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

Abstract

To provide fluid connectors and devices for blood collection systems. [Solution] The fluid connector device of the present invention can regulate blood flow through a catheter based on the catheter gauge for safe use with various gauges. When using, for example, 18 to 22 gauge catheters, the fluid connector device regulates blood flow by positioning the slider assembly within the fluid connector device so that a single channel delivers blood through the fluid connector device to the fluid inlet and from the fluid outlet of the fluid connector device. Alternatively, in another example, when using a 24 gauge or larger catheter, the slider assembly can be actuated to a new position so that multiple channels deliver blood to the fluid inlet and from the fluid outlet. By regulating blood flow, the fluid connector device can limit or prevent hemolysis while being used universally with various catheters.

Description

Technical Field

[0005] , ,

[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 content of which is incorporated herein by reference.

[0002] The present disclosure generally relates to blood collection and the administration of parenteral fluids to patients, and more particularly to systems and methods for suppressing hemolysis in PIVC blood collection.

Background Art

[0003] Catheters are commonly used in various infusion therapies. Catheters can be used to inject fluids, such as saline, various drugs, and total parenteral nutrition, into patients. Catheters can also be used to draw blood from patients.

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

[0005] Clinicians generally check for a "flashback" of blood in the catheter assembly's flashback chamber to ensure that the guide needle and / or catheter are properly positioned within the blood vessel. Once needle positioning is confirmed, the clinician can temporarily occlude the vascular flow to withdraw the needle and leave the catheter in place for future blood collection or fluid administration.

[0006] A blood collection container can be used to collect blood or blood samples from a patient. The blood collection container may be equipped with a syringe. Alternatively, the blood collection container may be equipped with a test tube with a rubber stopper at one end. In some examples, the test tube has all or part of the air removed, so the pressure inside the test tube is lower than the ambient pressure. Such a blood collection container is often called an internal vacuum or vacuum tube. The blood collection container may also be a VACUTAINER® blood collection tube, available from Becton Dickinson & Company.

[0007] The blood collection container can be connected to a catheter. When the blood collection container is connected to the catheter, the pressure in the vein becomes higher than the pressure in the blood collection container, which forces blood into the blood collection container, thus filling it with blood. As the blood collection container fills, the vacuum inside the blood collection container decreases until the pressure inside the container equals the pressure in the vein, stopping the blood flow.

[0008] Unfortunately, when blood is drawn into the blood collection container, the large initial pressure difference between the vein and the container places the red blood cells under high shear stress, making hemolysis more likely. Hemolysis can result in the blood sample being discarded. A large initial pressure difference can also cause other troublesome problems, such as catheter tip collapse, vein collapse, or preventing or limiting the blood from filling the blood collection container.

[0009] The descriptions presented in the background information paragraph should not be assumed to be prior art simply because they are mentioned in or related to the background information paragraph. The background information paragraph may contain information describing one or more aspects of the present art. [Overview of the Initiative] [Means for solving the problem]

[0010] This disclosure provides a fluid connector device comprising a first connector and a second connector which is combined 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) aligns with the first opening in a first position and seals the second opening, and ii) aligns with the second opening in a second position and seals the first opening.

[0011] This disclosure provides, in some examples, a blood collection system comprising a blood collection device and a fluid connector device fluidically coupled to the blood collection device, the fluid connector device comprising a first connector and a second connector which 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 or second opening based on the position of the slider assembly relative to the post.

[0012] The disclosure also provides a method for regulating fluid flowing through a blood collection system, the method comprising, in a fluid connector device, the steps of: receiving fluid from a first connector through a slider assembly; receiving fluid from a slider assembly at a first opening of a second connector; receiving fluid from a 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 should be understood that other configurations of this technology will be readily apparent to those skilled in the art from the following detailed description, where various configurations of this technology are shown and described for illustrative purposes. This technology is capable of other different configurations, as will be recognized, and some details of this technology can be modified in various other ways, all without departing from the scope of this technology. Therefore, the drawings and detailed description should be considered illustrative rather than restrictive.

[0014] The following figures are included to illustrate specific aspects of the embodiments and should not be considered exclusive embodiments. The disclosed subject matter can be substantially modified, altered, combined, and equivalent in form and function, which will be conceived by those skilled in the art and will benefit from this disclosure. [Brief explanation of the drawing]

[0015] [Figure 1] This figure shows a collection system according to several aspects of this disclosure. [Figure 2] Figure 1 is an exploded view of a fluid connector device according to several aspects of this disclosure. [Figure 3] Figure 2 is a perspective view of the components of the slider assembly, illustrating the additional features of the components according to the embodiments of this disclosure. [Figure 4] This is a perspective view of a fluid connector device, showing the features of a slider assembly in its initial position according to several aspects of the present disclosure. [Figure 5]This is 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 aspects of the present disclosure. [Figure 6] This is another partial cross-sectional view of a fluid connector device, showing the respective openings of the slider assembly and connector aligned with each other, according to some aspects of the present disclosure. [Figure 7] This is a perspective view of a fluid connector device showing the slider assembly in a different position, according to some aspects of the present disclosure. [Figure 8] This is 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 aspects of the present disclosure. [Figure 9] This 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] This flowchart illustrates a method for regulating the fluid flowing through a blood collection system according to some aspects of the present disclosure. [Modes for carrying out the invention]

[0016] The detailed description below illustrates various configurations of the Technology and is not intended to represent only the configurations in which the Technology may be implemented. The detailed description includes specific details to provide a complete understanding of the Technology. Therefore, dimensions relating to certain embodiments may be presented as non-limiting examples. However, it will be apparent to those skilled in the art that the Technology may be implemented without such specific details. In some examples, well-known structures and components are shown in the form of configuration diagrams to avoid obscuring the concepts of the Technology.

[0017] It should be understood that the present disclosure includes examples of the present technology and is not intended to limit the scope of the appended claims. Here, various aspects of the present technology will be disclosed according to specific non-limiting examples. The various embodiments described in the present disclosure can be implemented in various ways and variations and according to the desired use or implementation mode.

[0018] Blood collection via a vascular access device has been attracting increasing attention because it minimizes needle punctures and improves operational efficiency compared to the conventional blood collection method by venipuncture. There are several issues with current blood collection using a peripheral intravenous catheter (PIVC). One of the most important issues is the quality of blood related to hemolysis. In particular, in PIVC products equipped with standard connectors (such as short extension sets and needleless connectors) and blood collection devices (such as blood collection tubes) currently available on the market, the shear stress applied to blood cells tends to reach the verge of hemolysis.

[0019] Various embodiments of the present disclosure relate to providing a system and method for addressing hemolysis in PIVC blood collection using a hemolysis suppression 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 limiter to reduce the risk of hemolysis. The hemolysis suppression accessory is advantageous because it is compatible with the placement of the PIVC and does not require any changes to existing operations. The hemolysis suppression accessories of the various embodiments described herein are potentially applicable to a wide variety of PIVC products and are compatible with existing blood collection devices and disposable infusion supplies.

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

[0021] FIG. 1 shows a collection system 10 according to some aspects of the present disclosure. The collection system 10 is designed to collect fluid (e.g., blood) from a patient. The collection system 10 may thus be referred to as a blood collection system. The collection system 10 can take the form of a vascular access device with a PIVC assembly. The collection system 10 includes a catheter assembly 20, as shown. 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 and may include the extension tube. Non-limiting examples of integrated catheter assemblies include the BD NEXIVA (trademark) Closed IV Catheter system available from Becton Dickinson and Company. In some embodiments, the proximal end of the extension tube may be connected 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 called a blood collector if the fluid collected is blood from the patient.

[0023] The collection system 10 further comprises a fluid connector device 100, according to some aspects of this disclosure. The fluid connector device 100 may be configured to reduce the possibility of hemolysis during blood collection using the collection system 10. In some embodiments, the fluid connector device 100 has a distal end, which may comprise a body or distal connector configured to connect to a catheter assembly 20 via a connector 30. The connector 30 may include a male Luer connector or another preferred connector.

[0024] In some embodiments, the distal connector of the fluid connector device 100 may be configured to connect to the Y-adapter of the catheter assembly 20 without using the connector 30. In some embodiments, the catheter assembly 20 may not be integrated and may not have an extension tube. In these embodiments and other embodiments, the fluid connector device 100 may be configured to connect to the proximal end of the catheter hub or to another preferred part of the catheter assembly. In some embodiments, the catheter assembly 20 may be connected to a removable extension tube. In some embodiments, the fluid connector device 100 can be connected directly to the catheter adapter, eliminating the need for an extension tube and providing a compact catheter system.

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

[0026] The fluid connector device 100 also includes a slider assembly 110, which is partially located within the connector 102 and partially located within the connector 104 (i.e., the internal chamber). The slider assembly 110 comprises components 112 and 114, as shown in the figure. Components 112 and 114 may be referred to as the first component and the second component, respectively. However, "first" and "second" may be used interchangeably. The slider assembly 110 includes a ring 116 to enable sealing between components 112 and 114 and to prevent leakage between components 112 and 114. In some embodiments, the ring 116 is an O-ring. The slider assembly 110 is designed to act as a regulator or flow limiter for the fluid passing through the fluid connector device 100. The fluid connector device 100 can be integrated with various vascular access devices, which may each have different gauges (G). The fluid connector assembly 100, when used with the slider assembly 110, allows for safe blood collection by restricting blood flow in applications using catheter assemblies in the range of approximately 18G to 22G, 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 connectors 102 and 104 to regulate the fluid flow. In this regard, the slider assembly 110 includes a joint 118 designed to interact with the user in order to actuate the slider assembly 110. The joint 118 is integrated with component 112 and extends radially outward relative to connectors 102 and 104.

[0027] Connector 102 may take the form of a male luer, having a proximal end for connecting to the 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 through which it connects to the slider assembly 110. Connector 104 may also take the form of a female luer, having a proximal end for connecting to the 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) through which it connects to the slider assembly 110. Connectors 102 and 104 can thus fluidly connect the fluid connector device 100 to the fluid sampling component.

[0028] Figure 3 shows a perspective view of a component 114 of the slider assembly 110 shown in Figure 2, according to an aspect of the present disclosure, and illustrates additional features of component 114. Component 114 may comprise a cylindrical body 122 or at least a substantially cylindrical body. Component 114 may also comprise a plurality of recesses extending longitudinally along the long axis of the cylindrical body 122. Component 114 comprises, for example, recesses 124, 126, and 128 (shown by dotted lines). Recesses 124, 126, and 128 partially form separate fluid paths along the cylindrical body 122. Each of the recesses 124, 126, and 128, as will be shown in more detail below, combines with the respective recesses of component 112 to form a flow path or blood collection path.

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

[0030] Figure 5 shows a partial cross-sectional view of a fluid connector device 100 according to several aspects of the present disclosure, showing the opening of the slider assembly 110 aligned with the respective openings of the connector 104. The lumen 120 of the connector 102 provides a fluid inlet for the fluid connector device 100. Once the fluid enters the connector 102, it can pass through the opening 130 of component 112, and subsequently flow into a flow channel 132 formed by the recess 124 of component 114 and the recess 134 of component 112. The flow channel 132 is therefore fluid-connected 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 Figure 5) are also present, and the fluid can flow further into these additional flow channels.

[0031] The fluid can flow through multiple channels formed by components 112 and 114 based on the relative position of the slider assembly 110 with respect to connectors 102 and 104, but the fluid in the channel (i.e., channel 132) can enter the connector 104, while the remaining channels are sealed so that the fluid cannot flow into the connector 104. In this regard, the connector 104 comprises a lumen 140 with an opening 142. Component 114 further comprises an opening 144. Each of the openings 142 and 144 forms a radial opening in the lumen 140 and component 114, respectively. The openings 142 and 144 are also aligned with each other, as shown in Figure 5, so that the fluid in channel 132 can pass through the openings 142 and 144 and exit the connector 104 through the fluid outlet 146 of the connector 104. The fluid outlet 146 can form the fluid outlet of the fluid connector device 100.

[0032] In some embodiments of the present disclosure, the connector 104 comprises a post 105 extending into a lumen 106 formed by the inner surface of the connector 104. The post 105 forms a portion of the fluid passage through the connector 104. At least a portion of the fluid passage through the post 105 can be formed by an opening 142 through the post. In some embodiments, the post 105 comprises a plurality of openings extending through it, and in some embodiments, the post 105 comprises 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 passage between the lumen 106 and the fluid outlet 146.

[0033] Continuing to refer to Figure 5, the post 105 comprises a first opening 142 and a second opening 143, the first opening 142 and the second opening 143 being aligned along a longitudinal axis substantially parallel to the longitudinal axis formed by the post. In some embodiments of the present disclosure, a third opening 145 is radially offset by an angle relative to the first opening 142 and the second opening 143, with respect to the longitudinal axis formed by the post 105.

[0034] When the slider assembly 110 is connected to the connector 104, the post 105 can extend into either of the components 112 and 114 that form the slider assembly. In some embodiments, the slider assembly 110 is longitudinally movable or slidable relative to the post 105. The post 105 can be partially located, i.e., extend within the slider assembly 110, thereby allowing either of the components 112 and 114 of the slider assembly to move along the post 105 relative to the connector 104. In some embodiments, it is assumed that the slider assembly 110 is rotatable around the post 105, but in this disclosure, it is also assumed that the slider assembly 110 is rotatably connected to or fixed to the post 105.

[0035] Figure 6 shows another partial cross-sectional view of the fluid connector device 100 according to several aspects of the present disclosure, showing the respective openings of the slider assembly 110 (i.e., the components 114 of the slider assembly 110) and the connector 104 aligned with each other. The flow path 132 opens into the opening 144 of the component 114, as shown. Based on the alignment between the openings 142 and 144, the fluid flowing through the flow path 132 enters the lumen 140 of the connector 104 and exits the connector 104 through the fluid outlet 146 (shown in Figure 5).

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

[0037] Furthermore, in order to integrally connect components 112 and 114 of the slider assembly 110 and properly align the recess to form a flow path, components 112 and 114 may be equipped with an alignment mechanism. For example, as shown in Figure 6, component 112 is equipped with a recess 151, and component 114 is equipped with a projection 153 that fits into the recess 151. The recess 151 and the projection 153 can each extend longitudinally along component 112 and component 114, respectively. When component 114 is inserted into component 112, component 114 can be rotated relative to component 112 to align the projection 153 with the recess 151, and component 114 can be properly positioned within component 112 to form a desired flow path.

[0038] Figure 7 shows a perspective view of the fluid connector device 100 according to several embodiments of the present disclosure, showing the slider assembly 110 in a different position. The fluid connector device 100 is in the following position, i.e., the second position, based on the position of the slider assembly 110 relative to the connectors 102 and 104, as shown in the figure. 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 gauges of 24G, and possibly greater than 24G (corresponding to some pediatric catheter applications).

[0039] Figure 8 shows a partial cross-sectional view of a fluid connector device 100 according to several embodiments of the present disclosure, showing the openings of the slider assembly 110 aligned with the respective openings of the connector 104. Fluid flowing from the opening 130 of component 112 through the flow path 132 can flow into the connector 104 through an additional opening in component 114 and the lumen 140 of the connector 104. The lumen 140 includes an opening 154 representing an additional radial opening formed in the lumen 140, as shown in the figure. Based on the relative movement of the slider assembly 110 with respect to the connectors 102 and 104 (particularly connector 104), the openings 144 and 154 are aligned with each other, thereby allowing the fluid in the flow path 132 to flow through the openings 144 and 154 into the lumen 140, and the fluid exits the connector 104 through the fluid outlet 146 of the connector 104. Furthermore, due to the relative movement of the slider assembly 110, the openings 142 and 144 are not aligned with each other, thereby preventing the fluid in the flow path 132 from entering the lumen 140 through the openings 142 and 144. When the openings 142 and 144 are not aligned, the engagement between the lumen 140 and the component 114 enables fluid sealing, thereby preventing the fluid from entering the opening 142.

[0040] Furthermore, the fluid entering the flow path 148 can also enter the lumen 140. Thus, the lumen 140 is provided with an opening 156, and the component 114 is provided with an opening 158. Openings 156 and 158 represent additional radial openings formed in the lumen 140 and component 114, respectively. Openings 156 and 158 are aligned with each other, as shown in Figure 8, so that the fluid in the flow path 148 can flow through openings 156 and 158 into the lumen 140, and the fluid exits the connector 104 through the fluid outlet 146 of the connector 104.

[0041] Figure 9 shows another partial cross-sectional view of the fluid connector device 100 according to several aspects of the present disclosure, showing the respective openings of the slider assembly 110 (i.e., the components 114 of the slider assembly 110) and the connector 104 aligned with each other. The flow path 132 opens to an opening 144 of the component 114, as shown. Based on the alignment between openings 144 and 154, the fluid flowing through the flow path 132 enters the lumen 140 of the connector 104 and exits the connector 104 through a fluid outlet 146 (shown in Figure 8). The flow path 148 also opens to an opening 158 of the component 114. Based on the alignment between openings 156 and 158, the fluid flowing through the flow path 148 enters the lumen 140 of the connector 104 and exits the connector 104 through a fluid outlet 146 (shown in Figure 8). Furthermore, 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 the lumen 140 and component 114, respectively. The flow path 150 opens to opening 162 in component 114. Based on the alignment between openings 160 and 162, the fluid flowing through the flow path 150 enters the lumen 140 of the connector 104 and exits the connector 104 through the fluid outlet 146 (shown in Figure 8). Furthermore, when the slider assembly 110 is returned to its initial / first position (shown in Figures 4-6), the engagement between the lumen 140 and component 114 enables fluid sealing, thereby preventing fluid from entering openings 154, 156, and 158.

[0042] The slider assembly 110, therefore, in the second position, has additional fluid paths (3) compared to the single fluid path of the slider assembly 110 in the first position. The slider assembly 110 provides a flow limiting function to the fluid connector device 100, thereby enabling the fluid connector device 100 to function in medical device applications requiring various sizes / gauges.

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

[0044] In step 202, the slider assembly receives fluid from the first connector. The slider assembly may comprise one or more components, each located (or at least substantially located) 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, the first opening of the second connector receives fluid from the slider assembly. The first opening may be formed in the lumen of the second connector. Based on the position of the slider assembly, the first opening of the second connector is aligned with the opening of the slider assembly (or a component of the slider assembly). The slider assembly may further have multiple flow channels, one of which is fluid-connected to the opening of the slider assembly and the first opening of the second connector. Furthermore, one fluid-connected opening may represent the only flow channel that can supply fluid to the connector, while several other openings may be sealed to not receive fluid. This configuration is based on the position of the slider assembly.

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

[0047] In step 208, as the slider assembly moves relative to the second connector, the first opening is sealed from the fluid. While the first opening is sealed, the aforementioned additional openings, as well as the second opening, can receive fluid. Thus, flowchart 200 provides a method for limiting the number of channels that supply fluid through the fluid connector device, and at the same time, for increasing the number of channels based on the movement of the slider assembly.

[0048] The fluid connector devices and associated blood collection systems of the various embodiments described herein offer further advantages over existing blood collection systems. For example, the retrofit fluid connector devices described herein allow for the integration of hemolysis suppression functions for PIVC blood collection. The fluid connector devices described herein also conform to the placement of the PIVC, enabling uninterrupted blood collection during insertion. In some embodiments, the fluid connector devices may remain in series throughout the PIVC placement for multiple blood collections. Furthermore, because the fluid connector devices are retrofit devices that can be easily integrated without modifying existing PIVCs, the impact on clinical practice and surgery is minimal.

[0049] The fluid connector devices of the various embodiments described herein are advantageous over existing PIVC blood collection accessories / connectors because they can operate efficiently with multiple catheter gauge sizes. Therefore, the fluid connector devices of the various embodiments described herein may be referred to as general-purpose 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 the various embodiments described herein thus provide a single general-purpose connector that can demonstrate effective results across various catheter gauge ranges and brands, eliminating the need to own different blood collection accessories / connectors for each catheter gauge range, thus representing a superior improvement over existing PIVC blood collection accessories. The fluid connector devices of the various embodiments described herein aim to provide the same performance across all catheter gauges. The fluid connector devices of the various embodiments described herein can effectively function with 18G-22G gauges and other pediatric gauges by integrating a switchable blood flow path in the form of a sliding assembly with multiple blood collection routes. In contrast, currently available PIVC blood collection connectors / accessories are designed or manufactured to fit a specific range of catheter gauge sizes in order to achieve satisfactory blood collection performance.

[0050] According to various embodiments of this disclosure, the channels (e.g., channels 132, 148, and 150) may each be in the form of a microchannel fluid passage through which a fluid (e.g., blood) flows from the distal connector to the proximal connector for collection in a fluid collection device. Each blood collection channel in the form of a microchannel, through which a fluid (e.g., blood) can flow from the distal connector to the proximal connector for collection in a fluid collection device, may have a diameter ranging, for example, from about 0.254 millimeters (0.01 inches) to about 2.54 millimeters (0.1 inches). The length of the microchannel may range from about 12.7 millimeters (0.5 inches) to about 127 millimeters (5 inches). In some examples, the microchannel has a diameter of 0.635 millimeters (0.025 inches) and a length of 25.4 millimeters (1 inch). In some examples, the diameter is 0.635 millimeters (0.025 inches) and the length is 19.05 millimeters (0.75 inches). In some examples, the diameter is 0.635 millimeters (0.025 inches) and the length is 38.1 millimeters (1.5 inches). In other examples, the diameter is 0.762 millimeters (0.03 inches) and the length is 76.2 millimeters (3 inches). Blood can therefore flow into the blood collection device during blood collection or suction from a patient through one or all three of the microchannels of the first, second, and third blood collection channels having the smallest diameter.

[0051] This technology is demonstrated, for example, according to the various embodiments described below. Various examples of this technology are described as clauses numbered for convenience (1, 2, 3, etc.). These are presented as examples and do not limit the technology. Note that any combination of the dependent clauses may be added to each independent clause, for example, Clause 1 or Clause 5. Other clauses can be presented in a similar manner.

[0052] Article 1 A fluid connector device comprising a first connector and a second connector that is combined with the first connector to form an internal chamber, wherein the second connector comprises a post, a first opening formed in the post, a second opening in the post, and a slider assembly disposed within the internal chamber, the slider assembly i) aligns with the first opening in a first position and seals the second opening, and ii) aligns with the second opening in a second position and seals the first opening.

[0053] Article 2 The fluid connector device according to Clause 1, wherein the slider assembly comprises a flow path to which fluid is connected to a first opening and a second opening.

[0054] Article 3 A fluid connector device according to either clause 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 and fourth openings in the second position.

[0055] Article 4 The fluid connector device according to Clause 3, further comprising: a first flow path i) which is fluidly connected to a first opening when the slider assembly is in a first position and ii) which is fluidly connected to a second opening when the slider assembly is in a second position; a second flow path which is fluidly connected to a third opening when the slider assembly is in a second position; and a third flow path which is fluidly connected to a fourth opening when the slider assembly is in a second position.

[0056] Article 5 The fluid connector device according to Clause 4, further comprising a slider assembly, a first component and a second component, wherein the first component and the second component form a first flow path, a second flow path, and a third flow path.

[0057] Article 6 The post is located at least partially within the slider assembly of the fluid connector device as described in any one of Clauses 1 to 5.

[0058] Article 7 A slider assembly is rotatably connected to a post, as described in any one of clauses 1 to 5.

[0059] Article 8 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, in combination with the first connector, forms an internal chamber, and the second connector comprises 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 being configured to deliver fluid through the first opening or the second opening based on the position of the slider assembly relative to the post, the blood collection system.

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

[0061] Clause 10 A blood collection system according to any one of Clause 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 to which fluid is connected to at least one of the first opening and the second opening.

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

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

[0064] Article 13 A blood collection system according to 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 The blood collection system according to Clause 13, wherein the slider assembly comprises a joint, and the slider assembly is movable based on the operation of the joint.

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

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

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

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

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

[0071] Article 20 The method of clause 18, further comprising the step of receiving fluid in the second connector through the first channel, the second channel, and the third channel when the first opening is sealed.

[0072] This disclosure is presented so that any person skilled in the art can implement the various embodiments described herein. This disclosure presents various examples of the art, and the art is not limited to these examples. Various modifications to these embodiments will be readily apparent to a person skilled in the art. The general principles defined herein may also be applicable to other embodiments.

[0073] References to singular elements are intended to mean "one or more" rather than "just one," unless otherwise specified. Unless otherwise specified, the term "several" refers to one or more. 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 do not limit the invention.

[0074] The term “exemplary” is used herein to mean “serving as an example or illustration.” An embodiment or design described herein as “exemplary” should not necessarily be construed as being preferable or advantageous to other embodiments or designs. In one embodiment, 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, accompanied by the term “or” separating any of the items, modifies the entire list rather than each individual element of the list. The phrase “at least one” does not require the selection of at least one item; rather, it can mean that the list contains at least one of any of the items, at least one of any combination of items, and / or at least one of each of the items. For example, 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] Phrases such as "aspect" do not imply that such aspect is essential to the Technology, nor that such aspect applies to all configurations of the Technology. Disclosure relating to one aspect may apply to all configurations, or one or more configurations. One aspect may provide one or more examples. Phrases such as "aspect" may refer to one or more aspects, and vice versa. Phrases such as "example" do not imply that such examples are essential to the Technology, nor that such examples apply to all configurations of the Technology. Disclosure relating to one example may apply to all examples, or one or more examples. One example may provide one or more examples. The phrase "example" may refer to one or more examples, and vice versa. Phrases such as "configuration" do not imply that such configuration is essential to the Technology, nor that such configuration applies to all configurations of the Technology. Disclosure relating to one configuration may apply to all configurations, or one or more configurations. One configuration may provide one or more examples. The phrase "such a structure" can refer to one or more structures, or vice versa.

[0077] In one embodiment, unless otherwise specified, all measurements, values, ratings, locations, sizes, dimensions, and other specifications described herein, including those in the following claims, are approximate and not precise. In one embodiment, they are intended to have a reasonable range that is consistent with the function to which they relate and with what is customary in the art to which they relate.

[0078] It should be understood that the specific order or hierarchy of steps or operations in the disclosed process or method is illustrative. The specific order or hierarchy of steps, operations, or processes may be rearranged based on the preference or scenario of the embodiment. Some steps, operations, or processes may be performed simultaneously. Depending on the preference or scenario of some embodiments, certain operations may or may not be performed. Some or all of the steps, operations, or processes may be performed automatically without user intervention. The appended claims present various steps, operations, or process elements in an illustrative order and are not intended to be limited to the specific order or hierarchy presented.

[0079] All structural and functional equivalents of elements of various aspects described throughout this disclosure, whether known to those skilled in the art or to become known thereafter, are expressly incorporated herein by reference and intended to be included in the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, whether such disclosure is expressly enumerated in the claims or not. No claimed element should be construed under Section 112(f) of the United States Patent Act unless it is expressly enumerated using the phrase “means to do…” or, in the case of a method claim, unless it is enumerated using the phrase “steps to do…”. Furthermore, to the extent that terms such as “includes,” “have,” etc., are used, such terms are intended to be inclusive, in the same way that the term “equips” is construed when “equips” is used as a conjugate in a claim.

[0080] The “Title of the Invention,” “Background Art,” “Summary of the Invention,” “Brief Description of the Drawings,” and “Abstract” of this Disclosure are incorporated herein and presented not as limiting descriptions but as exemplary examples of the Disclosure. They are presented with the understanding that they are not used to limit the scope or meaning of the claims. In addition, in the “Means for Solving the Problem,” the description presents exemplary examples, and various features are grouped together in various embodiments to streamline the Disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed subject matter requires more features than those explicitly enumerated in each claim. Rather, as reflected in the following claims, the subject matter of the invention does not consist of all features of a single configuration or operation disclosed. The following claims are incorporated herein in the “Means for Solving the Problem,” and each claim stands independently as separately claimed subject matter.

[0081] The claims are not intended to be limited to the embodiments described herein, but are given the full scope consistent with the language of the claims and are intended to encompass all legal equivalents. Nevertheless, none of the claims are intended, nor should they be construed, to encompass subject matter that does not meet the requirements of Section 101, 102, or 103 of the U.S. Patent Act.

Claims

1. A connector forming an internal chamber, an inlet, an outlet, and a post extending into the internal chamber, wherein the post has a first opening and a second opening, A slider assembly comprising a first flow path and a first opening of the slider assembly, wherein the slider assembly is disposed within the internal chamber, and The first opening of the slider assembly is positioned at a first position such that the fluid flows between the first flow path, the first opening of the slider assembly, the first opening of the post, and the outlet, and the first opening of the post. The first opening of the slider assembly is positioned at a second position such that the fluid flows between the first flow path, the first opening of the slider assembly, the second opening of the post, and the outlet, and the second opening of the post is aligned with the second opening of the post. Between them, a slider assembly and which is movable relative to the connector. A fluid connector device equipped with the following features.

2. The fluid connector device according to claim 1, wherein the slider assembly is movable along the post.

3. The fluid connector device according to claim 1, wherein the slider assembly is rotatable relative to the post.

4. The fluid connector device according to claim 1, wherein the post comprises a third opening and a fourth opening, and at the second position, the second flow path of the slider assembly is fluidly connected to the third opening of the post, and the third flow path of the slider assembly is fluidly connected to the fourth opening of the post.

5. The fluid connector device according to claim 4, wherein the slider assembly further comprises a first component and a second component, and the second flow path and the third flow path are formed between the first component and the second component.

6. The fluid connector device according to claim 1, wherein the slider assembly further comprises a first component and a second component, and the first flow path is formed between the first component and the second component.

7. The fluid connector device according to claim 1, wherein both the first opening of the post and the second opening of the post extend radially outward relative to the longitudinal axis of the connector.

8. The fluid connector device according to claim 1, wherein the post extends within the lumen of the slider assembly.

9. Blood collection device, A fluid connector device according to claim 1, which is fluidly connected to the blood collection device. A blood collection system equipped with the following features.

10. The blood collection system according to claim 9, wherein when the slider assembly is in the first position, the flow of the fluid through the second opening of the post is obstructed.

11. The blood collection system according to claim 9, wherein when the slider assembly is in the second position, the flow of the fluid through the first opening of the post is obstructed.

12. The blood collection system according to claim 9, wherein the slider assembly comprises a joint and the slider assembly is movable based on the operation of the joint.

13. The fluid connector device according to claim 1, wherein the first opening and the second opening of the post are aligned along an axis of the opening of the post which is substantially parallel to the longitudinal axis formed by the post.

14. Blood collection device, A fluid connector device fluidly connected to the blood collection device and A blood collection system comprising the fluid connector device, A connector forming an internal chamber, an inlet, an outlet, and a post extending into the internal chamber, wherein the post has a first opening and a second opening, A slider assembly comprising a first flow path and a first opening of the slider assembly, wherein the slider assembly is disposed within the internal chamber, and The first opening of the slider assembly is positioned at a first position such that the fluid flows between the first flow path, the first opening of the slider assembly, the first opening of the post, and the outlet, and the first opening of the post. The first opening of the slider assembly is positioned at a second position such that the fluid flows between the first flow path, the first opening of the slider assembly, the second opening of the post, and the outlet, and the second opening of the post is aligned with the second opening of the post. Between them, a slider assembly and which is movable relative to the connector. A blood collection system equipped with the following features.

15. The blood collection system according to claim 14, wherein the post comprises a third opening and a fourth opening, and at the second position, the second flow path of the slider assembly is fluidly connected to the third opening of the post, and the third flow path of the slider assembly is fluidly connected to the fourth opening of the post.

16. The blood collection system according to claim 15, wherein the slider assembly further comprises a first component and a second component, and the second flow path and the third flow path are formed between the first component and the second component.

17. The blood collection system according to claim 14, wherein the slider assembly further comprises a first component and a second component, and the first flow path is formed between the first component and the second component.

18. A method for a fluid connector device, wherein the method is The step of placing a slider assembly inside the internal chamber of a connector, wherein the connector has an inlet, an outlet and a post, and the slider assembly is movable relative to the connector between a first position and a second position, When the slider assembly is moved to the first position, the first opening of the slider assembly aligns with the first opening of the post such that fluid flows between the first flow path of the slider assembly, the first opening of the slider assembly, the first opening of the post, and the outlet, and A method for aligning the first opening of the slider assembly with the second opening of the post such that when the slider assembly is moved to the second position, the first opening of the slider assembly, the second opening of the post, and the outlet, fluid flows between the first flow path and the first opening of the slider assembly and the second opening of the post.

19. The method according to claim 18, wherein when the slider assembly is moved to the second position, the second flow path of the slider assembly is fluidly connected to the third opening of the post, and the third flow path of the slider assembly is fluidly connected to the fourth opening of the post.

20. The method according to claim 19, further comprising the step of forming the second flow path and the third flow path between the first component of the slider assembly and the second component of the slider assembly.

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