Fluid shield assembly, and flow restriction device having fluid shield assembly

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, and an internal flow path extending transversely therethrough. The flow restricting device also includes a fluid shield assembly having an enclosure coupled to an end of the distal housing and a split septum coupled to an end of the enclosure, the split septum having a flexible material with a central slit. The fluid shield assembly is configured to enable connection of the female connector to the male connector of the distal housing through the slit in the split septum and to contain fluid within the enclosure and split septum when the female connector is withdrawn from the male connector. A blood collection system and a fluid shield assembly 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 inhibiting hemolysis in over-needle peripheral IV catheter (PIVC) blood withdrawal while reducing blood spillage. [Background technology]

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

[0003] A common type of catheter is the PIVC. Over-the-needle catheters, as the name suggests, may be attached to 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 such that the distal end of the introducer needle extends beyond the distal end of the catheter, with the bevel of the needle facing up and away from the patient's skin. The catheter and introducer needle are generally inserted at a shallow angle through the skin into the patient's vasculature.

[0004] To verify proper placement of the introducer needle and / or catheter within the blood vessel, clinicians typically check for the "backflow" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily block flow through the vasculature and remove the needle, leaving the catheter in place for future blood withdrawals or fluid injections.

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

[0006] A blood collection container may be coupled to the catheter. When the blood collection container is coupled to the catheter, the pressure in the vein is greater than the pressure in the blood collection container, forcing blood into the blood collection container, thereby filling the blood collection container. As the blood collection container fills, the vacuum in the blood collection container decreases, and when the pressure in the blood collection container equals the pressure in the vein, blood flow stops.

[0007] Unfortunately, when blood is drawn into a blood collection container, the high initial pressure difference between the vein and the blood collection container places red blood cells under high shear stress, making them susceptible to hemolysis. Hemolysis can lead to rejection and waste of the blood sample. The high initial pressure difference can also cause catheter tip collapse, vein collapse, or other complications that prevent or limit blood from filling the blood collection container. Furthermore, blood spillage during and / or after blood collection is common.

[0008] The statements provided in the Background section should not be considered prior art merely by virtue of their mention in or in connection 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, a flow restrictor 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 flow path extending transversely through the proximal, intermediate, and distal housings, and a fluid shield assembly. The fluid shield assembly includes an enclosure coupled to an end of the distal housing and a split septum coupled to an end of the enclosure, the split septum having a flexible material with a central slit. The fluid shield assembly is configured to allow connection and disconnection of the female connector to and from the male connector of the distal housing through the slit in the split septum, and to contain fluid within the enclosure and split septum when the female connector is disconnected and withdrawn from the male connector.

[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 having 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 flow path extending transversely through the proximal, intermediate, and distal housings, and a fluid shield assembly. The fluid shield assembly includes a Luer enclosure coupled to an end of the distal housing and a split septum coupled to an end of the enclosure, the split septum having a flexible material with a central slit disposed therein, the split septum and the Luer enclosure surrounding the male Luer connector and an end portion of the distal housing. The fluid shield assembly is configured to connect and disconnect the female connector of the catheter assembly to and from the male Luer connector of the distal housing through a slit in the split septum, and to contain excess blood within the enclosure and the split septum when the female connector is disconnected and withdrawn from the male Luer connector.

[0011] In one or more embodiments, a fluid shield assembly for a male Luer connector includes an enclosure configured to couple to an end of the male Luer connector and a split septum coupled to the end of the enclosure, the split septum having a flexible material with a slit disposed in its center, the fluid shield assembly enabling connection and disconnection of the female connector to and from the male Luer connector through the slit in the split septum and configured to contain fluid within the enclosure and split septum when the female connector is disconnected and withdrawn from the male Luer connector.

[0012] Other configurations of the subject technology will be readily apparent to those skilled in the art from the following detailed description, in which 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 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 should be regarded as illustrative in nature and not restrictive.

[0013] The following figures are included to illustrate certain aspects of the embodiments and should not be considered as exclusive examples. The disclosed subject matter is capable of considerable modification, permutation, combination, and equivalents in form and function, provided one skilled in the art and has 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 restricting device according to some embodiments of the present disclosure. [Figure 3] 1A-1C illustrate a vascular access device including a PIVC assembly including a flow-restricting extension set, according to some embodiments of the present disclosure. [Figure 4] FIG. 1 is a perspective view of a flow restrictor 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 shield assembly and a male luer connector according to some embodiments of the present disclosure. [Figure 6] FIG. 1 is a top view of a fluid shield assembly according to some embodiments of the present disclosure. [Figure 7] FIG. 7 is a bottom view of the fluid shield assembly of FIG. 6 according to some embodiments of the present disclosure. [Figure 8] FIG. 7 is a bottom perspective view of the fluid shield assembly of FIG. 6 according to some embodiments of the present disclosure. [Figure 9] FIG. 7 is a cross-sectional perspective view of the fluid shield assembly of FIG. 6 according to some embodiments of the present disclosure. [Figure 10] 1 is a perspective view of a connector assembly having a male connector and a female connector coupled to a fluid shield assembly according to some embodiments of the present disclosure. FIG. [Figure 11] FIG. 11 is a cross-sectional perspective view of the connector assembly of FIG. 10 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 intended to provide a thorough understanding of the subject technology. Thus, dimensions for particular embodiments may be given 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 this disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology are disclosed herein according to specific, but non-limiting examples. The various embodiments described in this disclosure may be implemented in different ways and variations according to the desired application or implementation.

[0017] Blood collection via vascular access devices has attracted attention because it minimizes needle sticks and improves operational efficiency compared to traditional venipuncture blood collection. However, current PIVC blood collection methods present several challenges, one of the most significant of which is hemolysis-related blood quality. Specifically, currently available PIVC products, standard connections (e.g., short extension sets and needleless connectors), and blood collection devices (e.g., vacutainers) are prone to hemolysis due to shear stress on blood cells.

[0018] Various embodiments of the present disclosure are directed to providing assemblies and methods for addressing blood spillage in PIVC blood collection using a hemolysis prevention accessory (also referred to herein as a flow restrictor) that is pre-attached to the PIVC and acts as a flow restrictor to reduce the risk of hemolysis. The hemolysis prevention accessory is advantageously compatible with PIVC placement and does not require modifications to existing procedures. The hemolysis prevention accessories of various embodiments described herein are applicable to a wide range of PIVC products and may be compatible with existing blood collection equipment and disposable infusion supplies.

[0019] Here, the flow restricting device regulates the overall flow rate of the entire flow path through which blood cells pass. The flow restricting device can be assembled with the PIVC or co-packaged with the PIVC. This eliminates the need for additional manipulation during catheter placement, as the device has a vent lumen that allows blood to flash back. The clinician may connect a blood collection device to the accessory port, after which the intended amount of blood can be drawn. After blood collection, the clinician may disconnect and discard the flow restricting device and the blood collection device together. This allows the flow restricting device to be used for a single blood draw or maintained 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 having an axially aligned flow path therein. Thus, fluid communication may be established between the proximal, distal, and intermediate housings to allow fluid to flow from the distal housing to the proximal housing through the intermediate housing. The aligned internal flow paths may combine to 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 into the blood collection device via the internal flow path of the flow restricting 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 Luer connection, the female Luer connection, 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 channel of the flow restrictor and into the 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 and is 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 with a very small diameter may facilitate increased flow resistance within the vascular access system, dispersing differential pressure and reducing the shear stress experienced by red blood cells. For example, minimizing the diameter of the internal flow channel may increase resistance to blood flow, thereby reducing the blood flow rate within the flow restricting device. Because reduced blood flow reduces the shear stress experienced by red blood cells, the risk of hemolysis during blood collection may be advantageously reduced.

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

[0024] Various embodiments of the present disclosure are directed to providing assemblies and methods for addressing blood spillage in PIVC blood collection using an extension set with a male Luer connector on one end and a female Luer connector on the other end. A standard ISO male Luer connector is used to connect to a needleless connector on the catheter, which presents the potential for blood exposure from the male Luer connector when disconnected after blood collection is complete.

[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 before being used to draw blood). It is usually prescribed that the LLAD or syringe and the blood collection device be placed together to avoid blood spillage. After blood collection, i.e., after removing the blood-filled container (e.g., Vacutainer), the next step is to disconnect the blood collection device, which contains the remaining blood. Therefore, the concern is potential blood exposure to the clinician when disconnecting the blood collection device from the PIVC needleless connector.

[0026] In some embodiments, a split septum having a small enclosure around a male Luer is provided at 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 when the needleless connector is removed, preventing or minimizing residual blood from spilling from the blood collection device. The septum provides a blockage within the enclosure, preventing spillage. The split septum may be made of a silicone material and may be bonded to the Luer enclosure in any suitable manner (e.g., by gluing, welding, or overmolding). The split septum may further be bonded to the blood collection device connector at the front of the male Luer. For example, the split septum may be glued to the enclosure, the enclosure may be friction-fit onto the front end of the male Luer connector of the blood collection device, and the split septum may be further glued to the front rim of the male Luer connector.

[0027] The various embodiments of the flow restriction devices and associated blood collection systems described herein additionally provide additional advantages over currently existing blood collection systems. For example, the retrofit flow restriction devices described herein allow for the integration of hemolysis suppression functionality into PIVC blood collection. Furthermore, the flow restriction devices described herein are compatible with PIVC placement, allowing for seamless blood collection during insertion. Furthermore, the flow restriction devices are retrofit devices that can be easily retrofitted without modification to existing PIVCs, minimizing impact on clinical practice and operations. 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 including 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, catheter assembly 50 may include or correspond to any suitable catheter assembly 50. In some embodiments, catheter assembly 50 may be one-piece and include extension tubing 60, which may extend from and be integrated with side port 59 of catheter hub 52. A non-limiting example of an one-piece catheter assembly includes the BD NEXIVA™ Closed IV Catheter System available from Becton Dickinson and Company. In some embodiments, the proximal end of extension tubing 60 may be coupled to an adapter, such as, for example, a Y-shaped adapter 70. In some embodiments, flow restrictor 110 may be fluidly coupled to Y-shaped adapter 70, such as needleless connector 72.

[0030] In some embodiments, the catheter assembly 50 may be non-integral 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 to 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, eliminating the extension tube 60 and providing a compact catheter system.

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

[0032] 2 is 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 with the blood draw device 40 as a single unit. As another example, the proximal housing 112 may include a female Luer connector 113, which may be coupled to 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 passage 170 may be disposed through the proximal housing 112, the intermediate housing 116, and the distal housing 114 to provide a fluid flow path throughout the flow restrictor 110.

[0034] The distal housing 114 may include a male Luer connector 115 and a fluid shield assembly 120 coupled to the distal housing 114. The fluid shield assembly 120 may include a split septum 122 coupled to a Luer enclosure 124. For example, the split septum 122 may be glued, welded, overmolded to the Luer enclosure 124, or any suitable coupling may be used. The Luer enclosure 124 is coupled to the distal housing 114. The Luer enclosure 124 may be removably coupled to the distal housing 114, such as by a friction fit. As another example, the Luer enclosure 124 may be integrally coupled (e.g., glued, welded, or overmolded) to the distal housing 114.

[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 likelihood 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 connector 115, and fluid shield assembly 120 described above. In some embodiments, the flow restriction device 210 may be fluidly coupled to the 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, eliminating the extension tube 60 and thereby achieving a compact catheter system.

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

[0037] 4 is 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, flow restriction device 210 may include a proximal housing 212 configured to couple to blood draw device 40. For example, proximal housing 212 may be integrated with blood draw device 40 or monolithically formed with blood draw device 40 as a single unit. As another example, proximal housing 212 may include a female Luer connector 213, which may be coupled to male Luer connector 42 of blood draw device 40.

[0038] In some embodiments, the flow restrictor 210 is in the form of an IV tubing 216 extending from the proximal housing 212 to the distal housing 114, and the IV tubing 216 may be 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 throughout the flow restrictor 210.

[0039] The distal housing 114 may include a male Luer connector 115, and a fluid shield assembly 120 may be coupled to the distal housing 114 of the flow restriction device 210. The fluid shield assembly 120 may be removably or integrally coupled to the distal housing 214 in any suitable manner, as described above.

[0040] 5 shows fluid shield assembly 120 coupled to distal housing 114 / male Luer connector 115 of either flow restriction device 110 or flow restriction device 210. Fluid shield assembly 120 may include engagement rib 126 sized and shaped to be received by groove 117 of distal housing 114. Luer enclosure 124 and / or engagement rib 126 may be formed of a flexible material configured to allow the enclosure to be pushed into distal housing 114 until engagement rib 126 slides into groove 117. Thus, fluid shield assembly 120 may be added to or removed from distal housing 114 as needed.

[0041] In some embodiments, fluid shield assembly 120 may be secured to distal housing 114. For example, an adhesive or solvent may be placed in groove 117 before sliding engagement rib 126 into groove 117. As another example, luer enclosure 124 and engagement rib 126 may be overmolded onto distal housing 114, with engagement rib 126 molded into groove 117. Here, a separate split septum 122 may be glued, welded, overmolded to luer enclosure 124, or any suitable bonding method may be used. As yet another example, the entire fluid shield assembly 120 may be overmolded onto distal housing 114. As another example, engagement rib 126 may be welded (e.g., ultrasonically or thermally) into groove 117.

[0042] As shown in Figures 6-9, the fluid shield assembly 120 may be cylindrically shaped to match the cylindrical shape of the connector (e.g., distal housing 114 / male Luer connector 115). In embodiments of the present disclosure, the fluid shield assembly 120 may be sized and shaped to fit any suitable connector size / shape (e.g., oval). The split septum 122 may include a slit 128 and may be formed of any suitable flexible material (e.g., silicone).

[0043] 10-11, connector assembly 300 includes fluid shield assembly 120 and female connector 310, shown in FIG. 5, that couples to distal housing 114 / male Luer connector 115 of either flow restriction device 110 or flow restriction device 210. Here, male Luer connector 115 is received within female Luer connector 315 such that internal flow channels 170, 270 of flow restriction devices 110, 210 are fluidly coupled to internal flow channel 370 of female connector 310. Additionally, threads 111 of distal housing 114 / male Luer connector 115 rotationally engage threads 311 of female connector 310, thereby providing a secure connection during use of connector assembly 300. As can be seen, slit 128 of fluid shield assembly 120 extends around the outer surface of female connector 310. In embodiments of the present disclosure, the female connector 310 may be any suitable female connector configured to mate with the male Luer connector 115, such as, for example, the needleless connector 72 or the proximal end 56 of the catheter hub 52.

[0044] In use, fluid shield assembly 120 is coupled to distal housing 114 such that the end of male Luer connector 115 is enclosed within Luer enclosure 124 and split septum 122. Any suitable female connector (e.g., proximal end 56, needleless connector 72, female connector 310) may then be coupled to male Luer connector 115. For example, as shown in FIGS. 10 and 11 , the end of female connector 310 is forced through slit 128 in split septum 122, causing the flexible material of split septum 122 to expand slit 128, thereby stretching flexible split septum 122 and maintaining contact with female connector 310 while female connector 310 is coupled to distal housing 114 / male Luer connector 115. Here, the female connector 310 and the distal housing 114 are each threaded (e.g., threads 311, 111), and full engagement requires rotating the female connector 310 relative to the distal housing 114 until it is at least partially or fully seated to create a secure connection.

[0045] When disconnection of the flow restriction device 110, 210 is desired, after the female connector 310 is uncoupled from the distal housing 114 / male Luer connector 115, the female connector 310 is pulled through the elongated slit 128, which then contracts back to or near the size of the slit 128 before being connected to the female connector 310. Thus, any fluid (e.g., blood) remaining in the lumen of the distal housing 114 and / or male Luer connector 115 is contained within the Luer enclosure 124 of the fluid shield assembly 120. In some aspects of the present disclosure, the split septum 122 may function to wipe the end of the female connector 310 as it passes back through the slit 128, thereby wiping the fluid from the surface of the female connector 310 and allowing the fluid to remain in the fluid shield assembly 120.

[0046] In embodiments of the present disclosure, the fluid shield assembly 120 prevents blood exposure and / or blood spillage when the female connector 310 is disconnected from the distal housing 114 / male Luer connector 115. Thus, blood dripping is blocked within the Luer enclosure 124 and split septum 122 disposed around the distal housing 114 / male Luer connector 115, eliminating the need for a clinician to take secondary actions such as wiping the connector. In embodiments of the present disclosure, the split septum 122 self-seals upon removal of the female connector 310.

[0047] According to various embodiments of the present disclosure, a method of manufacturing a flow restricting device with a fluid shield assembly may include molding a luer enclosure 124 to the distal housing 114 such that an engagement rib 126 is molded into the groove 117 and / or a portion of the luer enclosure 124 is molded to the exterior surface of the distal housing 114. In embodiments of the present disclosure, the engagement rib 126 may be secured to the groove 117 via glue or solvent and / or a portion of the luer enclosure 124 may be secured to the exterior surface of the distal housing 114 via glue or solvent. In embodiments of the present disclosure, a split septum 122 may then be secured to the exposed end of the luer enclosure 124 by any suitable method, such as by gluing, welding, or molding. In embodiments of the present disclosure, the split septum 122 may first be secured to the luer enclosure 124 to achieve the integrated fluid shield assembly 120, and then may be secured to the distal housing 114 as described above. In embodiments of the present disclosure, the distal housing 114 and the luer enclosure 124 may be molded as a single component, and then the fluid shield assembly 120 may be secured to the luer enclosure 124. In embodiments of the present disclosure, the distal housing 114, the luer enclosure 124, and the split septum 122 may be molded as a single component in one or more molding operations.

[0048] In operation, the flow restriction device 110, 210 with the fluid shield assembly 120 may be connected between the catheter assembly 50 and the blood draw set 40, as shown in Figures 1 and 3. Thus, during blood collection or withdrawal from a patient, blood may flow from the patient's vein through the extension tube 60 into the catheter assembly 50, enter the internal flow passage 170, 270 of the flow restriction device 110, 210 through the distal housing 114, exit the flow restriction device 110, 210 through the proximal housing 112, and enter the blood draw set 40. Thus, during blood collection or withdrawal from a patient, blood may flow into the blood draw set 40 through the internal flow passage 170, 270, which has a very small diameter.

[0049] The various embodiments of the flow restriction devices 110, 210 described herein offer advantages 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 and is 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, linear internal flow channels 170, 270 with very small diameters may facilitate increased flow resistance within the vascular access system 100 to distribute differential pressures and reduce shear stress experienced by red blood cells. For example, minimizing the diameter of the internal flow channels 170, 270 may increase resistance to blood flow, thereby reducing the blood flow rate within the flow restriction devices 110, 210. The reduced blood flow rate results in a reduction in the shear stress experienced by red blood cells of the blood, and therefore the risk of hemolysis during blood collection may be advantageously reduced.

[0050] Additionally, the above-described configuration of the flow restrictor 110, 210, in which the fluid shield assembly 120 blocks fluid leakage or spillage from the distal housing 114, is advantageous over other blood collection systems in that it prevents blood from spilling from the flow restrictor 110, 210 upon disconnection from the blood collection device 40. For example, in other blood collection systems, the recommended blood collection procedure stipulates that the blood collection connector not be disconnected from the blood collection device (e.g., a Luer Lock Access Device (LLAD)) after the blood collection procedure is complete. If the blood collection connector is disconnected from the blood collection device, blood may spill from the blood collection connector's flow path upon disconnection from the blood collection device. In contrast, the fluid shield assembly 120 of the various embodiments of the flow restricting device 110, 210 described herein, in which the split septum 122 blocks the passage of fluid from the distal housing 114, provides containment of blood within the fluid shield assembly 120, thereby preventing blood spillage when the flow restricting device 110, 210 is disconnected from the blood collection set 40 for disposal.

[0051] The various embodiments of the flow restriction devices and associated blood collection systems described herein additionally provide advantages over other blood collection systems. For example, the retrofit flow restriction devices described herein integrate hemolysis suppression functionality into PIVC blood collection, significantly reducing hemolysis. Furthermore, the flow restriction devices described herein are compatible with PIVC placement, allowing for seamless blood collection during insertion. Furthermore, the flow restriction devices are retrofit devices that can be easily retrofitted into existing PIVCs without modification, minimizing impact on clinical practice and operations. The flow restriction devices described herein also minimize or otherwise eliminate the risk of blood spillage upon disconnection from the blood collection device. Furthermore, the flow restriction devices described herein require a smaller prime volume compared to other blood collection systems, resulting in less blood waste. The flow restriction devices described herein also require a shorter fill time compared to currently existing blood collection systems.

[0052] The subject technology is exemplified, for example, according to various aspects described below. Various examples of aspects of the subject technology are described by way of example and not by way of limitation of the subject technology. It should be noted that one aspect may be combined with one or more other aspects in any combination.

[0053] In one or more embodiments, a flow restrictor 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 flow path extending transversely through the proximal, intermediate, and distal housings, and a fluid shield assembly. The fluid shield assembly includes an enclosure coupled to an end of the distal housing and a split septum coupled to an end of the enclosure, the split septum having a flexible material with a central slit. The fluid shield assembly is configured to allow connection and disconnection of the female connector to and from the male connector of the distal housing through the slit in the split septum, and to contain fluid within the enclosure and split septum when the female connector is disconnected and withdrawn from the male connector.

[0054] In an embodiment of the present disclosure, the enclosure of the fluid shield assembly has an internal engagement rib configured to mate with a groove on the distal housing. In an embodiment of the present disclosure, the engagement rib is secured to the groove by one of an adhesive and a solvent. In an embodiment of the present disclosure, the enclosure of the fluid shield assembly is welded to the distal housing. In an embodiment of the present disclosure, the enclosure of the fluid shield assembly is molded to the distal housing. In an embodiment of the present disclosure, the split septum is secured to the enclosure by one of an adhesive and a solvent. In an embodiment of the present disclosure, the split septum is welded to the enclosure. In an embodiment of the present disclosure, the split septum is molded to the enclosure. In an embodiment of the present disclosure, the flow restrictor is configured to flow blood from the proximal housing to the distal housing and to the fluid collection device, the fluid collection device having a blood collection device. In an embodiment of the present disclosure, the female connector is a needleless connector of the catheter assembly. In an embodiment of the present disclosure, the proximal housing, the intermediate housing, and the distal housing have an integrated connector assembly with a female connector on the proximal housing and a male connector on the distal housing, and the intermediate housing has an IV tubing that connects the female connector on the proximal housing to the male connector on the distal housing.

[0055] 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 having 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 flow path extending transversely through the proximal, intermediate, and distal housings, and a fluid shield assembly. The fluid shield assembly includes a Luer enclosure coupled to an end of the distal housing and a split septum coupled to an end of the enclosure, the split septum having a flexible material with a central slit disposed therein, the split septum and the Luer enclosure surrounding the male Luer connector and an end portion of the distal housing. The fluid shield assembly is configured to connect and disconnect the female connector of the catheter assembly to and from the male Luer connector of the distal housing through a slit in the split septum, and to contain excess blood within the enclosure and the split septum when the female connector is disconnected and withdrawn from the male Luer connector.

[0056] In an embodiment of the present disclosure, the enclosure of the fluid shield assembly has an internal engagement rib configured to mate with a groove on the distal housing. In an embodiment of the present disclosure, the engagement rib is secured to the groove by one of an adhesive, a solvent, welding, and overmolding. In an embodiment of the present disclosure, the split septum is secured to the enclosure 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 have 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 has an IV tubing connecting the female connector on the proximal housing and the male Luer connector on the distal housing.

[0057] In one or more embodiments, a fluid shield assembly for a male Luer connector includes an enclosure configured to couple to an end of the male Luer connector and a split septum coupled to the end of the enclosure, the split septum having a flexible material with a slit disposed in its center, the fluid shield assembly enabling connection and disconnection of the female connector to and from the male Luer connector through the slit in the split septum and configured to contain fluid within the enclosure and split septum when the female connector is disconnected and withdrawn from the male Luer connector.

[0058] In an aspect of the present disclosure, the enclosure of the fluid shield assembly has internal engaging ribs configured to mate with grooves on the exterior surface of the male Luer connector.

[0059] 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 general concepts defined herein may be applied to other aspects.

[0060] Reference to an element in the singular is intended to mean "one or more" and not "one and only one" unless specifically stated otherwise. The term "some" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. Headings and subheadings, if present, are used for convenience only and are not intended to limit the invention.

[0061] 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 advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0062] As used herein, the phrase "at least one of" preceding a list of items followed by the word "or" separating any of the items modifies the list as a whole, 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. As an example, the phrase "at least one of A, B, or C" may refer to A only, B only, or C only, or any combination of A, B, and C.

[0063] 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 relating to 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 "aspect" may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such an embodiment is essential to the subject technology or that such an embodiment applies to all configurations of the subject technology. Disclosure relating to an embodiment may apply to all embodiments, or to one or more examples. An embodiment may provide one or more examples. A phrase such as "embodiment" may refer to one or more examples, and vice versa. A phrase such as "configuration" does not imply that such an embodiment is essential to the subject technology or that such an embodiment applies to all configurations of the subject technology. Disclosure relating to 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 a configuration may refer to one or more configurations, and vice versa.

[0064] In one aspect, unless otherwise stated, all measurements, values, ratings, positions, dimensions, sizes, and other specifications set forth in this specification, including the claims that follow, are approximate and not precise, and are intended to have a reasonable range consistent with customary functionality in the art to which they pertain.

[0065] It is understood that the specific order or hierarchy of steps or operations in any disclosed process or method is an illustration of a sample approach. It is understood that the specific order or hierarchy of steps, operations, or processes may be rearranged based on implementation preferences or scenarios. Some of the steps, operations, or processes may be performed simultaneously. In some implementation preferences or scenarios, certain operations may or may not be performed. Some or all of the steps, operations, or processes may be performed automatically without user intervention. The accompanying method claims present the various steps, operations, or process elements in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0066] 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 claim element will be construed under 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, unless the element is expressly recited using the phrase "step for." Furthermore, to the extent terms such as "comprise," "have," and the like are used, such terms are intended to be inclusive in the same manner as the term "comprise," as "comprise" would be interpreted when employed as a transitional phrase in a claim.

[0067] The "Title," "Background," "Summary," "Brief Description of the Drawings," and "Abstract" sections of this disclosure are incorporated into this disclosure and are provided as examples to illustrate the disclosure, not as a limiting description. They are submitted with the understanding that they will not be used to limit the scope or meaning of the claims. It will also be appreciated that the description in this Detailed Description groups together various features of various embodiments for the purpose of providing illustrative examples and 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 this Detailed Description, with each claim standing on its own as separately claimed subject matter.

[0068] 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. Notwithstanding the foregoing, none of the claims are intended, nor should they be construed, to cover 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 disposed between the proximal housing and the distal housing; an internal flow passage extending transversely through the proximal housing, the intermediate housing, and the distal housing; 1. A fluid shield assembly comprising: an enclosure coupled to an end of the distal housing; and a split septum coupled to an end of the enclosure, the split septum having a flexible material with a centrally located slit; a fluid shield assembly having 1. A flow restrictor device having: the fluid shield assembly is configured to allow a female connector to be connected to and disconnected from the male connector of the distal housing through the slit in the split septum and to contain fluid within the enclosure and the split septum when the female connector is disconnected and withdrawn from the male connector; and A flow restrictor, wherein the enclosure of the fluid shield assembly has internal engaging ribs configured to mate with grooves on the distal housing.

2. The flow restrictor device of claim 1 , wherein the engagement rib is secured to the groove by one of an adhesive and a solvent.

3. The flow restrictor device of claim 1 , wherein the enclosure of the fluid shield assembly is welded to the distal housing.

4. The flow restrictor device of claim 1 , wherein the enclosure of the fluid shield assembly is molded to the distal housing.

5. 10. The flow restricting device of claim 1, wherein the split septum is secured to the enclosure by one of an adhesive and a solvent.

6. 2. The flow restricting device of claim 1, wherein the split septum is welded to the enclosure.

7. 10. The flow restrictor of claim 1, wherein the split septum is molded into the enclosure.

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

9. The flow restrictor of claim 1 , wherein the female connector is a needleless connector of the catheter assembly.

10. 2. The flow restrictor device of claim 1, wherein the proximal housing, the intermediate housing, and the distal housing have an integrated connector assembly with a female connector at the proximal housing and the male connector at the distal housing.

11. 10. The flow restrictor device of claim 1, wherein the intermediate housing has an intravenous tubing connecting a female connector at the proximal housing and the male connector at the distal housing.

12. A blood collection device; a catheter assembly; a flow restriction device fluidly coupled to the blood draw device; 1. A blood collection system comprising: The flow restrictor is a proximal housing coupled to the male connector of the blood draw device; a distal housing having a male Luer connector configured to mate with the female connector of the catheter assembly; an intermediate housing disposed between the proximal housing and the distal housing; an internal flow passage extending transversely through the proximal housing, the intermediate housing, and the distal housing; Fluid shield assembly and and the fluid shield assembly comprising: a luer enclosure coupled to an end of the distal housing, the luer enclosure having an internal engaging rib configured to mate with a groove on the distal housing; a split septum coupled to an end of the enclosure, the split septum having a flexible material with a centrally located slit, the split septum and the Luer enclosure surrounding the male Luer connector and an end portion of the distal housing; and A blood collection system, wherein the fluid shield assembly provides for the female connector of the catheter assembly to be connected to and disconnected from the male Luer connector of the distal housing through the slit in the split septum, and contains excess blood within the enclosure and the split septum when the female connector is disconnected and withdrawn from the male Luer connector.

13. 13. The blood collection system of claim 12, wherein the engagement rib is secured to the groove by one of an adhesive, a solvent, a weld, and an overmolding.

14. 13. The blood collection system of claim 12, wherein the split septum is secured to the enclosure by one of an adhesive, a solvent, a weld, and an overmolding.

15. 13. The blood collection system of claim 12, wherein the proximal housing, the intermediate housing, and the distal housing have an integrated connector assembly with a female connector at the proximal housing and the male Luer connector at the distal housing.

16. 13. The blood collection system of claim 12, wherein the intermediate housing includes an intravenous tubing connecting a female connector at the proximal housing and the male luer connector at the distal housing.

17. 1. A fluid shield assembly for a male luer connector, comprising: an enclosure configured to mate with an end of the male luer connector, the enclosure having internal engaging ribs configured to mate with grooves on an outer surface of the male luer connector; a split septum coupled to an end of the enclosure, the split septum having a flexible material with a centrally located slit; and A fluid shield assembly configured to provide for a female connector to be connected to and disconnected from the male Luer connector through the slit in the split septum, and to contain fluid within the enclosure and the split septum when the female connector is disconnected and withdrawn from the male Luer connector.

Images