Fluid connector device and blood collection system

Abstract

The utility model discloses a fluid connector device and a blood collection system. The fluid connector device may have a passageway for regulating movement of fluid therethrough, including a flow restriction device having an external flow channel to regulate fluid flow therethrough. The fluid connector device may include a first connector having an inner surface defining an inner lumen, a second connector coupled to an end of the first connector, and a flow restrictor insert contained in the lumens of the first and second connectors.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application Serial No. 63 / 455,211, filed on March 28, 2023, and entitled “Straight Canula Groove Hemoshield Connector,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates generally to blood extraction and administration of parenteral fluids to a patient, and more particularly to a fluid connector device and blood collection system. Background Art

[0004] Catheters are commonly used for various infusion therapies. For example, catheters can be used to infuse fluids, such as saline solutions, various medications, and total parenteral nutrition, into a patient. Catheters can also be used to draw blood from a patient.

[0005] One common type of catheter is an over-the-needle peripheral intravenous ("IV") catheter (PIVC). As the name implies, an over-the-needle catheter can be mounted on an introducer needle having a sharp distal tip. 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 introducer needle can be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the needle angled upward away from the patient's skin. The catheter and introducer needle are typically inserted through the skin into the patient's vasculature at a shallow angle.

[0006] To verify the correct placement of the introducer needle and / or catheter in the blood vessel, the clinician typically confirms the presence of "flashback" of blood in the flashback chamber of the catheter assembly. Once the placement of the needle is confirmed, the clinician can temporarily occlude the flow in the vasculature and remove the needle, leaving the catheter in place for future blood draws or fluid infusions.

[0007] For blood drawing or collecting a blood sample from a patient, a blood collection container may be used. The blood collection container may include a syringe. Alternatively, the blood collection container may include a test tube with a rubber stopper at one end. In some cases, the test tube has all or part of the air removed from the test tube so that the pressure within the test tube is lower than ambient pressure. Such blood collection containers are often referred to as internal vacuum devices or vacuum tubes. Often used as internal vacuum devices or vacuum tubes. The blood collection container may also be a . Blood collection tube.

[0008] The blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure in the vein is higher than the pressure in the blood collection container, which pushes blood into the blood collection container, thereby filling the blood collection container with blood. The vacuum within the blood collection container decreases as the blood collection container fills until the pressure in the blood collection container equals the pressure in the vein and the flow of blood stops.

[0009] Unfortunately, when blood is drawn into the blood collection container, the red blood cells are under high shear stress and susceptible to hemolysis due to the high initial pressure differential between the vein and the blood collection container. Hemolysis may result in rejection and discarding of the blood sample. The high initial pressure differential may also result in collapse of the catheter tip, collapse of the vein, or other complications that prevent or limit blood from filling the blood collection container.

[0010] The description provided in the background section should not be admitted to be prior art merely because it is mentioned in or related to the background section.The background section may include information describing one or more aspects of the subject technology. Utility Model Content

[0011] In some aspects, the present disclosure provides devices and accessories for reducing hemolysis, which may include features for restricting and regulating fluid flow therethrough.

[0012] In some cases, the present disclosure provides flow restriction devices that can regulate fluid flow moving through the device in one or more directions, such as a first fluid flow moving in a direction away from a patient and a second fluid flow moving in a direction toward the patient.

[0013] An embodiment of the present disclosure provides a fluid connector device including a first connector, a second connector combined with the first connector to form a housing, and a flow restrictor insert having an external flow channel, wherein the insert is assembled inside the housing.

[0014] In some embodiments, the external flow channel includes a groove extending from the proximal end of the flow restrictor insert to the distal end of the flow restrictor 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.

[0015] In some embodiments, the outer flow channel has a diameter of about 0.015 inches, about 0.020 inches, about 0.025 inches, about 0.030 inches, about 0.035 inches, or about 0.040 inches. In some embodiments, the outer flow channel has a length of about 0.70 inches, about 0.80 inches, about 0.90 inches, about 1.0 inches, about 1.10 inches, about 1.20 inches, or about 1.30 inches. In some embodiments, the flow restrictor insert has a maximum diameter of about 0.1 inches, about 0.2 inches, about 0.3 inches, about 0.4 inches, about 0.5 inches, about 0.6 inches, or about 0.7 inches. In some embodiments, the first connector has an inner diameter of about 0.1 inches, about 0.2 inches, about 0.3 inches, about 0.4 inches, about 0.5 inches, about 0.6 inches, or about 0.7 inches. In some embodiments, the second connector has an inner diameter of about 0.1 inches, about 0.2 inches, about 0.3 inches, about 0.4 inches, about 0.5 inches, about 0.6 inches, or about 0.7 inches.

[0016] In some embodiments, the fluid flows from the first connector to the second connector through the external flow channel. In some embodiments, the fluid is blood. In some embodiments, the flow restrictor insert reduces hemolysis during blood extraction. In some embodiments, the fluid connector device is configured to be coupled to a catheter assembly. In some embodiments, the flow restrictor insert is contained within the first connector and the second connector. In some embodiments, the flow restrictor insert is a solid cylinder having an external flow channel cut out from the outer surface of the flow restrictor insert.

[0017] An embodiment of the present disclosure provides a blood collection system, which includes a blood collection device and a fluid connector device fluidly connected to the blood collection device, the fluid connector device including a first connector, a second connector combined with the first connector to form a shell, and a fluid restrictor insert having an external flow channel, wherein the insert is assembled inside the shell.

[0018] It should be understood that from the following detailed description, those skilled in the art will readily understand other configurations of the subject technology, wherein the various configurations of the subject technology are shown and described by way of illustration. As will be appreciated, the subject technology can have other and different configurations and its several details can be modified in various other aspects, all without departing from the scope of the subject technology. Therefore, the accompanying drawings and detailed description are considered to be illustrative rather than restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The following drawings are included to illustrate certain aspects of the embodiments and should not be considered as exclusive embodiments. The disclosed subject matter is capable of considerable modification, alteration, combination, and equivalents in form and function, as will occur to those skilled in the art and having the benefit of this disclosure.

[0020] Figure 1A A vascular access device including a peripheral intravenous catheter (PIVC) assembly including a fluid connector device is shown according to some embodiments of the present disclosure.

[0021] Figure 1B Some embodiments of the present disclosure are shown Figure 1A A perspective exploded view of the components of a fluid connector device.

[0022] Figure 2 Some embodiments of the present disclosure are shown Figure 1A An exploded perspective view of a fluid connector device.

[0023] Figure 3 Some embodiments of the present disclosure are shown Figure 1A A cross-sectional view of a fluid connector device.

[0024] Figure 4 Some embodiments of the present disclosure are shown Figure 1A A cross-sectional view of a fluid connector device. DETAILED DESCRIPTION

[0025] The specific embodiments set forth below describe various configurations of the subject technology, and are not intended to represent the only configurations that can practice the subject technology. The specific embodiments include specific details for the purpose of providing a thorough understanding of the subject technology. Therefore, dimensions can be provided as non-limiting examples with respect to certain aspects. However, it is clear to those skilled in the art that the subject technology can be implemented without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid blurring the concept of the subject technology.

[0026] It should be understood that the present disclosure includes examples of subject technology and does not limit the scope of the appended claims. The following will illustrate various aspects of the subject technology according to specific but non-limiting examples. The various embodiments described in this disclosure can be implemented in different ways and variations and according to the intended application and implementation.

[0027] Compared with the traditional blood extraction method using venipuncture, blood extraction via vascular access devices has received increasing attention due to minimized needle insertion and improved operational efficiency. Currently, there are some challenges in using peripheral intravenous catheters (PIVCs) for blood extraction, one of the most critical challenges is hemolysis related to blood quality. In particular, for the currently available PIVC products on the market, together with standard connectors (such as short extension kits and needleless connectors) and blood collection devices (such as vacuum blood collection tubes), the shear stress applied to blood cells is often on the verge of hemolysis.

[0028] Various embodiments of the present disclosure are intended to provide systems and methods for addressing hemolysis in PIVC blood draws with a hemolysis reduction accessory (also referred to herein as a fluid connector device) that is pre-attached to the PIVC and acts as a flow restrictor to reduce the risk of hemolysis. The hemolysis reduction accessory is advantageously compatible with the placement of the PIVC and does not require any changes to existing operations. The hemolysis reduction accessories of the various embodiments described herein are potentially suitable for use with a wide variety of PIVC products and are compatible with existing blood collection devices and disposable infusion items.

[0029] Various embodiments of the present disclosure focus on effective flow restriction utilizing an attached hemolysis reduction attachment (also referred to herein as a fluid connector device) that regulates the total flow rate of the entire fluid path as blood cells pass through. The fluid connector device can be assembled with the PIVC, or can be packaged together with the PIVC. Therefore, there are no additional operations during catheter placement because the device has a ventilation lumen that enables blood to flow back. The clinician can connect a blood collection device to the port of the attachment, and can then draw blood to the desired volume. After the blood is drawn, the clinician can disconnect the fluid connector device from the blood collection device and discard it. Therefore, the fluid connector device can be used for a single blood draw or can remain inline throughout the indwelling period.

[0030] According to various embodiments of the present disclosure, a fluid connector device may include a distal connector configured to be coupled to a catheter assembly. The distal connector may have a proximal end including a first connecting portion and a distal end including a second connecting portion. The first connecting portion may have an inner surface defining a lumen passing therethrough, and the second connecting portion may have an inner surface defining a lumen passing therethrough. The distal connector may be in the form of a male Luer connector or another suitable connector, which may be coupled to a female Luer portion of a needleless connector, which may be coupled to a catheter fluidly via an extension tubing.

[0031] In some embodiments, the fluid connector device may further include a proximal connector coupled to the proximal end of the distal connector. The proximal connector may be configured to be coupled to a fluid collection device (e.g., a blood collection device). For example, the proximal connector may be integrated with the blood collection device, or may be integrally formed with the blood collection device as a single unit. As another example, the proximal connector may be in the form of a female Luer connector or another suitable connector that may be coupled to the male Luer portion of the blood collection device. The proximal connector may have a proximal end, a distal end, and an inner surface defining a lumen extending therethrough for coupling to the male Luer portion of the blood collection device.

[0032] According to various embodiments of the present disclosure, the fluid connector device may further include an insert (fluid restrictor), which is assembled in the lumen of the first connecting part and between the proximal connector and the distal connector. As shown, the insert may have an outer surface, a proximal end, and a distal end. The insert may further include a flow channel or multiple flow channels extending longitudinally from the proximal end of the insert to the distal end, for fluidly communicating the lumen of the first connecting part of the distal connector with the lumen of the proximal connector.

[0033] In some embodiments, the flow restrictor channel can be in the form of a microchannel fluid passage through which a fluid (e.g., blood) flows from a distal connector to a proximal connector for collection in a fluid collection device. The diameter of the flow restrictor channel in the form of a microchannel (along which a fluid (e.g., blood) can flow from a distal connector to a proximal connector for collection in a fluid collection device) can be in the range of 0.015 inches to 0.15 inches, in some cases 0.02 inches to 0.1 inches, in other cases 0.04 inches to 0.08 inches, and in other cases about 0.06 inches. Thus, during blood collection or extraction from a patient, blood can flow into a blood collection device via microchannels defined in a blood flow channel having a minimum diameter. The fluid connector devices of various embodiments described herein are superior to currently available blood collection systems. For example, during blood extraction with a currently available blood extraction device, blood cells may be subjected to wall shear stress as they flow from the distal end to the proximal end of a blood collection system. As described above, wall shear stress on blood cells is considered to be the main source of mechanical damage to blood cells that leads to hemolysis of blood cells. Microchannels defined in blood extraction channels with a minimum diameter can help increase the flow resistance within the vascular access system to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood. For example, the minimum diameter of the blood extraction channel can increase the resistance to blood flow and thus reduce the blood flow rate within the flow connector device. Since the reduced blood flow rate causes the shear stress experienced by the red blood cells in the blood to be reduced, the risk of hemolysis during blood collection can be advantageously reduced.

[0034] Microchannels have very small diameters and are relatively long, which leads to manufacturing problems. According to various embodiments of the present disclosure, an insert may have flow channels on an outer surface of the insert, which improves the manufacturability of the microchannels.

[0035] In the case where the medical fluid is blood drawn or collected from a patient, the medical fluid may be 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).

[0036] Figure 1AA vascular access device including a peripheral intravenous catheter (PIVC) assembly according to some embodiments of the present disclosure is shown, and the peripheral intravenous catheter assembly includes a fluid connector device 100. The fluid connector device 100 can be configured to reduce the possibility of hemolysis during blood collection using the vascular access device. In some embodiments, the vascular access device can include a catheter assembly (e.g., PIVC). In some embodiments, the fluid connector device 100 can include a distal end, which can include a body or a distal connector configured to be coupled to the catheter assembly. The distal connector can include a male Luer connector or another suitable connector. In some embodiments, the catheter assembly can include a catheter hub, which can include a distal end, a proximal end, and a lumen extending through the distal end and the proximal end. The catheter assembly can further include a catheter, which can be fixed in the catheter hub and can extend distally from the distal end of the catheter hub. In some embodiments, the catheter can be a peripheral intravenous catheter (PIVC).

[0037] Figure 1A A collection system 10 according to some aspects of the present disclosure is shown. The collection system 10 is designed to collect fluid (e.g., blood) from a patient. Therefore, the collection system 10 can be referred to as a blood collection system. The collection system 10 can take the form of a vascular access device with a PIVC component. As shown, the collection system 10 includes a catheter assembly 20. In some embodiments, the catheter assembly 20 can include or correspond to any suitable catheter assembly. In some embodiments, the catheter assembly 20 can be integrated with and include an extension tube that can extend from and be integrated with a side port of a catheter hub. A non-limiting example of an integrated catheter assembly is the BD NEXIVA TM A closed IV catheter system of the invention, which can be obtained from Becton Dickinson & Company. In some embodiments, the proximal end of the extension tube can be coupled to an adapter, such as a Y-adapter or a single-port Luer adapter.

[0038] In addition, the collection system 10 may include a connector 30 connected to the catheter assembly 20. In order to collect fluid (such as blood) from the patient, the collection system 10 further includes a collector 40. When the collected fluid is blood from the patient, the collector 40 may be called a blood collector.

[0039] In addition, according to some aspects of the present disclosure, the collection system 10 includes a fluid connector device 100. The fluid connector device 100 can be configured to reduce the possibility of hemolysis during blood collection using the collection system 10. In some embodiments, the fluid connector device 100 can include a distal end, which can include a body or distal connector that is configured to be coupled to the catheter assembly 20 via a connector 30. The connector 30 can include a male Luer connector or another suitable connector.

[0040] In certain embodiments, the distal connector of fluid connector device 100 can be configured to be coupled to the Y-shaped adapter of catheter assembly 20 without using connector 30. In certain embodiments, catheter assembly 20 can be non-integrated and can not include extension tube. In these and other embodiments, fluid connector device 100 can be configured to be coupled to the proximal end of catheter hub or another appropriate part of catheter assembly. In certain embodiments, catheter assembly 20 can be coupled to removable extension tube. In certain embodiments, fluid connector device 100 can be directly coupled to catheter adapter, thereby eliminating extension tube and providing compact catheter system.

[0041] According to some aspects of the present disclosure, Figure 1B Shows Figure 1A . The fluid connector device 100 may include a female Luer 103 on the proximal end, a flow restrictor insert 101, and a male Luer 104 on the distal end. The flow restrictor insert may vary based on the application of the fluid connector device and has a uniform channel, which supports effective flushing and reduces the risk of hemolysis.

[0042] refer to Figure 2 , the fluid connector device 100 may include a three-part design. In some embodiments, the fluid connector device 100 includes a first connector 103 and a second connector 104 that is combined with the first connector 103 to form a housing. In some embodiments, the fluid connector device 100 may include a first connector 103 having an inner surface defining an inner lumen, a second connector 104 coupled to an end of the first connector 103, and a flow restrictor insert 101 contained in the lumens of the first and second connectors. In some embodiments, the fluid connector device 100 includes a flow restrictor insert 101 having an external flow channel 102. In some embodiments, the insert is assembled (i.e., press-fitted) inside the housing formed by the connection of the first connector 103 and the second connector 104. In some embodiments, the first connector 103 is a female Luer piece and the second connector 104 is a male Luer piece. In the fully assembled fluid connector device, the flow restrictor insert 101 is contained in the male Luer piece and the female Luer piece.

[0043] In some embodiments, the outer flow channel 102 comprises a groove extending from a proximal end of the flow restrictor insert 101 to a distal end of the flow restrictor insert 101. In some embodiments, the outer flow channel 102 is a half parabolic cylinder. In some embodiments, the outer flow channel 102 is a half cylinder.

[0044] In some embodiments, the outer flow channel 102 has a diameter D of about 0.015 inches, about 0.020 inches, about 0.025 inches, about 0.030 inches, about 0.035 inches, or about 0.040 inches. In some embodiments, the outer flow channel 102 has a length L of about 0.70 inches, about 0.80 inches, about 0.90 inches, about 1.0 inches, about 1.10 inches, about 1.20 inches, or about 1.30 inches.

[0045] refer to Figure 3 , the external flow channel 102 can serve as a blood flow path of the fluid connector device 100. Fluid (i.e., blood) can flow from the first connector 103 to the second connector 104 through the external flow channel 102. The flow restrictor insert 101 can be easily manufactured because the groove is placed on the outer surface of the flow restrictor insert 101.

[0046] refer to Figure 4 , the flow restrictor insert 101 can be contained in a lumen defined by the first connector 103 and the second connector 104. Based on the size of the first connector 103 and the second connector 104, the flow restrictor insert 101 can include a maximum diameter d so that the flow restrictor insert 101 can be press-fit inside the lumen defined by the first connector 103 and the second connector 104. In some embodiments, the flow restrictor insert has a diameter d of about 0.1 inches, about 0.2 inches, about 0.3 inches, about 0.4 inches, about 0.5 inches, about 0.6 inches, or about 0.7 inches. In some embodiments, the first connector 103 has an inner diameter of about 0.1 inches, about 0.2 inches, about 0.3 inches, about 0.4 inches, about 0.5 inches, about 0.6 inches, or about 0.7 inches. The second connector 104 has an inner diameter of about 0.1 inches, about 0.2 inches, about 0.3 inches, about 0.4 inches, about 0.5 inches, about 0.6 inches, or about 0.7 inches.

[0047] In some embodiments, the present invention relates to a blood collection system, which includes a blood collection device and a fluid connector device 100 fluidically connected to the blood collection device. In some embodiments, the fluid connector device 100 includes a first connector 103 and a second connector 104 combined with the first connector 103 to form a housing. In some embodiments, the blood collection device includes a flow restrictor insert 101 having an external flow channel 102, wherein the insert 101 is fitted inside the housing.

[0048] The fluid connector devices and associated blood collection systems of the various embodiments described herein provide additional advantages over currently existing blood collection systems. For example, the additional fluid connector devices described herein allow for the integration of hemolysis reduction functionality for PIVC blood draws. Furthermore, the fluid connector devices described herein are compatible with PIVC placement and allow for seamless blood draws upon insertion. In some embodiments, the fluid connector device has the potential to remain inline throughout the PIVC indwelling period for multiple blood draws. Furthermore, because the fluid connector device is an additional device, it can be easily incorporated without requiring any changes to the existing PIVC, thereby having minimal impact on clinical setup and operation.

[0049] The optimized fluid pathway (also referred to herein as a first fluid pathway or flow path or microchannel) can be constructed to provide a restricted flow rate to reduce hemolysis, and can have features including but not limited to tubular fluid pathways, cannulas, lumens, continuous non-linear channels, grooves, fluid channels, etc.

[0050] The length of the fluid pathway can be selected based on one or more of the following: the specifications of a particular catheter, the configuration of a particular catheter assembly, or the clinical setting. In some embodiments, the optimized fluid pathway can include a length L from the female Luer adapter 103 to the male Luer adapter 104. In some embodiments, the optimized fluid pathway can include an inner diameter D.

[0051] Fluid flow in a tubular fluid path can be analyzed using the Poiseuille equation:

[0052]

[0053] where ΔP is the change in pressure gradient along the length of the fluid path, D and L are the inner diameter and length of the fluid channel, respectively, and is the fluid resistance. Since μ is the viscosity of the fluid and not part of the extended tube geometry, the geometry factor G f Defined as R f (Fluid resistance) is in

[0054] In some embodiments, the optimized fluid path may have multiple segments with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), then the geometric factor is:

[0055]

[0056] In some embodiments, the optimized fluid path may have a cross-section with a non-circular or complex inner diameter profile. The geometric factor can be determined by measuring the flow rate (Q) of a fluid of known viscosity (μ) at a given pressure (ΔP):

[0057]

[0058] G of the optimized fluid path can be selected f value to reduce the maximum shear stress of each catheter size to equal or less than BD 21G UltraTouch TM The maximum shear stress of a push-button blood collection kit, which was previously considered the gold standard for blood draws. In some embodiments, the G of the optimized fluid path can be selected. f value to reduce the maximum shear stress of each catheter size to be equal to or less than BD 25G UltraTouch TM Maximum shear stress of a push-button blood collection kit.

[0059] In some embodiments, by way of non-limiting example, the optimized fluid path can have a diameter of about 0.015 inches, about 0.020 inches, about 0.025 inches, about 0.030 inches, about 0.035 inches, or about 0.040 inches. In another non-limiting example, the cross-sectional area of ​​the optimized fluid path is about 0.000152 square inches.

[0060] The fluid connector devices and associated blood collection systems of the various embodiments described herein provide additional advantages over currently existing blood collection systems. For example, the additional fluid connector devices described herein allow for the integration of hemolysis reduction functionality for PIVC blood draws. Furthermore, the fluid connector devices described herein are compatible with PIVC placement and allow for seamless blood draws upon insertion. Furthermore, for multiple blood draws, the fluid connector devices have the potential to remain in series throughout the PIVC indwelling period. Furthermore, because the fluid connector device is an additional device, it can be easily incorporated without requiring any changes to the existing PIVC, thereby having minimal impact on clinical setup and operation.

[0061] In some embodiments, the catheter assembly can include or correspond to any suitable catheter assembly. In some embodiments, the catheter assembly can be integrated and include an extension tube that can extend from and be integrated with a side port of the catheter hub. A non-limiting example of an integrated catheter assembly is the BD NEXIVA TM A closed IV catheter system, which can be obtained from Becton Dickinson & Company. In some embodiments, the proximal end of the extension tube can be coupled to an adapter, such as a Y-shaped adapter or a single-port Luer adapter. In some embodiments, the distal connector of the fluid connector device can be configured to be coupled to a Y-shaped adapter.

[0062] In certain embodiments, catheter assembly can be non-integrated and can not include extension tube.In these and other embodiments, fluid connector device can be configured to be coupled to the proximal end of catheter hub or another appropriate part of catheter assembly.In certain embodiments, catheter assembly can be coupled to removable extension tube.In certain embodiments, fluid connector device can be directly coupled to catheter adapter, thereby eliminate extension tube and provide compact catheter system.

[0063] For convenience, multiple examples of various aspects of the present disclosure are described according to numbered clauses (1, 2, 3, etc.). These are provided only as examples and do not limit the subject technology. The reference numerals and the identification of the drawings are shown below only as examples and for the purpose of illustration, and the clauses are not limited by these identifications.

[0064] Item 1: A fluid connector device comprising a first connector, a second connector combined with the first connector to form a housing, and a flow restrictor insert having an external flow channel, wherein the insert is assembled inside the housing.

[0065] Clause 2: The fluid connector device of Clause 1, wherein the external flow channel comprises a groove extending from a proximal end of the flow restrictor insert to a distal end of the flow restrictor insert.

[0066] Clause 3: The fluid connector device of clause 2, wherein the groove is a semi-parabolic cylinder.

[0067] Clause 4: The fluid connector device of clause 1, wherein the first connector is a female Luer.

[0068] Clause 5. The fluid connector device of clause 1, wherein the second connector is a male luer.

[0069] Clause 6: The fluid connector device of clause 1, wherein the outer flow channel has a diameter of about 0.015 inches, about 0.020 inches, about 0.025 inches, about 0.030 inches, about 0.035 inches, or about 0.040 inches.

[0070] Clause 7: A fluid connector device as described in clause 1, wherein the outer flow channel has a length of about 0.70 inches, about 0.80 inches, about 0.90 inches, about 1.0 inches, about 1.10 inches, about 1.20 inches, or about 1.30 inches.

[0071] Clause 8: A fluid connector device as described in Clause 2, wherein the flow restrictor insert has a maximum diameter of about 0.1 inches, about 0.2 inches, about 0.3 inches, about 0.4 inches, about 0.5 inches, about 0.6 inches, or about 0.7 inches.

[0072] Clause 9: A fluid connector device as described in clause 1, wherein the first connector has an inner diameter of about 0.1 inches, about 0.2 inches, about 0.3 inches, about 0.4 inches, about 0.5 inches, about 0.6 inches, or about 0.7 inches.

[0073] Clause 10: A fluid connector device as described in clause 1, wherein the second connector has an inner diameter of about 0.1 inches, about 0.2 inches, about 0.3 inches, about 0.4 inches, about 0.5 inches, about 0.6 inches, or about 0.7 inches.

[0074] Clause 11: The fluid connector device of clause 1, wherein fluid flows from the first connector to the second connector through the external flow channel.

[0075] Clause 12: The fluid connector device of clause 11, wherein the fluid is blood.

[0076] Clause 13. The fluid connector device of clause 1, wherein the flow restrictor insert reduces hemolysis during blood extraction.

[0077] Clause 14: The fluid connector device of Clause 1, wherein the fluid connector device is configured to be coupled to a catheter assembly.

[0078] Clause 15: The fluid connector device of Clause 1, wherein the flow restrictor insert is contained within the first connector and the second connector.

[0079] Clause 16: The fluid connector device of clause 1, wherein the flow restrictor insert is a solid cylinder having external flow channels cut from an outer surface of the flow restrictor insert.

[0080] Item 17: A blood collection system comprising: a blood collection device, and a fluid connector device fluidly connected to the blood collection device, the fluid connector device comprising a first connector, a second connector combined with the first connector to form a housing, and a flow restrictor insert having an external flow channel, wherein the insert is assembled inside the housing.

[0081] The present disclosure is provided to enable those skilled in the art to practice the various aspects described herein. The present disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Multiple modifications to these aspects are very clear to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0082] Unless otherwise specified, reference to an element in the singular is not intended to mean "one and only one," but rather "one or more." Unless otherwise specified, the term "some" refers to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter genders (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the disclosure.

[0083] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, the various alternative configurations and operations described herein may be considered to be at least equivalent.

[0084] As used herein, the phrase "at least one" preceding a list of items (with the term "or" separating any items) modifies the list as a whole rather than each individual member of the list. The phrase "at least one" does not require selection of at least one of the items; rather, the phrase allows for a meaning that includes at least one of any one item, and / or at least one of any combination of items, and / or at least one of each item. For example, the phrase "at least one of A, B, or C" may mean: only A, only B, or only C; or any combination of A, B, and C.

[0085] Phrases such as "aspects" do not mean that such aspects are essential to the subject technology, or that such aspects apply to all configurations of the subject technology. The disclosure associated with an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. Phrases such as "an aspect" may refer to one or more aspects, and vice versa. Phrases such as "embodiments" do not mean that such embodiments are essential to the subject technology, or that such embodiments apply to all configurations of the subject technology. The disclosure associated with an embodiment may apply to all embodiments or one or more embodiments. An embodiment may provide one or more examples. Phrases such as "an embodiment" may refer to one or more embodiments, and vice versa. Phrases such as "constructions" do not mean that such constructions are essential to the subject technology, or that such constructions apply to all configurations of the subject technology. The disclosure associated with a construction may apply to all configurations or one or more constructions. A construction may provide one or more examples. Phrases such constructions may refer to one or more constructions, and vice versa.

[0086] In one aspect, unless otherwise indicated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications in this specification, including those set forth in the claims that follow, are approximate and not exact. In one aspect, they are intended to have a reasonable range consistent with the functions to which they are related and with the customary practices in the art to which they belong.

[0087] All structural and functional equivalents of the elements of the various aspects described throughout the present disclosure are known or will be known to those of ordinary skill in the art, and are expressly incorporated herein by reference and are intended to be covered by the claims. In addition, regardless of whether such disclosure is explicitly recited in the claims, the content disclosed herein is not intended to be committed to the public. No claim element can be interpreted according to the provisions of 35 U.S.C. § 112 (f) unless the element is explicitly stated using the phrase "means for..." In addition, for the scope of the terms "including", "having", etc. used, such terms are intended to refer to inclusiveness in a manner similar to the term "including", as explained when "including" is used as a transitional word in the claims.

[0088] The title, background technology, utility model content, description of the drawings and abstract of the present disclosure are incorporated into the present disclosure and are provided as illustrative examples of the present disclosure, rather than restrictive descriptions. The present application is submitted based on the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the specific implementation, it can be seen that the description provides illustrative examples, and in order to simplify the present disclosure, various features are combined together in various embodiments. The attached claims are therefore incorporated into the detailed description, and each claim is independently a subject matter claimed separately.

[0089] The claims are not intended to be limited to the aspects described herein but are to be accorded the full scope consistent with the language of the claims and including all legal equivalents. Nevertheless, all claims are not intended to include subject matter that fails to satisfy the requirements of 35 U.S.C. §101, 102, or 103 and should not be interpreted in such a manner.

Claims

1. A fluid connector device, characterized in that: It includes: a first connector; a second connector, which is combined with the first connector to form a housing; and A flow restrictor insert having an external flow channel, wherein the insert is mounted inside the housing.

2. The fluid connector device according to claim 1, characterized in that: The external flow channel includes a groove extending from a proximal end of the flow restrictor insert to a distal end of the flow restrictor insert.

3. The fluid connector device according to claim 2, characterized in that: The groove is a semi-parabolic cylinder.

4. The fluid connector device according to claim 1, characterized in that: The first connector is a female Luer.

5. The fluid connector device according to claim 1, characterized in that: The second connector is a male luer.

6. The fluid connector device according to claim 1, characterized in that: The outer flow channel has a diameter of 0.015 inches, 0.020 inches, 0.025 inches, 0.030 inches, 0.035 inches, or 0.040 inches.

7. The fluid connector device according to claim 1, characterized in that: The outer flow channel has a length of 0.70 inches, 0.80 inches, 0.90 inches, 1.0 inches, 1.10 inches, 1.20 inches, or 1.30 inches.

8. The fluid connector device according to claim 2, characterized in that: The flow restrictor insert has a maximum diameter of 0.1 inches, 0.2 inches, 0.3 inches, 0.4 inches, 0.5 inches, 0.6 inches, or 0.7 inches.

9. The fluid connector device according to claim 1, characterized in that: The first connector has an inner diameter of 0.1 inches, 0.2 inches, 0.3 inches, 0.4 inches, 0.5 inches, 0.6 inches, or 0.7 inches.

10. The fluid connector device according to claim 1, characterized in that: The second connector has an inner diameter of 0.1 inches, 0.2 inches, 0.3 inches, 0.4 inches, 0.5 inches, 0.6 inches, or 0.7 inches.

11. The fluid connector device according to claim 1, characterized in that: Fluid flows from the first connector to the second connector through the external flow channel.

12. The fluid connector device according to claim 11, characterized in that: The fluid is blood.

13. The fluid connector device according to claim 1, characterized in that: The flow restrictor insert reduces hemolysis during blood drawing.

14. The fluid connector device according to claim 1, characterized in that: The fluid connector device is configured to be coupled to a catheter assembly.

15. The fluid connector device according to claim 1, characterized in that: The flow restrictor insert is contained within the first connector and the second connector.

16. The fluid connector device according to claim 1, characterized in that The flow restrictor insert is a solid cylinder having external flow channels cut out of the outer surface of the flow restrictor insert.

17. A blood collection system, characterized in that: It includes: Blood collection devices; as well as a fluid connector device fluidly coupled to the blood collection device, the fluid connector device comprising: a first connector; a second connector combined with the first connector to form a housing; and A flow restrictor insert having an external flow channel, wherein the insert is mounted inside the housing.

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