Flow limiter to prevent hemolysis

Abstract

A fluid connector device for a blood collection system is disclosed. The fluid connector device includes a flow limiting device having an external flow path and a passage for regulating the movement of fluid passing through it, thereby regulating the flow of fluid passing through the device. The fluid connector device may include a first connector having an internal surface defining a lumen, a second connector coupled to the end of the first connector, and a flow limiting insert housed within the lumen of the first and second connectors.

Description

Technical Field

[0001] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 455,211, filed on March 28, 2023, entitled "Straight Canula Groove Hemoshield Connector", under 35 U.S.C. § 119, the entire contents of which are incorporated herein by reference.

[0002] The present invention generally relates to blood collection and parenteral fluid administration to a patient, and more particularly to improving the ease of manufacture of the blood flow path of a Hemoshield connector.

Background Art

[0003] Catheters are commonly used in various infusion therapies. For example, catheters can be used to inject body fluids such as saline, various medications, and total parenteral nutrition into a patient. Catheters can also be used to collect blood from a patient.

[0004] One common type of catheter is the over-the-needle type of peripheral intravenous catheter (PIVC). As its name indicates, an over-the-needle catheter can be mounted on an introducer needle having a sharp distal end. The catheter assembly can include a catheter hub, a catheter extending distally from the catheter hub, and an introducer needle extending through the catheter. The catheter and the introducer needle can be assembled such that the distal end of the introducer needle extends beyond the distal end of the catheter and the bevel of the needle is oriented upward from the patient's skin. The catheter and the introducer needle are typically inserted into the patient's vasculature through the skin at a shallow angle.

[0005] To confirm that the introducer needle and / or catheter is properly positioned within the blood vessel, the clinician typically checks for a “flashback” of blood within the catheter assembly’s flashback chamber. After needle placement is confirmed, the clinician may temporarily occlude the blood flow within the vessel, withdraw the needle, and leave the catheter in place for future blood draws or infusions.

[0006] A blood collection container may be used to draw blood from a patient or to collect a blood sample. A blood collection container may include a syringe. Alternatively, a blood collection container may include a test tube with a rubber stopper at one end. In some cases, all or part of the air is removed from the test tube, resulting in a pressure inside the test tube that is lower than the ambient pressure. Such blood collection containers are often called internal vacuum or vacuum tubes. A commonly used internal vacuum or vacuum tube is the Vacutainer® blood collection tube, available from Becton Dickinson & Company.

[0007] A blood collection container can be connected to a catheter. When a blood collection container is connected to a catheter, the pressure in the vein is higher than the pressure in the blood collection container, so blood is forced into the container, and as a result, the blood collection container fills with blood. The vacuum inside the blood collection container decreases as the container fills up, and this continues until the pressure inside the blood collection container equals the pressure in the vein, at which point the blood flow stops.

[0008] Unfortunately, when blood is drawn into the blood collection container, red blood cells are under high shear stress, making them susceptible to hemolysis due to the large initial pressure difference between the vein and the blood collection container. Hemolysis can lead to rejection and disposal of the blood sample. This large initial pressure difference can also cause other complications such as catheter tip collapse, vein collapse, or other issues that prevent or limit the filling of the blood collection container with blood.

[0009] The descriptions in the background section should not be assumed to be prior art simply because they are mentioned in or associated with the background section. The background section may contain information describing one or more aspects of the present art. [Overview of the project]

[0010] The present invention provides devices and accessories for reducing hemolysis, which may include features for restricting and regulating the fluid flow passing through them.

[0011] In some cases, the present invention provides a flow limiting device that can adjust the fluid flow moving within the device in one or more directions. For example, a first fluid flow moving away from the patient and a second fluid flow moving toward the patient.

[0012] Embodiments of the present invention provide a fluid connector device. The fluid connector device includes a first connector, a second connector coupled with the first connector to form a housing, and a flow limiting insert having an external flow path, the insert being mounted within the housing.

[0013] In some embodiments, the external flow path includes a groove extending from the proximal end to the distal end of the flow limiting insert. In some embodiments, the groove is a semi-parabolic cylinder. In some embodiments, the first connector is a female Luer. In some embodiments, the second connector is a male Luer.

[0014] In some embodiments, the external channel has a diameter of approximately 0.015 inches (approximately 0.038 cm), approximately 0.020 inches (approximately 0.051 cm), approximately 0.025 inches (approximately 0.064 cm), approximately 0.030 inches (approximately 0.076 cm), approximately 0.035 inches (approximately 0.089 cm), or approximately 0.040 inches (approximately 0.102 cm). In some embodiments, the external channel has a length of approximately 0.70 inches (approximately 1.778 cm), approximately 0.80 inches (approximately 2.032 cm), approximately 0.90 inches (approximately 2.286 cm), approximately 1.0 inch (approximately 2.54 cm), approximately 1.10 inches (approximately 2.794 cm), approximately 1.20 inches (approximately 3.048 cm), or approximately 1.30 inches (approximately 3.302 cm). In some embodiments, the flow limiting insert has a maximum diameter of approximately 0.1 inches (approximately 0.254 cm), approximately 0.2 inches (approximately 0.508 cm), approximately 0.3 inches (approximately 0.762 cm), approximately 0.4 inches (approximately 1.016 cm), approximately 0.5 inches (approximately 1.27 cm), approximately 0.6 inches (approximately 1.524 cm), or approximately 0.7 inches (approximately 1.778 cm). In some embodiments, the first connector has an inner diameter of approximately 0.1 inches (approximately 0.254 cm), approximately 0.2 inches (approximately 0.508 cm), approximately 0.3 inches (approximately 0.762 cm), approximately 0.4 inches (approximately 1.016 cm), approximately 0.5 inches (approximately 1.27 cm), approximately 0.6 inches (approximately 1.524 cm), or approximately 0.7 inches (approximately 1.778 cm). In some embodiments, the second connector has an inner diameter of approximately 0.1 inches (approximately 0.254 cm), approximately 0.2 inches (approximately 0.508 cm), approximately 0.3 inches (approximately 0.762 cm), approximately 0.4 inches (approximately 1.016 cm), approximately 0.5 inches (approximately 1.27 cm), approximately 0.6 inches (approximately 1.524 cm), or approximately 0.7 inches (approximately 1.778 cm).

[0015] In some embodiments, the fluid flows through an external channel from a first connector to a second connector. In some embodiments, the fluid is blood. In some embodiments, the flow limiting insert reduces hemolysis during blood collection. In some embodiments, the fluid connector device is configured to connect to a catheter assembly. In some embodiments, the flow limiting insert is housed within the first and second connectors. In some embodiments, the flow limiting insert is a solid cylinder having an external channel provided by machining the outer surface of the flow limiting insert.

[0016] Embodiments of the present invention provide a blood collection system comprising a blood collection device and a fluid connector device fluidically connected to the blood collection device. The fluid connector device includes a first connector, a second connector coupled with the first connector to form a housing, and a flow limiting insert having an external flow path, the insert being mounted within the housing.

[0017] Embodiments of the present invention provide a method for manufacturing a fluid connector device. The method includes obtaining a first connector, inserting a flow limiting insert having an external flow path into the first connector, obtaining a second connector, and coupling the first connector to the second connector to form a housing, wherein the flow limiting insert is press-fitted into the housing. In some embodiments, the method further includes forming the flow limiting insert on a solid cylinder having grooves provided by machining the outer surface. In some embodiments, the method further includes ultrasonic welding the first connector to the second connector.

[0018] Those skilled in the art will readily see from the following detailed description that other configurations of the Art are possible, illustrated and described by example. As will be understood, other different configurations of the Art are possible, and some of its details are modifiable in various ways, none of which deviate from the scope of the Art. Therefore, the drawings and detailed description are illustrative in nature and should not be interpreted as limiting. [Brief explanation of the drawing]

[0019] The following figures are included to illustrate specific aspects of the embodiments and should not be considered limiting embodiments. The disclosed subject matter is subject to substantial modifications, changes, combinations and equivalents in form and function, as those skilled in the art will understand in the interest of this specification. [Figure 1A] This is a diagram of a vascular access device comprising a peripheral venous catheter (PIVC) assembly including a fluid connector device according to some embodiments of the present invention. [Figure 1B] Figure 1A is an exploded perspective view of the components of a fluid connector device according to several embodiments of the present invention. [Figure 2] Figure 1A is an exploded perspective view of a fluid connector device according to several embodiments of the present invention. [Figure 3] Figure 1A is a cross-sectional view of a fluid connector device according to several embodiments of the present invention. [Figure 4] Figure 1A is a cross-sectional view of a fluid connector device according to several embodiments of the present invention. [Modes for carrying out the invention]

[0020] The detailed description below outlines various configurations of the Art and is not intended to represent only the possible configurations in which the Art can be implemented. The detailed description includes specific details for the purpose of ensuring a thorough understanding of the Art. Therefore, dimensions may be provided for specific embodiments as examples, without limitation. However, it will be apparent to those skilled in the art that the Art can be implemented without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the Art.

[0021] It should be understood that the present invention includes examples of the present technology and does not limit the scope of the appended claims. Various aspects of the present technology are disclosed according to the following specific but non-limiting examples. The various embodiments described in the present invention can be implemented in different ways and variations according to the desired application or embodiment.

[0022] Blood collection via a vascular access device has been attracting increasing attention because the number of punctures is minimized and the operation efficiency is improved compared to the conventional blood collection method by venipuncture. There are several problems with current blood collection using a peripheral intravenous catheter (PIVC), and one of the most important is the blood quality related to hemolysis. In particular, with current PIVC products available on the market, when used with standard connections (such as short extension tubes and needleless connectors) and blood collection devices (such as Vacutainer®), the shear stress applied to blood cells tends to be at the verge of causing hemolysis.

[0023] Various embodiments of the present invention aim to provide a system and method including an accessory for reducing hemolysis (also referred to as a fluid connector device in the present invention) that is pre-attached to a PIVC and functions as a flow limiter for reducing the risk of hemolysis in order to address hemolysis in PIVC blood collection. The accessory for reducing hemolysis has the advantage of being compatible with the placement of the PIVC and not requiring any changes to any of the existing operations. The accessories for reducing hemolysis in the various embodiments described in the present invention are applicable to various PIVC products and are compatible with existing blood collection devices and infusion disposables.

[0024] Various embodiments of the present invention focus on the effective flow rate limitation by an accessory for reducing hemolysis (also referred to as a fluid connector device in the present invention) that regulates the flow rate of the entire flow path when blood cells pass through. The fluid connector device may be assembled with the PIVC or co-packaged with the PIVC. For this reason, since the device has a breathable lumen that allows blood flashback, no additional operation is required during catheter placement. A clinician can connect a blood collection device to the port of the accessory and collect blood up to the desired amount. After blood collection, the clinician can detach and discard the fluid connector device and the blood collection device as a unit. For this reason, this fluid connector device can be used for single blood collection or can remain in-line throughout the indwelling period.

[0025] According to various embodiments of the present invention, the fluid connector device may include a distal connector configured to connect to a catheter assembly. The distal connector may have a proximal end including a first connection portion and a distal end including a second connection portion. The first connection portion may have an inner surface that defines a lumen, and the second connection portion may also have an inner surface that defines a lumen. The distal connector may be in the form of a male Luer connector or other suitable connector, which may be connected to the female Luer portion of a needleless connector that can be fluidly connected to a catheter via an extension tube.

[0026] In some embodiments, the fluid connector device may further include a proximal connector connected to the proximal end of the distal connector. The proximal connector may be configured to connect to a body fluid collection device (e.g., a blood collection device). For example, the proximal connector may be integrated with the blood collection device or integrally formed as a single unit with the blood collection device. As another example, the proximal connector may be in the form of a female Luer connector or other suitable connector, which may be connected to the male Luer portion of the blood collection device. The proximal connector may have an inner surface that defines a lumen extending therethrough for connection to the proximal end, the distal end, and the male Luer portion.

[0027] According to various embodiments of the present invention, the fluid connector device may further include an insert (flow limiter) fitted into the lumen of the first connection portion and interposed between the proximal connector and the distal connector. As shown in the figure, the insert may have an outer surface, a proximal end and a distal end. The insert may further include a flow path, or a plurality of flow paths, that extend longitudinally from the proximal end to the distal end and fluidly connect the lumen of the first connection portion of the distal connector to the lumen of the proximal connector.

[0028] In some embodiments, the flow restriction channel is in the form of a microchannel channel through which a fluid (e.g., blood) flows from the distal connector to the proximal connector and is collected in the body fluid collection device. The flow restriction channel in the form of a microchannel allows a fluid (e.g., blood) to flow from the distal connector to the proximal connector and be collected in the body fluid collection device, with a diameter ranging from 0.015 inches (approximately 0.038 cm) to 0.15 inches (approximately 0.381 cm), in some cases 0.02 inches (approximately 0.051 cm) to 0.1 inches (approximately 0.254 cm), in other cases 0.04 inches (approximately 0.102 cm) to 0.08 inches (approximately 0.203 cm), and in other cases approximately 0.06 inches (approximately 0.152 cm). Thus, during blood collection or extraction from a patient, blood flows into the blood collection device through a microchannel defined in a blood channel having the minimum diameter. The fluid connector devices of the various embodiments described in the present invention are advantageous compared to currently existing blood collection systems. Yes. For example, during blood collection using existing blood collection devices, blood cells may experience wall shear stress as they flow from the distal end to the proximal end of the blood collection system. As mentioned above, wall shear stress applied to blood cells is considered a major cause of mechanical damage to blood cells that leads to hemolysis. Microchannels defined within a blood collection channel with a minimum diameter can increase flow resistance within the vascular access system, disperse pressure differences, and contribute to reducing the shear stress experienced by red blood cells. For example, a minimized diameter of the blood collection channel increases resistance to blood flow, thereby reducing the blood flow velocity within the fluid connector device. A reduction in blood flow velocity leads to a reduction in the shear stress experienced by red blood cells, thus advantageously reducing the risk of hemolysis during blood collection.

[0029] Because microchannels have extremely small diameters and relatively long lengths, they pose manufacturing challenges. According to various embodiments of the present invention, the insert has a flow channel on its outer surface, which improves the ease of manufacturing microchannels.

[0030] When the medical fluid is blood drawn or collected from a patient, the medical fluid is a blood sample, and the fluid collection device may be a blood collection device. In some embodiments, the blood collection device may be a Luer lock access device (LLAD).

[0031] Figure 1A shows a vascular access device comprising a peripheral venous catheter (PIVC) assembly including a fluid connector device 100 according to some embodiments of the present invention. The fluid connector device 100 may be configured to reduce the possibility of hemolysis during blood collection using the vascular access device. In some embodiments, the vascular access device may include a catheter assembly (e.g., a PIVC). In some embodiments, the fluid connector device 100 may have a distal end including a body or distal connector configured to connect to the catheter assembly. The distal connector may include a male Luer connector or other suitable connector. In some embodiments, the catheter assembly may include a catheter hub including a distal end, a proximal end, and a lumen extending through them. The catheter assembly may further include a catheter fixed within the catheter hub and extending distally from the distal end of the catheter hub. In some embodiments, the catheter may be a peripheral venous catheter (PIVC).

[0032] Figure 1A shows a sampling system 10 according to several embodiments of the present invention. The sampling system 10 is designed to collect fluid (e.g., blood) from a patient. Therefore, the sampling system 10 may also be referred to as a blood collection system. The sampling system 10 may take the form of a vascular access device comprising a PIVC assembly. As shown in the figure, the sampling system 10 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 and include an extension tube. The extension tube may extend from a lateral port of the catheter hub and be integrated therewith. As an example, 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 connected to an adapter, such as a Y-type adapter or a single-port Luer adapter.

[0033] Furthermore, the collection system 10 may include a connector 30 connected to the catheter assembly 20. To collect fluid (e.g., blood) from the patient, the collection system 10 further includes a blood collector 40. If the fluid to be collected is blood from the patient, the blood collector 40 may be referred to as a blood collector.

[0034] Furthermore, the collection system 10 includes a fluid connector device 100 according to some aspects of the present invention. 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 includes a distal end, which may include a body or distal connector configured to connect to the catheter assembly 20 via a connector 30. The connector 30 may include a male Luer connector or other suitable connector.

[0035] In some embodiments, the distal connector of the fluid connector device 100 may be configured to connect to the Y-type adapter of the catheter assembly 20 without using the connector 30. In some embodiments, the catheter assembly 20 may be non-integrated and may not include an extension tube. In these and other embodiments, the fluid connector device 100 may be configured to connect to the proximal end of the catheter hub or to another suitable 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 connects directly to the catheter adapter without an extension tube, providing a compact catheter system.

[0036] Figure 1B shows a perspective view of a fluid connector device 100 shown in Figure 1A, which relates to several aspects of the present invention. The fluid connector device 100 may include a female Luer 103 at the proximal end, a flow limiting insert 101, and a male Luer 104 at the distal end. The flow limiting insert may be modified based on the application of the fluid connector device and has a uniform flow path, thereby supporting effective flushing and reducing the risk of hemolysis.

[0037] Referring to Figure 2, the fluid connector device 100 may include a three-part configuration. In some embodiments, the fluid connector device 100 includes a first connector 103 and a second connector 104 coupled to the first connector 103 to form a housing. In some embodiments, the fluid connector device 100 may include the first connector 103 having an internal surface defining a lumen, the second connector 104 coupled to the end of the first connector 103, and a flow limiting insert 101 housed within the lumen of the first and second connectors. In some embodiments, the fluid connector device 100 includes a flow limiting insert 101 having an external flow path 102. In some embodiments, the insert is press-fitted into the housing formed by the coupling of the first connector 103 and the second connector 104. In some embodiments, the first connector 103 is a female Luer, and the second connector 104 is a male Luer. In a fully assembled fluid connector device, the flow limiting insert 101 is housed within the male and female Luers.

[0038] In some embodiments, the external channel 102 includes a groove extending from the proximal end to the distal end of the flow limiting insert 101. In some embodiments, the external channel 102 is a semi-parabolic cylinder. In some embodiments, the external channel 102 is a semi-cylindrical shape.

[0039] In some embodiments, the external channel 102 has a diameter D of approximately 0.015 inches (approximately 0.038 cm), approximately 0.020 inches (approximately 0.051 cm), approximately 0.025 inches (approximately 0.064 cm), approximately 0.030 inches (approximately 0.076 cm), approximately 0.035 inches (approximately 0.089 cm), or approximately 0.040 inches (approximately 0.102 cm). In some embodiments, the external channel 102 has a length L of approximately 0.70 inches (approximately 1.778 cm), approximately 0.80 inches (approximately 2.032 cm), approximately 0.90 inches (approximately 2.286 cm), approximately 1.0 inch (approximately 2.54 cm), approximately 1.10 inches (approximately 2.794 cm), approximately 1.20 inches (approximately 3.048 cm), or approximately 1.30 inches (approximately 3.302 cm).

[0040] Referring to Figure 3, this external channel 102 can function as a blood channel for the fluid connector device 100. The fluid (i.e., blood) can flow through the external channel 102 from the first connector 103 to the second connector 104. The flow limiting insert 101 is easy to manufacture because the groove is provided on the outer surface of the flow limiting insert 101.

[0041] Referring to Figure 4, the flow limiting insert 101 can be housed within a lumen defined by the first connector 103 and the second connector 104. The flow limiting insert 101 has a maximum diameter d based on the size of the first connector 103 and the second connector 104, thereby allowing the flow limiting insert 101 to be press-fitted into the lumen defined by the first connector 103 and the second connector 104. In some embodiments, the flow limiting insert has a diameter d of approximately 0.1 inches (approximately 0.254 cm), approximately 0.2 inches (approximately 0.508 cm), approximately 0.3 inches (approximately 0.762 cm), approximately 0.4 inches (approximately 1.016 cm), approximately 0.5 inches (approximately 1.27 cm), approximately 0.6 inches (approximately 1.524 cm), or approximately 0.7 inches (approximately 1.778 cm). In some embodiments, the first connector 103 has an inner diameter of approximately 0.1 inches (approximately 0.254 cm), approximately 0.2 inches (approximately 0.508 cm), approximately 0.3 inches (approximately 0.762 cm), approximately 0.4 inches (approximately 1.016 cm), approximately 0.5 inches (approximately 1.27 cm), approximately 0.6 inches (approximately 1.524 cm), or approximately 0.7 inches (approximately 1.778 cm), and the second connector 104 has an inner diameter of approximately 0.1 inches (approximately 0.254 cm), approximately 0.2 inches (approximately 0.508 cm), approximately 0.3 inches (approximately 0.762 cm), approximately 0.4 inches (approximately 1.016 cm), approximately 0.5 inches (approximately 1.27 cm), approximately 0.6 inches (approximately 1.524 cm), or approximately 0.7 inches (approximately 1.778 cm).

[0042] In some embodiments, the present invention relates to a blood collection system comprising a blood collection device and a fluid connector device 100 fluidly connected to the blood collection device. In some embodiments, the fluid connector device 100 includes a first connector 103 and a second connector 104 coupled with the first connector 103 to form a housing. In some embodiments, the blood collection device includes a flow limiting insert 101 having an external flow path 102, the insert 101 being mounted within the housing.

[0043] In some embodiments of the present invention, a method for manufacturing a fluid connector device 100 is described. The method may include obtaining a first connector 103, inserting a flow limiting insert 101 having an external flow channel 102 into the first connector 103, obtaining a second connector 104, and coupling the first connector 103 to the second connector 104 to form a housing. In some embodiments, the flow limiting insert 101 is press-fitted into the housing. In some embodiments, the method further includes forming the flow limiting insert 101 on a solid cylinder having a flow channel 102 having a groove provided by machining the outer surface. In some embodiments, the flow channel 102 extends from the proximal end to the distal end of the flow limiting insert 101. In some embodiments, the flow channel 102 may be a semi-parabolic cylinder. In some embodiments, the flow channel 102 may be a semi-cylindrical shape. In some embodiments, the method further includes ultrasonic welding the first connector 103 to the second connector 104.

[0044] The fluid connector devices and associated blood collection systems of the various embodiments described in the present invention offer further advantages over existing blood collection systems. For example, the add-on fluid connector devices described in the present invention enable the incorporation of hemolysis reduction functions in PIVC blood collection. Furthermore, the fluid connector devices described in the present invention conform to the placement of the PIVC and enable seamless blood collection during insertion. In some embodiments, the fluid connector devices may remain inline throughout the PIVC placement period for multiple blood collections. In addition, because the fluid connector devices are add-on devices that can be easily incorporated into existing PIVCs without modification, the impact on the clinical environment and operation is minimal.

[0045] The optimized fluid path, also referred to in this invention as the first fluid path, flow path, or microchannel, may be configured to provide a limited flow rate to reduce hemolysis. It may have features including, but not limited to, tubular fluid paths, cannulas, lumens, continuous nonlinear channels, grooves, flow paths, etc.

[0046] The fluid path may have a length selected based on one or more of the gauge of a particular catheter, the configuration of a particular catheter assembly, or the clinical setup. In some embodiments, the optimized fluid path may include a length L from the female Luer adapter 103 to the male Luer adapter 104. In some embodiments, the optimized fluid path may include an inner diameter D.

[0047] The flow of fluid in a tubular fluid path can be analyzed using Poiseuille's equation.

number

number

number

number

[0048] In some embodiments, the optimized fluid path may include multiple sections having lengths (L1, L2, L3) and inner diameters (D1, D2, D3). In this case, the geometric coefficients are expressed by the following equation:

number

number

[0049] G of the optimized fluid path f The values ​​may be selected so that the maximum shear stress for each catheter gauge is equal to or less than the maximum shear stress of the BD 21G Vacutainer® UltraTouch® push-button blood collection set, which has been considered the gold standard for conventional blood collection. In some embodiments, the G of the optimized fluid path f The values ​​may be selected such that the maximum shear stress for each catheter gauge is equal to or less than the maximum shear stress of the BD 25G Vacutainer® UltraTouch® push-button blood collection set.

[0050] In some embodiments, as non-limiting examples, the optimized fluid path may have a diameter of approximately 0.015 inches (approximately 0.038 cm), approximately 0.020 inches (approximately 0.051 cm), approximately 0.025 inches (approximately 0.064 cm), approximately 0.030 inches (approximately 0.076 cm), approximately 0.035 inches (approximately 0.089 cm), or approximately 0.040 inches (approximately 0.102 cm). In another non-limiting example, the cross-sectional area of ​​the optimized fluid path is approximately 0.000152 square inches (approximately 0.0004 square cm).

[0051] The fluid connector devices and associated blood collection systems of the various embodiments described in the present invention offer further advantages over existing blood collection systems. For example, the add-on fluid connector device described in the present invention makes it possible to incorporate a hemolysis reduction function in PIVC blood collection. Furthermore, the fluid connector device described in the present invention conforms to the placement of the PIVC and enables seamless blood collection during insertion. Moreover, the fluid connector device may remain inline to accommodate multiple blood collections throughout the PIVC placement period. In addition, because the fluid connector device is an add-on that can be easily incorporated into existing PIVCs without modification, the impact on the clinical environment and operation is minimal.

[0052] In some embodiments, the catheter assembly may include or correspond to any suitable catheter assembly. In some embodiments, the catheter assembly may be integrated and include an extension tube. The extension tube may extend from a lateral port of the catheter hub and be integrated with it. 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 connected to an adapter, such as a Y-type adapter or a single-port Luer adapter. In some embodiments, the distal connector of the fluid connector device may be configured to connect to a Y-type adapter.

[0053] In some embodiments, the catheter assembly may be non-integrated and may not include an extension tube. In these and other embodiments, the fluid connector device may be configured to connect to the proximal end of the catheter hub or to another suitable part of the catheter assembly. In some embodiments, the catheter assembly may be connected to a removable extension tube. In some embodiments, the fluid connector device connects directly to the catheter adapter, omitting the extension tube, to provide a compact catheter system.

[0054] Various examples of aspects of the present invention are described for convenience as numbered clauses (1, 2, 3, etc.). These are provided as examples and do not limit the Art. The identification of figures and reference numbers is provided below for illustrative purposes only, and the clauses are not limited by their identification.

[0055] Clause 1: A fluid connector device comprising a first connector, a second connector coupled with the first connector to form a housing, and a flow limiting insert having an external flow path, the flow limiting insert being mounted within the housing.

[0056] Clause 2: The fluid connector device according to Clause 1, wherein the external flow path includes a groove extending from the proximal end of the flow limiting insert to the distal end of the flow limiting insert.

[0057] Clause 3: The fluid connector device according to Clause 2, wherein the groove is a semi-parabolic cylinder.

[0058] Clause 4: The fluid connector device according to Clause 1, wherein the first connector is a female Luer connector.

[0059] Clause 5: The fluid connector device according to Clause 1, wherein the second connector is a male luer.

[0060] Clause 6: The fluid connector device according to Clause 1, wherein the external flow path has a diameter of approximately 0.015 inches (approximately 0.038 cm), approximately 0.020 inches (approximately 0.051 cm), approximately 0.025 inches (approximately 0.064 cm), approximately 0.030 inches (approximately 0.076 cm), approximately 0.035 inches (approximately 0.089 cm), or approximately 0.040 inches (approximately 0.102 cm).

[0061] Clause 7: The fluid connector device as described in Clause 1, wherein the external flow path has a length of approximately 0.70 inches (approximately 1.778 cm), approximately 0.80 inches (approximately 2.032 cm), approximately 0.90 inches (approximately 2.286 cm), approximately 1.0 inch (approximately 2.54 cm), approximately 1.10 inches (approximately 2.794 cm), approximately 1.20 inches (approximately 3.048 cm), or approximately 1.30 inches (approximately 3.302 cm).

[0062] Clause 8: The fluid connector device described in Clause 2, wherein the flow limiting insert has a maximum diameter of approximately 0.1 inches (approximately 0.254 cm), approximately 0.2 inches (approximately 0.508 cm), approximately 0.3 inches (approximately 0.762 cm), approximately 0.4 inches (approximately 1.016 cm), approximately 0.5 inches (approximately 1.27 cm), approximately 0.6 inches (approximately 1.524 cm), or approximately 0.7 inches (approximately 1.778 cm).

[0063] Clause 9: The fluid connector device according to Clause 1, wherein the first connector has an inner diameter of approximately 0.1 inches (approximately 0.254 cm), approximately 0.2 inches (approximately 0.508 cm), approximately 0.3 inches (approximately 0.762 cm), approximately 0.4 inches (approximately 1.016 cm), approximately 0.5 inches (approximately 1.27 cm), approximately 0.6 inches (approximately 1.524 cm), or approximately 0.7 inches (approximately 1.778 cm).

[0064] Clause 10: The fluid connector device according to Clause 1, wherein the second connector has an inner diameter of approximately 0.1 inches (approximately 0.254 cm), approximately 0.2 inches (approximately 0.508 cm), approximately 0.3 inches (approximately 0.762 cm), approximately 0.4 inches (approximately 1.016 cm), approximately 0.5 inches (approximately 1.27 cm), approximately 0.6 inches (approximately 1.524 cm), or approximately 0.7 inches (approximately 1.778 cm).

[0065] Clause 11: The fluid connector device according to Clause 1, wherein a fluid flows through the external channel from the first connector toward the second connector.

[0066] Clause 12: The fluid connector device according to Clause 11, wherein the fluid is blood.

[0067] Clause 13: The fluid connector device described in Clause 1, wherein the flow limiting insert reduces hemolysis during blood collection.

[0068] Clause 14: The fluid connector device according to Clause 1, wherein the fluid connector device is configured to connect to a catheter assembly.

[0069] Clause 15: The fluid connector apparatus according to Clause 1, wherein the flow limiting insert is housed within the first connector and the second connector.

[0070] Clause 16: The fluid connector device according to Clause 1, wherein the flow limiting insert is a solid cylinder having an external flow channel provided by machining the outer surface of the flow limiting insert.

[0071] Clause 17: A blood collection system comprising a blood collection device and a fluid connector device fluidly coupled to the blood collection device, wherein the fluid connector device comprises a first connector, a second connector coupled to the first connector to form a housing, and a flow limiting insert having an external flow path, the flow limiting insert being mounted within the housing.

[0072] Clause 18: A method for manufacturing a fluid connector device, comprising: obtaining a first connector; inserting a flow limiting insert having an external flow path into the first connector; obtaining a second connector; and coupling the first connector to the second connector to form a housing, wherein the flow limiting insert is press-fitted into the housing.

[0073] Clause 19: The method according to Clause 17, further comprising forming the flow limiting insert into a solid cylinder having grooves provided by machining its outer surface.

[0074] Clause 20: The method according to Clause 17, further comprising ultrasonically welding the first connector to the second connector.

[0075] The present invention is provided so that those skilled in the art can carry out the various embodiments described herein. The present invention provides various examples of the art, but is not limited to these examples. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may also be applicable to other embodiments.

[0076] When an element is referred to in the singular form, it means "one or more" and not "the one and only" unless otherwise specified. Unless otherwise specified, the term "several" refers to "one or more." Masculine pronouns (e.g., his) include feminine and neuter forms (e.g., her and its), and vice versa. Headings and subheadings are used for convenience only and do not limit the invention.

[0077] As used in this invention, the term "exemplary" means "useful as an example or illustration." Embodiments or designs described as "exemplary" in this invention should not necessarily be construed as being preferable or advantageous to other embodiments or designs. In one embodiment, various alternative configurations and operations described in this invention may be considered at least equivalent.

[0078] In this invention, the phrase "at least one of" modifies the entire list, and does not modify each item individually, when placed before a series of items and separated by "or". "At least one of" does not require the selection of at least one item; rather, it allows for meanings including at least one of any single item, at least one of any combination of items, and at least one of each item. For example, the phrase "at least one of A, B, or C" could refer to A only, B only, C only, or any combination of A, B, and C.

[0079] In this invention, terms such as "aspects" do not mean that they are essential to the Art or that they apply to all configurations of the Art. Disclosures relating to aspects may apply to all configurations or one or more configurations. An aspect may provide one or more examples. For example, the term "aspects" may refer to one or more aspects, and vice versa. For example, the term "embodiment" also does not mean that it is essential to the Art or that it applies to all configurations of the Art. Disclosures relating to embodiments may apply to all embodiments or one or more embodiments. An embodiment may provide one or more examples. The term "embodiment" may refer to one or more embodiments, and vice versa. For example, the term "configuration" also does not mean that it is essential to the Art or that it applies to all configurations of the Art. Disclosures relating to configurations may apply to all configurations or one or more configurations. A configuration may provide one or more examples. The term "configuration" may refer to one or more configurations, and vice versa.

[0080] In one embodiment, unless otherwise specified, all measurements, numerical values, evaluations, locations, scales, sizes, and other specifications described in the present invention (including the claims described below) are approximate values ​​and not precise values. In one embodiment, they are intended to have a range that reasonably corresponds to the relevant function and the range that is customary in the art.

[0081] The specific sequence or hierarchy of steps or operations in the processes or methods disclosed in the present invention is understood to represent an exemplary approach. The specific sequence or hierarchy of steps, operations, or processes may be rearranged based on practical preferences or circumstances. Some steps, operations, or processes may be performed simultaneously. Depending on practical preferences or circumstances, certain operations may or may not be performed. Some or all steps, operations, or processes may be performed automatically without user intervention. The appended method claims merely illustrate various steps, operations, or processes in an exemplary order and are not limited to any specific sequence or hierarchy.

[0082] Structural and functional equivalents of elements of various aspects described throughout this invention, known or hereafter known to those skilled in the art, are incorporated by express reference into this invention and are intended to be encompassed by the claims. Furthermore, nothing disclosed in this invention, whether expressly stated in the claims or not, is intended to be made public. Claim elements should not be construed under Section 112(f) of the U.S. Patent Act except where the phrase “means for” is explicitly used, or, in the case of a method claim, where the phrase “step for” is used. Furthermore, terms such as “include,” “have,” or similar terms are intended to have an inclusive meaning, similar to how “comprise” is interpreted when used as a transitional term in a claim.

[0083] The "Title of the Invention," "Background Art," "Summary of the Invention," "Brief Description of the Drawings," and "Abstract" of this invention are incorporated into the invention and provided as illustrative examples, not as limiting descriptions. They are submitted on the premise that they are not used to limit the scope or meaning of the claims. Furthermore, in the "Modes for Carrying Out the Invention," it is understood that the description is illustrative and that various features are grouped together in various embodiments for the sake of brevity of 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 stated in each claim. Rather, as the following claims demonstrate, the subject matter of the invention consists of fewer features than all the features of a single disclosed configuration or operation. The following claims are incorporated into the "Modes for Carrying Out the Invention" of this invention, and each claim constitutes the claimed subject matter independently.

[0084] The claims are not intended to be limited to the embodiments described in the present invention, but are granted a full scope consistent with the language of the claims and to encompass all legal equivalents. However, none of the claims are intended to, nor should they be construed to, encompass subject matter that does not meet the requirements of Sections 101, 102, or 103 of the U.S. Patent Act.

Claims

1. A fluid connector device, The first connector and A second connector which is coupled with the first connector to form a housing, A flow limiting insert having an external flow path, wherein the flow limiting insert is mounted inside the housing, and A fluid connector device equipped with the following features.

2. The fluid connector device according to claim 1, wherein the external flow path includes a groove extending from the proximal end of the flow limiting insert to the distal end of the flow limiting insert.

3. The fluid connector device according to claim 2, wherein the groove is a semi-parabolic cylinder.

4. The fluid connector device according to claim 1, wherein the first connector is a female luer connector.

5. The fluid connector device according to claim 1, wherein the second connector is a male luer.

6. The fluid connector device according to claim 1, wherein the external flow path has a diameter of approximately 0.015 inches (approximately 0.038 cm), approximately 0.020 inches (approximately 0.051 cm), approximately 0.025 inches (approximately 0.064 cm), approximately 0.030 inches (approximately 0.076 cm), approximately 0.035 inches (approximately 0.089 cm), or approximately 0.040 inches (approximately 0.102 cm).

7. The fluid connector device according to claim 1, wherein the external flow path has a length of approximately 0.70 inches (approximately 1.778 cm), approximately 0.80 inches (approximately 2.032 cm), approximately 0.90 inches (approximately 2.286 cm), approximately 1.0 inch (approximately 2.54 cm), approximately 1.10 inches (approximately 2.794 cm), approximately 1.20 inches (approximately 3.048 cm), or approximately 1.30 inches (approximately 3.302 cm).

8. The fluid connector device according to claim 2, wherein the flow limiting insert has a maximum diameter of approximately 0.1 inches (approximately 0.254 cm), approximately 0.2 inches (approximately 0.508 cm), approximately 0.3 inches (approximately 0.762 cm), approximately 0.4 inches (approximately 1.016 cm), approximately 0.5 inches (approximately 1.27 cm), approximately 0.6 inches (approximately 1.524 cm), or approximately 0.7 inches (approximately 1.778 cm).

9. The fluid connector device according to claim 1, wherein the first connector has an inner diameter of approximately 0.1 inches (approximately 0.254 cm), approximately 0.2 inches (approximately 0.508 cm), approximately 0.3 inches (approximately 0.762 cm), approximately 0.4 inches (approximately 1.016 cm), approximately 0.5 inches (approximately 1.27 cm), approximately 0.6 inches (approximately 1.524 cm), or approximately 0.7 inches (approximately 1.778 cm).

10. The fluid connector device according to claim 1, wherein the second connector has an inner diameter of approximately 0.1 inches (approximately 0.254 cm), approximately 0.2 inches (approximately 0.508 cm), approximately 0.3 inches (approximately 0.762 cm), approximately 0.4 inches (approximately 1.016 cm), approximately 0.5 inches (approximately 1.27 cm), approximately 0.6 inches (approximately 1.524 cm), or approximately 0.7 inches (approximately 1.778 cm).

11. The fluid connector device according to claim 1, wherein the fluid flows from the first connector toward the second connector through the external flow path.

12. The fluid connector device according to claim 11, wherein the fluid is blood.

13. The fluid connector device according to claim 1, wherein the flow rate limiting insert reduces hemolysis during blood collection.

14. The fluid connector device according to claim 1, wherein the fluid connector device is configured to connect to a catheter assembly.

15. The fluid connector device according to claim 1, wherein the flow rate limiting insert is housed in the first connector and the second connector.

16. The fluid connector device according to claim 1, wherein the flow limiting insert is a solid cylinder having an external flow channel provided by machining the outer surface of the flow limiting insert.

17. It is a blood collection system, A blood collection device, A fluid connector device fluidly coupled to the blood collection device and The fluid connector device is equipped with, The first connector and A second connector which is coupled with the first connector to form a housing, A flow limiting insert having an external flow path, wherein the flow limiting insert is mounted inside the housing, and A blood collection system equipped with the following features.

18. A method for manufacturing a fluid connector device, Obtaining the first connector, Inserting a flow limiting insert having an external flow path into the first connector, To obtain a second connector, The first connector is coupled to the second connector to form a housing. Includes, A method in which the flow limiting insert is press-fitted into the housing.

19. The method according to claim 17, further comprising forming the flow limiting insert into a solid cylinder having grooves formed by machining its outer surface.

20. The method according to claim 17, further comprising ultrasonically welding the first connector to the second connector.

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