Overmolded hemolysis reduction accessory for direct blood collection

Abstract

To provide a system and method for addressing hemolysis in PIVC blood collection using a hemolysis reduction accessory that acts as a flow limiter to reduce the risk of hemolysis. [Solution] The present invention relates to a flow limiting device comprising a male Luer connector portion, a female Luer connector portion, a tube, and an overmolded body portion. The male Luer connector portion defines a first lumen. The female Luer connector portion defines a second lumen. The tube defines a third lumen. The third lumen is in fluid communication with the first and second lumens. The third lumen has a diameter of less than 0.635 mm (0.025 inches). The overmolded body portion is formed around the tube.

Description

Technical Field

[0001] The present disclosure generally relates to blood collection and parenteral fluid administration to patients, and more particularly to systems and methods for reducing hemolysis in PIVC blood collection using an overmolded flow restriction device.

Background Art

[0002] Catheters are generally used for various infusion therapies. For example, a catheter can be used to infuse fluids such as saline, various drugs, and total parenteral nutrition into a patient. A catheter can also be used to withdraw blood from a patient.

[0003] A common type of catheter is a percutaneous peripheral intravenous (''IV'') catheter (PIVC). As its name suggests, a percutaneous 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 the introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter while the bevel of the introducer needle faces upward away from the patient's skin. The catheter and the introducer needle are generally inserted at a shallow angle into the patient's vasculature through the skin.

[0004] To verify proper placement of the introducer needle and / or catheter within the blood vessel, a clinician generally checks for a ''flashback'' of blood within the flashback chamber of the catheter assembly. Once the needle placement is confirmed, the clinician can temporarily occlude the flow within the vasculature, remove the needle, and leave the catheter in place for future blood collection or fluid infusion.

[0005] A blood collection container may be used for collecting blood from a patient or for collecting 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 all or part of the air removed so that the pressure inside the test tube is lower than the ambient pressure. Such blood collection containers are often called internal vacuum or vacuum tubes. A commonly used blood collection container is the VACUTAINER® blood collection tube, available from Becton Dickinson & Company.

[0006] The blood collection container may be connected to a catheter. When the blood collection container is connected to a catheter, the pressure in the vein is higher than the pressure in the blood collection container. This causes blood to be forced into the blood collection container, filling it with blood. The vacuum inside the blood collection container decreases as it fills, and when the pressure inside the blood collection container equals the pressure in the vein, the blood flow stops.

[0007] Unfortunately, when blood is collected into a blood collection container, the high initial pressure difference between the vein and the container puts red blood cells under high shear stress, making hemolysis likely. Hemolysis can lead to rejection and disposal of the blood sample. The high initial pressure difference can also lead to other problems such as catheter tip collapse, vein collapse, or other issues that prevent or limit the blood from filling the blood collection container. Furthermore, blood spillage generally occurs during and / or after blood collection.

[0008] Descriptions made in a background section should not be considered prior art simply because they are stated in or associated with a background section. A background section may include information describing one or more aspects of the subject art. [Overview of the Initiative] [Means for solving the problem]

[0009] This disclosure provides a flow limiting device comprising a male luer connector portion defining a first lumen, a female luer connector portion defining a second lumen, and a tube defining a third lumen, the third lumen being in fluid communication with the first and second lumens, the third lumen having a diameter of less than 0.635 mm (0.025 inches), and the flow limiting device further comprises an overmolded body portion formed around the tube.

[0010] In some cases, the present disclosure provides a method for manufacturing a flow limiting device. The steps include providing a tube, the tube defining a lumen having a diameter of less than 0.635 mm (0.025 inches), and forming a body portion to be overmolded on the tube.

[0011] In some embodiments, the Disclosure provides a peripheral intravenous catheter assembly configured to limit hemolysis during blood collection from a patient, the peripheral intravenous catheter assembly comprising a catheter hub having a proximal and distal end, a fluid collection device, and a flow limiting device, the flow limiting device comprising a male Luer connector portion coupled to the catheter hub and defining a first lumen, a female Luer connector portion defining a second lumen and fluid-communicating with the fluid collection device, and a tube defining a third lumen, the third lumen being fluid-communicating with the first and second lumens, the third lumen having a diameter of less than 0.635 mm (0.025 inches), and the flow limiting device further comprising an overmolded body portion formed around the tube.

[0012] It will be understood that other configurations of the subject art will be readily apparent to those skilled in the art from the detailed description below, and various configurations of the subject art are shown and described by illustration. As will be understood, the subject art can have other and different configurations, and some of its details can all be modified in various other ways without departing from the scope of the subject art. Therefore, the drawings and detailed description should be considered illustrative and not restrictive in essence.

[0013] The following drawings are included to illustrate certain aspects of the embodiments and should not be considered exclusive embodiments. The disclosed subject matter can be considerably modified, altered, combined, and equivalent in forms and functions that are of interest to those skilled in the art. [Brief explanation of the drawing]

[0014] [Figure 1] This figure shows a vascular access device including a peripheral intravenous catheter (PIVC) assembly including a flow limiting device, according to some embodiments of the present disclosure. [Figure 2] This figure shows a perspective view of a flow limiting device according to some embodiments of the present disclosure. [Figure 3] This figure shows an exploded perspective view of the flow limiting device shown in Figure 2, according to some embodiments of the present disclosure. [Figure 4] This figure shows a cross-sectional view of the flow limiting device shown in Figure 2, according to some embodiments of the present disclosure. [Modes for carrying out the invention]

[0015] The detailed descriptions below describe various configurations of the subject art and are not intended to represent only the configurations in which the subject art can be practiced. The detailed descriptions include specific details necessary to achieve a complete understanding of the subject art. Therefore, dimensions may be given as non-limiting examples with respect to certain embodiments. However, it will be apparent to those skilled in the art that the subject art can be practiced without these specific details. In some cases, well-known structures and components are shown in block diagrams to avoid obscuring the concepts of the subject art.

[0016] It should be understood that this disclosure includes examples of the subject art and does not limit the scope of the appended claims. Various aspects of the subject art will be disclosed by specific but not limiting examples. The various embodiments described in this disclosure may be carried out in different forms and variations, and depending on the desired use or implementation.

[0017] Blood collection via vascular access devices is gaining increasing attention due to its reduced needle stick risk and improved work efficiency compared to traditional blood collection methods using venipuncture. However, current blood collection using peripheral intravenous catheters (PIVCs) faces several challenges, one of the most significant being the quality of the blood related to hemolysis. In particular, the shear stress acting on blood cells by PIVC products currently on the market, along with standard connections (short extension sets and needleless connectors, etc.) and blood collection devices (such as vacutainers), can easily lead to near-hemolysis.

[0018] Various embodiments of this disclosure aim to provide systems and methods for addressing hemolysis in PIVC blood collection using hemolysis reduction accessories (also referred to herein as flow limiting devices) that are pre-installed on the PIVC and act as flow limiters to reduce the risk of hemolysis. The hemolysis reduction accessories are advantageously adapted to the PIVC configuration and do not require any changes to existing operations. The hemolysis reduction accessories of the various embodiments described herein are potentially applicable to a wide range of PIVC products and are compatible with existing blood collection devices and disposable infusion supplies.

[0019] Various embodiments of this disclosure focus on effective flow restriction using add-on hemolysis reduction accessories (also referred to herein as flow limiters), which regulate the overall flow rate of the entire fluid pathway through which blood cells travel. The flow limiter may be assembled with the PIVC or packaged together with the PIVC. A clinician can connect a blood collection device to the port of the accessory and then draw blood into the target volume. After blood collection, the clinician can disconnect and discard the flow limiter and blood collection device together. Thus, the flow limiter may be for a single blood collection or may remain inline for the entire implantation.

[0020] The flow limiting devices and associated blood collection systems of the various embodiments described herein offer further advantages over existing blood collection systems. For example, the add-on flow limiting devices described herein enable the integration of hemolysis reduction functionality for PIVC blood collection. Furthermore, the flow limiting devices described herein are compatible with PIVC placement and enable seamless blood collection during insertion. Moreover, because the flow limiting devices are add-on, they can be easily incorporated into existing PIVCs without any modifications, minimizing the impact on the clinical environment and operation.

[0021] Figure 1 shows a vascular access device 10 including a peripheral intravenous catheter (PIVC) assembly 50 including a flow limiting device 100, according to some embodiments of the present disclosure. The flow limiting device 100 may be configured to reduce the possibility of hemolysis during blood collection using the vascular access device 10. In some embodiments, the vascular access device 10 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 and proximal ends. The catheter assembly 50 may further include a catheter 58 which can be fixed within the catheter hub 52 and which can extend distally from the distal end 54 of the catheter hub 52. In some embodiments, the catheter assembly 50 may be a peripheral intravenous catheter (PIVC).

[0022] In some embodiments, the catheter assembly 50 may include or correspond to any suitable catheter assembly 50. In some embodiments, the catheter assembly 50 may be integrated and include an extension tube 60, which 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® Closed IV Catheter System, available from Becton Dickinson and Company. In some embodiments, the proximal end of the extension tube 60 may be coupled to an adapter, such as a Y-adapter 70. In some embodiments, a flow limiter 100 may be fluid-coupled to the Y-adapter 70.

[0023] In some embodiments, the catheter assembly 50 may be in a non-integrated form and may not include the extension tube 60. In these and other embodiments, the flow restriction device 100 may be configured to be coupled 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 100 may be directly coupled to the catheter assembly 50, thereby eliminating the extension tube 60 and providing a compact catheter system.

[0024] FIG. 2A shows a perspective view of a flow restriction device 100 according to some embodiments of the present disclosure. FIG. 3 shows an exploded perspective view of the flow restriction device 100 of FIG. 2 according to some embodiments of the present disclosure. FIG. 4 shows a cross-sectional view of the flow restriction device 100 of FIG. 2 according to some embodiments of the present disclosure.

[0025] Continuing to refer to FIG. 1, as shown in FIGS. 2-4, in some embodiments, the flow restriction device 100 may include a male Luer connector portion 110 configured to couple to the catheter assembly 50. The male Luer connector portion 110 may have an inner surface 112 that defines a lumen 114 of the male Luer connector portion 110. In some embodiments, the flow restriction device 100 may further include a female Luer connector portion 130 disposed proximal to the male Luer connector portion 110. The female Luer connector portion 130 may be configured to couple to a fluid collection device 40 (e.g., a blood collection device). For example, the female Luer connector portion 130 may be integrated with the blood collection device 40 or may be integrally formed with the blood collection device 40 as a single unit or single part. As another example, the female Luer connector portion 130 may be in the form of a female Luer connector or another suitable connector that may be coupled to the male Luer portion of the blood collection device 40. The female Luer connector portion 130 may include an inner surface 132 that defines a lumen 136 that extends therethrough for coupling to the male Luer portion of the blood collection device 40. The lumen 136 of the female Luer connector portion 130 may be fluidly connected to the lumen 114 of the male Luer connector portion 110 via the tube 140 of the flow restriction device 100 as will be described below.

[0026] In the illustrated example, the flow limiting device 100 includes a tube 140 that extends longitudinally therein and is fluid-communicated to the lumens 114 and 136 of the male Luer portion 110 and the female Luer portion 130, respectively. The tube 140 can define a microchannel 142 through which fluid flows from the male Luer connector portion 110 through the female Luer connector portion 130 into the fluid collection device 40. As shown in the illustration, the tube 140 can fluid-communicate the catheter assembly 50 with the fluid collection device 40 via the flow limiting device 100. For example, in some embodiments, the leg 72 of the Y-adapter 70 may be coupled to the flow limiting device 100. The leg 72 of the Y-adapter 70 may include a lumen into which the distal end of the male Luer connector portion 110 can be coupled. The Y-adapter 70 can fluidly communicate with the catheter assembly 50 via the connector 90, indicated as a needleless connector, and the tube 140, for example via the extension tube 60, to the flow limiter 100 and the tube 140. Thus, the micro-channel 142 can define a fluid pathway, defined by a reduced, small, or micro-sized diameter (described later), through which the fluid entering the flow limiter 100 from the catheter assembly 50 can flow for collection into the fluid collection device 40. For example, if blood is being drawn or collected from a patient, the medical fluid may be blood, and the fluid collection device 40 may be a blood collection device. In some embodiments, the blood collection device may be a Luer-lock access device (LLAD). Thus, during blood collection or extraction from a patient, the blood sample can flow into the LLAD 40 from the distal end of the male Luer connector portion 110, via the flow path, or via the micro-channel 142 defined by the tube 140.

[0027] In some embodiments, the microchannel 142 defined by the tube 140 may be an elongated, narrow channel having a small, reduced, or microsized diameter. For example, in some embodiments, the tube 140 defining a flow path or microchannel through which fluid can flow from the male Luer connector portion 110 to the fluid collection device 40 may have a diameter ranging from one twenty-thousandth to one twenty-five-thousandth of 25.4 mm (1 inch). However, various embodiments of the present disclosure are not limited to the configurations described herein. In some embodiments, the length of the microchannel 142 may range from 25.4 mm (1 inch) to 33.02 mm (1.3 inches). Thus, during blood collection or extraction from a patient, blood 15 can flow into the blood collection device 40 via a flow path or microchannel defined by the microchannel 142 having the minimum diameter. The flow limiting devices 100 of the various embodiments described herein are advantageous over existing blood collection systems. For example, during blood collection with existing blood collection devices, blood cells flow from the distal end to the proximal end of the blood collection system, which can cause wall shear stress. Wall shear stress on blood cells is considered a major cause of mechanical damage to blood cells that leads to hemolysis. The microchannel 142 with a minimum diameter can facilitate increased flow resistance within the vascular access system, which helps to distribute the pressure difference and reduce the shear stress experienced by the red blood cells in the blood 15. For example, the minimized diameter of the microchannel 142 can result in increased resistance to the flow of blood 15, thereby reducing the blood flow rate in the flow limiting device 100. The reduction in blood flow rate leads to a decrease in the shear stress experienced by the red blood cells in the blood 15, which can favorably reduce the risk of hemolysis during blood collection. Furthermore, the geometry of the microchannel 142 can reduce the amount of blood consumed by the existing blood collection system.

[0028] According to various embodiments of the present disclosure, the flow limiting device 100 may further include a main body portion 120 that is overmolded onto the pipe 140 and extends between the male luer portion 110 and the female luer portion 130.

[0029] According to various embodiments of this disclosure, the outer surface 122 of the body portion 120 may include a plurality of transversely extending ribs arranged around and surrounding the longitudinal axis of the body portion 120. As shown in the figures, the plurality of transversely extending ribs may be spaced apart from each other along the longitudinal axis X between the female Luer connector portion 130 and the male Luer connector portion 110. In some embodiments, the outer surface 122 may further include at least one longitudinally extending rib arranged along the longitudinal axis and extending from the male Luer connector portion 110 to the female Luer connector portion 130. In some embodiments, as shown in Figure 2, the body portion 120 may include a pair of longitudinally extending ribs arranged on opposing sides of the body portion 120. As shown in the figures, the longitudinally extending ribs may be arranged transversely to each of the transversely extending ribs and may be interconnected with each of the transversely extending ribs. Therefore, multiple lateral ribs and one or more longitudinal ribs may form a grid or matrix shape surrounding the main body portion 120.

[0030] The grid or matrix shape surrounding the main body portion 120 can, advantageously, provide greater or improved structural integrity or rigidity compared to existing connectors for blood collection systems. For example, in some embodiments, a grid or matrix shape of laterally and longitudinally extending ribs surrounding the main body portion 120 increases the rigidity between the male Luer connector portion 110 and the female Luer connector portion 130 of the flow limiter 100, thereby making the flow limiter 100 less susceptible to bending or torsional forces. The aforementioned configuration is advantageous in that the increased rigidity of the flow limiter 100 reduces its flexibility, thereby reducing the likelihood of blood spillage due to accidental or unintentional bending or twisting of the flow limiter 100. Furthermore, the aforementioned configuration of the flow limiting device, which includes ribs extending laterally and ribs extending longitudinally surrounding the main body portion 120, may be advantageous in that it provides a surface on the main body portion that is easier to grip than when the gripping surface of the main body portion 120 is made uniform.

[0031] As described herein, the body portion 120 is overmolded onto the tube 140 to provide a gripping surface for the clinician. In some embodiments, the body portion 120 may further extend onto portions of the male Luer connector portion 110 and / or female Luer connector portion 130. Advantageously, by overmolding the body portion 120, the flow limiter 100 can provide a gripping surface for the clinician while reducing the manufacturing complexity of the flow limiter 100. For example, the body portion 120 may be molded directly onto the top surface of the tube 140 to create a single portion including the tube 140 and the body portion 120. Advantageously, the body portion 120 may define a simplified outline to simplify the overmolding process. In some embodiments, the body portion 120 may utilize a polymer or elastomer material. The aforementioned configuration in which the flow limiter 100 is formed by an overmolded body simplifies the manufacturing process while enabling the robust construction of the flow limiter 100.

[0032] Explanation of the subject as a technical clause The subject technology will be described, for example, according to the various embodiments described below. Various examples of embodiments of the subject technology will be described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and are not intended to limit the subject technology. Note that any of the dependent clauses can be combined in any combination and placed in their respective independent clauses, for example, Clause 1 or Clause 5. Other clauses can be presented in a similar manner.

[0033] Clause 1: A flow limiting device comprising a male Luer connector portion defining a first lumen, a female Luer connector portion defining a second lumen, and a tube defining a third lumen, wherein the third lumen is in fluid communication with the first and second lumens, the third lumen has a diameter of less than 0.635 mm (0.025 inches), and the flow limiting device further comprises an overmolded body portion formed around the tube.

[0034] Clause 2: The third lumen is a flow limiting device of Clause 1, having a length of 25.4 mm (1 inch) to 33.02 mm (1.3 inches).

[0035] Clause 3: The flow limiting device of Clause 1, wherein the third lumen is configured to increase the flow resistance through the third lumen in order to minimize the shear stress on the fluid flow.

[0036] Clause 4: The overmolded body portion extends over a portion of the male Luer connector portion of the flow limiting device of Clause 1.

[0037] Clause 5: The flow limiting device of Clause 1, the overmolded body portion extending over a portion of the female Luer connector portion.

[0038] Clause 6: A flow limiting device according to Clause 1, wherein the overmolded body portion comprises a first material and the tubing comprises a second material, the first material being different from the second material.

[0039] Clause 7: The flow limiting device of Clause 6, wherein the first material includes an elastomer material or a polymer material.

[0040] Clause 8: The flow limiting device of Clause 1, wherein the outer surface of the overmolded body portion includes a plurality of transversely extending ribs arranged around and surrounding the longitudinal axis of the overmolded body portion, the plurality of ribs being spaced apart from each other along the longitudinal axis between the female Luer connector portion and the male Luer connector portion.

[0041] Clause 9: The flow limiting device of Clause 8, wherein the outer surface of the overmolded body portion further includes at least one longitudinally extending rib arranged along the longitudinal axis and extending from the male Luer connector portion to the female Luer connector portion.

[0042] Clause 10: A method for manufacturing a flow limiting device, A method for providing a tube, comprising the steps of: providing a tube having a lumen having a diameter of less than 0.635 mm (0.025 inches); and forming an overmolded body portion on the tube.

[0043] Clause 11: The method of Clause 10, wherein the overmolded body portion comprises the first material and the tube comprises the second material, and the first material is different from the second material.

[0044] Clause 12: The method of Clause 11, wherein the first material includes an elastomer material or a polymer material.

[0045] Clause 13: A peripheral intravenous catheter assembly configured to limit hemolysis during blood collection from a patient, comprising a catheter hub having a proximal and distal end, a fluid collection device, and a flow limiting device, wherein the flow limiting device comprises a male Luer connector portion coupled to the catheter hub and defining a first lumen, a female Luer connector portion defining a second lumen and fluid-communicating with the fluid collection device, and a tube defining a third lumen, the third lumen being fluid-communicating with the first and second lumens, the third lumen having a diameter of less than 0.635 mm (0.025 inches), and the flow limiting device further comprises an overmolded body portion formed around the tube.

[0046] Clause 14: The third lumen of the peripheral intravenous catheter assembly of Clause 13 has a length of 25.4 mm (1 inch) to 33.02 mm (1.3 inches).

[0047] Clause 15: The peripheral intravenous catheter assembly of Clause 13, wherein the third lumen is configured to increase the flow resistance through the third lumen in order to minimize the shear stress on the fluid flow.

[0048] Clause 16: The overmolded body portion extends over a portion of the male Luer connector portion of the peripheral intravenous catheter assembly according to Clause 13.

[0049] Clause 17: The peripheral intravenous catheter assembly of Clause 13, wherein the overmolded body portion extends over a portion of the female Luer connector portion.

[0050] Clause 18: A peripheral intravenous catheter assembly according to Clause 13, wherein the overmolded body portion comprises a first material and the tube comprises a second material, the first material being different from the second material.

[0051] Clause 19: The peripheral intravenous catheter assembly of Clause 18, wherein the first material includes an elastomer material or a polymer material.

[0052] Clause 20: The peripheral intravenous catheter assembly of Clause 13, wherein the outer surface of the overmolded body portion includes a plurality of transversely extending ribs arranged around and surrounding the longitudinal axis of the overmolded body portion, the plurality of ribs being spaced apart from each other along the longitudinal axis between the female Luer connector portion and the male Luer connector portion.

[0053] This disclosure is provided to enable any person skilled in the art to practice the various embodiments described herein. This disclosure provides various examples of the subject art, but the subject art is not limited to these examples. Various modifications to these embodiments will be readily apparent to a person skilled in the art, and the general principles set forth herein can be applied to other embodiments.

[0054] A singular reference to an element is intended to mean "one or more" and not "just one" unless specifically stated otherwise. Unless specifically stated otherwise, the term "several" refers to one or more. Pronouns relating to masculine (e.g., his) include feminine and neuter (e.g., her and its), and vice versa. Titles and subtitles, where present, are used for convenience only and do not limit the invention.

[0055] The word “exemplary” is used herein to mean “to serve as an example or illustration.” Any aspect or design described herein as “exemplary” should not necessarily be construed as being preferable or advantageous to other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0056] As used herein, the phrase “at least one of” preceding a set of items modifies the list as a whole, rather than each individual item in the list, using the term “or” to distinguish any of the items. The phrase “at least one of” does not require the selection of at least one item, but rather allows the phrase to mean that it includes at least one of any items in the list, and / or at least one combination of any combination of items, and / or at least one of each item in the list. For 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.

[0057] The terms "aspects" and similar phrases do not imply that such aspects are essential to the subject art, nor that such aspects apply to all components of the subject art. Disclosures relating to aspects may apply to all components, or one or more components. Aspects may provide one or more examples. Terms such as "aspects" may refer to one or more aspects, and vice versa. The terms such as "examples" and similar phrases do not imply that such examples are essential to the subject art, nor that such examples apply to all components of the subject art. Disclosures relating to examples may apply to all examples, or one or more examples. Examples may provide one or more examples. Terms such as "examples" may refer to one or more examples, and vice versa. The terms such as "components" and similar phrases do not imply that such components are essential to the subject art, nor that such components apply to all components of the subject art. Disclosures relating to components may apply to all components, or one or more components. Components may provide one or more examples. The terms "composition" can refer to one or more compositions, and vice versa.

[0058] In one embodiment, unless otherwise stated, all measurements, values, ratings, locations, sizes, dimensions, and other specifications expressed herein, including those included in the following claims, are approximate and not exact. In one embodiment, they are intended to have a reasonable range consistent with the function to which they relate and with the conventions in the art to which they relate.

[0059] It is understood that any particular order or hierarchy of steps or operations in the disclosed process or method is illustrative of an exemplary technique. It is understood that any particular order or hierarchy of steps, operations, or processes may be rearranged based on implementation priorities or scenarios. Some of the steps, operations, or processes may be performed simultaneously. In some implementation priorities 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 appended method claims present various elements of steps, operations, or processes in a sample order and are not intended to limit the present order or hierarchy.

[0060] All structural and functional equivalents of elements of various forms described throughout this disclosure, which are known to those skilled in the art or will become known later, are expressly incorporated herein by reference and are intended to be included in the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, whether such disclosure is expressly included in the claims or not. No element of a claim should be construed under Section 112(f) of the U.S. Patent Act unless that element is expressly described using the phrase “means for” or, in the case of a method claim, the phrase “steps for.” Furthermore, wherever terms such as “includes,” “have,” etc., are used, such terms are intended to be inclusive in the same manner as the term “equip,” as “equip” is construed when used as a transitional word in a claim.

[0061] The Title of the Invention, Background Art, Summary of the Invention, Brief Description of the Drawings, and Abstract of the Invention are incorporated herein and provided not as limiting descriptions but as exemplary examples of the Disclosure. The Disclosure is submitted with the understanding that they are not intended to limit the scope or meaning of the claims. Furthermore, it is understood that in the modes for carrying out the invention, the descriptions provide exemplary examples and that various features are grouped together in various embodiments for the purpose of streamlining the Disclosure. This method of disclosure should not be interpreted as indicating an intention that the claimed subject matter requires more features than are explicitly stated in each claim. Rather, as the following claims demonstrate, the subject matter of the invention consists of fewer features than all the features of a single disclosed configuration or operation. The following claims are incorporated herein as modes for carrying out the invention, and each claim is based on itself as separately claimed subject matter.

[0062] The claims are not intended to be limited to the embodiments described herein, but should be given a complete scope consistent with the language of the claims and encompassing all legal equivalents. However, none of the claims are intended, nor should they be construed, to encompass subject matter that does not meet the requirements of Section 101, 102, or 103 of the U.S. Patent Act.

Claims

1. A flow limiting device for limiting the flow rate of blood, A tube that defines a microchannel, A male Luer connector portion defining a first lumen, wherein the first lumen includes a male Luer connector portion that receives the first end of the tube and extends through the male Luer connector portion, A female Luer connector portion defining a second lumen, wherein the second lumen includes a female Luer connector portion that receives the second end of the tube and extends through the female Luer connector portion, A body portion overmolded onto the aforementioned pipe, wherein the body portion extends over a portion of the male Luer connector portion and extends over a portion of the female Luer connector portion, and A flow limiting device for restricting blood flow, equipped with the following features.

2. The flow limiting device according to claim 1, wherein the microchannel has a diameter of less than 0.635 mm (0.025 inches).

3. The flow limiting device according to claim 1, wherein the microchannel has a diameter that is the smallest compared to the first diameter of the first lumen and the second diameter of the second lumen, such that the flow resistance through the microchannel is greater than the flow resistance through the first lumen and the second lumen.

4. The flow rate limiting device according to claim 1, wherein the pipe comprises a first material, and the main body portion comprises a second material, the second material being harder than the first material.

5. The flow rate limiting device according to claim 1, wherein the female Luer connector portion is integrally formed with the blood collection device.

6. The flow rate limiting device according to claim 1, wherein the outer surface of the main body portion includes a plurality of laterally extending ribs.

7. A method for assembling a flow limiting device for restricting blood flow, The steps of providing a tube having a microchannel, The steps include: positioning the first end of the pipe within the first lumen of the male Luer connector portion; The steps include: positioning the second end of the pipe within the second lumen of the female Luer connector portion; The steps include forming the main body portion on the pipe, on a portion of the male Luer connector portion, and on a portion of the female Luer connector portion. Methods that include...

8. The method according to claim 7, wherein the step of providing the tube having the microchannels includes the step of providing the tube having the microchannels having a diameter of less than 0.635 mm (0.025 inches).

9. The method according to claim 7, wherein the step of providing the tube having the microchannels includes the step of providing the tube comprising a first material, and the step of forming the body portion on the tube includes the step of forming the body portion comprising a second material that is harder than the first material.

10. A vascular access device configured to limit hemolysis during blood collection from a patient, Peripheral intravenous catheter assembly, Fluid sampling device, Flow limiting device and The flow rate limiting device is equipped with, A tube that defines a microchannel, A male Luer connector portion defining a first lumen, the first lumen receiving the first end of the tube and extending through the male Luer connector portion, the male Luer connector portion connecting the peripheral intravenous catheter assembly to the tube, A female Luer connector portion defining a second lumen, the second lumen receiving the second end of the pipe and extending through the female Luer connector portion, the female Luer connector portion connecting the fluid coupling device to the pipe, A body portion overmolded onto the aforementioned pipe, wherein the body portion extends over a portion of the male Luer connector portion and extends over a portion of the female Luer connector portion, and A vascular access device equipped with the following features.

11. The vascular access device according to claim 10, wherein the microchannel has a diameter of less than 0.635 mm (0.025 inches).

12. The vascular access device according to claim 10, wherein the microchannel has a diameter that is the smallest compared to the first diameter of the first lumen and the second diameter of the second lumen, such that the flow resistance through the microchannel is greater than the flow resistance through the first lumen and the second lumen.

13. The vascular access device according to claim 10, wherein the microchannel has a diameter that is the smallest compared to the first diameter of the first lumen and the second diameter of the second lumen, such that the flow rate of blood through the peripheral intravenous catheter assembly is less than the flow rate of blood through the flow limiting device.

14. The vascular access device according to claim 10, wherein the tube comprises a first material, and the main body portion comprises a second material, the second material being harder than the first material.

15. The vascular access device according to claim 10, wherein the outer surface of the main body portion includes a plurality of laterally extending ribs.

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