Hemolysis reduction extension set for direct blood collection

Abstract

The flow restrictor may include a male luer connector portion, a female luer connector portion, and a flexible tube. The male luer connector portion defines a first lumen. The female luer connector portion defines a second lumen. The flexible tube defines a third lumen. The third lumen is in fluid communication with the first and second lumens. The third lumen has a diameter of approximately 0.02 inches.

Description

[Technical Field]

[0001] The present disclosure relates generally to blood collection and administration of parenteral fluids to patients, and more particularly to systems and methods for reducing hemolysis in PIVC blood collection using an extension set. [Background technology]

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

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

[0004] To verify proper placement of the introducer needle and / or catheter within the blood vessel, clinicians typically confirm the presence of a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can 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 to withdraw blood from a patient or to collect 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 cases, the test tube has had all or a portion of the air removed from it so that the pressure within the tube is less than 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] A blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure in the vein is greater than the pressure in the blood collection container, forcing blood into the blood collection container, which then fills with blood. 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 drawn into a blood collection container, the high initial pressure difference between the vein and the blood collection container places red blood cells in a state of high shear stress, making them susceptible to hemolysis. Hemolysis can lead to rejection and discarding of the blood sample. The high initial pressure difference can also lead to collapsed catheter tips, collapsed veins, or other problems that prevent or restrict blood from filling the blood collection container. Additionally, blood spillage commonly occurs during and / or after blood collection.

[0008] A statement made in the Background Art section should not be considered prior art merely because it is mentioned in or associated with the Background Art section. The Background Art section may include information that describes one or more aspects of the subject technology. Summary of the Invention [Means for solving the problem]

[0009] The present disclosure provides a flow restrictor device comprising a male luer connector portion defining a first lumen, a female luer connector portion defining a second lumen, and a flexible tube defining a third lumen, the third lumen being in fluid communication with the first lumen and the second lumen, the third lumen having a diameter of approximately 0.508 mm (0.02 inches).

[0010] In some cases, the present disclosure provides a flow restrictor device comprising a male luer connector portion defining a first lumen, a female luer connector portion defining a second lumen, and a tube defining a third lumen, the third lumen being in fluid communication with the first lumen and the second lumen, the third lumen having a diameter of approximately 0.508 mm (0.02 inches) and a length of approximately 33.02 mm (1.3 inches).

[0011] In some embodiments, the present disclosure provides a peripheral intravenous catheter assembly configured to limit hemolysis during blood withdrawal from a patient, the peripheral intravenous catheter assembly comprising: a catheter hub having a proximal end and a distal end; a fluid collection device; and a flow restriction device, the flow restriction device comprising: a male luer connector portion coupled to the catheter hub and defining a first lumen; a female luer connector portion defining a second lumen in fluid communication with the fluid collection device; and tubing defining a third lumen, the third lumen in fluid communication with the first lumen and the second lumens, the third lumen having a diameter of approximately 0.508 mm (0.02 inches).

[0012] Various configurations of the subject technology have been shown and described by way of illustration, with the understanding that other configurations of the subject technology will be readily apparent to those skilled in the art from the following detailed description. As will be understood, the subject technology is capable of other and different configurations, and its several details can be modified 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.

[0013] The following figures are included to illustrate certain aspects of the embodiments and should not be considered as exclusive examples. The disclosed subject matter is capable of considerable modification, permutation, combinations, and equivalents in form and function that will occur to those skilled in the art and having the benefit of this disclosure. [Brief explanation of the drawings]

[0014] [Figure 1] 1 illustrates 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 2] FIG. 1 illustrates a perspective view of a flow restrictor device, according to some embodiments of the present disclosure. [Figure 3] 3 illustrates a cross-sectional view of the flow restrictor device of FIG. 2 according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0015] 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 practiced. The detailed description includes specific details to achieve a thorough understanding of the subject technology. Thus, dimensions may be given as non-limiting examples for certain embodiments. 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.

[0016] It should be understood that the present disclosure includes examples of the subject technology and is not intended to limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed by way of specific examples, but not by way of limitation. The various embodiments described in this disclosure can be implemented in different ways and variations and depending on the desired application or implementation.

[0017] Blood collection via vascular access devices has attracted increasing attention due to the minimized needle stick injury and improved operational efficiency compared to traditional blood collection by venipuncture. Current blood collection using peripheral intravenous catheters (PIVCs) encounters several challenges, one of the most significant being blood quality related to hemolysis. In particular, the shear stress acting on blood cells by existing PIVC products on the market with standard connections (such as short extension sets and needleless connectors) and blood collection devices (such as vacutainers) tends to be close to hemolysis.

[0018] Various embodiments of the present disclosure are directed to providing systems and methods for addressing hemolysis in PIVC blood collection with a hemolysis reduction accessory (also referred to herein as a flow restrictor), such as an extension set, that is pre-attached to the PIVC and acts as a flow restrictor to reduce the risk of hemolysis. The hemolysis reduction accessory is advantageously compatible with PIVC configurations and does not require any modifications to current operations. The hemolysis reduction accessories of various embodiments described herein are potentially applicable to a wide variety of PIVC products and are compatible with current blood collection devices and infusion disposables.

[0019] 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 restrictor), which regulates the overall flow rate of the entire fluid path through which blood cells travel. The flow restrictor may be assembled with the PIVC or co-packaged with the PIVC. The clinician can connect a blood collection device to the accessory's port and then draw blood into the volume of interest. After blood collection, the clinician can disconnect and discard the flow restrictor and blood collection device together. Thus, this flow restrictor can be for a single blood draw or can remain in-line throughout the entire placement.

[0020] The flow restrictor devices and associated blood collection systems of various embodiments described herein further provide additional advantages over existing blood collection systems. For example, the add-on flow restrictor devices described herein allow for the integration of hemolysis reduction functionality for PIVC blood collection. Furthermore, the flow restrictor devices described herein are compatible with PIVC placement, allowing for seamless blood collection during insertion. Furthermore, because the flow restrictor devices are add-on, they can be easily integrated into existing PIVCs without any modifications, with minimal impact on the clinical environment and operation.

[0021] FIG. 1 illustrates a vascular access device 10 including a peripheral intravenous catheter (PIVC) assembly 50 including an extension set or flow restrictor 100, according to some embodiments of the present disclosure. The flow restrictor 100 can be configured to extend the length of the vascular access device 10 and reduce the likelihood of hemolysis during blood collection using the vascular access device 10. In some embodiments, the vascular access device 10 can include a catheter assembly 50. The catheter assembly 50 can include a catheter hub 52, which can include a distal end 54, a proximal end 56, and a lumen extending through the distal and proximal ends. The catheter assembly 50 can further include a catheter 58, which can be secured within the catheter hub 52 and can extend distally from the distal end 54 of the catheter hub 52. In some embodiments, the catheter assembly 50 can be a peripheral intravenous catheter (PIVC).

[0022] In some embodiments, catheter assembly 50 may include or correspond to any suitable catheter assembly 50. In some embodiments, catheter assembly 50 may be integrated and include extension tube 60, which may extend from and be integrated with side port 59 of 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 extension tube 60 may be coupled to an adapter, such as, for example, a Y-adapter 70. In some embodiments, flow restrictor 100 may be fluidly coupled to Y-adapter 70.

[0023] In some embodiments, the catheter assembly 50 may be non-integral and may not include the extension tube 60. In these and other embodiments, the flow restrictor 100 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 flow restrictor 100 may be coupled directly to the catheter assembly 50, thereby eliminating the extension tube 60 and providing a compact catheter system.

[0024] Figure 2 shows a perspective view of a flow restrictor 100 according to some embodiments of the present disclosure. Figure 3 shows a cross-sectional view of the flow restrictor 100 of Figure 2 according to some embodiments of the present disclosure.

[0025] 2 and 3, with continued reference to FIG. 1 , in some embodiments, the flow restrictor 100 may include a male luer connector portion 110 configured to couple to the catheter assembly 50. The male luer connector portion 110 may have an interior surface 112 that defines a lumen 114 of the male luer connector portion 110. In some embodiments, a distal end 116 of the male luer connector portion 110 may be coupled to the catheter assembly 50.

[0026] In some embodiments, the flow restrictor 100 may further include a female luer connector portion 130 disposed proximally relative to the male luer connector portion 110. The female luer connector portion 130 may be configured to couple to a fluid collection device 40 (e.g., a blood collection device). For example, the female luer connector portion 130 may be integral with the blood collection device 40 or may be integrally formed with the blood collection device 40 as a single unit or portion. As another example, the female luer connector portion 130 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 130 may include an interior surface 135 defining a lumen 136 extending therethrough for coupling to the male luer portion of the blood collection device 40. In some embodiments, a proximal end 134 of the female luer connector portion 130 may be coupled to the blood collection device 40. Optionally, threaded portion 137 of female luer connector portion 130 can be utilized to engage female luer connector portion 130 with a corresponding male luer portion. In some embodiments, female luer connector portion 130 can be rotated by applying a torque to extension 132 to engage threaded portion 137.

[0027] The lumen 136 of the female luer connector portion 130 may be fluidly connected to the lumen 114 of the male luer connector portion 110 via the tubing 120 of the flow restrictor 100, as will be described below. In the depicted example, the flow restrictor 100 includes a tubing 120 extending longitudinally therethrough and in fluid communication with the lumens 114 and 136 of the male luer connector portion 110 and the female luer connector portion 130, respectively. In some embodiments, the distal end 124 of the tubing 120 may be coupled to the proximal end 118 of the male luer connector portion 110, and the proximal end 126 of the tubing 120 may be coupled to the distal end 138 of the female luer connector portion 130. Optionally, the tubing 120 may be flexible to allow portions of the vascular access device 10 to move relative to the flow restrictor 100. For example, male luer connector portion 110 and female luer connector portion 130 can move relative to one another.

[0028] The tubing 120 can define a channel 122 along which fluid flows from the male luer connector portion 110 via the female luer connector portion 130 into the fluid collection device 40. As depicted, the tubing 120 can 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 can be coupled to the flow restriction device 100. The leg 72 of the Y-adapter 70 can include a lumen into which the distal end of the male luer connector portion 110 can be coupled. The Y-adapter 70 can place the flow restriction device 100 via the connector 90, which is depicted as a needleless connector, and the tubing 120 in fluid communication with the catheter assembly 50, for example, via the extension tube 60. Thus, channel 122 can define a fluid pathway with a reduced, small, or micro-sized diameter (as discussed below) through which fluid entering flow restriction device 100 from catheter assembly 50 can flow through flow restriction device 100 for collection into fluid collection device 40. For example, if blood is being drawn or collected from a patient, the medical fluid may be blood and 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, a blood sample may flow from the distal end of male Luer connector portion 110 into LLAD 40 via flow path or channel 122 defined by tubing 120.

[0029] In some embodiments, the channel 122 defined by the tube 120 may be an elongated, narrow channel having a small, reduced, or micro-sized diameter. For example, in some embodiments, the tube 120 defining the flow path or microchannel along which fluid can flow from the male luer connector portion 110 into the fluid collection device 40 may have a diameter ranging from 1 / 20,000 to 1 / 25,000 of an inch. However, various embodiments of the present disclosure are not limited to the foregoing configuration. In some embodiments, the length of the channel 122 may range from 1 / 25,4 mm to 1.3 inches. Thus, during blood collection or withdrawal from a patient, blood 15 may flow into the blood collection device 40 via the flow path or microchannel defined by the channel 122 having the smallest diameter. The flow restriction device 100 of various embodiments described herein provides advantages over existing blood collection systems. For example, during blood collection in 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 a primary source of mechanical damage to the blood cells, leading to hemolysis of the blood cells. Channel 122 with a minimal diameter may facilitate increased flow resistance within the vascular access system, dissipating pressure differences and reducing the shear stress experienced by red blood cells of blood 15. For example, the minimized diameter of channel 122 may provide increased resistance to the flow of blood 15, thereby reducing the blood flow rate within flow restrictor 100. Because the reduced blood flow rate results in reduced shear stress experienced by red blood cells of blood 15, the risk of hemolysis during blood collection may advantageously be reduced. Furthermore, the geometry of channel 122 may reduce the amount of blood wasted by existing blood collection systems.

[0030] Furthermore, the flow restrictor 100 can reduce hemolysis without the use of active devices such as valves or other flow control devices. In some applications, the reduced number of parts or elements of the flow restrictor 100 can facilitate compact design and / or high volume manufacturing.

[0031] Description of the subject technology as a clause The subject technology is described according to various aspects, for example, as set forth 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 are not intended to limit the subject technology. Note that any of the dependent clauses can be combined in any combination and placed into their own independent clauses, e.g., clause 1 or clause 5. Other clauses can be presented in a similar manner.

[0032] Clause 1. A flow restrictor device comprising: a male luer connector portion defining a first lumen; a female luer connector portion defining a second lumen; and a flexible tube defining a third lumen, the third lumen being in fluid communication with the first lumen and the second lumen, the third lumen having a diameter of approximately 0.02 inches.

[0033] Clause 2. The flow restrictor of claim 1, wherein the third lumen has a length of about 1.3 inches.

[0034] Clause 3. The flow restrictor device of claim 1, wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow.

[0035] Clause 4. The flow restrictor device of claim 1, wherein the male luer is configured to be coupled to a catheter hub.

[0036] Clause 5. The flow restrictor of claim 1, wherein the female luer is configured to be coupled to a fluid collection device.

[0037] Clause 6. The flow restrictor of claim 1, wherein the female luer defines an extension portion.

[0038] Clause 7. A flow restrictor device comprising: a male luer connector portion defining a first lumen; a female luer connector portion defining a second lumen; and a tube defining a third lumen, the third lumen being in fluid communication with the first lumen and the second lumen, the third lumen having a diameter of approximately 0.02 inches and a length of approximately 1.3 inches.

[0039] Clause 8. The flow restrictor device of claim 7, wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow.

[0040] Clause 9. The flow restrictor device of claim 7, wherein the male luer is configured to be coupled to a catheter hub.

[0041] Clause 10. The flow restrictor of claim 7, wherein the female luer is configured to be coupled to a fluid collection device.

[0042] Clause 11. The flow restrictor of claim 7, wherein the female luer defines an extension portion.

[0043] Clause 12. A peripheral intravenous catheter assembly configured to limit hemolysis during blood withdrawal from a patient, the peripheral intravenous catheter assembly comprising: a catheter hub having a proximal end and a distal end; a fluid collection device; and a flow restriction device, the flow restriction device having a male luer connector portion coupled to the catheter hub and defining a first lumen, a female luer connector portion defining a second lumen in fluid communication with the fluid collection device, and tubing defining a third lumen, the third lumen in fluid communication with the first lumen and the second lumens, the third lumen having a diameter of approximately 0.508 mm (0.02 inches).

[0044] Clause 13. The peripheral intravenous catheter assembly of claim 12, wherein the third lumen has a length of about 33.02 mm (1.3 inches).

[0045] Clause 14. The peripheral intravenous catheter assembly of claim 12, wherein the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow.

[0046] Clause 15. The peripheral intravenous catheter assembly of claim 12, wherein the tubing is flexible.

[0047] Clause 16. The peripheral intravenous catheter assembly of claim 12, wherein the female luer defines the extension portion.

[0048] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. While this disclosure provides various examples of the subject technology, 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.

[0049] Reference to an element in the singular is not intended to mean "one and only one" unless specifically so stated, but rather "one or more." The term "some" refers to one or more unless specifically stated otherwise. Pronouns referring to the masculine (e.g., his) include the feminine and neuter (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.

[0050] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0051] As used herein, the phrase "at least one of" preceding a list of items modifies the list as a whole, rather than each item in the list, with the word "or" used to separate any of the items. The phrase "at least one of" does not require the selection of at least one item, but rather allows the phrase to mean including at least one item of any of the items, and / or at least one combination of any combination of the items, and / or at least one item of each of the items. Illustratively, the phrase "at least one of A, B, or C" can refer to A only, B only, or C only, or any combination of A, B, and C.

[0052] The use of 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 of 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 "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 of an embodiment may apply to all embodiments, or to one or more examples. An embodiment may provide one or more examples. A phrase such as "embodiment" may refer to one or more examples, 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 of 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 a configuration can refer to one or more configurations, and vice versa.

[0053] In one aspect, unless otherwise stated, all measurements, values, ratings, locations, dimensions, sizes, and other specifications set forth herein, including those contained in the claims that follow, are approximate and not precise, and are intended to have a reasonable range consistent with the functions to which they relate and with what is customary in the technical field to which they pertain.

[0054] It is understood that the specific order or hierarchy of steps or operations in the disclosed processes or methods is an illustration of an example approach. It is understood that the specific order or hierarchy of steps, operations, or operations may be rearranged based on implementation preferences or scenarios. Some of the steps, operations, or operations 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 operations may be performed automatically without user intervention. The accompanying method claims present elements of the various steps, operations, or operations in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0055] 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 made available to the public, regardless of whether such disclosure is expressly recited 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, unless the element is recited using the phrase "step for." Furthermore, to the extent the terms "comprise," "have," and the like are used, such terms are intended to be inclusive in the same manner as the term "comprise," as "comprises" is interpreted when used as a transitional word in a claim.

[0056] The title, background art, summary, brief description of the drawings, and abstract of this disclosure are hereby incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description. This disclosure is submitted with the understanding that they are not used to limit the scope or meaning of the claims. Furthermore, in the Detailed Description, it is understood that the description provides illustrative examples, and that various features have been grouped together in various embodiments to streamline the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that 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.

[0057] The claims are not intended to be limited to the embodiments described herein, but are to be accorded full scope consistent with the language of the claims and encompass all legal equivalents. However, none of the claims are intended, and should not be construed, to cover subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. A flow restriction device for restricting blood flow, comprising: a male luer connector portion defining a first lumen; a female luer connector portion defining a second lumen; a tube defining a third lumen; the third lumen is in fluid communication with the first lumen and the second lumen, the third lumen having a diameter of 0.02 inches and a length of 1.3 inches; the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow; A flow restriction device for restricting blood flow, wherein the tube is flexible relative to the male luer connector portion and the female luer connector portion.

2. The flow restrictor of claim 1 , wherein the male luer connector portion is configured to be coupled to a catheter hub.

3. 10. The flow restrictor of claim 1, wherein the female luer connector portion is configured to be coupled to a fluid collection device.

4. 2. The flow restrictor of claim 1, wherein said female luer connector portion defines an extension portion.

5. 1. A vascular access device configured to limit hemolysis during blood withdrawal from a patient, comprising: a peripheral intravenous catheter assembly including a catheter hub having a proximal end and a distal end; a fluid collection device; Flow restriction device and The flow restricting device comprises: a male luer connector portion coupled to the catheter hub and defining a first lumen; a female luer connector portion defining a second lumen in fluid communication with the fluid collection device; a tube defining a third lumen; the third lumen is in fluid communication with the first lumen and the second lumen, the third lumen having a diameter of 0.02 inches and a length of 1.3 inches; the third lumen is configured to increase flow resistance through the third lumen to minimize shear stress experienced by the fluid flow; A vascular access device, wherein the tubing is flexible relative to the male luer connector portion and the female luer connector portion.

6. The vascular access device of claim 5 , wherein the female luer connector portion defines an extension portion.

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