Hemolysis reduction connector for direct blood sampling

Abstract

The flow restrictor may include a housing and an insertion body. The housing defines a first lumen, a second lumen, and a cavity disposed between the first and second lumens. The insertion body may be disposed within the cavity. The insertion body includes a first end, a second end, a longitudinal axis extending through the first and second ends, an outer surface, and a channel. The channel is defined on the outer surface. The channel extends between the first and second ends. The channel includes a first portion extending in a first direction away from the longitudinal axis and a second portion extending in a second direction toward the longitudinal axis. The channel and an inner surface of the cavity define a fluid passageway in fluid communication with the first and second lumens.

Description

Technical Field

[0001] The present disclosure generally relates to blood collection and the administration of parenteral fluids to a patient, and more particularly to systems and methods for reducing hemolysis in PIVC blood collection using a connector.

Background Art

[0002] Catheters are generally used for various infusion therapies. For example, a catheter can be used to infuse fluids such as saline, various drugs, and total parenteral nutrition into a patient. A catheter can also be used to withdraw blood from a patient.

[0003] A common type of catheter is a needle-through peripheral intravenous (IV) catheter (PIVC). As its name suggests, a needle-through catheter can be mounted on a guide needle having a sharp distal tip. The catheter assembly can include a catheter hub, a catheter extending distally from the catheter hub, and a guide needle extending through the catheter. The catheter and the guide needle may be assembled such that the distal tip of the guide needle extends beyond the distal tip of the catheter while the bevel of the guide needle faces upward away from the patient's skin. The catheter and the guide needle are generally inserted at a shallow angle through the skin into the patient's vasculature.

[0004] To verify proper placement of the guide needle and / or catheter within the blood vessel, a clinician generally checks for a "flashback" of blood in the flashback chamber of the catheter assembly. Once the needle placement is confirmed, the clinician can temporarily occlude the flow within the vasculature, remove the needle, and leave the catheter in place for future blood collection or fluid infusion.

[0005] A blood collection container may be used for blood sampling from a patient or for collecting a blood sample from a patient. The blood collection container can include a syringe. Alternatively, the blood collection container may include a test tube having a rubber stopper at one end. In some cases, the test tube has all or part of the air removed from it, so the pressure inside the test tube is lower 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 a catheter. When the blood collection container is coupled to a catheter, the pressure inside the vein is higher than the pressure inside the blood collection container. As a result, blood is pushed into the blood collection container, and thus the blood collection container becomes filled with blood. The degree of vacuum inside the blood collection container decreases as the blood collection container is filled, and the pressure inside the blood collection container becomes equal to the pressure inside the vein, and finally the blood flow stops.

[0007] Unfortunately, when blood is collected into the blood collection container, due to the high initial pressure difference between the vein and the blood collection container, red blood cells are in a high shear stress state and are prone to hemolysis. Hemolysis can lead to rejection and discard of the blood sample. The high initial pressure difference can further cause problems such as collapse of the catheter tip, collapse of the vein, or other problems that prevent or limit the blood from filling the blood collection container. Furthermore, generally, blood leakage occurs during and / or after blood collection.

[0008] The description given in the background art section should not be regarded as prior art simply because it is stated or associated with the background art section. The background art section can include information explaining one or more aspects of the subject technology. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM

[0009] The present disclosure provides a flow rate limiting device, the flow rate limiting device comprising a housing defining a first lumen, a second lumen, and a cavity disposed between the first lumen and the second lumen, and an insertion body disposed within the cavity, the insertion body having a first end, a second end, a longitudinal axis extending through the first and second ends, an outer surface, and a channel defined on the outer surface, the channel extending between the first end and the second end, the channel having a first portion extending in a first direction away from the longitudinal axis and a second portion extending in a second direction toward the longitudinal axis, the channel and the inner surface of the cavity defining a fluid passage in fluid communication with the first lumen and the second lumen.

[0010] In some cases, the present disclosure provides a flow rate limiting device, the flow rate limiting device comprising a male luer connector portion defining a first lumen and a female luer connector portion defining a second lumen, the male luer connector portion and the female luer connector portion cooperating to define a cavity, the flow rate limiting device further comprising an insertion body disposed within the cavity, the insertion body having a first end, a second end, an outer surface, and a serpentine channel defined on the outer surface, the channel extending between the first end and the second end, the channel and the inner surface of the cavity defining a fluid passage in fluid communication with the first lumen and the second lumen.

[0011] In some aspects, the present disclosure provides a peripheral intravenous catheter assembly configured to limit hemolysis during blood sampling 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 housing defining a first lumen, a second lumen, and a cavity disposed between the first lumen and the second lumen, the first lumen being in fluid communication with the catheter hub, the second lumen being in fluid communication with the fluid collection device, and an insertion body disposed within the cavity, the insertion body having a first end, a second end, an outer surface, and a contoured channel defined on the outer surface, the channel extending between the first end and the second end, the channel and the inner surface of the cavity defining a fluid passage in fluid communication with the first lumen and the second lumen.

[0012] It is understood that other configurations of the technology of the subject matter will be readily apparent to those skilled in the art from the following detailed description, and various configurations of the technology of the subject matter are illustrated and described. As will be understood, the technology of the subject matter is capable of other and different configurations, and some of its details are capable of modification in various other respects without departing from the scope of the technology of the subject matter. Accordingly, the drawings and the detailed description are to be regarded essentially as illustrative and not restrictive.

[0013] The following drawings are included to illustrate certain specific aspects of the examples and should not be considered exclusive examples. Considerable modifications, variations, combinations, and equivalents of the disclosed subject matter are possible in forms and functions that will occur to those skilled in the art and that have the benefit of this disclosure.

Brief Description of the Drawings

[0014]

Figure 1

Figure 2

Figure 3

Figure 4

Mode for Carrying Out the Invention

[0015] The following detailed description describes various configurations of the subject technology and is not intended to represent only the configurations in which the subject technology can be practiced. The detailed description includes specific details for achieving a complete understanding of the subject technology. Accordingly, dimensions may be given as non-limiting examples with respect to a particular aspect. However, it will be apparent to those skilled in the art that the subject technology can 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. Next, various aspects of the subject technology will be disclosed by way of non-limiting but specific examples. The various embodiments described in the present disclosure can be implemented in different manners and variations, and according to the desired use or implementation.

[0017] Blood collection via a vascular access device has been attracting increasing attention because it minimizes needle sticks and improves work efficiency compared to the conventional blood collection method by venipuncture. Current blood collection using a peripheral intravenous catheter (PIVC) encounters several problems, and one of the most significant is the quality of the blood related to hemolysis. In particular, with the PIVC products currently available on the market together with standard connections (such as short extension sets and needleless connectors), and blood collection devices (such as vacutainers), the shear stress acting on blood cells is likely to be on the verge of hemolysis.

[0018] Various embodiments of the present disclosure are directed to systems and methods for addressing hemolysis in PIVC blood draws by a hemolysis reduction accessory (also referred to herein as a flow restriction device), such as a connector attached to a PIVC and acting as a flow restrictor to reduce the risk of hemolysis. The hemolysis reduction accessory is advantageously adapted to the PIVC placement and does not require any changes to current procedures. The hemolysis reduction accessories of the various embodiments described herein can potentially be applied to a wide variety of PIVC products and are compatible with current blood collection devices and infusion disposable supplies.

[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 restriction device), which regulates the overall flow rate of the entire fluid path through which blood cells travel. The flow restriction device may be assembled with the PIVC or co-packaged with the PIVC. A clinician can collect a blood collection device at the port of the accessory and then draw blood to the desired volume. After blood collection, the clinician can disconnect and discard the flow restriction device and the blood collection device together. Thus, this flow restriction device can be used for a single blood draw or can remain in-line throughout the indwelling period.

[0020] The flow restriction devices and related blood collection systems of the various embodiments described herein provide additional advantages over currently existing blood collection systems. For example, the add-on flow restriction devices described herein enable the integration of a hemolysis reduction function for PIVC blood draws. Further, the flow restriction devices described herein are adapted to the PIVC placement and enable seamless blood collection upon insertion. Additionally, since the flow restriction devices are of the add-on type, they can be easily incorporated without any changes to the current PIVC, with minimal impact on the clinical environment and procedures.

[0021] FIG. 1 shows a vascular access device 10 including a peripheral intravenous catheter (PIVC) assembly 50 including a connector or flow restrictor device 100 according to some embodiments of the present disclosure. The flow restrictor device 100 can be configured to facilitate connection to components 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 distal end 54, a proximal end 56, and a catheter hub 52 that can include a lumen extending through the distal and proximal ends. The catheter assembly 50 can further include a catheter 58 that can be fixed within the catheter hub 52 and extend distally from the distal end 54 of the catheter hub 52. In some embodiments, the catheter assembly 50 can be a peripheral intravenous catheter (PIVC).

[0022] In some embodiments, the catheter assembly 50 can include or correspond to any suitable catheter assembly 50. In some embodiments, the catheter assembly 50 can be integrated and can include an extension tube 60 that extends from a side port 59 of the catheter hub 52 and can be integrated with the side port 59. A non-limiting example of an integrated catheter assembly is the BD NEXIVA™ Closed IV Catheter System available from Becton Dickinson and Company. In some embodiments, the proximal end of the extension tube 60 can be coupled to an adapter such as, for example, a Y-adapter 70. In some embodiments, the flow restrictor device 100 can be fluidly coupled to the Y-adapter 70.

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

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

[0025] Continuing to refer to FIG. 1, as shown in FIGS. 2-4, in some embodiments, the flow restrictor device 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 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 can 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 integrated with the blood collection device 40, or may be integrally formed with the blood collection device 40 as a single unit or single part. 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 the male Luer portion of the blood collection device 40. The female Luer connector portion 120 can include an inner surface that defines a lumen 122 extending therethrough for coupling to the 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, the threaded portion 128 of the female Luer connector portion 120 can be utilized to engage the female Luer connector portion 120 to a corresponding male Luer portion. In some embodiments, the lumen 122 is in fluid communication with a cavity 126 defined by the body 124 of the female Luer connector portion 120.

[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 enable fluid communication between the lumen 112 and the lumen 122 of the flow restriction device 100 and to form a common housing. As shown, the cavity 116 of the male Luer connector portion 110 can be arranged in fluid communication with the cavity 126 of the female Luer connector portion 120 to form a common cavity. Accordingly, the lumen 112 of the male Luer connector portion 110 can be in fluid communication with the lumen 122 of the female Luer connector portion 120 through the common cavity formed by the respective cavities 116, 126.

[0028] In the illustrated example, the insertion body 130 can be disposed within a common cavity formed by the male Luer connector portion 110 and the female Luer connector portion 120 to control the fluid flow between the lumen 112 and the lumen 122 and reduce hemolysis passing through the flow restrictor 100. As shown, the insertion body 130 guides the fluid flow between the lumen 112 of the male Luer connector portion 110 and the lumen 122 of the female Luer connector portion 120, respectively, while inducing resistance to the fluid flow as the fluid flow moves across the insertion body 130. By inducing resistance to the fluid flow, the fluid flow rate is reduced as the fluid moves across the insertion body 130. By reducing the flow rate of a fluid such as blood passing through the flow restrictor 100, the hemolysis index of the blood can be reduced.

[0029] In some embodiments, the insertion body 130 defines a channel 132 that guides the fluid flow from the distal end 134 of the insertion body 130 to the proximal end 138 of the insertion body 130. As shown, the channel 132 can be defined along the outer surface of the insertion body 130. Thus, when the insertion body 130 is positioned within the common cavity defined by the male Luer connector portion 110 and the female Luer connector portion 120, at least a portion of the outer surface of the insertion body 130 can be pressed against and engaged with the inner surface of the common cavity so as to jointly define a fluid passage therebetween with the inner surface within the common cavity. The defined fluid passage can extend along the path between the distal end 134 and the proximal end 138 of the insertion body 130 to reduce the fluid flow rate across the insertion body 130. In some embodiments, the channel 132 can be defined on the inner surface of the body 114 such that when the insertion body 130 is received within the connector portion 110, a passageway is formed by the engagement of the outer surface of the insertion body 130 and the inner surface of the body 114. In some embodiments, the channel 132 is an open channel on either or both of the insertion body 130 and the body 114 of the connector portion 120, and the open channel is closed to form a passageway by the engagement of the inner surface of the body 114 and the outer surface of the insertion body 130.

[0030] Accordingly, in some embodiments, the channel 132 can guide a fluid flow from the male Luer connector portion 110, via the female Luer connector portion 120 (in cooperation with the inner surface of the common cavity), into the fluid collection device 40. As shown, the channel 132 can fluidly couple the catheter assembly 50 to the fluid collection device 40 via the flow restrictor device 100. For example, in some embodiments, the leg 72 of the Y - adapter 70 can be coupled to the flow restrictor 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 fluidly couple the flow restrictor device 100 and the channel 132, via a connector 90 shown as a needle - free connector, to the catheter assembly 50, for example via an extension tube 60. Thus, the channel 132 can define a path for the fluid by a meandering path, a tortuous path, an extended path, or other indirect paths (described below), and the fluid entering the flow restrictor device 100 from the catheter assembly 50 can flow through the flow restrictor device 100 and within that path for collection into the fluid collection device 40. For example, when blood is being withdrawn or collected from a patient, the medical fluid can be blood, and the fluid collection device 40 can be a blood collection device. In some embodiments, the blood collection device can be a Luer - Lock Access Device (LLAD). Accordingly, during blood collection or withdrawal from a patient, a blood sample can flow from the distal end of the male Luer connector portion 110, via the flow path or channel 132, into the LLAD 40.

[0031] In some embodiments, the insertion body 130 can define a longitudinal axis that extends through the distal end 134 and the proximal end 138. The channel 132 spans between the distal end 134 and the proximal end 138 of the insertion body 130 and is configured to extend in two or more directions along the path between the distal end 134 and the proximal end 138. Since the path extends in two or more directions, the channel 132 indirectly extends between the distal end 134 and the proximal end 138 of the insertion body 130. The indirect path between the distal end 134 and the proximal end 138 of the insertion body 130 can have a length greater than the distance between the distal end 134 and the proximal end 138 of the insertion body 130.

[0032] As shown, the channel 132 can be disposed along a serpentine path, a tortuous path, or a rotational path. In other words, the channel 132 can include a first portion 136 that extends in a first direction away from the longitudinal axis and a second portion 135 that extends in a second direction toward the longitudinal axis. Further, the channel 132 can include additional portions that extend toward the longitudinal axis and additional portions that extend away from the longitudinal axis. The change in direction of the channel 132 between the distal end 134 and the proximal end 138 of the insertion body 130 can be set by the angle between one or more portions of the channel 132. In some cases, the channel 132 can have a change in direction by an angle between about 45 degrees and about 90 degrees. The change in direction of the channel 132 can form a line representing a periodic wave such as a sine wave. The change in direction of the channel 132 is optimized to reduce the pressure of a fluid, such as blood, moving through the channel 132 by inducing resistance to the fluid. The reduction in blood flow reduces the shear stress experienced by the red blood cells of the blood, and advantageously, the risk of hemolysis during blood collection can be reduced. In some embodiments, the channel 132 can have a diameter in the range of 0.508 mm (0.02 inches) to 0.762 mm (0.03 inches). In some embodiments, the length of the channel 132 can be from about 24.638 mm (0.97 inches) to about 33.02 mm (1.30 inches).

[0033] As shown, the path of channel 132 can be disposed on a portion of the outer surface of the insertion body 130, or alternatively, can be limited to a portion thereof. For example, the path of channel 132 may extend within an arc defined by the cross-section of the cylindrical insertion body 130. In some embodiments, the path of channel 132 can extend within a 180-degree arc defined by the cross-section of the cylindrical insertion body 130. In some embodiments, the path of channel 132 can extend within a 90-degree arc defined by the cross-section of the cylindrical insertion body 130.

[0034] The flow rate limiting device 100 of the various embodiments described herein is advantageous over existing blood collection systems. For example, during blood collection with existing blood collection devices, blood cells may be subject to wall shear stress as they flow from the distal end to the proximal end of the blood collection system. Wall shear stress on blood cells is considered a major cause of mechanical damage to blood cells that causes hemolysis of the blood cells. The diameter and effective length of channel 132 can facilitate the dispersion of the pressure differential and the reduction of the shear stress experienced by the red blood cells of blood 15 due to the increased flow resistance within the vascular access system. For example, the minimized diameter and elongated effective length of channel 132 can result in increased resistance to the flow of blood 15, thereby reducing the blood flow rate within the flow rate limiting device 100. The reduction in blood flow rate results in a decrease in the shear stress experienced by the red blood cells of blood 15, and the risk of hemolysis during blood collection can be advantageously reduced. Further, the geometry of channel 132 can reduce the amount of blood consumed by existing blood collection systems.

[0035] Furthermore, the flow rate limiting device 100 can reduce hemolysis without using an active device such as a valve or other flow control device. In some applications, the configuration of the flow rate limiting device 100 as described herein can minimize the flushing of the vascular access device 10, minimize the dead volume, and facilitate a compact design. Additionally, the configuration of the flow rate limiting device 100 can facilitate ease of manufacture compared to some prior art designs. For example, in some applications, the flow rate limiting device 100 can be formed by press-fitting the insertion body 130 into the male Luer connector portion 110 and then performing ultrasonic welding of the female Luer connector portion 120.

[0036] Description as a technical clause of the subject matter The subject matter is described, for example, according to the various aspects described below. Various examples of aspects of the subject matter are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject matter. Any combination of the dependent clauses can be combined and incorporated into each independent clause, for example, clause 1 or clause 5. Other clauses can be presented in a similar manner.

[0037] Clause 1: A flow rate limiting device comprising a housing defining a first lumen, a second lumen, and a cavity disposed between the first lumen and the second lumen, and an insertion body disposed within the cavity, the insertion body having a first end, a second end, a longitudinal axis extending through the first and second ends, an outer surface, and a channel defined on the outer surface, the channel extending between the first end and the second end, the channel having a first portion extending in a first direction away from the longitudinal axis and a second portion extending in a second direction toward the longitudinal axis, the channel and the inner surface of the cavity defining a fluid passage in fluid communication with the first lumen and the second lumen.

[0038] Clause 2: The flow rate limiting device of clause 1, wherein the channel has a diameter of from about 0.508 mm (0.02 inches) to about 0.762 mm (0.03 inches).

[0039] Clause 3: The channel is the flow rate limiting device of Clause 1 having a length from approximately 24.638 mm (0.97 inches) to approximately 33.02 mm (1.30 inches).

[0040] Clause 4: The fluid passageway is the flow rate limiting device of Clause 1 configured to increase the flow resistance through the fluid passageway in order to minimize the shear stress experienced by the fluid flow.

[0041] Clause 5: The channel is the flow rate limiting device of Clause 1 that defines a serpentine fluid passageway.

[0042] Clause 6: The channel is the flow rate limiting device of Clause 1 that is at least partially sinusoidal.

[0043] Clause 7: The insertion body includes a cylindrical body, which is the flow rate limiting device of Clause 1.

[0044] Clause 8: The channel is the flow rate limiting device of Clause 7 that extends along the outer surface within the arc of the cross-section of the cylindrical body.

[0045] Clause 9: The arc is approximately 180 degrees, which is the flow rate limiting device of Clause 8.

[0046] Clause 10: The arc is approximately 90 degrees, which is the flow rate limiting device of Clause 8.

[0047] Clause 11: The housing has a male Luer connector portion that defines a first lumen and a female Luer connector portion that defines a second lumen, and the male Luer portion connector and the female Luer connector portion are integrally coupled to cooperate to define a cavity, which is the flow rate limiting device of Clause 1.

[0048] Clause 12: The first lumen is configured to be coupled to a catheter hub, which is the flow rate limiting device of Clause 1.

[0049] Clause 13: The second lumen is configured to be coupled to a fluid collection device, which is the flow rate limiting device of Clause 1.

[0050] Clause 14: A flow rate limiting device comprising a male Luer connector portion defining a first lumen and a female Luer connector portion defining a second lumen, wherein the male Luer connector portion and the female Luer connector portion cooperate to define a cavity, and the flow rate limiting device further comprises an insertion body disposed within the cavity, the insertion body having a first end, a second end, an outer surface, and a serpentine channel defined on the outer surface, the channel extending between the first end and the second end, and the channel and the inner surface of the cavity defining a fluid passage in fluid communication with the first lumen and the second lumen.

[0051] Clause 15: The flow rate limiting device of Clause 14, wherein the channel has a diameter of from about 0.508 mm (0.02 inches) to about 0.762 mm (0.03 inches).

[0052] Clause 16: The flow rate limiting device of Clause 14, wherein the channel has a length of from about 24.638 mm (0.97 inches) to about 33.02 mm (1.30 inches).

[0053] Clause 17: The flow rate limiting device of Clause 14, wherein the fluid passage is configured to increase the flow resistance through the fluid passage in order to minimize the shear stress experienced by the fluid flow.

[0054] Clause 18: The flow rate limiting device of Clause 14, wherein the channel is at least partially sinusoidal.

[0055] Clause 19: The flow rate limiting device of Clause 14, wherein the insertion body includes a cylindrical body.

[0056] Clause 20: The flow rate limiting device of Clause 19, wherein the channel extends along the outer surface within the arc of the cross-section of the cylindrical body.

[0057] Clause 21: The flow rate limiting device of Clause 20, wherein the arc is about 180 degrees.

[0058] Clause 22: The flow rate limiting device of Clause 20, wherein the arc is about 90 degrees.

[0059] Clause 23: The flow rate limiting device of Clause 14, wherein the first lumen is configured to be coupled to a catheter hub.

[0060] Clause 24: The flow rate limiting device of Clause 14, wherein the second lumen is configured to be coupled to a fluid collection device.

[0061] Clause 25: A peripheral intravenous catheter assembly configured to limit hemolysis during blood collection from a patient, comprising a catheter hub having a proximal end and a distal end, a fluid collection device, and a flow rate limiting device, the flow rate limiting device comprising a housing defining a first lumen, a second lumen, and a cavity disposed between the first lumen and the second lumen, the first lumen being in fluid communication with the catheter hub, the second lumen being in fluid communication with the fluid collection device, and a housing, and an insertion body disposed within the cavity, the insertion body having a first end, a second end, an outer surface, and a contoured channel defined on the outer surface, the channel extending between the first end and the second end, the channel and the inner surface of the cavity defining a fluid passage in fluid communication with the first lumen and the second lumen, a peripheral intravenous catheter assembly.

[0062] Clause 26: The peripheral intravenous catheter assembly of Clause 25, wherein the channel has a diameter of from about 0.508 mm (0.02 inches) to about 0.762 mm (0.03 inches).

[0063] Clause 27: The peripheral intravenous catheter assembly of Clause 25, wherein the channel has a length of from about 24.638 mm (0.97 inches) to about 33.02 mm (1.30 inches).

[0064] Clause 28: The peripheral intravenous catheter assembly of Clause 25, wherein the fluid passage is configured to increase the flow resistance through the fluid passage to minimize the shear stress experienced by the fluid flow.

[0065] Clause 29: The peripheral intravenous catheter assembly of Clause 25, wherein the channel is at least partially sinusoidal.

[0066] Clause 30: The peripheral intravenous catheter assembly of Clause 25, wherein the insertion body includes a cylindrical body.

[0067] Clause 31: The peripheral intravenous catheter assembly of Clause 30, wherein the channel extends along the outer surface within the arc of the cross-section of the cylindrical body.

[0068] Clause 32: The peripheral intravenous catheter assembly of Clause 31, wherein the arc is approximately 180 degrees.

[0069] Clause 33: The peripheral intravenous catheter assembly of Clause 31, wherein the arc is approximately 90 degrees.

[0070] Clause 34: The peripheral intravenous catheter assembly of Clause 25, wherein the housing has a male Luer connector portion defining a first lumen and a female Luer connector portion defining a second lumen, and the male Luer connector portion and the female Luer connector portion are integrally joined to cooperatively define a cavity.

[0071] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. The disclosure provides various examples of the technology of the subject matter, but the technology of the subject matter is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0072] References to elements in the singular are intended to mean "one or more" rather than "merely one" unless specifically stated otherwise. Unless specifically stated otherwise, the term "some" refers to one or more. Pronouns referring to a male (e.g., his) include those referring to a female 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.

[0073] As used herein, the word "exemplary" is used to mean "serving as an example or illustration". Any aspect or design described herein as "exemplary" should not necessarily be construed as more preferred or advantageous than other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0074] As used herein, the phrase "at least one of" preceding a series of items modifies the list as a whole, rather than each item in the list, using the term "or" to separate any of the items. The phrase "at least one of" does not require the selection of at least one item, but rather allows this phrase to mean including at least one item of any of the items, and / or at least one combination of any combination of the items, and / or at least one item of each of the items. By way of 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.

[0075] Phrases such as "aspect" do not imply that such an aspect is essential to the technology of the subject matter, nor that such an aspect applies to all configurations of the technology of the subject matter. The disclosure regarding an aspect may apply to all configurations, or to one or more configurations. An aspect can provide one or more examples. Phrases such as "aspect" can refer to one or more aspects, and vice versa. Phrases such as "embodiment" do not imply that such an embodiment is essential to the technology of the subject matter, nor that such an embodiment applies to all configurations of the technology of the subject matter. The disclosure regarding an embodiment may apply to all embodiments, or to one or more embodiments. An embodiment can provide one or more examples. Phrases such as "embodiment" can refer to one or more embodiments, and vice versa. Phrases such as "configuration" do not imply that such a configuration is essential to the technology of the subject matter, nor that such a configuration applies to all configurations of the technology of the subject matter. The disclosure regarding a configuration may apply to all configurations, or to one or more configurations. A configuration can provide one or more examples. Phrases such as "configuration" can refer to one or more configurations, and vice versa.

[0076] In one aspect, unless stated otherwise, all measurements, values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification are approximate and not exact, including those included in the following claims. In one aspect, they are intended to have a consistent and reasonable range with the functions they relate to and what is customary in the technical field to which they relate.

[0077] The specific order or hierarchy of steps or operations in the disclosed processes or methods is understood to be illustrative of exemplary approaches. It is understood that, based on implementation priorities or scenarios, the specific order or hierarchy of steps, operations, or processes may be rearranged. Some of the steps, operations, or processes may be performed concurrently. In some implementation priorities or scenarios, a particular operation may or may not be performed. Some or all of the steps, operations, or processes may be automatically performed without user intervention. The appended method claims present the elements of the various steps, operations, or processes in a sample order and are not meant to be limited to the specific order or hierarchy presented.

[0078] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure, known or later to become known to those skilled in the art, are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under 35 U.S.C. § 112, paragraph (f) unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is expressly recited using the phrase "step for." Further, to the extent the terms "comprising," "having," etc. are used, such terms are intended to be inclusive in a manner similar to the term "comprising" as interpreted when "comprising" is utilized as a transitional word in a claim.

[0079] The title, background art, summary of the invention, brief description of the drawings, and abstract of the present disclosure are incorporated herein by reference and provided as illustrative examples of the present disclosure, not as a limiting description. The present disclosure is submitted with the understanding that it is not to be used to limit what the claims scope or mean. Further, in the detailed description of the invention, the description provides illustrative examples, and it can be understood that various features are grouped together in various embodiments to rationalize the present disclosure. This method of disclosure should not be construed as indicating an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims show, the subject matter of the invention lies in less than all of the features of a single disclosed configuration or operation. The following claims are hereby incorporated into the detailed description of the invention, and each claim stands on its own as a separately claimed subject matter.

[0080] The claims are not intended to be limited to the aspects described herein, but rather should be given the full scope consistent with the language of the claims and should include all legal equivalents. However, none of the claims are intended to cover, nor should they be construed to cover, subject matter that fails to meet the requirements of 35 U.S.C. § 101, 102, or 103.

Claims

1. A flow rate limiting device comprising a first lumen, a second lumen, and a housing defining a cavity disposed between the first lumen and the second lumen, and an insertion body disposed within the cavity, the insertion body comprising: a first end, a second end, a longitudinal axis extending through the first end and the second end, an outer surface, and a channel defined on the outer surface, the channel extending between the first end and the second end, the channel having a first portion extending in a first direction away from the longitudinal axis and a second portion extending in a second direction toward the longitudinal axis, the channel and the inner surface of the cavity defining a fluid passage in fluid communication with the first lumen and the second lumen, wherein the second portion is disposed at an angle between 45 degrees and 90 degrees with respect to the first portion. A flow rate limiting device.

2. The flow rate limiting device according to claim 1, wherein the channel has a diameter of from about 0.508 mm (0.02 inches) to about 0.762 mm (0.03 inches).

3. The flow rate limiting device according to claim 1, wherein the channel has a length of from about 24.638 mm (0.97 inches) to about 33.02 mm (1.30 inches).

4. The flow rate limiting device according to claim 1, wherein the fluid passage is configured to increase the flow resistance through the fluid passage in order to minimize the shear stress experienced by the fluid flow.

5. The flow rate limiting device according to claim 1, wherein the channel defines a serpentine fluid passage.

6. The flow rate limiting device according to claim 1, wherein the channel is at least partially sinusoidal.

7. The flow rate limiting device according to claim 1, wherein the insertion body includes a cylindrical body.

8. The flow rate limiting device according to claim 7, wherein the channel extends along an outer surface within an arc of a cross section of the cylindrical body.

9. The flow rate limiting device according to claim 8, wherein the arc is about 180 degrees.

10. The flow rate limiting device according to claim 8, wherein the arc is about 90 degrees.

11. The flow rate limiting device according to claim 1, wherein the housing has a male Luer connector portion defining the first lumen and a female Luer connector portion defining the second lumen, and the male Luer connector portion and the female Luer connector portion are integrally joined to cooperatively define the cavity.

12. The flow rate limiting device according to claim 1, wherein the first lumen is configured to be coupled to a catheter hub.

13. The flow rate limiting device according to claim 1, wherein the second lumen is configured to be coupled to a fluid collection device.

14. A flow rate limiting device comprising a male Luer connector portion defining a first lumen and a female Luer connector portion defining a second lumen, wherein the male Luer connector portion and the female Luer connector portion cooperate to define a cavity, and the flow rate limiting device further comprises an insertion body disposed within the cavity, the insertion body having a first end, a second end, an outer surface, It has a meandering channel defined on the outer surface, the channel extends between the first end and the second end, the inner surface of the channel and the cavity define a fluid passage in fluid communication with the first lumen and the second lumen, and the meandering channel comprises a first portion and a second portion arranged at an angle between 45 degrees and 90 degrees with respect to the first portion. Flow rate limiting device.

15. The flow rate limiting device according to claim 14, wherein the channel has a diameter of from about 0.508 mm (0.02 inches) to about 0.762 mm (0.03 inches).

16. The flow rate limiting device according to claim 14, wherein the channel has a length of from about 24.638 mm (0.97 inches) to about 33.02 mm (1.30 inches).

17. The flow rate limiting device according to claim 14, wherein the fluid passage is configured to increase the flow resistance through the fluid passage in order to minimize the shear stress received by the fluid flow.

18. The flow rate limiting device according to claim 14, wherein the channel is at least partially sinusoidal.

19. The flow rate limiting device according to claim 14, wherein the insertion body includes a cylindrical body.

20. The flow rate limiting device according to claim 19, wherein the channel extends along the outer surface within an arc of the cross-section of the cylindrical body.

21. The flow rate limiting device according to claim 20, wherein the arc is about 180 degrees.

22. The flow rate limiting device according to claim 20, wherein the arc is about 90 degrees.

23. The flow rate limiting device according to claim 14, wherein the first lumen is configured to be coupled to a catheter hub.

24. The flow rate limiting device according to claim 14, wherein the second lumen is configured to be coupled to a fluid collection device. **Claim 25** A peripheral intravenous catheter assembly configured to limit hemolysis during blood collection from a patient, A catheter hub having a proximal end and a distal end, A fluid collection device, And a flow rate limiting device, the flow rate limiting device comprising: A housing defining a first lumen, a second lumen, and a cavity disposed between the first lumen and the second lumen, the first lumen being in fluid communication with the catheter hub, and the second lumen being in fluid communication with the fluid collection device; An insertion body disposed within the cavity, the insertion body comprising: A first end, A second end, An outer surface, And an intricate channel defined on the outer surface, the channel extending between the first end and the second end, the channel and the inner surface of the cavity defining a fluid passage in fluid communication with the first lumen and the second lumen, the intricate channel comprising a first portion and a second portion disposed at an angle between 45 degrees and 90 degrees with respect to the first portion. **Claim 26** The peripheral intravenous catheter assembly according to claim 25, wherein the channel has a diameter of from about 0.508 mm (0.02 inches) to about 0.762 mm (0.03 inches). **Claim 27** The peripheral intravenous catheter assembly according to claim 25, wherein the channel has a length of from about 24.638 mm (0.97 inches) to about 33.02 mm (1.30 inches). **Claim 28** The peripheral intravenous catheter assembly according to claim 25, wherein the fluid passage is configured to increase the flow resistance through the fluid passage in order to minimize the shear stress received by the fluid flow.

29. The peripheral intravenous catheter assembly according to claim 25, wherein the channel is at least partially sinusoidal.

30. The peripheral intravenous catheter assembly according to claim 25, wherein the insertion body includes a cylindrical body.

31. The peripheral intravenous catheter assembly according to claim 30, wherein the channel extends along the outer surface within an arc of a cross-section of the cylindrical body.

32. The peripheral intravenous catheter assembly according to claim 31, wherein the arc is approximately 180 degrees.

33. The peripheral intravenous catheter assembly according to claim 31, wherein the arc is approximately 90 degrees.

34. The peripheral intravenous catheter assembly according to claim 25, wherein the housing has a male Luer connector portion defining the first lumen and a female Luer connector portion defining the second lumen, and the male Luer connector portion and the female Luer connector portion are integrally coupled to cooperatively define the cavity.

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