Hemolysis reduction connector for direct blood collection

Abstract

The flow restricting device may include a male luer connector portion and a female luer connector portion. The male luer connector portion may define a cavity and a first lumen in fluid communication with the cavity. The female luer connector portion defines a second lumen and an extension in fluid communication with the second lumen. The extension includes a first end, a second end, an outer surface, and a channel. The channel is defined on the outer surface. The channel is helically disposed about the outer surface of the extension and extends between the first end and the second end. The extension is configured to be at least partially disposed within the cavity. The channel and an inner surface of the cavity define a fluid passageway in fluid communication with the first lumen and the second lumen.

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 connector. [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 subsequent blood withdrawal or fluid injection.

[0005] A blood collection container may be used for blood withdrawal or collection of 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 such 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, as blood is drawn into the blood collection container, red blood cells are subject to high shear stress due to the flow rate and geometry through the blood collection system, which can make them prone to hemolysis. Hemolysis can result in the rejection and discarding of the blood sample. Blood collection can also result in areas of localized negative pressure at the catheter tip, which can lead to collapse of the catheter tip, collapse of the vein, or other problems that prevent or limit the filling of the blood collection container with blood. Additionally, blood leakage can occur during and / or after blood collection.

[0008] A description provided in the Background section should not be presumed 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 restricting device comprising: a male luer connector portion defining a cavity and a first lumen in fluid communication with the cavity; and a female luer connector portion defining a second lumen and an extension in fluid communication with the second lumen, the extension including a first end, a second end, an outer surface and a channel defined on the outer surface, the channel being spirally disposed around the outer surface of the extension and extending between the first and second ends, the extension being configured to be at least partially disposed within the cavity, the channel and an inner surface of the cavity defining a fluid passage in fluid communication with the first and second lumens.

[0010] In some examples, the present disclosure provides a flow restriction device including: a male luer connector portion defining a first cavity and a first lumen in fluid communication with the first cavity; and a female luer connector portion defining a second lumen and an extension defining a second cavity in fluid communication with the second lumen, the extension including a first end, a second end, an outer surface and a channel defined on the outer surface, the channel being spirally disposed around the outer surface of the extension and extending between the first and second ends, the extension configured to be at least partially disposed within the first cavity, the channel and an inner surface of the first cavity defining a fluid passage in fluid communication with the first and second cavities.

[0011] In some aspects, the present disclosure provides a peripheral venous catheter assembly configured to limit hemolysis during blood withdrawal from a patient, the peripheral venous catheter assembly including: a catheter hub having a proximal end and a distal end; a fluid collection device; and a flow restriction device including: a male Luer connector portion defining a cavity and a first lumen in fluid communication with the cavity and the catheter hub; a female Luer connector portion defining a second lumen in fluid communication with the fluid collection device and an extension in fluid communication with the second lumen, the extension including a first end, a second end, an outer surface, and a channel defined on the outer surface, the channel being helically disposed around the outer surface of the extension and extending between the first end and the second end, the extension being configured to be at least partially disposed within the cavity, the channel and an inner surface of the cavity defining a fluid passageway in fluid communication with the first lumen and the second lumen.

[0012] 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.

[0013] 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]

[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. [Diagram 2]1 is a perspective view of a flow restricting device according to some embodiments of the present disclosure. [Diagram 3] 3 is an exploded view of the flow restricting device of FIG. 2 according to some embodiments of the present disclosure. [Figure 4] 3 is an exploded cross-sectional view of the flow restricting device of FIG. 2 according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[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 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.

[0016] 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 the desired application or implementation.

[0017] 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. Current blood collection using peripheral intravenous catheters (PIVCs) presents several challenges, one of the most important being blood quality related to hemolysis. In particular, shear stress exerted on red blood cells often causes hemolysis in existing PIVC products currently on the market as well as standard connections (such as short extension sets and needleless connectors) and blood collection devices (such as Vacutainers).

[0018] Various embodiments of the present disclosure relate to providing systems and methods to address hemolysis in PIVC blood collection using a hemolysis reduction accessory (also referred to herein as a flow restrictor), such as a connector, that attaches to the PIVC and acts 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.

[0019] 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 passes through. The flow restrictor may be assembled with the PIVC or packaged together with the PIVC. The clinician can connect a blood draw device to a port on the accessory and then draw blood to the intended volume. After blood draw, 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 may remain in-line throughout the entire placement.

[0020] The flow restriction devices and associated blood sampling systems of the various embodiments described herein additionally provide further advantages over existing blood sampling systems. For example, the add-on flow restriction devices described herein reduce hemolysis while allowing blood to be drawn through an already placed PIVC. Furthermore, the flow restriction devices described herein fit into the PIVC connection, allowing seamless blood sampling upon insertion. Furthermore, the flow restriction devices are add-ons that can be easily incorporated without modifying an existing PIVC, thus minimizing the impact on clinical settings and operations.

[0021] FIG. 1 illustrates a vascular access device 10 including a peripheral intravenous catheter (PIVC) assembly 50 including a connector or flow restriction device 100 according to some embodiments of the present disclosure. The flow restriction device 10 may be configured to facilitate connection of components of the vascular access device 10 and to reduce the possibility of hemolysis during blood draw 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).

[0022] 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 one-piece and 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 100 may be fluidly coupled to the Y adapter 70.

[0023] 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.

[0024] Figure 2 is a perspective view of a flow restriction device 100 according to some embodiments of the present disclosure. Figure 3 is an exploded view of the flow restriction device 100 of Figure 2 according to some embodiments of the present disclosure. Figure 4 is an exploded cross-sectional view of the flow restriction device 100 of Figure 2 according to some embodiments of the present disclosure.

[0025] 1 , and as shown in FIGS. 2-4 , in some embodiments, the flow restriction device 100 may include a male luer connector portion 110 configured to couple to a catheter assembly 50. The male luer connector portion 110 may have an inner surface that defines a lumen 112 of the male luer connector portion 110. In some embodiments, a distal end of the male luer connector portion 110 may be coupled to the catheter assembly 50. In some embodiments, the lumen 112 is in fluid communication with a cavity 116 defined by a body 114 of the male luer connector portion 110.

[0026] In some embodiments, the flow restriction device 100 may further include a female luer connector portion 120 disposed proximal to the male luer connector portion 110. The female luer connector portion 120 may be configured to couple to a fluid draw device 40 (e.g., a blood draw device). For example, the female luer connector portion 120 may be integral with the blood draw device 40 or monolithically formed as a single unit or piece with the blood draw device 40. As another example, the female luer connector portion 120 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 draw device 40. The female luer connector portion 120 may include an inner surface defining a lumen 128 extending therethrough for coupling to a male luer portion of the blood draw device 40. In some embodiments, a proximal end of the female luer connector portion 120 may be coupled to the blood draw device 40. Optionally, threads 122 of the female luer connector portion 120 may be utilized to engage the female luer connector portion 120 with a corresponding male luer portion.

[0027] In the illustrated example, the body 114 of the male luer connector portion 110 can be coupled to the body 124 of the female luer connector portion 120 to allow fluid communication between the lumens 112 and 128 of the flow restriction device 100 to form a common housing.

[0028] In the illustrated example, the female luer connector portion 120 can include an extension 130 to control fluid flow between the lumens 112, 128 and reduce hemolysis across the entire blood flow path from the PIVC to the blood draw device 100. As illustrated, the extension 130 can be disposed within the cavity 116 formed by the male luer connector portion 110. As illustrated, the extension 130 directs fluid flow between the lumen 112 of the male luer connector portion 110 and the lumen 128 of the female luer connector portion 120 while inducing a resistance to fluid flow 130. By inducing a resistance to fluid flow, the fluid flow rate from the PIVC to the blood draw device through the assembly is reduced 130. Reducing the flow rate of a fluid, such as blood, through the assembly can reduce the hemolytic index of the blood.

[0029] In some embodiments, the extension 130 defines a groove or channel 135 that directs fluid flow from the distal end 134 of the extension 130 to the proximal end 138 of the extension 130. As shown, the channel 135 can be defined along an outer surface of the extension 130. Thus, when the extension 130 is disposed within the cavity 116 of the male luer connector portion 110, at least a portion of the outer surface of the extension 130 can engage an inner surface of the cavity 116, allowing the channel 135 and the inner surface of the cavity 116 to cooperatively define a fluid passage therebetween. The defined fluid passage extends along a path between the distal end 134 and the proximal end 138 of the extension 130, and can reduce the flow rate of fluid across the extension 130. In some embodiments, the groove or channel 135 can be formed in an inner surface of the body 114 such that engagement with the outer surface of the extension 130 forms a fluid passage. In some embodiments, the groove or channel 135 can extend along one or both of the inner surface of the body 114 and the outer surface of the extension 130 such that when the body 114 receives the extension 130, a fluid pathway is formed to direct fluid between the body 114 and the extension 130.

[0030] In the illustrated example, fluid flow can pass from the lumen 112 of the male luer connector portion 110 through the cavity 116 to the distal end 134 of the extension 130. In some embodiments, fluid can flow from the proximal end 138 of the extension 130 to the lumen 128 of the female luer connector portion 120 through a port 136 formed through the extension 130. In some embodiments, the port 136 can allow fluid between the proximal end 138 of the extension 130 and / or the channel 135 to flow to a cavity 137 formed in the extension 130. The cavity 137 formed in the extension 130 can be separated from the cavity 116 of the male luer connector portion 110 by the body of the extension 130. As illustrated, the cavity 137 can be in fluid communication with the lumen 128. Thus, in some embodiments, fluid flow can pass from the proximal end 138 of the extension 130 through the port 136 and cavity 137 to the lumen 128 .

[0031] Thus, in some embodiments, the channel 135 (along with the inner surface of the cavity 116) can direct fluid flow from the male luer connector portion 110 through the female luer connector portion 120 to the fluid collection device 40. As shown, the channel 135 may provide a fluid path from the catheter assembly 50 through the flow restriction device 100 to the fluid collection device 40. 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 of the male luer connector portion 110 may be coupled. The Y adapter 70 can provide fluid communication between the flow restriction device 100 via the connector 90, shown as a needleless connector, and the channel 135 to the catheter assembly 50, for example, via the extension tube 60. Thus, the channel 135 may define a fluid pathway having a helical, spiral, drawn, or other indirect path (described below) through which fluid entering the flow restriction device 100 from the catheter assembly 50 may flow through the flow restriction device 100 and be collected 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 drawn or collected from a patient. In some embodiments, the blood collection device may be a blood collection tube holder, such as a BD Vacutainer® LuerLok™ Access Device (LLAD). Thus, during blood collection or withdrawal from a patient, a blood sample may flow from the distal end of the male Luer connector portion 110, through the flow path or channel 135, and into the LLAD 40.

[0032] In some embodiments, the extension 130 can define a longitudinal axis extending through the distal end 134 and the proximal end 138. The channel 135 is configured to extend helically or spirally along the longitudinal axis between the distal end 134 and the proximal end 138 of the extension 130. Because the path spirals around the longitudinal axis, the channel 135 extends indirectly between the distal end 134 and the proximal end 138 of the extension 130. The indirect path between the distal end 134 and the proximal end 138 of the extension 130 can be longer than the distance between the distal end 134 and the proximal end 138 of the extension 130. In some cases, the slope and angle of rotation of the helical channel 135 can be optimized to reduce the volumetric flow rate of a fluid, e.g., blood, moving through the channel 135 by inducing a resistance to the fluid. A reduction in blood flow may advantageously reduce the risk of hemolysis during blood collection, as this results in a decrease in the shear stress experienced by red blood cells.

[0033] The flow restriction device 100 of various embodiments described herein is advantageous over existing PIVC blood collection systems. For example, during blood collection by existing PIVCs, blood cells may experience supraphysiological levels of shear stress as they flow from the distal end to the proximal end of the blood collection system. Exposing red blood cells to supraphysiological levels of shear stress is believed to be a major cause of mechanical damage and hemolysis of red blood cells. The diameter and effective length of the channel 135 may facilitate an increase in flow resistance within the vascular access system to reduce the flow rate and reduce the shear stress experienced by the red blood cells 15. For example, the minimum diameter and extended effective length of the channel 135 may increase the resistance to the flow of blood 15, thereby reducing the blood flow rate within the PIVC, device and blood collection device assembly 100. The reduced blood flow rate may advantageously reduce the risk of hemolysis during blood collection, as it causes a reduction in the shear stress experienced by the red blood cells 15. Additionally, the geometry of the channel 135 may reduce the amount of blood wasted by existing PIVC blood collection systems.

[0034] Additionally, the flow restriction device 100 can reduce hemolysis without the use of active devices such as valves or other flow control devices. In some applications, the configuration of the flow restriction device 100 described herein can minimize flushing of the vascular access device 10, minimize dead volume, and facilitate a compact design. Additionally, the configuration of the flow restriction device 100 can facilitate manufacturing as compared to certain prior art designs. For example, in some applications, the male luer connector portion 110 and the female luer connector portion 120 can be joined together and then ultrasonically welded to form the flow restriction device 100.

[0035] (Examples of subject technology 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. It should be noted that any of the dependent claims may be combined in any combination and placed in a respective independent claim, e.g., clause 1 or clause 5. Other clauses may be presented as well.

[0036] Clause 1. A flow restricting device comprising: a male luer connector portion defining a cavity and a first lumen in fluid communication with the cavity; a female luer connector portion defining a second lumen and an extension in fluid communication with the second lumen, the extension including a first end, a second end, an outer surface and a channel defined on the outer surface, the channel being spirally disposed around the outer surface of the extension and extending between the first end and the second end, the extension being configured to be at least partially disposed within the cavity, the channel and an inner surface of the cavity defining a fluid passage in fluid communication with the first lumen and the second lumen.

[0037] Clause 2. The flow restriction device of clause 1, wherein the extension defines a second cavity disposed within the extension, and the second lumen is in fluid communication with the second cavity.

[0038] Clause 3. The flow restricting device of clause 1, wherein the channel is in fluid communication with the second lumen through a port extending through the extension.

[0039] Clause 4. The flow restriction device of clause 1, wherein the fluid passage is configured to increase flow resistance through the fluid passage to reduce shear stress experienced by the fluid.

[0040] Clause 5. The flow restriction device of clause 1, wherein the first lumen is configured to be coupled to a catheter hub.

[0041] Clause 6. The flow restriction device of clause 1, wherein the second lumen is configured to couple to a fluid collection device.

[0042] Clause 7. A flow restricting device comprising: a male luer connector portion defining a first cavity and a first lumen in fluid communication with the first cavity; a female luer connector portion defining a second lumen and an extension defining a second cavity in fluid communication with the second lumen, the extension including a first end, a second end, an outer surface and a channel defined on the outer surface, the channel being spirally disposed around the outer surface of the extension and extending between the first end and the second end, the extension configured to be at least partially disposed within the first cavity, the channel and an inner surface of the first cavity defining a fluid passage in fluid communication with the first cavity and the second cavity.

[0043] Clause 8. The flow restricting device of clause 7, wherein the channel is in fluid communication with the second cavity through a port extending through the extension.

[0044] Clause 9. The flow restriction device of clause 7, wherein the fluid passage is configured to increase flow resistance through the fluid passage to reduce shear stress experienced by the fluid.

[0045] Clause 10. The flow restriction device of clause 7, wherein the first lumen is configured to be coupled to a catheter hub.

[0046] Clause 11. The flow restriction device of clause 7, wherein the second lumen is configured to couple to a fluid collection device.

[0047] Clause 12. A peripheral venous catheter assembly configured to limit hemolysis during blood withdrawal from a patient, comprising: a catheter hub having a proximal end and a distal end; a fluid collection device; and a flow restriction device comprising: a male luer connector portion defining a cavity and a first lumen in fluid communication with the cavity and the catheter hub; a female luer connector portion defining a second lumen in fluid communication with the fluid collection device and an extension in fluid communication with the second lumen, the extension including a first end, a second end, an outer surface, and a channel defined on the outer surface, the channel being helically disposed about the outer surface of the extension and extending between the first end and the second end, the extension being configured to be at least partially disposed within the cavity, the channel and an inner surface of the cavity defining a fluid passageway in fluid communication with the first lumen and the second lumen.

[0048] Clause 13. The peripheral venous catheter assembly of clause 12, wherein the extension defines a second cavity disposed within the extension, and the second lumen is in fluid communication with the second cavity.

[0049] Clause 14. The peripheral venous catheter assembly of clause 12, wherein the channel is in fluid communication with the second lumen through a port extending through the extension.

[0050] Clause 15. The peripheral venous catheter assembly of clause 12, wherein the fluid passageway is configured to increase flow resistance through the fluid passageway to reduce shear stress experienced by the fluid.

[0051] Clause 16. The peripheral venous catheter assembly of clause 12, wherein the first lumen is configured to be coupled to a catheter hub.

[0052] Clause 17. The peripheral venous catheter assembly of clause 12, wherein the second lumen is configured to couple to a fluid collection device.

[0053] 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.

[0054] Reference to a singular element is intended to mean "one or more" and not "one and only one" unless specifically stated otherwise. The term "some" refers to one or more, unless specifically stated otherwise. 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.

[0055] 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.

[0056] 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" can refer to only A, only B, or only C, or any combination of A, B, and C.

[0057] 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.

[0058] In one aspect, unless otherwise specified, all measurements, values, ratings, positions, sizes, dimensions 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 that which is customary in the art to which they pertain.

[0059] 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 various steps, operations or process elements in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0060] All structural and functional equivalents to the elements of the various embodiments 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.

[0061] 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 are not used to limit the scope or meaning of the claims. In addition, in the detailed description, it will be understood that various features are 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, the 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.

[0062] 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

1. 1. A flow restriction device comprising: a male luer connector portion defining a cavity and a first lumen in fluid communication with the cavity; A female luer connector portion defining a second lumen and an extension in fluid communication with the second lumen, the extension comprising: A first end; A second end. The exterior and a channel defined on the outer surface, the channel helically disposed about the outer surface of the extension and extending between the first end and the second end, the extension configured to be at least partially disposed within the cavity, the channel and an inner surface of the cavity defining a fluid passageway in fluid communication with the first lumen and the second lumen; A flow restricting device comprising:

2. The flow restriction device of claim 1 , wherein the extension defines a second cavity disposed therein, and the second lumen is in fluid communication with the second cavity.

3. The flow restriction device of claim 1 , wherein the channel is in fluid communication with the second lumen through a port extending through the extension.

4. The flow restriction device of claim 1 , wherein the fluid passage is configured to increase flow resistance through the fluid passage to reduce shear stress experienced by the fluid.

5. The flow restriction device of claim 1 , wherein the first lumen is configured to be coupled to a catheter hub.

6. The flow restriction device of claim 1 , wherein the second lumen is configured to couple to a fluid collection device.

7. 1. A flow restriction device comprising: a male luer connector portion defining a first cavity and a first lumen in fluid communication with the first cavity; a female luer connector portion defining a second lumen and an extension defining a second cavity in fluid communication with the second lumen, the extension comprising: A first end; A second end. The exterior and a channel defined on the outer surface, the channel helically disposed about the outer surface of the extension and extending between the first end and the second end, the extension configured to be at least partially disposed within the first cavity, the channel and an inner surface of the first cavity defining a fluid passageway in fluid communication with the first cavity and the second cavity; A flow restricting device comprising:

8. The flow restricting device of claim 7 , wherein the channel is in fluid communication with the second cavity through a port extending through the extension.

9. The flow restriction device of claim 7 , wherein the fluid passage is configured to increase flow resistance through the fluid passage to reduce shear stress experienced by the fluid.

10. The flow restriction device of claim 7 , wherein the first lumen is configured to be coupled to a catheter hub.

11. The flow restriction device of claim 7 , wherein the second lumen is configured to couple to a fluid collection device.

12. 1. A peripheral venous catheter assembly configured to limit hemolysis during withdrawal of blood from a patient, comprising: a catheter hub having a proximal end and a distal end; A fluid collection device; 1. A flow restriction device comprising: a male luer connector portion defining a cavity and a first lumen in fluid communication with the cavity and with the catheter hub; a female luer connector portion defining a second lumen in fluid communication with the fluid collection device and an extension in fluid communication with the second lumen, the extension comprising: A first end; A second end. The exterior and a channel defined on the outer surface, the channel helically disposed about the outer surface of the extension and extending between the first end and the second end, the extension configured to be at least partially disposed within the cavity, the channel and an inner surface of the cavity defining a fluid passageway in fluid communication with the first lumen and the second lumen; a flow restricting device comprising: A peripheral venous catheter assembly comprising:

13. The peripheral venous catheter assembly of claim 12, wherein the extension defines a second cavity disposed therein, and the second lumen is in fluid communication with the second cavity.

14. The peripheral venous catheter assembly of claim 12 , wherein the channel is in fluid communication with the second lumen through a port extending through the extension.

15. The peripheral venous catheter assembly of claim 12, wherein the fluid passage is configured to increase flow resistance therethrough to reduce shear stress experienced by the fluid.

16. The peripheral venous catheter assembly of claim 12 , wherein the first lumen is configured to be coupled to a catheter hub.

17. The peripheral venous catheter assembly of claim 12 , wherein the second lumen is configured to couple to a fluid collection device.

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