PIVC integrated hemolysis suppression accessory for direct blood collection with multiple needle gauges

Abstract

A fluid connector device for a blood collection system is disclosed. The fluid connector device can regulate blood flow through a catheter based on the catheter gauge, allowing safe use with a variety of gauges. For example, when using an 18- to 22-gauge catheter, the fluid connector device regulates blood flow by positioning a slider assembly within the fluid connector device in a configuration that allows a single flow path to deliver blood through the fluid connector device to a fluid inlet and out of the fluid connector device's fluid outlet. Alternatively, in another example, when using a 24-gauge or larger catheter, the slider assembly can be actuated to a new position, allowing multiple flow paths to deliver blood to a fluid inlet and out of a fluid outlet. By regulating blood flow, the fluid connector device can limit or prevent hemolysis while allowing universal use with a variety of catheters.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority under 35 U.S.C. § 119 to Provisional Patent Application No. 63 / 411,099, filed September 28, 2022, entitled "PIVC-INTEGRATED HEMOLYSIS-REDUCTION ACCESSORIES FOR DIRECT BLOOD DRAW ON MULTIPLE NEEDLE GAUGES," the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to blood collection and parenteral fluid administration to patients, and more particularly to systems and methods for inhibiting hemolysis in PIVC blood collection. [Background technology]

[0003] Catheters are commonly used for various intravenous therapies. Catheters can be used to infuse fluids into a patient, such as saline, various medications, and total parenteral nutrition. Catheters can also be used to withdraw blood from a patient.

[0004] A common type of catheter is the over-the-needle peripheral intravenous ("IV") catheter ("PIVC"). As the name suggests, an over-the-needle catheter may be fitted over an introducer needle with a sharp distal tip. The catheter assembly may include a catheter hub, a catheter extending distally from the catheter hub, and an introducer needle extending through the catheter. The catheter and introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle pointing up and away from the patient's skin. The catheter and introducer needle are generally inserted through the skin at a shallow angle into the patient's vasculature.

[0005] Clinicians typically confirm proper placement of the introducer needle and / or catheter within the vessel by checking for a "flashback" of blood within the catheter assembly's flashback chamber. Once needle placement is confirmed, the clinician can temporarily occlude flow through the vasculature and withdraw the needle, leaving the catheter in place for future blood draws or infusions.

[0006] A blood collection container can be used to collect a blood draw or blood sample from a patient. The blood collection container can comprise a syringe. Alternatively, the blood collection container may comprise a test tube with a rubber stopper at one end. In some instances, the test tube has all or a portion of the air removed from it so that the pressure within the tube is less than ambient pressure. Such blood collection containers are often referred to as internally evacuated or evacuated tubes. The blood collection container may be a VACUTAINER® blood collection tube available from Becton Dickinson & Company.

[0007] The blood collection container can be connected to the catheter. When the blood collection container is connected to the catheter, the pressure in the vein becomes greater than the pressure in the blood collection container, forcing blood into the blood collection container, thereby filling it. As the blood collection container fills, the vacuum in the blood collection container decreases and blood flow stops until the pressure in the blood collection container equals the pressure in the vein.

[0008] Unfortunately, when blood is drawn into the blood collection container, the large initial pressure difference between the vein and the blood collection container places red blood cells under high shear stress, making them susceptible to hemolysis. Hemolysis can result in the blood sample being discarded and wasted. The large initial pressure difference can also cause collapse of the catheter tip, collapse of the vein, or other complications that prevent or restrict blood from filling the blood collection container.

[0009] A statement presented in the Background section should not be assumed to be prior art merely because it is mentioned in or related to the Background section. The Background section may contain information that describes one or more aspects of the present technology. Summary of the Invention [Means for solving the problem]

[0010] The present disclosure provides a fluid connector device comprising a first connector and a second connector that combines with the first connector to form an internal chamber, the second connector comprising a post, a first opening formed in the post, and a second opening in the post, and a slider assembly disposed within the internal chamber, the slider assembly i) in a first position aligned with the first opening and sealing the second opening, and ii) in a second position aligned with the second opening and sealing the first opening.

[0011] The present disclosure provides, in some examples, a blood collection system comprising a blood collection device and a fluid connector device fluidly connected to the blood collection device, the fluid connector device comprising a first connector and a second connector that combines with the first connector to form an internal chamber, the second connector comprising a post, a first opening formed in the post, and a second opening in the post, and a slider assembly disposed within the internal chamber, the slider assembly configured to deliver fluid through the first opening or the second opening based on the position of the slider assembly relative to the post.

[0012] The present disclosure also provides a method for regulating fluid through a blood collection system, the method including, in a fluid connector device, receiving fluid from a first connector through a slider assembly, receiving fluid from the slider assembly at a first opening of a second connector, receiving fluid from the slider assembly at a second opening of the second connector when the slider assembly is moved relative to the second connector, and sealing the first opening from the fluid.

[0013] It is understood that other configurations of the present technology will be readily apparent to those skilled in the art from the following detailed description, wherein various configurations of the present technology are shown and described for purposes of illustration. The present technology is capable of other different configurations, as will be recognized, and its several details are capable of modification in various other respects, all without departing from the scope of the present technology. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.

[0014] The following figures are included to illustrate certain aspects of the embodiments and should not be considered as exclusive examples. The disclosed subject matter is capable of considerable modification, alteration, combination, and equivalents in form and function that will occur to those skilled in the art having the benefit of this disclosure. [Brief explanation of the drawings]

[0015] [Figure 1] FIG. 1 illustrates a collection system according to some aspects of the present disclosure. [Figure 2] FIG. 2 is an exploded view of the fluid connector device shown in FIG. 1 according to some embodiments of the present disclosure. [Figure 3] 3 is a perspective view of components of the slider assembly shown in FIG. 2, illustrating additional features of the components, according to an embodiment of the present disclosure. [Figure 4] FIG. 1 is a perspective view of a fluid connector device showing features of a slider assembly in an initial position, according to some embodiments of the present disclosure. [Figure 5]A partial cross-sectional view of a fluid connector device showing the openings of the slider assembly aligned with the respective openings of the connector, according to some embodiments of the present disclosure. [Figure 6] FIG. 10 is another partial cross-sectional view of a fluid connector device showing the respective openings of the slider assembly and connector aligned with one another, according to some aspects of the present disclosure. [Figure 7] FIG. 10 is a perspective view of a fluid connector device showing the slider assembly moved to another position, according to some embodiments of the present disclosure. [Figure 8] A partial cross-sectional view of a fluid connector device showing the openings of the slider assembly aligned with the respective openings of the connector, according to some embodiments of the present disclosure. [Figure 9] FIG. 10 is another partial cross-sectional view of a fluid connector device showing the openings of the slider assembly aligned with the respective openings of the connector, according to some aspects of the present disclosure. [Figure 10] 1 is a flow chart illustrating a method for regulating fluid through a blood collection system according to some aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0016] The detailed description set forth below describes various configurations of the present technology and is not intended to represent the only configurations in which the technology may be practiced. The detailed description includes specific details to provide a thorough understanding of the technology. Thus, dimensions for particular embodiments may be provided as non-limiting examples. However, it will be apparent to those skilled in the art that the technology may be practiced without such specific details. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the technology.

[0017] It should be understood that the present disclosure includes examples of the present technology and does not limit the scope of the appended claims. Various aspects of the present technology will now be disclosed according to certain non-limiting examples. The various embodiments described in this disclosure can be implemented in a variety of ways and variations, and according to a desired application or implementation.

[0018] Blood collection via vascular access devices has been gaining increasing attention due to its ability to minimize needlestick injuries and improve operational efficiency compared to traditional venipuncture blood collection. Current blood collection methods using peripheral intravenous catheters (PIVCs) present several challenges, one of the most important of which is blood quality, which is related to hemolysis. In particular, PIVC products currently on the market with standard connections (e.g., short extension sets and needleless connectors) and blood collection devices (e.g., blood collection tubes) tend to exert shear stress on blood cells, leading to near-hemolysis.

[0019] Various embodiments of the present disclosure provide systems and methods for addressing hemolysis in PIVC blood collection using a hemolysis reduction accessory (also referred to herein as a fluid connector device) that is pre-attached to the PIVC and functions as a flow regulator or flow restrictor to reduce the risk of hemolysis. The hemolysis reduction accessory is advantageous because it fits into the placement of the PIVC and does not require any changes to existing operations. The hemolysis reduction accessories of various embodiments described herein are potentially applicable to a wide variety of PIVC products and are compatible with existing blood collection devices and IV disposables.

[0020] Various embodiments of the present disclosure focus on effective flow restriction using an add-on hemolysis control accessory (also referred to herein as a fluid connector device) that regulates the overall flow rate of the entire fluid pathway through which blood cells pass. The fluid connector device can be assembled with or packaged with the PIVC. Therefore, there is no additional manipulation during catheter placement because the device has a vented lumen that allows for blood backflow. The clinician can connect a blood collection device to the accessory port and then draw blood up to the desired volume. After blood collection, the clinician can remove and discard the fluid connector device and blood collection device together. Therefore, the fluid connector device can be used for a single blood draw or remain in-line throughout the entire placement.

[0021] FIG. 1 illustrates a collection system 10 according to some embodiments of the present disclosure. The collection system 10 is designed to collect fluid (e.g., blood) from a patient. The collection system 10 may therefore be referred to as a blood collection system. The collection system 10 may take the form of a vascular access device including a PIVC assembly. The collection system 10, as shown, includes a catheter assembly 20. In some embodiments, the catheter assembly 20 may include or correspond to any suitable catheter assembly. In some embodiments, the catheter assembly 20 may be integrated with an extension tube that extends from a side port of the catheter hub and may be integrated with the side port. A non-limiting example of an integrated catheter assembly is the BD NEXIVA™ Closed IV Catheter system available from Becton Dickinson and Company. In some embodiments, the proximal end of the extension tube may be coupled to an adapter, such as a Y adapter or a single-port Luer adapter.

[0022] The collection system 10 may also include a connector 30 that connects to the catheter assembly 20. The collection system 10 further includes a collector 40 for collecting fluid (e.g., blood) from the patient. The collector 40 may be referred to as a blood collector when the collected fluid is blood from the patient.

[0023] Collection system 10, according to some aspects of the present disclosure, further comprises a fluid connector device 100. Fluid connector device 100 may be configured to reduce the likelihood of hemolysis during blood collection using collection system 10. In some embodiments, fluid connector device 100 comprises a distal end, which may comprise a body or distal connector configured to couple to catheter assembly 20 via connector 30. Connector 30 may include a male luer connector or another suitable connector.

[0024] In some embodiments, the distal connector of the fluid connector device 100 may be configured to couple to a Y-adapter of the catheter assembly 20 without the use of connector 30. In some embodiments, the catheter assembly 20 may not be integrated and may not include an extension tube. In these and other embodiments, the fluid connector device 100 may be configured to couple to the proximal end of a catheter hub or another suitable portion of the catheter assembly. In some embodiments, the catheter assembly 20 may be coupled to a removable extension tube. In some embodiments, the fluid connector device 100 may be coupled directly to a catheter adapter, eliminating the need for an extension tube and providing a compact catheter system.

[0025] 2 illustrates an exploded view of the fluid connector device 100 shown in FIG. 1 , according to some embodiments of the present disclosure. The fluid connector device 100 can include a connector 102 configured to couple to the connector 30 (shown in FIG. 1 ) of the collection system 10. The fluid connector device 100 can further include a connector 104 configured to couple to the collector 40 of the collection system 10. The connector 102 and the connector 104 may be referred to as a first connector and a second connector, respectively. However, "first" and "second" may be used interchangeably. The connectors 102 and 104 can combine to form an internal chamber, i.e., an internal volume or space.

[0026] Fluid connector device 100 also includes a slider assembly 110, disposed partially within connector 102 and partially within connector 104 (i.e., the internal chamber). Slider assembly 110 includes a component 112 and a component 114, as shown. Components 112 and 114 may be referred to as a first component and a second component, respectively. However, "first" and "second" may be used interchangeably. Slider assembly 110 includes a ring 116 to provide a seal between components 112 and 114 and prevent leakage between components 112 and 114. In some embodiments, ring 116 is an O-ring. Slider assembly 110 is designed to act as a regulator or flow restrictor for fluid through fluid connector device 100. Fluid connector device 100 can be integrated with a variety of vascular access devices, each of which may have a different gauge (G), for example. The fluid connector assembly 100, using the slider assembly 110, can allow for safe blood collection by restricting blood flow in applications using catheter assemblies in the approximate 18G to 22G range, while allowing for increased (or relatively greater) blood flow in applications using catheter assemblies of 24G or greater. The slider assembly 110 is designed to move relative to the connectors 102 and 104 to regulate fluid flow. In this regard, the slider assembly 110 includes a joint 118 designed for user interaction to actuate the slider assembly 110. The joint 118 is integral with the component 112 and extends radially outward relative to the connectors 102 and 104.

[0027] Connector 102 may take the form of a male luer having a proximal end for connecting to slider assembly 110 and a distal end with a second connecting portion for connecting to a needleless connector. The first connecting portion may have an inner surface defining a lumen 120 therethrough for coupling to slider assembly 110. Connector 104 may also take the form of a female luer having a proximal end for connecting to slider assembly 110 and a distal end with a second connecting portion for connecting to a collector. Connector 104 may have an inner surface defining a lumen (not shown) therethrough for coupling to slider assembly 110. Connectors 102 and 104 may thus fluidly connect fluid connector device 100 to a fluid collection component.

[0028] FIG. 3 illustrates a perspective view of component 114 of slider assembly 110 shown in FIG. 2 according to an embodiment of the present disclosure, illustrating additional features of component 114. Component 114 can include a cylindrical body 122, or at least a substantially cylindrical body. Component 114 can also include a plurality of depressions extending longitudinally along the major axis of cylindrical body 122. Component 114 includes, for example, depressions 124, 126, and 128 (shown in dotted lines). Depressions 124, 126, and 128 partially define individual fluid pathways along cylindrical body 122. Each of depressions 124, 126, and 128 combines with a respective depression of component 112 to form a flow path or blood collection channel, as described in more detail below.

[0029] 4 shows a perspective view of a fluid connector device 100 according to some embodiments of the present disclosure. As shown, the fluid connector device 100 is in an initial or first position based on the position of the slider assembly 110 relative to the connectors 102 and 104. The position of the slider assembly 110 is suitable for use with catheters having gauges in the 18G to 22G size range, and is intended for some catheter applications.

[0030] FIG. 5 illustrates a partial cross-sectional view of the fluid connector device 100 according to some embodiments of the present disclosure, showing the openings of the slider assembly 110 aligned with the respective openings of the connectors 104. The lumen 120 of the connector 102 provides a fluid inlet for the fluid connector device 100. As fluid enters the connector 102, the fluid can pass through the opening 130 of the component 112, and subsequently flow into a flow channel 132 formed by the recess 124 of the component 114 and the recess 134 of the component 112. The flow channel 132 is thus fluidly coupled to the lumen 140 in the initial / first position of the slider assembly 110. The recesses 124 and 134 are aligned to form the flow channel 132, as shown. Additional flow channels (not shown in FIG. 5) may also be present, and fluid may further flow into these additional flow channels.

[0031] Fluid can flow through multiple flow paths formed by components 112 and 114 based on the position of slider assembly 110 relative to connectors 102 and 104; however, fluid within a flow path (i.e., flow path 132) can enter connector 104, while the remaining flow paths are sealed so that fluid cannot flow into connector 104. Connector 104, in this regard, includes lumen 140 with opening 142. Component 114 further includes opening 144. Each of openings 142 and 144 forms a radial opening in lumen 140 and component 114, respectively. Openings 142 and 144 are also aligned with one another, as shown in FIG. 5 , such that fluid within flow path 132 can pass through openings 142 and 144 and exit connector 104 through fluid outlet 146 of connector 104. Fluid outlet 146 can form a fluid outlet for fluid connector device 100.

[0032] In some embodiments of the present disclosure, the connector 104 includes a post 105 extending into a lumen 106 formed by the inner surface of the connector 104. The post 105 forms a portion of a fluid passageway through the connector 104. At least a portion of the fluid passageway through the post 105 can be formed by an opening 142 through the post. The post 105, in some aspects, includes multiple openings extending therethrough, and in some embodiments, the post 105 includes three or more openings 142, 143, 145. Any of the openings through the post 105 can extend radially outward relative to the longitudinal axis of the connector 104 and form a portion of the fluid passageway between the lumen 106 and a fluid outlet 146.

[0033] 5, post 105 includes first and second openings 142, 143 aligned along a longitudinal axis generally parallel to the longitudinal axis defined by the post. In some embodiments of the present disclosure, third opening 145 is radially offset by an angle about the longitudinal axis defined by post 105 relative to first and second openings 142, 143.

[0034] When the slider assembly 110 is coupled to the connector 104, the post 105 can extend into either of the components 112 and 114 that form the slider assembly. The slider assembly 110, in some aspects, is longitudinally movable or slidable relative to the post 105. The post 105 can be partially located or extend within the slider assembly 110, thereby allowing either of the slider assembly components 112 and 114 to move along the post 105 relative to the connector 104. While some embodiments contemplate the slider assembly 110 being rotatable about the post 105, the present disclosure also contemplates the slider assembly 110 being rotationally coupled to or fixed to the post 105.

[0035] 6 illustrates another partial cross-sectional view of fluid connector device 100 according to some embodiments of the present disclosure, showing the respective openings of slider assembly 110 (i.e., component 114 of slider assembly 110) and connector 104 aligned with one another. Flow channel 132 opens into opening 144 in component 114, as shown. Based on the alignment between openings 142 and 144, fluid flowing through flow channel 132 enters lumen 140 of connector 104 and exits connector 104 through fluid outlet 146 (shown in FIG. 5).

[0036] As further shown in FIG. 6 , additional flow paths are formed in components 112 and 114. For example, flow path 148 and flow path 150 (both similar to flow path 132) are formed by recesses in components 112 and 114, respectively. Flow path 132, flow path 148, and flow path 150 may be referred to as a first flow path, a second flow path, and a third flow path, respectively. However, the terms “first,” “second,” and “third” may be used interchangeably. Each of flow paths 132, 148, and 150 may also be referred to as a blood collection flow path. Fluid may flow through flow paths 148 and 150, but because the corresponding opening in lumen 140 is not aligned with the opening in component 114 based on the position of slider assembly 110, the fluid will instead flow into lumen 140 of connector 104. Thus, in the initial / first position of the slider assembly 110, only the flow channel 132 can deliver fluid to the connector 104, and the fluid exits the fluid connector device 100 through the fluid outlet 146.

[0037] Additionally, components 112 and 114 of slider assembly 110 may include alignment features to couple components 112 and 114 together and properly align the recesses to form the flow channels. For example, as shown in FIG. 6 , component 112 may include recess 151, and component 114 may include protrusion 153 that fits into recess 151. Recess 151 and protrusion 153 may extend longitudinally along component 112 and component 114, respectively. Once component 114 is inserted into component 112, component 114 may be rotated relative to component 112 to align protrusion 153 with recess 151 and properly position component 114 within component 112 to form the desired flow channels.

[0038] 7 illustrates a perspective view of the fluid connector device 100 according to some embodiments of the present disclosure, with the slider assembly 110 moved to another position. The fluid connector device 100 is in a next or second position, as shown, based on the position of the slider assembly 110 relative to the connectors 102 and 104. In this regard, the slider assembly 110 can be actuated in the direction of the arrow relative to the connectors 102 and 104 by engaging the joint 118. This position of the slider assembly 110 is suitable for use with catheters having a gauge of 24G (corresponding to some pediatric catheter applications) and possibly greater than 24G.

[0039] FIG. 8 illustrates a partial cross-sectional view of a fluid connector device 100 according to some embodiments of the present disclosure, showing the openings of slider assembly 110 aligned with the respective openings of connector 104. Fluid flowing from opening 130 of component 112 through flow path 132 can enter connector 104 through additional openings in component 114 and lumen 140 of connector 104. Lumen 140 includes opening 154, which represents an additional radial opening formed in lumen 140, as shown. Upon movement of slider assembly 110 relative to connectors 102 and 104 (particularly connector 104), openings 144 and 154 are aligned with one another, thereby allowing fluid in flow path 132 to pass through openings 144 and 154 into lumen 140 and exit connector 104 through fluid outlet 146 of connector 104. Furthermore, the relative movement of slider assembly 110 causes openings 142 and 144 to be misaligned with one another, thereby preventing fluid in flow path 132 from entering lumen 140 through openings 142 and 144. When openings 142 and 144 are misaligned, the engagement between lumen 140 and component 114 provides a fluid seal, thereby preventing fluid from entering opening 142.

[0040] Additionally, fluid entering flow path 148 can also enter lumen 140. Thus, lumen 140 includes opening 156, and component 114 includes opening 158. Openings 156 and 158 represent additional radial openings formed in lumen 140 and component 114, respectively. Openings 156 and 158 are aligned with one another, as shown in FIG. 8 , thereby allowing fluid in flow path 148 to pass through openings 156 and 158 into lumen 140, and for the fluid to exit connector 104 through fluid outlet 146 of connector 104.

[0041] FIG. 9 illustrates another partial cross-sectional view of the fluid connector device 100 according to some embodiments of the present disclosure, showing the respective openings of the slider assembly 110 (i.e., the component 114 of the slider assembly 110) and the connector 104 aligned with one another. The flow channel 132 opens into an opening 144 of the component 114, as shown. Based on the alignment between the openings 144 and 154, fluid flowing through the flow channel 132 enters the lumen 140 of the connector 104 and exits the connector 104 through the fluid outlet 146 (shown in FIG. 8). The flow channel 148 also opens into an opening 158 of the component 114. Based on the alignment between the openings 156 and 158, fluid flowing through the flow channel 148 enters the lumen 140 of the connector 104 and exits the connector 104 through the fluid outlet 146 (shown in FIG. 8). Additionally, the lumen 140 includes an opening 160, and the component 114 includes an opening 162. Openings 160 and 162 represent additional radial openings formed in lumen 140 and component 114, respectively. Flow path 150 opens into opening 162 in component 114. Based on the alignment between openings 160 and 162, fluid flowing through flow path 150 enters lumen 140 of connector 104 and exits connector 104 through fluid outlet 146 (shown in FIG. 8 ). Furthermore, when slider assembly 110 is returned to the initial / first position (shown in FIGS. 4-6 ), the engagement between lumen 140 and component 114 provides a fluid seal, thereby preventing fluid from entering openings 154, 156, and 158.

[0042] The slider assembly 110 thus has additional fluid paths (three) in the second position compared to the single fluid path of the slider assembly 110 in the first position. The slider assembly 110 provides a flow restriction function to the fluid connector device 100, allowing the fluid connector device 100 to function in medical device applications requiring a variety of sizes / gauges.

[0043] 10 shows a flow chart 200 illustrating a method for regulating fluid through a blood collection system. The steps of flow chart 200 can be performed using the fluid connector devices described herein. When performing one or more steps of flow chart 200, the fluid connector device can be part of a blood collection system that also includes, for example, a catheter and collector for collecting fluid.

[0044] In step 202, a slider assembly receives fluid from the first connector. The slider assembly can include one or more components, each disposed (or at least substantially disposed) within the fluid connector device. The slider assembly can further be actuated to multiple positions to regulate the flow of fluid through the fluid connector device.

[0045] In step 204, a first opening of the second connector receives fluid from the slider assembly. The first opening may be formed in a lumen of the second connector. Based on the position of the slider assembly, the first opening of the second connector is aligned with an opening of the slider assembly (or a component of the slider assembly). The slider assembly may further include multiple flow paths, one of which is fluidly connected to the opening of the slider assembly and the first opening of the second connector. Furthermore, the fluidly connected opening may represent the only flow path capable of supplying fluid to the connector, while other openings may be sealed to prevent fluid from being received. This configuration is based on the position of the slider assembly.

[0046] In step 206, when the slider assembly is moved relative to the second connector, a second opening in the second connector receives fluid from the slider assembly. A second opening in addition to the first opening may be formed in the lumen of the second connector. Several additional openings similar to the second opening may also be formed in the lumen. The slider assembly may also include multiple flow channels, each of which is aligned with and fluidly connected to at least one opening in the lumen. Furthermore, based on the position of the slider assembly, when moved, not only the second opening but also the additional similar openings may receive fluid.

[0047] In step 208, as the slider assembly is moved relative to the second connector, the first opening is sealed from fluid. While the first opening is sealed, the second opening as well as the additional openings can receive fluid. Thus, flow diagram 200 provides a method for limiting the number of flow paths supplying fluid through the fluid connector device while also increasing the number of flow paths based on movement of the slider assembly.

[0048] The fluid connector devices and associated blood collection systems of various embodiments described herein further provide additional advantages over currently existing blood collection systems. For example, the retrofit fluid connector devices described herein enable the integration of hemolysis control features for PIVC blood collection. The fluid connector devices described herein further conform to the placement of the PIVC, allowing for seamless blood collection upon insertion. In some embodiments, the fluid connector devices have the potential to remain in-line throughout PIVC placement for multiple blood collections. Furthermore, because the fluid connector devices are retrofittable, they can be easily integrated into existing PIVCs without modification, minimizing impact to clinical practice and surgery.

[0049] The fluid connector devices of various embodiments described herein are thus advantageous over currently existing PIVC blood collection accessories / connectors because they can efficiently operate with multiple catheter gauge sizes. Accordingly, the fluid connector devices of various embodiments described herein may be referred to as universal fluid connector devices because their design can be used across a wide range of catheter sizes (18G to 24+G) and catheter brands. The fluid connector devices of various embodiments described herein thus provide an improvement over currently existing PIVC blood collection accessories by providing a single universal connector that can effectively perform across various catheter gauge ranges and brands, eliminating the need to have different blood collection accessories / connectors for different catheter gauge ranges. The fluid connector devices of various embodiments described herein aim to provide consistent performance across all catheter gauges. The fluid connector devices of various embodiments described herein can effectively function with 18G to 22G gauges and other pediatric gauges by integrating a switchable blood flow path in the form of a sliding assembly with multiple blood collection paths. In contrast, currently available PIVC blood collection connectors / accessories are each designed or engineered to fit a specific range of catheter gauge sizes to achieve satisfactory blood collection performance.

[0050] According to various embodiments of the present disclosure, each of the flow paths (e.g., flow paths 132, 148, and 150) may be in the form of a microchannel fluid passage through which fluid (e.g., blood) can flow from a distal connector to a proximal connector for collection in a fluid collection device. Each blood collection flow path in the form of a microchannel through which fluid (e.g., blood) can flow from a distal connector to a proximal connector for collection in a fluid collection device may have a diameter ranging from about 0.01 inches to about 0.1 inches, for example. The length of the microchannel may range from about 0.5 inches to about 5 inches. In some examples, the microchannel has a diameter of 0.025 inches and a length of 1 inch. In some examples, the diameter is 0.025 inches and the length is 0.75 inches. In some examples, the diameter is 0.025 inches and the length is 1.5 inches. In some examples, the diameter is 0.03 inches and the length is 3 inches. Blood can therefore flow into the blood collection device through one or all three of the first, second, and third microchannels having the smallest diameter during blood collection or withdrawal from a patient.

[0051] The present technology is presented according to various aspects, for example, as described below. Various examples of aspects of the present technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are presented as examples and are not intended to limit the present technology. Note that any of the dependent clauses may be combined in any combination within a respective independent clause, e.g., clause 1 or clause 5. Other clauses may be presented in a similar manner.

[0052] Clause 1 A fluid connector device comprising: a first connector; and a second connector that combines with the first connector to form an internal chamber, the second connector comprising a post, a first opening formed in the post, and a second opening in the post; and a slider assembly disposed within the internal chamber, the slider assembly i) in a first position being aligned with the first opening and sealing the second opening, and ii) in a second position being aligned with the second opening and sealing the first opening.

[0053] Clause 2 10. The fluid connector device of claim 1, wherein the slider assembly comprises a flow channel fluidly connected to the first opening and the second opening.

[0054] Clause 3 A fluid connector device as described in any one of clauses 1 or 2, further comprising a third opening formed in the post and a fourth opening formed in the post, wherein the slider assembly is aligned with the third opening and the fourth opening in the second position.

[0055] Clause 4 The fluid connector device of clause 3, wherein the slider assembly further comprises a first flow path that i) is fluidly connected to the first opening when the slider assembly is in the first position and ii) is fluidly connected to the second opening when the slider assembly is in the second position, a second flow path that is fluidly connected to the third opening when the slider assembly is in the second position, and a third flow path that is fluidly connected to the fourth opening when the slider assembly is in the second position.

[0056] Clause 5 The fluid connector device described in clause 4, wherein the slider assembly further comprises a first component and a second component, the first component and the second component forming a first flow path, a second flow path, and a third flow path.

[0057] Clause 6 6. The fluid connector device of any one of clauses 1 to 5, wherein the post is at least partially disposed within the slider assembly.

[0058] Clause 7 6. The fluid connector device of any one of clauses 1 to 5, wherein the slider assembly is rotationally coupled to the post.

[0059] Article 8 1. A blood collection system comprising: a blood collection device; and a fluid connector device fluidly connected to the blood collection device, wherein the fluid connector device comprises a first connector and a second connector that combines with the first connector to form an internal chamber, the second connector comprising a post, a first opening formed in the post, and a second opening in the post; and a slider assembly disposed within the internal chamber, wherein the slider assembly is configured to deliver fluid through the first opening or the second opening based on the position of the slider assembly relative to the post.

[0060] Article 9 9. The blood collection system of claim 8, wherein when the slider assembly allows fluid to pass through the first opening, the slider assembly seals the second opening, and when the slider assembly allows fluid to pass through the second opening, the slider assembly seals the first opening.

[0061] Article 10 A blood collection system as described in any one of clauses 8 or 9, wherein the slider assembly comprises a first component and a second component, the first component and the second component forming a flow path fluidly connected to at least one of the first opening and the second opening.

[0062] Article 11 11. The blood collection system of any one of clauses 8 to 10, wherein the slider assembly is movable relative to the first connector and the second connector.

[0063] Article 12 12. The blood collection system of any one of clauses 8 to 11, further comprising a third opening formed in the post and a fourth opening formed in the post, wherein the slider assembly is configured to deliver fluid through the first opening or the third opening and the fourth opening based on the position of the slider assembly.

[0064] Article 13 13. The blood collection system of any one of clauses 8 to 12, wherein the slider assembly is movable relative to the first connector and the second connector.

[0065] Article 14 14. The blood collection system of clause 13, wherein the slider assembly comprises a joint, and wherein the slider assembly is movable upon actuation of the joint.

[0066] Article 15 A method for regulating fluid through a blood collection system, the method comprising the steps of: receiving fluid from a first connector through a slider assembly in a fluid connector device; receiving fluid from the slider assembly at a first opening of a second connector; receiving fluid from the slider assembly at a second opening of the second connector when the slider assembly is moved relative to the second connector; and sealing the first opening from the fluid.

[0067] Article 16 16. The method of clause 15, further comprising sealing the second opening from the fluid before the slider assembly is moved.

[0068] Article 17 17. The method of any one of clauses 15 or 16, further comprising receiving fluid from the slider assembly at the third opening and the fourth opening of the second connector when the slider assembly is moved relative to the second connector.

[0069] Article 18 18. The method of clause 17, further comprising the steps of supplying fluid through the first flow path to the second opening, supplying fluid through the second flow path to the second opening, and supplying fluid through the third flow path to the fourth opening.

[0070] Article 19 19. The method of clause 18, further comprising receiving fluid within the second connector only through the first flow path when the second opening is sealed.

[0071] Article 20 19. The method of clause 18, further comprising receiving fluid within the second connector through the first flow path, the second flow path, and the third flow path when the first opening is sealed.

[0072] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. This disclosure presents various examples of the technology, and the technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other aspects.

[0073] Reference to an element in the singular is intended to mean "one or more" rather than "one and only one" unless specifically so stated. The term "some" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and are not intended to limit the invention.

[0074] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0075] As used herein, the phrase "at least one" preceding a list of items, with the term "or" separating any of the items, modifies the list as a whole, not each member of the list. The phrase "at least one" does not require the selection of at least one item; rather, the phrase can mean including at least one of any one of the items, at least one of any combination of the items, and / or at least one of each of the items. Illustratively, the phrase "at least one of A, B, or C" can refer to A only, B only, or C only, or any combination of A, B, and C.

[0076] The use of a phrase such as "aspect" does not imply that such aspect is essential to the technology or that such aspect applies to all configurations of the technology. The disclosure of one aspect may apply to all configurations, or to one or more configurations. One aspect may provide one or more examples. A phrase such as "aspect" may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such embodiment is essential to the technology or that such embodiment applies to all configurations of the technology. The disclosure of one embodiment may apply to all embodiments, or to one or more examples. One embodiment may provide one or more examples. Such an embodiment phrase may refer to one or more embodiments, and vice versa. The use of a phrase such as "configuration" does not imply that such embodiment is essential to the technology or that such embodiment applies to all configurations of the technology. The disclosure of one configuration may apply to all configurations, or to one or more configurations. One configuration may provide one or more examples. The phrase "such a configuration" may refer to one or more configurations, and vice versa.

[0077] In one aspect, unless otherwise specified, all measurements, values, ratings, locations, dimensions, sizes, and other specifications set forth in this specification, including those in the following claims, are approximate and not exact, and are intended to have a reasonable range consistent with the function to which they relate and that which is customary in the art to which they pertain.

[0078] It is understood that the specific order or hierarchy of steps or operations in the disclosed processes or methods represents example approaches. It is understood that the specific order or hierarchy of steps, operations, or processes may be rearranged based on implementation preferences or scenarios. Some of the steps, operations, or processes may be performed simultaneously. Certain operations may or may not be performed, depending on implementation preferences or scenarios. Some or all of the steps, operations, or processes may be performed automatically without user intervention. The accompanying method claims present the various steps, operations, or process elements in an example order, and are not intended to be limited to the specific order or hierarchy presented.

[0079] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known, or that later become known, to those of ordinary skill in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Furthermore, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is expressly recited in the claims. No claimed element is to be construed under the provisions of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, unless the element is recited using the phrase "step for." Furthermore, to the extent the terms "comprise," "have," and the like are used, such terms are intended to be inclusive in the same manner as the term "comprises" is construed when "comprises" is used as a transitional term in the claims.

[0080] The "Title," "Background," "Summary," "Brief Description of the Drawings," and "Abstract" of this disclosure are hereby incorporated into this disclosure and are presented as illustrative examples of the disclosure, not as a limiting description. They are presented with the understanding that they will not be used to limit the scope or meaning of the claims. Additionally, in the "Summary," it will be understood that the description presents exemplary illustrations, and that various features, in various embodiments, have been grouped together to streamline the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The following claims are hereby incorporated into the "Summary," with each claim standing on its own as separately claimed subject matter.

[0081] The claims are not intended to be limited to the embodiments described herein, but are intended to be accorded full scope consistent with the claim language and encompass all legal equivalents. Nevertheless, none of the claims are intended, and should not be interpreted, to encompass subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. a first connector; a second connector that mates with the first connector to form an internal chamber; and 1. A fluid connector device comprising: post, a first opening formed in the post; and a second opening in the post; and a slider assembly disposed within the internal chamber; wherein the slider assembly i) in a first position is aligned with the first opening and seals the second opening, and ii) in a second position is aligned with the second opening and seals the first opening.

2. 2. The fluid connector device of claim 1, wherein the slider assembly comprises a flow passage fluidly connected to the first opening and the second opening.

3. a third opening formed in the post; a fourth opening formed in the post; 2. The fluid connector device of claim 1, further comprising: a slider assembly in said second position aligned with said third opening and said fourth opening.

4. The slider assembly is a first flow path i) fluidly connected to the first opening when the slider assembly is in the first position, and ii) fluidly connected to the second opening when the slider assembly is in the second position; a second flow path fluidly connected to the third opening when the slider assembly is in the second position; and a third flow path fluidly connected to the fourth opening when the slider assembly is in the second position; and The fluid connector device of claim 3 further comprising:

5. The slider assembly is a first component; and a second component; and 5. The fluid connector device of claim 4, further comprising: said first component and said second component forming said first flow path, said second flow path, and said third flow path.

6. The fluid connector device of claim 1 , wherein the post is at least partially disposed within the slider assembly.

7. The fluid connector device of claim 1 , wherein the slider assembly is rotationally coupled to the post.

8. a blood collection device; a fluid connector device fluidly connected to the blood collection device; 1. A blood collection system comprising: a first connector; a second connector that mates with the first connector to form an internal chamber; and and the second connector comprises: post, a first opening formed in the post; and a second opening in the post; and a slider assembly disposed within the internal chamber; wherein the slider assembly is configured to deliver fluid through the first opening or the second opening based on a position of the slider assembly relative to the post.

9. the slider assembly seals the second opening when the slider assembly allows the fluid to pass through the first opening; and the slider assembly seals the first opening when the slider assembly allows the fluid to pass through the second opening; 9. The blood collection system of claim 8.

10. The slider assembly is a first component; and a second component; and 9. The blood collection system of claim 8, comprising: the first component and the second component forming a flow path fluidly connected to at least one of the first opening and the second opening.

11. The blood collection system of claim 8 , wherein the slider assembly is movable relative to the first connector and the second connector.

12. a third opening formed in the post; a fourth opening formed in the post; 9. The blood collection system of claim 8, further comprising: a slider assembly configured to deliver the fluid through the first opening or the third opening and the fourth opening based on the position of the slider assembly.

13. The blood collection system of claim 8 , wherein the slider assembly is movable relative to the first connector and the second connector.

14. the slider assembly includes a joint; and the slider assembly is movable upon actuation of the joint; 14. The blood collection system of claim 13.

15. 1. A method for regulating fluid flow through a blood collection system, the method comprising: receiving the fluid from a first connector through a slider assembly; receiving the fluid from the slider assembly at a first opening of a second connector; When the slider assembly is moved relative to the second connector, receiving the fluid from the slider assembly at a second opening of a second connector; and sealing the first opening from the fluid; A method comprising:

16. The method of claim 15 , further comprising sealing the second opening from the fluid before the slider assembly is moved.

17. 16. The method of claim 15, further comprising receiving the fluid from the slider assembly at third and fourth openings of the second connector when the slider assembly is moved relative to the second connector.

18. supplying the fluid through a first flow path to the second opening; supplying the fluid to the second opening through a second flow path; supplying the fluid to the fourth opening through a third flow path; 20. The method of claim 17, further comprising:

19. 20. The method of claim 18, further comprising receiving the fluid in the second connector only through the first flow path when the second opening is sealed.

20. 20. The method of claim 18, further comprising receiving the fluid in the second connector through the first flow path, the second flow path, and the third flow path when the first opening is sealed.

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