Hemolysis reduction connector for direct blood collection

Abstract

A flow restriction device for reducing the risk of hemolysis in PIVC blood draws.SOLUTION: A flow restriction device comprising a cavity, a male luer connector portion, a second lumen, and a female luer connector portion, wherein an end of the cavity of the male luer connector portion is configured to be coupled to the female luer connector portion within a body of the female luer connector portion, wherein an extension is configured to be at least partially disposed within the cavity, and wherein the extension comprises a channel defining a fluid passageway in fluid communication with the first lumen and the second lumen.SELECTED DRAWING: Figure 3

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 connectors. [Background technology]

[0002] Catheters are commonly used for various 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 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 so 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 through the skin into the patient's vasculature at a shallow angle.

[0004] To verify proper placement of the introducer needle and / or catheter within the vessel, the clinician typically confirms the presence of 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 to draw blood or 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 instances, the test tube has had all or some of the air removed from it so that the pressure inside the tube is less than ambient pressure. Such blood collection containers are often referred to as internally evacuated 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 subjected 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 a localized area of ​​negative pressure at the catheter tip, which can lead to catheter tip collapse, vein collapse, or other problems that prevent or limit the filling of the blood collection container. 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 helically 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 restricting 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 the 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 helically 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 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 and second ends, the extension being configured to be at least partially disposed within the cavity, and an inner surface of the channel and the cavity defining a fluid passageway in fluid communication with the first and second lumens.

[0012] It is understood that other configurations of the subject technology will be readily apparent to those skilled in the art from the following detailed description, 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 exclusive embodiments. The disclosed subject matter is capable of considerable modification, permutation, combination, and equivalents in form and function, as will occur to those skilled in the art and having the benefit of this disclosure. [Brief explanation of the drawings]

[0014] [Figure 1] 1A-1C 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 2]1 is a perspective view of a flow restrictor device according to some embodiments of the present disclosure. FIG. [Figure 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 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 for the purpose of providing a thorough understanding of the subject technology. Thus, dimensions may be provided for particular embodiments as non-limiting examples. 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 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 this disclosure can be implemented in different ways and with modifications according to a desired application or implementation.

[0017] Blood collection via vascular access devices has been gaining increasing attention due to its minimal needlestick injury and improved operational efficiency compared to traditional venipuncture blood collection. Current blood collection using peripheral intravenous catheters (PIVCs) presents several challenges, one of the most important of which is hemolysis-related blood quality. In particular, shear stress exerted on red blood cells often leads to hemolysis in existing PIVC products and standard connections (e.g., short extension sets and needleless connectors) and blood collection devices (e.g., Vacutainers).

[0018] 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), such as a connector, that attaches 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 procedures. 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 pathway as blood passes through. The flow restrictor can be assembled with or packaged with the PIVC. The clinician connects a blood draw device to a port on the accessory and then draws blood to the intended volume. After blood collection, the clinician may disconnect and discard the flow restrictor and blood draw device. Thus, the flow restrictor can be for a single blood draw or can remain in-line throughout the entire placement.

[0020] The various embodiments of the flow restriction devices and associated blood collection systems described herein additionally provide further advantages over existing blood collection 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 are compatible with the PIVC connection, allowing for seamless blood collection upon insertion. Furthermore, because the flow restriction devices are add-ons that can be easily incorporated into an existing PIVC without modifying it, the impact on clinical settings and operations is minimal.

[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 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 and proximal ends. The catheter assembly 50 may further include a catheter 58, which may be secured within the catheter hub 52 and may extend distally from the distal end 54 of the catheter hub 52. In some embodiments, the catheter 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 be integrated and extend from a side port 59 of the catheter hub 52. A non-limiting example of an integrated catheter assembly is the BD NEXIVA™ Closed IV Catheter System available from Becton Dickinson and Company. In some embodiments, the proximal end of the extension tube 60 may be coupled to an adapter, such as 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 restrictor 100 according to some embodiments of the present disclosure. Figure 3 is an exploded view of the flow restrictor 100 according to some embodiments of the present disclosure. Figure 4 is an exploded cross-sectional view of the flow restrictor 100 according to some embodiments of the present disclosure.

[0025] Continuing with reference to FIG. 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, the 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 collection device 40 (e.g., a blood collection device). For example, the female Luer connector portion 120 may be integral with the blood collection device 40 or monolithically formed therewith as a single unit or piece. As another example, the female Luer connector portion 120 may be in the form of a female Luer connector or another suitable connector that can be coupled to a male Luer portion of the blood collection 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 collection device 40. In some embodiments, the proximal end of the female Luer connector portion 120 can be coupled to the blood collection device 40. Optionally, threads 122 of female luer connector portion 120 can be utilized to engage 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 lumen 112 and the lumen 128 of the flow restrictor device 100 and 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 throughout the entire blood flow path from the PIVC to the blood draw device 100. As shown, the extension 130 can be disposed within the cavity 116 formed by the male luer connector portion 110. As shown, 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 the 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 the 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 conduct 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 via 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 into a cavity 137 formed within the extension 130. The cavity 137 formed within 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 shown, 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 (together 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 and the catheter assembly 50, for example, via the extension tubing 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, if blood is being drawn or collected from a patient, the medical fluid may be blood and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a 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 to 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, such as blood, moving through the channel 135 by inducing resistance to the fluid. A reduction in blood flow may advantageously reduce the risk of hemolysis during blood collection, as this results in a reduction in the shear stress experienced by red blood cells.

[0033] The various embodiments of the flow restriction device 100 described herein are advantageous over existing PIVC blood collection systems. For example, during blood collection through existing PIVCs, blood cells can be subjected to 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 can facilitate increased flow resistance within the vascular access system, reducing the flow rate and the shear stress experienced by the red blood cells 15. For example, a minimum diameter and extended effective length of the channel 135 can increase resistance to the flow of blood 15, thereby reducing the blood flow rate within the PIVC, device, and blood collection device assembly 100. A reduced blood flow rate can result in reduced shear stress experienced by the red blood cells 15, thereby advantageously reducing the risk of hemolysis during blood collection. Furthermore, the geometry of the channel 135 can reduce the amount of blood wasted by existing PIVC blood collection systems.

[0034] Furthermore, 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 flow restriction device 100 described herein can minimize flushing of vascular access device 10, minimize dead volume, and facilitate a compact design. Furthermore, the configuration of flow restriction device 100 can facilitate manufacturing compared to certain prior art designs. For example, in some applications, male luer connector portion 110 and female luer connector portion 120 can be joined together and then ultrasonically welded to form 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. Note that any of the dependent claims may be combined in any combination and placed within 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; 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.

[0037] Clause 2. The flow restricting 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 restricting 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 restricting device of clause 1, wherein the first lumen is configured to be coupled to a catheter hub.

[0041] Clause 6. The flow restrictor 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; 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 being 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.

[0043] Clause 8. The flow restrictor 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 restricting 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 restricting device of clause 7, wherein the first lumen is configured to be coupled to a catheter hub.

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

[0047] 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 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 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.

[0048] Clause 13. The peripheral intravenous 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 intravenous 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 intravenous 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] This disclosure is provided to enable those skilled in the art to practice the various aspects described herein. This 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 an element in the singular is intended to mean "one or more" and not "one and only one" unless otherwise specified. The term "some" 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.

[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 may be considered at least equivalent.

[0056] As used herein, the phrase "at least one of," following a series of items, when followed by the word "or" separating 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 the inclusion of 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. By way of example, 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.

[0057] 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 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 embodiment is essential to the subject technology or that such 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 configuration is essential to the subject technology or that such 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 acts in any disclosed process or method is an illustration of a sample approach. It is understood that the specific order or hierarchy of steps, acts, or processes may be rearranged based on implementation preferences or scenarios. Some of the steps, acts, or processes may be performed simultaneously. In some implementation preferences or scenarios, certain acts may or may not be performed. Some or all of the steps, acts, or processes may be performed automatically without user intervention. The accompanying method claims present the various steps, acts, 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 aspects described throughout this disclosure that are known or later become known to those skilled in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Furthermore, nothing disclosed herein is intended to be exclusive 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, the element is recited using the phrase "step for." Furthermore, to the extent terms such as "comprising," "having," and the like are used, such terms are intended to be similarly inclusive, just as "comprising" is interpreted when used as a transitional term in the claims.

[0061] 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. 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 the description provides illustrative examples and that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to 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.

[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 encompass all legal equivalents. Nevertheless, none of the claims are intended to, and should not be construed to, encompass subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. 1. A flow restrictor device comprising: a male luer connector portion defining a cavity and a first lumen in fluid communication with said cavity; a female luer connector portion defining a second lumen and an extension in fluid communication with the second lumen; an end of the hollow male luer connector portion configured to be coupled to the female luer connector portion within a body of the female luer connector portion; the extension is configured to be at least partially disposed within the cavity; the extension includes a channel defining a fluid passageway in fluid communication with the first lumen and the second lumen. Flow restrictor.

2. The flow restricting 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 restricting 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 restrictor device of claim 3 , wherein the port is located between a proximal end of the extension and a distal end of the extension.

5. The flow restricting device of claim 1 , wherein the fluid passage is configured to increase fluid flow resistance through the fluid passage.

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

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

8. The flow restrictor device of claim 1 , wherein the channel extends along at least one of an outer surface of the extension and an inner surface of the male luer connector portion that defines the cavity.

9. The flow restrictor device of claim 1 , wherein the channel extends between a proximal end of the extension and a distal end of the extension.

10. The flow restrictor of claim 1 , wherein the channel extends in a helical or spiral direction along the longitudinal axis of the extension.

11. 2. The flow restrictor device of claim 1, wherein the channel has a first length and the extension has a second length from a proximal end of the extension to a distal end of the extension, the first length being greater than the second length.

12. 1. 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; 1. A flow restrictor 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; an end of the hollow male luer connector portion configured to be coupled to the female luer connector portion within a body of the female luer connector portion; the extension is configured to be at least partially disposed within the cavity; the extension includes a channel defining a fluid passageway in fluid communication with the first lumen and the second lumen. a flow restrictor; 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 14, wherein the port is located between the proximal end of the extension and the distal end of the extension.

16. The peripheral venous catheter assembly of claim 12 , wherein the fluid passageway is configured to increase fluid flow resistance therethrough.

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

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

19. The peripheral venous catheter assembly of claim 12, wherein the channel extends in a spiral or helical direction along the longitudinal axis of the extension.

20. 13. The peripheral venous catheter assembly of claim 12, wherein the channel has a first length and the extension has a second length from a proximal end of the extension to a distal end of the extension, the first length being greater than the second length.

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