A single monolithic piece of PIVC integrated hemolysis reduction accessory for direct blood collection

Abstract

The flow restrictor may include a male luer connector portion, a female luer connector portion disposed proximally to the male luer connector portion, and a body portion extending between the male luer portion and the female luer portion and integrally formed with the male luer portion to form a single monolithic piece. The male luer connector portion may have an inner surface defining a lumen thereof, and the female luer connector portion may have an inner surface defining a lumen fluidly connected to the lumen of the male luer connector portion. The body portion may have a recess extending longitudinally therethrough and in fluid communication with the lumens of the male luer portion and the female luer portion. The recess may define a microchannel along which fluid flows from the male luer connector portion through the female luer connector portion to the fluid collection device.

Description

[Technical field]

[0001] The present disclosure relates generally to blood collection and administration of parenteral fluids to a patient, and more particularly to a system and method for reducing hemolysis in PIVC blood collection using a single monolithic piece flow restrictor device. [Background technology]

[0002] Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used to infuse fluids, such as normal saline, various medications, and total parenteral nutrition, into a patient. Catheters may also be used to withdraw blood from a patient.

[0003] A common type of catheter is the over-the-needle peripheral intravenous ("IV") catheter (PIVC). As the name suggests, an over-the-needle catheter may be mounted over an introducer needle that has a sharp distal tip. The catheter assembly may include a catheter hub, a catheter extending distally from the catheter hub, and an introducer needle extending through the catheter. The catheter and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter and the bevel of the needle points up, away from the patient's skin. The catheter and introducer needle are generally inserted at a shallow angle through the skin and into the patient's vasculature.

[0004] To verify proper placement of the introducer needle and / or catheter within the vessel, the clinician will typically confirm that there is a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician may temporarily occlude flow within the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid injection.

[0005] A blood collection container may be used for blood collection or taking a blood sample from a patient. The blood collection container may include a syringe. Alternatively, the blood collection container may include a test tube with a rubber stopper at one end. In some instances, the test tube has had all or some of the air removed from the test tube so that the pressure within the test tube is less than the ambient pressure. Such blood collection containers are often referred to as internal vacuum or vacuum tubes. A commonly used blood collection container is the VACUTAINER® blood collection tube available from Becton Dickinson & Company.

[0006] The blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure in the vein becomes greater than the pressure in the blood collection container, forcing blood into the blood collection container and filling the blood collection container. The vacuum in the blood collection container decreases as the blood collection container fills until the pressure in the blood collection container equals the pressure in the vein and blood flow stops.

[0007] Unfortunately, when blood is collected in a blood collection container, red blood cells are in a state of high shear stress and are prone to hemolysis due to the high initial pressure difference between the vein and the blood collection container. Hemolysis can result in the rejection and discarding of the blood sample. The high initial pressure difference can also result in the collapse of the catheter tip, the collapse of the vein, or other complications that prevent or limit the filling of the blood collection container with blood. Furthermore, blood leakage during and / or after blood collection is a common occurrence.

[0008] A description provided in the Background section should not be assumed to be prior art merely because it is mentioned in or associated with the Background section. The Background section may include information that describes one or more aspects of the subject technology. Summary of the Invention

[0009] The present disclosure provides a flow restriction device comprising: a male Luer connector portion configured to couple to a catheter assembly, the male Luer connector portion including an inner surface defining a lumen thereof; a female Luer connector portion disposed proximal to the male Luer connector portion and configured to couple 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 body portion extending between the male and female Luer portions and formed integrally with the male and female Luer portions to form a single monolithic piece, the body portion including a recess extending longitudinally therethrough and in fluid communication with the lumens of the male and female Luer portions, the recess defining a microchannel along which fluid flows from the male Luer connector portion through the female Luer connector portion to the fluid collection device.

[0010] In some examples, the present disclosure provides a method of manufacturing a single monolithic piece of a flow restricting device configured to limit hemolysis during drawing of blood from a patient, the method comprising the steps of providing first and second mold parts, each of the first and second mold parts including an imprint recessed therein, the imprints including a male luer connector imprint portion at a distal end portion of the first mold part, a female luer connector imprint portion at a proximal end portion thereof, a microchannel imprint portion extending longitudinally between the male luer connector imprint portion and the female luer connector imprint portion, and a reinforcing rib imprint portion surrounding the microchannel imprint portion. the steps of: inserting a male luer connector mold part into the male luer connector imprint portion; inserting a female luer connector mold part into the female luer connector imprint portion, the female luer connector mold part comprising a microchannel mold part extending from a distal end of the female luer connector mold part, the microchannel mold part being inserted into the microchannel imprint portion; bonding the first mold part and the second mold part to form a mold assembly; injecting molten mold material into the mold assembly; and cooling the mold assembly.

[0011] In some aspects, the present disclosure provides a flow restriction device comprising first and second connector halves fused together to form a unitary connector comprising: a male Luer connector portion configured to couple to a catheter assembly, the male Luer connector portion including an inner surface defining a lumen thereof; a female Luer connector portion disposed proximal to the male Luer connector portion and configured to couple 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 body portion extending between the male and female Luer portions and integrally formed with the male and female Luer portions to form a single monolithic piece, the body portion comprising at least one recess extending longitudinally therethrough and in fluid communication with the lumens of the male and female Luer portions, the at least one recess defining a microchannel along which fluid flows from the male Luer connector portion through the female Luer connector portion to the fluid collection device.

[0012] In some examples, the present disclosure provides a peripheral venous catheter assembly configured to limit hemolysis during collection of blood from a patient, the peripheral venous catheter assembly comprising: a male Luer connector portion configured to couple to a catheter assembly, the male Luer connector portion including an inner surface defining a lumen thereof; a female Luer connector portion disposed proximal to the male Luer connector portion and configured to couple 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 peripheral venous catheter assembly configured to couple 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 body portion extending between the male and female luer portions and integrally formed with the male and female luer portions to form a single monolithic piece, the body portion having a recess extending longitudinally therethrough and in fluid communication with the lumens of the male and female luer portions, the recess defining a microchannel, the microchannel configured to limit hemolysis of blood as blood is drawn from the patient through the male luer connector portion to the fluid draw device; a catheter hub having a proximal end and a distal end; and a fluid connector fluidly coupling the catheter hub to the flow restricting device.

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

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

[0015] [Figure 1] 1A-1D illustrate a vascular access device including a peripheral intravenous catheter (PIVC) assembly including a flow restriction device, according to some embodiments of the present disclosure. [Figure 2A] 1 is a perspective view of a flow restricting device according to some embodiments of the present disclosure. [Figure 2B] 2B is a top view of the flow restrictor device of FIG. 2A according to some embodiments of the present disclosure. [Figure 2C] 2C is a cross-sectional view of the flow restricting device of FIG. 2B taken along line 2C-2C, according to some embodiments of the present disclosure. [Figure 2D] 2B is a side view of the flow restricting device of FIG. 2A according to some embodiments of the present disclosure. [Figure 2E] 2E-2E is a cross-sectional view of the flow restricting device of FIG. 2D taken along line 2E-2E, according to some embodiments of the present disclosure. [Figure 3A] 1 is a perspective view of multiple mold parts for forming a flow restricting device according to some embodiments of the present disclosure. [Figure 3B] 1A-1C show an assembled mold for a flow restrictor device without a top mold for the flow restrictor device, according to some embodiments of the present disclosure. [Figure 4] 1 is a cross-sectional view of first and second connector halves of a flow restricting device according to some embodiments of the present disclosure. [Figure 5A] 1 is a perspective view of a flow restricting device according to some embodiments of the present disclosure. [Figure 5B] 5B is a cross-sectional view of the first and second halves of the flow restrictor device of FIG. 5A according to some embodiments of the present disclosure. [Figure 6] 1 is a cross-sectional view of first and second connector halves of a flow restricting device according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be implemented. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Thus, dimensions may be provided for specific embodiments as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be implemented 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 the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology are disclosed herein according to specific, but non-limiting examples. The various embodiments described in the present disclosure can be implemented in different ways and with modifications according to a desired application or implementation.

[0018] Blood collection via vascular access devices has attracted increasing attention due to minimal needle prick and improved operational efficiency compared to traditional blood collection methods by venipuncture. Several challenges have been observed in current blood collection using peripheral intravenous catheters (PIVCs), one of the most important being hemolysis-related blood quality. In particular, with existing PIVC products currently on the market, together with standard connections (such as short extension sets and needleless connectors) and blood collection devices (such as Vacutainers), the shear stress exerted on blood cells tends to be on the verge of hemolysis.

[0019] Various embodiments of the present disclosure relate to providing systems and methods for addressing hemolysis in PIVC blood collection using a hemolysis reduction accessory (also referred to herein as a flow restrictor) that is pre-attached to the PIVC and functions as a flow restrictor to reduce the risk of hemolysis. The hemolysis reduction accessory is advantageously compatible with PIVC placement and does not require modifications to any existing operations. The hemolysis reduction accessory of various embodiments described herein is potentially applicable to a wide variety of PIVC products and is compatible with existing blood collection equipment and infusion disposables.

[0020] Various embodiments of the present disclosure focus on effective flow restriction with an add-on hemolysis reduction accessory (also referred to herein as a flow restrictor) that regulates the overall flow rate of the entire fluid path as blood cells pass through. The flow restrictor may be assembled with the PIVC or packaged together with the PIVC. Thus, there is no additional manipulation during catheter placement, as the device has a vent lumen that allows blood flashback. The clinician may connect a blood draw device to the port of the accessory and then draw blood into the intended volume. After blood collection, the clinician may disconnect the flow restrictor and blood draw device from each other and discard them. Thus, the flow restrictor may be for a single blood draw or remain in-line throughout the entire placement.

[0021] The flow restriction devices and associated blood sampling systems of the various embodiments described herein further provide additional advantages over currently existing blood sampling systems. For example, the add-on flow restriction devices described herein allow for the integration of hemolysis reduction functionality for PIVC blood sampling. Furthermore, the flow restriction devices described herein are compatible with PIVC placement, allowing seamless blood sampling upon insertion. In addition, the flow restriction devices are add-ons that can be easily incorporated without modification of existing PIVCs, with minimal impact on clinical settings and operations.

[0022] FIG. 1 illustrates a vascular access device 10 including a peripheral intravenous catheter (PIVC) assembly 50 including a flow restriction device 100, according to some embodiments of the present disclosure. The flow restriction device 100 may be configured to reduce the possibility of hemolysis during blood collection using the vascular access device 10. In some embodiments, the vascular access device 10 may include a catheter assembly 50. The catheter assembly 50 may include a catheter hub 52, which may include a distal end 54, a proximal end 56, and a lumen extending through the distal end and the proximal end. 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 assembly 50 may be a peripheral intravenous catheter (PIVC).

[0023] In some embodiments, the catheter assembly 50 may include or correspond to any suitable catheter assembly 50. In some embodiments, the catheter assembly 50 may be integrated or may include an extension tube 60 that may extend from and be integrated into the 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, such as, for example, a Y adapter 70. In some embodiments, the flow restriction device 110 may be fluidly coupled to the Y adapter 70.

[0024] In some embodiments, the catheter assembly 50 may not be integrated and may not include the extension tube 60. In these and other embodiments, the flow restriction device 100 may be configured to couple to the proximal end 56 of the catheter hub 52 or another suitable portion of the catheter assembly 50. In some embodiments, the flow restriction device 100 may be coupled directly to the catheter assembly 50, thereby eliminating the extension tube 60 and providing a compact catheter system.

[0025] FIG. 2A shows a perspective view of a flow restricting device according to some embodiments of the present disclosure. FIG. 2B shows a top view of the flow restricting device of FIG. 2A according to some embodiments of the present disclosure. FIG. 2C shows a cross-sectional view of the flow restricting device of FIG. 2B along line 2C-2C according to some embodiments of the present disclosure. FIG. 2D shows a side view of the flow restricting device of FIG. 2A according to some embodiments of the present disclosure. FIG. 2E shows a cross-sectional view of the flow restricting device of FIG. 2D along line 2E-2E according to some embodiments of the present disclosure.

[0026] Continuing with reference to FIG. 1, as shown in FIGS. 2A-2E, in some embodiments, the flow restriction device 100 may include a male luer connector portion 150 configured to couple to the catheter assembly 50. The male luer connector portion 150 may have an inner surface 156 that defines a lumen 154 of the male luer connector portion 150. In some embodiments, the flow restriction device 100 may further include a female luer connector portion 110 disposed proximally of the male luer connector portion 150. The female luer connector portion 110 may be configured to couple to a fluid collection device 40 (e.g., a blood collection device). For example, the female luer connector portion 110 may be integral with the blood collection device 40 or may be formed as a single unit or piece monolithically with the blood collection device 40. As another example, the female luer connector portion 110 may be in the form of a female luer connector or another suitable connector that may be coupled to a male luer portion of the blood collection device 40. The female luer connector portion 110 may include an inner surface 115 defining a lumen 114 extending therethrough for coupling to a male luer portion of the blood draw set 40. The lumen 114 of the female luer connector portion 110 may be fluidly connected to a lumen 154 of the male luer connector portion via a recess or lumen 140 in the body portion 120 of the flow restrictor 100, as described below.

[0027] According to various embodiments of the present disclosure, the flow restrictor 100 may further include a body portion 120 extending between the male luer portion 150 and the female luer portion 110 and integrally formed therewith to form a single monolithic piece. The above-described configuration in which the flow restrictor 100 is formed as a single monolithic piece is advantageous over currently existing blood collection connectors that generally include multiple connectors coupled together. For example, the structure of the flow restrictor 100 formed as a single monolithic piece advantageously provides a design with reduced complexity and reduced cost compared to currently existing blood collection connectors that incorporate several parts and connectors. The structure of the flow restrictor 100 formed as a single monolithic piece also advantageously reduces material waste compared to currently existing blood collection connectors that incorporate several parts and connectors. Further advantageously, the structure of the flow restrictor 100 formed as a single monolithic piece reduces or eliminates the need to perform leak testing, thereby saving time and costs associated with testing.

[0028] As shown, the body portion 120 may include a recess or lumen 140 extending longitudinally therethrough and in fluid communication with the lumens 154 and 114 of the male luer portion 150 and the female luer portion 110. The lumen or recess 140 may define a microchannel 142 along which fluid flows from the male luer connector portion 150 through the female luer connector portion 110 to the fluid collection device 40. As shown, the lumen or recess 140 may place the catheter assembly 50 in fluid communication with the fluid collection device 40 via the flow restriction device 100. For example, in some embodiments, the leg 72 of the Y adapter 70 may be coupled to the flow restriction device 100. The leg 72 of the Y adapter 70 may include a lumen to which the distal end 151 of the male luer connector portion 150 may be coupled. The Y-adapter 70 may fluidly communicate the catheter assembly 50 and the flow restriction device 100 via the connector 90, shown as a needleless connector, and the recess or lumen 140, for example, via the extension tube 60. The lumen or recess 140 of the microchannel 142 may thus define a fluid pathway having a reduced, small, or micro-sized diameter (described below) through which fluid entering the flow restriction device 100 from the catheter assembly 50 may flow through the flow restriction device 100 for collection in the fluid collection device 40. For example, the medical fluid may be blood and the fluid collection device 40 may be a blood collection device, where blood is being withdrawn or collected from a patient. In some embodiments, the blood collection device may be a Luer Lock Access Device (LLAD). Thus, during blood collection or collection from a patient, a blood sample may flow from the distal end 151 of the male Luer connector portion 150 to the LLAD 40 via the flow path or microchannel 142 defined by the recess or lumen 140.

[0029] In some embodiments, the microchannel 142 defined by the recess or lumen 140 may be an elongated thin channel having a small, reduced, or micro-sized diameter. For example, in some embodiments, the recess or lumen 140 that defines the flow path or microchannel along which fluid may flow from the distal end 151 to the fluid collection device 40 may be: 0.050mm~0.064mm( 0.020~0.025 inch ) However, various embodiments of the present disclosure are not limited to the above configurations. In some embodiments, the recesses or lumens 142 that define the microchannels may have diameters in the range of 100 mm to 150 mm. length teeth, 25.4mm~33.0mm( 1 to 1.3 inches ) . Thus, during blood collection or withdrawal from a patient, blood 15 may flow into blood collection device 40 through a flow path or microchannel defined by recess or lumen 142 having a minimum diameter. The flow restriction device 100 of the various embodiments described herein is advantageous over currently existing blood collection systems. For example, during blood collection with currently existing blood collection devices, blood cells may experience wall shear stress as they flow from the distal end to the proximal end of the blood collection system. Wall shear stress on blood cells is believed to be the primary cause of mechanical damage to blood cells that causes hemolysis of the blood cells. A flow path or microchannel defined by lumen 142 having a minimum diameter may facilitate increased flow resistance within the vascular access system to distribute pressure differences and reduce shear stress experienced by red blood cells of blood 15. For example, the minimum diameter of a flow path or microchannel defined by lumen 142 may increase resistance to the flow of blood 15, thereby reducing blood flow rate within flow resistance device 100. A reduced blood flow rate may advantageously reduce the risk of hemolysis during blood collection, as this causes a reduction in the shear stress experienced by red blood cells of the blood 15.

[0030] The various embodiments of the flow restriction device 100 described herein having an integral flow path or microchannel defined by the lumen 142 of the recess 140 may be more cost-effective than currently existing blood collection connectors or accessories that incorporate cannulas, which tend to significantly increase the cost of the blood collection connector or accessory.

[0031] According to various embodiments of the present disclosure, the exterior surface 122 of the body portion 120 may include a plurality of laterally extending ribs 124 disposed about and surrounding the longitudinal axis X of the body portion 120. As shown, the plurality of laterally extending ribs 124 may be spaced apart from one another along the longitudinal axis X between the female luer connector portion 110 and the male luer connector portion 150. In some embodiments, the exterior surface 122 may further include at least one longitudinally extending rib 130 disposed along the longitudinal axis X and extending from the male luer connector portion 150 to the female luer portion 110. In some embodiments, as shown in FIG. 3, the body portion 120 may include a pair of longitudinally extending ribs 130 disposed on opposite sides of the body portion 120. As shown, the longitudinally extending ribs 130 may be disposed across and interconnect each of the laterally extending ribs 124. Thus, the plurality of laterally extending ribs 124 and the one or more longitudinally extending ribs 130 may form a grid or matrix shape that surrounds body portion 120 .

[0032] The grid or matrix configuration surrounding the body portion 120 may advantageously provide additional or enhanced structural integrity or rigidity as compared to currently existing connectors for blood collection systems. For example, in some embodiments, the grid or matrix configuration of laterally extending ribs 124 and longitudinally extending ribs 130 surrounding the body portion 120 may increase the rigidity between the male luer connector portion 150 and the female luer connector portion 110 of the flow restriction device 100, thereby making the flow restriction device 100 less susceptible to bending or twisting forces. The above-described configuration is advantageous in that by increasing the rigidity of the flow restriction device 100, it is made less flexible, thereby reducing the likelihood of blood leakage due to accidental or inadvertent bending or twisting of the flow control device 100. The above-described configuration of the flow restriction device, in which the laterally extending ribs 124 and longitudinally extending ribs 130 surround the body portion 120, may be further advantageous in providing the body portion with a surface that is easier to grip than a more uniform surface of the body portion 120.

[0033] FIG. 3A shows a perspective view of multiple mold parts for forming a flow restricting device according to some embodiments of the present disclosure. FIG. 3B shows an assembled mold of a flow restricting device without a top mold of the flow restricting device according to some embodiments of the present disclosure. According to some embodiments, a method of manufacturing a single monolithic piece of flow restricting device 100 may include providing a first mold part 205 and a second mold part 215. In some embodiments, the first mold part 205 and the second mold part 215 may be identical in structure and mirror each other. As shown, each of the first mold part 205 and the second mold part 215 may include a recessed imprint 220 therein. The imprint 220 may include a male luer connector imprint portion 225 at the distal end portion 230 of the first mold part 205, a female luer connector imprint portion 212 at its proximal end portion 235, a microchannel imprint portion 242 extending longitudinally between the male luer connector imprint portion 225 and the female luer connector imprint portion 212, and reinforcing rib imprint portions 222 and 232 surrounding the microchannel imprint portion 242.

[0034] In some embodiments, the method of manufacturing a single monolithic piece of flow restricting device 100 may further include inserting a male luer connector mold part 250 into the male luer connector imprint portion 225 and inserting a female luer connector mold part 210 into the female luer connector imprint portion 212. As shown in FIG. 3B, the female luer connector mold part 210 may have a microchannel mold part 240 extending from a distal end of the female luer connector mold part 210, and the microchannel mold part may be inserted into the microchannel imprint portion 242. According to various embodiments of the present disclosure, the method may further include joining the first mold part 205 and the second mold part 215 to form a mold assembly and injecting molten mold material into the mold assembly. The method may further include cooling the mold assembly to allow the molten mold material to cool and assume the shape of the flow restricting device 100.

[0035] FIG. 4 shows a cross-sectional view of the first connector half 100A and the second connector half 100B of the flow restriction device 100 according to some embodiments of the present disclosure. According to various embodiments of the present disclosure, a single piece flow restriction device 100 may be formed by permanently bonding two identical halves 100A and 100B together, as shown in FIG. 4. The structure of the two connector halves 100A and 100B when joined may be identical to the structure of the flow restriction device 100. Thus, the same reference numbers are used to indicate corresponding features of the first connector half 100A and the second connector half 100B, except that corresponding elements of the first connector half 100A and the second connector half 100B include either an "A" or a "B" at the end of the reference number to indicate the respective connector half to which the feature corresponds. Thus, a detailed description of the features of the first connector half 100A and the second connector half 100B that are identical to the flow restriction device 100 is omitted with respect to FIG. 4. For example, in some embodiments, the single piece flow restriction device 100 may be formed by ultrasonically welding two halves 100A and 100B together. In particular, in some embodiments, the first half 100A and the second half 100B may be ultrasonically welded around weld lines defined along the inner surfaces 156A, 156B that define the lumens 154A, 154B of the male luer connector portions 150A, 150B, the inner surfaces 115A, 115B that define the lumens 114A, 114B of the female luer connector portions 110A, 110B, and the inner surfaces 156A, 156B of at least one recess or lumen 140A, 140B that defines the microchannels 142A, 142B. However, various embodiments of the present disclosure are not limited to the above-mentioned configurations. In some embodiments, the first connector half 100A and the second connector half 100B may be permanently attached to one another by any other suitable adhesive or attachment method.

[0036] The above-described configuration of the flow restriction device 100 having the first connector half 100A and the second connector half 100B may be advantageous in that the weld lines defined along the inner surfaces 156A, 156B defining the lumens 154A, 154B of the male luer connector portions 152A, 152B, the inner surfaces 115A, 115B defining the lumens 114A, 114B of the female luer connector portions 110A, 110B, and the at least one recess or inner surface 156A, 156B of the lumens 140A, 140B defining the microchannels 142A, 142B may provide additional or enhanced sealing of the fluid pathway from the male luer connector portion 150 to the female luer connector portion 110 to prevent leakage of medical fluids, e.g., blood during blood collection.

[0037] FIG. 5A is a perspective view of a flow restriction device 300 according to some embodiments of the present disclosure. FIG. 5B shows a cross-sectional view of the first half 300A and the second half 300B of the flow restriction device of FIG. 5A according to some embodiments of the present disclosure. As shown, the structure of the two connector halves 300A and 300B may be identical to the structure of the two connector halves 100A and 100B of the flow restriction device 100, except that the flow restriction device 300 may further include a tubing 340 attached to the lumen or recess 140 (i.e., 140A and 140B). Thus, the same reference numerals are used to indicate corresponding features in the first connector half 300A and the second connector half 300B. For this reason, a detailed description of the features of the first connector half 300A and the second connector half 300B that are identical to the flow restriction device 100 is omitted with respect to FIG. 5A and FIG. 5B. For example, in some embodiments, a single piece flow restrictor 300 may be formed by ultrasonically welding two halves 300A and 300B together with tubing 340 sandwiched between them.

[0038] In some embodiments, the tubing 340 may have a proximal end 346, a distal end 344, and an inner surface defining a lumen 342 extending therethrough. The tubing 340 may be attached to the lumen or recess 140 and may be interposed between and extend between the lumen 114 of the female luer connector portion 110 and the lumen 154 of the male luer connector portion. According to some embodiments of the present disclosure, the lumen 342 of the tubing 340 may define a flow path or microchannel along which a fluid (e.g., blood) may flow from the flow restriction device 300 to the fluid collection device 40. In some embodiments, the flow path or microchannel defined by the lumen 342 of the tubing may be an elongated thin channel having a small, reduced, or micro-sized diameter. For example, in some embodiments, the flow path or microchannel defined by the lumen 342 may be an elongated thin channel having a small, reduced, or micro-sized diameter. 0.050mm~0.064mm( 0.020~0.025 inch ) In some embodiments, the tubing 340 may be removed after joining of the two halves 300A and 300B, and with the tubing therebetween during joining of the two halves, the tubing can contribute to proper alignment of the microchannels 142A, 142B. However, various embodiments of the present disclosure are not limited to the above configurations.

[0039] In some embodiments, the flow path or microchannel defined by the lumen 342 length teeth, 25.4mm~33.0mm( 1 ~ 1.3 inches )3. Thus, during blood draw or withdrawal from a patient, blood may flow into blood draw device 40 through a flow path or microchannel defined by lumen 342 having a minimum diameter. The flow path or microchannel defined by lumen 342 of tubing 340 having a minimum diameter may promote increased flow resistance within the vascular access system to distribute pressure differentials and reduce shear stress experienced by red blood cells of the blood. For example, the minimum diameter of the flow path or microchannel defined by lumen 342 may increase resistance to blood flow, thereby reducing blood flow rate within flow restricting device 300. The reduced blood flow rate may advantageously reduce the risk of hemolysis during blood draw, as it causes a reduced shear stress experienced by red blood cells of blood 15.

[0040] FIG. 6 illustrates a cross-sectional view of a first connector half 400A and a second connector half 400B of a flow restriction device 400 according to some embodiments of the present disclosure. As illustrated, the structure of the two connector halves 400A and 400B may be identical to the structure of the two connector halves 100A and 100B of the flow restriction device 100, except that the flow restriction device 400 may include first lumens or recesses 440A, 440B and second lumens or recesses 444A, 444B. Thus, the same reference numerals are used to indicate corresponding features in the first connector half 400A and the second connector half 400B. For this reason, a detailed description of the features of the first connector half 400A and the second connector half 400B that are identical to the flow restriction device 100 is omitted with respect to FIG. 6. For example, in some embodiments, a single piece flow restriction device 400 may be formed by ultrasonically welding two halves 400A and 400B together.

[0041] In some embodiments, the first lumen or recess 440 defined by the combined lumen or recess halves 440A, 440B may have an inner surface 441A, 441B defining a microchannel 442A, 442B therein. Similarly, the second lumen or recess 444 defined by the combined lumen or recess halves 444A, 444B may have an inner surface 445A, 445B defining a microchannel 446A, 446B therein. According to various embodiments of the present disclosure, the flow path defined in each of the microchannels 442A, 442B, 446A, and 446B may be an elongated thin channel having a small, reduced, or micro-sized diameter. For example, in some embodiments, the flow path defined in each of the microchannels 442A, 442B, 446A, and 446B may be an elongated thin channel having a small, reduced, or micro-sized diameter. 0.050mm~0.064mm( 0.020~0.025 inch ) However, various embodiments of the present disclosure are not limited to the above configurations. In some embodiments, the flow path or microchannel defined by lumen 442 may have a diameter in the range of 0.01 mm to 0.1 mm. length teeth, 25.4mm~33.0mm( 1 ~ 1.3 inches ) Thus, during blood draw or withdrawal from a patient, blood may enter blood draw device 40 via a flow path or microchannel defined by lumen 442 having a smallest diameter.

[0042] A flow path defined in each of microchannels 442A, 442B, 446A, and 446B having a minimum diameter may advantageously promote increased flow resistance within the vascular access system to distribute pressure differentials and reduce shear stress experienced by red blood cells of the blood being drawn. For example, a minimum diameter of a flow path defined in each of microchannels 442A, 442B, 446A, and 446B may increase resistance to the flow of blood 15, thereby reducing blood flow rate within flow resistance device 400. A reduced blood flow rate may advantageously reduce the risk of hemolysis during blood draw, as it causes a reduction in shear stress experienced by red blood cells of the blood.

[0043] Examples of subject matter art as clauses The subject technology is exemplified by various aspects described below, for example. 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 are not intended to limit the subject technology. Note that any of the dependent clauses may be combined in any combination and placed in their own independent clause, e.g., clause 1 or clause 5. Other clauses may be presented as well.

[0044] Clause 1. A flow restriction device comprising: a male Luer connector portion configured to couple to a catheter assembly, the male Luer connector portion including an inner surface defining a lumen thereof; a female Luer connector portion disposed proximal to the male Luer connector portion and configured to couple 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 body portion extending between the male Luer portion and the female Luer portion and formed integrally with the male Luer portion and the female Luer portion to form a single monolithic piece, the body portion including a recess extending longitudinally therethrough and in fluid communication with the lumens of the male Luer portion and the female Luer portion, the recess defining a microchannel along which fluid flows from the male Luer connector portion through the female Luer connector portion to the fluid collection device.

[0045] Clause 2. A flow restricting device as described in clause 1, wherein the outer surface of the body portion is provided with a plurality of laterally extending ribs arranged about and circumscribing the longitudinal axis of the body portion, the plurality of ribs being spaced apart from one another along the longitudinal axis between the female luer connector portion and the male luer connector portion.

[0046] Clause 3. A flow restriction device as described in clause 2, wherein the outer surface of the body portion further comprises at least one longitudinally extending rib disposed along the longitudinal axis and extending from the male luer connector portion to the female luer connector portion.

[0047] Clause 4. The flow restrictor device of clause 3, wherein a longitudinally extending rib is disposed across and interconnects each of the transversely extending ribs.

[0048] Clause 5. A flow restrictor device as described in clause 3, wherein the at least one longitudinally extending rib comprises a pair of longitudinally extending ribs disposed on opposite sides of the outer surface of the body portion.

[0049] Clause 6. A flow restrictor device as described in clause 5, wherein a pair of longitudinally extending ribs are disposed across and interconnect each of the transversely extending ribs on opposite sides of the exterior surface of the body portion.

[0050] Clause 7. A flow restriction device as described in clause 4, wherein the fluid flowing from the male luer connector portion through the female luer connector portion into the fluid collection device comprises blood, and the fluid collection device comprises a blood collection device.

[0051] Clause 8. The flow restriction device of clause 8, wherein the blood draw device comprises a luer lock access device.

[0052] Clause 9. A method of manufacturing a single monolithic piece of flow restriction device configured to limit hemolysis during the withdrawal of blood from a patient, the method comprising the steps of providing first and second mold parts, each of the first and second mold parts including an imprint recessed therein, the imprint including a male luer connector imprint portion at a distal end portion of the first mold part, a female luer connector imprint portion at a proximal end portion thereof, a microchannel imprint portion extending longitudinally between the male luer connector imprint portion and the female luer connector imprint portion, and a reinforcing rib imprint portion surrounding the microchannel imprint portion; a step of inserting a male luer connector mold part into the male luer connector imprint portion; a step of inserting a female luer connector mold part into the female luer connector imprint portion, the female luer connector mold part comprising a microchannel mold part extending from a distal end of the female luer connector mold part, the microchannel mold part being inserted into the microchannel imprint portion; a step of bonding the first mold part and the second mold part to form a mold assembly; a step of injecting molten mold material into the mold assembly; and a step of cooling the mold assembly.

[0053] Clause 10. A flow restriction device comprising first and second connector halves fused together to form a single connector, the single connector comprising: a male luer connector portion configured to couple to a catheter assembly, the male luer connector portion including an inner surface defining a lumen thereof; a female luer connector portion disposed proximal to the male luer connector portion and configured to couple 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 body portion extending between the male luer portion and the female luer portion and integrally formed with the male luer portion and the female luer portion to form a single monolithic piece, the body portion comprising at least one recess extending longitudinally therethrough and in fluid communication with the lumens of the male luer portion and the female luer portion, the at least one recess defining a microchannel along which fluid flows from the male luer connector portion through the female luer connector portion to the fluid collection device.

[0054] Clause 11. A flow restriction device as described in clause 10, wherein the first and second connector halves are ultrasonically welded around a weld line defined along an inner surface that defines a lumen of the male luer connector portion, the inner surface defining a lumen of the female luer connector portion, and an inner surface of at least one recess defining a microchannel.

[0055] Clause 12. A flow restricting device as described in clause 11, wherein the lumen of the male luer connector portion, the microchannel, and the lumen of the female luer connector portion define a fluid path along which fluid travels through the flow restricting device, and the weld line seals the outer periphery of the fluid path against leakage.

[0056] Clause 13. A flow restricting device as described in clause 11, wherein the outer surface of the body portion is provided with a plurality of laterally extending ribs arranged about and circumscribing the longitudinal axis of the body portion, the plurality of ribs being spaced apart from one another along the longitudinal axis between the female luer connector portion and the male luer connector portion.

[0057] Clause 14. A flow restricting device as described in clause 13, wherein the outer surface of the body portion further comprises at least one longitudinally extending rib disposed along the longitudinal axis and extending from the male luer portion to the female luer portion.

[0058] Clause 15. The flow restricting device of clause 14, wherein at least one longitudinally extending rib is disposed across and interconnects each of the transversely extending ribs.

[0059] Clause 16. A flow restrictor device as described in clause 13, wherein the at least one longitudinally extending rib comprises a pair of longitudinally extending ribs respectively disposed on corresponding halves of a side of the exterior surface of the body portion.

[0060] Clause 17. The flow restriction device of clause 11, further comprising tubing mounted within the recess defining the microchannel.

[0061] Clause 18. A flow restricting device as described in clause 10, wherein at least one recess comprises a plurality of recesses defining a plurality of microchannels each fluidly connecting a lumen of the male luer connector portion with a lumen of the female luer connector portion.

[0062] Clause 19. A flow restricting device as described in clause 18, wherein the first and second connector halves are ultrasonically welded around a plurality of weld lines defined along an inner surface that defines a lumen of the male luer connector portion, the inner surface defining a lumen of the female luer connector portion, and each of the plurality of inner surfaces of the at least one recess defines a microchannel.

[0063] Clause 20. A flow restricting device as described in clause 19, wherein the lumen of the male luer connector portion, each of the plurality of microchannels, and the lumen of the female luer connector portion define a plurality of fluid paths along which fluid travels through the flow restricting device, and the weld seam seals the periphery of each fluid path against leakage.

[0064] Clause 21. A peripheral venous catheter assembly configured to limit hemolysis during collection of blood from a patient, comprising: a male luer connector portion configured to couple to the catheter assembly, the male luer connector portion including an inner surface defining a lumen thereof; a female luer connector portion disposed proximal to the male luer connector portion and configured to couple 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 female luer connector portion extending between the male luer portion and the female luer portion, the female luer connector portion including an inner surface defining a lumen fluidly connected to the lumen of the male luer connector portion. a body portion integrally formed with the male and female Luer portions to form a single monolithic piece, the body portion having a recess extending longitudinally therethrough and in fluid communication with the lumens of the male and female Luer portions, the recess defining a microchannel, the microchannel configured to limit hemolysis of blood as blood is drawn from a patient through the male Luer connector portion to the female Luer connector portion and into a fluid collection device; a flow restriction device; a catheter hub having a proximal end and a distal end; and a fluid connector fluidly coupling the catheter hub with the flow restriction device.

[0065] The present disclosure is provided to enable those skilled in the art to practice the various aspects described herein. The present disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0066] Reference to a singular element is intended to mean "one or more" and not "one and only one" unless otherwise specified. The term "several" refers to one or more, unless otherwise specified. Masculine pronouns (e.g., his) include feminine and neuter (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and are not intended to limit the invention.

[0067] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or useful over other aspects or designs. In one aspect, various alternative configurations and operations described herein can be considered at least equivalent.

[0068] As used herein, the phrase "at least one of" following a series of items, when followed by the term "or" to separate any of the items, modifies the entire list and not each item in the list. The phrase "at least one of" does not require the selection of at least one item; rather, the phrase allows for a meaning including at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. As an example, the phrase "at least one of A, B, or C" may refer to only A, only B, or only C, or any combination of A, B, and C.

[0069] A phrase such as "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure regarding an aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such an embodiment is essential to the subject technology or that such an embodiment applies to all configurations of the subject technology. Disclosure regarding an embodiment may apply to all embodiments, or to one or more embodiments. An embodiment may provide one or more examples. A phrase such as an embodiment may refer to one or more embodiments, and vice versa. A phrase such as "configuration" does not imply that such a configuration is essential to the subject technology or that such a configuration applies to all configurations of the subject technology. Disclosure regarding a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase such as "configuration" may refer to one or more configurations, and vice versa.

[0070] In one aspect, unless otherwise stated, all measurements, values, ratings, positions, dimensions, sizes, and other specifications set forth in this specification, including the claims that follow, are approximate and not exact, and are intended to have a reasonable range consistent with the function to which they relate and with those customary in the art to which they pertain.

[0071] It is understood that the specific order or hierarchy of steps or operations in the disclosed processes or methods is illustrative of example approaches. It is understood that the specific order or hierarchy of steps, operations, or processes may be rearranged based on implementation preferences or scenarios. Some of the steps, operations, or processes may be performed simultaneously. In some implementation preferences or scenarios, certain operations may or may not be performed. Some or all of the steps, operations, or processes may be performed automatically without user intervention. The accompanying method claims present the various steps, operations, or process elements in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0072] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or that later become known to those skilled in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is expressly set forth in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. 112(f) unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is recited using the phrase "step for". Moreover, to the extent that terms such as "comprises," "having," and the like are used, such terms are intended to be similarly inclusive in the manner in which "comprises" is interpreted when the term "comprises" is used as a transitional term in the claims.

[0073] The title, background, summary, brief description of the drawings, and abstract of the present disclosure are hereby incorporated into the present disclosure and are provided as illustrative examples of the present disclosure, not as limiting descriptions. They are submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the detailed description, it will be understood that various features have been grouped together in various embodiments for the purpose of providing illustrative examples and streamlining the disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The following claims are hereby incorporated into the detailed description, with each claim standing on its own as separately claimed subject matter.

[0074] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the full scope consistent with the language of the claims and include all legal equivalents. Nonetheless, none of the claims are intended, and should not be construed, to cover subject matter that does not meet the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

**Claim 1** A male luer connector portion configured to couple to a catheter assembly, the male luer connector portion including an inner surface that defines its lumen, the male luer connector portion, and A female luer connector portion disposed proximally to the male luer connector portion and configured to couple to a fluid sampling device, the female luer connector portion including an inner surface that defines a lumen fluidly connected to the lumen of the male luer connector portion, the female luer connector portion, and A body portion extending between the male luer portion and the female luer portion and integrally formed with the male luer portion and the female luer portion to form a single monolithic piece, the body portion having a recess extending longitudinally therethrough and in fluid communication with the lumens of the male luer portion and the female luer portion, the recess defining a microchannel along which fluid flows from the male luer connector portion through the female luer connector portion to the fluid sampling device, the body portion Comprising a flow restriction device. **Claim 2** The flow restriction device according to claim 1, wherein an outer surface of the body portion comprises a plurality of laterally extending ribs disposed around and surrounding a longitudinal axis of the body portion, the plurality of ribs being spaced apart from each other along the longitudinal axis between the female luer connector portion and the male luer connector portion. **Claim 3** The flow restriction device according to claim 2, wherein the outer surface of the body portion further comprises at least one longitudinally extending rib disposed along the longitudinal axis and extending from the male luer connector portion to the female luer connector portion. **Claim 4** The flow restriction device according to claim 3, wherein the longitudinally extending rib is disposed across each of the laterally extending ribs and interconnects them. **Claim 5** The flow restriction device according to claim 3, wherein the at least one longitudinally extending rib comprises a pair of longitudinally extending ribs disposed on both sides of the outer surface of the body portion. **Claim 6** The flow restriction device according to claim 5, wherein the pair of longitudinally extending ribs is disposed across each of the laterally extending ribs on both sides of the outer surface of the body portion and interconnects them. **Claim 7** 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 comprises a blood collection device. The flow restriction device according to claim 4.

8. The flow restriction device according to claim 7, wherein the blood collection device comprises a luer lock access device.

9. A method of manufacturing a single monolithic piece flow restriction device configured to limit hemolysis during blood collection from a patient, the method comprising: Providing first and second mold parts, each of the first and second mold parts including an imprint recessed therein, the imprint including a male luer connector imprint portion at a distal end portion of the first mold part, a female luer connector imprint portion at a proximal end portion thereof, a microchannel imprint portion extending longitudinally between the male luer connector imprint portion and the female luer connector imprint portion, and a reinforcing rib imprint portion surrounding the microchannel imprint portion. Inserting a male luer connector mold part into the male luer connector imprint portion. Inserting a female luer connector mold part into the female luer connector imprint portion, the female luer connector mold part comprising a microchannel mold part extending from a distal end of the female luer connector mold part, the microchannel mold part being inserted into the microchannel imprint portion. Combining the first mold part and the second mold part to form a mold assembly. Injecting molten mold material into the mold assembly. Cooling the mold assembly A method including.

10. First and second connector halves fused to each other to form a single connector A flow restriction device comprising: A male luer connector portion configured to couple to a catheter assembly, the male luer connector portion including an inner surface defining its lumen. A female luer connector portion disposed proximally to the male luer connector portion and configured to couple 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, the female luer connector portion and A body portion extending between the male luer portion and the female luer portion and integrally formed with the male luer portion and the female luer portion to form a single monolithic piece, the body portion having at least one recess extending longitudinally therethrough and in fluid communication with the lumens of the male luer portion and the female luer portion, the at least one recess defining a microchannel along which fluid flows from the male luer connector portion through the female luer connector portion into the fluid collection device, the body portion and Comprising A flow restriction device.

11. The first and second connector halves are ultrasonically welded around a weld line defined along the inner surface defining the lumen of the male luer connector portion, the inner surface defining the lumen of the female luer connector portion, and the inner surface of the at least one recess defining the microchannel. The flow restriction device according to claim 10.

12. The lumen of the male luer connector portion, the microchannel, and the lumen of the female luer connector portion define a fluid path along which fluid moves through the flow restriction device, and the weld line seals the outer periphery of the fluid path from leakage. The flow restriction device according to claim 11.

13. The outer surface of the body portion is disposed around the longitudinal axis of the body portion and includes a plurality of laterally extending ribs surrounding the longitudinal axis of the body portion, the plurality of ribs being spaced apart from each other along the longitudinal axis between the female luer connector portion and the male luer connector portion. The flow restriction device according to claim 11.

14. The outer surface of the body portion is disposed along the longitudinal axis and further includes at least one longitudinally extending rib extending from the male luer portion to the female luer portion. The flow restriction device according to claim 13.

15. The at least one longitudinally extending rib is disposed across each of the laterally extending ribs and interconnects them. The flow restriction device according to claim 14.

16. The flow restriction device according to claim 13, wherein the at least one longitudinally extending rib comprises a pair of longitudinally extending ribs respectively disposed on corresponding halves of the side surface of the outer surface of the body portion.

17. The flow restriction device according to claim 11, further comprising a tubing mounted in the recess defining the microchannel.

18. The flow restriction device according to claim 10, wherein the at least one recess comprises a plurality of recesses each defining a plurality of microchannels that fluidly communicate the lumen of the male luer connector portion with the lumen of the female luer connector portion.

19. The flow restriction device according to claim 18, wherein the first and second connector halves are ultrasonically welded around a plurality of weld lines defined along the inner surface defining the lumen of the male luer connector portion, the inner surface defining the lumen of the female luer connector portion, and each of the plurality of inner surfaces of the at least one recess defines the microchannel.

20. A peripheral venous catheter assembly configured to limit hemolysis during blood collection from a patient, A male luer connector portion configured to couple to the catheter assembly, the male luer connector portion including an inner surface defining its lumen, A female luer connector portion disposed proximal to the male luer connector portion and configured to couple 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 body portion extending between the male luer portion and the female luer portion and integrally formed with the male luer portion and the female luer portion to form a single monolithic piece, the body portion having a recess extending longitudinally therethrough and in fluid communication with the lumens of the male luer portion and the female luer portion, the recess defining a microchannel, the microchannel being configured to limit hemolysis of blood when the blood is collected from the patient through the male luer connector portion via the female luer connector portion to the fluid collection device, A flow restriction device comprising: A catheter hub having a proximal end and a distal end A fluid connector fluidly coupling the catheter hub to the flow restriction device and comprising a peripheral intravenous catheter assembly.

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