PIVC Integrated Hemolysis Reduction Accessory for Direct Blood Sampling

Abstract

A fluid flow device including a fluid passage for regulating the movement of fluid therethrough may include a flow rate limiting device having first and second passages capable of regulating fluid flow in a first direction through the device and capable of regulating fluid flow in a second direction through the device, and a fluid flow rate limiting device including a first connector having an inner surface defining an inner lumen, a second connector coupled to an end of the first connector, and a cannula attached to the inner lumen extending into the second connector. The lumen of the cannula may define a first flow path through which fluid flows into the fluid collection device, an annulus may be defined between the outer surface of the cannula and the inner surface of the first connector, and the annulus may define a second flow path through which fluid flows into the catheter assembly.

Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 351,565, filed on June 13, 2022, entitled "PIVC-INTEGRATED HEMOLYSIS-REDUCTION ACCESSORIES FOR DIRECT BLOOD DRAW", the disclosure of which is hereby incorporated by reference in its entirety.

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

Background Art

[0003] Catheters are generally used for various infusion therapies. For example, a catheter can be used to infuse fluids such as saline, various medications, and total parenteral nutrition into a patient. A catheter can also be used to withdraw blood from a patient.

[0004] A common type of catheter is a percutaneous peripheral intravenous (IV) catheter (PIVC). As the name suggests, a percutaneous 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 the introducer needle may be assembled such that the bevel of the introducer needle faces upward so that the distal tip of the introducer needle extends beyond the distal tip of the catheter while moving away from the patient's skin. The catheter and the introducer needle are generally inserted at a shallow angle through the skin into the patient's vasculature.

[0005] To verify proper placement of the introducer needle and / or catheter within a blood vessel, a clinician generally checks for a "flashback" of blood within the flashback chamber of the catheter assembly. Once the needle placement is confirmed, the clinician can temporarily occlude the flow within the vasculature, remove the needle, and leave the catheter in place for future blood sampling or fluid injection.

[0006] For blood collection from a patient, or for collecting a blood sample from a patient, a blood collection container may be used. The blood collection container can include a syringe. Alternatively, the blood collection container may include a test tube having a rubber stopper at one end. In some cases, the test tube has had all or a portion 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 or evacuated tubes. The blood collection container may be a VACUTAINER® blood collection tube available from Becton Dickinson & Company.

[0007] The blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure within the vein is higher than the pressure within the blood collection container. As a result, blood is pushed into the blood collection container, and thus the blood collection container becomes filled with blood. The degree of vacuum within the blood collection container decreases as the blood collection container becomes filled, and the pressure within the blood collection container becomes equal to the pressure within the vein, at which point the flow of blood finally stops.

[0008] Unfortunately, when blood is drawn into the blood collection container, due to the high initial pressure differential between the vein and the blood collection container, red blood cells are placed in a high shear stress state and are prone to hemolysis. Hemolysis can lead to rejection and discard of the blood sample. The high initial pressure differential can further lead to catheter tip collapse, vein collapse, or other problems that impede or limit filling of the blood collection container with blood.

[0009] The description given in the background section should not be regarded as prior art simply because it is stated or associated with the background section. The background section can include information that describes one or more aspects of the subject technology.

Summary of the Invention

[0010] The present disclosure provides an apparatus and an accessory for reducing hemolysis, which can include features for restricting and regulating a fluid flow passing therethrough. In some examples, the present disclosure provides a flow restriction device that can be attached to an indwelling venous catheter.

[0011] In some examples, the present disclosure provides a flow restriction device that can regulate a fluid flow moving in one or more directions through the device, such as a first fluid flow moving away from the patient and a second fluid flow moving toward the patient.

[0012] In some embodiments, the present disclosure also provides a flow restriction device configured to direct a fluid withdrawn from a patient to move through a first passageway and to direct a fluid injected toward the patient to move through either the first or the second passageway.

[0013] It is understood that other configurations of the subject technology will be readily apparent to those skilled in the art from the following detailed description, and various configurations of the subject technology are illustrated and described by way of example. As will be appreciated, the subject technology is capable of other and different configurations, and some of its details are capable of modification in various other respects without departing from the scope of the subject technology. Accordingly, the drawings and detailed description are to be regarded in essence as illustrative rather than restrictive.

[0014] The following drawings are included to illustrate certain aspects of the embodiments and should not be regarded as exclusive embodiments. The disclosed subject matter is capable of considerable modification, alteration, combination, and equivalents in forms and functions that will occur to those skilled in the art and that fall within the benefits of this disclosure.

Brief Description of the Drawings

[0015]

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Mode for Carrying Out the Invention

[0016] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent only those configurations in which the subject technology may be practiced. The detailed description includes specific details for achieving a complete understanding of the subject technology. Accordingly, dimensions may be given as non-limiting examples with respect to certain aspects. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology.

[0017] It should be understood that this disclosure includes examples of the subject technology and is not intended to limit the scope of the appended claims. Next, various aspects of the subject technology will be disclosed by way of non-limiting but specific examples. The various embodiments described in this disclosure may be implemented in different manners and variations and may be executed according to the desired use or implementation.

[0018] Blood collection via a vascular access device is attracting increasing attention due to minimal needle pricks and improved work efficiency compared to the conventional blood collection method by venipuncture. Current blood collection using a peripheral intravenous catheter (PIVC) encounters several problems, one of the most significant being the quality of the blood related to hemolysis. In particular, with standard connections (such as short extension sets and needleless connectors) and the PIVC products currently available on the market, as well as blood collection devices (such as vacutainers), the shear stress acting on blood cells tends to be on the verge of causing hemolysis.

[0019] Various embodiments of the present disclosure are directed to providing systems and methods for addressing hemolysis in PIVC blood collection using a hemolysis reduction accessory (also referred to herein as a flow restriction device), the hemolysis reduction accessory being pre-attached to the PIVC and acting as a flow restrictor to reduce the risk of hemolysis. The hemolysis reduction accessory is advantageously adapted to the PIVC placement and does not require any changes to current procedures. The hemolysis reduction accessories of the various embodiments described herein are potentially applicable to a wide variety of PIVC products and are compatible with current blood collection devices and infusion disposable supplies.

[0020] Various embodiments of the present disclosure focus on effective flow restriction using an add-on hemolysis reduction accessory (also referred to herein as a flow restriction device), the hemolysis reduction accessory regulating the overall flow rate of the entire fluid path through which blood cells travel. The flow restriction device may be assembled with the PIVC or co-packaged with the PIVC. Thus, the device does not have a vented lumen that would allow blood flashback and there is no additional manipulation during catheter placement. The clinician can connect the blood collection device to the port of the accessory and then draw blood into the desired volume. After blood collection, the clinician can disconnect and discard the flow restriction device and the blood collection device together. Thus, this flow restriction device can be used for a single blood collection or can remain in-line throughout the indwelling period.

[0021] A feature of the present application is that a flow restriction device configured for fluid flow in two directions can be provided, and the flow rates can be different in each direction. In some aspects of the present disclosure, the device can be configured to provide a first flow rate in a first direction and a second flow rate in a second direction, and the fluid flow is less restricted in the second direction relative to the first direction such that the second flow rate is greater than the first flow rate.

[0022] In some embodiments of the present disclosure, the fluid path for fluid flow in a first direction is isolated or separated from the fluid path for fluid flow in a second direction. In some examples, the fluid flow moving in the first direction moves through a first fluid path that is isolated or separated from a second fluid path configured for fluid flow in the second direction, and the fluid flow moving in the second direction moves through the second fluid path and the first fluid path.

[0023] In some aspects of the present disclosure, the flow rate limiting device is configured to move fluid in a first direction through a first fluid path during extraction of fluid or blood from a patient and to move fluid in a second direction through the first and second fluid paths during injection of fluid towards the patient, in order to reduce hemolysis of the blood.

[0024] In some embodiments, the flow rate limiting device may incorporate a check valve, a diverter, an insert, a removable adapter, and other structures that enable reduced hemolysis for fluid moving in a first direction and unobstructed injection for fluid moving in a second direction. In some embodiments of the present disclosure, the check valve, diverter, insert, removable adapter, or other structures are disposed in the central fluid passage of the device.

[0025] According to various embodiments of the present disclosure, the flow rate limiting device may be an insert having an external luer access and a helical continuous channel characterized by a flow resistance for each design. The flow rate limiting device may be a molded plastic insert characterized by a flow path of flow resistance for each design. The proximal end of the insert may have a female luer, whereby a vent plug may be inserted into the flow rate limiting device and connected to the port of a luer adapter of a PIVC packaged to allow blood flashback when the PIVC is placed. In some embodiments, a clinician or other user may remove the vent plug from the flow rate limiting device and attach a blood collection device to complete blood collection. In some embodiments, when a clinician connects a blood collection device to this insert, the vent plug may be pushed into a pocket, thereby opening a fluid passage for blood collection.

[0026] Accordingly, the flow rate limiting devices and systems of the various embodiments described herein are advantageous in that a helical continuous channel with a small (minimized) diameter may increase the length of a fluid path defined by a continuous channel or groove through which blood flows, providing an increased flow resistance and a reduced blood flow rate within the flow resistance device as opposed to a linear internal fluid path. Thereby, the risk of hemolysis during blood collection can be advantageously reduced.

[0027] The flow rate limiting devices and related blood collection systems of the various embodiments described herein provide further advantages over currently existing blood collection systems. For example, the add-on flow rate limiting device described herein enables integration of a hemolysis reduction function for PIVC blood collection. Further, the flow rate limiting device described herein is compatible with PIVC placement and enables seamless blood collection during insertion. Further, the flow rate limiting device has the possibility of staying in line through the PIVC for multiple blood draws. Further, since the flow rate limiting device is add-on type, it can be easily incorporated without any modification to the existing PIVC, and the impact on the clinical environment and operation is minimal.

[0028] In this specification, an optimized fluid path, also referred to as a first fluid path or flow path or microchannel, can be configured to provide a limited flow rate to reduce hemolysis and can have features including, but not limited to, a tubular fluid path, a cannula, a lumen, a continuous non-linear channel, a groove, a fluid channel, etc.

[0029] The fluid path can have a length selected based on one or more of the following: the dimensions of a particular catheter, a particular catheter assembly configuration, or a clinical setting. In some embodiments, the optimized fluid path can include a length L from a first luer adapter 14 to a second luer adapter 24. In some embodiments, the optimized fluid path can include an inner diameter D.

[0030] Fluid flow in a tubular fluid path therethrough can be analyzed using the Poiseuille equation:

Equation

Equation

Equation

Equation

[0031] In some embodiments, the optimized fluid path may have a plurality of sections with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), and thus, the geometric factor is:

Number

Number

[0032] The G of the optimized fluid path f value may be selected to reduce the maximum shear stress for each catheter gauge such that it is the same as or lower than the maximum shear stress of the BD 21G VACUTAINER® UltraTouch® push-button blood collection set, which was previously considered a representative presence for blood collection. In some embodiments, the G of the optimized fluid path f value may be selected to reduce the maximum shear stress for each catheter gauge such that it is the same as or lower than the maximum shear stress of the BD 25G VACUTAINER® UltraTouch® push-button blood collection set.

[0033] In some embodiments, the internal fluid passage of the catheter assembly 37, which may include the needle assembly 19, the extension tube 32, and another extension tube 46, may form a complete fluid path for blood collection. The system geometric factor G for the fluid path fs can be determined in a similar manner as described above. In some embodiments, the system geometric factor G fs is 7.34E+06 (l / in 3equal to or greater than. In some embodiments, G fs may include another value. In some embodiments, the system geometry factor G fs is 7.34E+06 (l / in 3 ) plus or minus 10 percent, plus or minus 25 percent, plus or minus 50 percent, plus or minus 75 percent. In some embodiments, G fs may include another value that can be selected based on the dimensions and / or length of the catheter.

[0034] In some embodiments, by way of non-limiting example, the optimized fluid path can have a diameter of about 0.3556 mm (0.014 inches). In another non-limiting example, the cross-sectional area of the optimized fluid path is about 0.0038608 mm 2 (0.000152 inches 2 ).

[0035] Figures 1A - 1C show a vascular access device 100 including a peripheral intravenous catheter (PIVC) assembly 50 including a flow restriction device 10, according to some embodiments of the present disclosure. Figure 1A shows an exploded view of a vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a fluid collection device, according to some embodiments of the present disclosure. Figure 1B shows an operational view of a vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a fluid collection device, according to some embodiments of the present disclosure. Figure 1C shows an operational view of a vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a fluid collection device, according to some embodiments of the present disclosure.

[0036] Referring now to FIGS. 1A-1C, a flow restriction device 10 according to some embodiments is shown. The flow restriction device 10 may be configured to reduce the likelihood of hemolysis during blood collection using the vascular access device 100. In some embodiments, the vascular access device 100 may include a catheter assembly (e.g., a PIVC) 50. In some embodiments, (as further shown in FIGS. 2A-3B) the flow restriction device 10 may include a distal end 12, which may include a body or distal connector 14 configured to be coupled to the catheter assembly 50. The distal connector 14 may include a male luer connector, or another suitable connector.

[0037] In some embodiments, the catheter assembly 50 may include a distal end 54, a proximal end 56, and a catheter hub 52 that may include a lumen extending through the distal and proximal ends. The catheter assembly 50 may further include a catheter 58, which may be secured within the catheter hub 52 and may extend distally from the distal end 54 of the catheter hub 52. In some embodiments, the catheter may be a peripheral intravenous catheter (PIVC).

[0038] In some embodiments, the catheter assembly 50 may include any suitable catheter assembly 50 or may correspond to any suitable catheter assembly 50. In some embodiments, the catheter assembly 50 may be integrated and may include an extension tube 60 that extends from a side port 59 of the catheter hub 52 and may be integrated with its side port 59. 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 60 may be coupled to an adapter 70 such as, for example, a Y-adapter or a single-port luer adapter. In some embodiments, the distal connector 14 of the flow restriction device 10 may be configured to be coupled to the Y-adapter 70.

[0039] In some embodiments, the catheter assembly 50 may be in a non-integrated form and may not include an extension tube 60. In these and other embodiments, the flow restriction device 10 may be configured to be coupled to the proximal end 56 of the catheter hub 52 or to another suitable portion of the catheter assembly 50. In some embodiments, the catheter assembly 50 may be coupled to a removable extension tube 60. In some embodiments, the flow restriction device 10 may be directly coupled to a catheter adapter, thereby omitting the extension tube and providing a compact catheter system.

[0040] FIG. 2A shows a perspective view of a flow restriction device 110 according to some embodiments of the present disclosure. FIG. 2B shows a cross-sectional view of the flow restriction device 110 of FIG. 2A according to some embodiments of the present disclosure. FIG. 2C shows an enlarged cross-sectional view of the flow path 165 of the flow restriction device of FIG. 2A according to some embodiments of the present disclosure.

[0041] As shown in FIG. 2A and referring subsequently to FIGS. 1A and 1B, in some embodiments, the flow restriction device 110 may include a first connector 112 configured to be coupled to the catheter assembly 50. The first connector 112 may have a proximal end 114, a distal end 116, and an inner surface 118 that defines an inner lumen 120 of the first connector 112. As shown, the first connector 112 may further include a support portion 160 disposed between the proximal end 114 and the distal end 116. The support portion 160 may have a proximal end 161 and a distal end 162 and may include a central mounting aperture 165 extending from the proximal end 161 to the distal end 162. In some embodiments, the support portion 160 may further include a plurality of flow paths 165 disposed radially outside of and surrounding the central mounting aperture 165. The plurality of flow paths 165 may extend from the proximal end 161 to the distal end 162 of the support portion 160 to place the inner lumen 120 in fluid communication with the catheter assembly.

[0042] In some embodiments, the flow restriction device 110 may further include a second connector 130 coupled to the proximal end 114 of the first connector 112. The second connector 130 may be configured to be coupled to a fluid collection device 40 (e.g., a blood collection device). For example, the second connector 130 may be integrated with the blood collection device 40 or may be integrally formed with the blood collection device 40 as a single unit. As another example, the second connector 130 may be in the form of a female luer connector or another suitable connector that can be coupled to the male luer portion of the blood collection device 40. The second connector 130 may include a lumen 134 extending therethrough for coupling to the male luer portion of the blood collection device 40.

[0043] According to various embodiments of the present disclosure, the flow restriction device 110 may further include a cannula 140 attached to the inner lumen 120 of the first connector 112. As shown, the cannula 140 may extend from the distal end 116 of the first connector 112 into the second connector 130. The cannula may have a proximal end 143, a distal end 145, and a lumen 142 extending therethrough. The lumen 142 may define a first flow path or microchannel along which fluid may flow from the distal end 116 towards the proximal end 114, e.g., from the distal end 116 to the proximal end 114 and into a fluid collection device 40 coupled to the proximal end 114. The fluid may also flow in a direction from the proximal end 114 towards the distal end 116 through the first flow path. In some aspects, the fluid may flow through the first flow path and a second flow path when moving in a direction from the proximal end 114 towards the distal end 116.

[0044] As shown, the cannula 140 may be attached to the central mounting opening 166 of the first connector support portion 160, and the cannula 140 may be in fluid communication with the catheter assembly 50. For example, in some embodiments, the leg 72 of the Y - adapter 70 may be coupled to the flow restrictor 110. For example, the leg 72 of the Y - adapter 70 may include a lumen, and the distal end 116 of the first connector 112 to which the cannula 140 is attached may be coupled into this lumen. The Y - adapter 70 may place the flow restrictor 110 and the cannula 140 attached thereto in fluid communication with the catheter assembly 50, for example, via the extension tube 60. Thus, the lumen 142 of the cannula 140 may define a linear fluid path having a reduced, small, or micro - sized diameter (as described below), and fluid entering the flow restrictor 110 from the catheter assembly may flow through the flow restrictor 110 for collection in the fluid collection device 40 through this linear fluid path. For example, when blood is being withdrawn or collected from a patient, the medical fluid 15 may be blood, and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a luer lock access device (LLAD). Thus, during blood collection or withdrawal from a patient, the blood sample 15 may flow from the distal end 116 of the first connector 112 into the LLAD 40 via the first flow path or microchannel.

[0045] In some embodiments, the cannula 140 may be an elongated, thin tube having a lumen with a small, reduced, or micro - sized diameter. For example, in some embodiments, the lumen 142 of the cannula 140 defines a first flow path or microchannel, along which fluid may flow from the distal end 116 into the fluid collection device 40 via the second connector 130. The cannula 140 can define a lumen 142 formed by any of length, diameter, and cross - sectional area, as described above with respect to the optimized fluid path.

[0046] When the fluid is blood withdrawn from a patient, blood cells can be subject to shear stress as they flow from the catheter assembly 50 into the blood collection device 40. For example, the maximum shear stress can be along the walls of the blood cells and is often referred to as wall shear stress. Wall shear stress in blood cells is thought to be a major cause of mechanical damage to blood cells and results in hemolysis of the blood cells. In some embodiments, the lumen 142 of the cannula 140 having a reduced or micro-sized diameter can promote an increased flow resistance within the vascular access system 100 to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15. The minimized diameter of the first fluid path or microchannel defined by the lumen 142 of the cannula 140 provides an increased resistance to the flow of the blood 15, thereby reducing the blood flow rate within the flow resistance device 110. The reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of the blood 15, so the risk of hemolysis during blood collection can be advantageously reduced.

[0047] In some embodiments, as shown in FIG. 2C, an annulus 146 may be defined between the outer surface of the cannula 140 and the inner surface 118 of the first connector 112. The annulus 146 may define a second fluid path along which fluid flows from the lumen 134 of the second connector 130 through the first connector 116 into the catheter assembly 50. A plurality of flow paths 165 may extend from the proximal end 161 to the distal end 162 of the support portion 160 to fluidly couple the annulus 146 to the catheter assembly. Thus, the plurality of flow paths 165 may define at least a portion of the second fluid path.

[0048] According to various embodiments of the present disclosure, the flow restriction device 110 may further include a check valve 150 attached to the annulus 146 at the proximal end 114 of the first connector 112. As shown, the check valve 150 may be sleeved over at least a portion of the cannula 140. The check valve 150 has a shape or structure configured to allow fluid to flow from the second connector 130 through the second flow path into the first connector 112 and the catheter assembly 50, while preventing fluid from flowing from the distal end 116 of the first connector 112 through the second flow path into the fluid collection device 40. In some embodiments, the fluid flowing from the second connector 130 through the second flow path into the first connector 112 and the catheter assembly may be the IV fluid 17. Thus, the blood 15 containing blood cells can be forced to flow through the microchannel fluid path defined by the lumen 142 of the cannula 140 to reach the blood collection device 40, whereas the IV fluid 36 may flow to the catheter assembly 50 through the second flow path including the annulus 146 and the plurality of flow paths 165.

[0049] In some embodiments, the flow path cross-sectional area of the annulus 146 may be larger than the flow path cross-sectional area of the lumen 142. For example, the cross-sectional area of the annulus 146 along a plane perpendicular to the central longitudinal axis X of the first connector 112 may be larger than the cross-sectional area of the lumen 142 along that plane. The cannula 140 can define a lumen 142 formed by any of length, diameter, and cross-sectional area, as described above with respect to the optimized fluid path.

[0050] As a non-limiting example, in some embodiments, the lumen 142 can include a diameter of about 0.3556 mm (0.014 inches). In some examples, the cross-sectional area of the lumen 142 is 0.0038608 mm 2 (0.000152 inches 2 ) and the cross-sectional area of the annulus 146 is about 0.92202 mm 2 (0.0363 inches 2) In some embodiments, the diameter of the lumen 142 of the cannula 140 may be smaller than the thickness of the lumen of the annulus 146. However, various embodiments of the present disclosure are not limited to the foregoing configuration.

[0051] The foregoing configuration may provide an increased flow resistance and a decreased blood flow rate within the flow resistance device 110, in contrast to when blood flows into the blood collection device 40 through the plurality of flow paths 165 and the annulus 146 of the second flow path, where the reduced or minimized diameter or size of the microchannel fluid path defined by the lumen 142 of the cannula 140 is involved. Thus, the risk of hemolysis during blood collection can be advantageously reduced. However, a larger size of the flow path cross-sectional area of the annulus 146 compared to the flow path cross-sectional area of the lumen 142 may provide an additional advantage of allowing an increased amount of IV fluid 17 to flow through the second flow path to the patient, as compared to flowing through the reduced or minimized diameter or size of the microchannel fluid path defined by the lumen 142 of the cannula 140. Thus, the IV fluid 36 may flow toward the catheter assembly 50 in a second, unrestricted (less flow resistance) direction (proximal to distal), opposite to the first direction (distal to proximal) in which the blood sample 15 having blood cells flows.

[0052] FIG. 3A shows a perspective view of a flow rate limiting device 210 according to some embodiments of the present disclosure. FIG. 3B shows a cross-sectional view of the flow rate limiting device 210 of FIG. 3A according to some embodiments of the present disclosure. FIG. 3C shows an enlarged cross-sectional view of the flow path 245 of the flow rate limiting device 210 of FIG. 3A according to some embodiments of the present disclosure.

[0053] As shown in FIG. 3A, and continuing to refer to FIGS. 1A and 1B, in some embodiments, the flow restriction device 210 may include a first connector 212 configured to be coupled to the catheter assembly 50. The first connector 212 may have a proximal end 214, a distal end 216, and an inner surface 218 that defines an inner lumen 220 of the first connector 212. In some embodiments, the flow restriction device 210 may further include a second connector 230 coupled to the proximal end 214 of the first connector 212. The second connector 230 may be configured to be coupled to a fluid collection device 40 (e.g., a blood collection device). For example, the second connector 230 may be integrated with the blood collection device 40, or may be integrally formed with the blood collection device 40 as a single unit. As another example, the second connector 230 may be in the form of a female luer connector or another suitable connector that can be coupled to the male luer portion of the blood collection device 40. The second connector 230 may include a lumen 234 that extends through the second connector 230 for coupling to the male luer portion of the blood collection device 40.

[0054] As shown, the second connector 230 may further include a proximal end 236, a distal end 238, and a support portion 260 disposed between the proximal end 236 and the distal end 238. The support portion 260 may have a proximal end 261 and a distal end 262, and may include a central mounting aperture 266 that extends from the proximal end 261 to the distal end 262. In some embodiments, the support portion 260 may further include a plurality of flow paths 265 disposed radially outside of and surrounding the central mounting aperture 266. The plurality of flow paths 265 may extend from the proximal end 261 to the distal end 262 of the support portion 260 to fluidly couple the lumen 234 of the second connector 230 with the inner lumen 220 of the first connector 212 fluidly coupled to the catheter assembly 50. Thus, the plurality of flow paths 265 may define at least a portion of a second flow path.

[0055] According to various embodiments of the present disclosure, the flow restriction device 210 may further include a cannula 140 attached to the lumen 234 of the second connector 230. In particular, the cannula 140 may have a proximal end 143, a distal end 145, and a lumen 142 extending through the cannula. As shown, the proximal end 143 of the cannula 140 may be attached to the central attachment opening 266 to fluidly connect the cannula 140 with the fluid collection device 40. The cannula 140 may extend from the lumen 234 of the second connector 230 into the first connector 212. The cannula 140 may have a proximal end 143, a distal end 145, and a lumen 142 extending through the cannula. The lumen 142 may define a first flow path or microchannel along which fluid may flow between the proximal end 214 and the distal end 216 of the first connector 212. As shown, the cannula 140 may be attached to the central attachment opening 266 of the second connector support portion 260 and may fluidly connect the cannula 140 with the catheter assembly 50. For example, in some embodiments, the leg 72 of the Y - adapter 70 may be coupled to the flow restriction device 210. For example, the leg 72 of the Y - adapter 70 may include a lumen into which the distal end 216 of the first connector 212 having the cannula 140 disposed therein may be coupled. The Y - adapter 70 may fluidly connect the flow restriction device 210 and the cannula 140 attached thereto with the catheter assembly 50 via, for example, an extension tube 60. Thus, the lumen 142 of the cannula 140 may define a linear fluid path having a reduced, small, or micro - sized diameter (as described later), through which fluid entering the flow restriction device 210 from the catheter assembly may flow through the flow restriction device 210 for collection in the fluid collection device 40. For example, when blood is being withdrawn or collected from a patient, the medical fluid 15 may be blood and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood or fluid collection device may be a luer - lock access device (LLAD).Thus, during blood collection or withdrawal from a patient, the blood sample 15 may flow from the distal end 216 of the first connector 212 into the LLAD 40 via the first flow path or microchannel.

[0056] In some embodiments, the cannula 140 may be an elongated, thin tube having a lumen with a small, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 142 of the cannula 140 defines a first flow path or microchannel along which fluid may flow from the distal end 116 into the fluid collection device 40 via the second connector 130. The cannula 140 can define a lumen 142 formed by any of length, diameter, and cross-sectional area, as described above with respect to the optimized fluid path.

[0057] When the fluid 15 is blood withdrawn from a patient, the blood cells can be subject to shear stress as they flow from the catheter assembly 50 into the blood collection device 40. For example, the maximum shear stress can be along the wall of the blood cells and is often referred to as wall shear stress. Wall shear stress in blood cells is thought to be a major cause of mechanical damage to the blood cells and results in hemolysis of the blood cells. In some embodiments, the lumen 142 of the cannula 140 having a reduced or micro-sized diameter can promote an increased flow resistance within the vascular access system 100 to dissipate the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15. The minimized diameter of the first fluid path or microchannel defined by the lumen 142 of the cannula 140 provides an increased resistance to the flow of the blood 15, thereby reducing the blood flow rate within the flow resistance device 210. The reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of the blood 15, so the risk of hemolysis during blood collection can be advantageously reduced.

[0058] In some embodiments, as shown in FIG. 3C, an annulus 246 may be defined between the outer surface of the cannula 140 and the inner surface 118 of the first connector 212. The annulus 246 may define a second flow path, along which fluid flows from the lumen 234 of the second connector 230 through the first connector 216 into the catheter assembly 50. A plurality of flow paths 265 may extend from the proximal end 261 to the distal end 262 of the support portion 260 to place the annulus 246 in fluid communication with the catheter assembly 50. Thus, the plurality of flow paths 265 may define at least a portion of the second flow path.

[0059] Similar to the flow restrictor device 110, the flow restrictor device 210 may further include a check valve 150 attached to the annulus 246 at the proximal end 214 of the first connector 212. As shown, the check valve 150 may cover at least a portion of the cannula 140. The check valve 150 may have a shape or structure configured to prevent fluid from flowing from the distal end 216 of the first connector 212 through the second flow path into the fluid collection device 40 while allowing fluid to flow from the second connector 230 through the second flow path into the first connector 212 and the catheter assembly 50. In some embodiments, the fluid flowing from the second connector 230 through the second flow path into the first connector 212 and the catheter assembly 50 may be IV fluid 17. Thus, blood 15 containing blood cells may be forced to flow through the microchannel fluid path defined by the lumen 142 of the cannula 140 to reach the blood collection device 40, while the IV fluid 17 may flow into the catheter assembly 50 through the second flow path including the annulus 246 and the plurality of flow paths 265.

[0060] In some embodiments, the flow channel cross-sectional area of the annulus 246 may be greater than the flow channel cross-sectional area of the lumen 142. For example, the cross-sectional area of the annulus 246 along a plane perpendicular to the central longitudinal axis X of the first connector 212 may be greater than the cross-sectional area of the lumen 142 along that plane. The cannula 140 can define a lumen 142 formed by any of length, diameter, and cross-sectional area, as described above with respect to the optimized fluid path. In some embodiments, the diameter of the lumen 142 of the cannula 140 may be smaller than the thickness of the lumen of the annulus 246.

[0061] The foregoing configuration can provide an increased flow resistance and a decreased blood flow rate within the flow resistance device 210, where the reduced or minimized diameter or size of the microchannel fluid path defined by the lumen 142 of the cannula 140 is in contrast to the case where blood flows into the blood collection device 40 through the plurality of flow channels 265 and the annulus 246 of the second flow path. Thus, the risk of hemolysis during blood collection can be advantageously reduced. However, the larger size of the flow channel cross-sectional area of the annulus 246 compared to the flow channel cross-sectional area of the lumen 142 can provide an additional advantage of allowing an increased amount of IV fluid 17 to flow to the patient through the second flow path, as compared to passing through the reduced or minimized diameter or size of the microchannel fluid path defined by the lumen 142 of the cannula 140. Thus, the IV fluid 17 may flow toward the catheter assembly 50 in a second, unrestricted (less flow resistance) direction (proximal to distal), opposite to the first direction (distal to proximal) in which the blood sample 15 having blood cells flows.

[0062] FIG. 4A shows a perspective view of a flow restriction device 310 according to some embodiments of the present disclosure. FIG. 4B is a cross-sectional view of the flow restriction device of FIG. 4A according to some embodiments of the present disclosure. FIG. 4C is an enlarged partial cross-sectional view of the flow restriction device of FIG. 4A according to some embodiments of the present disclosure. According to some embodiments, the flow restriction device 310 is similar to the flow restriction device 210, the elements are the same, the reference numerals are maintained, and detailed descriptions of these similar elements are omitted here.

[0063] The flow restriction device 310 may be different from the flow restriction device 210 with respect to the support portion 360 and the cannula 340, as will be described in more detail below.

[0064] Similar to the second connector 230 of the flow restriction device 210, the second connector 330 of the flow restriction device 310 may include a proximal end 336, a distal end 338, and a support portion 360 disposed between the proximal end 336 and the distal end 338. The support portion 360 may have a proximal end 361 and a distal end 362, and may include a central mounting opening 366 extending from the proximal end 261 to the distal end 262. However, in contrast to the support portion 260 of the second connector 230 of the flow restriction device 210, the support portion 360 of the second connector 330 of the flow restriction device 310 may not include a plurality of flow paths disposed radially outside the central mounting opening 366 and surrounding the central mounting opening 366.

[0065] According to some embodiments, the flow restriction device 310 may further include a cannula 340 attached to the lumen 334 of the second connector 330. In particular, the cannula 340 may have a proximal end 343, a distal end 345, and a lumen 342 extending therethrough. As shown, the proximal end 343 of the cannula 340 may be attached to the central mounting opening 366 to fluidly connect the cannula 340 to the fluid collection device 40. The cannula 340 may extend from the lumen 334 of the second connector 330 into the first connector 212. The cannula 340 may have a proximal end 343, a distal end 345, and a lumen 342 extending therethrough.

[0066] The lumen 342 of the cannula 340 may define a first flow path or microchannel along which fluid may flow from the distal end 216 of the first connector 212 into the fluid collection device 40. As shown, the cannula 340 may be attached to the central mounting opening 266 of the second connector support portion 260 to place the cannula 340 in fluid communication with the catheter assembly 50. For example, in some embodiments, the leg 72 of the Y - adapter 70 may be coupled to the flow restrictor 310. For example, the leg 72 of the Y - adapter 70 may include a lumen into which the distal end 216 of the first connector 212, within which the cannula 340 is disposed, may be coupled. The Y - adapter 70 may place the flow restrictor 310 and the cannula 340 attached thereto in fluid communication with the catheter assembly 50, for example, via an extension tube 60. Thus, the lumen 342 of the cannula 340 may define a linear fluid path having a reduced, small, or micro - sized diameter (as described below) through which fluid entering the flow restrictor 310 from the catheter assembly may flow through the flow restrictor 310 for collection in the fluid collection device 40. For example, when blood is being withdrawn or collected from a patient, the medical fluid 15 may be blood and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a luer lock access device (LLAD). Thus, during blood collection or withdrawal from a patient, the blood sample 15 may flow from the distal end 216 of the first connector 212 into the LLAD 40 via the first flow path or microchannel.

[0067] In some embodiments, the cannula 340 may be an elongated, thin tube having a lumen with a small, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 342 of the cannula 340 defines a first flow path or microchannel along which fluid may flow from the distal end 216 into the fluid collection device 40 via the second connector 330. The cannula 340 can define a lumen 342 formed by any of length, diameter, and cross-sectional area, as described above with respect to the optimized fluid path.

[0068] The cannula 340 may be configured simultaneously with the cannula 140, although in some embodiments, the cannula 340 differs in that it may include a notch 345 along the length of the cannula 340 between the proximal end 343 and the distal end 345 of the cannula 340. In particular, the notch 345 may be disposed at a position corresponding to the distal end of the check valve 150. Thus, in the open state of the check valve 150, for example, during injection of fluid (e.g., IV fluid) from the proximal end 343 of the cannula, the notch 345 may fluidly connect the lumen 342 of the cannula 340 to the annulus 246. Thereby, at least a portion of the injected fluid may flow from the proximal end 343 of the cannula 340 through the notch 345 of the cannula 340 into the annulus 246.

[0069] In some embodiments, the cross-sectional area of the flow path of the annulus 246 may be larger than the cross-sectional area of the flow path of the lumen 342. For example, the cross-sectional area of the annulus 246 along a plane perpendicular to the central longitudinal axis X of the first connector 212 may be larger than the cross-sectional area of the lumen 342 along that plane. The cannula 140 can define a lumen 142 formed by any of length, diameter, and cross-sectional area, as described above with respect to the optimized fluid path. In some embodiments, the diameter of the lumen 342 of the cannula 340 may be smaller than the thickness of the lumen of the annulus 246.

[0070] The foregoing configuration can provide an increased flow resistance and a decreased blood flow rate within the flow resistance device 310 when the diameter or size of the microchannel fluid pathway defined by the lumen 342 of the cannula 340 is reduced or minimized, as contrasted with the case where blood flows into the blood collection device 40 through the annulus 246 of the second flow path. Thus, the risk of hemolysis during blood collection can be advantageously reduced. However, the larger size of the flow path cross-sectional area of the annulus 246 compared to the flow path cross-sectional area of the lumen 342 can provide the additional advantage of allowing an unrestricted, increased amount of IV fluid 17 to flow from the lumen and notch 345 through the second flow path to the patient, as compared to flowing through the reduced or minimized diameter or size of the microchannel fluid pathway defined by the lumen 342 of the cannula 340. Thus, the IV fluid 17 may flow toward the catheter assembly 50 in a second, unrestricted (less flow resistance) direction (proximal to distal), opposite to the first direction (distal to proximal) in which the blood sample 15 having blood cells flows.

[0071] FIG. 5A shows a perspective view of a flow restriction device 410 according to some embodiments of the present disclosure. FIG. 5B shows a perspective view of the flow restriction device 410 of FIG. 5A during blood collection, according to some embodiments of the present disclosure. FIG. 5C shows a perspective view of the flow restriction device 410 of FIG. 5A during infusion, according to some embodiments of the present disclosure. As shown in FIGS. 5A and 5B, and referring subsequently to FIGS. 1A and 1B, in some embodiments, the flow restriction device 410 may include a distal connector portion 412 configured to be coupled to the catheter assembly 50, and a proximal connector portion 430 extending in a proximal direction from the distal connector portion 412 and configured to be coupled to the fluid collection device 40. The distal connector portion 412 may include an inner surface 414 that defines a lumen 416 of the distal connector portion 412, and the proximal connector portion 430 may include an inner surface 432 that defines a lumen 434 that is fluidly connected to the lumen 416 of the distal connector portion 412. As shown, the flow restriction device 410 may further include a plug 444 disposed within the lumen 434 of the proximal connector portion 430.

[0072] According to various embodiments of the present disclosure, the plug 444 may include a head portion 442 and a body portion 448 extending proximally from the head portion 442. As shown, the head portion may include a slit 456, and the body portion 448 may include a plurality of threads 446 extending along the outer surface of the body portion 448. The plug 444 may further include an inner surface 452 that defines a lumen 454 of the plug 444. In some embodiments, the lumen 454 may define an internal flow path 455 through which fluid may flow from the proximal connector portion 430 through the distal connector portion and into the catheter assembly 50.

[0073] As shown, the inner surface 432 of the proximal connector portion 430 may surround, enclose, or otherwise encapsulate the outer surface of the body portion 448 to define a continuous non-linear channel 450 along the spacing between adjacent threads of the plurality of threads 446. In some embodiments, the continuous non-linear channel 450 may be in the form of a continuous groove having a coil shape formed concavely in the outer surface of the body portion 448. In some embodiments, the continuous non-linear channel 450 may form a coil shape, an S-shape, or another suitable non-linear wound shape. For example, the continuous non-linear channel 450 may have a coil shape (which may include a helical shape) or an S-shape formed concavely in the outer surface of the body portion 448. The foregoing configuration is advantageous in that the length of the fluid path defined by the continuous non-linear channel 450 through which the blood sample 15 flows can be increased compared to a linear channel by virtue of the helical continuous non-linear channel 450 being wound around the outer periphery of the body portion 448. When the medical fluid being withdrawn from the patient is blood, blood cells may be subject to shear stress as they flow from the catheter assembly 50 into the blood collection device 40. In some embodiments, the continuous non-linear channel 450 may promote an increased flow resistance within the vascular access system 100 to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15.

[0074] In addition, in some embodiments, the continuous non-linear channel 450 may have a first diameter D1, the lumen 454 of the plug 444 may have a second diameter D2, and the first diameter D1 may be smaller than the second diameter D2. The continuous non-linear channel 450 can be formed by any of the length, diameter, and cross-sectional area as described above for the optimized fluid path.

[0075] As a non-limiting example, in some embodiments, the first diameter D1 may be from about 0.508 mm (0.02 inches) to 0.762 mm (0.03 inches), in some instances from about 0.5588 mm (0.022 inches) to 0.7112 mm (0.028 inches), more typically from about 0.6096 mm (0.024 inches) to 0.6604 mm (0.026 inches), and in some embodiments about 0.635 mm (0.025 inches). Although listed with respect to a range, it will be understood that all ranges from the lowest of the lower limits to the highest of the higher limits, including all intermediate ranges or specific angles, are included within this complete range or any specifically listed range. However, various embodiments of the present disclosure are not limited to the foregoing configurations.

[0076] The foregoing configuration provides an increased flow resistance and a reduced blood flow rate within the flow resistance device 410 due to the minimized diameter or size of the fluid path defined by the continuous non-linear channel 450, such that the fluid path defined by the continuous non-linear channel 450, in contrast to the internal flow path 455 defined by the lumen 454 of the plug 444. Accordingly, the risk of hemolysis during blood collection can be advantageously reduced.

[0077] The above-described configuration in which the second diameter D2 is greater than the first diameter allows a greater, unrestricted amount of IV fluid 17 to flow through (i) the larger-diameter internal flow path 445 and (ii) the reverse fluid path (shown in FIG. 5C) defined by the continuous non-linear channel 450, as opposed to flowing only through the smaller (minimized) diameter fluid path defined by the continuous non-linear channel 450. Thus, the IV fluid 17 may flow in a second, unrestricted (less flow resistance) direction (proximal to distal), opposite to the first direction (distal to proximal) in which the blood sample 15 having blood cells flows.

[0078] During operation, during blood collection or withdrawal from the patient, blood 15 may flow from the patient's blood vessel through the extension tube 60 into the catheter assembly 50 and through the lumen 416 into the distal connector portion 412 of the flow restrictor device 410 due to the presence of the plug 444 in the lumen 434 of the proximal connector portion 430. The slit 456 in the head portion may be closed or normally closed such that movement of blood through the slit 456 is resisted. Blood 15 may be forced by the head portion 442 and the body portion 448 to flow around the outer surface of the plug 444 into the continuous non-linear channel 450 and out of the flow restrictor device 410 into the blood collection device 40. Thus, during blood collection or withdrawal from the patient, blood 15 may flow into the blood collection device 40 through the continuous non-linear channel 450 having a minimum diameter.

[0079] The flow restriction device 410 of the various embodiments described herein is advantageous over existing blood collection systems. For example, during collection by an existing blood withdrawal device, blood cells can be subject to shear stress as they flow from the distal end to the proximal end of the blood collection system. The maximum shear stress can be along the wall of the blood cell and is often referred to as wall shear stress. Wall shear stress in blood cells is thought to be a major cause of mechanical damage to blood cells and results in hemolysis of the blood cells. In some embodiments, the continuous non-linear channel 450 having a minimum diameter can promote an increased flow resistance within the vascular access system 100 to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15. For example, the minimized diameter of the continuous non-linear channel 450 provides an increased resistance to the flow of the blood 15, thereby reducing the blood flow rate within the flow resistance device 410. The reduced blood flow rate results in a reduction of the shear stress experienced by the red blood cells of the blood 15, so that the risk of hemolysis during blood collection can advantageously be reduced.

[0080] FIG. 6A shows a perspective view of a flow restrictor 510 according to some embodiments of the present disclosure. FIG. 6B shows a cross-sectional view of the flow restrictor 510 of FIG. 6A according to some embodiments of the present disclosure. FIG. 6C shows an enlarged perspective view of the proximal connector 530 of the flow restrictor of FIG. 6A according to some embodiments of the present disclosure. As shown in FIGS. 6A-6C and referring subsequently to FIGS. 1A and 1B, in some embodiments, the flow restrictor 510 may include a distal connector 512 configured to be coupled to a catheter assembly 50, and a proximal connector 530 coupled to the distal connector 512 and configured to be coupled to a fluid collection device 40. Thus, during fluid extraction (e.g., blood collection), fluid may flow from the catheter assembly 50 into the flow restrictor 510 (e.g., through an extension tube 60) and out of the flow restrictor 510 into the blood collection device 40. In some embodiments, the distal connector 512 may include a first connection portion 514 at the proximal end of the distal connector 512 and a second connection portion 516 at the distal end of the distal connector 512. As shown, the first connection portion 514 may be in the form of a cylindrical body having an inner surface 515 that defines a lumen 520 of the distal connector 512. The lumen may be configured such that at least a portion of the proximal connector 530 can be inserted, fitted, or otherwise coupled therein to fluidly couple the distal connector 512 and the proximal connector 530. For example, in some embodiments, the proximal connector 530 may include an insertion portion 534 for insertion into the lumen 520 of the first connection portion 514. As shown, the outer surface of the insertion portion 534 may include a continuous non-linear channel 536 formed in a concave shape on the outer surface. In the coupled or assembled state of the distal connector 512 and the proximal connector 530, the inner surface 515 of the first connection portion 514 may surround, enclose, or otherwise encapsulate the outer surface of the insertion portion 534 such that the continuous non-linear channel 536 and the inner surface 515 of the first connection portion 514 define a non-linear fluid path through which fluid (e.g., blood) can flow from the distal connector 512 through the proximal connector 530 into the fluid collection device 40.

[0081] In some embodiments, the continuous non-linear channel 536 may form a coil shape, an S shape, or another suitable non-linear wound shape. For example, the continuous non-linear channel 536 may have a coil shape (which may include a helical shape) formed in a concave shape on the outer surface of the insertion portion 534. In some embodiments, the continuous non-linear channel 536 may have an S shape formed in a concave shape on the outer surface of the insertion portion 534. The foregoing configuration is advantageous in that the helical, coil, S-shaped, or otherwise suitable non-linear wound shape of the continuous non-linear channel 536 is wound around the periphery of the outer surface of the insertion portion 534, increasing the length of the fluid path defined by the continuous non-linear channel 536 through which the blood sample flows.

[0082] When the medical fluid is blood that is being withdrawn or collected from a patient, the medical fluid may be a blood sample, and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a luer lock access device (LLAD). When the medical fluid is blood being withdrawn from a patient, blood cells may be subject to shear stress as they flow from the distal connector 512 to the proximal connector 530 of the flow restriction device 510. For example, the maximum shear stress may be along the wall of the blood cell. Wall shear stress in blood cells is thought to be a major cause of mechanical damage to blood cells, resulting in hemolysis of the blood cells. In some embodiments, the insertion portion 534 having the continuous non-linear channel 536 may promote an increased flow resistance within the vascular access system 100 to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15.

[0083] According to various embodiments of the present disclosure, the insertion portion 534 may further include an inner surface 540 that defines a lumen 542 of the insertion portion 534. As shown in FIG. 6B and continuing to refer to FIG. 1C, the lumen 542 may form an internal flow path through which fluid 17 can flow from the proximal connector 530 into the catheter assembly 50, for example, through the distal connector 512 and the extension tube 60. In some embodiments, the fluid flowing from the proximal connector 530 through the distal connector 512 into the catheter assembly 50 may be an IV fluid. In some embodiments, the internal flow path through which the fluid flows from the proximal connector 530 through the distal connector 512 into the catheter assembly 50 may be a linear flow path.

[0084] According to some embodiments of the present disclosure, the flow restriction device 510 may further include a check valve 550 disposed in the lumen 542 of the insertion portion 534. For example, the check valve 550 may be disposed at the proximal end of the insertion portion 534. The check valve may selectively couple the fluid collection device 40 to the lumen 542 of the insertion portion 534 having the distal connector 512. For example, the check valve 550 may be a normally closed valve, whereby the check valve 550 may prevent fluid 15 (e.g., blood) from flowing from the distal connector 512 through the lumen 542 of the insertion portion 534 into the proximal connector 530. However, the check valve 550 may have a configuration to allow fluid 17 (e.g., IV fluid) to flow from the proximal connector 530 through the lumen 542 of the insertion portion 534 to the distal connector 512. For example, in some embodiments, the check valve 550 may be a normally closed check valve having a slit configured to open when receiving fluid pressure in the proximal-to-distal direction. Thus, when fluid (e.g., IV fluid) is injected into the flow restriction device 510, the slit may open and allow the fluid to flow from the proximal connector 530 into the distal connector 512 and ultimately into the catheter assembly 50. When fluid (e.g., blood) is being withdrawn from the catheter assembly 50 into the fluid collection device 40, the normally closed slit may remain closed, thereby preventing fluid flowing from the distal connector 512 to the proximal connector 530 from entering the fluid collection device 40 through the lumen 542 of the insertion portion 534. Thus, the blood sample 34, including blood cells, may be forced to flow through a curved or helical continuous non-linear channel 536 to reach the blood collection device 40, whereas the IV fluid 17 may flow to the catheter assembly 50 taking the internal flow path defined by the lumen 542.

[0085] In some embodiments, the continuous non-linear channel 536 may have a first diameter D3, the lumen 542 of the insertion portion 534 may have a second diameter D4, and the first diameter D3 may be smaller than the second diameter D4. The continuous non-linear channel 536 can be formed by any of the length, diameter, and cross-sectional area as described above with respect to the optimized fluid path.

[0086] As a non-limiting example, in some embodiments, the first diameter D3 may be from about 0.508 mm (0.02 inches) to 0.762 mm (0.03 inches), in some examples from about 0.5588 mm (0.022 inches) to 0.7112 mm (0.028 inches), more typically from about 0.6096 mm (0.024 inches) to 0.6604 mm (0.026 inches), and in some embodiments about 0.635 mm (0.025 inches). Although listed with respect to a range, it will be understood that all ranges from the lowest of the lower limits to the highest of the higher limits, including all intermediate ranges or specific angles, are included within this complete range or any specifically listed range. However, various embodiments of the present disclosure are not limited to the foregoing configurations.

[0087] The foregoing configuration provides an increased flow resistance and a reduced blood flow rate within the flow resistance device 510 due to the minimized diameter or size of the fluid path defined by the continuous non-linear channel 536, such that the fluid path defined by the continuous non-linear channel 536, in contrast to the internal flow path defined by the lumen 542 of the insertion portion 534. Accordingly, the risk of hemolysis during blood collection can be advantageously reduced.

[0088] The above-described configuration in which the second diameter D4 is larger than the first diameter D3 is further advantageous in that it allows a greater, unrestricted amount of IV fluid 17 to flow to the patient through the larger-diameter internal flow path defined by the lumen 542, as opposed to flowing only through the smaller (minimized) diameter fluid path defined by the continuous non-linear channel 536. Thus, the IV fluid 17 may flow in a second, unrestricted (less flow resistance) direction (proximal to distal), opposite to the first direction (distal to proximal) in which the blood sample 15 having blood cells flows.

[0089] During operation, during blood collection or withdrawal from a patient, blood 15 may flow from the patient's blood vessel through the extension tube 60 into the catheter assembly 50 and enter the distal connector 512 of the flow restriction device 510 through the lumen 519 of the distal connector 512. Due to the presence of the check valve 550 in the lumen 542 of the insertion portion 534, blood 15 may flow around the outer surface of the insertion portion 534 and into the continuous non-linear channel 536 and be forced out of the flow restriction device 510 into the blood collection device 40. Thus, during blood collection or withdrawal from a patient, blood 15 may flow into the blood collection device 40 through a continuous non-linear channel 536 having a minimum diameter. The flow restriction devices 510 of the various embodiments described herein are advantageous over existing blood collection systems. For example, during sampling by existing blood withdrawal devices, blood cells can be subject to shear stress as they flow from the distal end to the proximal end of the blood collection system. The maximum shear stress can be along the walls of the blood cells and is often referred to as wall shear stress. Wall shear stress in blood cells is thought to be a major cause of mechanical damage to blood cells and results in hemolysis of the blood cells. In some embodiments, the continuous non-linear channel 536 having a minimum diameter can promote increased flow resistance within the vascular access system 100 to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of blood 15. For example, the minimized diameter of the continuous non-linear channel 536 provides increased resistance to the flow of blood 15, which can thereby reduce the blood flow rate within the flow resistance device 510. The reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of blood 15, so the risk of hemolysis during blood collection can advantageously be reduced.

[0090] FIG. 7A shows a perspective view of a flow restrictor according to some embodiments of the present disclosure. FIG. 7B shows a cross-sectional view of the flow restrictor of FIG. 7A according to some embodiments of the present disclosure. As shown in FIGS. 7A and 7B and referring subsequently to FIGS. 1A and 1B, the flow restrictor 610 may include a first connector 630 having a female luer portion 632 at the proximal end, a male luer portion 634 at the distal end, an inner surface 636 defining an inner lumen 638 of the first connector 630, and a compressible valve member 640 attached to the inner lumen 638. The first connector 630 may be configured to be coupled to a fluid collection device 40 (shown in FIGS. 1A and 1B). For example, in some embodiments, the first connector 630 may be a needleless connector including a female luer portion 632 at the proximal end, a male luer portion 634 at the distal end, and a compressible valve member 640 attached to the first connector and extending longitudinally within the inner lumen 638 of the needleless connector. In some embodiments, the compressible valve member 640 may include a head portion 642 having a slot, slit, or other similar form of cut 650 at the proximal end of the head portion 642, and a body portion 644 extending distally from the head portion 642. The body portion 644 may be configured to elastically compress and expand based on the application and removal of an axial force. For example, in some embodiments, the body portion 644 may have an accordion or spring shape. The head portion 642 may be in the form of a split septum. For example, as shown, the proximal end of the head portion 642 may include a slot, slit, or other similar form of cut 650. In some embodiments, the valve member 640 may include an inner surface 646 defining an internal chamber 648 of the valve member 640.

[0091] According to various embodiments of the present disclosure, the flow restrictor 610 may further include a second connector 612 configured to be coupled to the male luer portion 634 of the first connector 630 and to be coupled to the catheter assembly 50. As shown, the second connector 612 may have an inner surface 614 that defines an inner lumen 616 of the second connector 612. In some embodiments, the second connector 612 may further include a support portion 660 that extends radially inward from the inner surface 614 of the second connector 612 into the inner lumen 616. The support portion 660 may include an attachment opening 662.

[0092] In some embodiments, the cannula 620 may be attached to the inner lumen 616 of the second connector 612. In particular, the cannula 620 may be attached to the attachment opening 662 to fluidly communicate the second connector 612 with the fluid collection device 40. As shown, the cannula 620 may extend from the inner lumen 616 through the male luer portion 634 of the first connector and into the female luer portion 632 of the first connector 630. In some embodiments, a compressible valve member 640 may be attached to surround at least a portion of the cannula 620. For example, in some embodiments, the proximal portion of the cannula 620 may extend into the internal chamber 648 of the valve member 640. In particular, in some embodiments, the proximal portion of the cannula 620 may extend into the head portion 642 of the compressible valve member 640. In some embodiments, the cannula 620 may be press-fit into the support portion 660. However, various embodiments of the present disclosure are not limited to the foregoing configurations. In some embodiments, the cannula 620 may be retained, attached, or otherwise coupled by any other suitable joining means.

[0093] In some embodiments, the cannula 620 may have a proximal end 623, a distal end 625, and a lumen 622 extending therethrough. The cannula 620 may extend from the lumen 616 of the second connector 612 into an internal chamber 648 of a compressible valve member 640 disposed within the inner lumen 638 of the first connector 630. The lumen 622 of the cannula 620 may define a flow path or microchannel along which fluid may flow from the second connector 612 into the fluid collection device 40. As shown, the cannula 620 may be attached to an attachment opening 662 of the second connector support portion 660 to fluidly couple the blood collection device 40 with the catheter assembly 50. For example, in some embodiments, the leg 72 of the Y - adapter 70 may be coupled to the flow restrictor 610. The leg 72 of the Y - adapter 70 may include a lumen into which the distal end 615 of the second connector 612 to which the cannula 620 is attached may be coupled. The Y - adapter 70 may fluidly communicate the flow restrictor 610 and the cannula 620 attached thereto with the catheter assembly 50, for example, via an extension tube 60. Thus, the lumen 622 of the cannula 620 may define a linear fluid path having a reduced, small, or micro - sized diameter (as described below) through which fluid entering the flow restrictor 610 from the catheter assembly may flow through the flow restrictor 610 for collection in the fluid collection device 40. For example, when blood is being withdrawn or collected from a patient, the medical fluid 15 may be blood and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a luer - lock access device (LLAD). Thus, during blood collection or withdrawal from a patient, the blood sample 15 may flow from the distal end 615 of the second connector 612 into the LLAD 40 through the flow path or microchannel defined by the lumen 622.

[0094] In some embodiments, cannula 620 may be an elongated, thin tube having a lumen with a small, reduced, or micro-sized diameter. For example, in some embodiments, lumen 622 of cannula 620 defines a first flow path or microchannel along which fluid may flow from distal end 615 through cannula 620 and into fluid collection device 40. Cannula 620 can define lumen 622 formed by any of length, diameter, and cross-sectional area, as described above with respect to the optimized fluid path.

[0095] To withdraw fluid (e.g., blood) from catheter assembly 50, fluid collection device 40 may be inserted into and coupled to female luer portion 632 of first connector 630. In the coupled state of first connector 630 and fluid collection device 40, compressible valve member 640 may be compressed distally by fluid collection device 40 to place proximal end 623 of cannula 620 in fluid communication with fluid collection device 40. For example, when the male luer portion of blood collection device 40 is inserted into female luer portion 632 of first connector 630, the male luer portion of blood collection device 40 may move head portion 642 of valve member 640 and compress valve member 640 distally. When the head portion is moved distally, proximal end 623 of cannula 620 may be exposed outside of valve member 640 through slot 650. Proximal end 623 of cannula 620 may thereby be fluidly coupled to the male luer portion of blood collection device 40 through the slot of the compressible valve member.

[0096] During operation, during blood collection or withdrawal from the patient, blood 15 may flow from the patient's blood vessel through the extension tube 60 into the catheter assembly 50 and enter the distal end 615 of the second connector 612. Due to the presence of the cannula 620 in the lumen 616 of the second connector, blood 15 may be forced to flow into and through the flow path and microchannels defined by the lumen 622 and out of the flow rate limiting device 610 into the blood collection device 40. Thus, during blood collection or withdrawal from the patient, blood 15 may flow into the blood collection device 40 through a flow path or microchannel defined by the lumen 622 having a minimum diameter. The flow rate limiting devices 610 of the various embodiments described herein are advantageous over existing blood collection systems. For example, during aspiration by an existing blood withdrawal device, blood cells may be subject to shear stress as they flow from the distal end to the proximal end of the blood collection system. The maximum shear stress can be along the wall of the blood cell and is often referred to as wall shear stress. Wall shear stress in blood cells is thought to be a major cause of mechanical damage to blood cells and results in hemolysis of the blood cells. In some embodiments, the continuous flow path or microchannel defined by the lumen 622 having a minimum diameter can promote increased flow resistance within the vascular access system 100 to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of blood 15. For example, the minimized diameter of the flow path or microchannel defined by the lumen 622 provides increased resistance to the flow of blood 15, thereby reducing the blood flow rate within the flow resistance device 610. The reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of blood 15, so the risk of hemolysis during blood collection can advantageously be reduced.

[0097] FIG. 8A shows a perspective view of a flow restrictor 710 according to some embodiments of the present disclosure. FIG. 8B shows a cross-sectional view of the first and second connectors 730 and 712 of the flow restrictor of FIG. 8A according to some embodiments of the present disclosure. FIG. 8C shows a cross-sectional view of the flow restrictor 710 of FIG. 8A according to some embodiments of the present disclosure. As shown in FIGS. 8A and 8B and referring subsequently to FIGS. 1A and 1B, the flow restrictor 710 may include a first connector 730 having a female luer portion 732 at the proximal end, a male luer portion 734 at the distal end, an inner surface 736 defining an inner lumen 738 of the first connector 730, and a compressible valve member 740 attached to the inner lumen 738. The first connector 730 may be configured to be coupled to a fluid collection device 40 (shown in FIGS. 1A and 1B). For example, in some embodiments, the first connector 730 may be a needleless connector including a female luer portion 732 at the proximal end, a male luer portion 734 at the distal end, and a compressible valve member 740 attached to the first connector 730 and extending longitudinally within the inner lumen 738 of the needleless connector. In some embodiments, the compressible valve member 740 may include a head portion 742 having a slot, slit, or other similar form of cut 750 at the proximal end of the head portion 742, and a body portion 744 extending distally from the head portion 742. The body portion 744 may be configured to elastically compress and expand based on the application and removal of an axial force. For example, in some embodiments, the body portion 744 may have an accordion or spring shape. The head portion 742 may be in the form of a split septum. For example, as shown, the proximal end of the head portion 742 may include a slot, slit, or other similar form of cut 750. In some embodiments, the valve member 740 may include an inner surface 746 defining an internal chamber 748 of the valve member 740.

[0098] According to various embodiments of the present disclosure, the flow restriction device 710 may further include a second connector 712 configured to be coupled to the male luer portion 734 of the first connector 730 and to be coupled to the catheter assembly 50. As shown, the second connector 712 may have an inner surface 714 that defines an inner lumen 716 of the second connector 712. In some embodiments, the second connector 712 may further include a support portion 760 that extends proximally from the proximal end of the male luer portion 734 of the second connector 712 into the inner lumen 716 of the female luer portion 732 of the second connector 712.

[0099] In some embodiments, the post 720 may be attached to the inner lumen 716 of the second connector 712. In particular, the post 720 may be attached to or cover the support portion 760 to fluidly connect the second connector 712 to the fluid collection device 40. As shown, the post 720 may extend from the inner lumen 716 through the male luer portion 734 of the first connector into the female luer portion 732 of the first connector 730. In some embodiments, the compressible valve member 740 may be attached surrounding at least a portion of the post 720. For example, in some embodiments, the proximal portion of the post 720 may extend into the internal chamber 748 of the valve member 740. In particular, in some embodiments, the proximal portion of the post 720 may extend into the head portion 742 of the compressible valve member 740. In some embodiments, the post 720 may be press-fitted into the support portion 760. However, various embodiments of the present disclosure are not limited to the foregoing configurations. In some embodiments, the post 720 may be fastened, attached, or otherwise coupled to the support portion 760 by any other suitable joining means.

[0100] In some embodiments, the post 720 may be in the form of an elongated tube having a proximal end 723, a distal end 725, and a lumen 722 extending therethrough. In some embodiments, the post 720 may have a shape that tapers from the distal end 725 to the proximal end 723 of the post 720. Thus, the shape or profile of the lumen 722 may also taper from the distal end 725 to the proximal end 723 of the post 720. As shown, the post 720 may extend into an internal chamber 748 of a compressible valve member 740 disposed within an inner lumen 738 of the first connector 730 from a lumen 716 of the second connector 712. The lumen 722 of the post 720 may define a flow path or microchannel along which fluid may flow from the second connector 712 into the fluid collection device 40. As illustrated, the post 720 may be attached to an attachment opening 762 of the second connector support portion 760 to fluidly couple the blood collection device 40 with the catheter assembly 50. For example, in some embodiments, the leg 72 of the Y - adapter 70 may be coupled to a flow restrictor 710. The leg 72 of the Y - adapter 70 may include a lumen into which the distal end 715 of the second connector 712 to which the post 720 is attached may be coupled. The Y - adapter 70 may fluidly communicate the flow restrictor 710 and the post 720 attached thereto with the catheter assembly 50, for example, via an extension tube 60. Thus, the lumen 722 of the post 720 may define a linear fluid path having a reduced, small, or micro - sized diameter (as described later) through which fluid entering the flow restrictor 710 from the catheter assembly 50 may flow through the flow restrictor 710 for collection in the fluid collection device 40. For example, when blood is being withdrawn or collected from a patient, the medical fluid 15 may be blood and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device 40 may be a luer lock access device (LLAD).Thus, during blood collection or withdrawal from a patient, the blood sample 15 may flow from the distal end 715 of the second connector 712 into the LLAD 40 through a flow path or microchannel defined by the lumen 722.

[0101] As described above, the post 720 may be an elongated, thin tube having a lumen 722 with a small, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 722 of the post 720 defines a flow path or microchannel along which fluid may flow from the distal end 715 through the post 720 into the fluid collection device 40. The post 720 can define a lumen 722 formed by any of length, diameter, and cross-sectional area, as described above with respect to the optimized fluid path.

[0102] To withdraw fluid (e.g., blood) from the catheter assembly 50, the fluid collection device 40 may be inserted into and coupled to the female Luer portion 732 of the first connector 730. In the coupled state of the first connector 730 and the fluid collection device 40, the compressible valve member 740 may be compressed distally by the fluid collection device 40 to fluidly communicate the proximal end 723 of the post 720 with the fluid collection device 40. For example, when the male Luer portion of the blood collection device 40 is inserted into the female Luer portion 732 of the first connector 730, the male Luer portion of the blood collection device 40 may move the head portion 742 of the valve member 740 and compress the valve member 740 distally. When the head portion 642 is moved distally, the proximal end 723 of the post 720 may be exposed outside the valve member 740 through the slot 750. The proximal end 723 of the post 720 may thereby be fluidly coupled to the male Luer portion of the blood collection device 40 through the slot 750 of the compressible valve member 740.

[0103] During operation, during blood collection or withdrawal from a patient, blood 15 may flow from the patient's blood vessel through the extension tube 60 into the catheter assembly 50 and enter the distal end 715 of the second connector 712. Due to the presence of the post 720 in the lumen 716 of the second connector, blood 15 may be forced to flow into and through the flow path and microchannels defined by the lumen 722 and out of the flow rate limiting device 710 into the blood collection device 40. Thus, during blood collection or withdrawal from a patient, blood 15 may flow into the blood collection device 40 through a flow path or microchannel defined by the lumen 722 having a minimum diameter. The flow rate limiting devices 710 of the various embodiments described herein are advantageous over existing blood collection systems. For example, during collection by an existing blood withdrawal device, blood cells may be subject to shear stress as they flow from the distal end to the proximal end of the blood collection system. The maximum shear stress can be along the walls of the blood cells and is often referred to as wall shear stress. Wall shear stress in blood cells is thought to be a major cause of mechanical damage to blood cells and results in hemolysis of the blood cells. In some embodiments, the continuous flow path or microchannel defined by the lumen 722 having a minimum diameter may promote increased flow resistance within the vascular access system 100 to dissipate the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15. For example, the minimized diameter of the flow path or microchannel defined by the lumen 722 provides increased resistance to the flow of blood 15, thereby reducing the blood flow rate within the flow resistance device 710. The reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of the blood 15, so the risk of hemolysis during blood collection can be advantageously reduced.

[0104] FIG. 9A shows an exploded view of a vascular access device including a flow restriction device and a fluid collection device in a peripheral intravenous catheter (PIVC) assembly according to some embodiments of the present disclosure. FIG. 9B is an operational view of a vascular access device including a flow restriction device and a fluid collection device in a peripheral intravenous catheter (PIVC) assembly according to some embodiments of the present disclosure. FIG. 9C is an operational view of a vascular access device including a flow restriction device and a needleless connector in a peripheral intravenous catheter (PIVC) assembly according to some embodiments of the present disclosure. Referring now to FIGS. 9A - 9C, a flow restriction device 1000 according to some embodiments is shown. The flow restriction device 1000 may be configured to reduce the likelihood of hemolysis during blood collection using the vascular access device 200. In some embodiments, the vascular access device 200 may include a catheter assembly (e.g., a PIVC) 50. In some embodiments, the flow restriction device 1000 may include a distal end, which may include a body or a distal connector configured to be coupled to the catheter assembly 50. The distal connector may include a male luer connector, or another suitable connector.

[0105] In some embodiments, the catheter assembly 50 may include a distal end 54, a proximal end 56, and a catheter hub 52 that may include a lumen extending through the distal and proximal ends. The catheter assembly 50 may further include a catheter 58 that can be fixed within the catheter hub 52 and extend distally from the distal end 54 of the catheter hub 52. In some embodiments, the catheter may be a peripheral intravenous catheter (PIVC).

[0106] In some embodiments, the catheter assembly 50 may comprise any suitable catheter assembly 50 or correspond to any suitable catheter assembly 50. In some embodiments, the catheter assembly 50 may be integrated and can include an extension tube 60 that extends from and may be integrated with a side port 59 of the catheter hub 52. 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 60 may be coupled to an adapter 70, such as a Y-adapter or a single port luer adapter. In some embodiments, the distal connector of the flow restriction device 1000 may be configured to be coupled to the Y-adapter 70.

[0107] In some embodiments, the catheter assembly 50 may be in a non-integrated form and may not include an extension tube 60. In these and other embodiments, the flow restriction device 1000 may be configured to be coupled to the proximal end 56 of the catheter hub 52 or to another suitable portion of the catheter assembly 50. In some embodiments, the catheter assembly 50 may be coupled to a removable extension tube 60. In some embodiments, the flow restriction device 1000 may be coupled directly to a catheter adapter, thereby omitting the extension tube and providing a compact catheter system.

[0108] FIG. 10A shows a perspective view of a flow restrictor device 1100 according to some embodiments of the present disclosure. FIG. 10B shows a cross-sectional view of the flow restrictor device 1100 of FIG. 10A according to some embodiments of the present disclosure. As shown in FIG. 10A and referring subsequently to FIGS. 9A and 9B, in some embodiments, the flow restrictor device 1100 may include a male Luer connector portion 1112 configured to be coupled to a catheter assembly 50. The male Luer connector portion 1112 may have a proximal end 1114, a distal end 1116, and an inner surface 1118 that defines an inner lumen 1120 of the male Luer connector 1112. As shown, the male Luer connector portion 1112 may further include a support portion 1160 disposed between the proximal end 1114 and the distal end 1116. The support portion 1160 may include a mounting aperture 1165 that extends therethrough.

[0109] In some embodiments, the flow restrictor device 1100 may further include a female Luer connector portion 1130 coupled to the proximal end 1114 of the male Luer connector portion 1112. The female Luer connector portion 1130 may be configured to be coupled to a fluid collection device 40 (e.g., a blood collection device). For example, the female Luer connector portion 1130 may be integrated with the blood collection device 40, or may be integrally formed with the blood collection device 40 as a single unit. As another example, the female Luer connector portion 1130 may be in the form of a female Luer connector or another suitable connector that can be coupled to the male Luer portion of the blood collection device 40. The female Luer connector portion 1130 may have a proximal end 1131, a distal end 1133, and an inner surface 1132 that defines a lumen 1134 that extends therethrough for coupling to the male Luer portion of the blood collection device 40. As shown, the female Luer connector portion 1130 may further include a support portion 1162 disposed between the proximal end 1131 and the distal end 1133. The support portion 1162 may include a mounting aperture 1167 that extends therethrough.

[0110] According to various embodiments of the present disclosure, the flow restriction device 1110 may further include a tube 1140 attached to at least one of the lumens 1120 and 1134 of the male luer connector portion 1112 and the female luer connector portion 1130. For example, in some embodiments, the tube 1140 may be attached to at least one of the support portions 1160 and 1162. As shown, the tube 1140 may be attached to or otherwise supported by both of the support portions 1160 and 1162 and may extend from the support portion 1160 of the male luer connector portion 1112 into the female luer connector portion 1130. The tube 1140 may have a proximal end 1143, a distal end 1145, and a lumen 1142 extending therethrough. The lumen 1142 may define a flow path or microchannel along which fluid may flow from the male luer connector portion 1112 through the female luer connector portion 1130 into the fluid collection device 40. As shown, the tube 1140 may fluidly couple the catheter assembly 50 to the fluid collection device 40 via the flow restriction device 1100. For example, in some embodiments, the leg 72 of the Y-adapter 70 may be coupled to the flow restriction device 1110. The leg 72 of the Y-adapter 70 may include a lumen into which the distal end 1116 of the male luer connector portion 1112 to which the tube 1140 is attached may be coupled. The Y-adapter 70 may fluidly couple the flow restriction device 1100 and the tube 1140 attached thereto to the catheter assembly 50 via, for example, an extension tube 60. Accordingly, the lumen 1142 of the tube 1140 may define a fluid path having a reduced, small, or micro-sized diameter (as described below) through which fluid entering the flow restriction device 1100 from the catheter assembly 50 may flow through the flow restriction device 1100 for collection in the fluid collection device 40. For example, when blood is being withdrawn or collected from a patient, the medical fluid 15 may be blood and the fluid collection device 40 may be a blood collection device.In some embodiments, the blood collection device may be a luer lock access device (LLAD). Thus, during blood collection or withdrawal from a patient, the blood sample 15 may flow from the distal end 1116 of the male luer connector portion 1112 through the flow path or microchannel defined by the lumen 1142 into the LLAD 40.

[0111] In some embodiments, the flow path or microchannel defined by the lumen 1142 may have a helical, coiled, S-shaped, or other suitable non-linear coiled shape. The foregoing configuration is advantageous in that the helical, coiled, S-shaped, or other suitable non-linear coiled shape of the flow path or microchannel defined by the lumen 1142 can increase the length of the fluid path defined by the flow path or microchannel defined by the lumen 1142 as compared to a linear microchannel due to its coiled nature.

[0112] When the medical fluid is blood being withdrawn or collected from a patient, the medical fluid may be a blood sample and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a luer lock access device (LLAD). When the medical fluid is blood being withdrawn from a patient, blood cells may be subject to wall shear stress as they flow from the male luer connector portion 1112 of the flow restriction device 1100 to the female luer connector portion 1130. Wall shear stress in blood cells is thought to be a major cause of mechanical damage to blood cells and results in hemolysis of the blood cells. In some embodiments, the flow restriction device 1110 having a non-linear coiled flow path or microchannel defined by the lumen 1142 may promote an increased flow resistance within the vascular access system 1100 to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15. In some embodiments, the tube 1140

[0113] In some embodiments, the tube 1140 may be a thin tube having a lumen with a small, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1142 of the tube 1140 defines a first flow path or microchannel along which fluid may flow from the male luer connector portion 1112 through the female luer connector portion 1130 and into the fluid collection device 40. The tube 1140 can define a lumen 1142 formed by any of length, diameter, and cross-sectional area as described above with respect to the optimized fluid path.

[0114] As described above, when the fluid 15 is blood withdrawn from a patient, blood cells can be subject to wall shear stress as they flow from the catheter assembly 50 into the blood collection device 40. For example, the maximum shear stress can be along the wall of the blood cells and is often referred to as wall shear stress. In some embodiments, the lumen 1142 of the tube 1140 having a reduced or micro-sized diameter can promote an increased flow resistance within the vascular access system 1100 to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15. The minimized diameter of the first fluid path or microchannel defined by the lumen 1142 of the tube 1140 provides an increased resistance to the flow of the blood 15, which can thereby reduce the blood flow rate within the flow resistance device 1110. The reduced blood flow rate results in a reduction of the shear stress experienced by the red blood cells of the blood 15, so the risk of hemolysis during blood collection can advantageously be reduced.

[0115] In some embodiments, at least a portion of the tube 1140 may be a linear tube 1146. For example, in some embodiments, the tube 1140 may include at least one linear portion 1146 at the proximal and distal ends of the tube 1140. As shown, the proximal end 1143 of the tube 1140 and the distal end 1145 of the tube 1140 may be formed from a linear tube 1146. The linear tube 1146 at the proximal end may be attached to the mounting opening 1167 of the support portion 1162, and the linear tube 1146 at the distal end may be attached to the mounting opening 1165 of the support portion 1160. In some embodiments, the linear portion 1146 of the tube 1140 may be in the form of a thin tube having a lumen with a small, reduced, or micro-sized diameter. In some embodiments, the lumen 1142 of the tube 1140 may have the same diameter in the linear portion 1146, such as the helical, coiled, S-shaped, or other suitable non-linear coiled-shaped flow path or microchannel described above. Either the tube 1140 or the linear portion 1146 can define a lumen formed by any of length, diameter, and cross-sectional area as described above with respect to the optimized fluid path.

[0116] As shown, a helical, coiled, S-shaped, or other suitable non-linear coiled-shaped flow path or microchannel may be disposed between the linear portions 1146 of the tube 1140. Thus, during fluid extraction, e.g., blood collection, the fluid withdrawn from the catheter assembly 50 may flow from the distal end 1116 of the male luer connector portion 1112 into the lumen of the micro-sized diameter of the distal linear portion 1146, through the helical, coiled, S-shaped, or other suitable non-linear coiled-shaped flow path or microchannel of the lumen 1142, and finally into the blood collection device 40 from the lumen of the micro-sized diameter of the proximal linear portion 1146.

[0117] FIG. 11A shows a perspective view of a flow restriction device 1200 according to some embodiments of the present disclosure. FIG. 11B shows a cross-sectional view of the flow restriction device 1200 of FIG. 11A according to some embodiments of the present disclosure. The flow restriction device 1200 may have a structure similar to that of the flow restriction device 1100, except that the flow restriction device 1200 may not include a female Luer connector portion 1130. Instead, as shown, the proximal end 1231 of the male Luer connector portion 1212 may be open and may include at least one thread 1230 on its outer surface for coupling to the blood collection device 40. Additionally, the flow restriction device 1200 may differ from the flow restriction device 1100 in that the tube 1240 may be a linear tube. For example, in some embodiments, the linear tube may be in the form of a cannula 1240 attached to the male Luer connector portion 1212. Thereby, the male Luer connector portion 1212 may further include a support portion 1260 that extends radially inwardly from the inner surface 1218 of the male Luer connector portion 1212 into the lumen 1220 of the male Luer connector portion 1212. As shown, the support portion 1260 may include a mounting opening 1262, and the cannula 1240 may be attached to the mounting opening 1262 to fluidly communicate the male Luer connector portion 1212 with the fluid collection device 40. In some embodiments, the cannula 1240 may be press-fitted into the support portion 1260. However, various embodiments of the present disclosure are not limited to the foregoing configurations, and the cannula may be attached by any other suitable fixing means such as welding.

[0118] In some embodiments, the cannula 1240 may be an elongated, thin tube having a lumen with a small, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1242 of the cannula 1240 may define a flow path or microchannel along which fluid may flow from the distal end 1216 into the fluid collection device 40. The cannula 1240 can define a lumen 1242 formed by any of length, diameter, and cross-sectional area, as described above with respect to the optimized fluid path.

[0119] Thus, during blood collection or withdrawal from a patient, the blood 15 may flow into the blood collection device 40 through a flow path or microchannel defined by the lumen 1242 having a minimum diameter. The flow rate limiting device 1210 of the various embodiments described herein is advantageous over existing blood collection systems. For example, during collection by an existing blood withdrawal device, blood cells can be subject to wall shear stress as they flow from the distal end to the proximal end of the blood collection system. Wall shear stress in blood cells is thought to be a major cause of mechanical damage to blood cells and results in hemolysis of the blood cells. The flow path or microchannel defined by the lumen 1242 having a minimum diameter can promote an increased flow resistance within the vascular access system to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15. For example, the minimized diameter of the flow path or microchannel defined by the lumen 1242 provides an increased resistance to the flow of the blood 15, which can thereby reduce the blood flow rate within the flow resistance device 1210. The reduced blood flow rate results in a reduction of the shear stress experienced by the red blood cells of the blood 15, so that the risk of hemolysis during blood collection can advantageously be reduced.

[0120] FIG. 12A shows a perspective view of a flow rate limiting device 1300 according to some embodiments of the present disclosure. FIG. 12B shows a perspective view of an insert 1350 of the flow rate limiting device of FIG. 12A according to some embodiments of the present disclosure. FIG. 12C shows a cross-sectional view of the flow rate limiting device 1300 of FIG. 12A according to some embodiments of the present disclosure.

[0121] As shown in FIGS. 12A - 12C, and continuing to refer to FIGS. 9A and 9B, in some embodiments, the flow restriction device 1300 may include a distal connector 1312 configured to be coupled to the catheter assembly 50. The distal connector 1312 may have a proximal end 1314 including a first connection portion 1315 and a distal end 1316 including a second connection portion 1317. The first connection portion 1315 may have an inner surface 1318 defining a through - lumen 1322, and the second connection portion 1317 may have an inner surface 1319 defining a through - lumen 1320. As shown, the distal connector 1312 may further include a support portion 1325 disposed between the proximal end 1314 and the distal end 1317. The support portion 1325 may include a mounting opening 1354 formed in a concave shape.

[0122] In some embodiments, the flow restriction device 1300 may further include a proximal connector 1330 coupled to the proximal end 1314 of the distal connector 1312. The proximal connector 1330 may be configured to be coupled to a fluid collection device 40 (e.g., a blood collection device). For example, the proximal connector 1330 may be integrated with the blood collection device 40, or may be integrally formed with the blood collection device 40 as a single unit. As another example, the proximal connector 1330 may be in the form of a female - type luer connector or another suitable connector that can be coupled to the male - type luer portion of the blood collection device 40. The proximal connector 1330 may have a proximal end 1331, a distal end 1333, and an inner surface 1332 defining a through - lumen 1334 that extends through for coupling to the male - type luer portion of the blood collection device 40.

[0123] According to various embodiments of the present disclosure, the flow restriction device 1300 may further include an insert 1350 attached to the lumen 1322 of the first connection portion 1315 and disposed between the proximal connector 1330 and the distal connector 1312. As shown, the insert 1350 may have an outer surface 1360 with a recessed groove 1364 formed therein. The groove 1364 may at least partially extend along the length of the outer surface 1360 and may be fluidly coupled to the lumen 1320 of the second connection portion 1317 and the lumen 1322 of the first connection portion 1315. In some embodiments, the groove 1364 may be a linear groove formed in the outer surface 1360 in a concave shape. For example, in some embodiments, the linear groove 1364 may be formed in a concave shape in the upper portion of the outer surface 1360.

[0124] Continuing to refer to FIG. 12B and as shown in FIG. 12C, the insert 1350 may include a first channel section 1372 fluidly coupled to the proximal end of the lumen 1320 of the second connection portion 1317 and a second channel section 1374 extending from the first channel section to the linear groove 1364. The first and second channel sections 1372 and 1374, together with the linear groove 1364, may define a flow path 1380 along which fluid flows from the distal connector 1312 through the proximal connector 1330 and into the fluid collection device 40. In some embodiments, the positions of the first channel section 1372 and the linear groove 1364 may be offset from each other. For example, as shown in FIG. 12C, in some embodiments, the first channel section 1372 may be disposed at a first height and the linear groove 1364 may be disposed at a second height. In some embodiments, the second height may be greater than the first height, i.e., the linear groove 1364 may be disposed above or higher than the first channel section 1372.

[0125] In some embodiments, the second channel section 1374 may be in the form of a ramp that connects or otherwise fluidly couples the first channel section 1372 to the linear groove 1364. For example, as shown, the second channel section 1374 may be disposed between the first channel section 1372 and the linear groove 1364 and may connect the first channel section 1372 to the linear groove 1364.

[0126] In some embodiments, the first connection portion 1315 may form an outer component for coupling to the insert 1350, and the insert 1350 may form an inner component having a flow path 1380 (defined by the first and second channel sections 1372 and 1374 and the linear groove 1364) that may be coupled to the lumen 1322 of the first connection portion 1315. Thus, the linear groove 1364 may be surrounded, enclosed, or otherwise encapsulated within the lumen of the first connection portion 1315. The linear groove 1364, when surrounded, inserted, or otherwise encapsulated within the lumen 1322 by the inner surface 1318 of the first connection portion 1315, may define a microchannel fluid path through which fluid (e.g., blood) flows from the second connection portion 1317 to the first connection portion 1315 for collection in the fluid collection device 40.

[0127] In some embodiments, the flow path or microchannel through which fluid may flow from the second connection portion 1317 to the first connection portion 1315 for collection in the fluid collection device 40 may be defined by any of length, diameter, and cross-sectional area as described above with respect to the optimized fluid path.

[0128] Thus, during blood collection or withdrawal from a patient, the blood 15 may flow into the blood collection device 40 through a flow path or microchannel defined by an enclosed groove 1364 having a minimum diameter. The flow rate limiting device 1300 of the various embodiments described herein is advantageous over existing blood collection systems. For example, during collection by an existing blood withdrawal device, blood cells may be subject to wall shear stress as they flow from the distal end to the proximal end of the blood collection system. As previously mentioned, wall shear stress in blood cells is thought to be a major cause of mechanical damage to blood cells and results in hemolysis of the blood cells. The flow path or microchannel defined by the enclosed groove 1364 having a minimum diameter may promote an increased flow resistance within the vascular access system to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15. For example, the minimized diameter of the flow path or microchannel defined by the enclosed groove 1364 provides an increased resistance to the flow of the blood 15, thereby reducing the blood flow rate within the flow resistance device 1210. The reduced blood flow rate results in a reduction of the shear stress experienced by the red blood cells of the blood 15, so that the risk of hemolysis during blood collection can be advantageously reduced.

[0129] According to various embodiments of the present disclosure, for example, as shown in FIG. 12B, the outer surface 1360 of the insert 1350 may include a longitudinally extending ledge 1362 that is disposed on the outer surface 1360 and at least partially extends along the length of the outer surface 1360. As shown, the ledge 1362 may be disposed at the edge opposite the linear groove 1364 to seal the edge. In some embodiments, the longitudinally extending ledge 1362 may partition the groove 1364 such that fluid flowing through the continuous channel or groove 1364 cannot escape from the continuous channel or groove 1364 except at the distal end 1354 and the proximal end 1352 of the groove 1364. In some embodiments, the longitudinally extending ledge 1362 may be a sealing element that may include silicon, rubber, plastic, or another suitable material. Thus, the longitudinally extending ledge 1362 may prevent fluid from escaping from the continuous channel or groove 1364 except at the distal end 1354 and the proximal end 1352 of the groove 1364.

[0130] According to various embodiments, the proximal end of the groove 1364 may be fluidly connected to the lumen 1334 of the proximal connector such that medical fluid is drawn into the fluid collection device 40 coupled to the proximal connector. Similarly, in some embodiments, the distal end 1354 of the groove 1364 may be fluidly connected to the lumen 1320 of the second connection portion 1317 to receive medical fluid from the catheter assembly 50. If the medical fluid is blood that is being withdrawn or collected from a patient, the medical fluid may be a blood sample and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a luer lock access device (LLAD).

[0131] FIG. 13A shows a perspective view of a flow rate limiting device according to some embodiments of the present disclosure. FIG. 13B shows a perspective view of the proximal connector of the flow rate limiting device of FIG. 13A according to some embodiments of the present disclosure. FIG. 13C shows a cross-sectional view of the flow rate limiting device of FIG. 13A according to some embodiments of the present disclosure.

[0132] As shown in FIGS. 13A - 13C, and continuing to refer to FIGS. 9A and 9B, in some embodiments, the flow restriction device 1400 may include a distal connector 1412 configured to be coupled to the catheter assembly 50, and a proximal connector 1430 coupled to the distal connector 1412 and configured to be coupled to the fluid collection device 40. Thus, during fluid extraction (e.g., blood collection), fluid may flow from the catheter assembly 50 into the flow restriction device 1400 (e.g., through the extension tube 60), and out of the flow restriction device 1400 into the blood collection device 40. In some embodiments, the distal connector 1412 may include a first connection portion 1434 at the proximal end of the distal connector 1412 and a second connection portion 1416 at the distal end of the distal connector 1412. As shown, the first connection portion 1434 may be in the form of a cylindrical body having an inner surface 1414 that defines the lumen 1418 of the distal connector 1412. The lumen 1418 may be configured such that at least a portion of the proximal connector 1430 can be inserted, fitted, or otherwise coupled therein to fluidly couple the distal connector 1412 and the proximal connector 1430. For example, in some embodiments, the proximal connector 1430 may include an insertion portion 1450 for insertion into the lumen 1418 of the first connection portion 1434. As shown, the outer surface 1420 of the insertion portion 1450 may include a continuous non - linear channel 1425 formed in a concave shape on the outer surface. In the coupled or assembled state of the distal connector 1412 and the proximal connector 1430, the inner surface 1414 of the first connection portion 1434 may surround, enclose, or otherwise encapsulate the outer surface 1420 of the insertion portion 1450 such that the continuous non - linear channel 1425 and the inner surface 1414 of the first connection portion 1434 define a non - linear fluid path through which fluid (e.g., blood) can flow from the distal connector 1412 through the proximal connector 1430 and into the fluid collection device 40.

[0133] In some embodiments, the continuous non-linear channel 1425 may form a coil shape, an S-shape, or another suitable non-linear wound shape. For example, the continuous non-linear channel 1425 may have a coil shape (which may include a helical shape) formed in a concave manner on the outer surface 1420 of the insertion portion 1450. In some embodiments, the continuous non-linear channel 1425 may have an S-shape formed in a concave manner on the outer surface 1420 of the insertion portion 1450. The foregoing configuration is advantageous in that the helical, coiled, S-shaped, or otherwise suitable non-linear wound shape of the continuous non-linear channel 1425 is wound around the outer surface 1420 of the insertion portion 1450, which can increase the length of the fluid path defined by the continuous non-linear channel 1425 through which the medical fluid flows.

[0134] In some embodiments, the continuous non-linear channel 1425 may have a small, reduced, or micro-sized diameter. For example, in some embodiments, the continuous non-linear channel 1425 defines a flow path or microchannel through which fluid can flow from the distal connector 1416 through the proximal connector 1430 and into the fluid collection device 40. The continuous non-linear channel 1425 can define a flow path or microchannel formed by any of the length, diameter, and cross-sectional area as described above with respect to the optimized fluid path.

[0135] As described above, when the fluid 15 is blood withdrawn from a patient, blood cells can be subjected to wall shear stress as they flow from the catheter assembly 50 into the blood collection device 40. For example, the maximum shear stress can be along the walls of the blood cells and is often referred to as wall shear stress. A continuous non-linear channel 1425 having a reduced or micro-sized diameter can promote an increased flow resistance within the vascular access system to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15. The minimized diameter of the continuous non-linear channel 1425 provides an increased resistance to the flow of the blood 15, thereby reducing the blood flow rate within the flow resistance device 1400. The reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of the blood 15, so that the risk of hemolysis during blood collection can advantageously be reduced. When the medical fluid is blood being withdrawn or collected from a patient, the medical fluid may be a blood sample and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a luer lock access device (LLAD).

[0136] FIG. 14A shows a perspective view of a flow restriction device, according to some embodiments of the present disclosure. FIG. 14B shows an exploded view of the flow restriction device of FIG. 14A, according to some embodiments of the present disclosure. As shown in FIGS. 14A and 14B, and continuing to refer to FIGS. 9A and 9B, in some embodiments, the flow restriction device 1500 may include a connector 1505 having a body portion 1510 with a lumen 1538 disposed at a proximal end and a base portion 1545 having a lumen 1518 disposed at a distal end. The body portion 1510 may be configured to be coupled to the fluid collection device 40. In some embodiments, the flow restriction device 1500 may further include a compressible valve member 1540 attached to the base portion 1545 and extending into the lumen 1538 of the body portion 1510. The compressible valve member 1540 may include an inner surface 1541 that defines an internal chamber 1543 of the compressible valve 1540. As shown, the compressible valve 1540 may have a head portion 1542 that includes a slot 1550 and a body portion 1544 that extends distally from the head portion 1542. In some embodiments, the body portion 1544 may have an accordion shape, or any other similar compressible or foldable shape. In some embodiments, the head portion 1542 having the slot 1550 may be a split septum head portion.

[0137] According to various embodiments of the present disclosure, the flow restrictor device 1500 may further include a post 1520 having a lumen 1522 that extends therethrough. The post 1520 may be attached to the lumen 1518 of the base portion and may extend into the internal chamber 1543 of the compressible valve member 1540. Thus, the compressible valve member 1540 may be attached surrounding the post 1520. The post 1520 may be configured to be in fluid communication with the catheter assembly 50. In some embodiments, the post 1520 may be press-fitted into the lumen 1518 of the base portion 1545. However, various embodiments of the present disclosure are not limited to the foregoing configuration. In some embodiments, the post 1520 may be fastened, attached, or otherwise coupled to the lumen 1518 of the base portion 1545 by any other suitable joining means.

[0138] In some embodiments, the post 1520 may be in the form of an elongated tube having a proximal end 1523, a distal end 1525, and a lumen 1522 extending therethrough. In some embodiments, the post 1520 may have a shape that tapers from the distal end 1525 to the proximal end 1523 of the post 1520. Thus, the shape or profile of the lumen 1522 may also taper from the distal end 1525 to the proximal end 1523 of the post 1520. As shown, the post 1520 may extend from the distal end 1523 into an internal chamber 1541 of a compressible valve member 1540 disposed within the inner lumen 1538 of the body portion 1510. The lumen 1522 of the post 720 may define a flow path or microchannel along which fluid may flow from the distal end 1525 into the fluid collection device 40. The post 1520 may be attached to a mounting opening of a support portion (not shown) of the base portion 1545 to fluidly couple the blood collection device 40 to the catheter assembly 50. For example, continuing to refer to FIGS. 9A and 9B, in some embodiments, the leg 72 of the Y - adapter 70 may be coupled to a flow rate limiting device 1500. The leg 72 of the Y - adapter 70 may include a lumen into which the distal end 1525 of the post 1520 may be coupled. The Y - adapter 70 may fluidly communicate a flow rate limiting device 1500 having the post 1520 with the catheter assembly 50, for example, via an extension tube 60. Thus, the lumen 1522 of the post 1520 may define a linear fluid path having a reduced, small, or micro - sized diameter (as described below) through which fluid entering the flow rate limiting device 1500 from the catheter assembly 50 may flow through the flow rate limiting device 1500 for collection in the fluid collection device 40. For example, when blood is being withdrawn or collected from a patient, the medical fluid 15 may be blood and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device 40 may be a luer - lock access device (LLAD) or a syringe.Thus, during blood collection or withdrawal from a patient, the blood sample 15 may flow from the distal end 1525 of the post 1520 into the LLAD 40 through a flow path or microchannel defined by the lumen 1522.

[0139] As described above, the post 1520 may be an elongated, thin tube having a lumen 1522 with a small, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1522 of the post 1520 that defines a flow path or microchannel through which fluid may flow from the distal end 1525 into the fluid collection device 40 may be formed by any of length, diameter, and cross-sectional area as described above with respect to the optimized fluid path.

[0140] To withdraw fluid (e.g., blood) from the catheter assembly 50, the fluid collection device 40 may be inserted into and coupled to the inlet 1534 of the body portion 1510. In the coupled state of the body portion 1510 and the fluid collection device 40, the compressible valve member 1540 may be compressed distally by the fluid collection device 40 to fluidly communicate the proximal end 1523 of the post 1520 with the fluid collection device 40. For example, when the male luer portion of the blood collection device 40 is inserted into the inlet 1534 of the body portion, the male luer portion of the blood collection device 40 may move or otherwise displace the head portion 1542 of the valve member 1540 and compress the valve member 1540 distally. When the head portion 1542 is displaced distally, the proximal end 1523 of the post 1520 may be exposed outside the valve member 1540 through the slot 1550. The proximal end 1523 of the post 1520 may thereby be fluidly coupled to the male luer portion of the blood collection device 40 through the slot 1550 of the compressible valve member 1540.

[0141] During operation, during blood collection or withdrawal from a patient, blood 15 may flow from the patient's blood vessel through the extension tube 60 into the catheter assembly 50 and enter the distal end 1525 of the post 1540. Due to the presence of the post 1520 in the lumen 1543 of the base 1545, blood 15 may be forced to flow into and through the flow path and microchannels defined by the lumen 1522 and out of the flow rate limiting device 1500 through the proximal end 1523 of the post 1520 into the blood collection device 40. Thus, during blood collection or withdrawal from a patient, blood 15 may flow into the blood collection device 40 through a flow path or microchannel defined by a lumen 1522 having a minimum diameter. The flow rate limiting device 1500 of the various embodiments described herein is advantageous over existing blood collection systems. For example, during collection by an existing blood withdrawal device, blood cells may be subjected to shear stress as they flow from the distal end to the proximal end of the blood collection system. The maximum shear stress can be along the wall of the blood cell and is often referred to as wall shear stress. Wall shear stress in blood cells is thought to be a major cause of mechanical damage to blood cells and causes hemolysis of blood cells. In some embodiments, the continuous flow path or microchannel defined by the lumen 1522 having a minimum diameter may promote an increased flow resistance within the vascular access system to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of blood 15. For example, the minimized diameter of the flow path or microchannel defined by the lumen 1522 provides an increased resistance to the flow of blood 15, which may thereby reduce the blood flow rate within the flow resistance device 1500. The reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of blood 15, so the risk of hemolysis during blood collection can be advantageously reduced.

[0142] FIG. 14C shows a cross-sectional view of a flow restriction device, according to some embodiments of the present disclosure. FIG. 14D shows a cross-sectional view of the flow restriction device when coupled to a fluid collection device, according to some embodiments of the present disclosure. As shown in FIGS. 14C and 14D, and referring subsequently to FIGS. 9A and 9B, in some embodiments, the flow restriction device 1503 may include a connector 1506 having a female luer portion 1532 with a lumen 1539 disposed at the proximal end and a male luer portion 1512 having a lumen 1519 disposed at the distal end. The female luer portion 1532 may be configured to couple to the fluid collection device 40, and the male luer portion 1512 may be configured to couple to the catheter assembly 50. In some embodiments, the flow restriction device 1503 may further include a compressible valve member 1540 attached to the lumen 1539 of the female luer portion 1532 and fluidly coupled to the lumen 1519 of the male luer portion 1545. The compressible valve member 1540 may include an inner surface 1541 that defines an internal chamber 1543 of the compressible valve member 1540. As shown, the compressible valve 1540 may have a head portion 1542 that includes a slot 1550 and a body portion 1544 that extends distally from the head portion 1542. In some embodiments, the body portion 1544 may have an accordion shape, or any other similar compressible or foldable shape. In some embodiments, the head portion 1542 having the slot 1550 may be a split septum head portion.

[0143] According to various embodiments of the present disclosure, the flow restriction device 1503 may further include a post 1520 that is attached to the female luer portion 1532 and extends into the internal chamber 1543 of the compressible valve member. Thus, the compressible valve member 1540 may be attached surrounding the post 1520. The post 1520 may be in fluid communication with the lumen 1519 of the male luer portion 1512, and the lumen 1519 may be in fluid communication with the catheter assembly 50. In some embodiments, the post 1520 may be press-fitted into the lumen 1539 of the female luer portion 1532. However, various embodiments of the present disclosure are not limited to the foregoing configurations. In some embodiments, the post 1520 may be retained, attached, or otherwise coupled to the lumen 1539 of the female luer portion 1532 by any other suitable joining means. In some embodiments, the female luer portion 1532 may further include a support portion 1546 at the distal end of the female luer portion 1532. The post 1520 may be attached to the support portion 1546 to fluidly communicate the lumen 1519 of the male luer portion 1512 with the fluid collection device 40.

[0144] In some embodiments, the post 1520 may be in the form of an elongated tube having a proximal end 1523, a distal end 1525, and a lumen 1522 extending therethrough. In some embodiments, the post 1520 may have a shape that tapers from the distal end 1525 to the proximal end 1523 of the post 1520. Thus, in some embodiments, the shape or profile of the lumen 1522 may also taper from the distal end 1525 to the proximal end 1523 of the post 1520. As shown, the post 1520 may extend from the distal end 1523 into an internal chamber 1541 of a compressible valve member 1540 disposed within the lumen 1539 of the female luer portion 1532. The lumen 1522 of the post 1520 may define a flow path or microchannel along which fluid may flow from the distal end 1525 into the fluid collection device 40. The post 1520 may fluidly couple the blood collection device 40 to the catheter assembly 50 via the lumen 1519 of the male luer portion 1512. For example, continuing to refer to FIGS. 9A and 9B, in some embodiments, the leg 72 of the Y - adapter 70 may be coupled to the flow restriction device 1503. The leg 72 of the Y - adapter 70 may include a lumen into which the distal end 1516 of the male luer portion 1512 may be coupled. The Y - adapter 70 may fluidly communicate the flow restriction device 1503 having the post 1520 with the catheter assembly 50, for example, via an extension tube 60. Thus, the lumen 1522 of the post 1520 may define a linear fluid path having a reduced, small, or micro - sized diameter (as described below) through which fluid entering the flow restriction device 1503 from the catheter assembly 50 may flow through the flow restriction device 15000 for collection in the fluid collection device 40. For example, when blood is being withdrawn or collected from a patient, the medical fluid 15 may be blood and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device 40 may be a luer - lock access device (LLAD).Thus, during blood collection or withdrawal from a patient, the blood sample 15 may flow from the distal end 1525 of the post 1520 into the LLAD 40 through a flow path or microchannel defined by the lumen 1522.

[0145] As described above, the post 1520 may be an elongated, thin tube having a lumen 1522 with a small, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1522 of the post 1520 that defines a flow path or microchannel through which fluid may flow from the distal end 1525 into the fluid collection device 40 may be formed by any of length, diameter, and cross-sectional area as described above with respect to the optimized fluid path.

[0146] To withdraw fluid (e.g., blood) from the catheter assembly 50, the fluid collection device 40 may be inserted into and coupled to the inlet 1535 of the female luer portion 1532. In the coupled state of the female luer portion 1532 and the fluid collection device 40, the compressible valve member 1540 may be compressed distally by the fluid collection device 40 to fluidly connect the proximal end 1523 of the post 1520 with the fluid collection device 40. For example, when the male luer portion 1502 of the blood collection device 40 is inserted into the inlet 1535 of the female luer portion 1532, the male luer portion 1502 of the blood collection device 40 may move or otherwise displace the head portion 1542 of the valve member 1540 and compress the valve member 1540 distally. When the head portion 1542 is displaced distally, the proximal end 1523 of the post 1520 may be exposed to the inlet of the male luer portion 1502 of the blood collection device 40 through the slot 1550. The proximal end 1523 of the post 1520 may thereby be fluidly coupled to the male luer portion of the blood collection device 40 through the slot 1550 of the compressible valve member 1540.

[0147] During operation, during blood collection or extraction from a patient, blood 15 may flow from the patient's blood vessel through the extension tube 60 into the catheter assembly 50 and enter the lumen 1519 at the distal end 1516 of the male Luer portion 1512 of the flow restriction device 1503. The blood 15 may then flow in a proximal direction towards the female Luer portion 1532. Due to the presence of the post 1520 in the lumen 1543 of the base 1545, the blood 15 is forced to flow into the distal end 1525 of the post 1540, through the flow path and microchannels defined by the lumen 1522, and out of the flow restriction device 1503 into the blood collection device 40 through the proximal end 1523 of the post 1520. Thus, during blood collection or extraction from a patient, the blood 15 may flow into the blood collection device 40 through a flow path or microchannel defined by the lumen 1522 having a minimum diameter. The flow restriction devices 1503 of the various embodiments described herein are advantageous over existing blood collection systems. For example, during collection by an existing blood extraction device, blood cells may be subjected to shear stress as they flow from the distal end to the proximal end of the blood collection system. The maximum shear stress can be along the walls of the blood cells and is often referred to as wall shear stress. Wall shear stress in blood cells is thought to be a major cause of mechanical damage to blood cells and results in hemolysis of the blood cells. In some embodiments, the continuous flow path or microchannel defined by the lumen 1522 having a minimum diameter can promote increased flow resistance within the vascular access system to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15. For example, the minimized diameter of the flow path or microchannel defined by the lumen 1522 provides increased resistance to the flow of blood 15, which can thereby reduce the blood flow rate within the flow resistance device 1503. The reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of the blood 15, so that the risk of hemolysis during blood collection can be advantageously reduced.

[0148] FIG. 15A shows a cross-sectional view of the flow restrictor 1600 at a first retracted position, according to some embodiments of the present disclosure. FIG. 15B shows a cross-sectional view of the flow restrictor 1600 of FIG. 15A at a fluid injection position, according to some embodiments of the present disclosure. FIG. 15C shows a perspective view of the flow restriction post or tube 1620 of the flow restrictor of FIG. 15A, according to some embodiments of the present disclosure. FIG. 15D shows a cross-sectional view of the slider 1650 of the flow restrictor of FIG. 15A, according to some embodiments of the present disclosure. As shown in FIGS. 15A-15E and continuing to refer to FIGS. 9A and 9B, in some embodiments, the flow restrictor 1600 may include a housing 1610 having a proximal end 1612 and an inner surface 1614 that defines an internal chamber 1616 of the housing 1610. In some embodiments, the internal chamber 1616 of the housing 1610 may be fluidly coupled to an interflow connector 1640, such as, but not limited to, a needleless connector. The flow restrictor 1600 may further include a male luer portion 1660 that defines a distal end 1617 of the housing 1610. The male luer portion 1660 may have a lumen that is in fluid communication with the internal chamber 1616. In some embodiments, the slider 1650 is reciprocally movably mounted within the internal chamber 1616. As shown, the slider 1650 may have a proximal end 1624, a proximal face 1662, a distal end 1622, a mounting aperture 1655 that extends from the proximal end 1624 to the distal end 1622 of the slider 1650, and a plurality of flow apertures 1656 that extend from the proximal end 1624 to the distal end 1622 of the slider 1650 and surround the mounting aperture 1655. In some embodiments, the plurality of flow apertures 1656 may be at least four flow apertures 1656. However, various embodiments of the present disclosure are not limited to the foregoing configurations. In some embodiments, there may be three or fewer flow apertures 1656, provided that there are two or more flow apertures 1656. In some embodiments, the plurality of flow apertures 1656 may extend longitudinally around the outer periphery 1652 of the slider 1650. For example, in some embodiments, the plurality of flow apertures 1656 may extend longitudinally around the outer periphery 1652 of the slider 1650.In some embodiments, the slider 1650 may be formed from a polyisopropene sealing material.

[0149] As shown in FIGS. 15A and 15B, the flow restriction device 1600 may further include a flow restriction post in the form of a tube 1620 having an inner surface 1628 that defines a lumen 1625 extending therethrough between the proximal end 1627 and the distal end 1626 of the tube 1620. The tube 1620 may be attached to the attachment opening 1655 and may extend distally from the proximal end 1624 of the slider 1650 through the distal end 1622 of the slider assembly 1650. According to some embodiments of the present disclosure, the lumen 1625 may define a flow path or microchannel along which fluid (e.g., blood) may flow from the internal chamber 1616 into the fluid collection device 40, e.g., through the connector 1640.

[0150] In some embodiments, the leg 72 of the Y - adapter 70 may be coupled to the flow restriction device 1600. For example, the leg 72 of the Y - adapter 70 may include a lumen, and the distal end 1617 of the housing 1610 to which the tube 1620 is attached may be coupled into this lumen. The Y - adapter 70 may place the flow restriction device 110 and the tube 1620 attached thereto in fluid communication with the catheter assembly 50, for example, via the extension tube 60. Thus, the lumen 1625 of the tube 1620 may define a linear fluid path having a reduced, small, or micro - sized diameter (as described below), through which fluid entering the flow restriction device 1600 from the catheter assembly may flow through the flow restriction device 1600 for collection in the fluid collection device 40. For example, when blood is being withdrawn or collected from a patient, the medical fluid 15 may be blood, and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a luer lock access device (LLAD). Thus, during blood collection or withdrawal from a patient, the blood sample 15 may flow from the distal end 1617 of the housing 1610 into the LLAD 40 through the flow path or microchannel defined by the lumen 1625.

[0151] In some embodiments, at least a portion of the tube 1620 may be in the form of a longitudinal body that extends uniformly within the internal chamber 1616 of the housing 1610. In some embodiments, at least one of the diameter of the tube at its proximal end 1627 and the diameter of the tube at its distal end 1626 is greater than the diameter of the portion L of the tube 1620 that includes the longitudinal body extending uniformly within the internal chamber 1616 of the housing 1610. For example, in some embodiments, the tube 1620 flares radially outward from the portion L of the tube 1620 that includes the longitudinal body extending uniformly within the internal chamber 1616 of the housing 1610 to at least one of the proximal end 1627 and the distal end 1626 of the tube 1620.

[0152] In some embodiments, portion L of tube 1620, which includes a longitudinally extending body that extends uniformly within internal chamber 1616 of housing 1610, may be a slender, thin tube having a lumen 1625 with a small, reduced, or micro-sized diameter. For example, in some embodiments, lumen 1625 of portion L of tube 1620 that defines a flow path or microchannel through which fluid may flow from distal end 1617 into fluid collection device 40, e.g., through connector 1640, may be formed by any of length, diameter, and cross-sectional area as described above with respect to the optimized fluid path.

[0153] According to various embodiments of the present disclosure, flow restrictor 1600 may further include a spring member 1630 attached to internal chamber 1616 surrounding at least a portion of tube 1620. Thus, tube 1620 may be spring-loaded by spring member 1630. During operation, during blood collection or a very light injection, when slider 1650 is under a retraction or very light injection pressure, spring member 1630, which is in an expanded / uncompressed state, applies a force to bias proximal end 1624 of slider 1650 in a proximal direction against inner surface 1614 of housing 1610. Thus, proximal end 1624 of slider 1650 and plurality of flow openings 1656 remain sealed against inner surface 1614 of the housing, thereby blocking fluid flow into connector 1640 through plurality of flow openings 1656. During blood collection, since the flow path between plurality of flow openings 1656 and connector 1640 is blocked, blood entering lumen 1618 of male luer portion 1660 of flow restrictor 1600 may flow into connector 1640 only through lumen 1625 of tube 1620.

[0154] When fluid 15 is blood withdrawn from a patient, blood cells can be subject to shear stress as they flow from catheter assembly 50 into blood collection device 40. For example, the maximum shear stress can be along the wall of the blood cells and is often referred to as wall shear stress. Wall shear stress in blood cells is thought to be a major cause of mechanical damage to the blood cells and results in hemolysis of the blood cells. In some embodiments, the lumen 1625 of tube 1620 having a reduced or micro-sized diameter can promote an increased flow resistance within the vascular access system to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of blood 15. The minimized diameter of the first fluid path or microchannel defined by lumen 1625 of tube 1620 provides an increased resistance to the flow of blood 15, thereby reducing the blood flow rate within flow resistance device 1600. The reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of blood 15, so the risk of hemolysis during blood collection can advantageously be reduced.

[0155] When slider 1650 is exposed to a distal fluid pressure, such as an injection pressure, and an injection fluid, such as an intravenous (IV) fluid, the IV fluid initially flows from connector 1640 through lumen 1625 of tube 1620 into internal chamber 1616 of the housing. As the injection pressure increases, slider 1650 may be configured to move distally away from the inner surface 1614 of housing 1610 and compress spring member 1630. As shown, each of the plurality of openings 1656 and the inner surface 1614 of internal chamber 1616 may define a flow path through which a fluid, such as an intravenous (IV) fluid, flows from the connector into the lumen of male luer portion 1660 when slider 1650 is exposed to a distal fluid pressure. Separation of the proximal end 1624 of the slider from the inner surface 1614 of housing 1610 opens the flow path through the plurality of flow openings 1656. Thus, a fluid, such as an injection fluid, may flow from connector 1640 through both lumen 1625 of tube 1620 and the plurality of secondary flow openings 1656 into lumen 1618 of male luer portion 1660.

[0156] Thus, the spring member 1630 holds the slider 1650 to which the tube 1620 is attached in a biased and sealed state against the inner surface of the housing 1610, so that at a slight vacuum (i.e., suction) and a very low injection pressure, fluid flows through the tube 1620 having the lumen 1625 that defines the microchannel. The initial burst of the flush also flows through the tube 1620 having the lumen 1625 that defines the microchannel, thereby enabling a higher pressure flush. As the injection pressure increases, the spring member 1630 may be compressed by the distal movement D of the slider 1650, and the plurality of flow openings 1656 are opened around the outer diameter of the slider, whereby a plurality of flow paths, i.e., the lumen 1625 of the tube 1620 and the plurality of flow paths through the plurality of flow openings 1656, are opened for flushing or injection. This enables complete flushing of all flow paths.

[0157] FIG. 16A shows a blood collection system 1700 according to some embodiments of the present disclosure. FIG. 16B shows a blood collection system 1700 according to some embodiments of the present disclosure. According to various embodiments of the present disclosure, the blood collection system 1700 may include a blood collection device 1702 that includes a container 1710 having an outer surface 1714, an inner surface 1722 that defines an internal chamber 1750, a needle 1730 that extends proximally from the inner surface 1722, and a connection portion 1720 that extends distally from the outer surface 1714. In some embodiments, the blood collection device 1702 may be a Luer Lock Access Device (LLAD). In some embodiments, the blood collection device 1702 may include a VACUTAINER® blood collection tube available from Becton Dickinson & Company.

[0158] In some embodiments, the blood collection system may further include a flow restriction device 1732 fluidly coupled to the connection portion 1720 of the blood collection device 1702. In some embodiments, the flow restriction device 1732 may be pre-attached or integrally formed with the blood collection device 1702. As shown, the flow restriction device 1732 may be a cannula 1740 having a lumen 1742 that defines a through-going internal flow path. The internal flow path may be fluidly coupled to the lumen 1734 of the needle 1730 to deliver blood withdrawn from the patient to the needle 1730.

[0159] In some embodiments, the cannula 1740 may be an elongated, thin tube having a lumen 1742 with a small, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1742 of the cannula 1740 that defines a flow path or microchannel through which fluid may flow into the needle 1730 may be formed by any of length, diameter, and cross-sectional area as described above with respect to the optimized fluid path. Thus, for example, during blood collection or withdrawal from a patient using a VACUTAINER® blood collection tube, the blood may be drawn into the needle 1730 under vacuum through a flow path or microchannel defined by the lumen 1742 having a minimum diameter.

[0160] FIG. 16B shows a blood collection system 1800 according to some embodiments of the present disclosure. According to various embodiments of the present disclosure, the blood collection system 1800 may include a blood collection device 1802 including a container 1710 having an outer surface 1714, an inner surface 1722 that defines an internal chamber 1750, and a connection portion 1720 having a lumen 1724 that extends distally and through-going from the outer surface 1714. In some embodiments, the blood collection device 1802 may be a luer lock access device (LLAD). In some embodiments, the blood collection device 1802 may include a VACUTAINER® blood collection tube available from Becton Dickinson & Company.

[0161] In some embodiments, the blood collection system may further include a flow restrictor 1832 that extends proximally from the inner surface 1722 and is fluidly coupled to the lumen 1724 of the connection portion 1720 of the blood collection device 1702. In some embodiments, the flow restrictor 1832 may be pre-attached to or integrally formed with the blood collection device 1802. As shown, the flow restrictor 1732 may be a cannula 1740 having a lumen 1742 that defines a through-going internal flow path. The internal flow path may be fluidly coupled to the catheter assembly via the lumen 1724 of the connection portion to deliver blood withdrawn from the patient to the blood collection device 1802.

[0162] In some embodiments, similar to the blood collection device 1700, the cannula 1740 may be an elongate, thin tube having a lumen 1742 with a small, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1742 of the cannula 1740 that defines a flow path or microchannel through which fluid may flow into the container 1710 may be formed by any of length, diameter, and cross-sectional area as described above with respect to the optimized fluid path. Thus, for example, during blood collection or withdrawal from a patient using a VACUTAINER® blood collection tube, the blood may be drawn under vacuum into the flow path or microchannel defined by the lumen 1742 having a minimum diameter.

[0163] The blood collection systems 1700 and 1800 of the various embodiments described herein having the flow restriction cannulas 1740 integrated with the blood collection devices 1702, 1802 are advantageous over existing blood collection systems. For example, during phlebotomy by an existing blood withdrawal device, blood cells can be subject to wall shear stress as they flow from the distal end to the proximal end of the blood collection system. Wall shear stress in blood cells is thought to be a major cause of mechanical damage to blood cells, resulting in hemolysis of the blood cells. A flow path or microchannel defined by a lumen 1742 having a minimum diameter can promote an increased flow resistance within the vascular access system to disperse the pressure differential and reduce the shear stress experienced by red blood cells of the blood. For example, the minimized diameter of the flow path or microchannel defined by the lumen 1742 provides an increased resistance to the flow of blood, thereby reducing the blood flow rate within the cannula 1740. The reduced blood flow rate results in a reduction in the shear stress experienced by red blood cells of the blood, so that the risk of hemolysis during blood collection can advantageously be reduced.

[0164] FIG. 17A shows a blood collection system 1900 according to some embodiments of the present disclosure. FIG. 17B shows a cross-sectional view of the blood collection system 1900 of FIG. 17A according to some embodiments of the present disclosure. According to various embodiments of the present disclosure, the blood collection system 1900 may include a blood collection device 1902 including a container 1910 having an outer surface 1914, an inner surface 1922 defining an internal chamber 1950, a needle 1930 extending proximally from the inner surface 1922, and a connection portion 1920 extending distally from the outer surface 1914. In some embodiments, the blood collection device 1902 may be a luer lock access device (LLAD). In some embodiments, the blood collection device 1902 may include a VACUTAINER® blood collection tube available from Becton Dickinson & Company.

[0165] In some embodiments, the blood collection system may further include a flow restriction device 1940 engaged with the connection portion 1920 and fluidly coupled to the lumen 1934 of the needle 1930. In some embodiments, the flow restriction device 1940 may be pre-attached to or integrally formed with the blood collection device 1902. As shown in FIGS. 17A and 17B, the flow restriction device 1940 may include a connector 1912 having a proximal end 1915 disposed at the connection portion 1920, a distal end 1916 configured to be coupled to the catheter assembly, and an inner surface 1918 defining an inner lumen 1925. The flow restriction device 1940 may further include a cannula 1955 attached to the inner lumen 1918 extending from the distal end 1916 of the connector 1912 into the connection portion 1920. The lumen 1952 of the cannula 1955 may define a flow path through which blood flows from the distal end 1916 into the lumen 1934 of the needle 1930.

[0166] In some embodiments, the cannula 1955 may be an elongated, thin tube having a lumen 1952 with a small, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1952 of the cannula 1955 that defines a flow path or microchannel through which fluid may flow into the needle 1930 may be formed by any of length, diameter, and cross-sectional area as described above with respect to the optimized fluid path. Thus, for example, during blood collection or withdrawal from a patient using a VACUTAINER® blood collection tube, the blood may be drawn into the needle 1930 under vacuum through the flow path or microchannel defined by the lumen 1952 having a minimum diameter.

[0167] In some embodiments, the connector 1912 may further include a support portion 1936 disposed between the proximal end 1915 and the distal end 1916. The support portion 1936 may include a proximal end, a distal end, and a central mounting opening 1938 extending from the proximal end to the distal end. As shown, the cannula 1955 may be attached to the central mounting opening 1938 to fluidly connect the flow restrictor to the catheter assembly.

[0168] FIG. 18A shows a blood collection system 2000 according to some embodiments of the present disclosure. FIG. 18B shows a cross-sectional view of the blood collection system 2000 of FIG. 18A according to some embodiments of the present disclosure. According to various embodiments of the present disclosure, the blood collection system 2000 may include a blood collection device 2002 including a container 1910 having an outer surface 1914, an inner surface 1922 defining an internal chamber 1950, a needle 1930 extending proximally from the inner surface 1922, and a connection portion 1920 extending distally from the outer surface 1914. In some embodiments, the blood collection device 2002 may be a Luer lock access device (LLAD). In some embodiments, the blood collection device 2002 may include a VACUTAINER® blood collection tube available from Becton Dickinson & Company.

[0169] In some embodiments, the blood collection system may further include a flow restriction device 2040 that engages the connection portion 1920 and is fluidly coupled to the lumen 1934 of the needle 1930. In some embodiments, the flow restriction device 1940 may be pre-attached or integrally formed with the blood collection device 1902. The flow restriction device 2040 may include a connector 2012 having a proximal end 1915 disposed at the connection portion 1920, a distal end 1916 configured to be coupled to the catheter assembly, and an inner surface 1918 that defines an inner lumen 1925. The flow restriction device 2040 may have features similar to those of the flow restriction device 1940 described above, and a detailed description thereof is omitted with respect to FIGS. 18A and 18B. However, the flow restriction device 2040 may differ from the flow restriction device 1940 in that the cannula 1955 of the flow restriction device 2040 may be attached to the inner lumen 1925 of the connector that extends from the distal end 1915 to the proximal end of the connector 2012. In particular, the cannula 1955 of the flow restriction device 2040 may be hidden within the body of the connector 2012, as opposed to the cannula 1955 of the flow restriction device 1940 that extends into the blood collection device 1902.

[0170] The blood collection systems 1900 and 2000 of the various embodiments described herein having a flow restriction cannula 1955 integrated with the blood collection devices 1902, 2002 are advantageous over existing blood collection systems. For example, during aspiration by an existing blood withdrawal device, blood cells can be subject to wall shear stress as they flow from the distal end to the proximal end of the blood collection system. Wall shear stress in blood cells is thought to be a major cause of mechanical damage to blood cells and results in hemolysis of the blood cells. A flow path or microchannel defined by a lumen 1952 having a minimum diameter can promote an increased flow resistance within the vascular access system to disperse the pressure differential and reduce the shear stress experienced by red blood cells of the blood. For example, the minimized diameter of the flow path or microchannel defined by the lumen 1952 provides an increased resistance to the flow of blood, thereby reducing the blood flow rate within the cannula 1955. The reduced blood flow rate results in a reduction of the shear stress experienced by red blood cells of the blood, so that the risk of hemolysis during blood collection can advantageously be reduced.

[0171] FIG. 19A shows a perspective view of a blood collection system 2100 according to some embodiments of the present disclosure. FIG. 19B shows a cross-sectional view of the blood collection system 2100 of FIG. 19A according to some embodiments of the present disclosure. According to various embodiments of the present disclosure, the blood collection system 2100 may include a blood collection device 2102 including a container 2110 having an outer surface 2114, an inner surface 2122 defining an internal chamber 2135, a needle 2130 extending proximally from the inner surface 2122, and a connection portion 2140 extending distally from the outer surface 2114. In some embodiments, the blood collection device 2102 may be a luer lock access device (LLAD). In some embodiments, the blood collection device 2102 may include a VACUTAINER® blood collection tube available from Becton Dickinson & Company.

[0172] In some embodiments, the connection portion 2140 may include an insertion portion 2150 having an outer surface 2120 with a continuous non-linear channel 2125 formed in a concave shape. The blood collection system may further include a connector 2112 configured to fluidly couple the blood collection device 2102 to the catheter assembly. The connector 2112 may include a first connection portion 2134 at the proximal end of the connector 2112 and a second connection portion 2116 at the distal end of the connector 2112. As shown in FIG. 19B, the first connection portion 2134 may have an inner surface 2138 that defines a lumen into which the insertion portion 2150 is coupled.

[0173] In the coupled state of the connector 2112 and the insertion portion 2150, the inner surface 2138 of the first connection portion 2134 may surround, enclose, or otherwise encapsulate the outer surface of the insertion portion 2150 such that the continuous non-linear channel 2125 and the inner surface 2138 of the first connection portion 2134 define a non-linear fluid path through which fluid (e.g., blood) can flow from the lumen 2119 of the second connection portion 2116 of the connector 2112 into the fluid collection device 2102.

[0174] In some embodiments, the continuous non-linear channel 2125 may form a coiled shape, an S-shape, or another suitable non-linear wound shape. For example, the continuous non-linear channel 2125 may have a coiled shape (which may include a helical shape) formed in a concave shape on the outer surface 2120 of the insertion portion 2150. In some embodiments, the continuous non-linear channel 2125 may have an S-shape formed in a concave shape on the outer surface of the insertion portion 2150. The foregoing configurations are advantageous in that the helical, coiled, S-shaped, or otherwise suitable non-linear wound shape of the continuous non-linear channel 2125 is wound around the perimeter of the outer surface of the insertion portion 2150, which can increase the length of the fluid path defined by the continuous non-linear channel 2125 through which the blood sample flows as compared to a linear fluid path.

[0175] In some embodiments, the continuous non-linear channel 2125 may have a small, reduced, or micro-sized diameter. For example, in some embodiments, the continuous non-linear channel 2125 that defines a flow path or microchannel through which fluid may flow from the connector 2112 into the fluid collection device 2102 may be formed by any of length, diameter, and cross-sectional area as described above with respect to the optimized fluid path.

[0176] As described above, when blood is being withdrawn from a patient, blood cells can be subject to wall shear stress as they flow from the catheter assembly into the blood collection device. For example, the maximum shear stress can be along the wall of the blood cell and is often referred to as wall shear stress. The continuous non-linear channel 2125 having a reduced or micro-sized diameter can promote an increased flow resistance within the vascular access system to disperse the pressure differential and reduce the shear stress experienced by the red blood cells of the blood. The minimized diameter of the continuous non-linear channel 2125 provides an increased resistance to the flow of blood, which can thereby reduce the blood flow rate within the flow-through blood collection device 2102. The reduced blood flow rate results in a reduction of the shear stress experienced by the red blood cells of the blood, so the risk of hemolysis during blood collection can advantageously be reduced.

[0177] The subject technology is described, for example, according to the various aspects described below. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology. Any combination of any of the dependent clauses can be combined and placed into each independent clause, for example, clause 1 or clause 5. Other clauses can be presented in a similar manner.

[0178] Clause 1: A flow rate limiting device, comprising: a first connector including a proximal end portion, a distal end portion, and an inner surface defining an inner lumen, the first connector being configured to be coupled to a catheter assembly; a second connector coupled to the proximal end portion of the first connector and configured to be coupled to a fluid collection device; a cannula attached to the inner lumen and extending from the distal end portion of the first connector into the second connector, the lumen of the cannula defining a first flow path through which fluid flows from the distal end portion to the fluid collection device, an annulus being defined between the outer surface of the cannula and the inner surface of the first connector, the annulus defining a second flow path through which fluid flows from the proximal end portion to the distal end portion and into the catheter assembly; a check valve attached to the annulus at the proximal end portion of the first connector and covering at least a portion of the cannula, the check valve being configured to (i) prevent fluid from flowing from the distal end portion into the fluid collection device through the second flow path and (ii) allow fluid to flow from the second connector into the first connector and the catheter assembly through the second flow path.

[0179] Clause 2: The flow rate limiting device according to Clause 1, wherein the cross-sectional area of the annulus along a plane perpendicular to the central longitudinal axis of the first connector is larger than the cross-sectional area of the lumen along the plane.

[0180] Clause 3: The second connector includes a proximal end portion, a distal end portion, and a support portion disposed between the proximal end portion and the distal end portion, the support portion including a proximal end portion, a distal end portion, and a central mounting opening extending from the proximal end portion to the distal end portion, the proximal end portion of the cannula being attached to the central mounting opening to fluidly communicate the flow rate limiting device with the fluid collection device. The flow rate limiting device according to Clause 2.

[0181] Clause 4: The flow rate limiting device according to Clause 3, wherein the support portion further includes a plurality of fluid channels disposed radially outside the central mounting opening and surrounding the central mounting opening.

[0182] Clause 5: The plurality of fluid channels extend from the proximal end to the distal end of the support portion to fluidly connect the second connector to the annulus, and the plurality of fluid channels define at least a portion of the second flow path, the flow rate limiting device according to clause 4.

[0183] Clause 6: The cannula includes a notch at a position corresponding to the distal end of the check valve, and the notch fluidly connects the lumen of the cannula to the annulus, the flow rate limiting device according to any one of clauses 3 to 5.

[0184] Clause 7: The first connector further includes a support portion disposed between the proximal end and the distal end of the first connector, and the support portion of the first connector includes a proximal end, a distal end, and a central mounting opening extending from the proximal end to the distal end, and the cannula is attached to the central mounting opening of the support portion of the first connector to fluidly connect the flow rate limiting device to the catheter assembly, the flow rate limiting device according to any one of clauses 2 to 6.

[0185] Clause 8: The support portion of the first connector further includes a plurality of fluid channels disposed radially outside the central mounting opening of the first connector and surrounding the central mounting opening of the first connector, the flow rate limiting device according to clause 7.

[0186] Clause 9: The plurality of fluid channels extend from the proximal end to the distal end of the support portion of the first connector to fluidly connect the annulus to the catheter assembly, and the plurality of fluid channels define at least a portion of the second flow path, the flow rate limiting device according to clause 8.

[0187] Clause 10: The fluid flowing from the distal end through the first flow path into the fluid collection device contains blood, and the fluid collection device includes a blood collection device, the flow rate limiting device according to clause 9.

[0188] Clause 11: The fluid flowing from the second connector through the second flow path into the first connector and the catheter assembly, which includes intravenous (IV) fluid, is the flow rate limiting device described in Clause 10.

[0189] Clause 12: A flow rate limiting device, comprising: a first connector including a proximal end, a distal end, and an inner surface defining an inner lumen, the distal end being configured to be coupled to a catheter assembly; a second connector including a proximal end, a distal end, and an inner surface defining a lumen of the second connector, the second connector being coupled to the proximal end of the first connector and configured to be coupled to a fluid collection device; a cannula attached to the lumen of the second connector and extending distally into the inner lumen of the first connector, the lumen of the cannula defining a first flow path through which fluid flows from the distal end of the first connector to the fluid collection device, an annulus being defined between the outer surface of the cannula and the inner surface of the first connector, the annulus defining a second flow path through which fluid flows from the proximal end to the distal end and into the catheter assembly; and a check valve attached to the annulus at the proximal end of the first connector and covering at least a portion of the cannula, the check valve being configured to (i) prevent fluid from flowing from the distal end of the first connector into the fluid collection device through the second flow path and (ii) allow fluid to flow from the second connector through the second flow path into the first connector and the catheter assembly.

[0190] Clause 13: The cross-sectional area of the annulus along a plane perpendicular to the central longitudinal axis of the first connector is larger than the cross-sectional area of the lumen along the same plane, for the flow rate limiting device described in Clause 12.

[0191] Clause 14: The second connector includes a support portion disposed between a proximal end and a distal end, the support portion including a proximal end, a distal end, and a central mounting opening extending from the proximal end to the distal end, and the proximal end of the cannula is attached to the central mounting opening to fluidly connect the cannula to the fluid collection device, the flow rate limiting device according to Clause 13.

[0192] Clause 15: The support portion further includes a plurality of fluid channels disposed radially outside the central mounting opening and surrounding the central mounting opening, the flow rate limiting device according to Clause 14.

[0193] Clause 16: The plurality of fluid channels extend from the proximal end to the distal end of the support portion to fluidly connect the second connector to the annulus, and the plurality of fluid channels define at least a part of the second flow path, the flow rate limiting device according to Clause 15.

[0194] Clause 17: The cannula includes a notch at a position corresponding to the distal end of the check valve, and the notch fluidly connects the lumen of the cannula to the annulus, the flow rate limiting device according to any one of Clauses 14 to 16.

[0195] Clause 18: A flow rate limiting device, a distal connector configured to be coupled to a catheter assembly, the distal connector including a first connection portion at the proximal end of the distal connector and a second connection portion at the distal end of the distal connector, the first connection portion including an inner surface defining a lumen, the distal connector, and a proximal connector coupled to the distal connector and configured to be coupled to a fluid collection device, the proximal connector including an insertion portion for insertion into the lumen of the first connection portion, the insertion portion including an outer surface having a concave continuous non-linear channel, the proximal connector, and the inner surface of the first connection portion surrounds the outer surface of the insertion portion, whereby the continuous non-linear channel and the inner surface of the first connection portion define a non-linear fluid path for fluid to flow from the distal connector into the fluid collection device, the flow rate limiting device.

[0196] Clause 19: The continuous non-linear channel is the flow rate limiting device according to Clause 18, including a continuous groove having a coil shape and formed concavely on the outer surface.

[0197] Clause 20: The continuous non-linear channel is the flow rate limiting device according to Clause 18 or 19, including a continuous groove having an S shape and formed concavely on the outer surface.

[0198] Clause 21: The fluid flowing from the distal end into the fluid collection device contains blood, and the fluid collection device is the flow rate limiting device according to any one of Clauses 18 to 20, including a blood collection device.

[0199] Clause 22: The blood collection device is the flow rate limiting device according to Clause 21, including a luer lock access device.

[0200] Clause 23: The insertion portion further includes an inner surface defining the lumen of the insertion portion, and the lumen forms an internal flow path through which fluid flows from the proximal connector through the distal connector into the catheter assembly. The flow rate limiting device is according to any one of Clauses 18 to 22.

[0201] Clause 24: The flow rate limiting device according to Clause 23 further includes a check valve disposed in the lumen of the insertion portion. The check valve is configured to (i) prevent fluid from flowing from the distal connector into the proximal connector through the lumen of the insertion portion, and (ii) allow fluid to flow from the proximal connector into the distal connector through the lumen of the insertion portion.

[0202] Clause 25: The fluid flowing from the proximal connector into the catheter assembly through the distal connector contains intravenous (IV) fluid. The flow rate limiting device is according to Clause 24.

[0203] Clause 26: The internal flow path through which fluid flows from the proximal connector into the catheter assembly through the distal connector includes a linear flow path. The flow rate limiting device is according to any one of Clauses 23 to 25.

[0204] Clause 27: A flow rate limiting device according to any one of Clauses 23 to 26, wherein the continuous non-linear channel includes a first diameter, the internal flow path includes a second diameter, and the first diameter is smaller than the second diameter.

[0205] Clause 28: A flow rate limiting device comprising: a distal connector portion configured to be coupled to a catheter assembly, the distal connector portion including an inner surface defining a lumen of the distal connector portion; a proximal connector portion extending proximally from the distal connector portion and configured to be coupled to a fluid collection device, the proximal connector portion including an inner surface defining a lumen fluidly connected to the lumen of the distal connector portion; and a plug disposed in the lumen of the proximal connector portion, the plug including a head portion and a body portion extending proximally from the head portion, the body portion including a plurality of threads extending along an outer surface of the body portion, wherein the inner surface of the proximal connector portion surrounds the outer surface of the body portion, such that when the fluid collection device is coupled to the proximal connector portion, a continuous non-linear channel is defined through which fluid flows from the distal connector portion through the proximal connector portion into the fluid collection device.

[0206] Clause 29: A flow rate limiting device according to Clause 28, wherein the continuous non-linear channel is defined along an interval between adjacent threads of the plurality of threads.

[0207] Clause 30: A flow rate limiting device according to Clause 29, wherein the continuous non-linear channel includes a continuous groove having a coil shape and formed concavely on an outer surface.

[0208] Clause 31: A flow rate limiting device according to Clause 29 or 30, wherein the continuous non-linear channel includes a continuous groove having an S shape and formed concavely on an outer surface.

[0209] Clause 32: A flow rate limiting device according to any one of Clauses 29 to 31, wherein the fluid flowing from the distal end into the fluid collection device includes blood, and the fluid collection device includes a blood collection device.

[0210] Clause 33: The blood collection device is the flow restriction device according to Clause 32, including a luer lock access device.

[0211] Clause 34: The plug includes an inner surface that defines the lumen of the plug, and the head portion includes a normally closed slit. The normally closed slit in the head portion is configured to prevent fluid from flowing from the distal connector into the proximal connector through the lumen, which is the flow restriction device according to any one of Clauses 29 to 33.

[0212] Clause 35: The plug includes an inner surface that defines the lumen of the plug, and the head portion includes a normally closed slit. When the normally closed slit is exposed to distal fluid pressure, the normally closed slit opens and allows fluid to flow from the proximal connector into the distal connector through the lumen, which is the flow restriction device according to Clause 34.

[0213] Clause 36: The continuous non-linear channel includes a first diameter, the lumen includes a second diameter, and the first diameter is smaller than the second diameter, which is the flow restriction device according to Clause 35.

[0214] Clause 37: The lumen defines an internal flow path through which fluid flows from the proximal connector into the catheter assembly through the distal connector, which is the flow restriction device according to Clause 36.

[0215] Clause 38: The fluid flowing from the proximal connector into the catheter assembly through the distal connector includes intravenous (IV) fluid, which is the flow restriction device according to Clause 37.

[0216] Clause 39: A flow rate limiting device, comprising a first connector including a female Luer portion at the proximal end, a male Luer portion at the distal end, an inner surface defining the inner lumen of the first connector, and a compressible valve member attached to the inner lumen, the first connector being configured to be coupled to a fluid collection device; a second connector coupled to the male Luer portion of the first connector and configured to be coupled to a catheter assembly, the second connector including an inner surface defining the inner lumen of the second connector; and a cannula attached to the inner lumen of the second connector and extending from the inner lumen into the female Luer portion of the first connector, the compressible valve member being attached so as to surround at least a portion of the cannula. In a state where the first connector and the fluid collection device are coupled, the compressible valve member is compressed by the fluid collection device to fluidly connect the cannula and the fluid collection device through a slot of the compressible valve member. A flow rate limiting device.

[0217] Clause 40: The compressible valve member includes a head portion including a slot and a body portion extending distally from the head portion. In a state where the first connector and the fluid collection device are coupled, the body portion of the compressible valve member is compressed to move the head portion distally, fluidly connecting the lumen of the cannula with the fluid collection device, thereby allowing fluid to flow from the second connector into the fluid collection device through the lumen of the cannula. The flow rate limiting device according to Clause 39.

[0218] Clause 41: The body portion includes an accordion shape. The flow rate limiting device according to Clause 40.

[0219] Clause 42: The head portion includes a split septum. The flow rate limiting device according to Clause 40.

[0220] Clause 43: The second connector further includes a support portion that extends radially inwardly from the inner surface into the inner lumen of the second connector and includes an attachment opening, and the cannula is attached to the attachment opening to fluidly connect the second connector to the fluid collection device, the flow rate limiting device according to any one of Clauses 39 to 42.

[0221] Clause 44: The cannula is press-fitted into the support portion, the flow rate limiting device according to Clause 43.

[0222] Clause 45: A flow rate limiting device, comprising a first connector having a lumen and a female Luer portion disposed at the proximal end, a male Luer portion having a lumen and disposed at the distal end, and a compressible valve member attached to the lumen of the female Luer; a first connector configured to be coupled to a fluid collection device; a second connector including a female Luer portion coupled to the male Luer portion of the first connector and a male Luer portion configured to be coupled to a catheter assembly, the female Luer portion of the second connector including an inner lumen, and the male Luer portion of the second connector including an inner lumen in fluid communication with the inner lumen of the female Luer portion of the second connector; and a post attached to the second connector and extending from the inner lumen of the male Luer portion of the second connector through the lumen of the male Luer portion of the first connector into the internal chamber of the compressible valve member, the compressible valve member being attached so as to surround at least a portion of the post, the flow rate limiting device, wherein in the coupled state of the first connector and the fluid collection device, the compressible valve member is compressed by the fluid collection device to fluidly connect the post and the fluid collection device through the slot of the compressible valve member.

[0223] Clause 46: The post includes an elongated tube having a lumen that tapers from the distal end to the proximal end of the post, the flow rate limiting device according to Clause 45.

[0224] Clause 47: The compressible valve member includes a head portion including a slot and a body portion extending distally from the head portion. In the coupled state of the first connector and the fluid collection device, the body portion of the compressible valve member is compressed to move the head portion distally, fluidly connecting the lumen of the post with the fluid collection device, thereby allowing fluid to flow from the second connector through the lumen of the post into the fluid collection device, the flow rate limiting device according to clause 45 or 46.

[0225] Clause 48: The body portion includes an accordion shape, the flow rate limiting device according to clause 47.

[0226] Clause 49: The head portion includes a split septum, the flow rate limiting device according to clause 47.

[0227] Clause 50: The second connector further includes a support portion at the proximal end of the male luer portion of the second connector, and the post is attached to the support portion to fluidly connect the second connector with the fluid collection device, the flow rate limiting device according to any one of clauses 45 to 49.

[0228] Clause 51: The support portion extends into the lumen of the female luer portion of the second connector so as to be distally away from the male luer portion of the second connector, the flow rate limiting device according to clause 50.

[0229] Clause 52: The fluid flowing from the second connector through the lumen of the post into the fluid collection device includes blood, and the fluid collection device includes a blood collection device, the flow rate limiting device according to any one of clauses 46 to 51.

[0230] Clause 53: A flow rate limiting device, comprising a male Luer connector portion configured to be coupled to a catheter assembly, the male Luer connector portion including an inner surface defining a lumen of the male Luer connector portion, a female Luer connector portion disposed proximal to the male Luer connector portion and configured to be coupled to a fluid collection device, the female Luer connector portion including an inner surface defining a lumen fluidly connected to the lumen of the male Luer connector portion, and a tube extending from the lumen of the male Luer connector portion into the lumen of the female Luer connector portion, the lumen of the tube defining a flow path through which fluid flows from the male Luer connector portion through the female Luer connector portion into the fluid collection device.

[0231] Clause 54: The flow rate limiting device according to clause 53, wherein at least a part of the tube includes a non-linear tube.

[0232] Clause 55: The flow rate limiting device according to clause 54, wherein a part of the non-linear tube including the non-linear tube is disposed in the lumen of the female Luer connector portion.

[0233] Clause 56: The flow rate limiting device according to clause 54 or 55, wherein the non-linear tube includes a coiled tube.

[0234] Clause 57: The flow rate limiting device according to clause 54 or 55, wherein the non-linear tube includes an S-shaped tube.

[0235] Clause 58: The fluid flowing from the male Luer connector portion through the female Luer connector portion into the fluid collection device includes blood, and the fluid collection device includes a blood collection device. The flow rate limiting device according to any one of clauses 53 to 57.

[0236] Clause 59: The flow rate limiting device according to clause 58, wherein the blood collection device includes a Luer lock access device.

[0237] Clause 60: The flow rate limiting device according to any one of clauses 53 to 59, wherein the tube includes a linear tube.

[0238] Clause 61: The linear tube is a flow rate limiting device according to Clause 60, including a cannula attached to the male Luer connector portion.

[0239] Clause 62: The male Luer connector portion further includes a support portion that extends radially inward from the inner surface into the lumen of the male Luer connector portion and includes an attachment opening, and the cannula is attached to the attachment opening to fluidly connect the male Luer connector portion to the fluid collection device. The flow rate limiting device according to Clause 61.

[0240] Clause 63: The cannula is press-fitted into the support portion. The flow rate limiting device according to Clause 62.

[0241] Clause 64: The fluid flowing from the male Luer connector portion through the female Luer connector portion into the fluid collection device contains blood, and the fluid collection device includes a blood collection device. The flow rate limiting device according to any one of Clauses 60 to 63.

[0242] Clause 65: The blood collection device includes a Luer lock access device. The flow rate limiting device according to Clause 64.

[0243] Clause 66: A flow rate limiting device, comprising a distal connector configured to be coupled to a catheter assembly, the distal connector including a first connection portion at a proximal end of the distal connector and a second connection portion at a distal end of the distal connector, each of the first and second connection portions including an inner surface defining a lumen; a proximal connector coupled to the distal connector and configured to be coupled to a fluid collection device; and an insert attached to the lumen of the first connection portion and including an outer surface, the outer surface having a groove formed therein in a concave shape and extending at least partially along the length of the outer surface, the groove being fluidly coupled to the lumen of the second connection portion and the lumen of the first connection portion. The inner surface of the first connection portion surrounds the outer surface of the insert such that the groove and the inner surface of the first connection portion define at least a portion of a fluid channel through which fluid flows from the distal connector into the fluid collection device.

[0244] Clause 67: The flow rate limiting device according to clause 66, wherein the groove includes a linear groove formed in a concave shape on the outer surface.

[0245] Clause 68: The flow rate limiting device according to clause 67, wherein the outer surface further includes longitudinally extending ledges, each ledge being disposed at an edge on both sides of the linear groove to seal the edge.

[0246] Clause 69: The insert includes a first channel section fluidly coupled to a proximal end of the lumen of the second connection portion and a second channel section extending from the first channel section to the linear groove. The first and second channel sections and the linear groove together define a fluid channel through which fluid flows from the distal connector into the fluid collection device.

[0247] Clause 70: The positions of the first channel section and the linear groove are offset from each other, and the second channel section includes an inclined surface that couples the first channel section to the linear groove.

[0248] Clause 71: The fluid flowing from the distal end into the fluid collection device includes blood, and the fluid collection device is a flow rate limiting device according to any one of Clauses 66 to 70, including a blood collection device.

[0249] Clause 72: The blood collection device is a flow rate limiting device according to Clause 71, including a luer lock access device.

[0250] Clause 73: A flow rate limiting device, which is a connector including a body portion having a lumen and disposed at the proximal end, a base portion having a lumen and disposed at the distal end, and a compressible valve member attached to the base portion and extending into the lumen of the body portion. The body portion is configured to be coupled to the fluid collection device. A post having a lumen extending therethrough, the post being attached to the lumen of the base portion and extending into the internal chamber of the compressible valve member, the compressible valve member being attached surrounding the post, the post being configured to be in fluid communication with a catheter assembly. In the coupled state of the body portion and the fluid collection device, the compressible valve member is compressed by the fluid collection device to fluidly connect the post and the fluid collection device through the slot of the compressible valve member.

[0251] Clause 74: The compressible valve member includes a head portion including a slot and a body portion extending distally from the head portion. In the coupled state of the body portion and the fluid collection device, the body portion of the compressible valve member is compressed to move the head portion distally, allowing fluid to flow from the distal end of the post through the lumen of the post into the fluid collection device by fluidly connecting the lumen of the post and the fluid collection device. The flow rate limiting device according to Clause 73.

[0252] Clause 75: The body portion includes an accordion shape. The flow rate limiting device according to Clause 74.

[0253] Clause 76: The head portion includes a split septum. The flow rate limiting device according to Clause 74 or 75.

[0254] Clause 77: The flow restriction device according to any one of Clauses 73 to 76, wherein the lumen of the post tapers from the distal end to the proximal end of the post.

[0255] Clause 78: The flow restriction device according to Clause 77, wherein the fluid flowing from the distal end of the post into the fluid collection device through the lumen of the post contains blood, and the fluid collection device includes a blood collection device.

[0256] Clause 79: A flow restriction device, which is a connector including a female Luer portion having a lumen and disposed at the proximal end, a male Luer portion having a lumen and disposed at the distal end, and a compressible valve member attached to the lumen of the female Luer portion and fluidly coupled to the lumen of the male Luer portion. The female Luer portion is configured to be coupled to a fluid collection device, and the male Luer portion is configured to be coupled to a catheter assembly. The flow restriction device further includes a post attached to the female Luer portion and extending into the internal chamber of the compressible valve member. The compressible valve member is attached surrounding the post, and the post is in fluid communication with the lumen of the male Luer portion. In a state where the female Luer portion and the fluid collection device are coupled, the compressible valve member is compressed by the fluid collection device to fluidly communicate the post and the fluid collection device through a slot of the compressible valve member.

[0257] Clause 80: The flow restriction device according to Clause 79, wherein the compressible valve member includes a head portion including a slot and a body portion extending distally from the head portion. In a state where the female Luer portion and the fluid collection device are coupled, the body portion of the compressible valve member is compressed to move the head portion distally, fluidly communicating the lumen of the post with the fluid collection device, thereby allowing fluid to flow from the male Luer portion through the lumen of the post into the fluid collection device.

[0258] Clause 81: The flow restriction device according to Clause 80, wherein the body portion includes an accordion shape.

[0259] Clause 82: The head portion is a flow rate limiting device as described in Clause 80 or 81, including a split septum.

[0260] Clause 83: The female luer portion further includes a support portion at the distal end of the female luer portion, and the post is attached to the support portion to fluidly connect the lumen of the male luer portion to the fluid collection device. The flow rate limiting device according to any one of Clauses 79 to 82.

[0261] Clause 84: The fluid flowing from the male luer portion into the fluid collection device through the lumen of the post contains blood, and the fluid collection device includes a blood collection device. The flow rate limiting device according to Clause 83.

[0262] Clause 85: A flow rate limiting device, comprising: a housing having a proximal end, an inner surface defining an internal chamber of the housing, and a male luer portion defining a distal end of the housing and having a lumen fluidly communicating with the internal chamber; a slider reciprocally mounted in the internal chamber of the housing, the slider including a proximal end, a distal end, a mounting opening extending from the proximal end to the distal end of the slider, and a plurality of flow openings extending from the proximal end to the distal end of the slider and surrounding the mounting opening; a tube having a lumen extending therethrough, the tube being attached to the mounting opening and extending distally from the proximal end of the slider through the distal end of the slider; and a spring member attached to the internal chamber surrounding at least a portion of the tube, the spring member applying a force to bias the proximal end of the slider against the inner surface of the housing to block fluid flow into the connector through the plurality of flow openings and allow fluid flow into the connector through the tube.

[0263] Clause 86: The flow rate limiting device according to clause 85, wherein when the slider is exposed to the fluid pressure in the distal direction, the slider moves distally away from the inner surface of the housing, and the fluid is configured to flow from the connector into the lumen of the male luer portion through the tube and the plurality of flow openings.

[0264] Clause 87: The flow rate limiting device according to clause 86, wherein the plurality of flow openings includes at least four flow openings.

[0265] Clause 88: The flow rate limiting device according to clause 86 or 87, wherein the plurality of flow openings extends longitudinally around the outer periphery of the slider.

[0266] Clause 89: The flow rate limiting device according to any one of clauses 85 to 88, wherein each of the plurality of flow openings and the inner surface of the inner chamber define a flow path through which the fluid flows from the connector into the lumen of the male luer portion when the slider is exposed to the fluid pressure in the distal direction.

[0267] Clause 90: The flow rate limiting device according to any one of clauses 86 to 89, wherein at least a part of the tube includes a longitudinal body that extends uniformly in the inner chamber of the housing.

[0268] Clause 91: The flow rate limiting device according to clause 90, wherein at least one of the diameter of the tube at the proximal end and the diameter of the tube at the distal end is larger than the diameter of the part of the tube that includes the longitudinal body that extends uniformly in the inner chamber of the housing.

[0269] Clause 92: The flow rate limiting device according to clause 90 or 91, wherein the tube extends radially outward from a part of the tube that includes the longitudinal body that extends uniformly in the inner chamber of the housing to at least one of the proximal end and the distal end of the tube.

[0270] Clause 93: The flow rate limiting device according to any one of clauses 86 to 92, wherein the slider includes a polyisopropene sealing material.

[0271] Clause 94: A blood collection system comprising a blood collection device including a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface, and a flow restriction device fluidly coupled to the connection portion of the blood collection device, the flow restriction device including a cannula having an inner surface defining a through-going internal flow path, the internal flow path being fluidly coupled to the lumen of the needle for delivering blood withdrawn from a patient to the needle.

[0272] Clause 95: The blood collection system according to clause 94, wherein the blood collection device includes a luer lock access device.

[0273] Clause 96: The blood collection system according to clause 94, wherein the blood collection device includes a vacutainer.

[0274] Clause 97: A blood collection system comprising a blood collection device including a container having an outer surface, an inner surface defining an internal chamber, and a connection portion extending distally from the outer surface and including a lumen extending therethrough, and a flow restriction device extending proximally from the inner surface and fluidly coupled to the lumen of the connection portion of the blood collection device, the flow restriction device including a cannula having an inner surface defining a through-going internal flow path, the internal flow path being fluidly coupled to the lumen of the connection portion for receiving blood withdrawn from a patient.

[0275] Clause 98: The blood collection system according to clause 97, wherein the blood collection device includes a luer lock access device.

[0276] Clause 99: The blood collection system according to clause 97, wherein the blood collection device includes a vacutainer.

[0277] Clause 100: A blood collection system, comprising a blood collection device including a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface; a flow restriction device engaged with the connection portion and fluidly coupled to the lumen of the needle, the flow restriction device including a connector having a proximal end disposed on the connection portion, a distal end configured to be coupled to a catheter assembly, and an inner surface defining an inner lumen; and a cannula attached to the inner lumen and extending from the distal end of the connector into the connection portion, the lumen of the cannula defining a flow path through which blood flows from the distal end into the lumen of the needle.

[0278] Clause 101: The blood collection system according to Clause 100, wherein the connector further includes a support portion disposed between the proximal end and the distal end of the connector, the support portion including a proximal end, a distal end, and a central attachment opening extending from the proximal end to the distal end, and the cannula is attached to the central attachment opening to fluidly communicate the flow restriction device with the catheter assembly.

[0279] Clause 102: The blood collection system according to Clause 100 or 101, wherein the blood collection device includes a luer lock access device.

[0280] Clause 103: The blood collection system according to any one of Clauses 100 to 102, wherein the blood collection device includes a vacutainer.

[0281] Clause 104: A blood collection system comprising a blood collection device including a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface; a flow restriction device engaged with the connection portion and fluidly coupled to the lumen of the needle, the flow restriction device including a connector having a proximal end disposed on the connection portion, a distal end configured to be coupled to a catheter assembly, and an inner surface defining an inner lumen; and a cannula attached to the inner lumen and extending from the distal end to the proximal end of the connector, the lumen of the cannula defining a flow path for blood to flow from the distal end into the lumen of the needle.

[0282] Clause 105: The blood collection system according to clause 104, wherein the connector further includes a support portion disposed between the proximal end and the distal end of the connector, the support portion including a proximal end, a distal end, and a central attachment opening extending from the proximal end to the distal end, and the cannula is attached to the central attachment opening to fluidly communicate the flow restriction device with the catheter assembly.

[0283] Clause 106: The blood collection system according to clause 104 or 105, wherein the blood collection device includes a luer lock access device.

[0284] Clause 107: The blood collection system according to any one of clauses 104 to 106, wherein the blood collection device includes a vacutainer.

[0285] Clause 108: A blood collection system, comprising a blood collection device including a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface, the connection portion including an insertion portion having an outer surface with a continuously formed concave non-linear channel, a connector configured to be coupled to a catheter assembly, the connector including a first connection portion at a proximal end of the connector and a second connection portion at a distal end of the connector, the first connection portion including an inner surface defining a lumen into which the insertion portion is coupled, wherein the inner surface of the first connection portion surrounds the outer surface of the insertion portion, whereby the continuously formed concave non-linear channel and the inner surface of the first connection portion define a non-linear fluid path through which fluid flows from the connector into the lumen of the needle.

[0286] Clause 109: The blood collection system according to clause 108, wherein the continuously formed concave non-linear channel includes a continuously formed groove having a coil shape, formed concavely on the outer surface.

[0287] Clause 110: The blood collection system according to clause 108 or 109, wherein the continuously formed concave non-linear channel includes a continuously formed groove having an S shape, formed concavely on the outer surface.

[0288] Clause 111: The blood collection system according to any one of clauses 108 to 110, wherein the blood collection device includes a luer lock access device.

[0289] Clause 112: The blood collection system according to any one of clauses 108 to 110, wherein the blood collection device includes a vacutainer.

[0290] Clause 113: The blood collection system according to any one of clauses 108 to 112, wherein the connection portion includes a male luer connection portion.

[0291] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. The disclosure provides various examples of the subject technology, but the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0292] References to elements in the singular are not intended to mean "only one" unless specifically stated otherwise, but rather "one or more." Unless specifically stated otherwise, the term "some" refers to one or more. Pronouns relating to a male (e.g., his) include those relating to a female and a neutral (e.g., her and its), and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.

[0293] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" should not necessarily be construed as more preferable or advantageous than other aspects or designs. In one aspect, the various alternative configurations and operations described herein may be considered at least equivalent.

[0294] As used herein, the phrase "at least one of" preceding a series of items modifies the list as a whole, rather than each item in the list, using the term "or" to separate any of the items of the list. The phrase "at least one of" does not require the selection of at least one item, but rather allows this phrase to mean including at least one item of any of the items of the list, and / or at least one combination of any combination of the items, and / or at least one item of each item of the list. As an example, the phrase "at least one of A, B, or C" can refer to only A, only B, or only C, or any combination of A, B, and C.

[0295] Terms such as "aspect" do not imply that such an aspect is essential to the technology of the subject matter, nor that such an aspect applies to all configurations of the technology of the subject matter. The disclosure regarding an aspect may apply to all configurations, or one or more configurations. An aspect can provide one or more examples. Terms such as "aspect" can refer to one or more aspects, and vice versa. Terms such as "embodiment" do not imply that such an embodiment is essential to the technology of the subject matter, nor that such an embodiment applies to all configurations of the technology of the subject matter. The disclosure regarding an embodiment may apply to all embodiments, or one or more embodiments. An embodiment can provide one or more examples. Terms such as "embodiment" can refer to one or more embodiments, and vice versa. Terms such as "configuration" do not imply that such a configuration is essential to the technology of the subject matter, nor that such a configuration applies to all configurations of the technology of the subject matter. The disclosure regarding a configuration may apply to all configurations, or one or more configurations. A configuration can provide one or more examples. Terms such as "configuration" can refer to one or more configurations, and vice versa.

[0296] In one aspect, unless stated otherwise, all measurements, values, ratings, positions, sizes, dimensions, and other specifications described in this specification, including those included in the following claims, are approximate and not exact. In one aspect, they are intended to have a consistent and reasonable range with the functions they relate to and what is customary in the technical field they are related to.

[0297] The specific order or hierarchy of steps or operations in the disclosed processes or methods is understood to be illustrative of exemplary approaches. It is understood that, based on implementation priorities or scenarios, the specific order or hierarchy of steps, operations, or processes may be rearranged. Some of the steps, operations, or processes may be performed simultaneously. In some implementation priorities or scenarios, a particular operation may or may not be performed. Some or all of the steps, operations, or processes may be automatically performed without user intervention. The appended method claims present the elements of the various steps, operations, or processes in a sample order and are not meant to be limited to the specific order or hierarchy presented.

[0298] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure, known or later to become known to those of ordinary skill in the art, are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. § 112, sixth paragraph, unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is expressly recited using the phrase "step for." Further, to the extent that the terms "comprising," "having," and the like are used, such terms are intended to be inclusive in a manner similar to the term "including" as that term is construed when employed as a transitional word in a claim.

[0299] The title, background art, summary of the invention, brief description of the drawings, and abstract of the present disclosure are incorporated herein by reference and provided as illustrative examples of the present disclosure rather than as a limiting description. The present disclosure is submitted with the understanding that it is not to be used to limit what the claims scope or mean. Further, in the detailed description of the invention, it can be understood that the description provides illustrative examples and various features are grouped together in various embodiments to streamline the present disclosure. This method of disclosure should not be construed as indicating an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims show, the subject matter of the invention lies in less than all of the features of a single disclosed configuration or operation. The following claims are hereby incorporated into the detailed description of the invention, and each claim stands on its own as a separately claimed subject matter.

[0300] The claims are not intended to be limited to the aspects described herein, but rather should be given the full scope consistent with the language of the claims and should include all legal equivalents. However, none of the claims is intended to cover, nor should be construed to cover, subject matter that fails to meet the requirements of 35 U.S.C. § 101, 102, or 103.

Claims

1. A flow rate limiting device, a first connector including a proximal end, a distal end, and an inner surface defining an inner lumen, and configured to be coupled to a catheter assembly, the first connector; a second connector coupled to the proximal end of the first connector and configured to be coupled to a fluid collection device; a cannula attached to the inner lumen and extending from the distal end of the first connector into the second connector, the lumen of the cannula defining a first flow path through which fluid flows from the distal end to the fluid collection device, an annulus being defined between the outer surface of the cannula and the inner surface of the first connector, the annulus defining a second flow path through which fluid flows from the proximal end to the distal end and into the catheter assembly, the cannula; a check valve attached to the annulus at the proximal end of the first connector and covering at least a portion of the cannula, the check valve being configured to (i) prevent fluid from flowing from the distal end into the fluid collection device through the second flow path, and (ii) allow fluid to flow from the second connector into the first connector and the catheter assembly through the second flow path, a flow rate limiting device comprising the check valve.

2. The flow rate limiting device according to claim 1, wherein a cross-sectional area of the annulus along a plane perpendicular to a central longitudinal axis of the first connector is larger than a cross-sectional area of the lumen along the plane.

3. The second connector includes a proximal end, a distal end, and a support portion disposed between the proximal end and the distal end, the support portion including a proximal end, a distal end, and a central mounting opening extending from the proximal end to the distal end, the proximal end of the cannula being attached to the central mounting opening to fluidly connect the flow rate limiting device to the fluid collection device, the flow rate limiting device according to claim 2.

4. The flow rate limiting device according to claim 3, wherein the support portion further includes a plurality of fluid channels disposed radially outside the central mounting opening and surrounding the central mounting opening.

5. The plurality of fluid channels extend from the proximal end to the distal end of the support portion to fluidly connect the second connector to the annulus, and the plurality of fluid channels define at least a portion of the second flow path. The flow rate limiting device according to claim 4.

6. The cannula includes a notch at a position corresponding to the distal end of the check valve, and the notch fluidly connects the lumen of the cannula to the annulus. The flow rate limiting device according to claim 3.

7. The first connector further includes a support portion disposed between the proximal end and the distal end of the first connector. The support portion of the first connector includes a proximal end, a distal end, and a central mounting opening extending from the proximal end to the distal end. The cannula is attached to the central mounting opening of the support portion of the first connector to fluidly connect the flow rate limiting device to the catheter assembly. The flow rate limiting device according to claim 2.

8. The support portion of the first connector further includes a plurality of fluid channels disposed radially outside the radius of the central mounting opening of the first connector and surrounding the central mounting opening of the first connector. The flow rate limiting device according to claim 7.

9. The plurality of fluid channels extend from the proximal end to the distal end of the support portion of the first connector to fluidly connect the annulus to the catheter assembly, and the plurality of fluid channels define at least a portion of the second flow path. The flow rate limiting device according to claim 8.

10. The fluid flowing from the distal end through the first flow path into the fluid collection device includes blood, and the fluid collection device includes a blood collection device. The flow rate limiting device according to claim 9.

11. The fluid flowing from the second connector through the second flow path into the first connector and the catheter assembly includes intravenous (IV) fluid. The flow rate limiting device according to claim 10.

12. A flow rate limiting device, A first connector including a proximal end, a distal end, and an inner surface defining an inner lumen, the distal end being configured to be coupled to a catheter assembly. A first connector, A second connector, comprising a proximal end, a distal end, and an inner surface defining a lumen of the second connector, coupled to the proximal end of the first connector and configured to be coupled to a fluid collection device. A cannula attached to the lumen of the second connector and extending distally into the inner lumen of the first connector. The lumen of the cannula defines a first flow path through which fluid flows from the distal end of the first connector into the fluid collection device. An annulus is defined between the outer surface of the cannula and the inner surface of the first connector, and the annulus defines a second flow path through which fluid flows from the proximal end to the distal end and into the catheter assembly. A check valve attached to the annulus at the proximal end of the first connector and covering at least a portion of the cannula, the check valve being configured to (i) prevent fluid from flowing from the distal end of the first connector into the fluid collection device through the second flow path, and (ii) allow fluid to flow from the second connector into the first connector and the catheter assembly through the second flow path. A flow rate limiting device comprising a check valve.

13. The flow rate limiting device according to claim 12, wherein a cross-sectional area of the annulus along a plane perpendicular to the central longitudinal axis of the first connector is larger than a cross-sectional area of the lumen along the plane.

14. The second connector includes a support portion disposed between the proximal end and the distal end, the support portion including a proximal end, a distal end, and a central attachment opening extending from the proximal end to the distal end, and a proximal end of the cannula is attached to the central attachment opening to place the cannula in fluid communication with the fluid collection device. The flow rate limiting device according to claim 13.

15. The flow rate limiting device according to claim 14, wherein the support portion further includes a plurality of fluid channels disposed radially outside the central attachment opening and surrounding the central attachment opening.

16. The plurality of fluid channels extend from the proximal end to the distal end of the support portion for fluidly communicating the second connector with the annulus, and the plurality of fluid channels define at least a portion of the second flow path, the flow rate limiting device according to claim 15.

17. The cannula includes a notch at a position corresponding to the distal end of the check valve, and the notch fluidly connects the lumen of the cannula to the annulus, the flow rate limiting device according to claim 14.

18. A flow rate limiting device, A distal connector configured to be coupled to a catheter assembly, the distal connector including a first connection portion at the proximal end of the distal connector and a second connection portion at the distal end of the distal connector, the first connection portion including an inner surface defining a lumen, a distal connector, A proximal connector coupled to the distal connector and configured to be coupled to a fluid collection device, the proximal connector including an insertion portion for insertion into the lumen of the first connection portion, the insertion portion including an outer surface having a continuously concave non-linear channel, a proximal connector, The inner surface of the first connection portion surrounds the outer surface of the insertion portion, whereby the continuous non-linear channel and the inner surface of the first connection portion define a non-linear fluid path through which fluid flows from the distal connector into the fluid collection device, a flow rate limiting device.

19. The continuous non-linear channel includes a continuous groove having a coil shape formed in a concave shape on the outer surface, the flow rate limiting device according to claim 18.

20. The continuous non-linear channel includes a continuous groove having an S shape formed in a concave shape on the outer surface, the flow rate limiting device according to claim 18.

21. The fluid flowing from the distal end into the fluid collection device includes blood, and the fluid collection device includes a blood collection device, the flow rate limiting device according to claim 18.

22. The blood collection device includes a luer lock access device, the flow rate limiting device according to claim 21.

23. The insertion portion further includes an inner surface that defines a lumen of the insertion portion, and the lumen forms an internal flow path through which fluid flows from the proximal connector through the distal connector into the catheter assembly. The flow rate limiting device according to claim 18.

24. The flow rate limiting device according to claim 23, further comprising a check valve disposed in the lumen of the insertion portion, the check valve configured to (i) prevent fluid from flowing from the distal connector into the proximal connector through the lumen of the insertion portion, and (ii) allow fluid to flow from the proximal connector into the distal connector through the lumen of the insertion portion.

25. The flow rate limiting device according to claim 24, wherein the fluid flowing from the proximal connector into the catheter assembly through the distal connector includes intravenous (IV) fluid.

26. The flow rate limiting device according to claim 23, wherein the internal flow path through which the fluid flows from the proximal connector into the catheter assembly through the distal connector includes a linear flow path.

27. The flow rate limiting device according to claim 23, wherein the continuous non-linear channel includes a first diameter, the internal flow path includes a second diameter, and the first diameter is smaller than the second diameter.

28. A flow rate limiting device, A distal connector portion configured to be coupled to a catheter assembly, the distal connector portion including an inner surface that defines a lumen of the distal connector portion; A proximal connector portion extending proximally from the distal connector portion and configured to be coupled to a fluid collection device, the proximal connector portion including an inner surface that defines a lumen fluidly connected to the lumen of the distal connector portion; A plug disposed in the lumen of the proximal connector portion, the plug including a head portion and a body portion extending proximally from the head portion, the body portion including a plurality of threads extending along an outer surface of the body portion; and The inner surface of the proximal connector portion surrounds the outer surface of the body portion, thereby defining a continuous non-linear channel through which fluid flows from the distal connector portion through the proximal connector portion into the fluid collection device when the fluid collection device is coupled to the proximal connector portion. A flow rate limiting device.

29. The flow rate limiting device according to claim 28, wherein the continuous non-linear channel is defined along an interval between adjacent threads among the plurality of threads.

30. The flow rate limiting device according to claim 29, wherein the continuous non-linear channel includes a continuous groove having a coil shape, which is formed in a concave shape on the outer surface.

31. The flow rate limiting device according to claim 29, wherein the continuous non-linear channel includes a continuous groove having an S shape, which is formed in a concave shape on the outer surface.

32. The flow rate limiting device according to claim 29, wherein the fluid flowing from the distal end into the fluid collection device includes blood, and the fluid collection device includes a blood collection device.

33. The flow rate limiting device according to claim 32, wherein the blood collection device includes a luer lock access device.

34. The plug includes an inner surface defining a lumen of the plug, and the head portion includes a normally closed slit. The normally closed slit of the head portion is configured to prevent fluid from flowing from the distal connector into the proximal connector through the lumen. The flow rate limiting device according to claim 29.

35. The plug includes an inner surface defining a lumen of the plug, and the head portion includes a normally closed slit. When the normally closed slit is exposed to distal fluid pressure, the normally closed slit opens and allows fluid to flow from the proximal connector into the distal connector through the lumen. The flow rate limiting device according to claim 34.

36. The flow rate limiting device according to claim 35, wherein the continuous non-linear channel includes a first diameter, the lumen includes a second diameter, and the first diameter is smaller than the second diameter.

37. The flow rate limiting device according to claim 36, wherein the lumen defines an internal flow path through which the fluid flows from the proximal connector through the distal connector into the catheter assembly.

38. The flow rate limiting device according to claim 37, wherein the fluid flowing from the proximal connector through the distal connector into the catheter assembly includes intravenous (IV) fluid.

39. A flow rate limiting device, A first connector, comprising a female Luer portion at the proximal end, a male Luer portion at the distal end, an inner surface defining an inner lumen of the first connector, and a compressible valve member attached to the inner lumen, and configured to be coupled to a fluid collection device, the first connector; A second connector coupled to the male Luer portion of the first connector and configured to be coupled to a catheter assembly, the second connector including an inner surface defining an inner lumen of the second connector; A cannula attached to the inner lumen of the second connector and extending from the inner lumen into the female Luer portion of the first connector, wherein the compressible valve member is attached so as to surround at least a portion of the cannula, the cannula; A flow rate limiting device, in a state where the first connector and the fluid collection device are coupled, the compressible valve member is compressed by the fluid collection device to fluidly communicate the cannula and the fluid collection device through a slot of the compressible valve member.

40. The compressible valve member includes a head portion including the slot and a body portion extending distally from the head portion, and in a state where the first connector and the fluid collection device are coupled, the body portion of the compressible valve member is compressed to move the head portion distally, and by fluidly communicating the lumen of the cannula with the fluid collection device, the flow rate limiting device according to claim 39, which allows fluid to flow from the second connector into the fluid collection device through the lumen of the cannula.

41. The flow rate limiting device according to claim 40, wherein the body portion includes an accordion shape.

42. The flow rate limiting device according to claim 40, wherein the head portion includes a split septum.

43. The second connector further includes a support portion extending radially inward from the inner surface into the inner lumen of the second connector and including a mounting opening, and the cannula is attached to the mounting opening to fluidly communicate the second connector with the fluid collection device, the flow rate limiting device according to claim 39.

44. The flow rate limiting device according to claim 43, wherein the cannula is press-fitted into the support portion.

45. A flow rate limiting device, A first connector, comprising a female Luer portion having a lumen and disposed at a proximal end, a male Luer portion having a lumen and disposed at a distal end, and a compressible valve member attached to the lumen of the female Luer, and configured to be coupled to a fluid collection device, the first connector; A second connector, comprising a female Luer portion coupled to the male Luer portion of the first connector and a male Luer portion configured to be coupled to a catheter assembly, the female Luer portion of the second connector including an inner lumen, and the male Luer portion of the second connector including an inner lumen in fluid communication with the inner lumen of the female Luer portion of the second connector, the second connector; A post attached to the second connector and extending from the inner lumen of the male Luer portion of the second connector through the lumen of the male Luer portion of the first connector into an internal chamber of the compressible valve member, the compressible valve member being attached so as to surround at least a portion of the post, the post; A flow rate limiting device, in a state where the first connector and the fluid collection device are coupled, the compressible valve member being compressed by the fluid collection device to fluidly communicate the post and the fluid collection device through a slot of the compressible valve member.

46. The flow rate limiting device according to claim 45, wherein the post includes an elongated tube having a lumen tapered from a distal end to a proximal end of the post.

47. The compressible valve member includes a head portion including the slot and a body portion extending distally from the head portion. In a state where the first connector and the fluid collection device are coupled, the body portion of the compressible valve member is compressed to move the head portion distally, fluidly communicating the lumen of the post with the fluid collection device, thereby allowing fluid to flow from the second connector through the lumen of the post into the fluid collection device. The flow rate limiting device according to claim 45.

48. The flow rate limiting device according to claim 47, wherein the body portion includes an accordion shape.

49. The flow rate limiting device according to claim 47, wherein the head portion includes a split septum.

50. The second connector further includes a support portion at a proximal end of the male luer portion of the second connector, and the post is attached to the support portion to fluidly connect the second connector to the fluid collection device. The flow rate limiting device according to claim 45.

51. The support portion extends into the lumen of the female luer portion of the second connector so as to be distally separated from the male luer portion of the second connector. The flow rate limiting device according to claim 50.

52. The fluid flowing from the second connector into the fluid collection device through the lumen of the post includes blood, and the fluid collection device includes a blood collection device. The flow rate limiting device according to claim 46.

53. A flow rate limiting device, A male luer connector portion configured to be coupled to a catheter assembly, the male luer connector portion including an inner surface defining a lumen of the male luer connector portion; A female luer connector portion disposed proximal to the male luer connector portion and configured to be coupled to a fluid collection device, the female luer connector portion including an inner surface defining a lumen fluidly connected to the lumen of the male luer connector portion; A tube extending from the lumen of the male luer connector portion into the lumen of the female luer connector portion, the lumen of the tube defining a flow path through which fluid flows from the male luer connector portion through the female luer connector portion into the fluid collection device. A flow rate limiting device.

54. At least a portion of the tube includes a non-linear tube. The flow rate limiting device according to claim 53.

55. The portion of the non-linear tube including the non-linear tube is disposed in the lumen of the female luer connector portion. The flow rate limiting device according to claim 54.

56. The non-linear tube includes a coiled tube. The flow rate limiting device according to claim 54.

57. The non-linear tube includes an S-shaped tube. The flow rate limiting device according to claim 54.

58. The fluid flowing from the male luer connector portion through the female luer connector portion into the fluid collection device includes blood, and the fluid collection device includes a blood collection device. The flow rate limiting device according to claim 53.

59. The blood collection device is the flow rate limiting device according to claim 58, including a luer lock access device.

60. The tube is the flow rate limiting device according to claim 53, including a linear tube.

61. The linear tube is the flow rate limiting device according to claim 60, including a cannula attached to the male luer connector portion.

62. The male luer connector portion further includes a support portion that extends radially inward from the inner surface into the lumen of the male luer connector portion and includes a mounting opening, and the cannula is attached to the mounting opening to fluidly communicate the male luer connector portion with the fluid collection device. The flow rate limiting device according to claim 61.

63. The cannula is press-fitted into the support portion. The flow rate limiting device according to claim 62.

64. The fluid flowing from the male luer connector portion through the female luer connector portion into the fluid collection device contains blood, and the fluid collection device is the flow rate limiting device according to claim 60, including a blood collection device.

65. The blood collection device is the flow rate limiting device according to claim 64, including a luer lock access device.

66. A flow rate limiting device, A distal connector configured to be coupled to a catheter assembly, including a first connection portion at the proximal end of the distal connector and a second connection portion at the distal end of the distal connector, each of the first and second connection portions including an inner surface defining a lumen, a distal connector, A proximal connector coupled to the distal connector and configured to be coupled to a fluid collection device, An insert attached to the lumen of the first connection portion and including an outer surface, the outer surface having a groove formed in a concave shape on the outer surface and at least partially extending along the length of the outer surface, the groove being fluidly coupled to the lumen of the second connection portion and the lumen of the first connection portion, an insert, The inner surface of the first connection portion surrounds the outer surface of the insert such that the groove and the inner surface of the first connection portion define at least a part of a fluid channel through which fluid flows from the distal connector into the fluid collection device. A flow rate limiting device.

67. The flow rate limiting device according to claim 66, wherein the groove includes a linear groove formed in a concave shape on the outer surface.

68. The flow rate limiting device according to claim 67, wherein the outer surface further includes a longitudinally extending ledge, and each ledge is disposed at an edge on both sides of the linear groove to seal the edge.

69. The insert includes a first channel section fluidly coupled to a proximal end of the lumen of the second connection portion and a second channel section extending from the first channel section to the linear groove, and the first and second channel sections and the linear groove together define a fluid channel through which the fluid flows from the distal connector into the fluid collection device. The flow rate limiting device according to claim 67.

70. The flow rate limiting device according to claim 69, wherein the positions of the first channel section and the linear groove are offset from each other, and the second channel section includes an inclined surface that couples the first channel section to the linear groove.

71. The fluid flowing from the distal end into the fluid collection device includes blood, and the fluid collection device includes a blood collection device. The flow rate limiting device according to claim 66.

72. The blood collection device includes a luer lock access device. The flow rate limiting device according to claim 71.

73. A flow rate limiting device, A connector including a body portion having a lumen and disposed at a proximal end, a base portion having a lumen and disposed at a distal end, and a compressible valve member attached to the base portion and extending into the lumen of the body portion, wherein the body portion is configured to be coupled to a fluid collection device. A connector, A post having a lumen extending therethrough, the post being attached to the lumen of the base portion and extending into an internal chamber of the compressible valve member, the compressible valve member being attached surrounding the post, and the post being configured to be in fluid communication with a catheter assembly. A post, In the coupled state of the body portion and the fluid collection device, the compressible valve member is compressed by the fluid collection device to fluidly communicate the post and the fluid collection device through a slot of the compressible valve member. A flow rate limiting device.

74. The compressible valve member includes a head portion including the slot and a body portion extending distally from the head portion. In the coupled state of the body portion and the fluid collection device, the body portion of the compressible valve member is compressed to move the head portion distally, fluidly connecting the lumen of the post with the fluid collection device, thereby allowing fluid to flow through the lumen of the post from the distal end of the post into the fluid collection device. The flow rate limiting device according to claim 73.

75. The flow rate limiting device according to claim 74, wherein the body portion includes an accordion shape.

76. The flow rate limiting device according to claim 80, wherein the head portion includes a split septum.

77. The flow rate limiting device according to claim 73, wherein the lumen of the post tapers from the distal end to the proximal end of the post.

78. The fluid flowing through the lumen of the post from the distal end of the post into the fluid collection device includes blood, and the fluid collection device includes a blood collection device. The flow rate limiting device according to claim 83.

79. A flow rate limiting device, A connector including a female Luer portion having a lumen and disposed at the proximal end, a male Luer portion having a lumen and disposed at the distal end, and a compressible valve member attached to the lumen of the female Luer portion and fluidly coupled to the lumen of the male Luer portion, wherein the female Luer portion is configured to be coupled to a fluid collection device, and the male Luer portion is configured to be coupled to a catheter assembly. A connector, A post attached to the female Luer portion and extending into an internal chamber of the compressible valve member, wherein the compressible valve member is attached surrounding the post, and the post is in fluid communication with the lumen of the male Luer portion. A post, In the coupled state of the female Luer portion and the fluid collection device, the compressible valve member is compressed by the fluid collection device to fluidly connect the post and the fluid collection device through a slot of the compressible valve member. A flow rate limiting device.

80. The compressible valve member includes a head portion including the slot and a body portion extending distally from the head portion. In the coupled state of the female Luer portion and the fluid collection device, the body portion of the compressible valve member is compressed to move the head portion distally, fluidly connecting the lumen of the post with the fluid collection device, thereby allowing fluid to flow from the male Luer portion through the lumen of the post into the fluid collection device. The flow rate limiting device according to claim 79.

81. The body portion includes an accordion shape. The flow rate limiting device according to claim 80.

82. The head portion includes a split septum. The flow rate limiting device according to claim 80.

83. The female Luer portion further includes a support portion at the distal end of the female Luer portion. The post is attached to the support portion to fluidly connect the lumen of the male Luer portion with the fluid collection device. The flow rate limiting device according to claim 79.

84. The fluid flowing from the male Luer portion through the lumen of the post into the fluid collection device includes blood. The fluid collection device includes a blood collection device. The flow rate limiting device according to claim 83.

85. A flow rate limiting device, A housing having a proximal end, an inner surface defining an internal chamber of the housing, and a male Luer portion defining a distal end of the housing and having a lumen fluidly communicating with the internal chamber. The internal chamber of the housing is fluidly coupled to a connector. A housing, A slider reciprocally movably attached to the internal chamber. The slider includes a proximal end, a distal end, a mounting opening extending from the proximal end to the distal end of the slider, and a plurality of flow openings extending from the proximal end to the distal end of the slider and surrounding the mounting opening. A slider, A tube having a lumen extending therethrough. The tube is attached to the mounting opening and extends distally from the proximal end of the slider through the distal end of the slider. A tube, A spring member attached to the internal chamber surrounding at least a portion of the tube, the spring member applying a force to bias the proximal end of the slider against the inner surface of the housing to block fluid flow into the connector through the plurality of flow openings and allow fluid flow into the connector through the tube, a flow rate limiting device comprising:

86. When the slider is exposed to fluid pressure in the distal direction, the slider moves distally away from the inner surface of the housing and is configured to allow fluid to flow from the connector through the tube and the plurality of flow openings into the lumen of the male luer portion, the flow rate limiting device according to claim 85.

87. The plurality of flow openings includes at least four flow openings, the flow rate limiting device according to claim 86.

88. The plurality of flow openings extends longitudinally around the outer periphery of the slider, the flow rate limiting device according to claim 86.

89. Each of the plurality of flow openings and the inner surface of the internal chamber define a flow path for fluid to flow from the connector into the lumen of the male luer portion when the slider is exposed to fluid pressure in the distal direction, the flow rate limiting device according to the claim.

90. At least a portion of the tube includes a longitudinal body that extends uniformly in the internal chamber of the housing, the flow rate limiting device according to claim 86.

91. At least one of the diameter of the tube at the proximal end and the diameter of the tube at the distal end is greater than the diameter of the portion of the tube that includes a longitudinal body that extends uniformly in the internal chamber of the housing, the flow rate limiting device according to claim 90.

92. The tube extends radially outward from the portion of the tube that includes a longitudinal body that extends uniformly in the internal chamber of the housing to at least one of the proximal end and the distal end of the tube, the flow rate limiting device according to claim 90.

93. The slider includes a polyisopropene sealing material, the flow rate limiting device according to claim 86.

94. A blood collection system, comprising: A blood collection device comprising a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface. A flow restriction device fluidly coupled to the connection portion of the blood collection device, the flow restriction device including a cannula having an inner surface defining a through-going internal flow path, the internal flow path being fluidly coupled to the lumen of the needle for delivering blood withdrawn from a patient to the needle.

95. The blood collection system according to claim 94, wherein the blood collection device includes a luer lock access device.

96. The blood collection system according to claim 94, wherein the blood collection device includes a vacutainer.

97. A blood collection system comprising: A blood collection device comprising a container having an outer surface, an inner surface defining an internal chamber, and a connection portion extending distally from the outer surface and including a through-going lumen. A flow restriction device extending proximally from the inner surface and fluidly coupled to the lumen of the connection portion of the blood collection device, the flow restriction device including a cannula having an inner surface defining a through-going internal flow path, the internal flow path being fluidly coupled to the lumen of the connection portion for receiving blood withdrawn from a patient.

98. The blood collection system according to claim 97, wherein the blood collection device includes a luer lock access device.

99. The blood collection system according to claim 97, wherein the blood collection device includes a vacutainer.

100. A blood collection system comprising: A blood collection device comprising a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface. A flow restriction device engaged with the connection portion and fluidly coupled to the lumen of the needle, the flow restriction device being A connector including a proximal end disposed on the connection portion, a distal end configured to be coupled to a catheter assembly, and an inner surface defining an inner lumen. A cannula attached to the inner lumen, extending from the distal end of the connector into the connection portion, wherein the lumen of the cannula defines a flow path through which blood flows from the distal end into the lumen of the needle, and a flow rate limiting device, a blood collection system comprising.

101. The connector further includes a support portion disposed between the proximal end and the distal end of the connector, the support portion including a proximal end, a distal end, and a central mounting opening extending from the proximal end to the distal end, the cannula being attached to the central mounting opening for fluidly communicating the flow rate limiting device with the catheter assembly. The blood collection system according to claim 100.

102. The blood collection device includes a luer lock access device. The blood collection system according to claim 100.

103. The blood collection device includes a vacutainer. The blood collection system according to claim 100.

104. A blood collection system, A blood collection device, including a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface. A blood collection device, A flow rate limiting device engaged with the connection portion and fluidly coupled to the lumen of the needle, the flow rate limiting device comprising A connector including a proximal end disposed on the connection portion, a distal end configured to be coupled to a catheter assembly, and an inner surface defining an inner lumen. A connector, A cannula attached to the inner lumen, extending from the distal end of the connector to the proximal end, wherein the lumen of the cannula defines a flow path through which blood flows from the distal end into the lumen of the needle, and a flow rate limiting device, a blood collection system comprising.

105. The connector further includes a support portion disposed between the proximal end and the distal end of the connector, the support portion including a proximal end, a distal end, and a central mounting opening extending from the proximal end to the distal end, the cannula being attached to the central mounting opening for fluidly communicating the flow rate limiting device with the catheter assembly. The blood collection system according to claim 104.

106. The blood collection device is the blood collection system according to claim 104, including a luer lock access device.

107. The blood collection device is the blood collection system according to claim 104, including a vacutainer.

108. A blood collection system, A blood collection device, including a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface, the connection portion including an insertion portion having an outer surface with a continuously non-linear channel formed in a concave shape. A connector configured to be coupled to a catheter assembly, the connector including a first connection portion at a proximal end of the connector and a second connection portion at a distal end of the connector, the first connection portion including an inner surface defining a lumen to which the insertion portion is coupled. The inner surface of the first connection portion surrounds the outer surface of the insertion portion, whereby the continuously non-linear channel and the inner surface of the first connection portion define a non-linear fluid path through which fluid flows from the connector into the lumen of the needle.

109. The continuously non-linear channel includes a continuously grooved coil shape formed in a concave shape on the outer surface, the blood collection system according to claim 108.

110. The continuously non-linear channel includes a continuously grooved S-shape formed in a concave shape on the outer surface, the blood collection system according to claim 108.

111. The blood collection device is the blood collection system according to claim 108, including a luer lock access device.

112. The blood collection device is the blood collection system according to claim 108, including a vacutainer.

113. The connection portion includes a male luer connection portion, the blood collection system according to claim 108.

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