INFUSION FLOW CONTROL DEVICE TO KEEP VEIN OPEN

Abstract

Keep-the-vein (KVO) infusion flow control devices are provided. The KVO infusion flow control device attaches to intravenous (IV) tubing and includes a flow controller that provides a full-open fluid flow rate through the IV tubing outlet when the flow controller is in the open position, and a KVO fluid flow rate through the IV tubing outlet when the flow controller is in the KVO position. Visual indicators are provided on the KVO infusion flow control device.

Description

INFUSION FLOW CONTROL DEVICE TO MAINTAIN OPEN VEIN Background of the Invention During the use of an intravenous (IV) infusion set, IV line occlusion is a common but undesirable occurrence in patient IV access due to the blood fibrin clotting function. Causes of catheter occlusion can be thrombotic, drug-related, or due to parenteral nutrition precipitates, or mechanical. Occlusion due to this effect also provides potential nesting material for microorganisms, thereby increasing the risk of catheter-related bloodstream infection. Typical solutions to catheter occlusion include flushing and blocking methods, such as tissue plasminogen activator (tPA), heparin blocks, and catheter replacement. However, these typical flushing and blocking methods have a significant impact on clinical specialist time and hospitalization costs. It is desirable to provide keep-open vein (KVO), also known as keep-open (TKO), infusion flow control devices that have safe, consistent fluid flow control that can Ref. 339277 can be easily configured to maintain fluid flow in the IV line at a KVO rate, thereby reducing clinician time and hospitalized patient costs. Summary of the Invention This description provides infusion flow control devices to keep the vein open to quickly and easily establish IV gravity infusion rates to KVO without interaction with other IV infusion equipment components. A KVO infusion flow control device is provided in one or more embodiments. The KVO infusion flow control device includes an inlet tubing connector comprising an IV inlet port, a first outlet port, and a second outlet port. The KVO infusion flow control device also includes an outlet tubing connector comprising an IV outlet port, a first inlet port, a second inlet port, and a flow control orifice disposed within the second inlet port. The KVO infusion flow control device further includes a full-flow tubing coupled at one end to the first outlet port of the inlet tubing connector and coupled at the other end to the first inlet port of the outlet tubing connector. The flow control device The KVO infusion set also includes a KVO flow tube connected at one end to the second outlet port of the inlet tube connector and connected at the other end to the second inlet port of the outlet connector or tube. The KVO infusion flow control device further includes a flow controller attached to the complete flow tube. In one or more aspects, the flow controller is configured to provide full fluid flow through the full-flow tube at the outlet tube connector when the flow controller is arranged in a first position that does not obstruct the full-flow tube. In one or more aspects, the flow controller is configured to allow fluid flow through the full-flow tube at the outlet tube connector when the flow controller is arranged in a second position that obstructs the full-flow tube to a predetermined degree. In one or more aspects, the flow control orifice is configured to restrict fluid flow within the outlet tube connector when the flow controller is arranged in the second position.In one or more aspects, the flow control orifice is sized and shaped to provide a predetermined fluid flow velocity (KVO) at the outlet tube connector when the flow controller is arranged in the second position. In one or more aspects, an inlet connector is attached. ML / a / ZUZZ / UI dUOl to the IV inlet port, the inlet connector configured to attach to an inlet IV tube. In one or more aspects, an outlet connector is coupled to the IV outlet port, the outlet connector being configured to couple to an IV outlet tube. In one or more aspects, the inlet connector is a female luer connector and the outlet connector is a male luer connector. In one or more aspects, the flow control orifice comprises a tube coupling portion configured to couple to the KVO flow tube, the tube coupling portion having a narrower internal diameter than the internal diameter of the KVO flow tube. In one or more aspects, the flow control orifice further comprises a restriction portion disposed adjacent to the tube coupling portion, the restriction portion being configured to block fluid flow from the tube coupling portion into the outlet connector.In one or more aspects, the flow control orifice further comprises a flow portion disposed within the restriction portion, the flow portion being configured to restrict fluid flow within the outlet connector to a fluid flow rate KVO. In one or more aspects, the flow controller is a clamping clamp. In one or more configurations, a KVO infusion flow control device is provided. The KVO infusion flow control device includes a body, a full open limb disposed on the body, a KVO limb disposed on the body separately from the full open limb, a control limb coupled to the body, and a visual indicator. A first position of the control limb is configured to couple to the full open limb with a fluid flow path to provide full fluid flow through an intravenous (IV) tube, and a second position of the control limb is configured to couple to the KVO limb with the fluid flow path to provide KVO fluid flow through the IV tube. In one or more aspects, the control member includes an open control arm having a first visual indicator disposed thereon and a KVO control arm having a second visual indicator disposed thereon, wherein the body is rotatably coupled to a fluid flow housing, the fluid flow housing including an inlet connector configured to receive a fluid inlet IV tube in one portion of the fluid flow housing and an outlet connector configured to receive a fluid outlet IV tube in another portion of the fluid flow housing, and wherein the fully open member is a fully open hole in the body and the KVO member is a KVO hole in the body. In one or more aspects, a first flange is arranged circumferentially around a portion of the inlet connector and a second flange is arranged circumferentially around a portion of the outlet connector, wherein the fluid inlet IV tube is received in a space between the first flange and the inlet connector and the fluid outlet IV tube is received in a space between the second flange and the outlet connector. In one or more aspects, the control member includes a control switch having first and second visual indicators disposed thereon, wherein the body is rotatably coupled to a fluid flow housing, the fluid flow housing configured to receive a fluid inlet IV tube in one portion of the fluid flow housing and to receive a fluid outlet IV tube in another portion of the fluid flow housing, and wherein the fully open member is a fully open hole in the body and the KVO member is a KVO hole in the body. In one or more aspects, the control member includes a cam disposed within a tube channel in the body, the cam slidably engaged with one or more cam channels in the body; and a ramp disposed at a base of the tube channel, wherein the body is box-like in shape with the visual indicator disposed thereon, the body configured to receive the IV tube within the tube channel, wherein the fully open member is a first portion of the body having a low end of the ramp, the first portion of the body configured such that the IV tube is unengaged and unobstructed when the cam is in the first position, and wherein the KVO member is a second portion of the body having a high end of the ramp, the second portion of the body configured to engage the IV tube such that the IV tube is obstructed when the cam is engaged with the IV tube in the second position. In one or more aspects, the control member includes a slide switch disposed within a switch channel in the body, wherein the body is a box-like housing with the visual indicator disposed thereon, the box-like housing configured to receive a fluid inlet IV tube at a first connector disposed on a side wall of the body and to receive a fluid outlet IV tube at a second connector disposed on an opposite side wall of the body, wherein the fully open member is a fully open channel disposed across a width of the slide switch, the fully open channel configured to align with the first and second connectors in the first position, and wherein the KVO member is a KVO channel disposed across the width of the slide switch, the KVO channel configured to align with the first and second indicators in the second position. In one or more aspects, the control member includes a rocker switch rotatably disposed in a tube channel of the body, the rocker switch having the visual indicator disposed therein, and the body configured to receive the IV tube in the tube channel, wherein the complete open member is a first portion of the rocker switch having an open coupling member disposed and formed to couple the IV tube so that the IV tube is not obstructed when the rocker switch is in the first position, and wherein the KVO member is a second portion of the rocker switch having a KVO coupling member sized and formed to couple with the IV tube so that the IV tube is obstructed when the rocker switch is in the second position. In one or more aspects, the control member includes a rocker switch rotatably disposed in a switch channel of the body, the body having a tube channel configured to receive the IV tube, wherein the fully open member is a coupling surface of the rocker switch in which the IV tube is one of uncoupled and unobstructed by the coupling surface when the rocker switch is in the first position, and wherein each KVO member comprises a retaining clip disposed on the body and a coupling member disposed on the rocker switch, the retaining clip configured to retain the coupling member so as to obstruct the IV tube by the coupling surface when the rocker switch is in the second position. In one or more aspects, the control member includes a switch slidably coupled to the body, the switch comprising: a front portion disposed within the body; an outer surface disposed within the body; a switch rib; and a switch connector configured to receive an inlet IV tube; the body comprising: a body connector configured to receive an outlet IV tube; a valve disposed adjacent to the body connector, the valve having rotatably connected valve flaps; a seal disposed on a portion of the outer surface of the switch;and a clamp, wherein the complete open member comprises the body clamp retaining the switch rib and the front portion of the switch retaining the valve flaps in an open position when the switch is in the first position, and wherein the KVO member comprises the front portion of the switch removed from the coupling with the valve flaps and the valve flaps deflecting into a closed position having a KVO gap when the switch is in the second position. Additional features and advantages of the description will be set out in the description below and will, in part, be evident from the description or can be learned through practical application. The objectives and other advantages of the description will be realized and obtained through the structure specifically indicated in the written description and its claims, as well as the accompanying figures. It is understood that both the above general description and the following detailed description are illustrative and explanatory and are intended to provide further explanation of the description as claimed. Brief Description of the Figures The accompanying figures, which are included to provide further understanding of the description and are incorporated into and constitute a part of this description, illustrate modalities of the description and together with the description serve to explain the principles of the description. Figure 1 is a perspective view of an illustrative KVO infusion fluid flow control device, in accordance with some aspects of the description. Figure 2 is a top view of the KVO infusion fluid flow control device of Figure 1 showing the fluid flow path with the clamp open, in accordance with some aspects of the description. Figure 3 is a cross-sectional perspective view of the KVO infusion fluid flow control device of Figure 2, in accordance with some aspects of the description. Figure 4 is a top view of the KVO infusion fluid flow control device of Figure 1 showing the fluid flow path with the clamp closed, in accordance with some aspects of the description. Figure 5 is a cross-sectional perspective view of the KVO infusion fluid flow control device of Figure 4, in accordance with some aspects of the description. Figure 6 is a partial enlarged view of the KVO infusion fluid flow control device from Figure 5, in accordance with some aspects of the description. Figure 7 is a schematic view of the fluid volume through the KVO infusion fluid flow control device of Figure 1 for all states, in accordance with some aspects of the description. Figure 8 is a partial enlarged view of the fluid volume in Figure 7, in accordance with some aspects of the description. Figure 9 is a schematic view of a fluid flow velocity model of the KVO infusion fluid flow control device of Figure 2, in accordance with some aspects of the description. Figures 10A-10E are various views of a KVO infusion fluid flow control device, in accordance with some aspects of the description. Figures 11A-11D are various views of a KVO infusion fluid flow control device, in accordance with some aspects of the description. Figures 12A-12D are various views of a KVO infusion fluid flow control device, in accordance with some aspects of the description. Figures 13A-13G are various views of a KVO infusion fluid flow control device, in accordance with some aspects of the description. Figures 14A-14D are various views of a KVO infusion fluid flow control device, in accordance with some aspects of the description. Figures 15A-15G are various views of a KVO infusion fluid flow control device, in accordance with some aspects of the description. Figures 16A-16D are various views of a KVO infusion fluid flow control device, in accordance with some aspects of the description. Figures 17A-17F are various views of a KVO infusion fluid flow control device, in accordance with some aspects of the description. Detailed Description of the Invention The detailed description below outlines several configurations of the technology in question and is not intended to represent the only configurations in which the technology can be practiced. The detailed description includes specific details for the purpose of providing a comprehensive understanding of the technology. Accordingly, dimensions regarding certain aspects are provided as non-limiting examples. However, it will be evident to those technically skilled in the field that the technology can 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 technology in question. The present description shall be understood to include examples of the technology in question and shall not limit the scope of the appended claims. Several aspects of the technology in question will now be described in accordance with particular, but not limiting, examples. Several embodiments described herein may be carried out in different forms and variations, and in accordance with a desired application or implementation. Typical connectors and flow regulators for gravity-fed IV infusion sets do not have a way to set a specific kVO rate. Although medical infusion pumps may have kVO rate adjustment features, kVO features are not typically found on current gravity-fed IV infusion sets. According to some aspects of the description, a KVO infusion flow control device allows a clinician (e.g., healthcare provider) to quickly and easily set gravity IV infusion rates to a KVO rate without interacting with other components in the IV infusion set (e.g., catheter, flush syringe, injection port, IV line component, roller clamp, flow controller). This frees the clinician to perform other duties without worry, as the KVO infusion flow control device keeps the injection site operational while maintaining the KVO rate. According to some aspects of the description, the KVO infusion flow control device reduces catheter occlusion and keeps the IV line open for future use. According to some aspects of the description, the KVO infusion flow control device reduces the likelihood of blood clots and drug precipitates forming, thereby keeping the IV site (e.g., needle injection site in vein) operational over time. According to some aspects of the description, the KVO infusion flow control device reduces the number of connections required to maintain the IV site (e.g., flush syringe), thereby keeping the IV site operational over time and reducing exposure to contaminants and infectious agents that could potentially enter the patient's bloodstream.According to some aspects of the description, the KVO infusion flow control device reduces the occurrence of blood reflux due to continuous IV fluid flow. A KVO 100 infusion flow control device is shown in Figures 1-9, in accordance with some aspects of the description. The KVO 100 infusion flow control device includes a full flow tube 110 and a KVO flow tube 120, each coupled to an inlet tube connector 130 (e.g., Y-connector) at one end and an outlet tube or connector 140 (e.g., Y-connector) at the other end. The inlet tube connector 130 includes an IV inlet port 132, a first outlet port 134, and a second outlet port 136. The outlet connector or tube 140 includes an IV outlet port 142, a first inlet port 144, and a second inlet port 146. The IV inlet port 132 is coupled to an inlet connector 150 (e.g., female luer connector), and the IV outlet port 142 is coupled to an outlet connector 160 (e.g., male luer connector).A flow controller 170 (e.g., clamping clamp) is coupled to the full-flow tube 110 to provide control of the fluid flow through the full-flow tube 110. For example, when the flow controller 170 is in an open position, the fluid can have a completely open flow in the full-flow tube 110, while when the flow controller 170 is in a closed position, fluid flow can be completely blocked in the full-flow tube 110. A flow control orifice 180 (see Figures 2-6) is arranged within the second inlet port 146, and the flow control orifice 180 is sized and formed to provide a desired fluid flow rate of KVO. As shown in Figures 2 and 3, with the flow controller 170 in an open-flow configuration, most of the fluid flows into the inlet tube connector 130 as the path of least resistance and flows out of the first outlet port 134 and through the full-flow tube 110 along the open-flow path X, in accordance with some aspects of the description. Here, some fluid may still flow out of the second outlet port 136 and through the KVO flow tube 120, but the fluid flow is restricted by the flow control orifice 180 so that the fluid flows back into the inlet tube connector 130.This causes additional flow coming from the inlet tube connector 130 from a fluid source (e.g., fluid bag, needleless syringe) to be diverted into the full flow tube 110 and flow freely without restriction to the first inlet port 144 and out of the IV outlet port 142 at a fully open flow rate. As shown in Figures 4 and 5, with the flow controller 170 in a flow-off configuration, most of the flow flows into the inlet tube connector 130 as the path of least resistance and flows out of the second outlet port 136 and through the KVO flow tube 120 along the open flow path Y, in accordance with some aspects of the description. Here, a portion of fluid remains in the full-flow tube 110 from the flow controller 170 to the inlet tube connector 130. This causes additional fluid coming into the inlet tube connector 130 from the fluid source (not shown) to be diverted to the KVO flow tube 120 and flow freely through the KVO flow tube 120 to the second inlet port 146 until it is restricted by the flow control orifice 180 in the outlet tube connector 140. The fluid then exits the IV outlet port 142 at a flow rate of KVO.As shown in Figure 6, in accordance with some aspects of the description, the flow control orifice 180 may have a flow portion 182, a restriction portion 184, and a pipe coupling portion 186. The coupling portion is configured to engage or couple with the KVO flow tube 120. The coupling portion 186 has a narrower internal diameter / volume than the KVO flow tube 120, providing a first restriction on fluid flow within the outlet pipe connector 140. The restriction portion 184 is configured to block fluid flow from the KVO flow tube 120 into the outlet pipe connector 140 through the area covered by the restriction portion 184.The flow portion 182 is a smaller opening (e.g., circular orifice) arranged within the restriction portion 184 and configured to receive fluid flow at a lower flow rate (e.g., KVO flow rate) than the fully open flow rate through the KVO flow tube 120 and the first restricted flow rate through the coupling portion 186. Thus, the size and shape of the flow portion 182 dictates the final fluid flow rate within the outlet tubing connector 140. For example, a neonatal gravity IV set for use with an infant may have a KVO 100 infusion flow control device with a very small flow portion 182, thereby causing a low KVO fluid flow rate appropriate for a small vein and / or body size. As another example, a gravity IV set for large adults may have a KVO 100 infusion flow control device with a larger flow portion 182, resulting in a higher KVO fluid flow rate appropriate for a larger vein and / or body size. The flow portion 182 can be configured as any shape (e.g., circle, square, oval, triangle), with different shapes providing different flow rates and levels of fluid turbulence. Figures 7 and 8 are schematic views illustrating the internal volume available for fluid flow through the KVO 100 infusion flow control device. The smaller available fluid volume in coupling portion 186 provides a somewhat restricted flow rate through coupling portion 186. The much smaller available fluid volume in flow portion 182 provides a more restricted flow rate (e.g., KVO flow rate) through flow portion 182. Consequently, the fluid flow output from flow control port 180 into outlet tubing connector 140 is controlled at the KVO flow rate. Figure 9 is an internal view of a modeled static fluid flow profile through the KVO 100 infusion flow control device in the fully open position. As shown, even though the vast majority of the fluid flows through the flow tube 110, when the flow controller 170 is in the open position, a portion of the fluid still flows through the KVO 120 flow tube and through the flow control orifice 180. In this way, the fluid flows from the full flow tube 110 and the control orifice 180 combine together in the outlet tube controller 140, and the combined fluid flow exits the outlet connector 160 at full flow rate.In contrast, when the flow controller 170 is in the closed position, the fluid flow through the full flow tube 110 is cut off and the only fluid flow in the outlet tube connector 140 comes from the flow control orifice 180, which then exits the outlet connector 160 at the flow rate of KVO. In operation, the KVO 100 infusion flow control device sets an IV set to open when the KVO 100 infusion flow control device is in the open position (e.g., unobstructed), thus allowing full fluid flow as shown in Figures 2, 3, and 4. When the KVO 100 infusion flow control device is in the closed position (e.g., obstructed), the KVO 100 infusion flow control device immediately sets the IV set to the KVO flow rate. In this way, the KVO 100 infusion flow control device can function as a binary / full KVO flow rate switch that can be easily operated (e.g., one-handed operation) and is easily visualized as being in either the open flow position or the flow chain position (e.g., clamp open or closed).Furthermore, the KVO 100 infusion flow control device no longer requires interaction with other IV equipment components (e.g., roller clamp, flow controller) when adjusting between full open flow and KVO flow. This simplified flow control operation of the KVO 100 infusion flow control device frees up time for the user (e.g., clinician, healthcare provider) to perform other care-related tasks, while providing an intuitive and straightforward way to set the IV flow rate with minimal operation or interaction. In terms of description, the KVO 100 infusion flow control device provides immediate feedback to the user when the 170 flow controller is activated (e.g., closed), and also allows for one-handed operation. The KVO 100 infusion flow control device also simplifies control over IV set functionality by providing quick and precise adjustment between open flow and KVO flow rates. The KVO 100 infusion flow control device can be mounted as part of a stock-keeping unit (SKU) of extension equipment and provides the user with familiar IV set components (e.g., clamp, luer connectors). In some aspects of the description, a KVO 200 infusion flow control device is configured as a stopcock device as shown in Figures 10A-10E. The KVO 200 infusion flow control device includes a body 210 having a fully open orifice 220 and a KVO orifice 230. An open control arm 240 and a KVO control arm 250 are coupled to the body 210. Visual indicators 260 are arranged on the open control arm 240 and the KVO control arm 250. The body 210 is coupled to a fluid flow housing 270 having connectors 272 configured to receive IV tubing 280 for fluid inlet and fluid outlet. In operation, the KVO 200 infusion flow control device can be controlled by grasping and rotating the open control arm 240 and / or the KVO 250 control arm to align one of the fully open orifices 220 and the KVO orifice 230 with the fluid flow path. This causes the KVO 200 infusion flow control device to operate between a fully open flow rate and a KVO flow rate. In some aspects of the description, the KVO 200 infusion flow control device does not have a shut-off setting to completely turn off the flow rate. In some aspects of the description, a KVO 300 infusion flow control device is configured as a stopcock device as shown in Figures 11A-11D. The KVO 300 infusion flow control device includes a body 310 having a fully open orifice 320 and a KVO orifice 330. An open control orifice 340 and a KVO control arm 350 are coupled to the body 310. Visual indicators 360 are arranged on the open control arm 340 and the KVO control arm 350. The body 310 is coupled to a fluid flow housing 370 having connectors 372 configured to receive IV tubing 380 for fluid inlet and fluid outlet. A flange 374 may be arranged around connector 372 so that tubing 380 is received between connector 372 and flange 374. In operation, the KVO 300 infusion flow control device can be controlled by grasping and rotating the open control arm 340 and / or the KVO 350 control arm to align one of the fully open orifices 320 and the KVO orifice 330 with the fluid flow path. This causes the KVO 300 infusion flow control device to operate between a fully open flow rate and a KVO flow rate. In some aspects of the description, the KVO 300 infusion flow control device does not have an off setting to completely shut off the flow rate. In some aspects of the description, the KVO 400 infusion flow control device is configured as a stopcock device, as shown in Figures 12A-12D. The KVO 400 infusion flow control device includes a body 410 having a fully open orifice 420 and a KVO orifice 430. A control switch 440 is coupled to the body 410; the control switch 440 is configured to rotate the body 410 between an open position and a KVO position. Visual indicators 460 are arranged on the control switch 440. The body 410 is coupled to a fluid flow housing 470 having connectors 472 configured to receive IV tubing 480 for fluid inlet and fluid outlet. In operation, the KVO 400 infusion flow control device can be controlled by holding and rotating control switch 440, causing one of the fully open ports 420 and one KVO port 430 to align with the fluid flow path. This causes the KVO 400 infusion flow control device to operate between a fully open flow rate and a KVO flow rate. In some aspects of the description, the KVO 400 infusion flow control device does not have a shut-off setting to completely stop the flow rate. In some aspects of the description, the KVO 500 infusion flow control device is configured as a roller clamp device, as shown in Figures 13A-13G. The KVO 500 infusion flow control device includes a body 510 and a cam 520 slidably arranged in cam channels 512 in the body 510. A ramp 514 is arranged on the base of a tube channel 516 in the body 510, the tube channel 516 being configured to receive an IV tube 580. Visual indicators 560 are arranged on the body 510. In operation, the KVO 500 infusion flow control device can be controlled by pushing / pulling cam 520 along the tubing channel 516 of the body 510. This causes cam 520 to engage with and strike IV tubing 580 between cam 520 and ramp 514 of the body 510. Placing cam 520 in the fully open position causes it to not obstruct (e.g., deform, compress) IV tubing 530 at all, providing a fully open fluid flow rate. Positioning cam 520 in the KVO position causes it to obstruct IV tubing 530 just enough to permit a KVO flow rate. In this way, the KVO 500 infusion flow control device operates between a fully open flow rate and a KVO flow rate.In some aspects of the description, the KVO 500 infusion flow control device does not have any shut-off settings to completely turn off the flow rate. In some aspects of the description, a KVO 600 infusion flow control device is configured as a slide-switch device as shown in Figures 14A-14D. The KVO 600 infusion flow control device includes a body 610 and a switch 620 slidably arranged in a switch channel 612 in the body 610. The switch 620 includes a full open channel 630 and a KVO channel 640, each arranged across the full width of a switch housing 622. Connectors 670 are arranged on opposite sides of the body 610, the connectors 670 configured to receive IV tubing 680. Visual indicators 660 are arranged on the body 610. In operation, the KVO 600 infusion flow control device can be controlled by pushing / pulling switch 620 in the switch channel 612 of the body 610 to align with either the fully open channel 630 or the KVO channel 640 with the connectors 670. Placing switch 620 in the fully open position causes it to align with the fully open channel 630 with the connectors 630 and, correspondingly, the IV tubing 680, providing a fully open fluid flow rate. Placing switch 620 in the KVO position causes it to align with the KVO channel 640 with the connectors 670 and, correspondingly, the IV tubing 680, allowing only a KVO flow rate. In this way, the KVO 600 infusion flow control device operates between a fully open flow rate and a KVO flow rate.In some aspects of the description, the KVO 600 infusion flow control device does not have a shut-off setting to completely turn off the flow rate. In some aspects of the description, the KVO 600 infusion flow control device may allow the flow rate to be completely turned off (for example, switch 620 is positioned so that neither the fully open channel 630 nor the KVO channel 640 is aligned with connectors 670). In some aspects of the description, a KVO 700 infusion flow control device is configured as a rocker adapter device as shown in Figures 15A-15G. The KVO 700 infusion flow control device includes a body 710 and a rocker switch 720 having a switch shaft 722 rotatably arranged in a tubing channel 712 of the body 710. An open coupling member 730 is arranged at one end of the rocker switch 720 and is sized and formed so as not to obstruct (e.g., deform, compress) IV tubing 780 arranged in the tubing channel 712. A KVO coupling member 740 is arranged at the other end of the rocker switch 720 and is sized and formed to obstruct IV tubing 780 to a predetermined degree when pressed into an activated position.Retaining clips 770 are arranged at both ends of the body 710 and are configured to engage and retain either of the open coupling member 730 and the KVO coupling member 740 when it is activated (e.g., pressed into the tube channel 712). Visual indicators 760 are arranged on the body 710. In operation, the KVO 700 infusion flow control device can be operated by pushing one end of the rocker switch 720 to cause the corresponding open coupling member 730 or KVO coupling member 740 to press against the tubing channel 712 in which the IV tubing 780 is arranged. Pushing the rocker switch 720 to the open end causes the open coupling member 730 to either not engage with the IV tubing 780 at all, or to engage but not obstruct the IV tubing 780, thus providing a full open fluid flow rate. The open coupling member 730 is then captured and retained by the retaining clips 770 arranged at the open end. Pushing the rocker switch 720 into the KVO end causes the KVO coupling member 740 to engage with and obstruct the IV pipe 780 sufficiently to allow only a KVO flow rate.Here, the KVO 740 coupling member is captured and retained by the 770 retaining clips located at the KVO end. In this way, the KVO 700 infusion flow control device operates between a fully open flow rate and a KVO flow rate. In some aspects of the description, the KVO 700 infusion flow control device does not have a shut-off setting to completely turn off the flow rate. In some aspects of the description, the KVO 800 infusion flow control device is configured as a toggle adapter device as shown in Figures 16A-16D. The KVO 800 infusion flow control device includes a body 810 and a toggle switch 820 having a switch shaft 822 rotatably disposed in a switch channel 812 of the body 810. A tubing channel 814 is disposed in the body 810 and is configured to receive an IV tubing 880. A clip coupling member 830 is disposed on the toggle switch 820 and is sized and formed to engage with and be retained by a retaining clip 870 disposed on the body 810. A mating surface 840 is arranged on the rocker switch 820 and is configured to engage with and obstruct the IV pipe 880 to a predetermined degree when the rocker switch 820 is pressed into an activated position. Visual indicators (not shown) may be arranged on the body 810. In operation, the KVO 800 infusion flow control device can be controlled by pushing / pulling the rocker switch 820 into an open position to move the coupling surface 840 away from the tube channel 814 in which the IV tubing 880 is disposed, causing the coupling surface 840 to either not engage with the IV tubing 880 at all or engage with but not obstruct the IV tubing 880, which provides the full open fluid flow rate through the IV tubing 880.The KVO 800 infusion flow control device can also be operated by pushing / pulling the rocker switch 820 to a KVO position to move the coupling surface 840 into the tubing channel 814 in which the IV tubing 880 is disposed, causing the coupling surface 840 to engage with and obstruct the IV tubing 880 to a predetermined amount, thereby permitting only a KVO fluid flow rate through the IV tubing 880. Here, the clip coupling member 830 is captured and retained by the retaining clip. 870 to keep it in the KVO position (e.g., on). In this way, the KVO 800 infusion flow control device operates between a fully open flow rate and a KVO flow rate. In some aspects of the description, the KVO 800 infusion flow control device does not have a shut-off setting to completely turn off the flow rate. In some aspects of the description, a KVO 900 infusion flow control device is configured as an in-line switch device as shown in Figures 17A-17F. The KVO 900 infusion flow control device includes a body 910 and a switch 920 slidably coupled to the body 910. The body 910 includes a body connector 930, and the switch 920 includes a switch connector 940, each sized and shaped to receive IV tubing 980. The body 910 also includes a valve 950 disposed adjacent to the body connector 930 within the body 910. The valve 950 includes valve flaps 952 that are configured to deflect to a closed position (e.g., valve flaps 852 aligned orthogonally to an axial fluid flow channel within the body 910), providing a KVO 950 gap between the valve flaps.The valve flaps 952 can be rotatably connected to the valve 950 (e.g., similar hinged swing doors) so that they can be opened by pivoting (e.g., swinging open) when a front portion 922 of the switch 920 engages and exerts force on the valve flaps 952. The body 910 also includes a seal 960 configured to engage with an outer surface 924 of the switch 920 through the full range of sliding motion within the body 910, thereby providing a sealing barrier that prevents leakage of fluid from the KVO 900 infusion flow control device. Visual indicators (not shown) can be arranged on the body 910 and / or the switch 920.The 920 switch includes 926 switch ribs and the 910 body includes 916 body ribs, wherein the 926 switch ribs and the 916 body ribs provide ergonomic grip of the 920 switch and the 910 body. The 910 body also includes 970 clamps disposed at one end adjacent to the 920 switch, the 970 clamps configured to engage and retain a 926 switch rib, thereby blocking the flow rate of the KVO 900 infusion flow control device. In operation, the KVO 900 infusion flow control device can be controlled by pushing / pulling switch 920 toward / away from valve 950. Here, the front portion 922 of switch 920 remains inside the body 910 when switch 920 is in either the open position or the KVO position. Pushing switch 920 to the open configuration causes the front portion 922 to engage with the valve flaps 952 and forces the valve flaps 952 to rotate inward toward the body connector 930, thereby opening a full flow path to allow an open fluid flow rate out of the body connector 930 into the IV outlet tubing 980.Pulling switch 920 out of the KVO setting causes the front portion 922 to disengage from the valve flaps 952 and allows the deflection force of the valve flaps 952 to rotate them away from the body connector 930 and align them orthogonally to an axial fluid flow channel within the body 910, thereby providing the KVO space 954 to permit only a KVO fluid flow rate out of the body connector 930 into an IV outlet tube 980. In this way, the KVO infusion flow control device 900 operates between a fully open flow rate and a KVO flow rate. In some aspects of the description, the KVO infusion flow control device 900 does not have an off setting to completely shut off the flow rate. It is understood that any specific order or hierarchy of blocks in the described process methods is an illustration of illustrative approaches. Based on design or implementation preferences, it is understood that the specific order or hierarchy of blocks in the processes may be rearranged, or that all illustrated blocks may be performed. In some implementations, any of the blocks may be performed simultaneously. This description is provided to enable any technician skilled in the art to practice the various aspects described herein. The description provides several examples of the technology in question, and the technology in question is not limited to these examples. Various modifications to these aspects will be evident to those skilled in the art, and the generic principles defined herein may be applied to other aspects. A reference to a singular item is not intended to mean one and only one unless specifically stated, but rather one or more. Unless otherwise specifically stated, the term "some" refers to one or more. Masculine pronouns (e.g., his / her) include feminine and neuter genders (e.g., her / her and her) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit invention. The word illustrative is used to mean that it serves as an example or illustration. A feature or design described here as illustrative should not necessarily be interpreted as preferred or advantageous over other features or designs. In one respect, several alternative configurations and operations described here may be considered at least equivalent. As used here, the phrase "at least one of" presenting a list of items, within the term or to separate any of the items, modifies the list as a whole, rather than each item in the list. The phrase "at least one of" does not require selecting "at least one item"; rather, the phrase allows for a meaning that includes 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. By way of example, 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. A phrase such as "an aspect" does not imply that such an aspect is essential to the technology in question or that such an aspect applies to all configurations of the technology in question. A description relating to an aspect may apply to all configurations, or to 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 "a modality" does not imply that such a modality is essential to the technology in question or that such a modality applies to all configurations of the technology in question. A description referring to a modality may apply to all modalities, or to one or more modalities. A modality may provide one or more examples. A phrase such as "a modality" may refer to one or more modalities and vice versa.A phrase such as "a configuration" does not imply that that configuration is essential to the technology in question or that such a configuration applies to all configurations of the technology in question. A description that refers to a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase such as "a configuration" may refer to one or more configurations and vice versa. In one respect, unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications set forth in this description, which are included in the claims below, are approximate, not exact. In one respect, they are intended to have a reasonable range consistent with the functions to which they relate and with what is customary in the art to which they belong. The specific order or hierarchy of steps, operations, or processes described is understood to be an illustrative approach. Based on design preferences, 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. Any attached method claims present elements of the various steps, operations, or processes in a sample order and are not intended to be limited to the specific order or hierarchy presented. All structural and functional equivalents to the elements of the various aspects described herein that are known or will later become known to those skilled in the art are expressly incorporated herein by reference and are intended to be covered by the claims. Furthermore, nothing described herein is intended to be directed to the public, regardless of whether such a description is explicitly mentioned in the claims. No element of a claim shall be construed as requiring the provisions of 35 U.S.C. §112(f) unless the element is expressly mentioned by using the phrase "means to" or, in the case of a method claim, the element is mentioned by using the phrase "step to".Furthermore, to the extent that the terms include, have, or similar are used, the terms are intended to be inclusive in a manner similar to the term comprise, since comprise is interpreted when used as a transition word in a claim. The Title, Background, Summary, Brief Description of Figures, and Abstract of Description are incorporated herein and are provided as illustrative examples, not as restrictive descriptions. It is stated with the understanding that they shall not be used to limit the scope or meaning of the claims. Furthermore, in the Detailed Description, it can be observed that the description provides illustrative examples, and the various features are grouped into several modes for the purpose of expeditious description. This method of description is not to be construed as reflecting an intention that the claimed subject matter requires more features than are expressly mentioned in each claim. Rather, as reflected in the following claims, inventive matter lies in less than all the features of a single described configuration or operation.The following claims are hereby incorporated into the Detailed Description, with each separate claim being a separately claimed subject matter. The claims are not intended to be limited to the aspects described herein, but are to agree in scope to the full language consistent with the claims and to encompass all legal equivalents. However, none of the claims purports to cover, nor should they be construed as covering, subject matter that fails to satisfy the requirement of 35 U.S.C. § 101, 102, or 103. It is hereby stated that, as of this date, the best method known to the applicant for putting the aforementioned invention into practice is the one that is clear from the present description of the invention.

Claims

1. A Keep Open Vein (KVO) infusion flow control device, characterized in that it comprises: an inlet tube connector comprising an intravenous (IV) inlet port, a first outlet port, and a second outlet port; an outlet tube connector comprising an IV outlet port, a first inlet port, a second inlet port, and a flow control orifice disposed within the second inlet port; a full-flow tube coupled at one end to the first inlet port of the inlet tube connector and coupled at the other end to the first inlet port of the outlet tube connector; a KVO flow tube coupled at one end to the second outlet port on the inlet tube connector and coupled at the other end to the second inlet port of the outlet tube connector; and a flow controller coupled to the full-flow tube.

2. The KVO infusion flow control device according to claim 1, characterized in that the flow controller is configured to provide full fluid flow through the full flow tube within the outlet tube connector when the flow controller is arranged in a first position that does not obstruct the full flow tube.

3. The KVO infusion flow control device according to claim 1, characterized in that the flow controller is configured to shut off the fluid flow through the full flow tube within the outlet tube connector when the flow controller is arranged in a second position that obstructs the full flow tube to a predetermined degree.

4. The KVO infusion flow control device according to claim 3, characterized in that the flow control orifice is configured to limit fluid flow in the outlet tube connector when the flow controller is arranged in the second position.

5. The KVO infusion flow control device according to claim 4, characterized in that the flow control orifice is sized and formed to provide a predetermined KVO fluid flow rate within the outlet tube connector when the flow controller is arranged in the second position.

6. The KVO infusion flow control device according to claim 1, characterized in that it further comprises an inlet connector coupled to the IV inlet port, the inlet connector being configured to couple to an inlet IV tube.

7. The KVO infusion flow control device according to claim 6, characterized in that it further comprises an outlet connector coupled to the IV outlet port, the outlet connector being configured to be coupled to an IV outlet tube.

8. The KVO infusion flow control device according to claim 7, characterized in that the inlet connector is a female luer connector and the outlet connector is a male luer connector.

9. The KVO infusion flow control device according to claim 1, characterized in that the flow control orifice comprises a tube coupling portion configured to couple with the KVO flow tube, the tube coupling portion having a narrower internal diameter than an internal diameter of the KVO flow tube.

10. The KVO infusion flow control device according to claim 9, characterized in that the flow control orifice further comprises a restriction portion disposed adjacent to the tube coupling portion, the restriction portion being configured to block fluid flow from the tube coupling portion into the outlet tube connector.

11. The KVO infusion flow control device according to claim 10, characterized in that the flow control orifice further comprises a flow portion disposed within the restriction portion, the flow portion being configured to restrict fluid flow within the outlet connector or tube to a KVO fluid flow rate.

12. The KVO infusion flow control device according to claim 1, characterized in that the flow controller is a clamping clamp.

13. An infusion flow control device for keeping the vein open (KVO), characterized in that it comprises: a body; a complete open member disposed in the body; a KVO member disposed in the body separately from the complete open member; a control member coupled to the body; and a visual indicator, wherein a first position of the control member is configured to couple the complete open member with a fluid flow path to provide full fluid flow through an intravenous (IV) tube and a second position of the control member is configured to couple the KVO member with the fluid flow path to provide KVO fluid flow through the IV tube. 14 - The KVO infusion flow control device according to claim 13, characterized in that the control member comprises: an open control arm having a first visual indicator disposed therein; and a KVO control arm having a second visual indicator disposed therein, wherein the body is rotatably coupled to a fluid flow housing, the fluid flow housing including an inlet connector configured to receive a fluid inlet IV tube in a portion of the fluid flow housing and an outlet connector configured to receive a fluid outlet IV tube in another portion of the fluid flow housing, and wherein the entire open member is a complete open orifice in the body and the KVO member is a KVO orifice in the body.

15. The KVO infusion flow control device 4 6 according to claim 14, characterized in that it further comprises a first flange arranged circumferentially around a portion of the inlet connector and a second flange arranged circumferentially around a portion of the outlet connector, wherein the fluid inlet IV tubing is received in a space between the first flange and the inlet connector and the fluid outlet IV tubing is received in a space between the second flange and the outlet connector.

16. The KVO infusion flow control device according to claim 13, characterized in that the control member comprises: a control switch having first and second visual indicators disposed thereon, wherein the body is rotatably coupled to a fluid flow housing, the fluid flow housing being configured to receive a fluid inlet IV tube in one portion of the fluid flow housing and to receive a fluid outlet IV tube in another portion of the fluid flow housing, and wherein the fully open member is a fully open orifice in the body and the KVO member is a KVO orifice in the body.

17. The KVO infusion flow control device according to claim 13, characterized in that the control member comprises: a cam disposed within a tube channel in the body, the cam slidably coupled with one or more cam channels in the body;and a ramp disposed at a base of the tube channel, wherein the body has a box-like shape with the visual indicator disposed therein, the body configured to receive the IV tube within the tube channel, wherein the fully open member is a first portion of the body having a low end of the ramp, the first portion of the body configured so that the IV tube is uncoupled and unobstructed when the cam is in the first position, and wherein the KVO member is a second portion of the body having a high end of the ramp, the second portion of the body configured to couple with the IV tube so that the IV tube is obstructed when the cam is coupled with the IV tube in the second position.

18. The KVO infusion flow control device according to claim 13, characterized in that the control member comprises: a sliding switch disposed within a switch channel in the body, wherein the body is a box-like housing with the visual indicator disposed therein, the box-like housing configured to receive a fluid inlet IV tubing at a first connector disposed in a side wall of the body and to receive a fluid outlet IV tubing at a second connector disposed in an opposite side wall of the body, wherein the fully open member is a fully open channel disposed across a width of the sliding switch, the fully open channel configured to align with the first and second connectors in the first position, and wherein the KVO member is a KVO channel disposed across the width of the sliding switch,The KVO channel is configured to align with the first and second connectors in a second position.

19. The KVO infusion flow control device according to claim 13, characterized in that the control member comprises: a rocker switch rotatably disposed in a tubing channel of the body, the rocker switch having the visual indicator disposed therein, and the body configured to receive the IV tubing in the tubing channel, wherein the complete open member is a first portion of the rocker switch having an open coupling member sized and formed to engage with the IV tubing such that the IV tubing is not obstructed when the rocker switch is in the first position, and wherein the KVO member is in a second portion of the rocker switch having a KVO coupling member sized and formed to engage with the IV tubing such that the IV tubing is obstructed when the rocker switch is in the second position.

20. The KVO infusion flow control device according to claim 13, characterized in that the control member comprises: a rocker switch rotatably disposed in a switch channel of the body, the body having a tubing channel configured to receive the IV tubing, wherein the fully open member is a coupling surface of the rocker switch wherein the IV tubing is one not coupled by the coupling surface and not obstructed by the coupling surface when the rocker switch is in the first position, and wherein the KVO member comprises a retaining clip disposed on the body and a coupling member disposed on the rocker switch, the retaining clip being configured to retain the coupling member so that the IV tubing is obstructed by the coupling surface when the rocker switch is in the second position.

21. The KVO infusion flow control device according to claim 13, characterized in that the control member comprises: a switch slidably coupled to the body, the switch comprising: a front portion disposed within the body; an outer surface disposed within the body; a switch rib; and a switch connector configured to receive an inlet IV tube; the body comprising: a body connector configured to receive an outlet IV tube; a valve disposed adjacent to the body connector, the valve having rotatably connected valve flaps; a seal disposed in a portion of the outer surface of the switch;and a clamp, wherein the complete open member comprises the body clamp retaining the switch rib and the front portion of the switch retaining the valve flaps in an open position when the switch is in the first position, and wherein the KVO member comprises the front portion 5 of the switch removed from coupling with the valve flaps and the valve flaps are deflected into a closed position having a KVO gap when the switch is in the second position.

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