinicians checking the patient's medication with uncertainty about the wheel position presented. For example, a previous clinician may have intended to fully occlude the tubing but not ensured that the wheel was in the full down position, or may have intended to deliver a volume of medication but the flow rate has drifted and decreased over time. If proper wheel position relative to the body is not achieved, clinicians must check the patient's chart to understand these metrics.

[0008] Another issue is the force required to move the wheel along the roller clamp body. If this force exceeds 20 N, it has been found that the wheel becomes difficult to operate. Repeated use of roller clamps with too high a moving force can cause pain in the clinician's thumb pads. In addition, if the clinician's hands are slippery with fluid, there may not be enough friction to move the wheel and allow drug control. Summary of the Invention [Problem to be solved by the invention]

[0009] It is therefore desirable to provide a precision roller wheel assembly that provides rapid and optimal flow rate adjustment, improves flow rate fine tuning within the clinically relevant high to low flow rate range, provides increased roller wheel distance from clinically relevant low flow to full occlusion range, eliminates or minimizes positive changes in flow rate over time, provides full occlusion only at the end of the roller wheel travel path, and reduces the force required to move the roller wheel along the body of the roller clamp. [Means for solving the problem]

[0010] A roller clamp assembly according to one or more embodiments is provided. The roller clamp assembly includes a housing configured to receive a portion of a tubing of an infusion set. The housing includes two opposing side walls spaced apart from one another, each side wall having opposing guide grooves positioned longitudinally on an inner surface thereof, a guide wall disposed between the side walls, and a tubing groove disposed within the guide wall. The roller clamp assembly also includes a roller wheel having two axial protrusions slidably seated within the guide grooves, the roller wheel configured to move through a range of motion along a longitudinal axis of the housing as the protrusions slide within the guide grooves.

[0011] According to one or more embodiments, a method of operating a roller clamp assembly is provided. The method includes inserting a tube of an infusion set into a precision roller clamp assembly including a housing having two opposing spaced apart side walls, each side wall having an opposing guide groove positioned longitudinally on an inner surface thereof, a guide wall disposed between the side walls, and a tube groove disposed within the guide walls, and a roller wheel having two axial projections slidably seated within the guide groove. The method also includes moving the roller wheel through a first range of travel of the guide groove to engage the tube and effect a flow rate of fluid through the tube from a full flow rate to a clinically determined high flow rate. The method further includes moving the roller wheel to a position in a second range of travel of the guide groove to incrementally impinge on the tube to effect a desired flow rate of fluid through the tube between the clinically determined high flow rate and the clinically determined low flow rate.

[0012] The above and other features, aspects, and advantages of the disclosed embodiments will become more apparent from the following detailed description and the accompanying drawings.

[0013] 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 description of the drawings]

[0014] [Figure 1] FIG. 1 shows a perspective view of an exemplary infusion set having a typical roller clamp. [Diagram 2] FIG. 2 shows a side cross-sectional view of the roller clamp. [Diagram 3] A top view of a typical roller clamp showing the positioning of the roller wheels for various flow rates is shown. [Figure 4] 13A-13D show perspective views of a precision roller clamp assembly illustrating positioning of roller wheels for various flow rates, according to an embodiment of the present disclosure. [Diagram 5] 5 illustrates a top view of the precision roller clamp assembly of FIG. 4 according to an embodiment of the present disclosure. [Figure 6] 5 illustrates a top view of the precision roller clamp assembly of FIG. 4 with the roller wheels removed, according to an embodiment of the present disclosure. [Figure 7] 7 illustrates a side cross-sectional view of the precision roller clamp assembly of FIG. 6 according to an embodiment of the present disclosure. [Figure 8] 7 illustrates a front cross-sectional view of the precision roller clamp assembly of FIG. 6 according to an embodiment of the present disclosure. [Figure 9] 5 illustrates a front cross-sectional view of the precision roller clamp assembly of FIG. 4 according to an embodiment of the present disclosure. [Figure 10] FIG. 5 illustrates a top view of the precision roller clamp assembly of FIG. 4 highlighting specific flow regions, according to an embodiment of the present disclosure. [Figure 11] FIG. 5 illustrates a top view of the precision roller clamp assembly of FIG. 4 highlighting specific flow regions, according to an embodiment of the present disclosure. [Figure 12] 1 illustrates a method of operating a precision roller clamp assembly according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] 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. Thus, dimensions are provided for specific embodiments as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology.

[0016] 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. Various embodiments described in the present disclosure may be implemented in different ways and with modifications according to a desired application or implementation.

[0017] The present disclosure relates to roller clamps, and in particular to roller clamps for use in gravity administration sets, pump sets, secondary sets, or any other sets in which a roller clamp may be used to regulate the flow rate of an infusion. The roller clamp regulates the flow rate of a medical fluid (e.g., a drug solution or blood to be administered to a patient) flowing through a tube. Typically, a standard infusion set is used to infuse the fluid. An example of a standard infusion set is shown in FIG.

[0018] The infusion set includes a piercing spike 20, which may be a sharp spike for piercing a rubber stopper or may be rounded and blunt for insertion into a bag. The spike includes one channel for fluid and optionally a second channel for ventilation. There is usually a vent 21 near the piercing spike to allow air to enter the drip chamber 22. The vent 21 may be provided with a bacterial filter to prevent bacteria from entering the device.

[0019] The drip chamber 22 has a droplet generator 23 at the top of the drip chamber 22 which creates droplets of a particular size. The droplets from the droplet generator 23 fall into the drip chamber 22 so that the drip chamber 22 is partially filled with fluid or liquid. This prevents air bubbles from getting into the connector tube 24 which could be harmful to the patient. A particle filter may be provided at the bottom hole of the drip chamber 22.

[0020] A connector tube 24 connects the drip chamber 22 to the patient. The connector tube 24 is typically approximately 150 cm long and may be manufactured from PVC. The tube 24 is shown shortened in Figure 1 for clarity. The connector tube 24 typically has a continuous diameter throughout its length.

[0021] At one end of the connector tube 24 is a standardized luer fitting 25 for connection to all other elements of the device having a standard luer cone. Those skilled in the art will appreciate that the luer fitting 25 can be fitted with a hypodermic needle (not shown) for injecting medical fluids into a patient's circulatory system (e.g., intravenously).

[0022] Between the drip chamber 22 and the luer fitting 25 is a roller clamp 26 which engages the connector tube 24. Although this disclosure is directed to an improved roller clamp assembly, a typical roller clamp 26 known in the art will now be described for background information.

[0023] The roller clamp 26 shown in FIG. 2 has a housing 32 having two opposing side walls 27 with a pair of guide grooves 30 that are aligned with and face each other. A flow metering roller wheel 28 is provided with an axially extending shaft 29 that projects from the center of each side of the roller wheel 28. The roller wheel 28 is shown in outline for clarity. The shaft 29 of the roller 28 is captured by and seats in the guide groove 30 such that the roller wheel 28 can move up and down the guide groove 30 along the housing 32 as shown by the arrow in FIG. 2.

[0024] 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 a connector tube 24. In use, the tube 24 passes through the roller clamp 26 between two opposing side walls 27, the roller wheels 28 and a guide wall 31 opposite the roller wheels 28.

[0025] Within roller clamp 26, the surfaces of guide wall 31 converge along their length 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 configuration facilitates biasing connector tube 24 within roller clamp 26 toward guide groove 30, and thus toward roller wheel 28.

[0026] Therefore, the roller wheel 28 is caused to roll downward along the guide groove 30 in a direction gradually approaching the guide wall 31 in the direction of the arrow, causing the roller wheel 28 to collide with the connector tube 24. As the roller wheel 28 collides with the tube 24, the tube 24 is crushed due to being a flexible material such as PVC, and therefore the lumen of the infusion tube 24 becomes smaller. In this manner, the flow rate of the fluid through the connector tube 24 can be adjusted by narrowing the lumen.

[0027] Thus, the roller clamp 26 controls the flow rate through the infusion tube 24 by clamping the infusion tube 24 between the roller wheel 28 and the guide wall 31. As discussed above, this results in rough changes in flow rate because small movements of the roller wheel 28 cause large changes in the flow rate of fluid through the tube 24. Also, the force of the fluid within the tube 24 exerts a biasing force against the roller wheel 28, which often causes the wheel roller 28 to slip out of its adjusted position (e.g., the roller wheel 28 retracts).

[0028] As shown in FIG. 3, a typical roller clamp 26a has a housing 32a with a tube groove 33a having a groove geometry (e.g., linear) with a constant groove draft angle, and a roller wheel 28a that rides over the tube groove 33a in a linear path along the housing 32a. The relationship between fluid orifice size and flow rate is nonlinear, especially at clinically relevant flow rates. If a typical roller wheel position is plotted against flow rate, the plot will be nonlinear indicating that large roller wheel movements are required to obtain clinical control of flow rate and small roller wheel movements are required to control flow rate throughout the clinically relevant flow rate range.

[0029] 3, the stroke range 90 of the roller wheel 28a for full flow to 250 mL / hr flow rates occupies a large portion of the stroke path of the roller wheel 28a in the housing 32a, whereas the stroke range 92 of the roller wheel 28a for the desired flow rate range of 250 mL / hr to 25 mL / hr (e.g., clinically relevant flow rate range) is much smaller (e.g., 7.05 mm). The stroke range 92 has subset ranges, such as a stroke range 94 for 250 mL / hr to 100 mL / hr flow rates (e.g., 4.24 mm), a stroke range 96 for 100 mL / hr to 60 mL / hr flow rates (e.g., 1.50 mm), and a stroke range 98 for 60 mL / hr to 25 mL / hr flow rates (e.g., 1.31 mm). Due to the large stroke range 90, a large portion of the movement of the roller wheel 28a in the housing 32a does not result in a clinically relevant flow rate.

[0030] As discussed above, current roller clamps often limit the total travel length of the wheel to set a flow rate of approximately 250 to approximately 25 mL / hr over a distance of approximately 7 mm on average, while the remainder of the distance the wheel can travel does not match the flow rate of approximately 250 mL / hr to approximately 25 mL / hr. A distance of 7 mm is a fairly small window for efficient and easy titration of infusions.

[0031] In an embodiment of the disclosure, the precision roller clamp assembly increases the utility of the roller clamp by dividing the distance the wheel travels across the roller clamp body into at least three regions: A first region near the top of the roller clamp body and up to approximately 25% of the total distance the wheel may travel regulates the flow rate from full flow to approximately 250 mL / hr; A second region from the last 25% to approximately 75% of the total distance the wheel may travel regulates the flow rate from approximately 250 mL / hr to approximately 25 mL / hr; A third region from the last 75% to approximately 100% of the total distance the wheel may travel regulates the flow rate from approximately 25 mL / hr to full flow stop and tubing occlusion.

[0032] In addition to the importance of a roller clamp with sufficient wheel adjustability within the range of clinically relevant flow rates, flow stability (e.g., the rate at which the flow rate changes after the roller clamp flow rate is set) is also important. Ideally, the flow rate stabilizes and remains the same after the flow rate is set. For example, problems can arise if a drug is infused too quickly, with some drugs causing the roller clamp flow rate to drift from a controlled flow rate to full on. Positive flow rate changes over time are more serious than negative flow rate changes over time. Stress relaxation caused by the tubing being compressed between the roller clamp body and the wheel changes the diameter of the constricted fluid orifice that governs the set flow rate, causing the flow rate to change over time.

[0033] While aspects of the present disclosure may not be able to completely eliminate the effects of tubing stress relaxation and the associated flow rate changes, the precision roller clamp assembly allows for the amount of stress relaxation to be managed to ensure that flow rate changes are as close to zero as possible and that, if any, flow rate only slows over time.

[0034] Another issue is a human factor issue related to roller clamps, as discussed above. Some current roller clamps can reach their full occlusion state even when the wheel is partway along the roller body. For clinicians checking a patient's medication, the presented wheel position is uncertain. Clinicians must check a patient's chart if they do not obtain the proper wheel position relative to the body to see if the previous clinician intended to fully occlude the tubing but found the wheel in the full down position, or intended to deliver medication but the flow rate has drifted and decreased over time.

[0035] Aspects of the present disclosure provide a precision roller clamp assembly that attempts to remove such uncertainty by ensuring that fluid flow is not unintentionally stopped when the wheel position is not completely under the roller body. In other words, fluid flow is only fully blocked or stopped as intended when the roller wheels are at the ends of the roller clamp body.

[0036] In an embodiment of the present disclosure, the precision roller clamp assembly has a nonlinear groove geometry adapted to each of three flow control regions. The first region shortens the distance the wheel must travel from full flow until the flow reaches a clinically relevant high flow rate (e.g., 250 mL / hr). The second region allows finer flow control by increasing the distance the roller wheel may travel during titration within a clinically relevant high to low flow rate range (e.g., 250 mL / hr to 25 mL / hr). The third region increases the distance the roller wheel may travel during titration within a clinically relevant low to total occlusion range (e.g., 25 mL / hr to 0 mL / hr).

[0037] In an embodiment of the present disclosure, the flow rate is dependent on the diameter of the fluid orifice created by the tubing being crushed, so the various flow control regions are achieved by managing the rate of reduction of the fluid orifice in each region. For the first region, the groove geometry is angled so that the tubing inner diameter is crushed quickly with a relatively small wheel stroke distance. The groove geometry of the second flow control region is angled more gradually than the first distance so that the wheel must travel a greater distance across the flow range. The groove geometry of the third flow control region is also angled separately so that the wheel must travel an appropriate distance to change the flow rate from low flow to full occlusion. Thus, the groove geometry of the third region, from low flow to closure, is adapted so that full occlusion is possible only when the roller wheel is positioned at the bottom of the roller clamp.

[0038] With regard to flow stability, a typical roller clamp can exhibit both negative and positive flow rate changes over time.

[0039] In an embodiment of the present disclosure, a roller clamp assembly is provided in which the groove geometry is adapted so that the tubing is appropriately clamped between the groove and the wheel. Thus, when the tubing undergoes stress relaxation, only the inner diameter of the tubing itself shrinks, which can result in only negative flow rate changes. In other words, the roller clamp assembly clamps the entire circumference of the tubing directly under the wheel, so that even if the tubing undergoes stress relaxation, it can only relax into the void of the fluid orifice. Thus, the roller clamp assembly can reduce the risk of faster than intended drug delivery by minimizing positive flow rate changes over time.

[0040] The amount that the tubing is compressed between the body and the wheel relates to how much force is involved in moving the wheel across the tubing. The wall thickness and durometer of the tubing are factors, as is the wheel diameter. A typical roller clamp will exert an unnecessary amount of compression on the tubing, resulting in more force being required to move the wheel.

[0041] In the disclosed aspects, the force required to move the wheel can be reduced by balancing the wheel diameter and the clearance of the tubing compression below the wheel and between the body. Thus, the disclosed roller clamp assembly limits the force required to move the roller wheel along the body of the roller clamp.

[0042] 4-11, a precision roller clamp assembly 100 is shown. The roller clamp assembly 100 has a housing 105 having an open ended box-like structure, sized and configured to receive tubing such as the connector tube 24. Two opposing side walls 110 each have a guide groove 120 that are aligned with and face each other. A roller wheel 130 is provided having an axially extending shaft 132 that protrudes from the center of each side of the roller wheel 130. The shaft 132 of the roller wheel 130 is seated in the guide groove 120 so that the roller wheel 130 can move up and down the guide groove 120. Opposing the roller wheel 130 is a guide wall 112, the surface of which converges along its length towards the location of the guide groove 120. A tube groove 133 is disposed in the guide wall 112, the tube groove 133 being non-linear. For example, the width W and / or depth D of the tube groove 133 may vary along the length L of the tube groove 133.

[0043] During use, the tube 24 passes through the roller clamp assembly 100 between the two opposing side walls 110, the roller 130, and the guide wall 112 opposite the roller 130. The roller 130 is rolled downward along the guide groove 120 in a direction gradually approaching the guide wall 112, causing the roller 130 to collide with the tube 24. When the roller 130 collide with the tube 24, the tube 24 is crushed against the tube groove 133 and the guide wall 112 due to the flexible material such as PCV, and thus the lumen of the infusion tube 24 is reduced. In this manner, the flow rate of the fluid through the connector tube 24 can be adjusted by narrowing the lumen.

[0044] 5, the roller wheel 130 has a range of travel 190 defined by the position of the shaft 132 when the roller wheel 130 is at the first housing end 107 and the position of the shaft 132 when the roller wheel 130 is at the second housing end 109. As shown, the stroke range 192 of the roller wheel 130 for full flow to 250 mL / hr flow rates occupies a small portion of the range of travel 190 (e.g., ≦25%) in contrast to the much larger stroke range 90 of the roller clamp 26a shown in FIG. 3. In addition, the stroke range 194 of the roller wheel 130 for a clinically relevant flow rate range of 250 mL / hr to 25 mL / hr occupies a much larger portion of the range of travel 190 (e.g., ≧50%) in contrast to the much smaller stroke range 92 of the roller clamp 26a shown in FIG. 3. Similar to the stroke range 192, the stroke range 196 of the roller wheel 130 from the lowest clinical flow rate (e.g., 25 mL / hr) to the fully closed flow rate occupies a similar sized portion (e.g., ≦25%) of the range of movement 190. In this regard, the large stroke range 194 ensures that at least half of the movement of the roller wheel 130 in the housing 105 results in a clinically relevant flow rate. This large stroke range 194 provides fine, precise control over flow rates within the clinically relevant flow rate range.

[0045] 6 and 7, the width W and / or depth D of the tube groove 133 may vary along the length L of the tube groove 133. For example, the width W may begin at or near zero at the end 172 closest to the second housing end 109 and widen to a width W1 at a transition point 174 between the stroke range 196 and the stroke range 194. The width W may then gradually widen to a wider width W2 at a transition point 176 between the stroke range 194 and the stroke range 192. The width W may then narrow and return to zero or near zero at the end 178 closest to the first housing end 107. Thus, the gradually widening width of the tube groove 133 from W1 to W2 corresponds to the entire range of travel 190. Also, the width W gradually widens throughout the stroke range 194, thus providing a large length of stroke for the roller wheel 130 that corresponds to fine fluid flow adjustment.

[0046] Similarly, the depth D of the tube groove 133 may vary, becoming deeper from the second housing end 109 to the first housing end 107. Thus, the varying depth D of the tube groove 133 may also correspond to an entire range of travel 194, again providing a large length of travel for the roller wheels 130 to accommodate fine fluid flow tuning. As shown, the tube groove 133 has a triangular or V-shaped geometry, although the tube groove 133 may have any suitable geometry (e.g., semicircular, square, rectangular, trapezoidal).

[0047] 9, a gap 150 is provided between the outer periphery 131 of the roller wheel 130 and the inner surface 111 of the guide wall 112. Similar to the width W and depth D of the tube groove 133, the gap distance GD of the gap 150 may vary along the length of the guide wall 112. For example, the gap distance GD may be smallest at the second housing end 109 and largest at the first housing end 107. Thus, the various gap distances GD may also correspond to an entire range of travel 194, again providing large lengths of travel for the roller wheel 130 corresponding to fine fluid flow adjustments.

[0048] 10 and 11, the width W and depth D of the tube groove 133 and the gap distance GD of the gap 150 can each be tailored to generate a flow profile 180 having particular flow regions 182, 184, 186. In this regard, the flow region 182 can be configured as a fully open region corresponding to the stroke range 192 of the roller wheel 130. Similarly, the flow region 184 can be configured as a fine flow rate region corresponding to the stroke range 194 of the roller wheel 130. And, the flow region 186 can be configured as a closed region corresponding to the stroke range 196 of the roller wheel 130.

[0049] Thus, in embodiments of the present disclosure, during manufacture of the precision roller clamp assembly 100, the flow region 182 may be configured or adapted to reduce the fluid flow rate from full flow to a clinically relevant controlled high flow rate (e.g., 250 mL / hr), the flow region 184 may be configured or adapted to reduce the fluid flow rate from a clinically relevant controlled high flow rate to a controlled low flow rate (e.g., from 250 mL / hr to 25 mL / hr), and the flow region 186 may be configured or adapted to reduce the fluid flow rate from a controlled low flow rate to total fluid cessation (e.g., from 25 mL / hr to 0 mL / hr). Thus, any one of the width W or depth D of the tube groove 133 and the gap distance GD may be designed to manufacture the precision roller clamp assembly 100 having a desired flow profile 180.

[0050] In an embodiment of the present disclosure, the precision roller clamp assembly 100 can provide complete flow cessation when the roller wheel 130 is positioned at the second housing end 109. For example, the roller wheel 130 can occlude flow during a pressure spike (e.g., during a syringe push) when the roller wheel 130 is so positioned. Additionally, positioning the roller wheel 130 at the far end of the range of travel 190 closest to the second housing end 109 provides an instant visual notification to the clinician or other user that the flow rate is halted.

[0051] In embodiments of the present disclosure, the precision roller clamp assembly 100 provides a user-friendly low actuation force (e.g., ≦20 Newtons (N)). For example, in the clinically relevant flow rate range of 250 mL / hr to 25 mL / hr, the large stroke range 194 of the roller wheel 130 provides a long stroke path for smooth and easy actuation of the roller wheel 130.

[0052] In an embodiment of the present disclosure, the precision roller clamp assembly 100 provides flow stability at any given position of the roller wheel 130. For example, the tube 24 is properly clamped between the roller wheel 130 and the tube groove 133 throughout the entire range of travel 190, so that as the tube 24 undergoes stress relaxation, only the inner diameter of the tube 24 itself can shrink, resulting in only possible negative flow rate changes and not unintended positive flow rate changes. In this regard, fine tuning of parameters over such a large portion of the range of travel 190 can also avoid large differences between flow rates at adjacent positions.

[0053] 12, a method 200 of operating the precision roller clamp assembly is shown. In step 210, tubing (e.g., IV tubing 24) is placed or provided within the precision roller clamp assembly 100. For example, the tubing 24 can be inserted into the housing 105 with the roller wheels 130 in a wide open position closest to the first housing end 107 (e.g., minimizing contact or collision with the tubing 24).

[0054] In step 220, the roller wheel 130 may be moved through the stroke range 192 to the beginning of the stroke range 194 to engage and impinge on the tube 24. For example, the roller wheel 130 may be moved from the first housing end 107 of the housing 105 toward the second housing end 109 of the housing 105, causing the roller wheel 130 to compress or crush the contacting portion of the tube 24 due to the narrowing (e.g., gap depth GD) between any of the guide walls 112 and the roller 130, the width W of the tube groove 133, and the depth D of the tube groove. This compression changes the fluid flow rate in the tube 24 from a full flow rate in the full flow region 182 to a controlled high clinical flow rate (e.g., full to 250 ml / hr) at the beginning of a clinical flow range in the flow rate fine tuning flow region 184.

[0055] In step 230, the roller wheel 130 can be moved to any portion of the stroke range 194 to further impinge on the tube 24. For example, the roller wheel 130 can be moved from the beginning of the stroke range 194 to any position including the end of the stroke range 194 nearest the second housing end 109, such that the narrowing (e.g., gap depth GD) between any of the guide walls 112 and the roller 130, the width W of the tube groove 133, and the depth D of the tube groove causes the roller wheel 130 to correspondingly press or crush the contacting portion of the tube 24, thus changing the fluid flow rate in the tube 24 from a controlled high clinical flow rate to a controlled low clinical flow rate and any desired clinical flow rate (e.g., 250 ml / hr to 25 ml / hr), including the flow rate.

[0056] In step 240, the roller wheel 130 can be moved from the stroke range 194 to any portion of the stroke range 196 to further impinge on the tube 24. For example, the roller wheel 130 can be moved from the stroke range 194 to any position including the end and portion of the stroke range 196 nearest the second housing end 109, such that the narrowing (e.g., gap depth GD) between any of the guide walls 112 and the roller 130, the width W of the tube groove 133, and the depth D of the tube groove causes the roller wheel 130 to correspondingly press or crush the contacting portion of the tube 24, and thus change the fluid flow rate in the tube 24 from a selected clinical flow rate in the fine flow rate adjustment flow region 184 to any desired low or no flow rate (e.g., 25 ml / hr to 0 ml / hr) in the closed flow region 186.

[0057] In one or more embodiments of the present disclosure, a roller clamp assembly includes a housing configured to receive a portion of a tubing of an infusion set, the housing having two opposing side walls spaced apart from one another, each side wall having opposing guide grooves positioned longitudinally on an inner surface thereof, a guide wall disposed between the side walls, and a tube groove disposed within the guide wall; and a roller wheel having two axial protrusions slidably seated within the guide grooves, the roller wheel configured to move through a range of motion along a longitudinal axis of the housing as the protrusions slide within the guide grooves.

[0058] In an embodiment of the present disclosure, the width of the tube groove varies over the length of the tube groove. In an embodiment of the present disclosure, the depth of the tube groove varies over the length of the tube groove. In an embodiment of the present disclosure, the gap between the circumference of the roller wheel and the guide wall varies over the length of the tube groove. In an embodiment of the present disclosure, the range of motion includes a first stroke range beginning at a first end of the housing, a first end of the first stroke range configured to provide a full open flow rate of fluid through the tube, and a second end of the first stroke range configured to provide a predetermined high flow rate of fluid through the tube. In an embodiment of the present disclosure, the predetermined high flow rate is 250 mL / hr. In an embodiment of the present disclosure, the first stroke range includes no more than 25% of the range of motion.

[0059] In an embodiment of the disclosure, the range of travel includes a second stroke range beginning at a second end of the first stroke range, the first end of the second stroke range configured to provide a predetermined high flow rate of fluid through the tube and the second end of the second stroke range configured to provide a predetermined low flow rate of fluid through the tube. In an embodiment of the disclosure, the predetermined low flow rate is 250 mL / hr. In an embodiment of the disclosure, the second stroke range includes 50% or more of the range of travel.

[0060] In an embodiment of the present disclosure, the range of travel includes a third stroke range beginning at a second end of the second stroke range, a first end of the third stroke range configured to provide a predetermined low flow rate of fluid through the tube, and a second end of the third stroke range configured to provide a fully closed flow rate of fluid through the tube. In an embodiment of the present disclosure, the fully closed flow rate is 0 mL / hr. In an embodiment of the present disclosure, the third stroke range includes 25% or less of the range of travel. In an embodiment of the present disclosure, the third stroke range ends at the second end of the housing.

[0061] In an aspect of the disclosure, the roller clamp assembly is configured to have a flow profile including a first flow region corresponding to a first stroke range, a second flow region corresponding to a second stroke range, and a third flow region corresponding to a third stroke range. In an aspect of the disclosure, one or more of the groove width, the groove depth, and the gap between the periphery of the roller wheel and the guide wall are configured to generate a desired flow profile. In an aspect of the disclosure, one or more of the groove width, the groove depth, and the gap between the periphery of the roller wheel and the guide wall are configured to generate one of the desired first flow region, the desired second flow region, and the desired third flow region. In an aspect of the disclosure, the range of travel is configured to operate the roller wheel with an actuation force of 20 Newtons or less.

[0062] In one or more embodiments of the present disclosure, a method of operating a roller clamp assembly includes inserting a tube of an infusion set into a precision roller clamp assembly including a housing having two opposing spaced apart side walls, each side wall having an opposing guide groove positioned longitudinally on an inner surface thereof, a guide wall disposed between the side walls, and a tube groove disposed within the guide walls, and a roller wheel having two axial projections slidably seated within the guide groove; moving the roller wheel through a first range of travel of the guide groove to engage the tube and effect a flow rate of fluid through the tube from a full flow rate to a clinically determined high flow rate; and moving the roller wheel to a position in a second range of travel of the guide groove to incrementally impinge on the tube and effect a desired flow rate of fluid through the tube between the clinically determined high flow rate and the clinically determined low flow rate.

[0063] In an embodiment of the present disclosure, the method further includes moving the roller wheel to a position within a third range of travel of the guide groove to further impact the tube and provide a desired flow rate of fluid through the tube between a clinically defined low flow rate and no flow rate.

[0064] It is understood that any particular order or hierarchy of blocks in the disclosed process methods is illustrative 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.

[0065] 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.

[0066] Reference to a singular element is intended to mean "one or more" and not "one and only one" unless specifically stated so. The term "several" 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.

[0067] 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.

[0068] As used herein, the phrase "at least one of" following a series of items, when followed by the word "or" to separate 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 a meaning including at least one of any 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 only A, only B, or only C, or any combination of A, B, and C.

[0069] A phrase such as "aspect" does not imply that such aspect is essential to the subject technology, nor that such aspect applies to all configurations of the subject technology. A 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 an 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, nor that such embodiment applies to all configurations of the subject technology. A disclosure of an embodiment may apply to all configurations, or one or more examples. An embodiment may provide one or more examples. A phrase such as embodiment may refer to one or more examples, and vice versa. A phrase such as "configuration" does not imply that such embodiment is essential to the subject technology, nor that such embodiment applies to all configurations of the subject technology. A 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.

[0070] In one aspect, unless otherwise stated, all measurements, values, ratings, locations, sizes, dimensions, and other specifications set forth herein, including those in the claims which follow, are approximate and not precise, and are intended in one aspect to have a reasonable range consistent with the function to which they relate and the practice in the art to which they pertain.

[0071] 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.

[0072] All structural and functional equivalents to the elements of the various embodiments described throughout this disclosure that are known or that later become known to those skilled in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Moreover, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly set forth 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 phrase "step for". Moreover, to the extent that terms such as "include", "have", and the like are used, such terms are intended to be inclusive in the same manner as the term "comprise", as "comprise" would be interpreted when used as a transitional term in a claim.

[0073] The title, background, 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 limiting descriptions of this 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 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.

[0074] 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 cover subject matter that does not comply with the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. 1. A roller clamp assembly comprising: A housing configured to receive a portion of a tubing of an infusion set, two opposing side walls spaced apart from one another, each side wall having opposing guide grooves positioned longitudinally on an inner surface thereof; A guide wall provided between the side walls; and A tube groove provided in the guide wall a housing comprising: a roller wheel having two axial projections slidably seated within the guide groove, the roller wheel configured to move through a range of motion along the longitudinal axis of the housing as the projections slide within the guide groove; 1. A roller clamp assembly comprising:

2. The roller clamp assembly of claim 1 , wherein the width of the tube groove varies over the length of the tube groove.

3. 2. The roller clamp assembly of claim 1, wherein the depth of the tube groove varies over the length of the tube groove.

4. 2. The roller clamp assembly of claim 1, wherein a gap between a circumference of said roller wheel and said guide wall varies over the length of said tube groove.

5. 2. The roller clamp assembly of claim 1, wherein the range of motion includes a first range of travel beginning at a first end of the housing, a first end of the first range of travel configured to provide a full open flow rate of fluid through the tube, and a second end of the first range of travel configured to provide a predetermined high flow rate of fluid through the tube.

6. 6. The roller clamp assembly of claim 5, wherein said predetermined high flow rate is 250 mL / hr.

7. 6. The roller clamp assembly of claim 5, wherein said first range of travel comprises 25% or less of said range of travel.

8. 6. The roller clamp assembly of claim 5, wherein the range of motion includes a second range of travel beginning at the second end of the first range of travel, the first end of the second range of travel configured to provide the predetermined high flow rate of fluid through the tube and the second end of the second range of travel configured to provide the predetermined low flow rate of fluid through the tube.

9. 9. The roller clamp assembly of claim 8, wherein said predetermined low flow rate is 250 mL / hr.

10. 9. The roller clamp assembly of claim 8, wherein the second range of travel comprises greater than or equal to 50% of the range of travel.

11. 9. The roller clamp assembly of claim 8, wherein the range of travel includes a third range of travel beginning at the second end of the second range of travel, a first end of the third range of travel configured to provide the predetermined low flow rate of fluid through the tube and a second end of the third range of travel configured to provide a full closed flow rate of fluid through the tube.

12. 12. The roller clamp assembly of claim 11, wherein the full closed flow rate is 0 mL / hr.

13. The roller clamp assembly of claim 11 , wherein the third range of travel comprises 25% or less of the range of travel.

14. The roller clamp assembly of claim 11 , wherein the third range of travel terminates at a second end of the housing.

15. 12. The roller clamp assembly of claim 11, wherein the roller clamp assembly is configured to have a flow profile including a first flow area corresponding to the first range of stroke, a second flow area corresponding to the second range of stroke, and a third flow area corresponding to the third range of stroke.

16. 16. The roller clamp assembly of claim 15, wherein one or more of the groove width, the groove depth, and the gap between the circumference of the roller wheel and the guide wall are configured to produce a desired flow profile.

17. 16. The roller clamp assembly of claim 15, wherein one or more of the groove width, the groove depth, and the gap between the circumference of the roller wheel and the guide wall are configured to create one of a desired first flow area, a desired second flow area, and a desired third flow area.

18. The roller clamp assembly of claim 1 , wherein the range of travel is configured to operate the roller wheel with an actuation force of 20 Newtons or less.

19. 1. A method of operating a roller clamp assembly, comprising: inserting a tubing of an infusion set into a precision roller clamp assembly comprising a housing having two opposing spaced apart side walls, each side wall having opposing guide grooves longitudinally positioned on an inner surface thereof, a guide wall disposed between said side walls, and a tube groove disposed within said guide walls, and a roller wheel having two axial projections slidably seated within said guide grooves; moving the roller wheel through a first range of travel of the guide channel to engage the tube and vary fluid flow through the tube from full flow to a clinically determined high flow rate; moving the roller wheel to a position within a second range of travel of the guide groove so as to incrementally impinge on the tube to effect a desired flow rate of fluid through the tube between the clinically determined high flow rate and the clinically determined low flow rate; A method comprising:

20. 20. The method of claim 19, further comprising moving the roller wheel to a position within a third range of travel of the guide groove to further impact the tube and provide a desired flow rate of fluid through the tube between the clinically determined low flow rate and no flow rate.

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