PIVC-INTEGRATED HEMOLYSIS-REDUCTION ACCESSORIES FOR DIRECT BLOOD DRAW

A flow restriction device may include a distal end configured to couple to a catheter assembly, a proximal end configured to couple to a fluid collection device, and a body extending from the proximal end to the distal end. The body may include an outer surface and an inner surface defining a lumen of the body. The flow restriction device may further include a fluid pathway disposed between the distal end and the proximal end when the outer surface is coupled within a mating luer. The fluid pathway may include a non-linear portion on at least a portion of the outer surface along which a fluid flows from the distal end into the fluid collection device.

TECHNICAL FIELD

The present disclosure generally relates to blood draw and administration of parenteral fluids to a patient, and particularly to systems and methods to reduce hemolysis in PIVC blood draw.

BACKGROUND

Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used for infusing fluids, such as normal saline solution, various medicaments, and total parenteral nutrition, into a patient. Catheters may also be used for withdrawing blood from the patient.

A common type of catheter is an over-the-needle peripheral intravenous (“IV”) catheter (PIVC). As its name implies, the over-the-needle catheter may be mounted over an introducer needle having a sharp distal tip. A catheter assembly may include a catheter hub, the catheter extending distally from the catheter hub, and the introducer needle extending through the catheter. The catheter and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from skin of the patient. The catheter and introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient.

In order to verify proper placement of the introducer needle and/or the catheter in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of the catheter assembly. Once placement of the needle has been confirmed, the clinician may temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion.

For blood withdrawal or collecting a blood sample from a patient, a blood collection container may be used. 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 a portion of air removed from the test tube so pressure within the test tube is lower than ambient pressure. Such a blood collection container is often referred to as an internal vacuum or a vacuum tube. A commonly used as an internal vacuum or a vacuum tube. The blood collection container may also be a VACUTAINER® blood collection tube, available from Becton Dickinson & Company.

The blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter, a pressure in the vein is higher than a pressure in the blood collection container, which pushes blood into the blood collection container, thus filling the blood collection container with blood. A vacuum within the blood collection container decreases as the blood collection container fills, until the pressure in the blood collection container equalizes with the pressure in the vein, and the flow of blood stops.

Unfortunately, as blood is drawn into the blood collection container, red blood cells are in a high shear stress state and susceptible to hemolysis due to a high initial pressure differential between the vein and the blood collection container. Hemolysis may result in rejection and discard of a blood sample. The high initial pressure differential can also result in catheter tip collapse, vein collapse, or other complications that prevent or restrict blood from filling the blood collection container.

SUMMARY

In accordance with various embodiments of the present disclosure, a flow restriction device may include a distal end configured to couple to a catheter assembly, a proximal end including a proximal connector configured to couple to a fluid collection device, a body extending from the proximal connector to the distal end, and a fluid pathway disposed between the distal end and the proximal end when the outer surface is coupled within a mating luer. The body may include an outer surface and an inner surface defining a lumen of the body. The fluid pathway may have a non-linear portion on at least a portion of the outer surface along which a fluid flows from the distal end into the fluid collection device.

In accordance with various embodiments of the present disclosure, a blood collection system may include a blood collection device, and a flow restriction device fluidly coupled to the blood collection device. The flow restriction device may include an outer surface, and an inner surface defining an internal flowpath therethrough, a distal end including a distal connector configured to couple to a catheter assembly, and a proximal end coupled to the blood collection device and having a lumen fluidly communicated with the internal flowpath. The flow restriction device may further include a non-linear fluid pathway disposed on the outer surface at least partially between the distal end and the proximal end when the outer surface is coupled within a mating luer.

DETAILED DESCRIPTION

It is to 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 will now be disclosed according to particular but non-limiting examples. Various embodiments described in the present disclosure may be carried out in different ways and variations, and in accordance with a desired application or implementation.

Blood draw via a vascular access device has drawn increasing attention attributed to minimized needle sticks and improved operation efficiency as compared with traditional blood draw methods with venipuncture. Current blood draw using a peripheral intravenous catheter (PIVC) has seen some challenges, one of the most critical is hemolysis related blood quality. In particular, with currently existing PIVC products in the market, along with the standard connection (such as a short extension set and a needleless connector), and blood collection devices (such as a Vacutainer), the shear stress exerted onto blood cells tends to be on the verge of hemolyzing.

Various embodiments of the present disclosure are directed to providing systems and methods to address hemolysis in PIVC blood draw with a hemolysis reduction accessory (also referred to herein as a flow restriction device) which is pre-attached to the PIVC and serves as a flow restrictor to reduce risk of hemolysis. The hemolysis-reduction accessory is advantageously compatible with PIVC placement and does not necessitate change to any of the existing operations. The hemolysis-reduction accessory of the various embodiments described herein is potentially applicable to a wide variety of PIVC products, and compatible with existing blood collection devices and infusion disposables.

Various embodiments of the present disclosure focus on effective flow restriction with the add-on hemolysis-reduction accessory (also referred to herein as a flow restriction device) that regulates the overall flow rate of the entire fluid path as blood cells travel through. The flow restriction device can be either assembled with the PIVC or co-packaged with the PIVC. As such, there is no additional operation during catheter placement since the device has a vented lumen that enables blood flashback. The clinician may connect a blood collection device to the port of the accessory and can then draw blood to the intended volume. After blood draw, the clinician may disconnect and discard the flow restriction device and the blood collection device together. As such, this flow restriction device can be either for single blood draw or stay inline throughout indwell.

In some embodiments, the flow restriction device may integrate a check valve in the central fluid path that allows hemolysis reduction and unobstructed infusion.

According to various embodiments of the present disclosure, the flow restriction device may be an insert with luer access and spiral continuous channel on the exterior featuring the flow resistance per design. The flow restriction device may be a plastic insert, as molded, featuring the fluid channel of flow resistance per design. The proximal end of the insert may have a female luer so that a vent plug may be inserted into the flow restriction device that is connected to a port of a luer adapter of the PIVC as packaged to enable blood flashback when the PIVC is placed. In some embodiments, a clinician or other user may remove the vent plug from the flow restriction device and attach a blood collection device to complete the blood draw. In some embodiments, when the clinician connects a blood collection device to this insert, the vent plug may be pushed into a pocket and thereby open the fluid path for blood draw.

Accordingly, the flow restriction devices and systems of the various embodiments described herein are advantageous in that the spiral continuous channel with small (minimized) diameter may increase a length of the fluid pathway defined by the continuous channel or groove through which the blood flows, and may provide increased flow resistance and decreased blood flow rate within the flow resistance device in contrast to the linear internal fluid pathways. As such, a risk of hemolysis during blood collection may be advantageously be reduced.

The flow restriction devices and associated blood collection systems of the various embodiments described herein additionally provide further advantages over currently existing blood collection systems. For example, add-on flow restriction devices described herein allow for hemolysis-reduction function to be integrated for PIVC blood draw. Further, the flow restriction devices described herein are compatible with PIVC placement and allow for seamless blood draw at insertion. Furthermore, the flow restriction devices have the potential to stay inline throughout PIVC indwell for multiple blood draws. Additionally, since the flow restriction devices are an add-on which can be easily incorporated without any changes to existing PIVC, there is minimal impact to clinical setting and operations.

FIGS.1A-1Dillustrate a vascular access device100including a peripheral intravenous catheter (PIVC) assembly50that includes a flow restriction device10, in accordance with some embodiments of the present disclosure.

Referring now toFIGS.1A-1C, flow restriction device10is illustrated, according to some embodiments. The flow restriction device10may be configured to reduce a likelihood of hemolysis during blood collection using a vascular access device100. In some embodiments, the vascular access device100may include a catheter assembly (e.g., a PIVC)50. In some embodiments, (as further illustrated inFIGS.2A-3B), the flow restriction device10may include a distal end12, which may include a body or distal connector14configured to couple to the catheter assembly50. The distal connector14may include a male luer connector, or another suitable connector.

In some embodiments, the catheter assembly50may include a catheter hub52, which may include a distal end54, a proximal end56, and a lumen extending through the distal end and the proximal end. The catheter assembly50may further include a catheter58, which may be secured within the catheter hub52and may extend distally from the distal end54of the catheter hub52. In some embodiments, the catheter may be a peripheral intravenous catheter (PIVC).

In some embodiments, the catheter assembly50may include or correspond to any suitable catheter assembly50. In some embodiments, the catheter assembly50may be integrated and include an extension tube60, which may extend from and be integrated with a side port59of the catheter hub52. 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, a proximal end of the extension tube60may be coupled to an adapter70, such as, for example, a Y-adapter or single port luer adapter. In some embodiments, the distal connector14of flow restriction device10may be configured to couple to the Y-adapter70.

In some embodiments, the catheter assembly50may be non-integrated and may not include the extension tube60. In these and other embodiments, the flow restriction device10may be configured to couple to the proximal end56of the catheter hub52or another suitable portion of the catheter assembly50. In some embodiments, the catheter assembly50may be coupled to a removable extension tube60. In some embodiments, the flow restriction device10may be coupled directly to the catheter adapter, eliminating the extension tube and providing a compact catheter system.

FIG.2Aillustrates a vascular access device100including a peripheral intravenous catheter (PIVC) assembly that includes a flow restriction device10, in accordance with some embodiments of the present disclosure. As illustrated inFIG.2A, with continued reference toFIGS.1B and1C, in some embodiments, the flow restriction device10may include a proximal end16, which may include a proximal connector18configured to couple to a blood collection device40(illustrated inFIG.1). In some embodiments, the proximal end16may be coupled to the blood collection device40. For example, the proximal end16may be integrated with the blood collection device40or monolithically formed with the blood collection device40as a single unit. As another example, the proximal end16may include a female luer connector, which may be coupled with a male luer connector of the blood collection device40.

In some embodiments, the proximal connector18may be a female luer connector or another suitable connector. The proximal connector18may include a lumen20extending therethrough for coupling to a male luer portion of the blood collection device. In some embodiments, the distal connector14of the flow restrictor device10may be in the form of a cylindrical body extending from the proximal connector18to the distal end12. As depicted, a fluid pathway may be disposed on at least a portion of an outer surface13between the distal end12and the proximal end16. In some embodiments, the fluid pathway may include a non-linear portion22on at least a portion of the outer surface13. The fluid pathway may be configured such that a medical fluid34flows from the distal end12and into fluid collection device40via the proximal connector18. For example, where blood is being withdrawn or collected from a patient, the medical fluid34may be a blood sample, and the fluid collection device40may be a blood collection device. In some embodiments, the blood collection device may be a luer lock access device (LLAD). Accordingly, during blood collection or withdrawal from the patients, the blood sample34may flow along the outer surface13on the non-linear portion22from the distal end12into the LLAD40.

In particular, as depicted the non-linear portion22of the fluid pathway may include a continuous channel or groove25. In some embodiments, the non-linear portion22may form a coil shape, an S-shape, or another suitable non-linear, winding shape. For example, the continuous channel or groove25may have a coil shape (which may include a spiral) recessed in the outer surface13of the non-linear portion22. In some embodiments, the continuous channel or groove25may have an S-shape recessed in the outer surface13of the non-linear portion22. Where the medical fluid34is blood being withdrawn from a patient, blood cells may experience shear stress as they flow from the distal end12to the proximal end16of the flow restriction device10. For example, the maximum shear stress may be along the wall of the blood cell, often referred to as wall shear stress. Wall shear stress on blood cells is considered a major source of mechanical damage to blood cells causing hemolysis of the blood cells. In some embodiments, the non-linear portion22may facilitate increased flow resistance within the vascular access system100to distribute the pressure differential and reduce shear stress experienced by the red blood cells of the blood34.

According to various embodiments of the present disclosure, no fluid flowing through the non-linear portion22may flow in a straight line. In some embodiments, the non-linear portion22may advantageously increase a length of the fluid pathway defined by continuous channel or groove25through which the blood flows. The minimized diameter of the fluid pathway defined by continuous channel or groove25may provide increased resistance to flow of the blood34and thereby decrease blood flow rate within the flow resistance device10. Since the decreased blood flow rate causes a reduction in shear stress experienced by the red blood cells of the blood34, a risk of hemolysis during blood collection may advantageously be reduced.

In some embodiments, a leg72of the Y-adapter70may form an outer component for coupling with the non-linear portion22of the flow restriction device10. For example, the leg72of Y-adapter70may include a lumen into which the outer surface13of the non-linear portion22having the continuous channel or groove25may be coupled. Accordingly, the non-linear portion22may form an inner component having the continuous channel or groove25which may be coupled in the lumen of the outer component (the leg72of Y-adapter70). In some embodiments, the continuous channel or groove25may include a coil or spiral shape. In some embodiments, the continuous channel or groove25may be surrounded, encased, or otherwise enveloped in the lumen of the leg72of Y-adapter70, which may bound the continuous channel or groove25such that fluid flowing through the continuous channel or groove25may not escape the continuous channel or groove25except at a distal end and a proximal end of the continuous channel or groove25. Accordingly, the continuous channel or groove25when encased, inserted or otherwise enveloped in the lumen of the leg72of Y-adapter70may define the non-linear fluid pathway through which fluid (e.g., blood) flows from the distal end12to the proximal end16for collection in the fluid collection device40.

As depicted, coupling and/or contact between the inner component (i.e., the non-linear portion22) and the outer component (the leg72of Y-adapter70) may form a seal between the non-linear portion22and the leg72of Y-adapter70. In some embodiments, the outer surface of the non-linear portion22may include a seal element27, which may include silicon, rubber, plastic, or another suitable material. In some embodiments, the seal element27may have a coil or spiral shape and may be offset from the continuous channel or groove25in the distal-proximal direction. The seal element27may prevent fluid from escaping the continuous channel or groove25except at a distal end and a proximal end of the continuous channel or groove25.

According to various embodiments of the present disclosure, an outer diameter of the non-linear portion22may be approximately equal to or slightly less than an inner diameter of the lumen of the leg72of Y-adapter70such that the non-linear portion22is fitted within the lumen of the leg72of Y-adapter70. For example, in some embodiments, the non-linear portion22and the leg72of Y-adapter70may form a male luer to female luer connection. For example, the outer surface of the non-linear portion22having the continuous channel or groove25may be encased, enveloped, or otherwise coupled in the lumen of the leg72of Y-adapter70.

In some embodiments, the lumen of the leg72of Y-adapter70may be generally cylindrical, and the outer surface13of the non-linear portion22may be generally cylindrical. In some embodiments, the lumen of the leg72of Y-adapter70may be a standard female luer, and the outer surface13of the non-linear portion22may be a standard male luer. In some embodiments, the non-linear portion22and the leg72may be concentric. In some embodiments, the non-linear portion22and the leg72may be integrally formed or monolithically formed as a single unit.

According to various embodiments, a proximal end of the continuous channel or groove25may include a hole that may fluidly connect the continuous channel or groove25to an opening of the proximal end16. Similarly, in some embodiments, a distal end of the continuous channel or groove25may include a hole that may fluidly connect the continuous channel or groove25to an opening of the distal end12.

In some embodiments, a removable vent plug80may be coupled to the lumen20at the proximal end16of the flow resistance device10. The vent plug80may allow air to vent from the catheter assembly50during the catheter insertion process. This may advantageously allow blood to flashback to fill the fluid path from the catheter through the adapter56and the extension tube60to provide the clinician with visual confirmation that the catheter has been properly placed within a patient's vein. Accordingly, blood may fill the catheter system all the way up to the vent plug65that may allow air to escape, but prevent blood leakage. The vent plug80may be removed prior to connecting the blood collection device40.

In some embodiments, the flow resistance device10may include a vent plug (similar to the vent plug65illustrated inFIG.3Abelow) disposed in the lumen20at the proximal end16. The vent plug65may be incorporated for non-obstructed extended flashback on the catheter assembly50. As shall be described in further detail below with respect toFIG.3A, the vent plug65may allow air to vent from the catheter assembly50during the catheter insertion process. This may advantageously allow blood to flashback to fill the fluid path from the catheter through the adapter56and the extension tube60to provide the clinician with visual confirmation that the catheter has been properly placed within a patient's vein.

FIG.2Billustrates a peripheral intravenous catheter (PIVC) assembly that includes a flow restriction device11having a check valve38and coupled to a needleless connector90, in accordance with some embodiments of the present disclosure. Referring now toFIG.2B, a flow restriction device11is illustrated, according to some embodiments. In some embodiments, the flow restriction device11may be similar or identical in terms of one or more included features and/or operation to the flow restriction device10. For example, the flow restriction device11may be coupled to the blood collection device40(see, for example,FIG.1C). According to various embodiments of the present disclosure, the body14may include the outer surface13and an inner surface15defining a lumen30of the body14. The lumen30of the body14and the lumen20of the proximal connector18may be selectively fluidly communicated via the check valve38. When fluidly communicated, the lumen30of the body14and the lumen20of the proximal connector18may form an internal flowpath24in which a fluid, e.g., an intravenous (IV) fluid36flows from the lumen20at the proximal end16to the distal end12and into the catheter assembly50. In these embodiments, the fluid, e.g., IV fluid36may flow from the lumen20at the proximal end16to the distal end12and into the catheter assembly50via the continuous channel or groove25and the hole that fluidly connects the continuous channel or groove25to an opening of the distal end12. Accordingly, the fluid, e.g. IV fluid may flow from the proximal end16to the distal end12via both the internal flowpath24and the continuous channel or groove25, and into the catheter assembly50.

In some embodiments, the internal flowpath24in which the IV fluid36flows from the proximal end16to the distal end12and into the catheter assembly50is a linear flowpath. Accordingly, fluid flowing through the internal flowpath24may flow linearly. In some embodiments, the linearity of internal flowpath24through which the IV fluid36flows may advantageously result in a decreased length of the flowpath24as compared to a curved or spiraling flowpath, and may thereby decrease flow resistance and increase IV fluid flow rate to the patient within the flow resistance device11. Accordingly, the IV fluid36may flow uninterrupted or un-delayed to the patient whilst still reducing the risk of hemolysis during blood collection.

Similar to the flow restriction device10, the flow restriction device11may include a fluid pathway disposed on at least a portion of the outer surface13between the distal end12and the proximal end16. In some embodiments, the fluid pathway may include the non-linear portion22on at least a portion of the outer surface13. Similar to the flow restriction device10, the non-linear portion22of the fluid pathway of fluid restriction device11may include a continuous channel or groove25. In some embodiments, the non-linear portion22may form a coil shape, an S-shape, or another suitable non-linear, winding shape. For example, the continuous channel or groove25may have a coil shape (which may include a spiral) recessed in the outer surface13of the non-linear portion22. In some embodiments, the continuous channel or groove25may have an S-shape recessed in the outer surface13of the non-linear portion22. Where the medical fluid34is blood being withdrawn from a patient, blood cells may experience shear stress as they flow from the distal end12to the proximal end16of the flow restriction device11. In some embodiments, the non-linear portion22may facilitate increased flow resistance within the vascular access system100to distribute the pressure differential and reduce shear stress experienced by the red blood cells of the blood34.

Additionally, in some embodiments, the continuous channel or groove25of the non-linear portion22may have a first diameter D1, the internal flowpath24within the lumen30may have a second diameter D2, and the second diameter D2may be larger than the first diameter D1. The aforementioned configuration with the second diameter D2being larger than the first diameter D1may be advantageous in further allowing an unrestricted and increased amount of the IV fluid36to flow to the patient versus the smaller (minimized) diameter D1. Accordingly, the IV fluid36may flow in a second unrestricted (less flow resistance) direction (proximal to distal) opposite from the first direction (distal to proximal) in which the blood sample34having blood cells flows.

According to various embodiments, the check valve38may disposed in the internal flowpath24. The check valve38may be configured to prevent the medical fluid (e.g., blood sample34) from flowing from the distal end12to the proximal end16via the internal flowpath24. The check valve38, may however allow the IV fluid36to flow from the proximal end16to the distal end12. Accordingly, the blood sample34containing blood cells may be forced to flow through the curved or spiral continuous channel or groove25of the non-linear portion22in order to arrive at the blood collection device40, while the IV fluid36may flow to the catheter assembly50through the internal flowpath24and the curved or spiral continuous channel or groove25.

The aforementioned configuration is advantageous in that the spiral continuous channel or groove25of non-linear portion22—by virtue of its wrapping around the outer surface13—may increase a length of the fluid pathway defined by continuous channel or groove25through which the blood sample34flows. Further, due to the minimized diameter or size of the fluid pathway defined by continuous channel or groove25, the fluid pathway defined by continuous channel or groove25may thereby provide increased flow resistance and decreased blood flow rate within the flow resistance device11in contrast to the linear internal flowpath24. Accordingly, a risk of hemolysis during blood collection may advantageously be reduced.

FIG.3Aillustrates a peripheral intravenous catheter (PIVC) assembly that includes a flow restriction device having a vent plug65disposed therein, in accordance with some embodiments of the present disclosure. Referring now toFIG.3A, a flow restriction device17is illustrated, according to some embodiments. In some embodiments, the flow restriction device17may be similar or identical in terms of one or more included features and/or operation to the flow restriction device10. For example, the flow restriction device17may be coupled to the blood collection device40(see, for example,FIG.1C). As depicted, the flow restriction device17may include a vent plug65disposed in the lumen20at the proximal end16. The vent plug65may be incorporated for non-obstructed extended flashback on the catheter assembly50.

In some embodiments, the vent plug65may allow air to vent from the catheter assembly50during the catheter insertion process. This may advantageously allow blood to flashback to fill the fluid path from the catheter through the adapter56and the extension tube60to provide the clinician with visual confirmation that the catheter has been properly placed within a patient's vein. Accordingly, blood may fill the catheter system all the way up to the vent plug65that may allow air to escape, but prevent blood leakage. The clinician may then connect the blood collection device40. During connection of the blood connection device40, the male luer of the blood collection device40may push the vent plug65from its position at the proximal end16and further into the lumen20of the flow restriction device10, thereby opening a fluid pathway for blood collection. Accordingly, the internal vent plug65may advantageously serve the same purpose as the removable vent plug80illustrated inFIG.2A. The internal vent plug65may serve a similar purpose as the vent plug80with the difference between the vent plug65and the vent plug80being that the vent plug80may be removed by the clinician prior to connecting the blood collection device40, while vent plug65may be pushed out of place by connection of the blood collection device40.

In some embodiments, the fluid within entering the lumen20from the fluid pathway in the non-linear portion22may flow through the proximal end16in response to an axial displacement of the vent plug65disposed within the proximal end16. For example, in some embodiments, the vent plug65may be displaced and open the fluid pathway in response to coupling of the blood collection device40to the proximal end16of the flow restriction device17. Accordingly, the vent plug65may be removed/nudged to open the fluid pathway20at the proximal end16for blood to travel into from the curved or spiral continuous channel or groove25into the blood collection device40.

Accordingly, in operation the blood sample34containing blood cells may be forced to flow through the curved or spiral continuous channel or groove25of the non-linear portion22in order to arrive at the blood collection device40. The aforementioned configuration is advantageous in that the spiral continuous channel or groove25of non-linear portion22may increase a length of the fluid pathway defined by continuous channel or groove25through which the blood flows, and may thereby provide increased flow resistance and decreased blood flow rate within the flow resistance device17in contrast to a linear fluid pathway. Accordingly, a risk of hemolysis during blood collection may be advantageously be reduced.

FIG.3Billustrates a vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device19with a check valve and a vent plug disposed therein, in accordance with some embodiments of the present disclosure. In some embodiments, the flow restriction device19may be similar or identical in terms of one or more included features and/or operation to the flow restriction device11, with the addition of the vent plug65disposed in the lumen20at the proximal end16. The vent plug65may be incorporated for non-obstructed extended flashback on the catheter assembly50. The vent plug65may be similar in structure, function and purpose as the vent plug65described above with respect toFIG.3A, therefore a detailed description thereof shall be omitted with respect toFIG.3B.

The flow restriction devices and associated blood collection systems of the various embodiments described herein additionally provide further advantages over currently existing blood collection systems. For example, add-on flow restriction devices described herein allow for hemolysis-reduction function to be integrated for PIVC blood draw. Further, the flow restriction devices described herein are compatible with PIVC placement and allow for seamless blood draw at insertion. Furthermore, the flow restriction devices have the potential to stay inline throughout PIVC indwell for multiple blood draws. Additionally, since the flow restriction devices are an add-on which can be easily incorporated without any changes to existing PIVC, there is minimal impact to clinical setting and operations.

The subject technology is illustrated, for example, according to various aspects described below. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology. It is noted that any of the dependent clauses may be combined in any combination, and placed into a respective independent clause, e.g., clause 1 or clause 5. The other clauses can be presented in a similar manner.

Clause 1. A flow restriction device, comprising: a distal end configured to couple to a catheter assembly; a proximal end including a proximal connector configured to couple to a fluid collection device; a body extending from the proximal connector to the distal end, the body comprising an outer surface and an inner surface defining a lumen of the body; and a fluid pathway disposed between the distal end and the proximal end when the outer surface is coupled within a mating luer, the fluid pathway comprising a non-linear portion on at least a portion of the outer surface along which a fluid flows from the distal end into the fluid collection device.

Clause 2. The flow restriction device of Clause 1, wherein the non-linear portion comprises a continuous groove having a coil shape recessed in the outer surface.

Clause 3. The flow restriction device of Clause 1, wherein the non-linear portion comprises a continuous groove having an S-shape recessed in the outer surface.

Clause 4. The flow restriction device of Clause 1, wherein the fluid flowing from the distal end into the fluid collection device comprises blood and the fluid collection device comprises a blood collection device.

Clause 5. The flow restriction device of Clause 4, wherein the blood collection device comprises a luer lock access device.

Clause 6. The flow restriction device of Clause 1, wherein the lumen of the body defines an internal flowpath in which a fluid flows from the proximal end to the distal end and into the catheter assembly.

Clause 7. The flow restriction device of Clause 6, wherein the fluid flowing from the proximal end to the distal end and into the catheter assembly comprises an intravenous (IV) fluid.

Clause 8. The flow restriction device of Clause 6, wherein the internal flowpath in which a fluid flows from the proximal end to the distal end and into the catheter assembly comprises a linear flowpath.

Clause 9. The flow restriction device of Clause 6, wherein the non-linear portion of the fluid pathway comprises a first diameter, the internal flowpath comprises a second diameter, and the second diameter is larger than the first diameter.

Clause 10. The flow restriction device of Clause 6, further comprising a check valve disposed in the internal flowpath, the check valve configured to (i) prevent fluid flowing from the distal end to the proximal end via the internal flowpath, and (ii) allow fluid to flow from the proximal end to the distal end via the internal flowpath.

Clause 11. The flow restriction device of Clause 1, further comprising a vent plug disposed in the lumen at the proximal end.

Clause 12. A blood collection system, comprising: a blood collection device; and a flow restriction device fluidly coupled to the blood collection device, the flow restriction device comprising: an outer surface, and an inner surface defining an internal flowpath therethrough; a distal end, comprising a distal connector configured to couple to a catheter assembly; a proximal end coupled to the blood collection device and comprising a lumen fluidly communicated with the internal flowpath; and a non-linear fluid pathway disposed on the outer surface at least partially between the distal end and the proximal end when the outer surface is coupled within a mating luer.

Clause 13. The blood collection system of Clause 12, wherein the blood collection device comprises a luer lock access device.

Clause 14. The blood collection system of Clause 12, wherein the non-linear fluid pathway comprises a continuous a groove having a coil shape recessed in the outer surface.

Clause 15. The blood collection system of Clause 12, wherein the non-linear fluid pathway comprises a continuous groove having an S-shape recessed in the outer surface.

Clause 16. The blood collection system of Clause 12, wherein the distal connector comprises a male luer connector.

Clause 17. The blood collection system of Clause 12, wherein the non-linear fluid pathway comprises a first diameter, the internal flowpath comprises a second diameter, and the second diameter is larger than the first diameter.

Clause 18. The blood collection system of Clause 12, further comprising a check valve disposed in the internal flowpath, the check valve configured to (i) prevent fluid flowing from the distal end into the proximal end, and (ii) allow fluid to flow from the proximal end to the distal end.

Clause 19. The blood collection system of Clause 12, further comprising a vent plug disposed in the lumen of the proximal end.

Clause 20. The blood collection system of Clause 12, wherein the proximal end comprises a proximal connector, wherein the proximal connector comprises a female luer connector.

It is understood that the specific order or hierarchy of steps, or operations in the processes or methods disclosed are illustrations of exemplary approaches. Based upon implementation preferences or scenarios, it is understood that the specific order or hierarchy of steps, operations or processes may be rearranged. 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 the intervention of a user. The accompanying method claims present 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.