Fluid barrier device and flow restriction device having a fluid barrier device - Patents.com

Abstract

The flow restricting device includes a proximal housing configured to couple to a fluid collection device, a distal housing configured to couple to a catheter assembly, an intermediate housing interposed between the proximal and distal housings, an internal fluid channel extending laterally through the proximal, intermediate, and distal housings, and a fluid shielding device coupled to the distal housing and including a flexible material. The fluid shielding device covers an end of a male center post of the distal housing in a disconnected position, depresses the male center post into a groove in the distal housing in a connected position, and returns the end of the male center post to contain fluid within the male center post when returned to the disconnected position. A blood collection system and a fluid shielding device are also provided.

Description

[Technical Field]

[0001] The present disclosure relates generally to intravenous (IV) blood withdrawal from a patient, and more particularly to systems and methods for reducing hemolysis in over-the-needle peripheral IV catheter (PIVC) blood withdrawal while reducing blood leakage. [Background technology]

[0002] Catheters are commonly used for various infusion therapies. For example, catheters may be used to infuse fluids, such as normal saline, various medications, and total parenteral nutrition, into a patient. Catheters may also be used to withdraw blood from a patient.

[0003] A common type of catheter is the PIVC. As the name suggests, an over-the-needle catheter may be mounted over an introducer needle with a sharp distal tip. The catheter assembly may include a catheter hub, a catheter extending distally from the catheter hub, and an introducer needle extending through the catheter. The catheter and introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter and the bevel of the needle points up, away from the patient's skin. The catheter and introducer needle are typically inserted through the skin into the patient's vasculature at a shallow angle.

[0004] To verify proper placement of the introducer needle and / or catheter within the vessel, the clinician typically confirms the presence of a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician may temporarily occlude flow within the vasculature and remove the needle, leaving the catheter in place for subsequent blood withdrawal or fluid injection.

[0005] A blood collection container may be used to withdraw blood or collect a blood sample from a patient. The blood collection container may include a syringe. Alternatively, the blood collection container may include a test tube with a rubber stopper at one end. In some instances, the test tube has had all or some of the air removed from it, so that the pressure inside the tube is less than ambient pressure. Such blood collection containers are often referred to as internally evacuated or vacuum tubes. A commonly used blood collection container is the VACUTAINER® blood collection tube, available from Becton Dickinson & Company.

[0006] The blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure in the vein becomes greater than the pressure in the blood collection container, forcing blood into the blood collection container and filling the blood collection container. The vacuum in the blood collection container decreases as the blood collection container fills until the pressure in the blood collection container equals the pressure in the vein and blood flow stops.

[0007] Unfortunately, when blood is drawn into a blood collection container, red blood cells are under high shear stress and are prone to hemolysis due to the high initial pressure difference between the vein and the blood collection container. Hemolysis can result in the rejection and disposal of the blood sample. The high initial pressure difference can also lead to catheter tip collapse, vein collapse, or other complications that prevent or limit the filling of the blood collection container. Furthermore, blood leakage during and / or after blood collection is common.

[0008] A description provided in the Background section should not be presumed to be prior art merely because it is mentioned in or associated with the Background section. The Background section may include information that describes one or more aspects of the subject technology. Summary of the Invention

[0009] In one or more embodiments, the flow restricting device includes a proximal housing configured to couple to a fluid collection device, a distal housing configured to couple to a catheter assembly, an intermediate housing interposed between the proximal and distal housings, an internal fluid channel extending laterally through the proximal, intermediate, and distal housings, and a fluid shielding device coupled to the distal housing and comprising a flexible material, the fluid shielding device configured to cover an end of a male center post of the distal housing in the disconnected position, to depress the male center post into a groove in the distal housing in the connected position, and to return the end of the male center post to contain fluid within the male center post when returned to the disconnected position.

[0010] In one or more embodiments, a blood collection system includes a blood collection device, a catheter assembly, and a flow restriction device fluidly coupled to the blood collection device. The flow restriction device includes a proximal housing coupled to the male connector of the blood collection device, a distal housing including a male Luer connector configured to mate with the female connector of the catheter assembly, an intermediate housing interposed between the proximal and distal housings, an internal fluid channel extending laterally through the proximal, intermediate, and distal housings, and a fluid barrier device coupled to the distal housing, the fluid barrier device including a flexible shape-memory material. The fluid barrier device is configured to cover the end of the male center post of the male Luer connector in an uncompressed position, to slide the male center post downward into a groove in the distal housing in a compressed position, and to slide the male center post upward over the end of the male center post when returned to the uncompressed position to contain fluid within the male center post.

[0011] In one or more embodiments, a fluid barrier device for a male luer connector comprises a flexible shape memory material configured to cover the end of the male center post of the male luer connector in an uncompressed position, to slide the male center post downward to a compressed position, and when returned to the uncompressed position, to slide the male center post upward over the end of the male center post to contain fluid within the male center post.

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

[0013] The following figures are included to illustrate certain aspects of the embodiments and should not be considered exclusive embodiments. The disclosed subject matter is capable of considerable modification, permutation, combination, and equivalents in form and function, as will occur to those skilled in the art and having the benefit of this disclosure. [Brief explanation of the drawings]

[0014] [Figure 1] 1A-1C illustrate a vascular access device including a PIVC assembly including a flow restriction device, according to some embodiments of the present disclosure. [Figure 2] 1 is a perspective view of a flow restrictor device according to some embodiments of the present disclosure. FIG. [Figure 3] 1A-1C illustrate a vascular access device including a PIVC assembly including a flow limiting extension set, according to some embodiments of the present disclosure. [Figure 4] FIG. 1 is a perspective view of a flow restricting extension set according to some embodiments of the present disclosure. [Figure 5]FIG. 1 is a cross-sectional perspective view of a portion of a fluid barrier device and a male luer connector according to some embodiments of the present disclosure. [Figure 6] 1 is a cross-sectional front view of a connector assembly having a female connector coupled to a male connector and a fluid shielding device prior to connection, according to some embodiments of the present disclosure. FIG. [Figure 7] FIG. 7 is a cross-sectional front view of the connector assembly of FIG. 6 after connection, according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0015] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Thus, dimensions may be provided for particular embodiments as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology.

[0016] It should be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology are disclosed herein according to specific, but non-limiting, examples. The various embodiments described in the present disclosure can be implemented in different ways and with modifications according to a desired application or implementation.

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

[0018] Various embodiments of the present disclosure relate to providing assemblies and methods for addressing blood leaks in PIVC blood collection using a hemolysis reduction accessory (also referred to herein as a flow restrictor) that is pre-attached to the PIVC and functions as a flow restrictor to reduce the risk of hemolysis. The hemolysis reduction accessory is advantageously compatible with PIVC placement and does not require modifications to any existing operation. The hemolysis reduction accessory of various embodiments described herein is potentially applicable to a wide variety of PIVC products and is compatible with existing blood collection devices and infusion disposables.

[0019] Here, the flow restrictor regulates the overall flow rate of the entire fluid pathway as blood cells pass through. The flow restrictor can be assembled with or packaged with the PIVC. This allows for blood flashback, eliminating additional movement during catheter placement. The clinician can connect a blood draw device to the accessory port and then draw blood into the intended volume. After blood collection, the clinician can disconnect and discard the flow restrictor and blood draw device. This allows for a single blood draw or can remain in-line throughout the entire placement.

[0020] In some embodiments, the flow restricting device may be a one-piece connector including a proximal housing, a distal housing, and an intermediate housing, each housing having an aligned fluid channel axially disposed therein. Thus, fluid communication may be established between the proximal housing, the distal housing, and the intermediate housing to allow fluid to flow from the distal housing through the intermediate housing to the proximal housing. Together, the aligned internal fluid channels may define a linear internal flow path through the flow restricting device. Thus, during blood collection or withdrawal from a patient, blood may flow from the patient's vein through the internal flow path of the flow restricting device to a blood collection device.

[0021] In some embodiments, the flow restrictor may be an extension set including IV tubing having a male Luer connection on one end and a female Luer connection on the other end. Thus, fluid communication can be established between the male and female Luer connections and the IV tubing, allowing fluid to flow from the female Luer connection through the IV tubing to the male Luer connection. Thus, during blood collection or withdrawal from a patient, blood can flow from the patient's vein through the internal flow path of the flow restrictor to a blood collection device.

[0022] For example, during blood collection using currently existing blood collection devices, blood cells may experience shear stress as they flow from the distal housing to the proximal housing. The maximum shear stress may be along the wall of the blood cell, often referred to as wall shear stress. Wall shear stress on blood cells is believed to be the primary cause of mechanical damage to blood cells, leading to hemolysis. In some embodiments, a linear internal flow channel of a flow restricting device having a minimum diameter can facilitate increased flow resistance within a vascular access system to distribute pressure differences and reduce the shear stress experienced by red blood cells of the blood. For example, a minimum diameter of the internal flow channel can increase resistance to blood flow, thereby reducing the blood flow rate within the flow restricting device. A reduced blood flow rate can advantageously reduce the risk of hemolysis during blood collection because it reduces the shear stress experienced by red blood cells of the blood.

[0023] In some embodiments, the distal housing of the integrated connector flow restrictor device can include a male connector, such as a male Luer connector, and the proximal housing can include a female connector, such as a needleless connector. In some embodiments, the extension set flow restrictor device can include a male connector, such as a male Luer connector, and a female connector, such as a needleless connector. In some embodiments, the flow restrictor device can include a fluid seal assembly coupled to the distal housing or the male connector. For example, the fluid seal assembly can include a dividing septum and an enclosure for mating with the male Luer connector.

[0024] Various embodiments of the present disclosure relate to providing assemblies and methods for addressing blood leakage in PIVC blood collection, including an extension set having a male Luer connector on one end and a female Luer connector on the opposite end. A standard ISO male Luer connector is used to connect to the catheter-side needleless connector, which has the potential for blood exposure from the male Luer connector during disconnection after blood collection is completed.

[0025] Blood collection devices are often used with a Luer Lock Access Device (LLAD) or syringe (e.g., the blood collection device is connected to the LLAD or syringe and then used for blood collection). To avoid blood leakage, it is generally prescribed to discard the LLAD or syringe and blood collection device together. After blood collection, i.e., after removing the blood-filled container (e.g., Vacutainer), the next step is to disconnect the blood collection device containing the remaining blood. Therefore, potential blood exposure to the clinician when disconnecting the blood collection device from the PIVC needleless connector is an issue.

[0026] In some embodiments, a split septum with a small enclosure around the male luer is provided on the front of the blood collection device connector. The needleless connector is pressed into the split septum while connected to the blood collection device. The split septum self-seals, preventing or minimizing residual blood from leaking out of the blood collection device when the needleless connector is removed. The septum seals the interior of the enclosure, preventing any leakage. The split septum may be made of a silicone material and may be attached to the luer enclosure in any suitable manner (e.g., glued, welded, overmolded). The split septum may also be attached to the blood collection device connector on the front side of the male luer. For example, the split septum may be glued to the enclosure, which may be friction-fitted to the front end of the male luer connector of the blood collection device, and the split septum may also be glued to the front edge of the male luer connector.

[0027] The various embodiments of the flow restriction devices and associated blood collection systems described herein further provide additional advantages over currently existing blood collection systems. For example, the add-on flow restriction devices described herein allow for the integration of hemolysis reduction functionality for PIVC blood collection. Furthermore, the flow restriction devices described herein are compatible with PIVC placement, allowing for seamless blood collection upon insertion. Furthermore, because the flow restriction devices are add-ons that can be easily incorporated into existing PIVCs without modification, the impact on clinical settings and operations is minimal. As another example, the extension sets with male Luer connectors described herein allow for safe disconnection from existing PIVCs.

[0028] FIG. 1 illustrates a vascular access device 100 including a PIVC assembly 50, which includes a flow restriction device 110, according to some embodiments of the present disclosure. The flow restriction device 110 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 50. The catheter assembly 50 may include a catheter hub 52, which may include a distal end 54, a proximal end 56, and a lumen extending through the distal end 54 and the proximal end 56. The catheter assembly 50 may further include a catheter 58, which may be secured within the catheter hub 52 and may extend distally from the distal end 54 of the catheter hub 52. In some embodiments, the catheter assembly 50 may be a PIVC or any other suitable catheter device.

[0029] In some embodiments, the catheter assembly 50 may include or correspond to any suitable catheter assembly 50. In some embodiments, the catheter assembly 50 may be one-piece and may include an extension tube 60 that may extend from and be integrated into the side port 59 of the catheter hub 52. A non-limiting example of an one-piece catheter assembly is the BD NEXIVA™ Closed IV Catheter System available from Becton Dickinson and Company. In some embodiments, the proximal end of the extension tube 60 may be coupled to an adapter, such as a Y adapter 70. In some embodiments, the flow restriction device 110 may be fluidly coupled to the Y adapter 70, such as a needleless connector 72.

[0030] In some embodiments, the catheter assembly 50 may not be integrated and may not include the extension tube 60. In these and other embodiments, the flow restriction device 110 may be configured to couple to the proximal end 56 of the catheter hub 52 or another suitable portion of the catheter assembly 50. In some embodiments, the flow restriction device 110 may be coupled directly to the catheter assembly 50, thereby eliminating the extension tube 60 and providing a compact catheter system.

[0031] According to some embodiments, the flow restriction device 110 may be configured to couple to the blood draw device 40. For example, the flow restriction device 110 may include a female luer connector 113 on the proximal housing 112, which may mate with the male luer connector 42 of the blood draw device 40. In some embodiments, the blood draw device 40 may be an LLAD.

[0032] 2 shows an exploded perspective view of a flow restriction device 110, according to some embodiments of the present disclosure. As shown in FIG. 2, in some embodiments, the flow restriction device 110 may include a proximal housing 112 configured to couple to the blood draw device 40. For example, the proximal housing 112 may be integrated with the blood draw device 40 or monolithically formed therewith as a single unit. As another example, the proximal housing 112 may include a female luer connector 113, which may mate with the male luer connector 42 of the blood draw device 40.

[0033] In some embodiments, the flow restrictor 110 may be in the form of a cylinder extending from a proximal housing 112 to a distal housing 114, with an intermediate housing 116 interposed between the proximal and distal housings 112, 114. An internal flow path 170 may be disposed through the proximal housing 112, the intermediate housing 116, and the distal housing 114 to provide a fluid flow path from end to end of the flow restrictor 110.

[0034] The distal housing 114 may include a male luer center post 115, and the fluid barrier device 120 may be coupled to the distal housing 114. The fluid barrier device 120 may be an elastomeric seal that partially or completely covers the male luer center post 115. For example, the fluid barrier device 120 (e.g., an elastomeric seal) may be stretched over the male luer center post 115. The fluid barrier device 120 may be removably coupled to the male luer center post 115 via a friction fit. As another example, the fluid barrier device 120 may be integrally coupled to the male luer center post 115 (e.g., glued, welded, overmolded).

[0035] FIG. 3 illustrates a vascular access device 100 including a PIVC assembly 50 that includes a flow restriction device 210 (e.g., an extension set) according to some embodiments of the present disclosure. The flow restriction device 210 may be configured to reduce the possibility of hemolysis during blood collection using the vascular access device 100. In some embodiments, the flow restriction device 210 may include the distal housing 114, male Luer center post 115, and fluid shielding device 120 described above. In some embodiments, the flow restriction device 210 may be fluidly coupled to a Y-adapter 70. In some embodiments, the flow restriction device 210 may be configured to couple to the proximal end 56 of the catheter hub 52 or another suitable portion of the catheter assembly 50. In some embodiments, the flow restriction device 210 may be coupled directly to the catheter assembly 50, thereby eliminating the extension tube 60 and providing a compact catheter system.

[0036] According to some embodiments, the flow restrictor 210 may be configured to couple to the blood draw device 40. For example, the flow restrictor 210 may include a female luer connector 213 on the proximal housing 212, which may mate with the male luer connector 42 of the blood draw device 40.

[0037] 4 shows a partial cross-sectional perspective view of a flow restriction device 210, according to some embodiments of the present disclosure. As shown in FIG. 4, in some embodiments, the flow restriction device 210 may include a proximal housing 212 configured to couple to the blood draw device 40. For example, the proximal housing 212 may be integrated with the blood draw device 40 or monolithically formed therewith as a single unit. As another example, the proximal housing 212 may include a female luer connector 213, which may mate with the male luer connector 42 of the blood draw device 40.

[0038] In some embodiments, the flow restrictor 210 may be in the form of an IV tubing 216 extending from the proximal housing 212 to the distal housing 114, with the IV tubing 216 interposed between the proximal housing 212 and the distal housing 114. An internal flow path 270 may be disposed through the proximal housing 112, the IV tubing 216, and the distal housing 114 to provide a fluid flow path from end to end of the flow restrictor 210.

[0039] The distal housing 114 may include a male luer center post 115, and the fluid shut-off device 120 may be coupled to the distal housing 114 and / or the male luer center post 115 of the flow restrictor 210. The fluid shut-off device 120 may be removably or integrally coupled to the distal housing 114 and / or the male luer center post 115 in any suitable manner described herein.

[0040] 5 shows a fluid barrier device 120 coupled to the distal housing 114 / male luer center post 115 of either flow restriction device 110 or flow restriction device 210. The fluid barrier device 120 may be shaped to be received by a groove 117 in the distal housing 114. The fluid barrier device 120 may be formed of a flexible material configured to allow the fluid barrier device 120 to be pressed onto the male luer center post 115 of the distal housing 114 to a desired depth within the groove 117 (e.g., to the inner end or bottom of the groove 117). Thus, the fluid barrier device 120 may be added to or removed from the distal housing 114 as needed.

[0041] In some embodiments, the fluid barrier device 120 may be secured to the distal housing 114. For example, an adhesive or solvent may be placed in the groove 117 before sliding the fluid barrier device 120 into the groove 117 and over the male luer center post 115. As another example, the fluid barrier device 120 may be overmolded onto the distal housing 114, with the fluid barrier device 120 molded into the groove 117 and over the male luer center post 115. As another example, a portion of the fluid barrier device 120 may be welded (e.g., sonic welded, heat welded) to the groove 117 and / or the male luer center post 115.

[0042] 6 and 7, connector assembly 300 includes a fluid shielding device 120 of either flow restrictor 110 or flow restrictor 210 (shown in FIG. 5) and a female connector 310 coupled to a distal housing 114 / male luer center post 115. Here, male luer center post 115 is received within female connector 310 such that internal flow channels 170, 270 of flow restrictor 110, 210 are fluidly coupled to an internal flow channel 370 of female connector 315. Additionally, threads 111 of distal housing 114 rotatably engage with threads 311 of female connector 310, thus providing a secure connection during use of connector assembly 300. As seen in FIG. 6, in the disconnected position of connector assembly 300, fluid shielding device 120 is disposed (e.g., stretched, friction-fitted, slidably coupled) around the outer surface of male luer center post 115. In embodiments of the present disclosure, the female connector 310 may be any suitable female connector configured to mate with any male luer connector, such as, for example, the needleless connector 72 and the proximal end 56 of the catheter hub 52.

[0043] Fluid barrier device 120 may be used with any male luer connector, such as a stand-alone male luer connector or a male luer connector that is part of any injection component (e.g., drip chamber, syringe, valve, flow controller), where fluid barrier device 120 may be sized and shaped to cover part or all of the center post of the male luer connector.

[0044] The fluid shielding device 120 may be formed of any suitable material, such as a shape memory material (e.g., elastic rubber, elastomeric silicone, latex) that, after being compressed by an opposing connector, such as the female luer connector 315, as shown in FIG. 7, returns to its uncompressed shape (e.g., the shape shown in FIG. 6) when the male luer center post 115 is disconnected or disengaged from the opposing connector (e.g., the female luer connector 315).

[0045] In use, the fluid barrier device 120 is coupled to the distal housing 114 such that at least one end of the male luer center post 115 is enclosed within the fluid barrier device 120. Any suitable female connector (e.g., proximal end 56, needleless connector 72, female connector 310) may then be coupled to the distal housing 114 / male luer center post 115. For example, as shown in FIGS. 6 and 7, upon connection of the connector assembly 300, the end of the female connector 310 contacts the outer end of the fluid barrier device 120. The fluid barrier device 120 is then pushed down or compressed into the groove 117 of the distal housing 114, thus moving the fluid barrier device 120 away from covering the internal flow passage 170, 270 of the flow restriction device 110, 210. The flexible material of the fluid barrier device 120 remains compressed within the groove 117 of the distal housing 114 while the female connector 310 is mated with the distal housing 114 / male luer center post 115. Here, the female connector 310 and the distal housing 114 may each be threaded (e.g., threads 311, 111), and full mating may involve rotating the female connector 310 relative to the distal housing 114 until at least partially or fully seated, thus providing a secure connection.

[0046] When it is desired to disconnect the flow restricting device 110, 210, the female connector 310 may be uncoupled from the distal housing 114 / male luer center post 115, the female connector 310 may then be pulled out of the groove 117, and the fluid blocking device 120 may extend back beyond the male luer center post 115, covering the internal flow passage 170, 270 of the flow restricting device 110, 210. Thus, any fluid (e.g., blood) remaining within the internal flow passage 170, 270 (e.g., lumen) of the male luer center post 115 is contained within the male luer center post 115.

[0047] In aspects of the present disclosure, the fluid shielding device 120 prevents blood exposure and / or leakage during disconnection of the female connector 310 from the distal housing 114 / male luer center post 115. Thus, the clinician does not need to perform a secondary action, such as manually covering the distal housing 114 / male luer center post 115, because any blood remaining within the male luer center post 115 is blocked within the internal flow path 170, 270 (e.g., lumen) by the fluid shielding device 120 being repositioned around the male luer center post 115. Thus, in aspects of the present disclosure, the fluid shielding device 120 self-seals upon removal of the female connector 310.

[0048] According to various embodiments of the present disclosure, a method of manufacturing a flow restricting device having a fluid barrier assembly may include securing a fluid barrier device 120 to the distal housing 114 and / or the male luer center post 115. For example, an end of the fluid barrier device 120 may be secured to the groove 117 and / or the end of the fluid barrier device 120 may be secured to the outer surface of the male luer center post 115, while an unsecured portion of the fluid barrier device 120 may slidably move within the groove 117 and / or along the outer surface of the male luer center post 115. In aspects of the present disclosure, the end of the fluid barrier device 120 may be secured to the groove 117 and / or the male luer center post 115 via a glue or solvent. In aspects of the present disclosure, the end of the fluid barrier device 120 may be secured to the groove 117 and / or the male luer center post 115 by any suitable method, such as glueing, welding, molding, and overmolding. In embodiments of the present disclosure, the distal housing 114, male luer center post 115, and fluid shielding device 120 may be molded as a single component in one or more molding operations.

[0049] In operation, the flow restriction device 110, 210 having the fluid shut-off device 120 may be connected between the catheter assembly 50 and the blood draw device 40, as shown in Figures 1 and 3. Thus, during blood draw or withdrawal from a patient, blood may flow from the patient's vein into the catheter assembly 50, through the extension tube 60, into the internal flow passage 170, 270 of the flow restriction device 110, 210 via the distal housing 114, out of the flow restriction device 110, 210 via the proximal housing 112, and into the blood draw device 40. Thus, during blood draw or withdrawal from a patient, blood may enter the blood draw device 40 via the internal flow passage 170, 270 having the smallest diameter.

[0050] The various embodiments of the flow restriction devices 110, 210 described herein are advantageous over currently existing blood collection systems. For example, during blood collection using currently existing blood collection devices, blood cells may experience shear stress as they flow from a catheter (e.g., catheter system 50) to a blood collection device (e.g., blood collection device 40). The maximum shear stress may be along the wall of the blood cell, often referred to as wall shear stress. Wall shear stress on blood cells is believed to be the primary cause of mechanical damage to blood cells, leading to hemolysis. In some embodiments, a linear internal flow channel 170, 270 with a minimum diameter can facilitate increased flow resistance within the vascular access system 100 to distribute pressure differences and reduce the shear stress experienced by red blood cells. For example, a minimum diameter of the internal flow channel 170, 270 can increase resistance to blood flow, thereby reducing the blood flow rate within the flow resistance device 110, 210. A reduced blood flow rate can advantageously reduce the risk of hemolysis during blood collection because it reduces the shear stress experienced by red blood cells.

[0051] Additionally, the above-described configuration of the flow restricting device 110, 210 is advantageous over other blood collection systems in that the fluid shutoff device 120 blocks fluid leakage or spillage from the male Luer center post 115, but can prevent blood leakage from the flow restricting device 110, 210 during disconnection from the blood collection device 40. For example, in other blood collection systems, recommended blood collection procedures stipulate that the blood collection connector should not be disconnected from the blood collection device (e.g., a Luer Lock Access Device (LLAD)) after the blood collection procedure is completed. If the blood collection connector is disconnected from the blood collection device, the blood collection connector may cause potential blood leakage from the blood collection connector channel when disconnected from the blood collection device. In contrast, the fluid shut-off device 120 of the various embodiments of the flow restricting devices 110, 210 described herein blocks the passage of fluid from the male luer center post 115 but allows blood to be contained within the fluid shut-off device 120, thereby preventing blood leakage when the flow restricting device 110, 210 is disconnected from the blood collection device 40 for disposal.

[0052] The various embodiments of the flow restriction devices and associated blood collection systems described herein additionally provide further advantages over other blood collection systems. For example, the add-on flow restriction devices described herein allow for the integration of hemolysis reduction functionality for PIVC blood collection, significantly reducing hemolysis. Furthermore, the flow restriction devices described herein are compatible with PIVC placement, allowing for seamless blood collection upon insertion. Furthermore, because the flow restriction devices are add-ons that can be easily incorporated without modifying an existing PIVC, there is minimal impact on the clinical setting and operation. Furthermore, the flow restriction devices described herein minimize or otherwise eliminate the risk of blood leakage during disconnection from the blood collection device. Furthermore, the flow restriction devices described herein have a smaller priming volume compared to other blood collection systems, resulting in less blood waste. Furthermore, the flow restriction devices described herein require a shorter fill time compared to currently existing blood collection systems.

[0053] The subject technology is illustrated, for example, in accordance with various aspects described below. Various examples of aspects of the subject technology are described by way of example, but not limitation of the subject technology. It should be noted that aspects can be combined with one or more other aspects in any combination.

[0054] In one or more embodiments, the flow restricting device comprises a proximal housing configured to couple to a fluid collection device, a distal housing configured to couple to a catheter assembly, an intermediate housing interposed between the proximal and distal housings, an internal fluid channel extending laterally through the proximal, intermediate, and distal housings, and a fluid shielding device coupled to the distal housing and comprising a flexible material, the fluid shielding device configured to cover the end of the male center post of the distal housing in the disconnected position, to depress the male center post into a groove in the distal housing in the connected position, and to return the end of the male center post to contain fluid within the male center post when returned to the disconnected position.

[0055] In an embodiment of the present disclosure, the flexible material of the fluid shielding device includes a shape memory material. In an embodiment of the present disclosure, the shape memory material includes one of elastic rubber, elastomeric silicone, and latex. In an embodiment of the present disclosure, a portion of the flexible material is secured to the groove by one of an adhesive and a solvent. In an embodiment of the present disclosure, a portion of the flexible material is secured to the male center post by one of an adhesive and a solvent. In an embodiment of the present disclosure, a portion of the flexible material is welded to the distal housing. In an embodiment of the present disclosure, a portion of the flexible material is welded to the male center post. In an embodiment of the present disclosure, a portion of the flexible material is molded to the distal housing. In an embodiment of the present disclosure, a portion of the flexible material is molded to the male center post. In an embodiment of the present disclosure, the fluid shielding device is coupled to the male center post by a friction fit.

[0056] In an aspect of the present disclosure, a portion of the fluid shielding device is configured to slide downward along the outer surface of the male center post and fit into the groove under a compressive force. In an aspect of the present disclosure, a portion of the fluid shielding device is configured to slide upward along the outer surface of the male center post upon removal of the compressive force. In an aspect of the present disclosure, the flow restricting device is configured to allow blood to flow from the proximal housing to the distal housing and to the fluid collection device, the fluid collection device including a blood collection device. In an aspect of the present disclosure, the proximal housing, the intermediate housing, and the distal housing comprise an integrated connector assembly having a female connector on the proximal housing and a male connector on the distal housing. In an aspect of the present disclosure, the intermediate housing comprises an intravenous tubing connecting the female connector on the proximal housing and the male connector on the distal housing.

[0057] In one or more embodiments, a blood collection system includes a blood collection device, a catheter assembly, and a flow restriction device fluidly coupled to the blood collection device. The flow restriction device includes a proximal housing coupled to the male connector of the blood collection device, a distal housing including a male Luer connector configured to mate with the female connector of the catheter assembly, an intermediate housing interposed between the proximal and distal housings, an internal fluid channel extending laterally through the proximal, intermediate, and distal housings, and a fluid barrier device coupled to the distal housing, the fluid barrier device including a flexible shape-memory material, the fluid barrier device configured to cover an end of a male center post of the male Luer connector in an uncompressed position, to slide the male center post downward into a groove in the distal housing in a compressed position, and to slide the male center post upward over the end of the male center post when returned to the uncompressed position to contain fluid within the male center post.

[0058] In an embodiment of the present disclosure, the fluid barrier device is secured to the male luer connector by one of an adhesive, a solvent, welding, and overmolding. In an embodiment of the present disclosure, the proximal housing, the intermediate housing, and the distal housing comprise an integrated connector assembly having a female connector on the proximal housing and a male luer connector on the distal housing. In an embodiment of the present disclosure, the intermediate housing comprises an intravenous tubing connecting the female connector on the proximal housing and the male luer connector on the distal housing.

[0059] In one or more embodiments, a fluid barrier device for a male luer connector comprises a flexible shape memory material, and is configured to cover the end of the male center post of the male luer connector in an uncompressed position, to slide the male center post downward to a compressed position, and when returned to the uncompressed position, to slide the male center post upward over the end of the male center post to contain fluid within the male center post.

[0060] This disclosure is provided to enable those skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0061] Reference to an element in the singular is intended to mean "one or more" rather than "one and only one" unless otherwise specified. The term "some" refers to one or more unless otherwise specified. Masculine pronouns (e.g., his) include feminine and neuter (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and are not intended to limit the invention.

[0062] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or useful over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0063] As used herein, the phrase "at least one of," preceding a list of items, when followed by the word "or" separating any of the items, modifies the list as a whole and not each item in the list. The phrase "at least one of" does not require the selection of at least one item; rather, the phrase allows for the inclusion of at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the phrase "at least one of A, B, or C" can refer to A only, B only, or C only, or any combination of A, B, and C.

[0064] The use of a phrase such as "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure regarding an aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. Disclosure regarding an embodiment may apply to all embodiments, or to one or more embodiments. An embodiment may provide one or more examples. A phrase such as an embodiment may refer to one or more embodiments, and vice versa. A phrase such as "configuration" does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. Disclosure regarding a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase such as an embodiment may refer to one or more configurations, and vice versa.

[0065] In one aspect, unless otherwise specified, all measurements, values, ratings, positions, dimensions, sizes, and other specifications set forth in this specification, including the claims that follow, are approximate and not exact, and are intended to have a reasonable range consistent with the function to which they relate and that which is customary in the art to which they pertain.

[0066] It is understood that the specific order or hierarchy of steps or acts in any disclosed process or method is an illustration of a sample approach. It is understood that the specific order or hierarchy of steps, acts, or processes may be rearranged based on implementation preferences or scenarios. Some of the steps, acts, or processes may be performed simultaneously. In some implementation preferences or scenarios, certain acts may or may not be performed. Some or all of the steps, acts, or processes may be performed automatically without user intervention. The accompanying method claims present the various steps, acts, or process elements in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0067] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those skilled in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, the element is recited using the phrase "step for." Furthermore, to the extent terms such as "comprising," "including," and "having" are used, such terms are intended to be inclusive in the same manner as the term "comprising" is interpreted when used as a transitional term in a claim.

[0068] The title, background art, summary, brief description of the drawings, and abstract of this disclosure are hereby incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description. It is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. Additionally, in the Detailed Description, it will be appreciated that the description provides illustrative examples and that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The following claims are incorporated into the Detailed Description, with each claim standing on its own as separately claimed subject matter.

[0069] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the full scope consistent with the language of the claims and encompass all legal equivalents. Nevertheless, none of the claims are intended to, and should not be construed to, encompass subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. a proximal housing configured to couple to a fluid collection device; a distal housing configured to couple to the catheter assembly; an intermediate housing interposed between the proximal housing and the distal housing; an internal fluid channel extending laterally through the proximal housing, the intermediate housing, and the distal housing; a fluid shielding device coupled to the distal housing and including a flexible material; Equipped with a flow restricting device configured such that the fluid shielding device covers an end of the male center post of the distal housing in a disconnected position, depresses the male center post into a groove in the distal housing in a connected position, and returns the end of the male center post to contain fluid within the male center post when returned to the disconnected position.

2. The flow restrictor device of claim 1 , wherein the flexible material of the fluid barrier device comprises a shape memory material.

3. The flow restrictor device of claim 2 , wherein the shape memory material comprises one of a resilient rubber, an elastomeric silicone, and a latex.

4. The flow restrictor of claim 1 , wherein the portion of the flexible material is secured to the groove by one of an adhesive and a solvent.

5. The flow restrictor device of claim 1 , wherein the portion of flexible material is secured to the male center post with one of an adhesive and a solvent.

6. The flow restrictor device of claim 1 , wherein a portion of the flexible material is welded to the distal housing.

7. The flow restrictor device of claim 1 , wherein a portion of the flexible material is welded to the male center post.

8. The flow restrictor device of claim 1 , wherein a portion of the flexible material is molded to the distal housing.

9. The flow restrictor of claim 1 , wherein a portion of the flexible material is molded to the male center post.

10. The flow restrictor of claim 1 , wherein the fluid shutoff device is coupled to the male center post by a friction fit.

11. The flow restrictor device of claim 1 , wherein a portion of the fluid shutoff device is configured to slide downward along an outer surface of the male center post into the groove under a compressive force.

12. The flow restrictor device of claim 11 , wherein the portion of the fluid shutoff device is configured to slide upwardly along the outer surface of the male center post upon removal of the compressive force.

13. The flow restrictor of claim 1 , wherein the flow restrictor is configured to allow blood to flow from the proximal housing to the distal housing and to the fluid drawer, the fluid drawer comprising a blood drawer.

14. The flow restrictor device of claim 1 , wherein the proximal housing, the intermediate housing, and the distal housing comprise an integrated connector assembly having a female connector on the proximal housing and a male connector on the distal housing.

15. The flow restrictor device of claim 1 , wherein the intermediate housing comprises an intravenous tubing connecting the female connector of the proximal housing and the male connector of the distal housing.

16. A blood collection device; a catheter assembly; a flow restriction device fluidly coupled to the blood draw device, a proximal housing coupled to the male connector of the blood draw device; a distal housing comprising a male luer connector configured to mate with the female connector of the catheter assembly; an intermediate housing interposed between the proximal housing and the distal housing; an internal fluid channel extending laterally through the proximal housing, the intermediate housing, and the distal housing; and a fluid barrier device coupled to the distal housing, the fluid barrier device including a flexible shape memory material; Equipped with the fluid barrier device is configured to cover an end of a male center post of the male luer connector in an uncompressed position, to slide the male center post downward into a groove in the distal housing in a compressed position, and to slide the male center post upward over the end of the male center post to contain fluid within the male center post when returned to the uncompressed position. Flow restrictor and A blood collection system comprising:

17. 17. The blood collection system of claim 16, wherein the fluid barrier device is secured to the male luer connector by one of an adhesive, a solvent, welding, and overmolding.

18. 17. The blood collection system of claim 16, wherein the proximal housing, the intermediate housing, and the distal housing comprise an integrated connector assembly having a female connector on the proximal housing and a male luer connector on the distal housing.

19. 17. The blood collection system of claim 16, wherein the intermediate housing comprises intravenous tubing connecting the female connector of the proximal housing and the male luer connector of the distal housing.

20. 1. A fluid shutoff device for a male luer connector, comprising: flexible shape memory material Including, 2. The fluid barrier device of claim 1, wherein the fluid barrier device is configured to cover an end of a male center post of the male luer connector in an uncompressed position, sliding the male center post downward to a compressed position, and when returned to the uncompressed position, sliding the male center post upward over the end of the male center post to contain fluid within the male center post.

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