Flow limiting device and peripheral venous catheter assembly for reducing hemolysis

Abstract

The utility model relates to a flow limiting device for reducing hemolysis. The flow limiting device can comprise a male Luer connector part and a female Luer connector part. The male luer connector portion may define a first lumen and the female luer connector portion may define a second lumen. The flexible tube preferably provides fluid communication between the first lumen and the second lumen. The flexible tube may be helically wound around the solid core, and the flexible tube may be helically wound within the hollow cavity. The flexible tubing is configured to increase flow resistance through the tubing to reduce shear stress on the fluid, thereby reducing the incidence of hemolysis. The utility model further relates to a peripheral venous catheter assembly.

Description

Technical Field

[0001] The utility model relates to a flow limiting device for reducing hemolysis and a peripheral venous catheter component. Background Art

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

[0003] One common type of catheter is a peripheral intravenous ("IV") catheter (PIVC) over a needle. As the name implies, an over-the-needle catheter can be mounted on an introducer needle having a sharp distal tip. The catheter assembly can 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 can be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter, with the bevel of the needle pointing upward away from the patient's skin. The catheter and introducer needle are typically inserted through the skin at a shallow angle into the patient's vasculature.

[0004] To verify the correct placement of the puncture needle and / or catheter in the blood vessel, the clinician typically confirms the presence of "flashback" of blood in the flashback chamber of the catheter assembly. Once the placement of the needle is confirmed, the clinician can temporarily occlude the flow in the vasculature and remove the needle, leaving the catheter in place for future blood draws or fluid infusions.

[0005] In order to draw blood from a patient or collect a blood sample, a blood collection container may be used. The blood collection container may include a syringe. Alternatively, the blood collection container may include a test tube with a rubber stopper at one end. In some cases, the test tube has all or part of the air removed from the test tube so that the pressure inside the test tube is lower than the ambient pressure. Such blood collection containers are often referred to as internal vacuum devices or vacuum tubes. A commonly used blood collection container is Blood collection tubes, which can be obtained from Becton Dickinson & Company (BD Company, USA).

[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 is higher than the pressure in the blood collection container, which pushes blood into the blood collection container, so that the blood fills the blood collection container. The vacuum within 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 the flow of blood stops.

[0007] Unfortunately, when blood is drawn into a blood collection container, due to the flow rate through the blood collection system and the geometry of the blood collection system, the red blood cells may experience high shear stress and be susceptible to hemolysis. Hemolysis may result in rejection and discarding of the blood sample. The blood draw may also result in a localized area of ​​negative pressure at the catheter tip, which may cause catheter tip collapse, vein collapse, or other difficulties that prevent or limit blood from filling the blood collection container. In addition, blood spillage often occurs during and / or after the blood draw.

[0008] The description provided in the Background section should not be considered prior art merely because it is mentioned in or associated with the Background section.The Background section may include information describing one or more aspects of the subject technology. Utility Model Content

[0009] Provided herein are embodiments of flow restriction devices configured to reduce the incidence of hemolysis. In some embodiments, the flow restriction device includes a male Luer connector portion defining a first lumen; a female Luer connector portion defining a second lumen; and an intermediate connector portion, the intermediate connector portion including a flexible tubing having a first end and a second end, the first end being configured to be fluidically coupled to the first lumen, and the second end being configured to be fluidically coupled to the second lumen; wherein the tubing is helically disposed between the male Luer connector portion and the female Luer connector portion and includes a fluid channel configured to provide fluid communication between the first lumen and the second lumen.

[0010] Some embodiments provide a flow restriction device comprising: a first connector portion defining a first lumen; a second connector portion defining a second lumen; and a third connector portion, the third connector portion comprising a tubular fitting having a first end and a second end, the first end being configured to be fluidically coupled to the first lumen, the second end being configured to be fluidically coupled to the second lumen, wherein the tubular fitting comprises a fluid channel configured to provide fluid connectivity between the first lumen and the second lumen.

[0011] In some embodiments, a peripheral intravenous catheter assembly is provided that is configured to limit hemolysis during the extraction of blood from a patient. Some embodiments of these assemblies include: a catheter hub having a proximal end and a distal end; a fluid collection device; and a flow restriction device, the flow restriction device including: a male Luer connector portion defining a first lumen; a female Luer connector portion defining a second lumen; and an intermediate connector portion, the intermediate connector portion including a flexible tubing having a first end and a second end, the first end being configured to be fluidically coupled to the first lumen, and the second end being configured to be fluidically coupled to the second lumen; wherein the tubing is disposed between the male Luer connector portion and the female Luer connector portion and includes a fluid channel that (i) is configured to provide fluid communication between the first lumen and the second lumen, and (ii) has a length and diameter configured to increase flow resistance through the tubing to reduce shear stress on the fluid.

[0012] The present disclosure provides a flow restriction device, which includes: a male Luer connector portion, which defines a cavity and a first tubular cavity that is continuous with the cavity fluid flow; and a female Luer connector portion, which defines a second tubular cavity and an extension portion that is continuous with the second tubular cavity fluid flow, the extension portion includes: a first end; a second end; an outer surface; and a channel defined on the outer surface, wherein the channel is spirally arranged around the outer surface of the extension portion and extends between the first end and the second end, the extension portion is configured to be at least partially arranged in the cavity, and the channel and the inner surface of the cavity define a fluid channel that is continuous with the first tubular cavity and the second tubular cavity fluid flow.

[0013] In some cases, the present disclosure provides a flow restriction device comprising: a male Luer connector portion defining a first cavity and a first lumen that is fluid-flow continuous with the first cavity; and a female Luer connector portion defining a second lumen and an extension, wherein the extension defines the second cavity that is fluid-flow continuous with the second lumen, and the extension comprises: a first end; a second end; an outer surface; and a channel defined on the outer surface, wherein the channel is spirally disposed around the outer surface of the extension and extends between the first end and the second end, the extension is configured to be at least partially disposed within the first cavity, and the channel and the inner surface of the first cavity define a fluid passage that is fluid-flow continuous with the first cavity and the second cavity.

[0014] In some aspects, the present invention provides a peripheral intravenous catheter assembly configured to limit hemolysis during blood extraction from a patient, the peripheral intravenous catheter assembly comprising: a catheter hub having a proximal end and a distal end; a fluid collection device; and a flow restriction device, the flow restriction device comprising: a male Luer connector portion defining a cavity and a first lumen that is fluid-flow continuous with the cavity and the catheter hub; and a female Luer connector portion defining a second lumen that is fluid-flow continuous with the fluid collection device and an extension that is fluid-flow continuous with the second lumen; the extension comprising: a first end; a second end; an outer surface; and a groove defined on the outer surface, wherein the groove is spirally disposed around the outer surface of the extension and extends between the first end and the second end, the extension is configured to be at least partially disposed within the cavity, and the groove and the inner surface of the cavity define a fluid channel that is fluid-flow continuous with the first lumen and the second lumen.

[0015] It should be understood that from the following detailed description, those skilled in the art will readily understand other configurations of the subject technology, wherein the various configurations of the subject technology are shown and described by way of illustration. As will be appreciated, the subject technology can have other and different configurations and its several details can be modified in various other aspects, all of which do not depart from the scope of the subject technology. Therefore, the accompanying drawings and detailed description are essentially considered to be illustrative and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The following drawings are included to illustrate certain aspects of the embodiments and should not be considered as exclusive embodiments. The disclosed subject matter is capable of considerable modification, alteration, combination, and equivalents in form and function, as will occur to those skilled in the art and having the benefit of this disclosure.

[0017] Figure 1 A vascular access device including a peripheral intravenous catheter (PIVC) assembly including a flow restriction device is shown according to some embodiments of the present disclosure.

[0018] Figure 2 A perspective view of a flow restriction device according to some embodiments of the present disclosure is shown.

[0019] Figure 3 Some embodiments of the present disclosure are shown Figure 2 Exploded view of the flow restriction device.

[0020] Figure 4 Some embodiments of the present disclosure are shown Figure 2 Exploded cross-sectional view of a flow restriction device.

[0021] Figure 5AA perspective view of a flow restriction device according to some embodiments of the present disclosure is shown.

[0022] Figure 5B Some embodiments of the present disclosure are shown Figure 5A Partial anatomical view of a flow restriction device.

[0023] Fig. 6A A perspective view of a flow restriction device according to some embodiments of the present disclosure is shown.

[0024] Figure 6B Some embodiments of the present disclosure are shown Fig. 6A Exploded view of the flow restriction device. DETAILED DESCRIPTION

[0025] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configuration in which the subject technology can be practiced. The detailed description includes specific details to provide a thorough understanding of the subject technology. Therefore, dimensions may be provided as non-limiting examples with respect to certain aspects. However, it is clear to those skilled in the art that the subject technology may be implemented without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid blurring the concept of the subject technology.

[0026] It should be understood that the present disclosure includes examples of subject technology and does not limit the scope of the appended claims. The following will illustrate various aspects of the subject technology according to specific but non-limiting examples. The various embodiments described in this disclosure can be implemented in different ways and variations and according to the intended application and implementation.

[0027] Compared with the traditional method of blood extraction using venipuncture, blood extraction via vascular access devices has received increasing attention due to the minimization of needle insertion and the improvement of operating efficiency. Currently, there are some challenges in using peripheral intravenous catheters (PIVC) for blood extraction, one of the most critical challenges is blood quality related to hemolysis. In particular, for the currently available PIVC products on the market, together with standard connectors (such as short extension kits and needleless connectors), and blood collection devices (such as vacuum blood collection tubes), the shear stress applied to blood cells often causes hemolysis.

[0028] Various embodiments of the present disclosure are intended to provide systems and methods for addressing hemolysis in PIVC blood draws using a hemolysis reducing accessory (also referred to herein as a flow restrictor), such as a connector, that is attached to the PIVC and acts as a flow restrictor to reduce the risk of hemolysis. The hemolysis reducing accessory is advantageously compatible with PIVC placement and does not require any changes to existing operations. The hemolysis reducing accessories of the various embodiments described herein are potentially applicable to a wide variety of PIVC products and are compatible with existing blood collection devices and disposable infusion sets.

[0029] Various embodiments of the present disclosure are directed to effective flow restriction utilizing an attached hemolysis reducing accessory (also referred to herein as a flow restrictor) that regulates the overall flow rate of the entire fluid path as blood travels therethrough. The flow restrictor may be assembled with the PIVC, or may be packaged together with the PIVC. The clinician may connect a blood collection set to the port of the accessory, and may then draw blood to a desired volume. After the blood is drawn, the clinician may disconnect the flow restrictor and discard it with the blood collection set. Thus, the flow restrictor may be used for a single blood draw, or may remain inline throughout the indwelling period.

[0030] The flow restriction devices and associated blood collection systems of the various embodiments described herein also provide additional advantages over currently existing blood collection systems. For example, the add-on flow restriction devices described herein reduce hemolysis while allowing blood to be drawn through an already placed PIVC. In addition, the flow restriction devices described herein are compatible with PIVC connections and allow for seamless blood withdrawal upon insertion. Furthermore, because the flow restriction device is an add-on device that can be easily integrated without any modifications to the existing PIVC, the impact on clinical settings and operations is minimal.

[0031] Figure 1 A vascular access device 10 including a peripheral intravenous catheter (PIVC) assembly 50 is shown according to some embodiments of the present disclosure, the vascular access device including a connector or flow restriction device 100. The flow restriction device 100 can be configured to facilitate the connection of components of the vascular access device 10 and reduce the possibility of hemolysis during blood collection using the vascular access device 10. In some embodiments, the vascular access device 10 can include a catheter assembly 50. The catheter assembly 50 can include a catheter hub 52, which can include a distal end 54, a proximal end 56, and a lumen extending through the distal end and the proximal end. The catheter assembly 50 can also include a catheter 58, which can be fixed in the catheter hub 52 and can extend distally from the distal end 54 of the catheter hub 52. In some embodiments, the catheter assembly 50 can be a peripheral intravenous catheter (PIVC).

[0032] 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 integrate and include an extension tube 60 that may extend from and be integrated with the side port 59 of the catheter hub 52. A non-limiting example of an integrated catheter assembly is the BD NEXIVA TM A closed IV catheter system is available from Becton Dickinson and Company. In some embodiments, the proximal end of the extension tube 60 can be coupled to an adapter, such as a Y-adapter 70. In some embodiments, the flow restriction device 100 can be fluidly coupled to the Y-adapter 70.

[0033] In some embodiments, the catheter assembly 50 may be non-integrated and may not include the extension tube 60. In these and other embodiments, the flow restriction device 100 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 100 may be coupled directly to the catheter assembly 50, thereby eliminating the extension tube 60 and providing a compact catheter system.

[0034] Figure 2 A perspective view of a flow restriction device 100 is shown, according to some embodiments of the present disclosure. Figure 3 Some embodiments of the present disclosure are shown Figure 2 An exploded view of the flow restriction device 100; Figure 4 Some embodiments of the present disclosure are shown Figure 2 An exploded sectional view of a flow restriction device 100; Figure 5A A perspective view of a flow restriction device according to some embodiments of the present disclosure is shown. Figure 5B Some embodiments of the present disclosure are shown Figure 5A Partial anatomical view of a flow restriction device. Fig. 6A A perspective view of a flow restriction device according to some embodiments of the present disclosure is shown. Figure 6B Some embodiments of the present disclosure are shown Fig. 6A Exploded view of the flow restriction device.

[0035] like Figure 2-Figure 4 As shown, and continue to refer to Figure 1In some embodiments, the flow restriction device 100 can include a male luer connector portion 110 configured to be coupled to the catheter assembly 50. The male luer connector portion 110 can have an inner surface defining a lumen 112 of the male luer connector portion 110. In some embodiments, a distal end of the male luer connector portion 110 can be coupled to the catheter assembly 50. In some embodiments, the lumen 112 is in fluid flow continuity with a cavity 116 defined by a body 114 of the male luer connector portion 110.

[0036] In some embodiments, the flow restriction device 100 can further include a female Luer connector portion 120 disposed proximal to the male Luer connector portion 110. The female Luer connector portion 120 can be configured to be coupled to a fluid collection device 40 (e.g., a blood collection device). For example, the female Luer connector portion 120 can be integrated with the blood collection device 40, or integrally formed with the blood collection device 40 as a single unit or component. As another example, the female Luer connector portion 120 can be in the form of a female Luer connector or another suitable connector that can be coupled to the male Luer portion of the blood collection device 40. The female Luer connector portion 120 can include an inner surface that defines a lumen 128 extending therethrough and for coupling to the male Luer portion of the blood collection device 40. In some embodiments, the proximal end of the female Luer connector portion 120 can be coupled to the blood collection device 40. Optionally, a threaded portion 122 of the female Luer connector portion 120 can be used to engage the female Luer connector portion 120 to a corresponding male Luer portion.

[0037] In the depicted example, the body 114 of the male luer connector portion 110 can be coupled to the body 124 of the female luer connector portion 120 to allow fluid flow continuity between the lumens 112 and 128 of the flow restriction device 100 and form a common housing.

[0038] In the depicted example, the female Luer connector portion 120 may include an extension 130 to control fluid flow between the lumens 112, 128 and reduce hemolysis throughout the blood flow path from the PIVC to the blood collection device 40. As shown, the extension 130 may be disposed within the cavity 116 formed by the male Luer connector portion 110. As shown, the extension 130 guides fluid flow between the lumen 112 of the male Luer connector portion 110 and the lumen 128 of the female Luer connector portion 120, respectively, while creating resistance to fluid flow. By creating resistance to fluid flow, the fluid flow rate through the assembly from the PIVC to the blood collection device is reduced. Reducing the flow rate of a fluid (such as blood) through the assembly can reduce the hemolysis index of the blood.

[0039] In some embodiments, the extension 130 defines a groove or channel 135 that directs fluid flow from the distal end 134 of the extension 130 to the proximal end 138 of the extension 130. As shown, the channel 135 can be defined along the outer surface of the extension 130. Thus, when the extension 130 is positioned within the cavity 116 of the male luer connector portion 110, at least a portion of the outer surface of the extension 130 can engage against the inner surface of the cavity 116 to allow the channel 135 and the inner surface of the cavity 116 to cooperatively define a fluid passageway therebetween. The defined fluid passageway can extend along a path between the distal end 134 and the proximal end 138 of the extension 130 to reduce the flow rate of the fluid through the extension 130. In some embodiments, the groove or channel 135 can be formed on the inner surface of the body 114 such that engagement with the outer surface of the extension 130 forms a fluid passageway. In some embodiments, the groove or channel 135 can extend along one or both of the inner surface of the body 114 and the outer surface of the extension 130 so that when the body 114 receives the extension 130, a fluid passage is formed to guide fluid between the body 114 and the extension 130.

[0040] In the depicted example, fluid flow can flow from lumen 112 of male Luer connector portion 110 via cavity 116 to distal end 134 of extension 130. In some embodiments, fluid can flow from proximal end 138 of extension 130 to lumen 128 of female Luer connector portion 120 via port 136 formed through extension 130.

[0041] In some embodiments, port 136 can allow fluid flow between the proximal end 138 of extension 130 and / or channel 135 to a cavity 137 formed in extension 130. Cavity 137 formed in extension 130 can be separated from cavity 116 of male Luer connector portion 110 by the body of extension 130. As shown, cavity 137 can have fluid flow continuity with lumen 128. Thus, in some embodiments, fluid flow can flow from proximal end 138 of extension 130 to lumen 128 via port 136 and cavity 137.

[0042] Thus, in some embodiments, the channel 135 (in combination with the inner surface of the cavity 116) can direct fluid flow from the male Luer connector portion 110 via the female Luer connector portion 120 to the fluid collection device 40. As shown, the channel 135 can provide a fluid pathway from the catheter assembly 50 via the flow restriction device 100 to the fluid collection device 40. For example, in some embodiments, the leg 72 of the Y-shaped adapter 70 can be coupled to the flow restriction device 100. The leg 72 of the Y-shaped adapter 70 can include a lumen into which the distal end of the male Luer connector portion 110 can be coupled. The Y-shaped adapter 70 can provide fluid flow continuity between the flow restriction device 100 and the catheter assembly 50, for example, via the extension tubing 60, via the connector 90 and the channel 135, which are described as needleless connectors. Thus, the channel 135 can define a fluid passage having a spiral, serpentine, extended, or other indirect path (described below) through which fluid entering the flow restriction device 100 from the catheter assembly 50 can flow through the flow restriction device 100 to be collected in the fluid collection device 40. For example, in the case of extracting or collecting blood from a patient, the medical fluid can be blood, and the fluid collection device 40 can be a blood collection device. In some embodiments, the blood collection device can be a blood collection tube holder, such as a BD LuerLok TM Thus, during the process of collecting or drawing blood from a patient, a blood sample can flow from the distal end of the male Luer connector portion 110 through the flow path or channel 135 into the LLAD 40 .

[0043] In some embodiments, the extension 130 may define a longitudinal axis extending through the distal end 134 and the proximal end 138. The channel 135 spans between the distal end 134 and the proximal end 138 of the extension 130 and is configured to spiral or helically extend along the longitudinal axis. Because the path spirals around the longitudinal axis, the channel 135 extends indirectly between the distal end 134 and the proximal end 138 of the extension 130. The length of the indirect path between the distal end 134 and the proximal end 138 of the extension 130 may be greater than the distance between the distal end 134 and the proximal end 138 of the extension 130. In some cases, the pitch and turning angle of the spiral channel 135 may be optimized to reduce the volumetric flow rate of the fluid (e.g., blood) moving through the channel 135 by creating resistance to the fluid. Since the reduced blood flow rate results in a reduced shear stress experienced by the red blood cells, the risk of hemolysis during blood collection can be advantageously reduced.

[0044] like Figure 5A-Figure 5B As shown, and continue to refer to Figure 1-Figure 4In some embodiments, the flow restriction device 200 can include a male Luer connector portion 210 configured to be coupled to the catheter assembly 50. The flow restriction device also includes an intermediate connector portion 215 and a female Luer connector portion 220. The male Luer connector portion 210 can have an inner surface defining a lumen 212 of the male Luer connector portion 210. In some embodiments, a distal end of the male Luer connector portion 210 can be coupled to the catheter assembly 50. In some embodiments, the lumen 212 is in fluid flow continuity or fluid communication with the tubing 216 through the first port 218.

[0045] The tubing 216 is preferably a flexible tubing that can be manipulated and wrapped around the core 222 of the intermediate connector portion 215. The wrapping of the tubing 216 around the intermediate connector portion 215 can be guided or fixed by the outer profile of the core 222. For example, the intermediate connector portion 215 can include a spiral groove that forms a series of grooves 227 and ridges 229 in cross section. The tubing 216 can be wrapped around the core 222 against the grooves or grooves 227, wherein the ridges 229 extend between or along adjacent coils of the tubing 216.

[0046] In some embodiments, the female Luer connector portion 220 is disposed proximal to the male Luer connector portion 210. The female Luer connector portion 220 can be configured to be coupled to a fluid collection device 40 (e.g., a blood collection device). For example, the female Luer connector portion 220 can be integrated with the blood collection device 40, or integrally formed with the blood collection device 40 as a single unit or component. As another example, the female Luer connector portion 220 can be in the form of a female Luer connector or another suitable connector that can be coupled to the male Luer portion of the blood collection device 40. The female Luer connector portion 220 can include an inner surface defining a lumen 228 that extends through the female Luer connector portion 220 for fluid communication between the male Luer connector portion 210 and the female Luer connector portion 220. In some embodiments, the female Luer connector portion 220 can include a threaded portion 224 that can be used to couple the female Luer connector portion 220 to a corresponding male Luer portion.

[0047] In the depicted example, the tubing 216 can fluidly couple the lumen 212 of the male luer connector portion 210 with the lumen 228 of the female luer connector portion 220 . Figure 5BAn exploded view of the flow restriction device 200 is shown. As shown, the tubing 216 includes a first end 231 and a second end 233. The first end 231 is preferably configured to be coupled to the first port 218 of the male Luer connector portion 210. The first end 231 can be sized to fit within the first port 218 and secured by an adhesive, ultrasonic welding, or some other coupling means. In some embodiments, the tubing 216 can fit over the protruding port, and in some embodiments, the tubing 216 can be connected to the male Luer connector portion 210 without a friction coupling of the first end 231 received within or fitted over the first port 218. When the first end 231 is coupled to the first port 218, the tubing is fluidly coupled to the lumen 212 through the first port 218.

[0048] In an embodiment, the second end 233 is preferably configured to be coupled to the second port 236 of the female Luer connector portion 220. The second end 233 can be sized to fit within the second port 236 and secured by adhesive, ultrasonic welding, or some other coupling means. In some embodiments, the tubing 216 can fit over the protruding port, and in some embodiments, the tubing 216 can be connected to the female Luer connector portion 220 without a friction coupling of the second end 233 received within or fitted over the second port 236. When the second end 233 is coupled to the second port 236, the tubing is fluidly coupled to the lumen 228 through the second port 236. Thus, with the first end 231 coupled to the first port 218 and the second end coupled to the second port 236, fluid communication is provided between the lumen 212 of the male Luer connector portion 210 and the lumen 228 of the female Luer connector portion 220 through the first port 218 and the second port 236 and through the tubing 216. In this configuration, the lumens 212, 228, the first port 218 and the second port 236, and / or the tubing 216 can be configured by their features (e.g., length, diameter, size, etc.) to control the flow of fluid between the lumens 212, 228 and reduce hemolysis through the entire blood flow path from the PIVC to the blood collection device 40. As shown, the flow restriction device is configured to create resistance to fluid flow. By creating resistance to fluid flow, the fluid flow rate from the PIVC through the assembly to the blood collection device is reduced. Reducing the flow rate of fluid (such as blood) through the assembly can reduce the hemolysis index of the blood.

[0049] Figure 6A-6B An embodiment of a flow restriction device 300 is shown having a Figure 1-Figure 5BThe flow restriction device includes a male luer connector portion 310, an intermediate connector portion 315, and a female luer connector portion 320. The intermediate connector portion 315 preferably includes an extended skirt or hollow chamber 319, which is configured to extend between the male luer connector portion 310 and the female luer connector portion 320. The hollow chamber 319 is preferably an extension of the male luer connector portion 310 or the female luer connector portion 320, and is configured to couple with the other of the male luer connector portion 310 or the female luer connector portion 320.

[0050] The hollow chamber 319 can be Figure 5A-Figure 5B 310 and 320, wherein the chamber 319 is configured to hold a tubing 316 extending and conducting fluid between the male Luer connector portion 310 and the female Luer connector portion 320. The hollow chamber 319 includes an inner surface 321 that is configured to accommodate the tubing 316 within the hollow chamber 319. As shown, the tubing 316 is preferably coiled when it extends through the chamber 319. The tubing 316 is preferably a flexible tubing that can be coiled within the hollow chamber 319, but the tubing 316 can also be arranged in other ways (e.g., straight, wavy, tortuous, etc.) within the hollow chamber 319.

[0051] The tubing 316 preferably includes a first end 331 and a second end 333, and the first end 331 is configured to be coupled to the first port 318 of the male luer connector portion 310, as described in other embodiments herein. The second end 333 is configured to be coupled to the second port 336 of the female luer connector portion 320, as also described in other embodiments herein. Thus, when the tubing 316 is coupled to the male luer connector portion 310 and the female luer connector portion 320, fluid communication is provided from the lumen 312 of the male luer connector portion 310 through the first port 318 and the second port 336 and the tubing 316 to the lumen 328 of the female luer connector portion 320.

[0052] Thus, in some embodiments, the devices 100, 200, and 300 can direct fluid flow from the male Luer connector portion via the female Luer connector portion into the fluid collection device 40. As depicted, the devices 100, 200, and 300 can provide a fluid pathway from the catheter assembly 50 to the fluid collection device 40 that functions to provide a flow restriction. For example, in some embodiments, the legs 72 of the Y-shaped adapter 70 can be coupled to the flow restriction device 100, 200, and / or 300. The legs 72 of the Y-shaped adapter 70 can include a lumen into which the distal end of the male Luer connector portion 110 can be coupled. The Y-shaped adapter 70 can provide fluid flow continuity between the flow restriction device via the connector 90 and the channel 135 depicted as a needleless connector and the catheter assembly 50, for example, via the extension tube 60. Thus, the devices 100, 200, and / or 300 can define a fluid pathway having a spiral, convoluted, extended, or other indirect path (as described herein) through which fluid entering the flow restriction from the catheter assembly 50 can flow through the flow restriction to be collected in the fluid collection device 40. For example, in the case of extracting or collecting blood from a patient, the medical fluid can be blood, and the fluid collection device 40 can be a blood collection device. In some embodiments, the blood collection device can be a blood collection tube holder, such as a BD LuerLok TM Thus, during the process of collecting or drawing blood from a patient, a blood sample can flow from the distal end of the male Luer connector into the LLAD 40 via the flow path.

[0053] The devices 100, 200 and / or 300 of various embodiments described herein are superior to currently available PIVC blood collection systems. For example, during blood extraction with currently available blood extraction devices, when blood cells flow from the distal end to the proximal end of the blood collection system, the blood cells may be subjected to supraphysiological levels of shear stress. Exposing red blood cells to supraphysiological levels of shear stress is considered to be the main source of mechanical damage and hemolysis of red blood cells. The diameter and effective length of the fluid pathway in the channel 135 or the tubing 216, 316 can help increase the flow resistance within the vascular access system to reduce the flow rate and reduce the shear stress experienced by the red blood cells 15. For example, the minimized diameter and extended effective length of the fluid pathway can provide increased flow resistance to the blood 15, thereby reducing the blood flow rate within the PIVC, the device, and the blood collection device assembly. Since the reduced blood flow rate results in a reduction in the shear stress experienced by the red blood cells, the risk of hemolysis during blood collection can be advantageously reduced. In addition, the geometry of the channel 135 or the tubing 216, 316 can reduce the amount of blood wasted by the currently available PIVC blood collection system.

[0054] In addition, the flow restrictor can reduce hemolysis without the use of active devices, such as valves or other flow control devices. In some applications, the configuration of the flow restrictor as described herein can minimize flushing of the vascular access device 10, minimize dead volume, and facilitate a compact design. In addition, the configuration of the flow restrictor can facilitate manufacturing compared to certain prior art designs. For example, in some applications, some embodiments provide that the male Luer connector portion 110, 310 and the female Luer connector portion 120, 320 can be joined together and then ultrasonically welded to form the flow restrictor 100, 300.

[0055] The fluid connector devices and associated blood collection systems of the various embodiments described herein also provide additional advantages over currently existing blood collection systems. For example, the additional fluid connector devices described herein allow for the integration of hemolysis reduction functionality for PIVC blood draws. In addition, the fluid connector devices described herein are compatible with PIVC placement and allow for seamless blood draws upon insertion. In some embodiments, for multiple blood draws, it is possible for the fluid connector device to remain inline throughout the PIVC in-vivo indwelling period. In addition, because the fluid connector device is an additional device, it can be easily incorporated without requiring any changes to the existing PIVC, and therefore has minimal impact on clinical setup and operation.

[0056] The optimized fluid pathway (also referred to herein as a first fluid pathway or a first flow path or a first microchannel) can be configured to provide a restricted flow rate for reducing hemolysis and can have features including but not limited to tubular fluid pathways, cannulas, lumens, continuous non-linear channels, grooves, fluid channels, etc.

[0057] The length of the fluid pathway can be selected based on one or more of the following factors: the specifications of a particular catheter, the configuration of a particular catheter assembly, or the clinical setting. In some embodiments, the optimized fluid pathway can include a length L from the female Luer adapter 101 to the male Luer adapter 102. In some embodiments, the optimized fluid pathway can include an inner diameter D.

[0058] The flow of fluid in a tubular fluid path can be analyzed using the Poiseuille equation:

[0059]

[0060] where ΔP is the change in pressure gradient across the length of the fluid path, D and L are the inner diameter and length of the fluid path, respectively, μ is the viscosity of the fluid, and is the fluid resistance. Since μ is the viscosity of the fluid and not part of the extended tube geometry, the geometric factor G f is defined such that Rf (Fluid resistance) is in

[0061] In some embodiments, the optimized fluid path may have multiple segments with lengths (L1, L2, L3) and inner diameters (D1, D2, D3), then the geometric factor is:

[0062]

[0063] In some embodiments, the optimized fluid passage may have a cross-section with a non-circular or complex inner diameter profile. The geometric factor can be determined by measuring the flow rate (Q) of a fluid of known viscosity (μ) at a given pressure (ΔP):

[0064]

[0065] G of optimized fluid path can be selected f values ​​to reduce the maximum shear stress for each catheter size to be equal to or less than BD 21G UltraTouch TM The maximum shear stress of a push-button blood collection kit, which was previously considered the gold standard for blood draws. In some embodiments, the G of the optimized fluid path can be selected. f value to reduce the maximum shear stress for each catheter size to be equal to or less than BD 25G UltraTouch TM Maximum shear stress of a push-button blood collection kit.

[0066] In some embodiments, and by way of non-limiting example, the optimized fluid passageway may have a diameter of approximately 0.014 inches. In another non-limiting example, the cross-sectional area of ​​the optimized fluid passageway is approximately 0.000152 square inches.

[0067] Description of the terms of this subject technology

[0068] For example, according to the various aspects described below, the subject technology is shown. For convenience, various examples of various aspects of the subject technology are described according to numbered clauses (1, 2, 3, etc.). These are provided only as examples and do not limit the subject technology. It should be noted that any dependent clauses can be combined in any combination and placed in corresponding independent clauses, such as clause 1 or clause 5. Other clauses can be presented in a similar manner.

[0069] Item 1. A flow restriction device comprising: a male Luer connector portion defining a first lumen; a female Luer connector portion defining a second lumen; and an intermediate connector portion, the intermediate connector portion comprising a flexible tubing having a first end and a second end, the first end being configured to be fluidically coupled to the first lumen, and the second end being configured to be fluidically coupled to the second lumen; wherein the tubing is spirally disposed between the male Luer connector portion and the female Luer connector portion and comprises a fluid channel configured to provide fluid communication between the first lumen and the second lumen.

[0070] Clause 2. The flow restriction device of Clause 1, wherein the intermediate connector portion includes a solid core extending between the male and female luer connector portions, the tubing being supported around the solid core.

[0071] Clause 3. The flow restriction device of Clause 2, wherein the tubing is helically wrapped around a core of the intermediate connector portion.

[0072] Clause 4. The flow restriction device of Clause 1, wherein the length and diameter of the fluid passageway are configured to increase flow resistance through the tubing to reduce shear stress of the fluid.

[0073] Clause 5. The flow restriction device of Clause 1, wherein the intermediate connector portion includes a hollow chamber, and the tubing extends between the male Luer connector portion and the female Luer connector portion within the hollow chamber.

[0074] Clause 6. The flow restriction device of Clause 5, wherein the tubing is helically wound within the hollow chamber.

[0075] Clause 7. A flow restriction device according to Clause 1, wherein the first end of the tubing is connected to the first lumen through a first port formed in the male Luer connector portion, and the second end of the tubing is connected to the second lumen through a second port formed in the female Luer connector portion.

[0076] Item 8. A flow restriction device comprising: a first connector portion defining a first lumen; a second connector portion defining a second lumen; and a third connector portion, the third connector portion comprising a tubular fitting having a first end and a second end, the first end being configured to be fluidically coupled to the first lumen, the second end being configured to be fluidically coupled to the second lumen, wherein the tubular fitting comprises a fluid channel configured to provide fluid connectivity between the first lumen and the second lumen.

[0077] Clause 9. The flow restriction device of Clause 8, wherein the third connector portion is configured to extend between the first connector portion and the second connector portion and includes a core supporting the tubing therearound.

[0078] Clause 10. The flow restriction device of Clause 9, wherein the tubing is flexible and is helically wrapped around the core of the third connector portion.

[0079] Clause 11. The flow restriction device of Clause 9, wherein the core is a solid core that does not conduct fluid and includes a helically wound groove that provides grooves and ridges to secure placement of the tube.

[0080] Clause 12. The flow restriction device of Clause 8, wherein the length and diameter of the fluid passageway are configured to increase flow resistance through the tubing to reduce shear stress of the fluid.

[0081] Clause 13. The flow restriction device of Clause 8, wherein the third connector portion includes a hollow chamber within which the tube extends between the first connector portion and the second connector portion.

[0082] Clause 14. The flow restriction device of Clause 13, wherein the tubing is helically wound within the hollow chamber.

[0083] Clause 15. A flow restriction device according to Clause 8, wherein the first end of the tubing is connected to the first lumen via a first port formed in the first connector portion, and the second end of the tubing is connected to the second lumen via a second port formed in the second connector portion.

[0084] Clause 16. The flow restriction device of Clause 8, wherein at least one of the first connector portion and the second connector portion comprises a Luer connector.

[0085] Clause 17. The flow restriction device of Clause 8, wherein the third connector portion extends between the first connector portion and the second connector portion.

[0086] Item 18. A peripheral intravenous catheter assembly configured to limit hemolysis during the extraction of blood from a patient, the peripheral intravenous catheter assembly comprising: a catheter hub having a proximal end and a distal end; a fluid collection device; and a flow restriction device, the flow restriction device comprising: a male Luer connector portion defining a first lumen; a female Luer connector portion defining a second lumen; and an intermediate connector portion, the intermediate connector portion comprising a flexible tubing having a first end and a second end, the first end being configured to be fluidically coupled to the first lumen, and the second end being configured to be fluidically coupled to the second lumen; wherein the tubing is disposed between the male Luer connector portion and the female Luer connector portion and comprises a fluid channel, (i) the fluid channel being configured to provide fluid communication between the first lumen and the second lumen, and (ii) the length and diameter of the fluid channel being configured to increase flow resistance through the tubing to reduce shear stress on the fluid.

[0087] Clause 19. A peripheral intravenous catheter assembly according to Clause 18, wherein the intermediate connector portion includes a solid core extending between the male Luer connector portion and the female Luer connector portion, and the tubing is supported and helically wrapped around the solid core.

[0088] Clause 20. The peripheral intravenous catheter assembly of Clause 18, wherein the intermediate connector portion includes a hollow chamber, and the tubing is helically wrapped between the male Luer connector portion and the female Luer connector portion within the hollow chamber.

[0089] The present disclosure is provided to enable those skilled in the art to practice the various aspects described herein. The present disclosure provides various examples of subject technology, and subject technology is not limited to these examples. Multiple modifications to these aspects are very clear to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0090] Unless expressly specified otherwise, elements referred to in the singular are not intended to mean "one and only one," but rather "one or more." Unless expressly specified otherwise, the term "some" refers to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter genders (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the disclosure.

[0091] 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, the various alternative configurations and operations described herein may be considered to be at least equivalent.

[0092] As used herein, the phrase "at least one" preceding a list of items (with the term "or" separating any items) modifies the list as a whole rather than each item in the list. The phrase "at least one" does not require selection of at least one of the items; rather, the phrase allows for a meaning that includes at least one of any one item, and / or at least one of any combination of items, and / or at least one of each item. For example, the phrase "at least one of A, B, or C" may mean: only A, only B, or only C; or any combination of A, B, and C.

[0093] Phrases such as "aspects" do not mean that such aspects are essential to the subject technology, or that such aspects apply to all configurations of the subject technology. The disclosure related to an aspect may apply to all configurations or one or more configurations. One aspect may provide one or more examples. Phrases such as "an aspect" may refer to one or more aspects, and vice versa. Phrases such as "an embodiment" do not mean that such an embodiment is essential to the subject technology, or that such an embodiment applies to all configurations of the subject technology. The disclosure related to an embodiment may apply to all embodiments or one or more embodiments. An embodiment may provide one or more examples. Phrases such as "an embodiment" may refer to one or more embodiments, and vice versa. Phrases such as "configuration" do not mean that such a configuration is essential to the subject technology, or that such a configuration applies to all configurations of the subject technology. The disclosure related to a configuration may apply to all configurations or one or more configurations. A configuration may provide one or more examples. Phrases such as configurations may refer to one or more configurations, and vice versa.

[0094] In one aspect, unless otherwise indicated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications in this specification, including those set forth in the appended claims, are approximate and not exact. In one aspect, they are intended to have a reasonable range consistent with the functions to which they are related and with the customary practices in the art to which they belong.

[0095] It should be understood that the specific order or hierarchy of steps or operations in the disclosed process or method is an illustration of an exemplary method. Based on implementation preferences or scenarios, it should be understood that the specific order or hierarchy of steps, operations or processes can be rearranged. Some steps, operations or processes can be performed simultaneously. In some implementation preferences or scenarios, certain operations may or may not be performed. Some or all of the steps, operations or processes can be performed automatically without user intervention. The attached method claims present the elements of various steps, operations or processes in an exemplary order and are not meant to be limited to the specific order or hierarchy presented.

[0096] All structural and functional equivalents of the elements of the various aspects described throughout the present disclosure are known or will become known to those of ordinary skill in the art, are expressly incorporated herein by reference and are intended to be covered by the claims. In addition, the content disclosed herein is not intended to be dedicated to the public, regardless of whether such disclosure is explicitly recited in the claims. In addition, with respect to the scope of the terms "including," "having," and the like, such terms are intended to be inclusive in a manner similar to the term "comprising," as interpreted when "comprising" is used as a transitional word in the claims.

[0097] The title, background technology, utility model content, figure description and abstract of the present disclosure are incorporated into the present disclosure hereby, and are provided as illustrative examples of the present disclosure rather than as restrictive descriptions. The present application is submitted based on the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the specific embodiments, it can be seen that the description provides illustrative examples, and in order to simplify the present disclosure, various features are combined together in various embodiments. The disclosure method should not be interpreted as reflecting the intention that the claimed subject matter requires more features than those explicitly stated in each claim. On the contrary, as reflected in the attached claims, the utility model subject matter lies in less than all the features of a single disclosed configuration or operation. The claims below are therefore incorporated into the detailed description, and each claim is independently a subject matter claimed separately.

[0098] The claims are not intended to be limited to the aspects described herein but are to be accorded the full scope consistent with the language of the claims and including all legal equivalents.

Claims

1. A flow restriction device for reducing hemolysis, comprising: a male Luer connector portion defining a first lumen; a female Luer connector portion defining a second lumen; and an intermediate connector portion comprising a flexible tubing having a first end configured to fluidly couple with the first lumen and a second end configured to fluidly couple with the second lumen; Characterized in that the tubing is helically disposed between the male Luer connector portion and the female Luer connector portion and includes a fluid channel configured to provide fluid communication between the first lumen and the second lumen.

2. The flow restriction device according to claim 1, characterized in that: The intermediate connector portion includes a solid core extending between the male and female Luer connector portions, the solid core supporting the tubing.

3. The flow restriction device according to claim 2, characterized in that: The tube is helically wrapped around the core of the intermediate connector portion.

4. The flow restriction device according to claim 1, characterized in that: The length and diameter of the fluid passageway are configured to increase flow resistance through the tubing to reduce shear stress of the fluid.

5. The flow restriction device according to claim 1, characterized in that: The intermediate connector portion includes a hollow chamber within which the tubing extends between the male and female Luer connector portions.

6. The flow restriction device according to claim 5, characterized in that: The tube is helically wound within the hollow chamber.

7. The flow restriction device according to claim 1, characterized in that: The first end of the tubing is coupled to the first lumen through a first port formed in the male Luer connector portion, and the second end of the tubing is coupled to the second lumen through a second port formed in the female Luer connector portion.

8. A flow restriction device for reducing hemolysis, comprising: a first connector portion defining a first lumen; a second connector portion defining a second lumen; and a third connector portion including a core and a tube having a first end configured to be fluidly coupled to the first lumen and a second end configured to be fluidly coupled to the second lumen, Characterized in that the tubing is wrapped around the core and includes a fluid channel configured to provide fluid communication between the first lumen and the second lumen.

9. The flow restriction device according to claim 8, characterized in that: The tubing is flexible and is helically wrapped around the core of the third connector part.

10. The flow restriction device according to claim 8, characterized in that: The core is a solid core that does not conduct fluid and includes helically wound grooves that provide grooves and ridges to secure the placement of the tube.

11. The flow restriction device according to claim 8, characterized in that: The length and diameter of the fluid passageway are configured to increase flow resistance through the tubing to reduce shear stress of the fluid.

12. The flow restriction device according to claim 8, characterized in that: The third connector part includes a hollow chamber within which the tube extends between the first connector part and the second connector part.

13. The flow restriction device according to claim 12, characterized in that: The tube is helically wound within the hollow chamber.

14. The flow restriction device according to claim 8, characterized in that: The first end of the tubing is coupled to the first lumen through a first port formed in the first connector portion, and the second end of the tubing is coupled to the second lumen through a second port formed in the second connector portion.

15. The flow restriction device according to claim 8, characterized in that: At least one of the first connector portion and the second connector portion comprises a Luer connector.

16. The flow restriction device according to claim 8, characterized in that The third connector portion extends between the first connector portion and the second connector portion.

17. A peripheral intravenous catheter assembly configured to reduce hemolysis during the extraction of blood from a patient, the peripheral intravenous catheter assembly comprising: a catheter hub having a proximal end and a distal end; Fluid collection device; and A flow restriction device comprising: a male Luer connector portion defining a first lumen; a female Luer connector portion defining a second lumen; and an intermediate connector portion comprising a flexible tubing having a first end configured to fluidly couple with the first lumen and a second end configured to fluidly couple with the second lumen; Characterized in that the tubing is arranged between the male Luer connector portion and the female Luer connector portion and includes a fluid channel, (i) the fluid channel is configured to provide fluid communication between the first lumen and the second lumen, and (ii) the length and diameter of the fluid channel are configured to increase the flow resistance through the tubing to reduce shear stress on the fluid.

18. The peripheral intravenous catheter assembly according to claim 17, characterized in that The intermediate connector portion includes a solid core extending between the male and female luer connector portions, the tubing being supported by and helically wrapped around the solid core.

19. The peripheral intravenous catheter assembly according to claim 17, characterized in that The intermediate connector portion includes a hollow chamber within which the tubing is helically wound between the male and female Luer connector portions.

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