Flow limiting device and blood collection system

Abstract

The present application relates to a flow restricting device and a blood collection system, the blood collection system comprising a fluid channel for regulating the passage of a fluid therethrough, comprising a flow restricting device having a first channel and a second channel, the first channel and the second channel can adjust fluid flow passing through the device in a first direction and can adjust fluid flow passing through the device in a second direction; a fluid collection device may include a first connector having an interior surface defining an inner lumen, a second connector connected to the first connector, a cannula mounted in the inner lumen extending into the second connector, a lumen of the cannula may define a first flow path along which fluid flows into the fluid collection device, and a second flow path along which fluid flows into the fluid collection device. And an annular space may be defined between the outer surface of the cannula and the inner surface of the first connector, the annular space may define a second flow path through which fluid may flow into the conduit assembly.

Description

[0001] This application is a divisional application of a Chinese patent application with the application number 202321505405.1, the application date of June 13, 2023, and the invention title of "Flow Restriction Device and Blood Collection System". Technical Field

[0002] The present disclosure generally relates to blood withdrawal and the administration of parenteral fluids to a patient, and more particularly to systems and methods for reducing hemolysis in PIVC blood withdrawal. Background Art

[0003] Catheters are commonly used in various infusion therapies. For example, a catheter can be used to infuse fluids into a patient, such as a saline solution, various drugs, and total parenteral nutrition. A catheter can also be used to withdraw blood from a patient.

[0004] One common type of catheter is a peripheral intravenous ("IV") catheter over needle ("PIVC"). As the name implies, a catheter over needle can be mounted on a guide needle having a sharp distal end. The catheter assembly can include a catheter hub, the catheter extending distally from the catheter hub, and the guide needle extending through the catheter. The catheter and the guide needle can be assembled such that the distal end of the guide needle extends beyond the distal end of the catheter, with the bevel of the needle facing away from the patient's skin upward. The catheter and the guide needle are typically inserted into the patient's vasculature at a shallow angle through the skin.

[0005] To verify the correct placement of the guide needle and / or catheter in a blood vessel, a clinician typically confirms the presence of "blood return" in the blood return chamber of the catheter assembly. Once the placement of the needle is confirmed, the clinician can temporarily occlude the flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion.

[0006] To withdraw blood from a patient or collect a blood sample, a blood collection container can be used. The blood collection container can include a syringe. Alternatively, the blood collection container can include a test tube having a rubber stopper at one end. In some cases, the test tube has removed all or part of the air from the test tube, so the pressure inside the test tube is lower than the ambient pressure. Such blood collection containers are commonly referred to as internal vacuumers or vacuum tubes. The blood collection container can also be a blood collection tube available from Becton Dickinson & Company.

[0007] A blood collection container can be coupled to a catheter. When the blood collection container is coupled to the catheter, the pressure in the vein is higher than the pressure in the blood collection container, which pushes the blood into the blood collection container, thereby filling the blood collection container with blood. The vacuum within the blood collection container decreases as the blood collection container is filled until the pressure in the blood collection container equals the pressure in the vein and the flow of blood stops.

[0008] Unfortunately, when blood is drawn 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 state of high shear stress and are prone to hemolysis. Hemolysis may result in the rejection and discard of the blood sample. The high initial pressure difference may also cause other complications such as collapse of the catheter tip, collapse of the vein, or prevention or limitation of the filling of the blood collection container with blood.

[0009] The description provided in the background section should not be considered prior art merely because it is mentioned in or related to the background section. The background section may include information describing one or more aspects of the subject technology. Summary of the Utility Model

[0010] The present disclosure provides devices and accessories for reducing hemolysis, which may include features for restricting and regulating the flow of fluid therethrough. In some cases, the present disclosure provides a flow restriction device that can be attached to a peripheral intravenous catheter.

[0011] In some cases, the present disclosure provides a flow restriction device that can regulate the flow of fluid moving through the device in one or more directions, such as a first fluid flow moving in a direction away from the patient and a second fluid flow moving in a direction toward the patient.

[0012] In some embodiments, the present disclosure further provides a flow restriction device configured to direct the fluid drawn from the patient's body to move through a first channel and direct the fluid infused into the patient to move through either the first channel or the second channel.

[0013] The present disclosure provides a flow restriction device, comprising: a first connector including a proximal end, a distal end, and an inner surface defining an inner lumen, the first connector being configured to be coupled to a catheter assembly; a second connector coupled to the proximal end of the first connector and configured to be coupled to a fluid collection device; an intubation tube mounted in the inner lumen and extending from the distal end of the first connector into the second connector, wherein a lumen of the intubation tube defines a first flow path along which fluid flows from the distal end into the fluid collection device, and an annular space is defined between an outer surface of the intubation tube and the inner surface of the first connector, the annular space defining a second flow path along which fluid flows from the proximal end to the distal end and into the catheter assembly; and a check valve mounted in the annular space at the proximal end of the first connector and surrounding at least a portion of the intubation tube, the check valve being configured to (i) prevent fluid from flowing from the distal end to the fluid collection device via the second flow path, and (ii) allow fluid to flow from the second connector to the first connector and the catheter assembly via the second flow path.

[0014] The present disclosure provides a flow restriction device, comprising: a first connector including a proximal end, a distal end, and an inner surface defining an inner lumen, the distal end being configured to be coupled to a catheter assembly; a second connector including a proximal end, a distal end, and an inner surface defining a lumen of the second connector, the second connector being coupled to the proximal end of the first connector and configured to be coupled to a fluid collection device; an intubation tube mounted in the lumen of the second connector and extending distally into the inner lumen of the first connector, wherein: a lumen of the intubation tube defines a first flow path along which fluid flows from the distal end of the first connector into the fluid collection device; and an annular space is defined between an outer surface of the intubation tube and the inner surface of the first connector, the annular space defining a second flow path along which fluid flows from the proximal end to the distal end and into the catheter assembly; and a check valve mounted in the annular space at the proximal end of the first connector and surrounding at least a portion of the intubation tube, the check valve being configured to (i) prevent fluid from flowing from the distal end of the first connector to the fluid collection device via the second flow path, and (ii) allow fluid to flow from the second connector to the first connector and the catheter assembly via the second flow path.

[0015] The present disclosure provides a flow restriction device, characterized in that it comprises: a distal connector configured to be coupled to a catheter assembly, the distal connector including a first connection portion at its proximal end and a second connection portion at its distal end, the first connection portion including an inner surface defining a lumen; a proximal connector coupled to the distal connector and configured to be coupled to a fluid collection device, the proximal connector including an insertion portion for insertion into the lumen of the first connection portion, the insertion portion including an outer surface having a continuous non-linear channel recessed therein; wherein the inner surface of the first connection portion surrounds the outer surface of the insertion portion such that the inner surface of the first connection portion and the continuous non-linear channel define a non-linear fluid path along which fluid flows from the distal connector into the fluid collection device.

[0016] The present disclosure provides a flow restriction device, characterized in that it comprises: a distal connector portion configured to be coupled to a catheter assembly, the distal connector portion including an inner surface defining its lumen; a proximal connector portion extending proximally from the distal connector portion and configured to be coupled to a fluid collection device, the proximal connector portion including an inner surface defining a lumen that is fluidly connected to the lumen of the distal connector portion; a plug disposed in the lumen of the proximal connector portion, the plug including a head portion and a body portion extending proximally from the head portion, and the body portion including a plurality of threads extending along the outer surface of the body portion, wherein the inner surface of the proximal connector portion surrounds the outer surface of the body portion to define a continuous non-linear channel along which fluid flows from the distal connector portion through the proximal connector portion into the fluid collection device when the fluid collection device is coupled to the proximal connector portion.

[0017] The present disclosure provides a flow restriction device, characterized in that it comprises: a first connector including a female Luer portion at a proximal end, a male Luer portion at a distal end, an inner surface defining an inner lumen of the first connector, and a compressible valve member mounted in the inner lumen, the first connector being configured to be coupled to a fluid collection device; a second connector coupled to the male Luer portion of the first connector and configured to be coupled to a catheter assembly, the second connector including an inner surface that defines an inner lumen of the second connector; and a cannula mounted in the inner lumen of the second connector and extending from the inner lumen into the female Luer portion of the first connector, the compressible valve member being mounted around at least a portion of the cannula, wherein in a coupling configuration of the first connector and the fluid collection device, the compressible valve member is compressed by the fluid collection device to place the cannula in fluid communication with the fluid collection device via a slot of the compressible valve member.

[0018] The present disclosure provides a flow restriction device, characterized in that it comprises: a first connector including a female Luer portion and a male Luer portion and a compressible valve member, the female Luer portion having a lumen and being provided at a proximal end, the male Luer portion having a lumen and being provided at a distal end, the compressible valve member being mounted in the lumen of the female Luer, the first connector being configured to be coupled to a fluid collection device; a second connector including a female Luer portion coupled to the male Luer portion of the first connector and a male Luer portion configured to be coupled to a catheter assembly, the female Luer portion of the second connector including an inner lumen, and the male Luer portion of the second connector including an inner lumen in fluid communication with the inner lumen of the female Luer portion of the second connector; and a post mounted in the second connector and extending from the inner lumen of the female Luer portion of the second connector through the lumen of the male Luer portion of the first connector into an inner chamber of the compressible valve member, the compressible valve member being mounted around at least a portion of the post, wherein in a coupling configuration of the first connector and the fluid collection device, the compressible valve member is compressed by the fluid collection device to place the post in fluid communication with the fluid collection device via a slot of the compressible valve member.

[0019] The present disclosure provides a flow restriction device, characterized by comprising: a male Luer connector portion configured to be coupled to a catheter assembly, the male Luer connector portion including an inner surface defining its lumen; a female Luer connector portion disposed adjacent to the male Luer connector portion and configured to be coupled to a fluid collection device, the female Luer connector portion including an inner surface defining a lumen fluidly connected to the lumen of the male Luer connector portion; and a tube extending from the lumen of the male Luer connector portion into the lumen of the female Luer connector portion, wherein the lumen of the tube defines a fluid path along which fluid flows from the male Luer connector portion through the female Luer connector portion into the fluid collection device.

[0020] The present disclosure provides a flow restriction device, characterized by comprising: a distal connector configured to be coupled to a catheter assembly, the distal connector including a first connection portion at its proximal end and a second connection portion at its distal end, each of the first connection portion and the second connection portion including an inner surface defining a lumen; a proximal connector coupled to the distal connector and configured to be coupled to a fluid collection device; and an insert mounted in the lumen of the first connection portion and including an outer surface having a groove recessed in the outer surface and extending at least partially along the length of the outer surface, wherein the groove is fluidly coupled to the lumen of the second connection portion and the lumen of the first connection portion, and wherein the inner surface of the first connection portion surrounds the outer surface of the insert such that the inner surface of the first connection portion and the groove define at least a portion of a fluid channel along which fluid flows from the distal connector into the fluid collection device.

[0021] The present disclosure provides a flow restriction device, characterized by comprising: a connector including a body portion having a lumen and disposed at a proximal end, a base portion having a lumen and disposed at a distal end, and a compressible valve member disposed on the base portion and extending into the lumen of the body portion, the body portion being configured to be coupled to a fluid collection device; and a post having a lumen extending therethrough, the post being mounted in the lumen of the base portion and extending into an internal chamber of the compressible valve member, the compressible valve member being mounted around the post, and the post being configured to be in fluid communication with the catheter assembly, wherein in the coupling configuration of the body portion and the fluid collection device, the compressible valve member is compressed by the fluid collection device to place the post in fluid communication with the fluid collection device via slots in the compressible valve member.

[0022] The present disclosure provides a flow restriction device, characterized in that it includes: a connector, which includes a female Luer portion having a lumen and provided at the proximal end, a male Luer portion having a lumen and provided at the distal end, and a compressible valve member installed in the lumen of the female Luer portion and fluidly connected to the lumen of the male Luer portion, the female Luer portion being configured to be connected to a fluid collection device, and the male Luer portion being configured to be connected to a catheter assembly; and a post, which is installed in the female Luer portion and extends into the internal chamber of the compressible valve member, the compressible valve member being installed around the post, and the post being in fluid communication with the lumen of the male Luer portion, wherein, in the connection configuration between the female Luer portion and the fluid collection device, the compressible valve member is compressed by the fluid collection device to enable the post to be in fluid communication with the fluid collection device via the slot of the compressible valve member.

[0023] The present disclosure provides a flow restriction device, characterized in that it includes: a housing, which has a proximal end, an inner surface defining the internal chamber of the housing, and a male Luer portion, which defines the distal end of the housing and has a lumen in fluid communication with the internal chamber, the internal chamber of the housing being fluidly connected to a connector; a slider, which is reciprocally installed in the internal chamber, the slider including a proximal end, a distal end, a mounting hole extending from the proximal end to the distal end of the slider, and a flow hole surrounding the mounting hole and extending from the proximal end to the distal end of the slider; a pipe fitting, which has a lumen extending therefrom, the pipe fitting being installed in the mounting hole and extending distally from the proximal end of the slider through the distal end of the slider; and a spring member, the spring member being installed around at least a portion of the pipe fitting in the internal chamber, wherein, the spring member applies a force to bias the proximal end of the slider against the inner surface of the housing to block the fluid flow entering the connector via the plurality of flow holes, and allows the fluid flow to enter the connector via the pipe fitting.

[0024] The present disclosure provides a blood collection system, characterized in that it includes: a blood collection device, which includes a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface; and a flow restriction device, which engages with the connection portion and is fluidly connected to the lumen of the needle, the flow restriction device including: a connector, which includes a proximal end disposed in the connection portion, a distal end configured to be connected to a catheter assembly, and an inner surface defining an inner lumen; and an intubation tube, which is installed in the inner lumen and extends from the distal end of the connector into the connection portion, wherein, the lumen of the intubation tube defines a flow path along which blood flows from the distal end to the lumen of the needle.

[0025] It should be understood that from the following detailed description, those skilled in the art will readily understand other configurations of the subject technology, where various configurations of the subject technology are shown and described by way of illustration. As will be recognized, the subject technology is capable of having other and different configurations and several details thereof can be modified in various other aspects, all without departing from the scope of the subject technology. Accordingly, the drawings and the detailed description are to be regarded as illustrative rather than restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The following drawings are included to illustrate certain aspects of the embodiments and should not be considered exclusive embodiments. The disclosed subject matter can be subject to considerable modification, change, combination, and equivalence in form and function, as will occur to those skilled in the art and having the benefit of this disclosure.

[0027] Figure 1A A exploded view of a vascular access device according to some embodiments of the present disclosure is shown, the vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a fluid collection device.

[0028] Figure 1B is a schematic operational view of a vascular access device according to some embodiments of the present disclosure, the vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a fluid collection device.

[0029] Figure 1C is a schematic operational view of a vascular access device according to some embodiments of the present disclosure, the vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a needleless connector.

[0030] Figure 2A A perspective view of a flow restriction device according to some embodiments of the present disclosure is shown.

[0031] Figure 2B A Figure 2A cross-sectional view of the flow restriction device according to some embodiments of the present disclosure is shown.

[0032] Figure 2C A Figure 2A magnified cross-sectional view of the flow channels of the flow restriction device according to some embodiments of the present disclosure is shown.

[0033] Figure 3A A perspective view of a flow restriction device according to some embodiments of the present disclosure is shown.

[0034] Figure 3B A Figure 3ACross-sectional view of the flow restriction device.

[0035] Figure 3C Shows a Figure 3A Magnified cross-sectional view of the flow channel of the flow restriction device according to some embodiments of the present disclosure.

[0036] Figure 4A Perspective view of the flow restriction device according to some embodiments of the present disclosure.

[0037] Figure 4B Shows a Figure 3A Cross-sectional view of the flow restriction device.

[0038] Figure 4C Shows a Figure 4A Magnified partial cross-sectional view of the flow restriction device.

[0039] Figure 5A Perspective view of the flow restriction device according to some embodiments of the present disclosure.

[0040] Figure 5B Shows a Figure 5A Perspective view of the flow restriction device during infusion.

[0041] Figure 5C Shows a Figure 5A Perspective view of the flow restriction device during blood draw.

[0042] Figure 6A Perspective view of the flow restriction device according to some embodiments of the present disclosure.

[0043] Figure 6B Shows a Figure 6A Cross-sectional view of the flow restriction device.

[0044] Figure 6C Shows a Figure 6A Magnified perspective view of the proximal connector of the flow restriction device.

[0045] Figure 7A Perspective view of the flow restriction device according to some embodiments of the present disclosure.

[0046] Figure 7B Shows a Figure 7A Cross-sectional view of the flow restriction device.

[0047] Figure 8AShows a perspective view of a flow restriction device according to some embodiments of the present disclosure.

[0048] Figure 8B Shows a Figure 8A cross-sectional view of the first and second connectors of the flow restriction device according to some embodiments of the present disclosure.

[0049] Figure 8C Shows a Figure 8A cross-sectional view of the flow restriction device according to some embodiments of the present disclosure.

[0050] Figure 9A Shows an exploded view of a vascular access device according to some embodiments of the present disclosure, the vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a fluid collection device.

[0051] Figure 9B Is a schematic diagram of the operation of a vascular access device according to some embodiments of the present disclosure, the vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a fluid collection device.

[0052] Figure 9C Is a schematic diagram of the operation of a vascular access device according to some embodiments of the present disclosure, the vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a needleless connector.

[0053] Figure 10A Shows a perspective view of a flow restriction device according to some embodiments of the present disclosure.

[0054] Figure 10B Shows a Figure 10A cross-sectional view of the flow restriction device according to some embodiments of the present disclosure.

[0055] Figure 11A Shows a perspective view of a flow restriction device according to some embodiments of the present disclosure.

[0056] Figure 11B Shows a Figure 11A cross-sectional view of the flow restriction device according to some embodiments of the present disclosure.

[0057] Figure 12A Shows a perspective view of a flow restriction device according to some embodiments of the present disclosure.

[0058] Figure 12B Shows a Figure 12A perspective view of the insert of the flow restriction device according to some embodiments of the present disclosure.

[0059] Figure 12CShows a cross-sectional view of a flow restriction device in accordance with some embodiments of the present disclosure. Figure 12A of the flow restriction device.

[0060] Figure 13A Shows a perspective view of a flow restriction device in accordance with some embodiments of the present disclosure.

[0061] Figure 13B Shows a perspective view of the proximal connector of a flow restriction device in accordance with some embodiments of the present disclosure. Figure 13A of the flow restriction device.

[0062] Figure 13C Shows a cross-sectional view of a flow restriction device in accordance with some embodiments of the present disclosure. Figure 13A of the flow restriction device.

[0063] Figure 14A Shows a perspective view of a flow restriction device in accordance with some embodiments of the present disclosure.

[0064] Figure 14B Shows an exploded view of a flow restriction device in accordance with some embodiments of the present disclosure. Figure 14A of the flow restriction device.

[0065] Figure 14C Shows a cross-sectional view of a flow restriction device in accordance with some embodiments of the present disclosure.

[0066] Figure 14D Shows a cross-sectional view of a flow restriction device when coupled to a fluid collection device in accordance with some embodiments of the present disclosure.

[0067] Figure 15A Shows a cross-sectional view of a flow restriction device in a fluid aspiration position in accordance with some embodiments of the present disclosure.

[0068] Figure 15B Shows a cross-sectional view of a flow restriction device in a fluid infusion position in accordance with some embodiments of the present disclosure. Figure 15A of the flow restriction device.

[0069] Figure 15C Shows a perspective view of the flow restriction posts of a flow restriction device in accordance with some embodiments of the present disclosure. Figure 15A of the flow restriction device.

[0070] Figure 15D Shows a cross-sectional view of the sliding assembly of a flow restriction device in accordance with some embodiments of the present disclosure. Figure 15A of the flow restriction device.

[0071] Figure 15E Shows a cross-sectional view of the sliding assembly of a flow restriction device in accordance with some embodiments of the present disclosure. Figure 15A of the flow restriction device.

[0072] Figure 16A Shows a blood collection system according to some embodiments of the present disclosure.

[0073] Figure 16B Shows a blood collection system according to some embodiments of the present disclosure.

[0074] Figure 17A Shows a blood collection system according to some embodiments of the present disclosure.

[0075] Figure 17B Shows a cross-sectional view of a blood collection system according to some embodiments of the present disclosure Figure 17A of.

[0076] Figure 18A Shows a blood collection system according to some embodiments of the present disclosure.

[0077] Figure 18B Shows a cross-sectional view of a blood collection system according to some embodiments of the present disclosure Figure 18A of.

[0078] Figure 19A Shows a perspective view of a blood collection system according to some embodiments of the present disclosure.

[0079] Figure 19B Shows a cross-sectional view of a blood collection system according to some embodiments of the present disclosure Figure 19A of. Detailed Description

[0080] 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. Accordingly, dimensions may be provided with respect to certain aspects 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 in order to avoid obscuring the concepts of the subject technology.

[0081] It should be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Aspects of the subject technology will be described hereinafter according to specific but non-limiting examples. The various embodiments described in the present disclosure may be implemented in different ways and variations and according to the intended application and implementation.

[0082] Compared with traditional methods of blood extraction using venipuncture, blood extraction via a vascular access device has received increasing attention due to the minimization of needle insertion and the improvement of surgical efficiency. Currently, blood extraction using a peripheral intravenous catheter (PIVC) has encountered some challenges, and one of the most critical challenges is the blood quality related to hemolysis. In particular, for currently available PIVC products on the market, together with standard connectors (such as short extension kits and needleless connectors) and blood collection devices (such as vacuum blood collection tubes), the shear stress applied to blood cells often lies on the verge of hemolysis.

[0083] Various embodiments of the present disclosure are directed to systems and methods for solving hemolysis in PIVC blood extraction with an accessory that reduces hemolysis (also referred to herein as a flow restriction device), the accessory that reduces hemolysis being pre-attached to the PIVC and serving as a flow limiter to reduce the risk of hemolysis. The accessory that reduces hemolysis is advantageously compatible with PIVC placement and requires no change to any existing operations. The accessory that reduces hemolysis of various embodiments described herein is potentially applicable to a wide variety of PIVC products and is compatible with existing blood collection devices and disposable infusion articles.

[0084] Various embodiments of the present disclosure focus on effective flow restriction using an additional accessory that reduces hemolysis (also referred to herein as a flow restriction device), the accessory that reduces hemolysis regulating the total flow rate of the entire fluid path as blood cells pass through. The flow restriction device can be assembled with the PIVC or can be co-packaged with the PIVC. Thus, there is no additional operation during catheter placement because the device has an exhaust lumen that allows blood to flow back. The clinician can connect the blood collection device to the port of the accessory and subsequently can extract blood to the desired volume. After blood extraction, the clinician can disconnect the flow restriction device and discard it together with the blood collection device. Thus, the flow restriction device can be used for single blood extraction or can remain in series throughout the indwelling period.

[0085] The features of the present application can provide a flow restriction device configured for fluid flow in two directions, where the flow rate can be different in each direction. In some aspects of the present disclosure, the device can be configured to provide a first flow rate in a first direction and a second flow rate in a second direction, where fluid flow is less restricted in the second direction relative to the first direction such that the second flow rate is greater than the first flow rate.

[0086] In some embodiments of the present disclosure, the fluid path for fluid flow in a first direction is isolated or separated from the fluid path for fluid flow in a second direction. In some examples, the fluid flow moving in the first direction moves through a first fluid path that is isolated or separated from a second fluid path configured for fluid flow in the second direction, and the fluid flow moving in the second direction moves through the second fluid path and the first fluid path.

[0087] In some aspects of the present disclosure, the flow restriction device is configured such that during the process of withdrawing fluid or blood from a patient's body to reduce blood hemolysis, the fluid moves in a first direction through the first fluid path, and during the process of infusing fluid to the patient, the fluid moves in a second direction through the first fluid path and the second fluid path.

[0088] In some embodiments, the flow restriction device may incorporate a check valve, a diverter, an insert, a removable adapter, or another structure that allows for reduced hemolysis of the fluid moving in the first direction and unobstructed infusion of the fluid moving in the second direction. In some embodiments of the present disclosure, the check valve, diverter, insert, removable adapter, or other structure is located in the central fluid path of the device.

[0089] According to various embodiments of the present disclosure, the flow restriction device may be an insert having a Luer interface and a helical continuous channel on the outside, characterized in that each design has a flow resistance. The flow restriction device may be a molded plastic insert having fluid channels with a flow resistance for each design. The proximal end of the insert may have a female Luer, so that an air vent plug can be inserted into the flow restriction device, which is connected to the port of the Luer adapter of the packaged PIVC to enable blood backflow when placing the PIVC. In some embodiments, a clinician or other user can remove the air vent plug from the flow restriction device and attach a blood collection device to complete blood withdrawal. In some embodiments, when the clinician connects the blood collection device to the insert, the air vent plug can be pushed into the bag and thus open the fluid path for blood withdrawal.

[0090] Therefore, the flow restriction devices and systems of the various embodiments described herein are advantageous because the helical continuous channel with a smaller (minimized) diameter can increase the length of the fluid path defined by the continuous channels or grooves through which the blood flows, and compared with a linear internal fluid path, can provide increased flow resistance and reduced blood flow rate within the flow restriction device. Therefore, the risk of hemolysis during blood collection can be advantageously reduced.

[0091] The flow restriction devices and related blood collection systems of the various embodiments described herein also additionally provide advantages over current existing blood collection systems. For example, the additional flow restriction devices described herein allow for the integration of hemolysis reduction functionality for PIVC blood draws. Additionally, the flow restriction devices described herein are compatible with PIVC placement and allow for seamless blood draws during insertion. Further, for multiple blood draws, the flow restriction device has the potential to remain online throughout the PIVC indwelling period. Moreover, since the flow restriction device is an add-on device, it can be easily incorporated without any changes to the existing PIVC, thus having a minimal impact on clinical settings and operations.

[0092] The optimized fluid path (also referred to herein as the first fluid path or flow path or microchannel) can be configured to provide a restricted flow rate for reducing hemolysis and can have features including but not limited to a tubular fluid path, cannula, lumen, continuous non-linear channels, grooves, fluid channels, etc.

[0093] The length of the fluid path can be selected based on one or more of the following factors: the specifications of a particular catheter, the configuration of a particular catheter assembly, or the clinical setting. In some embodiments, the optimized fluid path can include a length L from a first Luer adapter 14 to a second Luer adapter 24. In some embodiments, the optimized fluid path can include an inner diameter D.

[0094] The Poiseuille equation can be used to analyze fluid flow in a tubular fluid path:

[0095]

[0096] where ΔP is the change in pressure gradient across the length of the fluid path, D and L are the inner diameter and length of the fluid channel, μ is the viscosity of the fluid, and is the fluid resistance. Since μ is the viscosity of the fluid and not part of the extension tube geometry, the geometric factor G f is defined as (fluid resistance) such that R f (fluid resistance) is where

[0097] In some embodiments, the optimized fluid path can have multiple segments with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), then the geometric factor is:

[0098]

[0099] In some embodiments, the optimized fluid path can have a cross-section with a non-circular or complex inner diameter profile.

[0100] The geometric factor can be determined by measuring the flow rate (Q) of a fluid with a known viscosity (μ) under a given pressure (ΔP):

[0101]

[0102] The G value of the optimized fluid path can be selected f to reduce the maximum shear stress of each catheter specification to be equal to or less than the maximum shear stress of the BD 21G UltraTouch TM button - type blood collection kit, which was previously considered the gold standard for blood draw. In some embodiments, the G value of the optimized fluid path can be selected f to reduce the maximum shear stress of each catheter specification to be equal to or less than the maximum shear stress of the BD 25G UltraTouch TM button - type blood collection kit.

[0103] In some embodiments, the internal fluid paths of the needle assembly 19, the extension tube 32, and the catheter assembly 37 which may include another extension tube 46 can form a complete fluid path for blood collection. The system geometric factor of the fluid path G fs can be determined in a manner similar to that described above. In some embodiments, the system geometric factor G fs can be equal to or greater than 7.34E + 06 (1 / in³). In some embodiments, G fs can include another value. In some embodiments, the system geometric factor G fs can be 7.34E + 06 (1 / in 3 ) plus or minus 10%, plus or minus 25%, plus or minus 50%, or plus or minus 75%. In some embodiments, G fs can include another value, which can be selected based on the catheter specification and / or length.

[0104] In some embodiments, and as a non - limiting example, the optimized fluid path can have a diameter of approximately 0.014 inches. In another non - limiting example, the cross - sectional area of the optimized fluid path is approximately 0.000152 square inches.

[0105] Figures 1A - 1C A vascular access device 100 including a peripheral intravenous catheter (PIVC) assembly 50 according to some embodiments of the present disclosure is shown, and the peripheral intravenous catheter assembly includes a flow restriction device 10. Figure 1A A disassembled view of a vascular access device according to some embodiments of the present disclosure is shown, and the vascular access device includes a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a fluid collection device.Figure 1B FIG. 1 is an operational schematic diagram of a vascular access device according to some embodiments of the present disclosure, the vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a fluid collection device. Figure 1C FIG. 2 is an operational schematic diagram of a vascular access device according to some embodiments of the present disclosure, the vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a needleless connector.

[0106] Now referring to Figures 1A - 1C , FIG. 3 shows a flow restriction device 10 according to some embodiments. The flow restriction device 10 may be configured to reduce the likelihood of hemolysis during blood collection using the vascular access device 100. In some embodiments, the vascular access device 100 may include a catheter assembly (e.g., a PIVC) 50. In some embodiments, (as Figures 2A - 3B further shown), the flow restriction device 10 may include a distal end 12, which may include a distal connector 14 or body configured to be coupled to the catheter assembly 50. The distal connector 14 may include a male Luer connector or another suitable connector.

[0107] In some embodiments, 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 fixed within the catheter hub 52 and may extend distally from the distal end 54 of the catheter hub 52. In some embodiments, the catheter may be a peripheral intravenous catheter (PIVC).

[0108] 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 integrally include an extension tube 60, which may extend from and be integrated with a side port 59 of the catheter hub 52. A non-limiting example of an integrated catheter assembly is the BD NEXIVA TM Closed IV Catheter System, which may be obtained from Becton Dickinson and Company. In some embodiments, the proximal end of the extension tube 60 may be coupled to an adapter 70, such as a Y-shaped adapter or a single-port Luer adapter. In some embodiments, the distal connector 14 of the flow restriction device 10 may be configured to be coupled to the Y-shaped adapter 70.

[0109] In some embodiments, the catheter assembly 50 can be non-integrated and can not include an extension tube 60. In these and other embodiments, the flow restriction device 10 can be configured to be coupled to the proximal end 56 of the catheter hub 52 or another suitable portion of the catheter assembly 50. In some embodiments, the catheter assembly 50 can be coupled to a removable extension tube 60. In some embodiments, the flow restriction device 10 can be directly coupled to a catheter adapter, thereby eliminating the extension tube and providing a compact catheter system.

[0110] Figure 2A A perspective view of a flow restriction device 110 in accordance with some embodiments of the present disclosure is shown. Figure 2B Shown in accordance with some embodiments of the present disclosure Figure 2A a cross-sectional view of the flow restriction device 110. Figure 2C Shown in accordance with some embodiments of the present disclosure Figure 2A an enlarged cross-sectional view of the flow channels 165 of the flow restriction device.

[0111] As Figure 2A shown, continuing to refer to Figure 1A and Figure 1B , in some embodiments, the flow restriction device 110 can include a first connector 112 configured to be coupled to the catheter assembly 50. The first connector 112 can have a proximal end 114, a distal end 116, and an inner surface 118 that defines an inner lumen 120 of the first connector 112. As shown, the first connector 112 can also include a support portion 160 disposed between the proximal end 114 and the distal end 116. The support portion 160 can have a proximal end 161, a distal end 162, and can include a central mounting hole 165 that extends from the proximal end 161 to the distal end 162. In some embodiments, the support portion 160 can also include a plurality of fluid channels 165 that are disposed radially outward of the central mounting hole 165 and surround the central mounting hole. The plurality of fluid channels 165 can extend from the proximal end 161 to the distal end 162 of the support portion 160 to place the inner lumen 120 in fluid communication with the catheter assembly.

[0112] In some embodiments, the flow restriction device 110 may further include a second connector 130 coupled to the proximal end 114 of the first connector 112. The second connector 130 may be configured to couple to a fluid collection device 40 (e.g., a blood collection device). For example, the second connector 130 may be integrated with the blood collection device 40 or formed integrally with the blood collection device 40 as a single unit. As another example, the second connector 130 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 second connector 130 may include a lumen 134 extending therethrough for coupling to the male Luer portion of the blood collection device 40.

[0113] According to various embodiments of the present disclosure, the flow restriction device 110 may further include an intubation 140 mounted in the inner lumen 120 of the first connector 112. As shown, the intubation 140 may extend from the distal end 116 of the first connector 112 into the second connector 130. The intubation may have a proximal end 143, a distal end 145, and a lumen 142 extending therethrough. The lumen 142 may define a first flow path or microchannel along which fluid may flow from the distal end 116 toward the proximal end 114, such as from the distal end 116 to the proximal end 114 and into the fluid collection device 40 coupled thereto. Fluid may also flow through the first flow path in a direction from the proximal end 114 toward the distal end 116. In some aspects, when moving in a direction from the proximal end 114 toward the distal end 116, the fluid may also flow through the first flow path and a second flow path.

[0114] As shown, cannula 140 may be installed in central mounting hole 166 of first connector support portion 160 and may place cannula 140 in fluid communication with catheter assembly 50. For example, in some embodiments, legs 72 of Y - adapter 70 may be coupled to flow restriction device 110. For example, legs 72 of Y - adapter 70 may include lumens in which distal end 116 of first connector 112 to which cannula 140 may be coupled is mounted. Y - adapter 70 may place flow restriction device 110 and cannula 140 mounted therein in fluid communication with catheter assembly 50, for example, via extension fitting 60. Thus, lumen 142 of cannula 140 may define a linear fluid path having a reduced, small, or micro - diameter (as described below) through which fluid from catheter assembly entering flow restriction device 110 may flow through flow restriction device 110 for collection in fluid collection device 40. For example, in the case of withdrawing or collecting blood from a patient, medical fluid 15 may be blood and fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a Luer - Lock access device (LLAD). Thus, during the process of collecting or withdrawing blood from a patient, blood sample 15 may flow from distal end 116 of first connector 112 via a first flow path or microchannel into LLAD 40.

[0115] In some embodiments, cannula 140 may be an elongate thin tube having a lumen with a small, reduced, or micro - sized diameter. For example, in some embodiments, lumen 142 of cannula 140 defines a first flow path or microchannel along which fluid may flow from distal end 116 via second connector 130 into fluid collection device 40. Cannula 140 may define lumen 142 formed by any length, diameter, and cross - sectional area as described above with reference to optimized fluid paths.

[0116] When the fluid is blood withdrawn from a patient's body, blood cells may be subject to shear stress as they flow from catheter assembly 50 into blood collection device 40. For example, the maximum shear stress may be along the wall of the blood cells, commonly referred to as wall shear stress. Wall shear stress on blood cells is considered a major source of mechanical damage to blood cells that leads to hemolysis of the blood cells. In some embodiments, lumen 142 of cannula 140 having a reduced or micro - sized diameter may help increase the flow resistance within vascular access system 100 to distribute the pressure differential and reduce the shear stress experienced by red blood cells of blood 15. The minimum diameter of the first fluid path or microchannel defined by lumen 142 of cannula 140 may provide increased resistance to the flow of blood 15 and thereby reduce the blood flow rate within flow restriction device 110. Since the reduced blood flow rate results in a reduction in the shear stress experienced by red blood cells in blood 15, the risk of hemolysis during blood collection may be advantageously reduced.

[0117] In some embodiments, as Figure 2C shown, an annular space 146 may be defined between an outer surface of the cannula 140 and an inner surface 118 of the first connector 112. The annular space 146 may define a second flow path along which fluid flows from the lumen 134 of the second connector 130 into the catheter assembly 50 via the first connector 116. A plurality of fluid channels 165 may extend from a proximal end 161 of the support portion 160 to a distal end 162 to fluidly connect the annular space 146 with the catheter assembly. Thus, the plurality of fluid channels 165 may define at least a portion of the second flow path.

[0118] According to various embodiments of the present disclosure, the flow restriction device 110 may further include a check valve 150 mounted in the annular space 146 at the proximal end 114 of the first connector 112. As shown, the check valve 150 may be sleeved on at least a portion of the cannula 140. The check valve 150 may have a shape or structure configured to prevent fluid from flowing from the distal end 116 of the first connector 112 into the fluid collection device 40 via the second flow path, while allowing fluid to flow from the second connector 130 into the first connector 112 and the catheter assembly 50 via the second flow path. In some embodiments, the fluid flowing from the second connector 130 into the first connector 112 and the catheter assembly via the second flow path may be IV fluid 17. Thus, blood 15 containing blood cells may be forced to flow through a microchannel fluid path defined by the lumen 142 of the cannula 140 to reach the blood collection device 40, while the IV fluid 36 may flow to the catheter assembly 50 through the second flow path including the annular space 146 and the plurality of fluid channels 165.

[0119] In some embodiments, the cross-sectional flow area of the annular space 146 may be greater than the cross-sectional flow area of the lumen 142. For example, the cross-sectional area of the annular space 146 around a plane transverse to the central longitudinal axis X of the first connector 112 may be greater than the cross-sectional area of the lumen 142 around that plane. The cannula 140 may define a lumen 142 formed by any length, diameter, and cross-sectional area as described above with reference to the optimized fluid path.

[0120] As a non-limiting example, in some embodiments, the lumen 142 may include a diameter of about 0.014 inches. In some embodiments, the cross-sectional area of the lumen 142 is approximately 0.000152 square inches, and the cross-sectional area of the annular space 146 is approximately 0.0363 square inches. In some embodiments, the diameter of the lumen 142 of the cannula 140 may be less than the thickness of the lumen of the annular space 146. However, the various embodiments of the present disclosure are not limited to the above configurations.

[0121] The advantage of the foregoing configuration is that, compared to blood flowing into the blood collection device 40 through the plurality of fluid channels 165 and the annular space 146 of the second flow path, the reduced or minimized diameter or size of the microchannel fluid path defined by the lumen 142 of the cannula 140 can provide increased flow resistance and reduced blood flow rate within the flow restriction device 110. Accordingly, the risk of hemolysis during blood collection can be advantageously reduced. However, compared to the reduced or minimized diameter or size of the microchannel fluid path defined by the lumen 142 of the cannula 140, the larger size of the cross-sectional flow area of the annular space 146 compared to the cross-sectional flow area of the lumen 142 can provide an additional advantage, namely allowing an unrestricted and increased amount of IV fluid 17 to flow to the patient via the second flow path. Thus, the IV fluid 36 can flow toward the catheter assembly 50 in a second unrestricted (less flow resistant) direction (from the proximal end to the distal end), which is opposite to the first direction (from the distal end to the proximal end) in which the blood sample 15 with blood cells flows.

[0122] Figure 3A A perspective view of a flow restriction device 210 in accordance with some embodiments of the present disclosure is shown. Figure 3B Shown in accordance with some embodiments of the present disclosure Figure 3A A cross-sectional view of the flow restriction device 210. Figure 3C Shown in accordance with some embodiments of the present disclosure Figure 3A An enlarged cross-sectional view of the flow channel 245 of the flow restriction device 210.

[0123] As Figure 3A shown, continuing to refer to Figure 1A and Figure 1B In some embodiments, the flow restriction device 210 may include a first connector 212 configured to be coupled to the catheter assembly 50. The first connector 212 may have a proximal end 214, a distal end 216, and an inner surface 218 defining an inner lumen 220 of the first connector 212. In some embodiments, the flow restriction device 210 may further include a second connector 230 coupled to the proximal end 214 of the first connector 212. The second connector 230 may be configured to be coupled to a fluid collection device 40 (e.g., a blood collection device). For example, the second connector 230 may be integrated with the blood collection device 40 or formed as a single unit integrally with the blood collection device 40. As another example, the second connector 230 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 second connector 230 may include a lumen 234 extending therethrough for coupling to the male Luer portion of the blood collection device 40.

[0124] In some embodiments, the second connector 230 may further include a proximal end 236, a distal end 238, and a support portion 260 disposed between the proximal end 236 and the distal end 238. The support portion 260 may have a proximal end 261, a distal end 262, and may include a central mounting hole 266 extending from the proximal end 261 to the distal end 262. In some embodiments, the support portion 260 may further include a plurality of fluid channels 265 disposed radially outside the central mounting hole 266 and surrounding the central mounting hole. The plurality of fluid channels 265 may extend from the proximal end 261 to the distal end 262 of the support portion 260 to fluidly communicate the lumen 234 of the second connector 230 with the inner lumen 220 of the first connector 212, which is fluidly coupled to the conduit assembly 50. Thus, the plurality of fluid channels 265 may define at least a portion of the second flow path.

[0125] According to various embodiments of the present disclosure, the flow restriction device 210 may further include an intubation tube 140 installed in the lumen 234 of the second connector 230. In particular, the intubation tube 140 may have a proximal end 143, a distal end 145, and a lumen 142 extending therethrough. As shown, the proximal end 143 of the intubation tube 140 may be installed in the central mounting hole 266 for fluid communication between the intubation tube 140 and the fluid collection device 40. The intubation tube 140 may extend from the lumen 234 of the second connector 230 into the first connector 212. The intubation tube 140 may have a proximal end 143, a distal end 145, and a lumen 142 extending therethrough. The lumen 142 may define a first flow path or microchannel along which fluid may flow between the proximal end 214 and the distal end 216 of the first connector 212. As shown, the intubation tube 140 may be installed in the central mounting hole 266 of the second connector support portion 260 and may provide fluid communication between the intubation tube 140 and the catheter assembly 50. For example, in some embodiments, the leg 72 of the Y-shaped adapter 70 may be coupled to the flow restriction device 210. For example, the leg 72 of the Y-shaped adapter 70 may include a lumen in which the distal end 216 of the first connector 212 of the intubation tube 140 disposed therein may be coupled. The Y-shaped adapter 70 may fluidly communicate the flow restriction device 210 and the intubation tube 140 installed therein with the catheter assembly 50, for example, via the extension pipe fitting 60. Thus, the lumen 142 of the intubation tube 140 may define a linear fluid path having a reduced, small, or micro-sized diameter (as described below) through which fluid entering the flow restriction device 210 from the catheter assembly may flow through the flow restriction device 210 for collection in the fluid collection device 40. For example, in the case of withdrawing or collecting blood from a patient, the medical fluid 15 may be blood, and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood or fluid collection device may be a Luer lock access device (LLAD). Thus, during the process of collecting or withdrawing blood from a patient, the blood sample 15 may flow from the distal end 216 of the first connector 212 into the LLAD 40 via the first flow path or microchannel.

[0126] In some embodiments, the intubation tube 140 may be an elongated thin tube having a lumen with a small, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 142 of the intubation tube 140 defines a first flow path or microchannel along which fluid may flow from the distal end 116 into the fluid collection device 40 via the second connector 130. The intubation tube 140 may define a lumen 142 formed by any length, diameter, and cross-sectional area as described above with reference to the optimized fluid path.

[0127] When the fluid 15 is blood drawn from a patient's body, blood cells may be subject to shear stress as the blood cells flow from the catheter assembly 50 into the blood collection device 40. For example, the maximum shear stress may be along the wall of the blood cell, commonly referred to as wall shear stress. The wall shear stress on the blood cells is considered to be the main source of mechanical damage to the blood cells that causes hemolysis of the blood cells. In some embodiments, the lumen 142 of the cannula 140 having a reduced or micro-sized diameter may help increase the flow resistance within the vascular access system 100 to distribute the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15. The minimum diameter of the first fluid path or microchannel defined by the lumen 142 of the cannula 140 may provide increased resistance to the flow of the blood 15 and thereby reduce the blood flow rate within the flow restriction device 210. Since the reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells in the blood 15, the risk of hemolysis during blood collection can be advantageously reduced.

[0128] In some embodiments, as Figure 3C shown, an annular space 246 may be defined between the outer surface of the cannula 140 and the inner surface 118 of the first connector 212. The annular space 246 may define a second flow path along which fluid flows from the lumen 234 of the second connector 230 through the first connector 216 into the catheter assembly 50. A plurality of fluid channels 265 may extend from the proximal end 261 to the distal end 262 of the support portion 260 to place the annular space 246 in fluid communication with the catheter assembly 50. Thus, the plurality of fluid channels 265 may define at least a portion of the second flow path.

[0129] Similar to the flow restriction device 110, the flow restriction device 210 may also include a check valve 150 mounted in the annular space 246 at the proximal end 214 of the first connector 212. As shown, the check valve 150 may be sleeved on at least a portion of the cannula 140. The check valve 150 may have a shape or structure configured to prevent fluid from flowing from the distal end 216 of the first connector 212 into the fluid collection device 40 via the second flow path, while allowing fluid to flow from the second connector 230 into the first connector 212 and the catheter assembly 50 via the second flow path. In some embodiments, the fluid flowing from the second connector 230 into the first connector 212 and the catheter assembly 50 via the second flow path may be IV fluid 17. Thus, the blood 15 containing blood cells may be forced to flow through the microchannel fluid path defined by the lumen 142 of the cannula 140 in order to reach the blood collection device 40, while the IV fluid 17 may flow to the catheter assembly 50 through the second flow path including the annular space 246 and the plurality of fluid channels 265.

[0130] In some embodiments, the cross-sectional flow area of the annular space 246 can be greater than the cross-sectional flow area of the lumen 142. For example, the cross-sectional area of the annular space 246 around a plane transverse to the central longitudinal axis X of the first connector 212 can be greater than the cross-sectional area of the lumen 142 around that plane. The cannula 140 can define a lumen 142 formed by any length, diameter, and cross-sectional area as described above with reference to the optimized fluid path. In some embodiments, the diameter of the lumen 142 of the cannula 140 can be less than the thickness of the lumen of the annular space 246.

[0131] An advantage of the foregoing configuration is that, compared to blood flowing into the blood collection device 40 via the plurality of fluid channels 265 and the annular space 246 of the second flow path, the reduced or minimized diameter or size of the microchannel fluid path defined by the lumen 142 of the cannula 140 can provide increased flow resistance and reduced blood flow rate within the flow restriction device 210. Accordingly, the risk of hemolysis during blood collection can be advantageously reduced. However, compared to the reduced or minimized diameter or size of the microchannel fluid path defined by the lumen 142 of the cannula 140, the larger size of the cross-sectional flow area of the annular space 246 compared to the cross-sectional flow area of the lumen 142 can provide an additional advantage of allowing an unrestricted and increased amount of IV fluid 17 to flow towards the patient via the second flow path. Thus, the IV fluid 17 can flow towards the catheter assembly 50 in a second unrestricted (less flow resistant) direction (from proximal to distal), which is opposite to the first direction (from distal to proximal) in which the blood sample 15 having blood cells flows.

[0132] Figure 4A A perspective view of a flow restriction device 310 in accordance with some embodiments of the present disclosure is shown. Figure 4B A cross-sectional view of a flow restriction device in accordance with some embodiments of the present disclosure is shown. Figure 4A Figure 4C An enlarged partial cross-sectional view of a flow restriction device in accordance with some embodiments of the present disclosure is shown. In accordance with some embodiments, the flow restriction device 310 is similar to the flow restriction device 210, and where the elements are the same, the reference numerals remain the same, and the detailed description of these like elements is omitted herein. Figure 4A

[0133]

[0134] In terms of the support portion 360 and the cannula 340, the flow restriction device 310 can be different from the flow restriction device 210, which will be described in further detail below.

[0134] Similar to the second connector 230 of the flow restriction device 210, the second connector 330 of the flow restriction device 310 can include a proximal end 336, a distal end 338, and a support portion 360 disposed between the proximal end 336 and the distal end 338. The support portion 360 can have a proximal end 361, a distal end 362, and can include a central mounting hole 366 extending from the proximal end 261 to the distal end 262. However, contrary to the support portion 260 of the second connector 230 of the flow restriction device 210, the support portion 360 of the second connector 330 of the flow restriction device 310 may not include a plurality of fluid channels radially outwardly disposed and surrounding the central mounting hole 366.

[0135] In some embodiments, the flow restriction device 310 can include an intubation tube 340 mounted in the lumen 334 of the second connector 330. In particular, the intubation tube 340 can have a proximal end 343, a distal end 345, and a lumen 342 extending therethrough. As shown, the proximal end 343 of the intubation tube 340 can be mounted in the central mounting hole 366 for fluid communication of the intubation tube 340 with the fluid collection device 40. The intubation tube 340 can extend from the lumen 334 of the second connector 330 into the first connector 212. The intubation tube 340 can have a proximal end 343, a distal end 345, and a lumen 342 extending therethrough.

[0136] The lumen 342 of the cannula 340 can define a first flow path or microchannel along which fluid can flow from the distal end 216 of the first connector 212 into the fluid collection device 40. As shown, the cannula 340 can be mounted in the central mounting hole 266 of the second connector support portion 260 and can place the cannula 340 in fluid communication with the catheter assembly 50. For example, in some embodiments, the leg 72 of the Y - adapter 70 can be coupled to the flow restriction device 310. For example, the leg 72 of the Y - adapter 70 can include a lumen in which the distal end 216 of the first connector 212 of the cannula 340 disposed therein can be coupled. The Y - adapter 70 can fluidly communicate the flow restriction device 310 and the cannula 340 mounted therein with the catheter assembly 50, for example, via the extension tube 60. Thus, the lumen 342 of the cannula 340 can define a linear fluid path having a reduced, small, or micro - sized diameter (as described below) through which fluid entering the flow restriction device 310 from the catheter assembly can flow through the flow restriction device 310 for collection in the fluid collection device 40. For example, in the case of withdrawing or collecting blood from a patient, the medical fluid 15 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). Thus, during the process of collecting or withdrawing blood from a patient, the blood sample 15 can flow from the distal end 216 of the first connector 212 into the LLAD 40 via the first flow path or microchannel.

[0137] In some embodiments, the cannula 340 can be an elongate thin tube having a lumen with a small, reduced, or micro - sized diameter. For example, in some embodiments, the lumen 342 of the cannula 340 defines a first flow path or microchannel along which fluid can flow from the distal end 216 via the second connector 330 into the fluid collection device 40. The cannula 340 can define a lumen 342 formed by any length, diameter, and cross - sectional area as described above with reference to the optimized fluid path.

[0138] The cannula 340 may be structurally similar to the cannula 140, except that, in some embodiments, the cannula 340 may include a notch 345 along the length of the cannula 340 between the proximal end 343 and the distal end 345 of the cannula 340. In particular, the notch 345 may be disposed at a position corresponding to the distal end of the check valve 150. Thus, in the open configuration of the check valve 150, for example, during infusion of fluid (e.g., IV fluid) from the proximal end 343 of the cannula, the notch 345 may fluidly connect the lumen 342 of the cannula 340 to the annular space 246. Accordingly, at least a portion of the infused fluid may flow from the proximal end 343 of the cannula 340 into the annular space 246 via the notch 345 of the cannula 340.

[0139] In some embodiments, the cross-sectional flow area of the annular space 246 may be greater than the cross-sectional flow area of the lumen 342. For example, the cross-sectional area of the annular space 246 about a plane transverse to the central longitudinal axis X of the first connector 212 may be greater than the cross-sectional area of the lumen 342 about that plane. The cannula 140 may define a lumen 142 formed by any length, diameter, and cross-sectional area as described above with reference to the optimized fluid path. In some embodiments, the diameter of the lumen 342 of the cannula 340 may be less than the thickness of the lumen of the annular space 246.

[0140] An advantage of the foregoing configuration is that, compared to blood flowing into the blood collection device 40 via the annular space 246 of the second flow path, the reduced or minimized diameter or size of the microchannel fluid path defined by the lumen 342 of the cannula 340 may provide increased flow resistance and reduced blood flow rate within the flow restriction device 310. Accordingly, the risk of hemolysis during blood collection may be advantageously reduced. However, compared to the reduced or minimized diameter or size of the microchannel fluid path defined by the lumen 342 of the cannula 340, the larger size of the cross-sectional flow area of the annular space 246 compared to the cross-sectional flow area of the lumen 342 may provide an additional advantage, namely, allowing an unrestricted and increased amount of IV fluid 17 to flow from the lumen and the notch 345 to the patient via the second flow path. Accordingly, the IV fluid 17 may flow toward the catheter assembly 50 in a second unrestricted (less flow resistant) direction (from the proximal end to the distal end), which is opposite to the first direction (from the distal end to the proximal end) in which the blood sample 15 with blood cells flows.

[0141] Figure 5A A perspective view of a flow restriction device 410 in accordance with some embodiments of the present disclosure is shown. Figure 5B A perspective view of the flow restriction device 410 during blood withdrawal in accordance with some embodiments of the present disclosure is shown. Figure 5A is shown. Figure 5C A perspective view of a flow restriction device 410 in accordance with some embodiments of the present disclosure is shown.Figure 5A Perspective view of the flow restriction device 410 during infusion. As Figures 5A - 5B shown, continuing to refer to Figure 1A and Figure 1B , in some embodiments, the flow restriction device 410 can include a distal connector portion 412 configured to be coupled to the catheter assembly 50, and a proximal connector portion 430 extending proximally from the distal connector portion 412 and configured to be coupled to the fluid collection device 40. The distal connector portion 412 can include an inner surface 414 that defines its lumen 416, and the proximal connector portion 430 can include an inner surface 432 that defines a lumen 434 that is fluidly connected to the lumen 416 of the distal connector portion 412. As shown, the flow restriction device 410 can also include a plug 444 disposed in the lumen 434 of the proximal connector portion 430.

[0142] According to various embodiments of the present disclosure, the plug 444 can include a head portion 442 and a body portion 448 extending proximally from the head portion 442. As shown, the head portion can include a slit 456, and the body portion 448 can include a plurality of threads 446 extending along the outer surface of the body portion 448. The plug 444 can also include an inner surface 452 that defines a lumen 454 of the plug 444. In some embodiments, the lumen 454 can define an internal flow path 455 in which fluid can flow from the proximal connector portion 430 through the distal connector portion into the catheter assembly 50.

[0143] As shown, the inner surface 432 of the proximal connector portion 430 can surround, encircle, or otherwise enclose the outer surface of the body portion 448 to define a continuous non-linear channel 450 along the spacing between adjacent threads of the plurality of threads 446. In some embodiments, the continuous non-linear channel 450 can be in the form of a continuous groove having a coil shape recessed in the outer surface of the body portion 448. In some embodiments, the continuous non-linear channel 450 can form a coil shape, an S shape, or another suitable non-linear winding shape. For example, the continuous non-linear channel 450 can have a helical shape (which can include a helix) or an S shape recessed in the outer surface of the body portion 448. The advantage of the foregoing configuration is that, compared to a linear channel, the helical continuous non-linear channel 450 (due to its surrounding the outer surface of the body portion 448) can increase the length of the fluid path defined by the continuous non-linear channel 450 through which the blood sample 15 flows. In the case where the medical fluid withdrawn from the patient's body is blood, when blood cells flow from the catheter assembly 50 into the blood collection device 40, the blood cells may be subjected to shear stress. In some embodiments, the continuous non-linear channel 450 can help increase the flow resistance within the vascular access system 100 to distribute the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15.

[0144] In addition, in some embodiments, the continuous non-linear channel 450 may have a first diameter D1, and the lumen 454 of the plug 444 may have a second diameter D2, and the first diameter D1 may be less than the second diameter D2. The continuous non-linear channel 450 may be formed with any length, diameter, and cross-sectional area as described above with reference to the optimized fluid path.

[0145] As a non-limiting example, in some embodiments, the first diameter D1 may range from about 0.02 inches to 0.03 inches, in some cases from about 0.022 inches to 0.028 inches, more typically from about 0.024 inches to 0.026 inches, and in some embodiments about 0.025 inches. Although certain ranges are recited, it should be understood that all ranges including the lowest value of the lower limit to the highest value of the upper limit are included, including all intermediate ranges or specific angles within that complete range or any particular recited range. However, the various embodiments of the present disclosure are not limited to the above configurations.

[0146] An advantage of the foregoing configuration is that, due to the minimization of the diameter or size of the fluid path defined by the continuous non-linear channel 450, the fluid path defined by the continuous non-linear channel 450 can thus provide increased flow resistance and reduced blood flow rate within the flow restriction device 410, as contrasted with the internal flow path 455 defined within the lumen 454 of the plug 444. Accordingly, the risk of hemolysis during blood collection can be advantageously reduced.

[0147] Compared to flowing only in the smaller (minimized) diameter fluid path defined by the continuous non-linear channel 450, the above-described configuration with a second diameter D2 greater than the first diameter D1 may be more advantageous in further allowing an unrestricted and increased amount of IV fluid 17 to flow to the patient via (i) the larger diameter internal flow path 445 and (ii) the reverse fluid path defined by the continuous non-linear channel 450, as Figure 5C shown. Accordingly, the IV fluid 17 can flow in a second unrestricted (less flow resistant) direction (from proximal to distal) opposite to the first direction (from distal to proximal) in which the blood sample 15 with blood cells flows.

[0148] During operation, during blood collection or blood drawing from a patient, blood 15 can flow from the patient's vein into the catheter assembly 50, through the extension tubing 60, and due to the presence of the plug 444 in the lumen 434 of the proximal connector portion 430, enter the distal connector portion 412 of the flow restriction device 410 via the lumen 416. The slit 456 of the head portion can be closed or nominally closed, thereby preventing blood from moving through the slit 456. The blood 15 can be forced by the head portion 442 and the body portion 448 to flow around the outer surface of the plug 444 into the continuous non-linear channel 450 and out of the flow restriction device 410 into the blood collection device 40. Thus, during blood collection or blood drawing from a patient, the blood 15 can flow via the continuous non-linear channel 450 having a minimum diameter into the blood collection device 40.

[0149] The flow restriction device 410 of various embodiments described herein is superior to existing blood collection systems. For example, during blood extraction with an existing blood extraction device, as blood cells flow from the distal end to the proximal end of the blood collection system, they are subjected to shear stress. The maximum shear stress can be along the wall of the blood cell, commonly referred to as wall shear stress. The wall shear stress on blood cells is considered the main source of mechanical damage to blood cells causing hemolysis. In some embodiments, the continuous non-linear channel 450 having a minimum diameter can help increase the flow resistance within the vascular access system 100 to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood 15. For example, the minimum diameter of the continuous non-linear channel 450 can provide increased resistance to the flow of the blood 15, thereby reducing the blood flow rate within the flow restriction device 410. Since the reduced blood flow rate results in a lower shear stress experienced by the red blood cells of the blood 15, the risk of hemolysis during blood collection can be advantageously reduced.

[0150] Figure 6A A perspective view of a flow restriction device 510 according to some embodiments of the present disclosure is shown. Figure 6B A flow restriction device according to some embodiments of the present disclosure is shown Figure 6A in cross-section. Figure 6C A flow restriction device according to some embodiments of the present disclosure is shown Figure 6A in an enlarged perspective view of the proximal connector 530 of the flow restriction device. As Figures 6A - 6C shown, continuing to refer to Figure 1A and 1B, in some embodiments, the flow restriction device 510 can include a distal connector 512 configured to be coupled to the catheter assembly 50, and a proximal connector 530 coupled to the distal connector 512 and configured to be coupled to the fluid collection device 40. Thus, during fluid withdrawal (e.g., blood draw), fluid can flow from the catheter assembly 50 into the flow restriction device 510 (e.g., via the extension fitting 60), and out of the flow restriction device 510 into the blood collection device 40. In some embodiments, the distal connector 512 can include a first connection portion 514 at its proximal end and a second connection portion 516 at its distal end. As shown, the first connection portion 514 can be in the form of a cylindrical body having an inner surface 515 that defines a lumen 520 of the distal connector 512. The lumen can be configured such that at least a portion of the proximal connector 530 can be inserted, fitted, or otherwise coupled therein to fluidly couple the distal connector 512 and the proximal connector 530. For example, in some embodiments, the proximal connector 530 can include an insertion portion 534 for insertion into the lumen 520 of the first connection portion 514. As shown, the outer surface of the insertion portion 534 can include a continuous non-linear channel 536 recessed therein. In the coupled or assembled configuration of the distal connector 512 and the proximal connector 530, the inner surface 515 of the first connection portion 514 can surround, encircle, or otherwise enclose the outer surface of the insertion portion 534 such that the continuous non-linear channel 536 and the inner surface 515 of the first connection portion 514 define a non-linear fluid path along which fluid (e.g., blood) can flow from the distal connector 512 through the proximal connector 530 into the fluid collection device 40.

[0151] In some embodiments, the continuous non-linear channel 536 can form a coil shape, an S shape, or other suitable non-linear winding shape. For example, the continuous non-linear channel 536 can have a coil shape (which can include a helix) recessed in the outer surface of the insertion portion 534. In some embodiments, the continuous non-linear channel 536 can have an S shape recessed in the outer surface of the insertion portion 534. The advantage of the foregoing configuration is that the helical, coiled, S-shaped, or other suitable non-linear, winding shape of the continuous non-linear channel 536 (due to its winding around the outer surface of the insertion portion 534) can increase the length of the fluid path through which a blood sample flowing through the continuous non-linear channel 536 passes.

[0152] In cases where the medical fluid is blood withdrawn or collected from a patient's body, the medical fluid can be a blood sample, 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). In cases where the medical fluid is blood withdrawn from a patient, as blood cells flow from the distal connector 512 to the proximal connector 530 of the flow restriction device 510, they are subject to shear stress. For example, the maximum shear stress can be along the wall of the blood cell. The wall shear stress on the blood cell is considered to be the main source of mechanical damage to the blood cell that causes hemolysis. In some embodiments, the insertion portion 534 having the continuous non-linear channel 536 can help increase the flow resistance within the vascular access system 100 to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood 15.

[0153] According to various embodiments of the present disclosure, the insertion portion 534 can further include an inner surface 540 that defines a lumen 542 of the insertion portion 534. As Figure 6B shown, continuing to refer to Figure 1C , the lumen 542 can form an internal flow path along which the fluid 17 can flow from the proximal connector 530 to the catheter assembly 50 via, for example, the distal connector 512 and the extension fitting 60. In some embodiments, the fluid flowing from the proximal connector 530 to the catheter assembly 50 via the distal connector 512 can be IV fluid. In some embodiments, the internal flow path for the fluid to flow from the proximal connector 530 to the catheter assembly 50 via the distal connector 512 can be a linear flow path.

[0154] According to some embodiments of the present disclosure, the flow restriction device 510 may further include a check valve 550 disposed in the lumen 542 of the insertion portion 534. For example, the check valve 550 may be disposed at the proximal end of the insertion portion 534. The check valve may selectively couple the fluid collection device 40 with the distal connector 512 via the lumen 542 of the insertion portion 534. For example, the check valve 550 may be a normally closed valve such that the check valve 550 may prevent fluid 15 (e.g., blood) from flowing from the distal connector 512 to the proximal connector 530 via the lumen 542 of the insertion portion 534. However, the check valve 550 may have a configuration that allows fluid 17 (e.g., IV fluid) to flow from the proximal connector 530 to the distal connector 512 via the lumen 542 of the insertion portion 534. For example, in some embodiments, the check valve 550 may be a check valve having a normally closed slit configured to open when subjected to fluid pressure in the proximal-to-distal direction. Thus, when fluid (e.g., IV fluid) is infused into the flow restriction device 510, the slit may open and allow fluid to flow from the proximal connector 530 to the distal connector 512 and ultimately to the catheter assembly 50. When fluid (e.g., blood) is drawn from the catheter assembly 50 into the fluid collection device 40, the normally closed slit may remain closed, thereby preventing fluid flowing from the distal connector 512 to the proximal connector 530 from entering the fluid collection device 40 via the lumen 542 of the insertion portion 534. Thus, the blood sample 34 containing blood cells may be forced to flow through the curved or helical continuous non-linear channel 536 and thus reach the blood collection device 40, while the IV fluid 17 may flow through the internal flow path defined by the lumen 542 to the catheter assembly 50.

[0155] In some embodiments, the continuous non-linear channel 536 may have a first diameter D3, the lumen 542 of the insertion portion 534 may have a second diameter D4, and the first diameter D3 may be less than the second diameter D4. The continuous non-linear channel 536 may be formed with any length, diameter, and cross-sectional area as described above with reference to the optimized fluid path.

[0156] As a non-limiting example, in some embodiments, the first diameter D3 may range from about 0.02 inches to 0.03 inches, in some cases from about 0.022 inches to 0.028 inches, more typically from about 0.024 inches to 0.026 inches, and in some embodiments about 0.025 inches. Although certain ranges are recited, it should be understood that all ranges from the lowest value of the lower limit to the highest value of the upper limit (including all intermediate ranges or specific angles) are included within that complete range or any specifically recited range. However, the various embodiments of the present disclosure are not limited to the foregoing configurations.

[0157] The advantage of the foregoing construction is that, due to the minimized diameter or size of the fluid path defined by the continuous non-linear channel 536, the fluid path defined by the continuous non-linear channel 536 can provide increased flow resistance and reduced blood flow velocity within the flow restriction device 510 as compared to the internal flow path defined by the lumen 542 of the insertion portion 534. Accordingly, the risk of hemolysis during blood collection can be advantageously reduced.

[0158] Compared to flowing only in the fluid path with a smaller (minimized) diameter defined by the continuous non-linear channel 536, the foregoing construction with a second diameter D4 greater than the first diameter D3 may be more advantageous in further allowing an unrestricted and increased amount of IV fluid 17 to flow to the patient via the larger-diameter internal flow path defined by the lumen 542. Accordingly, the IV fluid 17 can flow in a second unrestricted (less flow resistance) direction (from proximal to distal), opposite to the first direction (from distal to proximal) in which the blood sample 15 with blood cells flows.

[0159] In operation, during collection or withdrawal of blood from a patient's body, the blood 15 can flow from the patient's vein into the catheter assembly 50, through the extension fitting 60, and into the distal connector 512 of the flow restriction device 510 via the lumen 519 of the distal connector 512. Due to the presence of the check valve 550 in the lumen 542 of the insertion portion 534, the blood 15 can be forced to flow around the outer surface of the insertion portion 534 into the continuous non-linear channel 536 and out of the flow restriction device 510 into the blood collection device 40. Accordingly, during collection or withdrawal of blood from a patient's body, the blood 15 can flow via the continuous non-linear channel 536 with the minimum diameter into the blood collection device 40. The flow restriction device 510 of various embodiments described herein is superior to existing blood collection systems. For example, during blood withdrawal with an existing blood withdrawal device, as blood cells flow from the distal end to the proximal end of the blood collection system, they are subject to shear stress. The maximum shear stress can be along the wall of the blood cell, commonly referred to as wall shear stress. The wall shear stress on blood cells is considered the main source of mechanical damage to blood cells causing hemolysis. In some embodiments, the continuous non-linear channel 536 with the minimum diameter can help increase the flow resistance within the vascular access system 100 to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood 15. For example, the minimum diameter of the continuous non-linear channel 536 can provide increased resistance to the flow of the blood 15, thereby reducing the blood flow velocity within the flow restriction device 510. Since the reduced blood flow velocity results in a reduced shear stress experienced by the red blood cells of the blood 15, the risk of hemolysis during blood collection can be advantageously reduced.

[0160] Figure 7AA perspective view of a flow restriction device in accordance with some embodiments of the present disclosure is shown. Figure 7B A flow restriction device in accordance with some embodiments of the present disclosure is shown Figure 7A in cross-section. As Figure 7A and 7B shown, continuing reference to Figure 1A and 1B , the flow restriction device 610 may include a first connector 630 having a female Luer portion 632 at a proximal end, a male Luer portion 634 at a distal end, an inner surface 636 defining an inner lumen 638 of the first connector 630, and a compressible valve member 640 mounted within the inner lumen 638. The first connector 630 may be configured to couple to a fluid collection device 40 (as Figure 1A and 1B shown). For example, in some embodiments, the first connector 630 may be a needleless connector that includes a female Luer portion 632 at a proximal end, a male Luer portion 634 at a distal end, and a compressible valve member 640 mounted within the first connector and longitudinally extending within the inner lumen 638 of the needleless connector. In some embodiments, the compressible valve member 640 may include a head portion 642 and a body portion 644 extending distally from the head portion 642, the head portion having a slot, slit, or other similarly formed incision 650 at a proximal end of the head portion 642. The body portion 644 may be configured to elastically compress and expand based on the application and removal of an axial force. For example, in some embodiments, the body portion 644 may have a bellows or spring shape. The head portion 642 may be in the form of a split diaphragm. For example, as shown, the proximal end of the head portion 642 may include a slot, slit, or other similarly formed incision 650. In some embodiments, the valve member 640 may include an inner surface 646 defining an inner chamber 648 of the valve member 640.

[0161] In accordance with various embodiments of the present invention, the flow restriction device 610 may further include a second connector 612 that couples to the male Luer portion 634 of the first connector 630 and is configured to couple to a catheter assembly 50. As shown, the second connector 612 may have an inner surface 614 defining an inner lumen 616 of the second connector 612. In some embodiments, the second connector 612 may further include a support portion 660 extending radially inward from the inner surface 614 into the inner lumen 616 of the second connector 612. The support portion 660 may include a mounting hole 662.

[0162] In some embodiments, cannula 620 may be installed within inner lumen 616 of second connector 612. In particular, cannula 620 may be installed within mounting hole 662 to fluidly couple second connector 612 with fluid collection device 40. As shown, cannula 620 may extend from inner lumen 616, through male Luer portion 634 of first connector, and into female Luer portion 632 of first connector 630. In some embodiments, compressible valve member 640 may be installed around at least a portion of cannula 620. For example, in some embodiments, a proximal portion of cannula 620 may extend into internal chamber 648 of valve member 640. In particular, in some embodiments, a proximal portion of cannula 620 may extend into head portion 642 of compressible valve member 640. In some embodiments, cannula 620 may be press fit within support portion 660. However, the various embodiments of the present disclosure are not limited to the configurations mentioned above. In some embodiments, cannula 620 may be fastened, attached, or otherwise coupled by any other suitable means of attachment.

[0163] In some embodiments, cannula 620 may have a proximal end 623, a distal end 625, and a lumen 622 extending therethrough. Cannula 620 may extend from the lumen 616 of second connector 612 into the internal chamber 648 of a compressible valve member 640 disposed within the inner lumen 638 of first connector 630. The lumen 622 of cannula 620 may define a flow path or microchannel along which fluid may flow from second connector 612 to fluid collection device 40. As shown, cannula 620 may be mounted within mounting hole 662 of second connector support portion 660 and may fluidly couple blood collection device 40 to catheter assembly 50. For example, in some embodiments, legs 72 of Y-shaped adapter 70 may be coupled to flow restriction device 610. Legs 72 of Y-shaped adapter 70 may include lumens within which distal end 615 of second connector 612, to which cannula 620 is coupled, may be mounted. Y-shaped adapter 70 may fluidly communicate flow restriction device 610 and cannula 620 mounted therein with catheter assembly 50, for example, via extension fitting 60. Thus, lumen 622 of cannula 620 may define a linear fluid channel having a diameter of reduced, small, or microscale dimensions (as described below) through which fluid entering flow restriction device 610 from catheter assembly 50 may flow through flow restriction device 610 and be collected in fluid collection device 40. For example, in a case where blood is withdrawn or collected from a patient, medical fluid 15 is blood and fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a luer lock access device (LLAD). Thus, during collection or withdrawal of blood from a patient, blood sample 15 may flow from distal end 615 of second connector 612 into LLAD 40 via the flow path or microchannel defined by lumen 622.

[0164] In some embodiments, cannula 620 may be an elongate, thin tube having a lumen with a small, reduced, or microscale diameter. For example, in some embodiments, lumen 622 of cannula 620 defines a flow path or microchannel along which fluid may flow from distal end 615 through cannula 620 to fluid collection device 40. Cannula 620 may define lumen 622 having any length, diameter, and cross-sectional area, as described above with reference to optimized fluid paths.

[0165] To withdraw fluid (e.g., blood) from the catheter assembly 50, the fluid collection device 40 can be inserted and connected in parallel to the female Luer portion 632 of the first connector 630. In the coupling configuration of the first connector 630 and the fluid collection device 40, the compressible valve member 640 can be compressed distally by the fluid collection device 40 to fluidly connect the proximal end 623 of the cannula 620 and the fluid collection device 40. For example, as the male Luer portion of the blood collection device 40 is inserted into the female Luer portion 632 of the first connector 630, the male Luer portion of the blood collection device 40 can move the head portion 642 of the valve member 640 and cause the valve member 640 to be compressed in the distal direction. As the head portion is displaced distally, the proximal end 623 of the cannula 620 can be exposed to the outside of the valve member 640 via the slot 650. Thus, the proximal end 623 of the cannula 620 can be fluidly coupled to the male Luer portion of the blood collection device 40 via the slot of the compressible valve member.

[0166] In operation, during collection or withdrawal of blood from a patient's body, blood 15 can flow from the patient's vein into the catheter assembly 50, through the extension tube 60, and into the distal end 615 of the second connector 612. Since the cannula 620 is present in the lumen 616 of the second connector, the blood 15 can be forced to flow into and through the flow path or microchannel defined by the lumen 622 and exit the flow restriction device 610 into the blood collection device 40. Thus, during collection or withdrawal of blood from a patient's body, the blood 15 can flow through the flow path or microchannel having a small diameter defined by the lumen 622 to the blood collection device 40. The flow restriction device 610 of various embodiments described herein is superior to existing blood collection systems. For example, during blood withdrawal with an existing blood withdrawal device, as blood cells flow from the distal end to the proximal end of the blood collection system, they are subject to shear stress. The maximum shear stress can be along the wall of the blood cell, commonly referred to as the wall shear stress. The wall shear stress on the blood cells is considered to be the main source of mechanical damage to the blood cells causing hemolysis. In some embodiments, the continuous flow path or microchannel having the minimum diameter defined by the lumen 622 can help increase the flow resistance within the vascular access system 100 to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood 15. For example, the minimum diameter of the flow path or microchannel defined by the lumen 622 can provide increased resistance to the flow of the blood 15, thereby reducing the blood flow rate within the flow restriction device 610. Since the reduced blood flow rate reduces the shear stress experienced by the red blood cells of the blood 15, the risk of hemolysis during blood collection can be advantageously reduced.

[0167] Figure 8A A perspective view of a flow restriction device 710 in accordance with some embodiments of the present disclosure is shown. Figure 8BSome embodiments of the present disclosure are shown Figure 8A 2 is a cross-sectional view of the first and second connectors 730 and 712 of the flow restriction device. Figure 8C Some embodiments of the present disclosure are shown Figure 8A A cross-sectional view of a flow restriction device 710 is shown. Figure 8A and 8B As shown, continue to refer to Figure 1A and 1B , the flow restriction device 710 may include a first connector 730 having a female Luer portion 732 at a proximal end, a male Luer portion 734 at a distal end, an interior surface 736 defining an inner lumen 738 of the first connector 730, and a compressible valve member 740 mounted in the inner lumen 738. The first connector 730 may be configured to be coupled to a fluid collection device 40 (e.g., Figure 1A and 1B ). For example, in some embodiments, the first connector 730 can be a needleless connector, which includes a female Luer portion 732 at a proximal end, a male Luer portion 734 at a distal end, and a compressible valve member 740 installed in the first connector 730, which extends longitudinally in the inner lumen 738 of the needleless connector. In some embodiments, the compressible valve member 740 may include a head portion 742 and a body portion 744 extending distally from the head portion 742, and the head portion has a slot, slit, or other similar form of cutout 750 at the proximal end of the head portion 742. The body portion 744 can be configured to elastically compress and expand based on the application and removal of axial force. For example, in some embodiments, the body portion 744 can have an accordion or spring shape. The head portion 742 can be in the form of a split diaphragm. For example, as shown in the figure, the proximal end of the head portion 742 may include a slot, slit, or other similar form of cutout 750. In some embodiments, the valve member 740 may include an inner surface 746 that defines an internal chamber 748 of the valve member 740 .

[0168] According to various embodiments of the present invention, the flow restriction device 710 may further include a second connector 712 that is coupled to the male Luer portion 734 of the first connector 730 and is configured to be coupled to the catheter assembly 50. As shown, the second connector 712 may have an interior surface 714 that defines an inner lumen 716 of the second connector 712. In some embodiments, the second connector 712 may further include a support portion 760 that extends proximally from the proximal end of the male Luer portion 734 of the second connector 712 into the inner lumen 716 of the female Luer portion 732 of the second connector 712.

[0169] In some embodiments, the post 720 can be installed in the inner lumen 716 of the second connector 712. In particular, the post 720 can be installed on or sleeved on the support portion 760 to fluidly connect the second connector 712 to the fluid collection device 40. As shown, the post 720 can extend from the inner lumen 716, through the male Luer portion 734 of the first connector, and into the female Luer portion 732 of the first connector 730. In some embodiments, the compressible valve member 740 can be installed around at least a portion of the post 720. For example, in some embodiments, the proximal portion of the post 720 can extend into the internal chamber 748 of the valve member 740. In particular, in some embodiments, the proximal portion of the post 720 can extend into the head portion 742 of the compressible valve member 740. In some embodiments, the post 720 can be press-fitted onto the support portion 760. However, the various embodiments of the present disclosure are not limited to the configurations mentioned above. In some embodiments, the post 720 can be fastened, attached, or otherwise coupled to the support portion 760 by any other suitable attachment means

[0170] In some embodiments, the column 720 can be in the form of an elongate tube having a proximal end 723, a distal end 725, and a lumen 722 extending therethrough. In some embodiments, the column 720 can have a shape that tapers from the distal end 725 to the proximal end 723 of the column 720. Thus, the shape or profile of the lumen 722 can also taper from the distal end 725 to the proximal end 723 of the column 720. As shown, the column 720 can extend from the lumen 716 of the second connector 712 into the internal chamber 748 of a compressible valve member 740 disposed within the inner lumen 738 of the first connector 730. The lumen 722 of the column 720 can define a flow path or microchannel along which fluid can flow from the second connector 712 to the fluid collection device 40. As shown, the column 720 can be mounted in the mounting hole 762 of the second connector support portion 760 and can fluidly couple the blood collection device 40 to the catheter assembly 50. For example, in some embodiments, the leg 72 of the Y - adapter 70 can be coupled to the flow restriction device 710. The leg 72 of the Y - adapter 70 can include a lumen in which the distal end 715 of the second connector 712 to which the column 720 is coupled can be mounted. The Y - adapter 70 can fluidly communicate the flow restriction device 710 and the column 720 mounted therein with the catheter assembly 50, for example, via the extension fitting 60. Thus, the lumen 722 of the column 720 can define a linear fluid channel having a diameter of reduced, small, or micro - sized dimensions (as described below) through which fluid entering the flow restriction device 710 from the catheter assembly 50 can flow through the flow restriction device 710 and be collected in the fluid collection device 40. For example, in the case where blood is drawn or collected from a patient, the medical fluid 15 is blood and the fluid collection device 40 can be a blood collection device. In some embodiments, the blood collection device 40 can be a Luer - lock access device (LLAD). Thus, during the collection or withdrawal of blood from a patient, the blood sample 15 can flow from the distal end 715 of the second connector 712 into the LLAD 40 via the flow path or microchannel defined by the lumen 722.

[0171] As described above, the column 720 can be an elongate thin tube, the lumen 722 of which has a diameter of small, reduced, or micro - sized dimensions. For example, in some embodiments, the lumen 722 of the column 720 defines a flow path or microchannel along which fluid can flow from the distal end 715 through the column 720 to the fluid collection device 40. The column 720 can define a lumen 722 formed by any length, diameter, and cross - sectional area, as described above with reference to the optimized fluid path.

[0172] To withdraw fluid (e.g., blood) from the catheter assembly 50, the fluid collection device 40 can be inserted into and coupled to the female Luer portion 732 of the first connector 730. In the coupling configuration of the first connector 730 and the fluid collection device 40, the compressible valve member 740 can be compressed distally by the fluid collection device 40 to place the proximal end 723 of the column 720 in fluid communication with the fluid collection device 40. For example, as the male Luer portion of the blood collection device 40 is inserted into the female Luer portion 732 of the first connector 730, the male Luer portion of the blood collection device 40 can move the head portion 742 of the valve member 740 and cause the valve member 740 to compress in the distal direction. As the head portion 642 is displaced distally, the proximal end 723 of the column 720 can be exposed to the exterior of the valve member 740 via the slot 750. Accordingly, the proximal end 723 of the column 720 can be fluidly coupled to the male Luer portion of the blood collection device 40 via the slot 750 of the compressible valve member 740.

[0173] In operation, during collection or withdrawal of blood from a patient's body, blood 15 can flow from the patient's vein into the catheter assembly 50, through the extension tubing 60, and into the distal end 715 of the second connector 712. Due to the presence of the column 720 in the lumen 716 of the second connector, the blood 15 can be forced to flow into and through the flow path or microchannel defined by the lumen 722 and exit the flow restrictor 710 into the blood collection device 40. Accordingly, during collection or withdrawal of blood from a patient's body, the blood 15 can flow through the flow path or microchannel of small diameter defined by the lumen 722 into the blood collection device 40. The flow restrictor 710 of the various embodiments described herein is superior to existing blood collection systems. For example, during blood withdrawal with an existing blood withdrawal device, as blood cells flow from the distal end to the proximal end of the blood collection system, they are subject to shear stress. The maximum shear stress can be along the wall of the blood cell, commonly referred to as wall shear stress. The wall shear stress on the blood cells is considered to be the main source of mechanical damage to the blood cells that causes hemolysis. In some embodiments, the continuous flow path or microchannel of minimum diameter defined by the lumen 722 can help increase the flow resistance within the vascular access system 100 to distribute the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15. For example, the minimum diameter of the flow path or microchannel defined by the lumen 722 can provide increased resistance to the flow of the blood 15, thereby reducing the blood flow rate within the flow restrictor 710. Because the reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of the blood 15, the risk of hemolysis during blood collection can be advantageously reduced.

[0174] Figure 9AFIG. 0 shows an exploded view of a vascular access device according to some embodiments of the present disclosure, the vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a fluid collection device. Figure 9B FIG. 1 is a schematic diagram of the operation of a vascular access device according to some embodiments of the present disclosure, the vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a fluid collection device. Figure 9C FIG. 2 is a schematic diagram of the operation of a vascular access device according to some embodiments of the present disclosure, the vascular access device including a peripheral intravenous catheter (PIVC) assembly having a flow restriction device and a needleless connector. Now referring to Figures 9A - 9C FIG. 3, there is shown a flow restriction device 1000 according to some embodiments. The flow restriction device 1000 can be configured to reduce the likelihood of hemolysis during blood collection using the vascular access device 200. In some embodiments, the vascular access device 200 can include a catheter assembly (e.g., a PIVC) 50. In some embodiments, the flow restriction device 1000 can include a distal end, which can include a body or a distal connector configured to be coupled to the catheter assembly 50. The distal connector can include a male Luer connector or other suitable connector.

[0175] In some embodiments, the catheter assembly 50 can include a catheter hub 52, which can include a distal end 54, a proximal end 56, and a lumen extending through the distal end and the proximal end. The catheter assembly 50 can further include a catheter 58, which can be fixed within the catheter hub 52 and can extend distally from the distal end 54 of the catheter hub 52. In some embodiments, the catheter can be a peripheral intravenous catheter (PIVC).

[0176] 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 include an extension tube 60, which can extend from a side port 59 of the catheter hub 52 and be integrated with the side port of the catheter hub. A non-limiting example of an integrated catheter assembly is the BD NEXIVA TM Closed IV catheter system, which is available from Becton Dickinson and Company. In some embodiments, the proximal end of the extension tube 60 can be coupled to an adapter 70, such as a Y-shaped adapter or a single-port Luer adapter. In some embodiments, the distal connector of the flow restriction device 1000 can be configured to be coupled to the Y-shaped adapter 70.

[0177] In some embodiments, the catheter assembly 50 may be non-integrated and may not include an extension tube 60. In these and other embodiments, the flow restriction device 1000 may be configured to be coupled to the proximal end 56 of the catheter hub 52 or another suitable portion of the catheter assembly 50. In some embodiments, the catheter assembly 50 may be coupled to a removable extension tube 60. In some embodiments, the flow restriction device 1000 may be directly coupled to a catheter adapter, eliminating the extension tube and providing a compact catheter system.

[0178] Figure 10A A perspective view of a flow restriction device 1100 in accordance with some embodiments of the present disclosure is shown. Figure 10B Shown are some embodiments in accordance with the present disclosure Figure 10A of a cross-sectional view of the flow restriction device 1100. As Figure 10A and 10B shown, continuing reference to Figure 9A and 9B , in some embodiments, the flow restriction device 1100 may include a male luer connector portion 1112 configured to be coupled to the catheter assembly 50. The male luer connector portion 1112 may have a proximal end 1114, a distal end 1116, and an inner surface 1118 defining an inner lumen 1120 of the male luer connector portion 1112. As shown, the male luer connector portion 1112 may further include a support portion 1160 disposed between the proximal end 1114 and the distal end 1116. The support portion 1160 may include a mounting hole 1165 extending therethrough.

[0179] In some embodiments, the flow restriction device 1100 may further include a female luer connector portion 1130 coupled to the proximal end 1114 of the male luer connector portion 1112. The female luer connector portion 1130 may be configured to be coupled to a fluid collection device 40 (e.g., a blood collection device). For example, the female luer connector portion 1130 may be integrated with the blood collection device 40 or formed as a single unit integrally with the blood collection device 40. As another example, the female luer connector portion 1130 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 1130 may have a proximal end 1131, a distal end 1133, and an inner surface 1132 defining a lumen 1134 extending therethrough for coupling to the male luer portion of the blood collection device 40. As shown, the female luer connector portion 1130 may further include a support portion 1162 disposed between the proximal end 1131 and the distal end 1133. The support portion 1162 may include a mounting hole 1167 extending therethrough.

[0180] According to various embodiments of the present disclosure, the flow restriction device 1110 may further include a fitting 1140 installed in at least one of the lumens 1120 and 1134 of the male Luer connector portion 1112 and the female Luer connector portion 1130. For example, in some embodiments, the fitting 1140 may be installed in at least one of the support portions 1160 and 1162. As shown, the fitting 1140 may be installed or otherwise supported in the support portions 1160 and 1162 and may extend from the support portion 1160 of the male Luer connector portion 1112 into the female Luer connector portion 1130. The fitting 1140 may have a proximal end 1143, a distal end 1145, and a lumen 1142 extending therethrough. The lumen 1142 may define a flow path or microchannel through which fluid may flow from the male Luer connector portion 1112 via the female Luer connector portion 1130 to the fluid collection device 40. As shown, the fitting 1140 may fluidly connect the catheter assembly 50 to the fluid collection device 40 via the flow restriction device 1100. For example, in some embodiments, the leg 72 of the Y-shaped adapter 70 may be coupled to the flow restriction device 1110. The leg 72 of the Y-shaped adapter 70 may include a lumen in which the distal end 1116 of the male Luer connector portion 1112 to which the fitting 1140 is coupled may be installed. The Y-shaped adapter 70 may fluidly connect the flow restriction device 1100 and the fitting 1140 installed therein to the catheter assembly 50, for example, via the extension fitting 60. Thus, the lumen 1142 of the fitting 1140 may define a fluid channel having a reduced, small, or micro-sized diameter (as described below) through which fluid entering the flow restriction device 1100 from the catheter assembly 50 may flow through the flow restriction device 1100 and thus be collected in the fluid collection device 40. For example, in the case where blood is drawn or collected from a patient's body, the medical fluid 15 is blood, and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a Luer lock access device (LLAD). Thus, during collection or withdrawal of blood from a patient's body, the blood sample 15 may flow from the distal end 1116 of the male Luer connector portion 1112 via the flow path or microchannel defined by the lumen 1142 to the LLAD 40.

[0181] In some embodiments, the flow path or microchannel defined by the lumen 1142 may have a helical shape, a coil shape, an S shape, or other suitable non-linear, wound shape. The advantage of the foregoing configuration is that, compared to a linear microchannel, the helical, coil, S-shaped, or other suitable non-linear, wound shape of the flow path or microchannel defined by the lumen 1142 - due to its winding characteristics - may increase the length of the fluid path defined by the flow path or microchannel defined by the lumen 1142.

[0182] In cases where the medical fluid is blood withdrawn or collected from a patient's body, the medical fluid can be a blood sample, 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). In cases where the medical fluid is blood withdrawn from a patient's body, as blood cells flow from the male luer connector portion 1112 of the flow restriction device 1100 to the female luer connector portion 1130, they are subject to wall shear stress. The wall shear stress on blood cells is considered to be the main source of mechanical damage to blood cells that causes hemolysis. In some embodiments, the flow restriction device 1110 having a non-linear, coiled flow path or microchannel defined by the lumen 1142 can help increase the flow resistance within the vascular access system 1100 to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood 15.

[0183] In some embodiments, the tubing 1140 can be a thin tube having a lumen with a small, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1142 of the tubing 1140 defines a first flow path or microchannel along which fluid can flow from the male luer connector portion 1112 through the female luer connector portion 1130 to the fluid collection device 40. The tubing 1140 can define a lumen 1142 formed by any one of the length, diameter, and cross-sectional area described above with reference to the optimized fluid path.

[0184] As previously described, when the fluid 15 is blood withdrawn from a patient's body, blood cells are subject to wall shear stress as they flow from the catheter assembly 50 to the blood collection device 40. For example, the maximum shear stress can be along the wall of the blood cell, commonly referred to as wall shear stress. In some embodiments, the lumen 1142 of the tubing 1140 having a reduced or micro-sized diameter can help increase the flow resistance within the vascular access system 1100 to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood 15. The minimum diameter of the first fluid path or microchannel defined by the lumen 1142 of the tubing 1140 can provide increased resistance to the flow of the blood 15, thereby reducing the blood flow rate within the flow restriction device 1110. Since the reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of the blood 15, the risk of hemolysis during blood collection can be advantageously reduced.

[0185] In some embodiments, at least a portion of the fitting 1140 can be a linear fitting 1146. For example, in some embodiments, the fitting 1140 can include at least one linear portion 1146 at its proximal and distal ends. As shown, the proximal end 1143 of the fitting 1140 and the distal end 1145 of the fitting 1140 can be formed by the linear fitting 1146. The linear fitting 1146 at the proximal end can be installed in the mounting hole 1167 of the support portion 1162, and the linear fitting 1146 at the distal end can be installed in the mounting hole 1165 of the support portion 1160. In some embodiments, the linear portion 1146 of the fitting 1140 can be in the form of a capillary tube having a lumen with a small, reduced, or micro-sized diameter. In some embodiments, the lumen 1142 of the fitting 1140 in the linear portion 1146 can have the same diameter as the above-described helical, coiled, S-shaped, or other suitable non-linear, wound flow paths or microchannels. Either the fitting 1140 or the linear portion 1146 can define a lumen formed by any one of length, diameter, and cross-sectional area, as described above with reference to the optimized fluid path.

[0186] As shown, helical, coiled, S-shaped, or other suitable non-linear, wound flow paths or microchannels can be disposed between the linear portions 1146 of the fitting 1140. Thus, during fluid extraction, such as blood extraction, blood withdrawn from the catheter assembly 50 can enter the micro-sized diameter lumen of the distal linear portion 1146 from the distal end 1116 of the male luer connector portion 1112, pass through the helical, spiral, S-shaped, or other suitable non-linear, wound flow path or microchannel of the lumen 1142, flow out of the micro-sized diameter lumen of the proximal linear portion 1146, and ultimately enter the blood collection device 40.

[0187] Figure 11A A perspective view of a flow restriction device 1200 in accordance with some embodiments of the present disclosure is shown. Figure 11B Shown are some embodiments in accordance with the present disclosure Figure 11ACross-sectional view of the flow restriction device 1200. The flow restriction device 1200 may be structurally similar to the flow restriction device 1100, except that the flow restriction device 1200 may not include the female Luer connector portion 1130. Instead, as shown, the proximal end 1231 of the male Luer connector portion 1212 may be open and include at least one thread 1230 on its outer surface for coupling to the blood collection device 40. Additionally, the flow restriction device 1200 differs from the flow restriction device 1100 in that the tube member 1240 may be a linear tube member. For example, in some embodiments, the linear tube member may be in the form of an intubation tube 1240 mounted in the male Luer connector portion 1212. Thus, the male Luer connector portion 1212 may further include a support portion 1260 that extends radially inward from the inner surface 1218 of the male Luer connector portion 1212 into the lumen 1220 of the male Luer connector portion 1212. As shown, the support portion 1260 may include a mounting hole 1262, and the intubation tube 1240 may be mounted in the mounting hole 1262 to fluidly connect the male Luer connector portion 1212 to the fluid collection device 40. In some embodiments, the intubation tube 1240 may be press-fitted into the support portion 1260. However, the various embodiments of the present disclosure are not limited to the foregoing configuration, and the intubation tube may be attached by any other suitable fastening means, such as welding.

[0188] In some embodiments, the intubation tube 1240 may be an elongated thin tube having a lumen with a small, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1242 of the intubation tube 1240 may define a flow path or microchannel through which fluid may flow from the distal end 1216 into the fluid collection device 40. The intubation tube 1240 may define a lumen 1242 formed by any length, diameter, and cross-sectional area, as described above with reference to the optimized fluid path.

[0189] Thus, during blood collection or blood drawing from a patient's body, blood 15 can flow into the blood collection device 40 via a flow path or microchannel having a small diameter defined by the lumen 1242. The flow restriction devices 1210 of the various embodiments described herein are superior to existing blood collection systems. For example, during blood drawing with an existing blood drawing device, as blood cells flow from the distal end to the proximal end of the blood collection system, they are subject to wall shear stress. Wall shear stress on blood cells is considered to be a major source of mechanical damage to blood cells that causes hemolysis. The flow path or microchannel having a minimum diameter defined by the lumen 1242 can help increase the flow resistance within the vascular access system to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood 15. For example, the minimum diameter of the flow path or microchannel defined by the lumen 1242 can provide increased resistance to the flow of blood 15, thereby reducing the blood flow rate within the flow restriction device 1210. Since the reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of the blood 15, the risk of hemolysis during blood collection can be advantageously reduced.

[0190] Figure 12A A perspective view of a flow restriction device 1300 in accordance with some embodiments of the present disclosure is shown. FIG. 12 shows a Figure 12A perspective view of the insert 1350 of the flow restriction device in accordance with some embodiments of the present disclosure. FIG. 12 shows a Figure 12A cross-sectional view of the flow restriction device 1300 in accordance with some embodiments of the present disclosure.

[0191] As Figures 12A - 12C shown, continuing to refer to Figure 9A and 9B , in some embodiments, the flow restriction device 1300 can include a distal connector 1312 configured to be coupled to the catheter assembly 50. The distal connector 1312 can have a proximal end 1314 including a first connection portion 1315 and a distal end 1316 including a second connection portion 1317. The first connection portion 1315 can have an inner surface 1318 defining a lumen 1322 therethrough, and the second connection portion 1317 can have an inner surface 1319 defining a lumen 1320 therethrough. As shown, the distal connector 1312 can further include a support portion 1325 disposed between the proximal end 1314 and the distal end 1317. The support portion 1325 can include a mounting hole 1354 recessed therein.

[0192] In some embodiments, the flow restriction device 1300 may further include a proximal connector 1330 that is coupled to the proximal end 1314 of the distal connector 1312. The proximal connector 1330 may be configured to be coupled to a fluid collection device 40 (e.g., a blood collection device). For example, the proximal connector 1330 may be integrated with the blood collection device 40 or formed as a single unit integrally with the blood collection device 40. As another example, the proximal connector 1330 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 proximal connector 1330 may have a proximal end 1331, a distal end 1333, and an inner surface 1332 that defines a lumen 1334 extending therethrough for coupling to the male luer portion of the blood collection device 40.

[0193] According to various embodiments of the present invention, the flow restriction device 1300 may further include an insert 1350 that is mounted in the lumen 1322 of the first connection portion 1315 and disposed between the proximal connector 1330 and the distal connector 1312. As shown, the insert 1350 may have an outer surface 1360 that has a groove 1364 recessed therein. The groove 1364 may extend at least partially along the length of the outer surface 1360 and may be fluidly coupled to the lumen 1320 of the second connection portion 1317 and the lumen 1322 of the first connection portion 1315. In some embodiments, the groove 1364 may be a linear groove recessed in the outer surface 1360. For example, in some embodiments, the linear groove 1364 may be recessed in the upper portion of the outer surface 1360.

[0194] Continuing to refer Figure 12B , as Figure 12C shown, the insert 1350 may include a first channel segment 1372 fluidly coupled to the proximal end of the lumen 1320 of the second connection portion 1317, and a second channel segment 1374 that extends from the first channel segment to the linear groove 1364. The first and second channel segments 1372 and 1374 and the linear groove 1364 may together define a fluid channel 1380 along which fluid flows from the distal connector 1312 via the proximal connector 1330 to the fluid collection device 40. In some embodiments, the first channel segment 1372 and the linear groove 1364 may be offset from each other in position. For example, as Figure 12C shown, in some embodiments, the first channel segment 1372 may be located at a first height and the linear groove 1364 may be located at a second height. In some embodiments, the second height may be greater than the first height, i.e., the linear groove 1364 may be located above or higher than the first channel segment 1372.

[0195] In some embodiments, the second channel segment 1374 can be in the form of an inclined surface that connects or otherwise fluidly couples the first channel segment 1372 to the linear groove 1364. For example, as shown, the second channel segment 1374 can be positioned between the first channel segment 1372 and the linear groove 1364 and connect them.

[0196] In some embodiments, the first connection portion 1315 can form an external component for coupling with the insert 1350, and the insert 1350 can form an internal component having a fluid channel 1380 (defined by the first and second channel segments 1372 and 1374 and the linear groove 1364), and the insert can be coupled in the lumen 1322 of the first connection portion 1315. Thus, the linear groove 1364 can be surrounded, enclosed, or otherwise encapsulated by the lumen of the first connection portion 1315. When the linear groove 1364 is surrounded, inserted, or otherwise encapsulated by the inner surface 1318 of the first connection portion 1315 in the lumen 1322, the linear groove can define a microchannel fluid path through which fluid (e.g., blood) flows from the second connection portion 1317 to the first connection portion 1315 for collection in the fluid collection device 40.

[0197] In some embodiments, the flow path or microchannel along which fluid flows from the second connection portion 1317 to the first connection portion 1315 for collection in the fluid collection device 40 can be defined by any one of the length, diameter, and cross-sectional area as described above with reference to the optimized fluid path.

[0198] Thus, during blood collection or blood drawing from a patient's body, the blood 15 can flow through a flow path or microchannel having a small diameter defined by the enclosed groove 1364 into the blood collection device 40. The flow restriction device 1300 of the various embodiments described herein is superior to existing blood collection systems. For example, during blood drawing with an existing blood drawing device, as blood cells flow from the distal end to the proximal end of the blood collection system, they are subject to wall shear stress. As described above, the wall shear stress on blood cells is considered to be the main source of mechanical damage to blood cells causing hemolysis. The flow path or microchannel having a minimum diameter defined by the enclosed groove 1364 can help increase the flow resistance within the vascular access system to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood 15. For example, the minimum diameter of the flow path or microchannel defined by the enclosed groove 1364 can provide increased resistance to the flow of the blood 15, thereby reducing the blood flow rate within the flow restriction device 1210. Since the reduced blood flow rate results in a reduced shear stress experienced by the red blood cells of the blood 15, the risk of hemolysis during blood collection can be advantageously reduced.

[0199] According to various embodiments of the present disclosure, for example as Figure 12B depicted in, the outer surface 1360 of the insert 1350 may include a longitudinally extending flange 1362 that is disposed on the outer surface 1360 and extends at least partially along the length of the outer surface. As shown, the flange 1362 may be positioned at opposite edges of the linear groove 1364 for sealing the edges. In some embodiments, the longitudinally extending flange 1362 may define the groove 1364 such that fluid flowing through the continuous channel or groove 1364 may not spill out of the continuous channel or groove 1364 except at the distal end 1354 and the proximal end 1352 of the groove 1364. In some embodiments, the longitudinally extending flange 1362 may be a sealing element, which may include silicon, rubber, plastic, or other suitable materials. Thus, the longitudinally extending flange 1362 may prevent fluid from spilling out of the continuous channel or groove 1364 except at the distal end 1354 and the proximal end 1352 of the groove 1364.

[0200] According to various embodiments, the proximal end of the groove 1364 may be fluidly connected to the lumen 1334 of the proximal connector for drawing a medical fluid into a fluid collection device 40 coupled to the proximal connector. Similarly, in some embodiments, the distal end 1354 of the groove 1364 may be fluidly connected to the lumen 1320 of the second connection portion 1317 to receive a medical fluid from the catheter assembly 50. In the case where the medical fluid is blood drawn or collected from a patient's body, the medical fluid may be a blood sample, and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a Luer lock access device (LLAD).

[0201] Figure 13A A perspective view of a flow restriction device according to some embodiments of the present disclosure is shown. Figure 13B A perspective view of a Figure 13A proximal connector of the flow restriction device according to some embodiments of the present disclosure is shown. Figure 13C A perspective view of a Figure 13A cross-sectional view of the flow restriction device according to some embodiments of the present disclosure is shown.

[0202] As Figures 13A - 13C shown in, continuing to refer to Figure 9A and 9B, in some embodiments, the flow restriction device 1400 may include a distal connector 1412 and a proximal connector 1430. The distal connector is configured to be coupled to the catheter assembly 50, and the proximal connector is coupled to the distal connector 1412 and is configured to be coupled to the fluid collection device 40. Thus, during fluid withdrawal (e.g., blood withdrawal), fluid can flow from the catheter assembly 50 into the flow restriction device 1400 (e.g., via the extension fitting 60) and out of the flow restriction device 1400 into the blood collection device 40. In some embodiments, the distal connector 1412 may include a first connection portion 1434 at its proximal end and a second connection portion 1416 at its distal end. As shown, the first connection portion 1434 may be in the form of a cylindrical body having an inner surface 1414 that defines the lumen 1418 of the distal connector 1412. The lumen 1418 may be configured such that at least a portion of the proximal connector 1430 can be inserted, mated, or otherwise coupled therein to fluidly couple the distal connector 1412 and the proximal connector 1430. For example, in some embodiments, the proximal connector 1430 may include an insertion portion 1450 for insertion into the lumen 1418 of the first connection portion 1434. As shown, the outer surface 1420 of the insertion portion 1450 may include a continuous non-linear channel 1425 recessed therein. In the coupled or assembled configuration of the distal connector 1412 and the proximal connector 1430, the inner surface 1414 of the first connection portion 1434 may surround, encircle, or otherwise enclose the outer surface 1420 of the insertion portion 1450 such that the continuous non-linear channel 1425 and the inner surface 1414 of the first connection portion 1434 define a non-linear fluid path along which fluid (e.g., blood) can flow from the distal connector 1412 through the proximal connector 1430 into the fluid collection device 40.

[0203] In some embodiments, the continuous non-linear channel 1425 may form a coil shape, an S shape, or other suitable non-linear winding shape. For example, the continuous non-linear channel 1425 may have a coil shape (which may include a helix) recessed in the outer surface 1420 of the insertion portion 1450. In some embodiments, the continuous non-linear channel 1425 may have an S shape recessed in the outer surface 1420 of the insertion portion 1450. The advantage of the foregoing configuration is that the spiral shape, coil shape, S shape, or other suitable non-linear winding shape of the continuous non-linear channel 1425 - due to its winding around the outer surface 1420 of the insertion portion 1450 - can increase the length of the fluid path through which the medical fluid defined by the continuous non-linear channel 1425 flows.

[0204] In some embodiments, the continuous non-linear channel 1425 may have a small, reduced, or micro-sized diameter. For example, in some embodiments, the continuous non-linear channel 1425 defines a flow path or microchannel along which fluid may flow from the distal connector 1416 through the proximal connector 1430 into the fluid collection device 40. The continuous non-linear channel 1425 may define a flow path or microchannel formed by any one of the length, diameter, and cross-sectional area as described above with reference to the optimized fluid path.

[0205] As previously described, when the fluid 15 is blood drawn from a patient's body, blood cells may be subject to wall shear stress as the blood cells flow from the catheter assembly 50 into the blood collection device 40. For example, the maximum shear stress may be along the wall of the blood cells, which is commonly referred to as wall shear stress. The continuous non-linear channel 1425 having a reduced or micro-sized diameter may help increase the flow resistance within the vascular access system to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood 15. The minimum diameter of the continuous non-linear channel 1425 may provide increased resistance to the flow of the blood 15, thereby reducing the blood flow rate within the flow restriction device 1400. Since the reduced blood flow rate results in a decrease in the shear stress experienced by the red blood cells of the blood 15, the risk of hemolysis during blood collection can be advantageously reduced. In the case where the medical fluid is blood drawn or collected from a patient's body, the medical fluid may be a blood sample, and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a Luer lock access device (LLAD).

[0206] Figure 14A A perspective view of a flow restriction device according to some embodiments of the present disclosure is shown. Figure 14B A perspective view of a flow restriction device according to some embodiments of the present disclosure is shown. Figure 14A An exploded view of the flow restriction device of is shown. As Figure 14A and 14B shown, continuing to refer to Figure 9A and 9B, in some embodiments, the flow restriction device 1500 may include a connector 1505 having a body portion 1510 and a base portion 1545. The body portion has a lumen 1538 and is disposed at the proximal end, and the base portion has a lumen 1518 and is disposed at the distal end. The body portion 1510 may be configured to be coupled to the fluid collection device 40. In some embodiments, the flow restriction device 1500 may further include a compressible valve member 1540 mounted on the base portion 1545 and extending into the lumen 1538 of the body portion 1510. The compressible valve member 1540 may include an inner surface 1541 that defines an internal chamber 1543 of the compressible valve 1540. As shown, the compressible valve member 1540 may have a head portion 1542 including a slot 1550 and a body portion 1544 extending distally from the head portion 1542. In some embodiments, the body portion 1544 may have an accordion shape or any other similar compressible or foldable shape. In some embodiments, the head portion 1542 having the slot 1550 may be a split diaphragm head portion.

[0207] According to various embodiments of the present disclosure, the flow restriction device 1500 may further include a post 1520 having a lumen 1522 extending therethrough. The post 1520 may be mounted in the lumen 1518 of the base portion and extend into the internal chamber 1543 of the compressible valve member 1540. Thus, the compressible valve member 1540 may be mounted around the post 1520. The post 1520 may be configured to be in fluid communication with the conduit assembly 50. In some embodiments, the post 1520 may be press-fitted into the lumen 1518 of the base portion 1545. However, the various embodiments of the present disclosure are not limited to the foregoing configuration. In some embodiments, the post 1520 may be fastened, attached, or otherwise coupled in the lumen 1518 of the base portion 1545 by any other suitable coupling means.

[0208] In some embodiments, the column 1520 can be in the form of an elongated tube having a proximal end 1523, a distal end 1525, and a lumen 1522 extending therethrough. In some embodiments, the column 1520 can have a shape that tapers from the distal end 1525 to the proximal end 1523 of the column 1520. Accordingly, the shape or profile of the lumen 1522 can also taper from the distal end 1525 to the proximal end 1523 of the column 1520. As shown, the column 1520 can extend from the distal end 1523 into the internal chamber 1541 of a compressible valve member 1540 disposed within the inner lumen 1538 of the body portion 1510. The lumen 1522 of the column 1520 can define a flow path or microchannel along which fluid can flow from the distal end 1525 into the fluid collection device 40. The column 1520 can be mounted in a mounting hole of a support portion (not shown) of the base portion 1545 and can fluidly couple the blood collection device 40 to the catheter assembly 50. For example, continuing to refer to Figure 9A and 9B , in some embodiments, the legs 72 of the Y-shaped adapter 70 can be coupled to the flow restriction device 1500. The legs 72 of the Y-shaped adapter 70 can include lumens into which the distal end 1525 of the column 1520 can be coupled. The Y-shaped adapter 70 can fluidly communicate the flow restriction device 1500 having the column 1520 with the catheter assembly 50, for example, via the extension fitting 60. Accordingly, the lumen 1522 of the column 1520 can define a linear fluid path having a reduced, smaller, or micro-sized diameter (as discussed below) through which fluid entering the flow restriction device 1500 from the catheter assembly 50 can flow through the flow restriction device 1500 for collection in the fluid collection device 40. For example, in the case of withdrawing or collecting blood from a patient's body, the medical fluid 15 can be blood, and the fluid collection device 40 can be a blood collection device. In some embodiments, the blood collection device 40 can be a luer lock access device (LLAD) or a syringe. Thus, during the process of collecting or withdrawing blood from a patient's body, the blood sample 15 can flow from the distal end 1525 of the column 1520 and into the LLAD 40 via the flow path or microchannel defined by the lumen 1522.

[0209] As described above, the column 1520 can be an elongated thin tube, where the lumen 1522 has a smaller, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1522 of the column 1520 (which defines the flow path or microchannel along which fluid can flow from the distal end 1525 into the fluid collection device 40) can be formed by any one of the length, diameter, and cross-sectional area as described above with reference to the optimized fluid path.

[0210] To withdraw fluid (e.g., blood) from the catheter assembly 50, the fluid collection device 40 can be inserted and coupled to the inlet 1534 of the body portion 1510. In the coupling configuration of the body portion 1510 and the fluid collection device 40, the compressible valve member 1540 can be compressed distally by the fluid collection device 40 to place the proximal end 1523 of the column 1520 in fluid communication with the fluid collection device 40. For example, when the male Luer portion of the blood collection device 40 is inserted into the inlet 1534 of the body portion, the male Luer portion of the blood collection device 40 can cause the head portion 1542 of the valve member 1540 to move or otherwise displace and cause the valve member 1540 to compress in the distal direction. As the head portion 1542 is displaced distally, the proximal end 1523 of the column 1520 can be exposed to the exterior of the valve member 1540 via the slot 1550. Accordingly, the proximal end 1523 of the column 1520 can be fluidly coupled to the male Luer portion of the blood collection device 40 via the slot 1550 of the compressible valve member 1540.

[0211] In operation, during blood collection or blood withdrawal from a patient, blood 15 can flow from the patient's vein into the catheter assembly 50, through the extension tube 60, and into the distal end 1525 of the column 1540. Due to the presence of the column 1520 within the lumen 1543 of the base 1545, the blood 15 can be forced to flow into and through the flow path or microchannel defined by the lumen 1522 and out of the flow restriction device 1500 via the proximal end 1523 of the column 1520 and into the blood collection device 40. Accordingly, during blood collection or blood withdrawal from a patient, the blood 15 can flow into the blood collection device 40 via the flow path or microchannel defined by the lumen 1522 having a minimum diameter. The flow restriction device 1500 of the various embodiments described herein is superior to currently available blood collection systems. For example, during blood withdrawal using currently available blood withdrawal devices, when blood cells flow from the distal end to the proximal end of the blood collection system, the blood cells can be subjected to shear stress. The maximum shear stress can be along the wall of the blood cell, which is commonly referred to as wall shear stress. The wall shear stress on the blood cells is considered to be the main source of mechanical damage to the blood cells that causes hemolysis of the blood cells. In some embodiments, the continuous flow path or microchannel defined by the lumen 1522 having a minimum diameter can help increase the flow resistance within the vascular access system to distribute the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15. For example, the minimum diameter of the flow path or microchannel defined by the lumen 1522 can provide increased resistance to the flow of the blood 15, thereby reducing the blood flow rate within the flow restriction device 1500. Because the reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of the blood 15, the risk of hemolysis during blood collection can be advantageously reduced.

[0212] Figure 14C Shows a cross-sectional view of a flow restriction device according to some embodiments of the present disclosure. Figure 14D Shows a cross-sectional view of a flow restriction device when coupled to a fluid collection device. As Figure 14C and 14D shown, with continued reference to Figure 9A and 9B , in some embodiments, the flow restriction device 1503 may include a connector 1506 having a female Luer portion 1532 and a male Luer portion 1512. The female Luer portion has a lumen 1539 and is disposed at the proximal end, and the male Luer portion has a lumen 1519 and is disposed at the distal end. The female Luer portion 1532 may be configured to couple to a fluid collection device 40, while the male Luer portion 1512 may be configured to couple to a catheter assembly 50. In some embodiments, the flow restriction device 1503 may further include a compressible valve member 1540 mounted in the lumen 1539 of the female Luer portion 1532 and fluidly coupled to the lumen 1519 of the male Luer portion 1545. The compressible valve member 1540 may include an inner surface 1541 that defines an internal chamber 1543 of the compressible valve member 1540. As shown, the compressible valve member 1540 may have a head portion 1542 including a slot 1550 and a body portion 1544 extending distally from the head portion 1542. In some embodiments, the body portion 1544 may have an accordion shape or any other similar compressible or foldable shape. In some embodiments, the head portion 1542 having the slot 1550 may be a split diaphragm head portion.

[0213] According to various embodiments of the present disclosure, the flow restriction device 1503 may further include a post 1520 mounted in the female Luer portion 1532 and extending into the internal chamber 1543 of the compressible valve member. Thus, the compressible valve member 1540 may be mounted around the post 1520. The post 1520 may be in fluid communication with the lumen 1519 of the male Luer portion 1512, which in turn may be in fluid communication with the catheter assembly 50. In some embodiments, the post 1520 may be press-fit into the lumen 1539 of the female Luer portion 1532. However, the various embodiments of the present disclosure are not limited to the foregoing configuration. In some embodiments, the post 1520 may be fastened, attached, or otherwise coupled in the lumen 1539 of the female Luer portion 1532 by any other suitable connection means. In some embodiments, the female Luer portion 1532 may further include a support portion 1546 at its distal end. The post 1520 may be mounted on the support portion 1546 for fluid communication between the lumen 1519 of the male Luer portion 1512 and the fluid collection device 40.

[0214] In some embodiments, the column 1520 can be in the form of an elongate tube having a proximal end 1523, a distal end 1525, and a lumen 1522 extending therethrough. In some embodiments, the column 1520 can have a shape that tapers from the distal end 1525 to the proximal end 1523 of the column 1520. Thus, in some embodiments, the shape or profile of the lumen 1522 can also taper from the distal end 1525 to the proximal end 1523 of the column 1520. As shown, the column 1520 can extend from the distal end 1523 into an internal chamber 1541 of a compressible valve member 1540 that is disposed within a lumen 1539 of the body portion 1532. The lumen 1522 of the column 1520 can define a flow path or microchannel along which fluid can flow from the distal end 1525 into the fluid collection device 40. The column 1520 can fluidly couple the blood collection device 40 to the catheter assembly 50 via the lumen 1519 of the male Luer portion 1512. For example, continuing to refer Figure 9A and 9B , in some embodiments, the legs 72 of the Y-shaped adapter 70 can be coupled to the flow restriction device 1503. The legs 72 of the Y-shaped adapter 70 can include lumens into which the distal end 1516 of the male Luer connector portion 1512 can be coupled. The Y-shaped adapter 70 can fluidly communicate the flow restriction device 1503 having the column 1520 with the catheter assembly 50, for example, via the extension fitting 60. Thus, the lumen 1522 of the column 1520 can define a linear fluid path having a reduced, smaller, or micro-sized diameter (as discussed below) through which fluid entering the flow restriction device 1503 from the catheter assembly 50 can flow through the flow restriction device 1500 for collection in the fluid collection device 40. For example, in the case of withdrawing or collecting blood from a patient's body, the medical fluid 15 can be blood, and the fluid collection device 40 can be a blood collection device. In some embodiments, the blood collection device 40 can be a Luer lock access device (LLAD). Thus, during the process of collecting or withdrawing blood from a patient's body, the blood sample 15 can flow from the distal end 1525 of the column 1520 and into the LLAD 40 via the flow path or microchannel defined by the lumen 1522.

[0215] As described above, the column 1520 can be an elongate thin tube, wherein the lumen 1522 has a smaller, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1522 of the column 1520 (which defines a flow path or microchannel along which fluid can flow from the distal end 1525 into the fluid collection device 40) can be formed by any one of the length, diameter, and cross-sectional area as described above with reference to the optimized fluid path.

[0216] To withdraw fluid (e.g., blood) from the catheter assembly 50, the fluid collection device 40 can be inserted and coupled to the inlet 1535 of the female Luer portion 1532. In the coupling configuration between the female Luer portion 1532 and the fluid collection device 40, the compressible valve member 1540 can be compressed distally by the fluid collection device 40 to place the proximal end 1523 of the column 1520 in fluid communication with the fluid collection device 40. For example, when the male Luer portion 1502 of the blood collection device 40 is inserted into the inlet 1535 of the female Luer portion 1532, the male Luer portion 1502 of the blood collection device 40 can cause the head portion 1542 of the valve member 1540 to move or otherwise be displaced and result in compression of the valve member 1540 in the distal direction. When the head portion 1542 is displaced distally, the proximal end 1523 of the column 1520 can be exposed to the inlet of the male Luer portion 1502 of the blood collection device 40 via the slot 1550. Accordingly, the proximal end 1523 of the column 1520 can be fluidly coupled to the male Luer portion of the blood collection device 40 via the slot 1550 of the compressible valve member 1540.

[0217] In operation, during the process of collecting or withdrawing blood from a patient, blood 15 can flow from the patient's vein into the catheter assembly 50, through the extension fitting 60, and enter the lumen 1519 at the distal end 1516 of the male Luer portion 1512 of the flow restriction device 1503. Then, the blood 15 can flow proximally towards the female Luer portion 1532. Due to the presence of the column 1520 in the lumen 1543 of the base 1545, the blood 15 can be forced into the distal end 1525 of the column 1540 and flow through the flow path or microchannel defined by the lumen 1522 and leave the flow restriction device 1503 via the proximal end 1523 of the column 1520 and enter the blood collection device 40. Thus, during the process of collecting or withdrawing blood from a patient, the blood 15 can flow into the blood collection device 40 via the flow path or microchannel defined by the lumen 1522 having the smallest diameter. The flow restriction devices 1503 of various embodiments described herein are superior to currently existing blood collection systems. For example, during blood withdrawal using currently existing blood withdrawal devices, when blood cells flow from the distal end to the proximal end of the blood collection system, the blood cells may be subject to shear stress. The maximum shear stress can be along the wall of the blood cell, which is generally referred to as the wall shear stress. The wall shear stress on the blood cells is considered to be the main source of mechanical damage to the blood cells that causes hemolysis of the blood cells. In some embodiments, the continuous flow path or microchannel defined by the lumen 1522 having the smallest diameter can help increase the flow resistance within the vascular access system to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood 15. For example, the smallest diameter of the flow path or microchannel defined by the lumen 1522 can provide increased resistance to the flow of the blood 15, thereby reducing the blood flow rate within the flow restriction device 1503. Since the reduced blood flow rate results in a decrease in the shear stress experienced by the red blood cells of the blood 15, the risk of hemolysis during blood collection can be advantageously reduced.

[0218] Figure 15A FIG. shows a cross-sectional view of a flow restriction device 1600 in a fluid withdrawal position according to some embodiments of the present disclosure. Figure 15B FIG. shows some embodiments according to the present disclosure Figure 15A of the flow restriction device 1600 in a fluid infusion position in a cross-sectional view. Figure 15C FIG. shows some embodiments according to the present disclosure Figure 15A of a flow restriction column or fitting 1620 of the flow restriction device in a perspective view. Figure 15D FIG. shows some embodiments according to the present disclosure Figure 15A of a slider 1650 of the flow restriction device in a cross-sectional view. As Figures 15A - 15E shown in, with continued reference to Figure 9A and 9B, in some embodiments, the flow restriction device 1600 may include a housing 1610 having a proximal end 1612 and an inner surface 1614 that defines an internal chamber 1616 of the housing 1610. In some embodiments, the internal chamber 1616 of the housing 1610 may be fluidly coupled to a reciprocating flow connector 1640, such as but not limited to a needleless connector. The flow restriction device 1600 may further include a male Luer portion 1660 that defines a distal end 1617 of the housing 1610. The male Luer portion 1660 may have a lumen that is in fluid communication with the internal chamber 1616. In some embodiments, a slider 1650 may be reciprocally mounted within the internal chamber 1616. As shown, the slider 1650 may have a proximal end 1624, a proximal face 1662, a distal end 1622, a mounting hole 1655 that extends from the proximal end 1624 to the distal end 1622 of the slider 1650, and a plurality of flow holes 1656 that extend from the proximal end 1624 to the distal end 1622 of the slider 1650 and surround the mounting hole 1655. In some embodiments, the plurality of flow holes 1656 may be at least four flow holes 1656. However, the various embodiments of the present disclosure are not limited to the foregoing configurations. In some embodiments, there may be fewer than four flow holes 1656, but more than one flow hole 1656. In some embodiments, the plurality of flow holes 1656 may extend longitudinally around an outer perimeter 1652 of the slider 1650. For example, in some embodiments, the plurality of flow holes 1656 may extend longitudinally around the outer perimeter 1652 of the slider 1650. In some embodiments, the slider 1650 may be formed of a polyisopropene sealing material.

[0219] As Figure 15A and 15B depicted in, the flow restriction device 1600 may further include a flow restriction column in the form of a tube member 1620 having an inner surface 1628 that defines a lumen 1625 that extends between a proximal end 1627 and a distal end 1626 of the tube member 1620. The tube member 1620 may be mounted within the mounting hole 1655 and may extend distally from the proximal end 1624 of the slider 1650 through the distal end 1622 of the slider assembly 1650. According to some embodiments of the present disclosure, the lumen 1625 may define a flow path or microchannel along which fluid (e.g., blood) may flow from the internal chamber 1616 into the fluid collection device 40, such as via the connector 1640.

[0220] In some embodiments, the leg 72 of the Y-shaped adapter 70 can be coupled to the flow restriction device 1600. For example, the leg 72 of the Y-shaped adapter 70 can include a lumen into which the distal end 1617 of the housing 1610 of the fitting 1620 can be coupled, where the fitting 1620 is mounted. The Y-shaped adapter 70 can fluidly couple the flow restriction device 110 and the fitting 1620 mounted therein to the catheter assembly 50, for example, via the extension fitting 60. Thus, the lumen 1625 of the fitting 1620 can define a linear fluid path having a reduced, smaller, or micro-sized diameter (as discussed below) through which fluid entering the flow restriction device 1600 from the catheter assembly can flow through the flow restriction device 1600 and be collected in the fluid collection device 40. For example, in the case of withdrawing or collecting blood from a patient's body, the medical fluid 15 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). Thus, during the process of collecting or withdrawing blood from a patient's body, the blood sample 15 can flow from the distal end 1617 of the housing 1610 into the LLAD 40 via the flow path or microchannel defined by the lumen 1625.

[0221] In some embodiments, at least a portion of the fitting 1620 can be in the form of a longitudinal body that extends uniformly within the internal chamber 1616 of the housing 1610. In some embodiments, at least one of the diameter of the fitting at its proximal end 1627 and the diameter of the fitting at its distal end 1626 is greater than the diameter of the portion L of the fitting 1620 that includes the longitudinal body extending uniformly within the internal chamber 1616 of the housing 1610. For example, in some embodiments, the fitting 1620 flares radially outward from the portion L of the fitting 1620 that includes the longitudinal body extending uniformly within the internal chamber 1616 of the housing 1610 to at least one of the proximal end 1627 and the distal end 1626 of the fitting 1620.

[0222] In some embodiments, the portion L of the fitting 1620 that includes the longitudinal body extending uniformly within the internal chamber 1616 of the housing 1610 can be an elongated thin tube, where the lumen 1625 has a smaller, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1625 of the portion L of the fitting 1620 (which defines the flow path or microchannel along which fluid can flow from the distal end 1617, for example, via the connector 1640, into the fluid collection device 40) can be formed by any one of the length, diameter, and cross-sectional area as described above with reference to the optimized fluid path.

[0223] According to various embodiments of the present disclosure, the flow restriction device 1600 may further include a spring member 1630 mounted within the internal chamber 1616, the spring member surrounding at least a portion of the tube member 1620. Accordingly, the tube member 1620 may be spring-loaded by the spring member 1630. In operation, during blood withdrawal or very light infusion, when the slider 1650 is under withdrawal pressure or very light infusion pressure, the spring member 1630 in its extended / uncompressed state applies a force to bias the proximal end 1624 of the slider 1650 proximally against the inner surface 1614 of the housing 1610. Accordingly, the proximal end 1624 of the slider 1650 and the plurality of flow holes 1656 will remain sealed against the inner surface 1614 of the housing, thereby blocking fluid flowing into the connector 1640 via the plurality of flow holes 1656. Since the fluid path between the plurality of flow holes 1656 and the connector 1640 is blocked, during blood withdrawal, blood entering the lumen 1618 of the male luer portion 1660 of the flow restriction device 1600 can only flow into the connector 1640 through the lumen 1625 of the tube member 1620.

[0224] When the fluid 15 is blood withdrawn from a patient's body, blood cells may be subject to shear stress when flowing from the catheter assembly 50 into the blood collection device 40. For example, the maximum shear stress may be along the wall of the blood cell, which is commonly referred to as the wall shear stress. The wall shear stress on the blood cells is considered to be the main source of mechanical damage to the blood cells that causes hemolysis of the blood cells. The lumen 1625 of the tube member 1620 having a reduced or micro-sized diameter may contribute to increasing the flow resistance within the vascular access system to distribute the pressure differential and reduce the shear stress experienced by the red blood cells of the blood 15. The minimum diameter of the first fluid path or microchannel defined by the lumen 1625 of the tube member 1620 may provide increased resistance to the flow of the blood 15, thereby reducing the blood flow rate within the flow restriction device 1600. Since the reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells of the blood 15, the risk of hemolysis during blood collection can be advantageously reduced.

[0225] When the slider 1650 is subjected to fluid pressure in the distal direction, such as infusion pressure, the infusion fluid, such as intravenous (IV) fluid, will initially flow from the connector 1640 through the lumen 1625 of the tube member 1620 into the internal chamber 1616 of the housing. As the infusion pressure increases, the slider 1650 can be configured to move distally away from the inner surface 1614 of the housing 1610 and compress the spring member 1630. As shown, each of the plurality of holes 1656 and the inner surface 1614 of the internal chamber 1616 can define a flow path through which fluid (such as intravenous (IV) fluid) flows from the connector into the lumen of the male Luer portion 1660 when the slider 1650 is subjected to fluid pressure in the distal direction. Due to the separation of the proximal end 1624 of the slider from the inner surface 1614 of the housing 1610, the flow path through the plurality of flow holes 1656 is opened. Thus, fluid (such as infusion fluid) can flow from the connector 1640 through the lumen 1625 of the tube member 1620 and the plurality of secondary flow holes 1656 into the lumen 1618 of the male Luer portion 1660.

[0226] Thus, the spring member 1630 biases the slider 1650 in which the tube member 1620 is mounted and seals against the inner surface of the housing 1610 such that at a slight vacuum (i.e., suction) and a very light infusion pressure, fluid will flow through the tube member 1620 having a lumen 1625 defining a microchannel. The initial burst of flushing will also flow through the tube member 1620 having a lumen 1625 defining a microchannel, enabling some higher pressure flushing. When the infusion pressure becomes greater, the spring member 1630 can be compressed by the distal movement D of the slider 1650, and the plurality of flow holes 1656 are opened around the outer diameter of the slider, such that a plurality of flow paths (i.e., the flow paths through the lumen 1625 of the tube member 1620 and the plurality of flow holes 1656) are opened for flushing or infusion. Thus, it is fully possible to flush all fluid paths.

[0227] Figure 16A A blood collection system 1700 is shown in accordance with some embodiments of the present disclosure. Figure 16B A blood collection system 1700 is shown in accordance with some embodiments of the present disclosure. According to various embodiments of the present disclosure, the blood collection system 1700 can include a blood collection device 1702 that includes a container 1710 having an outer surface 1714, an inner surface 1722 defining an internal chamber 1750, a needle 1730 extending proximally from the inner surface 1722, and a connection portion 1720 extending distally from the outer surface 1714. In some embodiments, the blood collection device 1702 can be a Luer lock access device (LLAD). In some embodiments, the blood collection device 1702 can include one available from Becton Dickinson & Company Blood collection tube.

[0228] In some embodiments, the blood collection system may further include a flow restriction device 1732 fluidly coupled to the connection portion 1720 of the blood collection device 1702. In some embodiments, the flow restriction device 1732 may be pre-attached to or integrally formed with the blood collection device 1702. As shown, the flow restriction device 1732 may be a cannula 1740 having a lumen 1742 that defines an internal flow path therethrough. The internal flow path may be fluidly coupled to the lumen 1734 of the needle 1730 for delivering blood drawn from a patient to the needle 1730.

[0229] In some embodiments, the cannula 1740 may be an elongated thin tube, where the lumen 1742 has a smaller, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1742 of the cannula 1740 (which may define a flow path or microchannel through which fluid may flow into the needle 1730) may be formed by any one of the length, diameter, and cross-sectional area as described above with reference to the optimized fluid path. Thus, during, for example, the process of collecting or drawing blood from a patient using a blood collection tube, the blood may be drawn into the needle 1730 under vacuum via the flow path or microchannel defined by the lumen 1742 having the smallest diameter.

[0230] Figure 16B A blood collection system 1800 is shown in accordance with some embodiments of the present disclosure. In accordance with various embodiments of the present disclosure, the blood collection system 1800 may include a blood collection device 1802 that includes a container 1710 having an outer surface 1714, an inner surface 1722 that defines an internal chamber 1750, and a connection portion 1720 that extends distally from the outer surface 1714 and has a lumen 1724 extending therethrough. In some embodiments, the blood collection device 1802 may be a Luer Lock Access Device (LLAD). In some embodiments, the blood collection device 1802 may include a blood collection tube that can be obtained from Becton Dickinson & Company. Blood collection tube.

[0231] In some embodiments, the blood collection system may further include a flow restriction device 1832 that extends proximally from the inner surface 1722 and is fluidly coupled to the lumen 1724 of the connection portion 1720 of the blood collection device 1702. In some embodiments, the flow restriction device 1832 may be pre-attached to or integrally formed with the blood collection device 1802. As shown, the flow restriction device 1732 may be a cannula 1740 having a lumen 1742 that defines an internal flow path therethrough. The internal flow path may be fluidly connected via the lumen 1724 of the connection portion to a catheter assembly for delivering blood drawn from a patient into the blood collection device 1802.

[0232] In some embodiments, similar to the blood collection system 1700, the cannula 1740 may be an elongated thin tube, where the lumen 1742 has a small, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1742 of the cannula 1740 (which may define a flow path or microchannel along which fluid may flow into the container 1710) may be formed by any of the lengths, diameters, and cross-sectional areas described above with reference to the optimized fluid path. Thus, during, for example, the process of collecting or withdrawing blood from a patient using a blood collection tube, the blood may be drawn under vacuum into the flow path or microchannel defined by the lumen 1742 having the smallest diameter.

[0233] The blood collection systems 1700 and 1800 of the various embodiments described herein having the flow restriction cannula 1740 integrated into the blood collection devices 1702, 1802 are superior to currently existing blood collection systems. For example, during the process of blood withdrawal using currently existing blood withdrawal devices, when blood cells flow from the distal end to the proximal end of the blood collection system, the blood cells may be subject to wall shear stress. The wall shear stress on blood cells is considered to be the main source of mechanical damage to blood cells that causes hemolysis of blood cells. The flow path or microchannel defined by the lumen 1742 having the smallest diameter may help to increase the flow resistance within the vascular access system to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood. For example, the smallest diameter of the flow path or microchannel defined by the lumen 1742 may provide increased resistance to the flow of blood, thereby reducing the blood flow rate within the flow cannula 1740. Because the reduced blood flow rate results in a decrease in the shear stress experienced by the red blood cells of the blood, the risk of hemolysis during blood collection can be advantageously reduced.

[0234] Figure 17A A blood collection system 1900 is shown in accordance with some embodiments of the present disclosure. Figure 17B A blood collection system in accordance with some embodiments of the present disclosure is shown Figure 17ACross-sectional view of blood collection system 1900. According to various embodiments of the present disclosure, blood collection system 1900 may include a blood collection device 1902, which includes a container 1910 having an outer surface 1914, an inner surface 1922 defining an internal chamber 1950, a needle 1930 extending proximally from the inner surface 1922, and a connection portion 1920 extending distally from the outer surface 1914. In some embodiments, blood collection device 1902 may be a Luer lock access device (LLAD). In some embodiments, blood collection device 1902 may include a blood collection tube available from Becton Dickinson & Company Blood collection tube.

[0235] In some embodiments, the blood collection system may further include a flow restriction device 1940, which engages with the connection portion 1920 and is fluidly coupled to the lumen 1934 of the needle 1930. In some embodiments, flow restriction device 1940 may be pre-attached to or integrally formed with blood collection device 1902. As depicted in Figure 17A and 17B , flow restriction device 1940 may include a connector 1912, which has a proximal end 1915 disposed in the connection portion 1920, a distal end 1916 configured to be coupled to a catheter assembly, and an inner surface 1918 defining an inner lumen 1925. Flow restriction device 1940 may further include an intubation 1955 installed in the inner lumen 1918, which extends from the distal end 1916 of the connector 1912 into the connection portion 1920. The lumen 1952 of the intubation 1955 may define a flow path along which blood flows from the distal end 1916 into the lumen 1934 of the needle 1930.

[0236] In some embodiments, the intubation 1955 may be an elongated thin tube, where the lumen 1952 has a smaller, reduced, or micro-sized diameter. For example, in some embodiments, the lumen 1952 of the intubation 1955 (which may define a flow path or microchannel along which fluid may flow into the needle 1930) may be formed by any one of the length, diameter, and cross-sectional area as described above with reference to the optimized fluid path. Thus, during the process of collecting or withdrawing blood from a patient using, for example a blood collection tube, blood may be withdrawn into the needle 1930 under vacuum via the flow path or microchannel defined by the lumen 1952 having the smallest diameter.

[0237] In some embodiments, the connector 1912 may further include a support portion 1936 disposed between the proximal end 1915 and the distal end 1916. The support portion 1936 may have a proximal end, a distal end, and a central mounting hole 1938 extending from the proximal end to the distal end. As shown, the cannula 1955 may be mounted in the central mounting hole 1938 for fluid communication of the flow restricting device with the catheter assembly.

[0238] Figure 18A A blood collection system 2000 is shown in accordance with some embodiments of the present disclosure. Figure 18B Shown in accordance with some embodiments of the present disclosure Figure 18A a cross-sectional view of the blood collection system 2000. According to various embodiments of the present disclosure, the blood collection system 2000 may include a blood collection device 2002 that includes a container 1910 having an outer surface 1914, an inner surface 1922 defining an internal chamber 1950, a needle 1930 extending proximally from the inner surface 1922, and a connection portion 1920 extending distally from the outer surface 1914. In some embodiments, the blood collection device 2002 may be a luer lock access device (LLAD). In some embodiments, the blood collection device 2002 may include a blood collection tube available from Becton Dickinson & Company.

[0239] In some embodiments, the blood collection system may further include a flow restricting device 2040 that engages the connection portion 1920 and is fluidly coupled to the lumen 1934 of the needle 1930. In some embodiments, the flow restricting device 1940 may be pre-attached or integrally formed with the blood collection device 1902. The flow restricting device 2040 may include a connector 2012 having a proximal end 1915 disposed in the connection portion 1920, a distal end 1916 configured to be coupled to a catheter assembly, and an inner surface 1918 defining an inner lumen 1925. The flow restricting device 2040 may have features similar to those of the flow restricting device 1940 described above, Figure 18A and 18B a detailed description thereof will be omitted. However, the flow restricting device 2040 may be different from the flow restricting device 1940 in that the cannula 1955 of the flow restricting device 2040 may be mounted in the inner lumen 1925 of the connector extending from the distal end 1915 to the proximal end of the connector 2012. In particular, compared to the cannula 1955 of the flow restricting device 1940 that extends into the blood collection device 1902, the cannula 1955 of the flow restricting device 2040 may be hidden within the body of the connector 2012.

[0240] The blood collection systems 1900 and 2000 of the various embodiments described herein have flow restriction cannulas 1955 integrated into the blood collection devices 1902, 2002, which are superior to currently existing blood collection systems. For example, during blood extraction with currently existing blood extraction devices, when blood cells flow from the distal end to the proximal end of the blood collection system, the blood cells may be subject to wall shear stress. The wall shear stress on blood cells is considered to be the main source of mechanical damage to blood cells that causes hemolysis of blood cells. The flow path or microchannel defined by the lumen 1952 with the smallest diameter can help increase the flow resistance within the vascular access system to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood. For example, the smallest diameter of the flow path or microchannel defined by the lumen 1952 can provide increased resistance to the flow of blood, thereby reducing the blood flow rate within the flow cannula 1955. Since the reduced blood flow rate results in a decrease in the shear stress experienced by the red blood cells of the blood, the risk of hemolysis during blood collection can be advantageously reduced.

[0241] Figure 19A A perspective view of a blood collection system 2100 in accordance with some embodiments of the present disclosure is shown. Figure 19B Shown in accordance with some embodiments of the present disclosure Figure 19A A cross-sectional view of the blood collection system 2100. In accordance with various embodiments of the present disclosure, the blood collection system 2100 may include a blood collection device 2102 that includes a container 2110 having an outer surface 2114, an inner surface 2122 that defines an internal chamber 2135, a needle 2130 that extends proximally from the inner surface 2122, and a connection portion 2140 that extends distally from the outer surface 2114. In some embodiments, the blood collection device 2102 may be a Luer Lock access device (LLAD). In some embodiments, the blood collection device 2102 may include a blood collection tube available from Becton Dickinson & Company. Blood collection tube.

[0242] In some embodiments, the connection portion 2140 may include an insertion portion 2150 that has an outer surface 2120 with a continuous non-linear channel 2125 recessed therein. The blood collection system may further include a connector 2112 that is configured to fluidly couple the blood collection device 2102 to a catheter assembly. The connector 2112 may include a first connection portion 2134 at its proximal end and a second connection portion 2116 at its distal end. As Figure 19B depicted, the first connection portion 2134 may have an inner surface 2138 that defines a lumen into which the insertion portion 2150 is coupled.

[0243] In the coupling structure of the connector 2112 and the insertion portion 2150, the inner surface 2138 of the first connection portion 2134 may surround, encircle, or otherwise enclose the outer surface of the insertion portion 2150 such that the continuous non-linear channel 2125 and the inner surface 2138 of the first connection portion 2134 define a non-linear fluid path along which fluid (e.g., blood) can flow from the lumen 2119 of the second connection portion 2116 of the connector 2112 into the fluid collection device 2102.

[0244] In some embodiments, the continuous non-linear channel 2125 may form a coil shape, an S shape, or other suitable non-linear winding shape. For example, the continuous non-linear channel 2125 may have a coil shape (which may include a helix) recessed in the outer surface 2120 of the insertion portion 2150. In some embodiments, the continuous non-linear channel 2125 may have an S shape recessed in the outer surface of the insertion portion 2150. The advantage of the foregoing structure is that the helical shape, coil shape, S shape, or other suitable non-linear winding shape of the continuous non-linear channel 2125 - due to its winding around the outer surface of the insertion portion 2150 - can increase the length of the fluid path defined by the continuous non-linear channel 2125 through which the blood sample flows as compared to a linear fluid path.

[0245] In some embodiments, the continuous non-linear channel 2125 may have a small, reduced, or micro-sized diameter. For example, in some embodiments, the continuous non-linear channel 2125 (which defines a flow path or microchannel along which fluid can flow from the connector 2112 into the fluid collection device 2102) may be formed by any one of the length, diameter, and cross-sectional area as described above with reference to the optimized fluid path.

[0246] As previously described, when blood is drawn from a patient's body, blood cells may be subject to wall shear stress as they flow from the catheter assembly into the blood collection device. For example, the maximum shear stress may be along the wall of the blood cells, which is commonly referred to as wall shear stress. The continuous non-linear channel 2125 having a reduced or micro-sized diameter can help increase the flow resistance within the vascular access system to distribute the pressure difference and reduce the shear stress experienced by the red blood cells of the blood. The minimum diameter of the continuous non-linear channel 2125 can provide increased resistance to the flow of blood, thereby reducing the blood flow rate within the flowing blood collection device 2102. Since the reduced blood flow rate results in a decrease in the shear stress experienced by the red blood cells of the blood, the risk of hemolysis during blood collection can be advantageously reduced.

[0247] For example, the present subject matter technology is described in accordance with the following various aspects. For convenience, each example of the aspects of the present subject matter technology is described as numbered clauses (1, 2, 3, etc.). These clauses are provided as examples and do not limit the present subject matter technology. Note that any dependent clauses can be combined in any combination and can be placed in the corresponding independent clause (e.g., clause 1 or clause 5). Other clauses can be presented in a similar manner.

[0248] Clause 1. A flow restriction device, comprising: a first connector including a proximal end, a distal end, and an inner surface defining an inner lumen, the first connector being configured to couple to a catheter assembly; a second connector coupled to the proximal end of the first connector and configured to couple to a fluid collection device; an intubation tube mounted in the inner lumen and extending from the distal end of the first connector into the second connector, wherein the lumen of the intubation tube defines a first flow path along which fluid flows from the distal end into the fluid collection device, and an annular space is defined between the outer surface of the intubation tube and the inner surface of the first connector, the annular space defining a second flow path along which fluid flows from the proximal end to the distal end and into the catheter assembly; and a check valve mounted in the annular space at the proximal end of the first connector and sleeved on at least a portion of the intubation tube, the check valve being configured to (i) prevent fluid from flowing from the distal end to the fluid collection device via the second flow path, and (ii) allow fluid to flow from the second connector to the first connector and the catheter assembly via the second flow path.

[0249] Clause 2. The flow restriction device according to clause 1, wherein the cross-sectional area of the intubation tube with respect to a plane transverse to the central longitudinal axis of the first connector is greater than the cross-sectional area of the lumen with respect to this plane.

[0250] Clause 3. The flow restriction device according to clause 2, wherein the second connector includes a proximal end, a distal end, and a support portion disposed between the proximal end and the distal end, and wherein the support portion has a proximal end, a distal end and includes a central mounting hole extending from the proximal end to the distal end, and the proximal end of the intubation tube is mounted in the central mounting hole to fluidly connect the flow restriction device to the fluid collection device.

[0251] Clause 4. The flow restriction device according to clause 3, wherein the support portion further includes a plurality of fluid channels disposed radially outwardly around and from the central mounting hole.

[0252] Clause 5. The flow restriction device according to Clause 4, wherein the plurality of fluid channels extend from the proximal end of the support portion to the distal end of the support portion to fluidly connect the second connector to the annular space, and the plurality of fluid channels define at least a part of the second flow path.

[0253] Clause 6. The flow restriction device according to any one of Clauses 3 to 5, wherein the annular space includes a notch at a position corresponding to the distal end of the check valve, and the notch fluidly connects the lumen of the cannula to the annular space.

[0254] Clause 7. The flow restriction device according to any one of Clauses 2 to 6, wherein the first connector further includes a support portion disposed between the proximal end and the distal end of the first connector, and wherein the support portion of the first connector has a proximal end, a distal end and includes a central mounting hole extending from the proximal end to the distal end, and the cannula is mounted in the central mounting hole of the support portion of the first connector to fluidly connect the flow restriction device to the catheter assembly.

[0255] Clause 8. The flow restriction device according to Clause 7, wherein the support portion of the first connector further includes a plurality of fluid channels disposed radially outwardly around and from the central mounting hole of the first connector.

[0256] Clause 9. The flow restriction device according to Clause 8, wherein the plurality of fluid channels extend from the proximal end of the support portion of the first connector to the distal end of the support portion of the first connector to fluidly connect the annular space to the catheter assembly, and the plurality of fluid channels define at least a part of the second flow path.

[0257] Clause 10. The flow restriction device according to Clause 9, wherein the fluid flowing into the fluid collection device from the distal end via the first flow path includes blood, and the fluid collection device includes a blood collection device.

[0258] Clause 11. The flow restriction device according to Clause 10, wherein the fluid flowing from the second connector into the first connector and the catheter assembly via the second flow path includes intravenous (IV) fluid.

[0259] Clause 12. A flow restriction device, comprising: a first connector including a proximal end, a distal end, and an inner surface defining an inner lumen, the distal end being configured to couple to a catheter assembly; a second connector including a proximal end, a distal end, and an inner surface defining a lumen of the second connector, the second connector being coupled to the proximal end of the first connector and being configured to couple to a fluid collection device; an intubation tube mounted in the lumen of the second connector and extending distally into the inner lumen of the first connector, wherein: the lumen of the intubation tube defines a first flow path along which fluid flows from the distal end of the first connector into the fluid collection device, and an annular space is defined between the outer surface of the intubation tube and the inner surface of the first connector, the annular space defining a second flow path along which fluid flows from the proximal end to the distal end and into the catheter assembly; and a check valve mounted in the annular space at the proximal end of the first connector and sleeving at least a portion of the intubation tube, the check valve being configured to (i) prevent fluid from flowing from the distal end of the first connector to the fluid collection device via the second flow path, and (ii) allow fluid to flow from the second connector to the first connector and the catheter assembly via the second flow path.

[0260] Clause 13. The flow restriction device according to Clause 12, wherein the cross-sectional area of the intubation tube with respect to a plane transverse to the central longitudinal axis of the first connector is greater than the cross-sectional area of the lumen with respect to this plane.

[0261] Clause 14. The flow restriction device according to Clause 13, wherein the second connector further includes a support portion disposed between the proximal end and the distal end, and wherein the support portion has a proximal end, a distal end and includes a central mounting hole extending from the proximal end to the distal end, the proximal end of the intubation tube being mounted in the central mounting hole to fluidly communicate the intubation tube with the fluid collection device.

[0262] Clause 15. The flow restriction device according to Clause 14, wherein the support portion further includes a plurality of fluid channels disposed radially outwardly of the central mounting hole and surrounding the central mounting hole.

[0263] Clause 16. The flow restriction device according to Clause 15, wherein the plurality of fluid channels extend from the proximal end of the support portion to the distal end of the support portion to fluidly communicate the second connector with the annular space, the plurality of fluid channels defining at least a portion of the second flow path.

[0264] Clause 17. The flow restriction device according to any one of Clauses 14 to 16, wherein the annular space includes a notch at a position corresponding to the distal end of the check valve, and the notch fluidly connects the lumen of the cannula to the annular space.

[0265] Clause 18. A flow restriction device, comprising: a distal connector configured to be coupled to a catheter assembly, the distal connector including a first connection portion at its proximal end and a second connection portion at its distal end, the first connection portion including an inner surface defining a lumen; a proximal connector coupled to the distal connector and configured to be coupled to a fluid collection device, the proximal connector including an insertion portion for insertion into the lumen of the first connection portion, the insertion portion including an outer surface having a continuous non-linear channel recessed therein; wherein the inner surface of the first connection portion surrounds the outer surface of the insertion portion such that the inner surface of the first connection portion and the continuous non-linear channel define a non-linear fluid path along which fluid flows from the distal connector into the fluid collection device.

[0266] Clause 19. The flow restriction device according to Clause 18, wherein the continuous non-linear channel includes a continuous groove having a coil shape recessed in the outer surface.

[0267] Clause 20. The flow restriction device according to any one of Clauses 18 and 19, wherein the continuous non-linear channel includes a continuous groove having an S shape recessed in the outer surface.

[0268] Clause 21. The flow restriction device according to any one of Clauses 18 to 20, wherein the fluid flowing from the distal end into the fluid collection device includes blood, and the fluid collection device includes a blood collection device.

[0269] Clause 22. The flow restriction device according to Clause 21, wherein the blood collection device includes a Luer lock access device.

[0270] Clause 23. The flow restriction device according to any one of Clauses 18 to 22, wherein the insertion portion further includes an inner surface defining a lumen of the insertion portion, and the lumen forms an internal flow path along which fluid flows from the proximal connector through the distal connector into the catheter assembly.

[0271] Clause 24. The flow restriction device according to Clause 23 further includes a check valve disposed in the lumen of the insertion portion, the check valve being configured to (i) prevent fluid from flowing from the distal connector through the lumen of the insertion portion into the proximal connector, and (ii) allow fluid to flow from the proximal connector through the lumen of the insertion portion into the distal connector.

[0272] Clause 25. The flow restriction device according to Clause 24, wherein the fluid flowing from the proximal connector through the distal connector into the catheter assembly includes intravenous (IV) fluid.

[0273] Clause 26. The flow restriction device according to any one of Clauses 23 to 25, wherein the internal flow path along which the fluid flows from the proximal connector through the distal connector into the catheter assembly includes a linear flow path.

[0274] Clause 27. The flow restriction device according to any one of Clauses 23 to 26, wherein the continuous non-linear channel includes a first diameter, the internal flow path includes a second diameter, and the first diameter is smaller than the second diameter.

[0275] Clause 28. A flow restriction device includes: a distal connector portion configured to be coupled to a catheter assembly, the distal connector portion including an inner surface defining its lumen; a proximal connector portion extending proximally from the distal connector portion and configured to be coupled to a fluid collection device, the proximal connector portion including an inner surface defining a lumen that is fluidly connected to the lumen of the distal connector portion; a plug disposed in the lumen of the proximal connector portion, the plug including a head portion and a body portion extending proximally from the head portion, and the body portion including a plurality of threads extending along an outer surface of the body portion, wherein the inner surface of the proximal connector portion surrounds the outer surface of the body portion to define a continuous non-linear channel, and when the fluid collection device is coupled to the proximal connector portion, fluid flows from the distal connector portion through the proximal connector portion along the continuous non-linear channel into the fluid collection device.

[0276] Clause 29. The flow restriction device according to Clause 28, wherein the continuous non-linear channel is defined along an interval between adjacent threads of the plurality of threads.

[0277] Clause 30. The flow restriction device according to Clause 29, wherein the continuous non-linear channel includes a continuous groove having a coil shape recessed in the outer surface.

[0278] Clause 31. The flow restriction device according to any one of Clauses 29 to 30, wherein the continuous non-linear channel comprises continuous grooves having an S-shape recessed in the outer surface.

[0279] Clause 32. The flow restriction device according to any one of Clauses 29 to 31, 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.

[0280] Clause 33. The flow restriction device according to Clause 32, wherein the blood collection device comprises a luer lock access device.

[0281] Clause 34. The flow restriction device according to any one of Clauses 29 to 33, wherein the plug comprises an inner surface defining a lumen of the plug, and the head portion comprises a normally closed slit, and the normally closed slit of the head portion is configured to prevent fluid from flowing from the distal connector to the proximal connector via the lumen.

[0282] Clause 35. The flow restriction device according to Clause 34, wherein the plug comprises an inner surface defining a lumen of the plug, and the head portion comprises a normally closed slit, and when the normally closed slit is subjected to distal fluid pressure, the normally closed slit opens to allow fluid to flow from the proximal connector to the distal connector via the lumen.

[0283] Clause 36. The flow restriction device according to Clause 35, wherein the continuous non-linear channel comprises a first diameter, the lumen comprises a second diameter, and the first diameter is smaller than the second diameter.

[0284] Clause 37. The flow restriction device according to Clause 36, wherein the lumen defines an internal flow path along which the fluid flows from the proximal connector to the catheter assembly via the distal connector.

[0285] Clause 38. The flow restriction device according to Clause 37, wherein the fluid flowing from the proximal connector to the catheter assembly via the distal connector comprises intravenous (IV) fluid.

[0286] Clause 39. A flow restriction device, comprising: a first connector including a female Luer portion at a proximal end, a male Luer portion at a distal end, an inner surface defining an inner lumen of the first connector, and a compressible valve member mounted in the inner lumen, the first connector being configured to couple to a fluid collection device; a second connector coupled to the male Luer portion of the first connector and configured to couple to a catheter assembly, the second connector including an inner surface defining an inner lumen of the second connector; and an intubation tube mounted in the inner lumen of the second connector and extending from the inner lumen into the female Luer portion of the first connector, the compressible valve member being mounted around at least a portion of the intubation tube, wherein, in the coupling configuration of the first connector and the fluid collection device, the compressible valve member is compressed by the fluid collection device to place the intubation tube in fluid communication with the fluid collection device via a slot of the compressible valve member.

[0287] Clause 40. The flow restriction device according to Clause 39, wherein the compressible valve member includes a head portion having a slot and a body portion extending distally from the head portion, and in the coupling configuration of the first connector and the fluid collection device, the body portion of the compressible valve member compresses to move the head portion distally to place the lumen of the intubation tube in fluid communication with the fluid collection device to allow fluid to flow from the second connector through the lumen of the intubation tube into the fluid collection device.

[0288] Clause 41. The flow restriction device according to Clause 40, wherein the body portion includes an accordion shape.

[0289] Clause 42. The flow restriction device according to Clause 40, wherein the head portion includes a split diaphragm.

[0290] Clause 43. The flow restriction device according to any one of Clauses 39 to 42, wherein the second connector further includes a support portion that extends radially inward from the inner surface into the inner lumen of the second connector and includes a mounting hole, and the intubation tube is mounted in the mounting hole to place the second connector in fluid communication with the fluid collection device.

[0291] Clause 44. The flow restriction device according to Clause 43, wherein the intubation tube is press-fitted into the support portion.

[0292] Clause 45. A flow restriction device, comprising: a first connector including a female Luer portion, a male Luer portion, and a compressible valve member, the female Luer portion having a lumen and being disposed at a proximal end, the male Luer portion having a lumen and being disposed at a distal end, the compressible valve member being mounted in the lumen of the female Luer portion, the first connector being configured to couple to a fluid collection device; a second connector including a female Luer portion coupled to the male Luer portion of the first connector and a male Luer portion configured to couple to a catheter assembly, the female Luer portion of the second connector including an inner lumen, and the male Luer portion of the second connector including an inner lumen in fluid communication with the inner lumen of the female Luer portion of the second connector; a post mounted in the second connector and extending from the inner lumen of the male Luer portion of the second connector through the lumen of the male Luer portion of the first connector into an internal chamber of the compressible valve member, the compressible valve member being mounted around at least a portion of the post, wherein, in the coupling configuration of the first connector with the fluid collection device, the compressible valve member is compressed by the fluid collection device to place the post in fluid communication with the fluid collection device via a slot in the compressible valve member.

[0293] Clause 46. The flow restriction device according to Clause 45, wherein the post includes an elongate tube having a lumen that tapers from a distal end to a proximal end of the post.

[0294] Clause 47. The flow restriction device according to any one of Clauses 45 and 46, wherein the compressible valve member includes a head portion having a slot and a body portion extending distally from the head portion, and in the coupling configuration of the first connector with the fluid collection device, the body portion of the compressible valve member compresses to move the head portion distally to place the lumen of the post in fluid communication with the fluid collection device to allow fluid to flow from the second connector through the lumen of the post into the fluid collection device.

[0295] Clause 48. The flow restriction device according to Clause 47, wherein the body portion includes an accordion shape.

[0296] Clause 49. The flow restriction device according to Clause 47, wherein the head portion includes a split diaphragm.

[0297] Clause 50. The flow restriction device according to any one of Clauses 45 to 49, wherein the second connector further includes a support portion at a proximal end of the male Luer portion of the second connector, and the post is mounted on the support portion to place the second connector in fluid communication with the fluid collection device.

[0298] Clause 51. The flow restriction device according to Clause 50, wherein the support portion extends distally away from the male Luer portion of the second connector into the lumen of the female Luer portion of the second connector.

[0299] Clause 52. The flow restriction device according to any one of Clauses 46 to 51, wherein the fluid flowing from the second connector through the lumen of the port into the fluid collection device includes blood, and the fluid collection device includes a blood collection device.

[0300] Clause 53. A flow restriction device, comprising: a male Luer connector portion configured to be coupled to a catheter assembly, the male Luer connector portion including an inner surface defining its lumen; a female Luer connector portion extending proximally from the male Luer connector portion and configured to be coupled to a fluid collection device, the female Luer connector portion including an inner surface defining a lumen fluidly connected to the lumen of the male Luer connector portion; a tube extending from the lumen of the male Luer connector portion into the lumen of the female Luer connector portion, wherein the lumen of the tube defines a fluid path along which fluid flows from the male Luer connector portion through the female Luer connector portion into the fluid collection device.

[0301] Clause 54. The flow restriction device according to Clause 53, wherein at least a portion of the tube includes a non-linear tube.

[0302] Clause 55. The flow restriction device according to Clause 54, wherein the portion of the non-linear tube including the non-linear tube is disposed in the lumen of the female Luer connector portion.

[0303] Clause 56. The flow restriction device according to any one of Clauses 54 and 55, wherein the non-linear tube includes a tube in a coil shape.

[0304] Clause 57. The flow restriction device according to any one of Clauses 54 to 55, wherein the non-linear tube includes a tube in an S shape.

[0305] Clause 58. The flow restriction device according to any one of Clauses 53 to 57, wherein the fluid flowing from the male Luer connector portion through the female Luer connector portion into the fluid collection device includes blood, and the fluid collection device includes a blood collection device.

[0306] Clause 59. The flow restriction device according to Clause 58, wherein the blood collection device includes a Luer lock access device.

[0307] Clause 60. The flow restriction device according to any one of Clauses 53 to 59, wherein the pipe fitting includes a linear pipe fitting.

[0308] Clause 61. The flow restriction device according to Clause 60, wherein the linear pipe fitting includes an intubation tube installed in the male Luer connector portion.

[0309] Clause 62. The flow restriction device according to Clause 61, wherein the male Luer connector portion further includes a support portion that radially extends inward from the inner surface into the lumen of the male Luer connector portion and includes a mounting hole, and the intubation tube is installed in the mounting hole to fluidly connect the male Luer connector portion with the fluid collection device.

[0310] Clause 63. The flow restriction device according to Clause 62, wherein the intubation tube is press-fitted into the support portion.

[0311] Clause 64. The flow restriction device according to any one of Clauses 60 to 63, wherein the fluid flowing from the male Luer connector portion through the female Luer connector portion to the fluid collection device includes blood, and the fluid collection device includes a blood collection device.

[0312] Clause 65. The flow restriction device according to Clause 64, wherein the blood collection device includes a Luer lock access device.

[0313] Clause 66. A flow restriction device, comprising: a distal connector configured to be coupled to a catheter assembly, the distal connector including a first connection portion at its proximal end and a second connection portion at its distal end, each of the first connection portion and the second connection portion including an inner surface defining a lumen; a proximal connector coupled to the distal connector and configured to be coupled to a fluid collection device; an insert installed in the lumen of the first connection portion and including an outer surface having a groove, the configuration recessed in the outer surface and extending at least partially along the length of the outer surface, wherein the groove is fluidly coupled to the lumen of the second connection portion and the lumen of the first connection portion, and wherein the inner surface of the first connection portion surrounds the outer surface of the insert such that the inner surface of the first connection portion and the groove define at least a part of a fluid channel, and fluid flows along the fluid channel from the distal connector to the fluid collection device.

[0314] Clause 67. The flow restriction device according to Clause 66, wherein the groove includes a linear groove recessed in the outer surface.

[0315] Clause 68. The flow restriction device according to Clause 67, wherein the outer surface further includes longitudinally extending flanges, each flange being disposed at opposite edges of the linear groove to seal the edges.

[0316] Clause 69. The flow restriction device according to Clause 67, wherein the insert includes a first channel segment fluidly coupled to the proximal end of the lumen of the second connection portion, and a second channel segment extends from the first channel segment to the linear groove, and the first and second channel segments and the linear groove together define the fluid channel, and the fluid flows along the fluid channel from the distal connector into the fluid collection device.

[0317] Clause 70. The flow restriction device according to Clause 69, wherein the first channel segment and the linear groove are offset from each other in position, and the second channel segment includes an inclined surface that couples the first channel segment to the linear groove.

[0318] Clause 71. The flow restriction device according to any one of Clauses 66 to 70, wherein the fluid flowing from the distal end into the fluid collection device includes blood, and the fluid collection device includes a blood collection device.

[0319] Clause 72. The flow restriction device according to Clause 71, wherein the blood collection device includes a luer lock access device.

[0320] Clause 73. A flow restriction device, comprising: a connector including a body portion having a lumen and disposed at a proximal end, a base portion having a lumen and disposed at a distal end, and a compressible valve member disposed on the base portion and extending into the lumen of the body portion, the body portion being configured to couple to a fluid collection device; and a post having a lumen extending therethrough, the post being mounted in the lumen of the base portion and extending into an internal chamber of the compressible valve member, the compressible valve member being mounted around the post, and the post being configured to be in fluid communication with a catheter assembly, wherein in the coupling configuration of the body portion and the fluid collection device, the compressible valve member is compressed by the fluid collection device to place the post in fluid communication with the fluid collection device via a slot of the compressible valve member.

[0321] Clause 74. The flow restriction device according to Clause 73, wherein the compressible valve member includes a head portion having a slot and a body portion extending distally from the head portion, and in the coupling configuration of the body portion with the fluid collection device, the body portion of the compressible valve member is compressed to allow the head portion to move distally to place the lumen of the column in fluid communication with the fluid collection device and to allow fluid to flow from the distal end of the column through the lumen of the column into the fluid collection device.

[0322] Clause 75. The flow restriction device according to Clause 74, wherein the body portion includes an accordion shape.

[0323] Clause 76. The flow restriction device according to any one of Clauses 74 and 75, wherein the head portion includes a split diaphragm.

[0324] Clause 77. The flow restriction device according to any one of Clauses 73 to 76, wherein the lumen of the column tapers from the distal end to the proximal end of the column.

[0325] Clause 78. The flow restriction device according to Clause 77, wherein the fluid flowing from the distal end of the column through the lumen of the column into the fluid collection device includes blood, and the fluid collection device includes a blood collection device.

[0326] Clause 79. A flow restriction device, comprising: a connector including a female Luer portion having a lumen and disposed at a proximal end, a male Luer portion having a lumen and disposed at a distal end, and a compressible valve member mounted in the lumen of the female Luer portion and fluidly coupled to the lumen of the male Luer portion, the female Luer portion being configured to couple to a fluid collection device, and the male Luer portion being configured to couple to a catheter assembly; and a column mounted in the female Luer portion and extending into an internal chamber of the compressible valve member, the compressible valve member being mounted around the column, and the column being in fluid communication with the lumen of the male Luer portion, wherein in the coupling configuration of the female Luer portion with the fluid collection device, the compressible valve member is compressed by the fluid collection device to place the column in fluid communication with the fluid collection device via a slot of the compressible valve member.

[0327] Clause 80. The flow restriction device according to Clause 79, wherein the compressible valve member includes a head portion having a slot and a body portion extending distally from the head portion, and in the coupling structure of the female Luer portion and the fluid collection device, the body portion of the compressible valve member is compressed to move the head portion distally so as to put the lumen of the column in fluid communication with the fluid collection device and allow fluid to flow from the male Luer portion through the lumen of the column into the fluid collection device.

[0328] Clause 81. The flow restriction device according to Clause 80, wherein the body portion has an accordion shape.

[0329] Clause 82. The flow restriction device according to any one of Clauses 80 and 81, wherein the head portion includes a split diaphragm.

[0330] Clause 83. The flow restriction device according to any one of Clauses 79 to 82, wherein the female Luer portion further includes a support portion at its distal end, and the column is mounted on the support portion to put the lumen of the male Luer portion in fluid communication with the fluid collection device.

[0331] Clause 84. The flow restriction device according to Clause 83, wherein the fluid flowing from the male Luer portion through the lumen of the column into the fluid collection device includes blood, and the fluid collection device includes a blood collection device.

[0332] Clause 85. A flow restriction device, comprising: a housing having a proximal end, an inner surface defining an internal chamber of the housing, and a male Luer portion that defines the distal end of the housing and has a lumen in fluid communication with the internal chamber, the internal chamber of the housing being fluidly coupled to a connector; a slider reciprocally mounted in the internal chamber, the slider including a proximal end, a distal end, a mounting hole extending from the proximal end to the distal end of the slider, and a flow hole surrounding the mounting hole and extending from the proximal end to the distal end of the slider; a pipe member having a lumen extending therethrough, the pipe member being mounted in the mounting hole and extending distally from the proximal end of the slider through the distal end of the slider; and a spring member mounted in the internal chamber around at least a portion of the pipe member, wherein the spring member applies a force to bias the proximal end of the slider against the inner surface of the housing to block the fluid flow into the connector via the plurality of flow holes, and allows the fluid flow to enter the connector via the pipe member.

[0333] Clause 86. The flow restriction device according to Clause 85, wherein when the sliding member is subjected to an outwardly directed fluid pressure, the sliding member is configured to move outwardly away from the inner surface of the housing to allow fluid to flow from the connector through the pipe fitting and the plurality of flow holes into the lumen of the male luer portion.

[0334] Clause 87. The flow restriction device according to Clause 86, wherein the plurality of flow holes includes at least four flow holes.

[0335] Clause 88. The flow restriction device according to any one of Clauses 86 and 87, wherein the plurality of flow holes extends longitudinally around the outer periphery of the sliding member.

[0336] Clause 89. The flow restriction device according to any one of Clauses 85 to 88, wherein each of the plurality of flow holes defines a flow path with the inner surface of the internal chamber, and when the sliding member is subjected to an outwardly directed fluid pressure, the fluid flows from the connector to the lumen of the male luer portion through the flow path.

[0337] Clause 90. The flow restriction device according to any one of Clauses 86 to 89, wherein at least a portion of the pipe fitting includes a longitudinal body that extends uniformly in the internal chamber of the housing.

[0338] Clause 91. The flow restriction device according to Clause 90, wherein at least one of the diameter of the pipe fitting at the proximal end and the diameter of the pipe fitting at the distal end is greater than the diameter of the portion of the pipe fitting that includes the longitudinal body extending uniformly in the internal chamber of the housing.

[0339] Clause 92. The flow restriction device according to any one of Clauses 90 and 91, wherein the pipe fitting flares radially outward from the portion of the pipe fitting that includes the longitudinal body, and the longitudinal body extends uniformly in the internal chamber of the housing to at least one of the proximal end and the distal end of the pipe fitting.

[0340] Clause 93. The flow restriction device according to any one of Clauses 86 to 92, wherein the sliding member includes a polyisopropene sealing material.

[0341] Clause 94. A blood collection system, comprising: a blood collection device including a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface; and a flow restriction device fluidly coupled to the connection portion of the blood collection device, the flow restriction device including a cannula having an inner surface defining an internal flow path therethrough, wherein the internal flow path is fluidly coupled to the lumen of the needle to convey blood drawn from a patient's body to the needle.

[0342] Clause 95. The blood collection system according to Clause 94, wherein the blood collection device includes a Luer lock access device.

[0343] Clause 96. The blood collection system according to Clause 94, wherein the blood collection device includes a Vacutainer.

[0344] Clause 97. A blood collection system, comprising: a blood collection device including a container having an outer surface, an inner surface defining an internal chamber, and a connection portion extending distally from the outer surface and including a lumen extending therethrough; and a flow restriction device extending proximally from the inner surface and fluidly coupled to the lumen of the connection portion of the blood collection device, the flow restriction device including a cannula having an inner surface defining an internal flow path therethrough, wherein the internal flow path is fluidly coupled to the lumen of the connection portion to receive blood drawn from a patient's body.

[0345] Clause 98. The blood collection system according to Clause 97, wherein the blood collection device includes a Luer lock access device.

[0346] Clause 99. The blood collection system according to Clause 97, wherein the blood collection device includes a Vacutainer.

[0347] Clause 100. A blood collection system, comprising: a blood collection device including a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface; and a flow restriction device engaging the connection portion and fluidly coupled to the lumen of the needle, the flow restriction device including: a connector including a proximal end disposed in the connection portion, a distal end configured to couple to a catheter assembly, and an internal surface defining an inner lumen; and a cannula mounted in the inner lumen, extending from the distal end of the connector into the connection portion, wherein the lumen of the cannula defines a flow path along which blood extends from the distal end to the lumen of the needle.

[0348] Clause 101. The blood collection system according to Clause 100 further includes a support portion disposed between the proximal end and the distal end of the connector. The support portion includes a proximal end, a distal end, and a central mounting hole extending from the proximal end to the distal end. The cannula is mounted in the central mounting hole to fluidly connect the flow restriction device to the catheter assembly.

[0349] Clause 102. The blood collection system according to any one of Clauses 100 and 101, wherein the blood collection device includes a Luer lock access device.

[0350] Clause 103. The blood collection system according to any one of Clauses 100 to 102, wherein the blood collection device includes a Vacutainer.

[0351] Clause 104. A blood collection system includes: a blood collection device including a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connecting portion extending distally from the outer surface; and a flow restriction device engaging the connecting portion and fluidly coupled to the lumen of the needle. The flow restriction device includes: a connector including a proximal end disposed in the connecting portion, a distal end configured to be coupled to a catheter assembly, and an inner surface defining an inner lumen; and a cannula mounted in the inner lumen, extending from the distal end of the connector into the proximal end, wherein the lumen of the cannula defines a flow path along which blood extends from the distal end to the lumen of the needle.

[0352] Clause 105. The blood collection system according to Clause 104 further includes a support portion disposed between the proximal end and the distal end of the connector. The support portion includes a proximal end, a distal end, and a central mounting hole extending from the proximal end to the distal end. The cannula is mounted in the central mounting hole to fluidly connect the flow restriction device to the catheter assembly.

[0353] Clause 106. The blood collection system according to any one of Clauses 104 and 105, wherein the blood collection device includes a Luer lock access device.

[0354] Clause 107. The blood collection system according to any one of Clauses 104 to 106, wherein the blood collection device includes a Vacutainer.

[0355] Clause 108. A blood collection system, comprising: a blood collection device including a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface, wherein the connection portion includes an insertion portion having an outer surface with a continuous non-linear channel recessed therein; and a connector configured to be coupled to a catheter assembly, the connector including a first connection portion at its proximal end and a second connection portion at its distal end, and the first connection portion including an inner surface defining a lumen in which the insertion portion is coupled, wherein the inner surface of the first connection portion surrounds the outer surface of the insertion portion such that the inner surface of the first connection portion and the continuous non-linear channel define a non-linear fluid path along which fluid flows from the connector into the lumen of the needle.

[0356] Clause 109. The blood collection system according to Clause 108, wherein the continuous non-linear channel includes a continuous groove having a coil shape recessed in the outer surface.

[0357] Clause 110. The blood collection system according to any one of Clauses 108 and 109, wherein the continuous non-linear channel includes a continuous groove having an S shape recessed in the outer surface.

[0358] Clause 111. The blood collection system according to any one of Clauses 108 to 110, wherein the blood collection device includes a Luer lock access device.

[0359] Clause 112. The blood collection system according to any one of Clauses 108 to 110, wherein the blood collection device includes a Vacutainer.

[0360] Clause 113. The blood collection system according to any one of Clauses 108 to 112, wherein the connector includes a male Luer connector portion.

[0361] 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 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 general principles defined herein may be applied to other aspects.

[0362] Unless otherwise specified, elements in the singular form are not intended to mean "one and only one" but "one or more." Unless otherwise specified, the term "some" means one or more. Masculine pronouns (such as "his") include feminine and neuter genders (such as "her" and "its"), and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the present utility model.

[0363] The term "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 more preferred or advantageous than other aspects or designs. In one aspect, the various alternative configurations and operations described herein can be considered to be at least equivalent.

[0364] As used herein, the phrase "at least one" before a series of items, separating any items with the term "or," modifies the listed items as a whole rather than each of the listed items. The phrase "at least one" does not require the selection of at least one item; rather, the phrase allows for the meaning 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: only A, only B, or only C; or any combination of A, B, and C.

[0365] Phrases such as "aspect" do not mean that such an aspect is necessary for the subject technology or that such an aspect applies to all configurations of the subject technology. The disclosure related to an aspect can apply to all configurations, or 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 mean that such an embodiment is necessary for the subject technology or that such an embodiment applies to all configurations of the subject technology. The disclosure related to an embodiment can apply to all embodiments, or one or more embodiments. An embodiment can provide one or more examples. Such phrases of an embodiment can refer to one or more embodiments, and vice versa. Phrases such as "configuration" do not mean that such a configuration is necessary for the subject technology or that such a configuration applies to all configurations of the subject technology. The disclosure related to a configuration can apply to all configurations or one or more configurations. A configuration can provide one or more examples. Such a configuration can refer to one or more configurations, and vice versa.

[0366] In one aspect, unless otherwise stated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification, including those set forth in the appended claims, are approximate and not exact. In one aspect, they are intended to have a reasonable range that is consistent with the functions they relate to and the conventions of the fields to which they belong.

[0367] It should be understood that the particular order or hierarchy of steps or operations in the disclosed processes or methods is an illustration of exemplary methods. Based on implementation preferences or scenarios, it should be understood that the particular order or hierarchy of steps, operations, or processes can be rearranged. Some steps, operations, or processes can 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 can be performed automatically without user intervention. The appended method claims present the elements of the various steps, operations, or processes in an exemplary order and are not meant to be limited to the particular order or hierarchy presented.

[0368] All structural and functional equivalents of the elements of the various aspects described throughout this disclosure that are known or later will be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be covered by the claims. In addition, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly 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 phrase "step for... " to recite the element. Further, with respect to the scope of use of the terms "comprising," "having," etc., such terms are intended to be open-ended in a manner similar to the term "including" as that term is interpreted when used as a transitional word in a claim.

[0369] The title, background art, summary of the utility model, brief description of the drawings, and abstract of the specification of the present disclosure are hereby incorporated into the present disclosure and provided as illustrative examples of the present disclosure, rather than as restrictive descriptions. It should be understood when filing this application that they will not be used to limit the scope or meaning of the claims. Further, in the detailed description, it can be seen that the description provides illustrative examples and, for the purpose of streamlining the present disclosure, various features are combined in each embodiment. The methods of the present disclosure should not be construed as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Instead, as reflected in the following claims, the subject matter of the present utility model lies in less than all the features of a single disclosed construction or operation. The following claims are hereby incorporated into the detailed description, with each claim standing alone as a separately claimed subject matter.

[0370] The claims are not intended to be limited to the aspects described herein, but rather to the full scope consistent with the language of the claims and to cover all lawful equivalents. Nevertheless, no claim is intended to cover subject matter that fails to meet the requirements of 35 U.S.C. § 101, 102, or 103, nor should they be construed in such a way.

Claims

1. A flow restriction device, characterized in that, Comprising: A first connector including a proximal end, a distal end, and an inner surface defining an inner lumen, the first connector being configured to couple to a catheter assembly; A second connector coupled to the proximal end of the first connector and configured to couple to a fluid collection device; A cannula mounted within the inner lumen extending from the distal end of the first connector into the second connector, wherein a lumen of the cannula defines a first flow path along which fluid flows from the distal end into the fluid collection device, and an annular space is defined between an outer surface of the cannula and the inner surface of the first connector, the annular space defining a second flow path along which fluid flows from the proximal end to the distal end and into the catheter assembly; and A check valve mounted within the annular space at the proximal end of the first connector and surrounding at least a portion of the cannula, the check valve being configured to prevent fluid from flowing from the distal end through the second flow path into the fluid collection device and to permit fluid to flow from the second connector through the second flow path into the first connector and the catheter assembly, wherein a cross-sectional area of the cannula with respect to a plane transverse to a central longitudinal axis of the first connector is greater than a cross-sectional area of the lumen with respect to the plane, wherein the second connector includes a proximal end, a distal end, and a support portion disposed between the proximal end and the distal end, and wherein the support portion has a proximal end, a distal end and includes a central mounting hole extending from the proximal end to the distal end, and a proximal end of the cannula is mounted within the central mounting hole to fluidly couple the flow restricting device to the fluid collection device.

2. The flow restriction device according to claim 1, wherein The support portion further includes a plurality of fluid channels disposed radially outwardly from the central mounting hole and surrounding the central mounting hole.

3. The flow restriction device according to claim 2, wherein, The plurality of fluid channels extend from a proximal end of the support portion to a distal end of the support portion to fluidly couple the second connector to the annular space, the plurality of fluid channels defining at least a portion of the second flow path.

4. The flow restriction device according to claim 1, wherein The annular space includes a notch at a location corresponding to a distal end of the check valve, the notch fluidly connecting the lumen of the cannula to the annular space.

5. The flow restriction device according to claim 1, wherein The first connector further includes a support portion disposed between the proximal end and the distal end of the first connector, and wherein the support portion of the first connector has a proximal end, a distal end and includes a central mounting hole extending from the proximal end to the distal end, and the cannula is mounted within the central mounting hole of the support portion of the first connector to fluidly couple the flow restricting device to the catheter assembly.

6. The flow restriction device according to claim 5, characterized in that, The support portion of the first connector further includes a plurality of fluid channels disposed radially outwardly from the central mounting hole of the first connector and surrounding the central mounting hole.

7. The flow restriction device according to claim 6, wherein The plurality of fluid channels extend from a proximal end of a support portion of the first connector to a distal end of the support portion of the first connector to fluidly connect the annular space with the catheter assembly, and the plurality of fluid channels define at least a portion of the second flow path.

8. The flow restriction device according to claim 7, wherein The fluid flowing into the fluid collection device from the distal end via the first flow path includes blood.

9. The flow restriction device according to claim 8, wherein The fluid flowing from the second connector into the first connector and the catheter assembly via the second flow path includes intravenous fluid.

10. A flow restriction device, characterized in that, Comprising: A first connector including a proximal end, a distal end, and an inner surface defining an inner lumen, the distal end being configured to couple to a catheter assembly; A second connector including a proximal end, a distal end, and an inner surface defining a lumen of the second connector, the second connector being coupled to the proximal end of the first connector and being configured to couple to a fluid collection device; A cannula mounted in the lumen of the second connector and extending distally into the inner lumen of the first connector, wherein: The lumen of the cannula defines a first flow path along which fluid flows from the distal end of the first connector into the fluid collection device; and An annular space is defined between an outer surface of the cannula and the inner surface of the first connector, the annular space defining a second flow path along which fluid flows from the proximal end to the distal end and into the catheter assembly; and A check valve mounted in the annular space at the proximal end of the first connector and sleeving at least a portion of the cannula, the check valve being configured to prevent fluid from flowing from the distal end of the first connector into the fluid collection device via the second flow path and to allow fluid to flow from the second connector into the first connector and the catheter assembly via the second flow path, wherein a cross-sectional area of the cannula with respect to a plane transverse to a central longitudinal axis of the first connector is greater than a cross-sectional area of the lumen with respect to the plane wherein the second connector further includes a support portion disposed between the proximal end and the distal end, and wherein the support portion has a proximal end, a distal end and includes a central mounting hole extending from the proximal end to the distal end, and a proximal end of the cannula is mounted in the central mounting hole to fluidly connect the cannula with the fluid collection device.

11. The flow restriction device according to claim 10, wherein, The support portion further includes a plurality of fluid channels disposed radially outwardly of and around the central mounting hole.

12. The flow restriction device according to claim 11, characterized in that, The plurality of fluid channels extend from a proximal end of the support portion to a distal end of the support portion to fluidly connect the second connector with the annular space, and the plurality of fluid channels define at least a portion of the second flow path.

13. The flow restriction device according to claim 10, wherein The annular space includes a notch at a position corresponding to a distal end of the check valve, and the notch fluidly connects the lumen of the cannula with the annular space.

14. A flow restriction device, characterized in that, Comprising: A distal connector configured to be coupled to a catheter assembly, the distal connector including a first connection portion at its proximal end and a second connection portion at its distal end, the first connection portion including an inner surface defining a lumen; A proximal connector coupled to the distal connector and configured to be coupled to a fluid collection device, the proximal connector including an insertion portion for insertion into the lumen of the first connection portion, the insertion portion including an outer surface having a continuous non-linear channel recessed therein; Wherein the inner surface of the first connection portion surrounds the outer surface of the insertion portion such that the inner surface of the first connection portion and the continuous non-linear channel define a non-linear fluid path along which fluid flows from the distal connector into the fluid collection device; Wherein the continuous non-linear channel includes a continuous groove having a coil shape recessed in the outer surface; Wherein the distal connector further includes a support portion disposed between the proximal end and the distal end, the support portion including a mounting hole recessed therein.

15. The flow restriction device according to claim 14, wherein The continuous non-linear channel includes a continuous groove having an S shape recessed in the outer surface.

16. The flow restriction device according to claim 14, wherein, The fluid flowing from the distal end into the fluid collection device includes blood.

17. The flow restriction device according to claim 14, wherein The insertion portion further includes an inner surface defining a lumen of the insertion portion, the lumen forming an internal flow path along which fluid flows from the proximal connector, through the distal connector, into the catheter assembly.

18. The flow restriction device according to claim 17, wherein, A check valve is further included disposed in the lumen of the insertion portion, the check valve configured to prevent fluid from flowing from the distal connector through the lumen of the insertion portion into the proximal connector and to allow fluid to flow from the proximal connector through the lumen of the insertion portion into the distal connector.

19. The flow restriction device according to claim 18, wherein, The fluid flowing from the proximal connector, through the distal connector, into the catheter assembly includes an intravenous injection fluid.

20. The flow restriction device according to claim 17, wherein, The internal flow path along which the fluid flows from the proximal connector, through the distal connector, into the catheter assembly includes a linear flow path.

21. The flow restriction device according to claim 17, wherein The continuous non-linear channel includes a first diameter, the internal flow path includes a second diameter, and the first diameter is less than the second diameter.

22. A flow restriction device, characterized in that, Comprising: A first connector including a female Luer portion at its proximal end, a male Luer portion at its distal end, an inner surface defining an inner lumen of the first connector, and a compressible valve member mounted in the inner lumen, the first connector configured to be coupled to a fluid collection device; A second connector coupled to the male Luer portion of the first connector and configured to be coupled to a catheter assembly, the second connector including an inner surface defining an inner lumen of the second connector; And A cannula mounted in the inner lumen of the second connector and extending from the inner lumen into the female Luer portion of the first connector, the compressible valve member being mounted around at least a portion of the cannula Wherein, in the coupling structure between the first connector and the fluid collection device, the compressible valve member is compressed by the fluid collection device to fluidly connect the cannula with the fluid collection device via a slot of the compressible valve member. Wherein, the compressible valve member includes a head portion having a slot and a body portion extending distally from the head portion, and in the coupling structure between the first connector and the fluid collection device, the body portion of the compressible valve member is compressed to move the head portion distally to fluidly connect the lumen of the cannula with the fluid collection device, allowing fluid to flow from the second connector through the lumen of the cannula into the fluid collection device. Wherein, the second connector further includes a support portion that extends radially inward from the inner surface into the inner lumen of the second connector and includes a mounting hole, and the cannula is mounted in the mounting hole to fluidly connect the second connector with the fluid collection device.

23. The flow restriction device according to claim 22, characterized in that, The body portion has an accordion shape.

24. The flow restriction device according to claim 22, wherein The head portion includes a split diaphragm.

25. The flow restriction device according to claim 22, characterized in that, The cannula is press-fitted in the support portion.

26. A flow restriction device, characterized in that, Comprising: A first connector including a female Luer portion, a male Luer portion, and a compressible valve member, the female Luer portion having a lumen and being disposed at a proximal end, the male Luer portion having a lumen and being disposed at a distal end, the compressible valve member being mounted in the lumen of the female Luer, the first connector being configured to couple to a fluid collection device; A second connector including a female Luer portion coupled to the male Luer portion of the first connector and a male Luer portion configured to couple to a catheter assembly, the female Luer portion of the second connector including an inner lumen, and the male Luer portion of the second connector including an inner lumen fluidly communicating with the inner lumen of the female Luer portion of the second connector; And A column mounted in the second connector and extending from the inner lumen of the female Luer portion of the second connector through the lumen of the male Luer portion of the first connector into an internal chamber of the compressible valve member, the compressible valve member being mounted around at least a portion of the column. Wherein, in the coupling structure between the first connector and the fluid collection device, the compressible valve member is compressed by the fluid collection device to fluidly connect the column with the fluid collection device via a slot of the compressible valve member. Wherein, the column includes an elongate tube having a lumen that tapers from a distal end to a proximal end of the column. Wherein, the second connector further includes a support portion at a proximal end of the male Luer portion of the second connector, and the column is mounted on the support portion to fluidly connect the second connector with the fluid collection device.

27. The flow restriction device according to claim 26, wherein, The compressible valve member includes a head portion having a slot and a body portion extending distally from the head portion, and in the coupling configuration of the first connector to the fluid collection device, the body portion of the compressible valve member is compressed to move the head portion distally to fluidly connect the lumen of the column to the fluid collection device to allow fluid to flow from the second connector through the lumen of the column into the fluid collection device.

28. The flow restriction device according to claim 27, wherein The body portion includes an accordion shape.

29. The flow restriction device according to claim 27, wherein, The head portion includes a split diaphragm.

30. The flow restriction device according to claim 26, wherein, The support portion extends distally from the male Luer portion of the second connector into the lumen of the female Luer portion of the second connector.

31. The flow restriction device according to claim 26, wherein The fluid flowing from the second connector through the lumen of the column into the fluid collection device includes blood.

32. A flow restriction device, characterized in that, Comprising: A male Luer connector portion configured to be coupled to a catheter assembly, the male Luer connector portion including an inner surface defining its lumen; A female Luer connector portion disposed adjacent to the male Luer connector portion and configured to be coupled to a fluid collection device, the female Luer connector portion including an inner surface defining a lumen that is fluidly connected to the lumen of the male Luer connector portion; A tube extending from the lumen of the male Luer connector portion into the lumen of the female Luer connector portion, wherein the lumen of the tube defines a fluid path along which fluid flows from the male Luer connector portion through the female Luer connector portion into the fluid collection device, wherein at least a portion of the tube includes a non-linear tube, wherein the male Luer connector portion further includes a support portion that extends radially inward from the inner surface into the lumen of the male Luer connector portion and includes a mounting hole.

33. The flow restriction device according to claim 32, wherein The portion of the non-linear tube that includes the non-linear tube is disposed in the lumen of the female Luer connector portion.

34. The flow restriction device according to claim 32, wherein, The non-linear tube includes a coiled-shaped tube.

35. The flow restriction device according to claim 32, wherein The non-linear tube includes an S-shaped tube.

36. The flow restriction device according to claim 32, wherein, The fluid flowing from the male Luer connector portion through the female Luer connector portion into the fluid collection device includes blood.

37. The flow restriction device according to claim 32, wherein The tube includes a linear tube.

38. The flow restriction device according to claim 37, characterized in that, The linear tube includes an intubation tube mounted in the male Luer connector portion.

39. The flow restriction device according to claim 38, wherein, The intubation tube is mounted in the mounting hole to fluidly connect the male Luer connector portion to the fluid collection device.

40. The flow restriction device according to claim 39, wherein The intubation tube is press-fitted in the support portion.

41. The flow restriction device according to claim 37, wherein, The fluid flowing from the male Luer connector portion through the female Luer connector portion into the fluid collection device includes blood.

42. A flow restriction device, characterized in that, Comprising: A distal connector configured to be coupled to a catheter assembly, the distal connector including a first connection portion at its proximal end and a second connection portion at its distal end, each of the first connection portion and the second connection portion including an inner surface defining a lumen; A proximal connector coupled to the distal connector and configured to be coupled to a fluid collection device; An insert, which is installed in the lumen of the first connection part and includes an outer surface having a groove, the groove being recessed in the outer surface and at least partially extending along the length of the outer surface, wherein the groove is fluidly coupled to the lumen of the second connection part and the lumen of the first connection part, wherein the inner surface of the first connection part surrounds the outer surface of the insert such that the inner surface of the first connection part and the groove define at least a part of a fluid channel, and fluid flows along the fluid channel from the distal connector into the fluid collection device, wherein the groove includes a linear groove recessed in the outer surface, wherein the distal connector further includes a support portion disposed between the proximal end and the distal end, and the support portion includes a mounting hole recessed therein.

43. The flow restriction device according to claim 42, wherein The outer surface further includes longitudinally extending flanges, each flange being disposed at opposite edges of the linear groove to seal the edges.

44. The flow restriction device according to claim 42, wherein The insert includes a first channel segment fluidly coupled to the lumen of the proximal end of the second connection part, and a second channel segment extends from the first channel segment to the linear groove, and the first and second channel segments and the linear groove together define the fluid channel, and fluid flows along the fluid channel from the distal connector into the fluid collection device.

45. The flow restriction device according to claim 44, wherein, The first channel segment and the linear groove are offset from each other in position, and the second channel segment includes an inclined surface that couples the first channel segment to the linear groove.

46. The flow restriction device according to claim 42, wherein, The fluid flowing from the distal end into the fluid collection device includes blood.

47. A flow restriction device, characterized in that, Comprising: A connector, which includes a body portion having a lumen and disposed at the proximal end, a base portion having a lumen and disposed at the distal end, and a compressible valve member disposed on the base portion and extending into the lumen of the body portion, and the body portion is configured to be coupled to a fluid collection device; And A column having a lumen extending therethrough, the column being installed in the lumen of the base portion and extending into the inner chamber of the compressible valve member, the compressible valve member being installed around the column, and the column being configured to be in fluid communication with a catheter assembly, wherein, in the coupling configuration of the body portion and the fluid collection device, the compressible valve member is compressed by the fluid collection device to fluidly communicate the column with the fluid collection device via a slot of the compressible valve member, wherein the compressible valve member includes a head portion having a slot and a body portion extending distally from the head portion, and in the coupling configuration of the body portion and the fluid collection device, the body portion of the compressible valve member is compressed to allow the head portion to move distally to fluidly communicate the lumen of the column with the fluid collection device and allow fluid to flow from the distal end of the column through the lumen of the column into the fluid collection device, Wherein, the connector further includes a support portion disposed between the proximal end and the distal end of the connector, the support portion including a proximal end, a distal end, and a central mounting hole extending from the proximal end to the distal end.

48. The flow restriction device according to claim 47, wherein, The main body portion has an accordion shape.

49. The flow restriction device according to claim 47, wherein The head portion includes a split diaphragm.

50. The flow restriction device according to claim 47, wherein The lumen of the column tapers from the distal end to the proximal end of the column.

51. The flow restriction device according to claim 50, wherein, The fluid flowing from the distal end of the column through the lumen of the column into the fluid collection device includes blood.

52. A flow restriction device, characterized in that, Comprising: A connector including a female Luer portion having a lumen and disposed at the proximal end, a male Luer portion having a lumen and disposed at the distal end, and a compressible valve member mounted in the lumen of the female Luer portion and fluidly coupled to the lumen of the male Luer portion, the female Luer portion being configured to be coupled to a fluid collection device, and the male Luer portion being configured to be coupled to a catheter assembly; And A column mounted in the female Luer portion and extending into an internal chamber of the compressible valve member, the compressible valve member being mounted around the column, and the column being in fluid communication with the lumen of the male Luer portion, Wherein, in the coupling configuration between the female Luer portion and the fluid collection device, the compressible valve member is compressed by the fluid collection device to fluidly communicate the column with the fluid collection device via a slot of the compressible valve member, Wherein, the compressible valve member includes a head portion having a slot and a main body portion extending distally from the head portion, and in the coupling configuration between the female Luer portion and the fluid collection device, the main body portion of the compressible valve member compresses to move the head portion distally to fluidly communicate the lumen of the column with the fluid collection device and allow fluid to flow from the male Luer portion through the lumen of the column into the fluid collection device, Wherein, the female Luer portion further includes a support portion at its distal end, and the column is mounted on the support portion to fluidly communicate the lumen of the male Luer portion with the fluid collection device.

53. The flow restriction device according to claim 52, wherein, The main body portion has an accordion shape.

54. The flow restriction device according to claim 52, wherein, The head portion includes a split diaphragm.

55. The flow restriction device according to claim 52, characterized in that, The fluid flowing from the male Luer portion through the lumen of the column into the fluid collection device includes blood.

56. A blood collection system, characterized in that, Comprising: A blood collection device including a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface, wherein the blood collection device includes a Luer lock access device; and A flow restriction device engaged with the connection portion and fluidly coupled to the lumen of the needle, the flow restriction device including: A connector including a proximal end disposed in the connection portion, a distal end configured to be coupled to a catheter assembly, and an inner surface defining an inner lumen; and A cannula mounted in the inner lumen and extending from the distal end of the connector into the connection portion, wherein the lumen of the cannula defines a flow path along which blood flows from the distal end into the lumen of the needle. Wherein, the connector further includes a support portion disposed between the proximal end and the distal end of the connector, the support portion includes a proximal end, a distal end, and a central mounting hole extending from the proximal end to the distal end, and the cannula is mounted in the central mounting hole to fluidly connect the flow restriction device with the catheter assembly.

57. The blood collection system according to claim 56, wherein, The blood collection device includes a Luer lock access device.

58. The blood collection system according to claim 56, characterized in that, The blood collection device includes a vacuum blood collection tube.

59. A blood collection system, characterized in that, Comprising: A blood collection device, the blood collection device includes a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface, wherein the blood collection device includes a Luer lock access device; and A flow restriction device, the flow restriction device is engaged with the connection portion and fluidly coupled to the lumen of the needle, the flow restriction device includes: A connector, the connector includes a proximal end disposed in the connection portion, a distal end configured to be coupled to a catheter assembly, and an inner surface defining an inner lumen; and A cannula, the cannula is mounted in the inner lumen, extending from the distal end to the proximal end of the connector, wherein the lumen of the cannula defines a flow path, and blood flows along the flow path from the distal end to the lumen of the needle. Wherein, the connector further includes a support portion disposed between the proximal end and the distal end of the connector, the support portion includes a proximal end, a distal end, and a central mounting hole extending from the proximal end to the distal end, and the cannula is mounted in the central mounting hole to fluidly connect the flow restriction device with the catheter assembly.

60. The blood collection system according to claim 59, wherein, The blood collection device includes a vacuum blood collection tube.

61. A blood collection system, characterized in that, Comprising: A blood collection device, which includes a container having an outer surface, an inner surface defining an internal chamber, a needle extending proximally from the inner surface, and a connection portion extending distally from the outer surface, wherein the connection portion includes an insertion portion having an outer surface, and the outer surface has a continuous non-linear channel recessed therein, and wherein the blood collection device includes a Luer lock access device; and A connector, which is configured to be coupled to a catheter assembly, the connector includes a first connection portion at its proximal end and a second connection portion at its distal end, and the first connection portion includes an inner surface defining a lumen, and the insertion portion is coupled into the lumen; Wherein, the inner surface of the first connection portion surrounds the outer surface of the insertion portion, such that the inner surface of the first connection portion and the continuous non-linear channel define a non-linear fluid path, and fluid flows along the non-linear fluid path from the connector to the lumen of the needle. Wherein, the connector further includes a support portion disposed between the proximal end and the distal end of the connector, the support portion includes a proximal end, a distal end, and a central mounting hole extending from the proximal end to the distal end.

62. The blood collection system according to claim 61, wherein the continuous non-linear channel includes a continuous groove, and the continuous groove has a coil shape recessed in the outer surface.

63. The blood collection system according to claim 61, wherein, The continuous non-linear channel includes continuous grooves, and the continuous grooves have an S shape recessed in the outer surface.

64. The blood collection system according to claim 61, wherein, The blood collection device includes a vacuum blood collection tube.

65. The blood collection system according to claim 61, wherein, The connector includes a male Luer connector portion.

Images