Venous Openness Maintenance Injection Flow Control Device

Abstract

A keep venous open (KVO) infusion flow control device is provided. The KVO infusion flow control device includes a flow controller that couples to intravenous (IV) tubing and provides full fluid flow through an outlet portion of the IV tubing when the flow controller is in an open position and provides KVO fluid flow through the outlet portion of the IV tubing when the flow controller is in a KVO position. A visual indicator is disposed on the KVO infusion flow control device.

Description

Technical Field

[0001] Cross - reference to related applications N / A

Background Art

[0002] During the use of an intravenous (IV) infusion set, occlusion of the IV line is a common but undesirable occurrence at the patient's IV access due to the blood fibrin clotting function. The causes of catheter occlusion can be drug or parenteral nutrition precipitates or thrombus - related due to machinery. Occlusion due to this effect also provides a potential nesting material for microorganisms and thus increases the risk of catheter - related bloodstream infections. Typical solutions to catheter occlusion are flushing and locking methods such as tissue plasminogen activator (tPA), heparin lock, and catheter replacement. However, these typical flushing and locking methods have a significant impact on the clinician's time and the patient's cost.

[0003] It is desirable to provide an infusion flow control device with a safe and consistent fluid flow control that can be easily set to maintain the fluid flow in the IV line at a KVO rate, also known as keep - vein - open (KVO) or keep - the - line - open (TKO), and thus reduce the clinician's time and the patient's cost.

Summary of the Invention

[0004] The present disclosure provides a keep - vein - open infusion flow control device for quickly and easily setting the gravity IV infusion rate to KVO without interacting with other IV infusion set components.

[0005] In one or more embodiments, a KVO infusion flow control device is provided. The KVO infusion flow control device includes an inlet tube connector having an IV inlet port, a first outlet port, and a second outlet port. The KVO infusion flow control device also includes an outlet tube connector having 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 tube coupled at one end to the first outlet port of the inlet tube connector and at the other end to the first inlet port of the outlet tube connector. The KVO infusion flow control device further includes a KVO flow tube coupled at one end to the second outlet port of the inlet tube connector and at the other end to the second inlet port of the outlet tube connector. The KVO infusion flow control device further includes a flow controller coupled to the full flow tube.

[0006] In one or more aspects, the flow controller is configured to provide a full fluid flow into the outlet tube connector through the full flow tube when the flow controller is disposed in a first position where the flow controller does not block the full flow tube. In one or more aspects, the flow controller is configured to block the fluid flow through the full flow tube to the outlet tube connector when the flow controller is disposed in a second position where the flow controller blocks the full flow tube to a predetermined extent. In one or more aspects, the flow control orifice is configured to limit the fluid flow to the outlet tube connector when the flow controller is disposed in the second position. In one or more aspects, the flow control orifice is sized and shaped to provide a predetermined KVO fluid flow rate to the outlet tube connector when the flow controller is disposed in the second position. In one or more aspects, an inlet connector is coupled to the IV inlet port and is configured to be coupled to an inlet IV tube.

[0007] In one or more aspects, an outlet connector is coupled to an IV outlet port, and the outlet connector is configured to be coupled to an outlet IV 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 engagement portion configured to couple with a KVO flow tube, and the tube engagement portion has an inner diameter narrower than the inner 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 engagement portion, and the restriction portion is configured to block fluid flow from the tube engagement portion to the outlet connector. In one or more aspects, the flow control orifice further comprises a flow portion disposed within the restriction portion, and the flow portion is configured to limit fluid flow to the outlet connector to the KVO fluid flow rate. In one or more aspects, the flow controller is a pinch clamp.

[0008] In one or more embodiments, a KVO infusion flow control device is provided. The KVO infusion flow control device includes a body, a fully open member disposed in the body, a KVO member disposed in the body separately from the fully open member, a control member coupled to the body, and a visual indicator. A first position of the control member is configured to engage the fully 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 engage the KVO member with the fluid flow path to provide KVO fluid flow through the IV tube.

[0009] 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, and the body is rotatably coupled to a fluid flow housing that includes an inlet connector configured to receive a fluid inlet IV tube at a portion of the fluid flow housing and an outlet connector configured to receive a fluid outlet IV tube at another portion of the fluid flow housing. The fully open member is a fully open orifice within the body, and the KVO member is a KVO orifice within the body.

[0010] In one or more embodiments, the first flange is circumferentially disposed around a portion of the inlet connector, the second flange is circumferentially disposed around a portion of the outlet connector, the fluid inlet IV tube is received in the gap between the first flange and the inlet connector, and the fluid outlet IV tube is received in the gap between the second flange and the outlet connector.

[0011] In one or more embodiments, the control member includes a control switch having first and second visual indicators disposed thereon, the body is rotatably coupled to the fluid flow housing, the fluid flow housing is configured to receive the fluid inlet IV tube at a portion of the fluid flow housing and the fluid outlet IV tube at another portion of the fluid flow housing, the fully open member is a fully open orifice within the body, and the KVO member is a KVO orifice within the body.

[0012] In one or more embodiments, the control member is a cam disposed within a tube channel in the body, the cam slidably engaging one or more cam channels in the body, and includes a lamp disposed at the base of the tube channel, the body having a box-shaped configuration with a visual indicator disposed thereon, the body being configured to receive the IV tube within the tube channel, the fully open member being a first portion of the body having a lower end of the lamp, the first portion of the body being configured such that the IV tube is not engaged and not blocked when the cam is in the first position, and the KVO member being a second portion of the body having an upper end of the lamp, the second portion of the body being configured to engage the IV tube such that the IV tube is blocked when the cam engages the IV tube at the second position.

[0013] In one or more aspects, the control member includes a slide switch disposed within a switch channel in the body, the body is a box-shaped housing on which a visual indicator is disposed, the box-shaped housing is configured to receive a fluid inlet IV tube with a first connector disposed on a sidewall of the body and to receive a fluid outlet IV tube with a second connector disposed on the opposite sidewall of the body, the fully open member is a fully open channel disposed through the width of the slide switch, the fully open channel is configured to align with the first and second connectors in a first position, the KVO member is a KVO channel disposed through the width of the slide switch, and the KVO channel is configured to align with the first and second connectors in a second position.

[0014] In one or more aspects, the control member includes a rocker switch pivotally disposed within a tube channel of the body, the rocker switch has a visual indicator disposed thereon, the body is configured to receive an IV tube within the tube channel, the fully open member is a first portion of the rocker switch having an open engagement member sized and shaped to engage the IV tube such that the IV tube is not blocked when the rocker switch is in a first position, and the KVO member is a second portion of the rocker switch having a KVO engagement member sized and shaped to engage the IV tube such that the IV tube is blocked when the rocker switch is in a second position.

[0015] In one or more aspects, the control member includes a rocker switch pivotally disposed within a switch channel of the body, the body has a tube channel configured to receive an IV tube, the fully open member is an engagement surface of the rocker switch, and when the rocker switch is in the first position, the IV tube is not engaged by and not blocked by the engagement surface. The KVO member includes a retaining clip disposed on the body and an engagement member disposed on the rocker switch, and the retaining clip is configured to hold the engagement member such that the IV tube is blocked by the engagement surface when the rocker switch is in the second position.

[0016] In one or more aspects, the control member includes a switch slidably coupled to the body, the switch includes a leading 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 includes a body connector configured to receive an outlet IV tube, a valve disposed adjacent to the body connector and having a valve flap pivotally connected thereto, a seal disposed on a portion of the outer surface of the switch, and a gripper. When the switch is in the first position, the fully open member includes a gripper of the body that holds the switch rib and a leading portion of the switch that holds the valve flap in the open position. When the switch is in the second position, the KVO member includes a leading portion of the switch disengaged from the valve flap and a valve flap biased to a closed position having a KVO gap.

[0017] Further features and advantages of the present disclosure are described in the following description, some of which will be apparent from the description or can be learned by practice of the present disclosure. The objectives and other advantages of the present disclosure are realized and attained by the structure particularly pointed out in this specification, the claims, and the appended drawings.

[0018] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the claimed present disclosure.

[0019] Included to provide a further understanding of the present disclosure, the accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

Brief Description of the Drawings

[0020]

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DETAILED DESCRIPTION OF THE INVENTION

[0021] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configuration in which the subject technology may be implemented. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Accordingly, dimensions are provided as non-limiting examples with respect to specific aspects. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology.

[0022] It should be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Here, various aspects of the technology are disclosed according to specific but non-limiting examples. The various embodiments described in the present disclosure can be implemented in different ways and variations according to the desired application or implementation form.

[0023] Typical connectors and flow regulators for gravity IV infusion sets do not have a way to set a specific KVO rate. Medical infusion pumps can have a KVO rate setting function, but the KVO function is not typically found in current gravity IV infusion sets.

[0024] According to some aspects of the present disclosure, with a KVO infusion flow control device, a clinician (e.g., a healthcare provider) can quickly and easily set the gravity IV infusion rate to the KVO rate without interacting with other components within the IV infusion set (e.g., a catheter, a flush syringe, an infusion port, IV line components, a roller clamp, a flow controller). Thereby, since the KVO infusion flow control device maintains the infusion site operable while maintaining the KVO rate, the clinician can perform other tasks without worry.

[0025] According to some aspects of the present disclosure, the KVO infusion flow control device reduces occlusions within the catheter and maintains the patency of the IV line for future use. According to some aspects of the present disclosure, the KVO infusion flow control device reduces the probability that thrombi and drug precipitates are formed, and thus keeps the IV site (e.g., the infusion site of the needle within the vein) operable over time. According to some aspects of the present disclosure, the KVO infusion flow control device reduces the connections necessary to maintain the IV site (e.g., a flush syringe), and thus keeps the IV site operable over time and reduces exposure to contaminants and infectious agents that may potentially enter the patient's bloodstream. According to some aspects of the present disclosure, the KVO infusion flow control device reduces the occurrence of blood backflow due to the continuous flow of the IV fluid.

[0026] As shown in FIGS. 1-9, a KVO infusion flow control device 100 according to some aspects of the present disclosure is shown. The KVO infusion flow control device 100 includes a full flow tube 110 and a KVO flow tube 120, which are coupled to an inlet tube connector 130 (e.g., a Y connector) at one end and an outlet tube connector 140 (e.g., a Y connector) at the other end, respectively. The inlet tube connector 130 includes an IV inlet port 132, a first outlet port 134, and a second outlet port 136. The outlet tube connector 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., a female Luer connector), and the IV outlet port 142 is coupled to an outlet connector 160 (e.g., a male Luer connector). A flow controller 170 (e.g., a pinch clamp) is coupled to the full flow tube 110 to control the fluid flow through the full flow tube 110. For example, when the flow controller 170 is in the open position, the fluid may have a full open flow within the full flow tube 110, while when the flow controller 170 is in the closed position, the fluid flow may be completely blocked within the full flow tube 110. A flow control orifice 180 (see FIGS. 2-6) is disposed within the second inlet port 146, and the flow control orifice 180 is sized and shaped to provide a desired KVO fluid flow rate.

[0027] As shown in FIGS. 2 and 3, according to some aspects of the present disclosure, with the flow controller 170 in the open flow setting, most of the fluid flowing into the inlet tube connector 130 takes the path of least resistance and flows out from the first outlet port 134 and through the full flow tube 110 along the open flow path X. Here, some portions of the fluid may still flow out from the second outlet port 136 through the KVO flow tube 120, but the fluid flow is restricted by the flow control orifice 180 such that the fluid does not reverse flow into the inlet tube connector 130. Thereby, additional fluid entering the inlet tube connector 130 from a fluid source (e.g., a fluid bag, an unnecessary syringe) bypasses within the full flow tube 110 and freely flows without being restricted to the first inlet port 144 and exits from the IV outlet port 142 at the full open flow rate.

[0028] As shown in FIGS. 4 and 5, according to some aspects of the present disclosure, with the flow controller 170 in the flow-off setting, most of the fluid flowing into the inlet tube connector 130 takes the path of least resistance, flows out from the second outlet port 136, and flows through the KVO flow tube 120 along the open flow path Y. Here, a portion of the fluid remains within the full flow tube 110 from the flow controller 170 to the inlet tube connector 130. As a result, additional fluid entering the inlet tube connector 130 from a fluid source (not shown) bypasses within the KVO flow tube 120 and freely flows through the KVO flow tube 120 to the second inlet port 146 until restricted by the flow control orifice 180 within the outlet tube connector 140. The fluid then exits the IV outlet port 142 at the KVO flow rate.

[0029] As shown in FIG. 6, according to some aspects of the present disclosure, the flow control orifice 180 may have a flow portion 182, a restriction portion 184, and a tube engagement portion 186. The engagement portion is configured to engage or couple with the KVO flow tube 120. The engagement portion 186 has an inner diameter / volume smaller than that of the KVO flow tube 120 and provides a first restriction to the fluid flow to the outlet tube connector 140. The restriction portion 184 is configured to block the flow of fluid from the KVO flow tube 120 to the outlet tube connector 140 through the area covered by the restriction portion 184. The flow portion 182 is disposed within the restriction portion 184 and is a small opening (e.g., a circular hole) configured to restrict the fluid flow to a flow rate lower (e.g., the KVO flow rate) than the full open flow rate through the KVO flow tube 120 and the first restricted flow rate through the engagement portion 186.

[0030] Accordingly, the size and shape of the flow portion 182 define the final flow rate of the fluid to the outlet tube connector 140. For example, a neonatal gravity IV set for use in infants can have a KVO infusion flow control device 100 with a very small flow portion 182, thus providing a low KVO fluid flow rate suitable for small veins and / or small body sizes. As another example, a large adult gravity IV can have a KVO infusion flow control device 100 with a larger flow portion 182, resulting in a higher KVO fluid flow rate suitable for larger veins and / or larger body sizes. The flow portion 182 can be configured in any shape (e.g., circular, square, elliptical, triangular), and different shapes can achieve different flow rates and fluid turbulence levels.

[0031] Figures 7 and 8 are schematic views showing the internal volume available for fluid flow through the entire KVO infusion flow control device 100. The smaller the available fluid volume of the engagement portion 186, the more restricted the flow rate through the engagement portion 186. The much smaller the available fluid volume of the flow portion 182, the more restricted the flow rate (e.g., KVO flow rate) through the flow portion 182. Accordingly, the fluid flow output from the flow control orifice 180 to the outlet tube connector 140 is controlled to the KVO flow rate.

[0032] Figure 9 is an internal view of a modeled static fluid flow profile through the KVO infusion flow control device 100 in the fully open position. As shown, even when most of the fluid flows through the full flow tube 110 when the flow controller 170 is in the open position, a portion of the fluid still flows through the KVO flow tube 120 and through the flow control orifice 180. Accordingly, the fluid flows from the full flow tube 110, the flow control orifice 180 merges within the outlet tube connector 140, and the merged fluid flow exits the outlet connector 160 at the 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 blocked, and the only fluid flow to the outlet tube connector 140 comes from the flow control orifice 180 and then exits the outlet connector 160 at the KVO flow rate.

[0033] During operation, the KVO infusion flow control device 100 is set to open the IV set when the KVO infusion flow control device 100 is in the open position (e.g., not occluded), and thus allows all fluid flow as shown in FIGS. 2, 3, and 9. When the KVO infusion flow control device 100 is in the closed position (e.g., occluded), the KVO infusion flow control device 100 immediately sets the IV set to the KVO flow rate. Thus, the KVO infusion flow control device 100 can be easily operated (e.g., one-handed operation) and can function as a binary full flow / KVO flow rate switch that is easily visualized as being in either the open flow position or the KVO flow position (e.g., the pinch clamp is open or closed). Further, the KVO infusion flow control device 100 allows for no further interaction with other IV set components (e.g., roller clamp, flow controller) to adjust between full open flow and KVO flow. Thus, the simplified flow control operation of the KVO infusion flow control device 100 provides an intuitive and direct way to set the flow rate of the IV set with minimal operation or interaction, freeing up time for the user (e.g., clinician, healthcare provider) to perform other medical-related tasks.

[0034] In aspects of the present disclosure, the KVO infusion flow control device 100 provides immediate feedback to the user when the flow controller 170 is actuated (e.g., closed) while allowing one-handed operation by the user. The KVO infusion flow control device 100 also provides simplified control in the function of the IV set by providing a quick and accurate adjustment between the open flow rate and the KVO flow rate. The KVO infusion flow control device 100 may be attached as part of an extension set stock keeping unit (SKU), providing the user with familiar IV set components (e.g., pinch clamp, luer connector).

[0035] In some aspects of the present disclosure, the KVO infusion flow control device 200 is configured as a stopcock device as shown in FIGS. 10A - 10E. The KVO infusion flow control device 200 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. A visual indicator 260 is disposed on the open control arm 240 and the KVO control arm 250. The body 210 is coupled to a fluid flow housing 270 having a connector 272 configured to receive an IV tube 280 for a fluid inlet and a fluid outlet.

[0036] During operation, the KVO infusion flow control device 200 may be controlled by gripping and rotating the open control arm 240 and / or the KVO control arm 250 to align one of the fully open orifice 220 and the KVO orifice 230 with the fluid flow path, whereby the KVO infusion flow control device 200 operates between a fully open flow rate and a KVO flow rate. In some aspects of the present disclosure, the KVO infusion flow control device 200 does not have an off setting to completely shut off the flow rate.

[0037] In some aspects of the present disclosure, the KVO infusion flow control device 300 is configured as a stopcock device as shown in FIGS. 11A - 11D. The KVO infusion flow control device 300 includes a body 310 having a fully open orifice 320 and a KVO orifice 330. An open control arm 340 and a KVO control arm 350 are coupled to the body 310. A visual indicator 360 is disposed on the open control arm 340 and the KVO control arm 350. The body 310 is coupled to a fluid flow housing 370 having a connector 372 configured to receive an IV tube 380 for a fluid inlet and a fluid outlet. A flange 374 may be disposed around the connector 372 such that the tube 380 is received between the connector 372 and the flange 374.

[0038] During operation, the KVO infusion flow control device 300 may be controlled by gripping and rotating the open control arm 340 and / or the KVO control arm 350 so as to align one of the fully open orifice 320 and the KVO orifice 330 with the fluid flow path. Thereby, the KVO infusion flow control device 300 operates between the fully open flow rate and the KVO flow rate. In some aspects of the present disclosure, the KVO infusion flow control device 300 does not have an off setting to completely shut off the flow rate.

[0039] In some aspects of the present disclosure, the KVO infusion flow control device 400 is configured as a stopcock device as shown in FIGS. 12A-12D. The KVO infusion flow control device 400 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, and the control switch 440 is configured to rotate the body 410 between an open position and a KVO position. A visual indicator 460 is disposed on the control switch 440. The body 410 is coupled to a fluid flow housing 470 having a connector 472 configured to receive IV tubes 480 for a fluid inlet and a fluid outlet.

[0040] During operation, the KVO infusion flow control device 400 may be controlled by gripping and rotating the control switch 440 so as to align one of the fully open orifice 420 and the KVO orifice 430 with the fluid flow path. Thereby, the KVO infusion flow control device 400 operates between the fully open flow rate and the KVO flow rate. In some aspects of the present disclosure, the KVO infusion flow control device 400 does not have an off setting to completely shut off the flow rate.

[0041] In some aspects of the present disclosure, the KVO infusion flow control device 500 is configured as a roller clamp device as shown in FIGS. 13A-13G. The KVO infusion flow control device 500 includes a body 510 and a cam 520 slidably disposed within a cam channel 512 within the body 510. A clamp 514 is disposed at the base of a tube channel 516 within the body 510, and the tube channel 516 is configured to receive an IV tube 580. A visual indicator 560 is disposed on the body 510.

[0042] During operation, the KVO infusion flow control device 500 can be controlled by pushing / pulling the cam 520 along the tube channel 516 of the main body 510 to engage the cam 520 with the IV tube 580 between the cam 520 and the lamp 514 of the main body 510 and applying pressure. By positioning the cam 520 at the fully open position, the cam 520 does not block the IV tube 530 at all (e.g., deform, crush), thereby achieving a fully open fluid flow rate. By positioning the cam 520 at the KVO position, the cam 520 blocks the IV tube 530 enough to allow only the KVO flow rate. Thus, the KVO infusion flow control device 500 operates between the fully open flow rate and the KVO flow rate. In some aspects of the present disclosure, the KVO infusion flow control device 500 does not have an off setting for completely blocking the flow rate.

[0043] In some aspects of the present disclosure, the KVO infusion flow control device 600 is configured as a slide switch device as shown in FIGS. 14A - 14D. The KVO infusion flow control device 600 includes a main body 610 and a switch 620 slidably disposed within a switch channel 612 in the main body 610. The switch 620 includes a fully open channel 630 and a KVO channel 640 respectively disposed across the full width of the switch housing 622. Connectors 670 are disposed on both sides of the main body 610, and the connectors 670 are configured to receive the IV tube 680. A visual indicator 660 is disposed on the main body 610.

[0044] During operation, the KVO infusion flow control device 600 can be controlled by pushing / pulling a switch 620 within a switch channel 612 of a main body 610 to align either a fully open channel 630 or a KVO channel 640 with a connector 670. By positioning the switch 620 in the fully open position, the switch 620 aligns the fully open channel 630 with the connector 670 and a corresponding IV tube 680 therewith to achieve a fully open fluid flow rate. By positioning the switch 620 in the KVO position, the switch 620 aligns the KVO channel 640 with the connector 670 and a corresponding IV tube 680 therewith to achieve only the KVO flow rate. Thus, the KVO infusion flow control device 600 operates between a fully open flow rate and a KVO flow rate. In some aspects of the present disclosure, the KVO infusion flow control device 600 does not have an off setting for completely blocking the flow rate. In some aspects of the present disclosure, the KVO infusion flow control device 600 can be enabled to completely block the flow rate (e.g., the switch 620 is positioned such that neither the fully open channel 630 nor the KVO channel 640 is aligned with the connector 670).

[0045] In some aspects of the present disclosure, the KVO infusion flow control device 700 is configured as a rocker adapter device as shown in FIGS. 15A - 15G. The KVO infusion flow control device 700 includes a main body 710 and a rocker switch 720 having a switch shaft 722 pivotally disposed within a tube channel 712 of the main body 710. An open engagement member 730 is disposed at one end of the rocker switch 720 and is sized and shaped so as not to occlude (e.g., deform, crush) an IV tube 780 disposed within the tube channel 712. A KVO engagement member 740 is disposed at the other end of the rocker switch 720 and is sized and shaped to occlude the IV tube 780 to a predetermined extent when pushed into an operating position. Retaining clips 770 are disposed at both ends of the main body 710 and are configured to engage and hold regardless of which of the open engagement member 730 and the KVO engagement member 740 is actuated (e.g., pushed into the tube channel 712). A visual indicator 760 is disposed on the main body 710.

[0046] During operation, the KVO infusion flow control device 700 can be controlled by pressing one end of the rocker switch 720 to push the corresponding release engagement member 730 or KVO engagement member 740 into the tube channel 712 where the IV tube 780 is disposed. When the rocker switch 720 is pushed into the open end, the release engagement member 730 either does not engage with the IV tube 780 at all or engages with the IV tube 780 but does not block the IV tube 780, thereby achieving a fully open fluid flow rate. Here, the release engagement member 730 is captured and held by a retaining clip 770 disposed at the open end. When the rocker switch 720 is pushed into the KVO end, the KVO engagement member 740 engages with the IV tube 780 enough to allow only the KVO flow rate and blocks it. Here, the KVO engagement member 740 is captured and held by a retaining clip 770 disposed at the KVO end. Accordingly, the KVO infusion flow control device 700 operates between a fully open flow rate and a KVO flow rate. In some aspects of the present disclosure, the KVO infusion flow control device 700 does not have an off setting to completely shut off the flow rate.

[0047] In some aspects of the present disclosure, the KVO infusion flow control device 800 is configured as a rocker adapter device as shown in FIGS. 16A-16D. The KVO infusion flow control device 800 includes a body 810 and a rocker switch 820 having a switch shaft 822 pivotally disposed within a switch channel 812 of the body 810. A tube channel 814 is disposed within the body 810 and configured to receive an IV tube 880. A clip engagement member 830 is disposed on the rocker switch 820 and sized and shaped to engage with a retaining clip 870 disposed on the body 810 and thereby be held. An engagement surface 840 is disposed on the rocker switch 820 and configured to engage with the IV tube 880 and block the IV tube 880 to a predetermined extent when the rocker switch 820 is pushed into an operating position. A visual indicator (not shown) may be disposed on the body 810.

[0048] During operation, the KVO infusion flow control device 800 may be controlled by pushing / pulling the rocker switch 820 to the open position to move the engagement surface 840 away from the tube channel 814 in which the IV tube 880 is disposed, such that the engagement surface 840 is not engaged with the IV tube 880 at all, or is engaged with the IV tube 880 but does not block the IV tube 880, thereby achieving a fully open fluid flow rate through the IV tube 880. The KVO infusion flow control device 800 may also be controlled by pushing / pulling the rocker switch 820 to the KVO position to move the engagement surface 840 toward the tube channel 814 in which the IV tube 880 is disposed, engaging the engagement surface 840 with the IV tube 880 and blocking the IV tube 880 to a predetermined extent, thus achieving only the KVO fluid flow rate through the IV tube 880. Here, the clip engagement member 830 is captured and held by the retaining clip 870 and held in the KVO (e.g., operative) position. Accordingly, the KVO infusion flow control device 800 operates between a fully open flow rate and a KVO flow rate. In some aspects of the present disclosure, the KVO infusion flow control device 800 does not have an off setting for completely blocking the flow rate.

[0049] In some aspects of the present disclosure, the KVO infusion flow control device 900 is configured as an in-line switch device as shown in FIGS. 17A-17F. The KVO infusion flow control device 900 includes a body 910 and a switch 920 slidably engaged with the body 910. The body 910 includes a body connector 930, and the switch 920 includes a switch connector 940, and each is sized and shaped to receive an IV tube 980. The body 910 also includes a valve 950 disposed adjacent to the body connector 930 within the body 910. The valve 950 includes a valve flap 952 (e.g., a valve flap 952 aligned orthogonally to the axial fluid flow path within the body 910) configured to be biased toward a closed position, and in the closed position, a KVO gap 954 is provided between the valve flaps. The valve flap 952 can be pivotally connected to the valve 950 (e.g., like a hinged swing door) such that when the leading portion 922 of the switch 920 engages and applies force to the valve flap 952, it can be rotated open (e.g., swung open). The body 910 also includes a seal 960 configured to engage the outer surface 924 of the switch 920 over the entire range of slidable movement within the body 910, thus providing a seal barrier to prevent leakage of liquid from the KVO infusion flow control device 900. A visual indicator (not shown) may be disposed on the body 910 and / or the switch 920. The switch 920 includes a switch rib 926, and the body 910 includes a body rib 916, and the switch rib 926 and the body rib 916 provide ergonomic gripping of the switch 920 and the body 910. The body 910 also includes a gripper 970 disposed at an end adjacent to the switch 920, and the gripper 970 is configured to engage and hold the switch rib 926, thus locking the flow rate of the KVO infusion flow control device 900.

[0050] During operation, the KVO injection flow control device 900 can be controlled by pushing / pulling the switch 920 towards / away from the valve 950. Here, the leading portion 922 of the switch 920 remains within the body 910 when the switch 920 is in the open position and the KVO position, respectively. Pushing the switch 920 into the open setting causes the leading portion 922 to engage the valve flap 952 and pivot the valve flap 952 inwardly towards the body connector 930, thus opening the complete flow path and enabling the release fluid flow rate from the body connector 930 into the outlet IV tube 980. Pulling the switch 920 into the KVO setting disengages the leading portion 922 from the valve flap 952 and allows the biasing force of the valve flap 952 to pivot the valve flap 952 away from the body connector 930 and align it orthogonally to the axial fluid flow path within the body 910, thus providing a KVO gap 954 and enabling only the KVO fluid flow rate from the body connector 930 to the outlet IV tube 980. Thus, the KVO injection flow control device 900 operates between the fully open flow rate and the KVO flow rate. In some aspects of the present disclosure, the KVO injection flow control device 900 does not have an off setting for completely shutting off the flow rate.

[0051] It is understood that any particular order or hierarchy of blocks in the disclosed process methods is an illustration of exemplary approaches. Based on design or implementation preferences, the particular order or hierarchy of blocks within a process may be rearranged, or all illustrated blocks may be executed, as understood. In some implementations, any of the blocks may be executed simultaneously.

[0052] The present disclosure is provided to enable those skilled in the art to practice the various aspects described herein. The present 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 general principles defined herein may be applied to other aspects.

[0053] References to elements in the singular are not meant to mean "one and only one" unless expressly specified otherwise, but rather "one or more." Unless expressly specified otherwise, the term "some" refers to one or more. Masculine pronouns (e.g., "his") include feminine and neuter forms (e.g., "her" and "its"), and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the present invention.

[0054] As used herein, the term "exemplary" is used to mean "serving as an example or illustration." Aspects or designs described as "exemplary" herein should not necessarily 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.

[0055] As used herein, the phrase "at least one of" before a series of items, together with the term "or" used to separate any of the items, modifies the entire list rather than each item in the list. The phrase "at least one of" does not require the selection of at least one item. Rather, the phrase enables the meaning of including at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. 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.

[0056] Phrases such as "aspect" do not mean that such an aspect is essential to the subject technology or that such an aspect applies to all components of the subject technology. The disclosure regarding an aspect may apply to all components, or may apply to one or more components. An aspect can provide one or more examples. Phrases such as "one aspect" can refer to one or more aspects, and vice versa. Phrases such as "embodiment" do not mean that such an embodiment is essential to the subject technology or that such an embodiment applies to all components of the subject technology. The disclosure regarding an embodiment can apply to all embodiments, or can apply to one or more embodiments. An embodiment can provide one or more examples. Phrases such as "one embodiment" can refer to one or more embodiments, and vice versa. Phrases such as "configuration" do not mean that such a configuration is essential to the subject technology or that such a configuration applies to all components of the subject technology. The disclosure regarding a configuration may apply to all configurations, or may apply to one or more configurations. A configuration can provide one or more examples. Phrases such as "such a configuration" can refer to one or more configurations, and vice versa.

[0057] In one aspect, unless otherwise specified, all measurements, values, ratings, positions, sizes, dimensions, and other specifications described in this specification, including the following claims, are approximate and not exact. In one aspect, they are intended to have a reasonable range consistent with the functions they relate to and what is customary in the technical field to which they relate.

[0058] It is understood that the specific order or hierarchy of the disclosed steps, operations, or processes are examples of exemplary approaches. Based on design preferences, it is understood that the specific order or hierarchy of steps, operations, or processes can be rearranged. Some of the steps, operations, or processes may be executed simultaneously. Some or all of the steps, operations, or processes may be automatically executed without user intervention. If there are appended method claims, presenting the various steps, operations, or process elements in a sample order does not mean being limited to the presented specific order or hierarchy.

[0059] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known to those skilled in the art or will become known to those skilled in the art are hereby expressly incorporated by reference herein and are intended to be encompassed within the claims. Further, what is disclosed herein is not intended to be an open disclosure of the invention, regardless of whether such disclosure is expressly recited in the claims. No claim element shall 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, the element is recited using the phrase "step for". Further, to the extent terms such as "include", "have", etc. are used, such terms are intended to be as inclusive as the term "comprise" as interpreted when "comprise" is used as a transitional term in a claim.

[0060] The title, background art, summary of the invention, brief description of the drawings, and abstract of the present disclosure are incorporated herein by reference in the present disclosure, and are provided as exemplary examples of the present disclosure rather than as a limiting description. It is submitted with the understanding that it is not used to limit the scope or meaning of the claims. Further, in the detailed description of the invention, it can be seen that the description provides exemplary examples and various features are grouped together in various embodiments for the purpose of simplifying the present disclosure. This method of disclosure should not be construed as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as reflected in the following claims, the subject matter of the present invention lies in fewer features than all the features of a single disclosed configuration or operation. The following claims are incorporated into the detailed description of the invention, and each claim stands on its own as a separately claimed subject matter.

[0061] The claims are not intended to be limited to the aspects described herein, but rather are to be accorded the full scope consistent with the language of the claims and to include all legal equivalents. Nevertheless, none of the claims are intended to cover, nor should they be construed to cover, subject matter that fails to meet the requirements of 35 U.S.C. § 101, 102, or 103.

Claims

1. 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 having one end coupled to the first outlet port of the inlet tube connector and the other end coupled to the first inlet port of the outlet tube connector, A KVO flow tube having one end coupled to the second outlet port of the inlet tube connector and the other end coupled to the second inlet port of the outlet tube connector, A flow controller coupled to the full flow tube, comprising, The flow control orifice comprises a tube engagement portion configured to couple with the KVO flow tube, and the tube engagement portion has an inner diameter narrower than the inner diameter of the KVO flow tube. A keep vein open (KVO) infusion flow control device.

2. When the flow controller is disposed in a first position that does not occlude the full flow tube, the flow controller is configured to provide a full fluid flow through the full flow tube into the outlet tube connector. The KVO infusion flow control device according to claim 1.

3. When the flow controller is disposed in a second position that occludes the full flow tube to a predetermined extent, the flow controller is configured to block the fluid flow through the full flow tube to the outlet tube connector. The KVO infusion flow control device according to claim 1.

4. When the flow controller is disposed in the second position, the flow control orifice is configured to restrict the fluid flow to the outlet tube connector. The KVO infusion flow control device according to claim 3.

5. The KVO injection flow control device according to claim 4, wherein when the flow controller is disposed at the second position, the flow control orifice is sized and shaped to provide a predetermined KVO fluid flow rate to the outlet tube connector.

6. The KVO injection flow control device according to claim 1, further comprising an inlet connector coupled to the IV inlet port, wherein the inlet connector is configured to be coupled to an inlet IV tube.

7. The KVO injection flow control device according to claim 6, further comprising an outlet connector coupled to the IV outlet port, wherein the outlet connector is configured to be coupled to an outlet IV tube.

8. The KVO injection flow control device according to claim 7, wherein the inlet connector is a female Luer connector and the outlet connector is a male Luer connector.

9. The KVO injection flow control device according to claim 1, wherein the flow control orifice further comprises a restriction portion disposed adjacent to the tube engagement portion within the outlet tube connector, and the restriction portion is configured to block fluid flow from the tube engagement portion to the outlet tube connector.

10. The KVO injection flow control device according to claim 9, wherein the flow control orifice further comprises a flow portion disposed within the restriction portion, the tube engagement portion is configured to provide a first restricted fluid flow rate from the KVO flow tube to the outlet tube connector, the flow portion is configured to provide a second restricted fluid flow rate through the outlet tube connector, and the second restricted fluid flow rate is a KVO fluid flow rate smaller than the first restricted fluid flow rate.

11. The KVO injection flow control device according to claim 1, wherein the flow controller is a pinch clamp.

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